Basel, 21 April 2004
First
quarter exceeds expectations: 15% rise in sales results in further market share gains; Avastin successfully
launched in United States Release as PDF: English
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as PDF: English only Roche
Group • Roche Group lifts core business sales by 15% in local currencies and 14%
in Swiss francs • Redemption of outstanding LYONs IV convertible notes further reduces
debt and interest expense: transaction yields one-time after-tax gain of 613 million Swiss francs •
Outlook for the current year - Sales growth in both divisions to outpace global market -
Margins in pharmaceuticals and diagnostics businesses improving as planned - Substantial
increase in net income expected Roche Pharmaceuticals •
Pharmaceuticals Division achieves double-digit sales growth in local currencies (+17%) and Swiss francs
(+16%) - global market up 9%* • Oncology franchise posts 27% growth. Avastin successfully
launched in the United States • Pegasys and Copegus: sales for first quarter already
at 391 million Swiss francs • Anti-anemia product CERA enters phase III clinical testing
in patients with renal disease * IMS, Moving Annual Total
February 2003–January 2004.
Roche Diagnostics •
Diagnostics Division grows twice as fast as the market, with sales up 10% in local currencies (+11%
in CHF) • Above-average sales growth in diabetes care and molecular diagnostics segments
(+15% and +14%, respectively, in local currencies) • Igen acquisition completed — strong
growth in key immunodiagnostics segment (+24% in local currencies) Roche
recorded sales of 7.6 billion Swiss francs in the first quarter of 2004. Compared with the same period
last year, this represents an increase of 15% in local currencies (+14% in CHF) for the Group’s core
businesses. The Pharmaceuticals Division continued to grow faster than the market, increasing its sales
by 17% in local currencies (+16% in CHF). The Diagnostics Division gained additional market share on
sales growth of 10% in local currencies (+11% in CHF). Commenting
on the first-quarter figures, Roche Chairman and CEO Franz B. Humer said, ‘Roche has started the new
year very well. Our Pharmaceuticals and Diagnostics Divisions continue to grow significantly faster
than the market. The launch of Avastin in the United States makes us the only healthcare company in
the world to supply four medicines that can help extend the lives of people with cancer and underscores
our leadership in oncology. Barring unforeseen events, our continuing progress on the operational side
and the redemption of our LYONs IV convertible notes will result in a substantial improvement in our
net income this year and will also strengthen our balance sheet further.’
| 2004 | 2003 | % Change | % Change |
Sales from January to March | m CHF | mCHF | In CHF | In local currencies |
Pharmaceuticals | 5,646 | 4,888 | 16 | 17 |
Roche prescription | 3,546 | 3,053 | 16 | 16 |
Genentech prescription | 923 | 777 | 19 | 29 |
Chugai prescription | 748 | 656 | 14 | 12 |
Prescription | 5,217 | 4,486 | 16 | 18 |
OTC | 429 | 402 | 7 | 5 |
Diagnostics | 1,908 | 1,725 | 11 | 10 |
Core businesses (continuing businesses) | 7,554 | 6,613 | 14 | 15 |
Vitamins and Fine Chemicals | - | 743 | -100 | -100 |
Group | 7,554 | 7,356 | 3 | 3 |
Finance:
major step towards strengthening the Group’s balance sheet In early April Roche
completed the call of its LYONs IV convertible notes. This marks a major step towards further reducing
the Group’s debt and strengthening its balance sheet. The notes were mainly exchanged for Genentech
shares. The transaction yielded a one-time pre-tax gain of 968 million Swiss francs and an after-tax
gain of 613 million Swiss francs for Roche. The transaction has reduced Roche’s debt by 1.36 billion
Swiss francs. The delivery of Genentech shares in exchange for the notes has decreased Roche’s interest
in Genentech by 2.5% to 55.3%. Roche continues to hold a majority stake in Genentech, and its successful
relationship with the US biotechnology company will remain unchanged. Pharmaceuticals
Division
The Pharmaceuticals Division increased its
sales by 17% in local currencies and 16% in Swiss francs in the first quarter of 2004. Sales of prescription
medicines were up 18% in local currencies (+16% in CHF), with Roche, Genentech and Chugai all contributing
to this strong growth with solid double-digit gains. Consumer Health also grew well ahead of the market,
increasing its sales by 5%. The division’s oncology, virology
and transplantation franchises continued to be the main drivers of growth in prescription drug sales.
Sales of oncology products1 were up 27%2, with major contributions to growth coming from products such
as MabThera (+33%), Herceptin (+27%) and Kytril (+28%). Pegasys and Copegus captured additional market
share both in the United States and internationally, as combined sales of the two products reached 391
million Swiss francs in the first quarter. In the transplantation segment, CellCept and Valcyte/Cymevene
continued on a growth path, with sales rising by 23% and 38%, respectively. Sales of NeoRecormon and
Epogin advanced 5% in the face of intense price competition. Sales
of prescription medicines outpaced market growth3 in all major regions. In North America sales increased
by 22%, or twice as fast as the market (+11%), resulting in additional market share gains. European
sales also grew at a double-digit rate (+17%), and thus substantially faster than the market average
(+8%). Chugai likewise posted double-digit sales growth (+12%), despite a virtually stagnant Japanese
market (+3%). In Latin America sales increased by 22% amidst an overall market recovery (+9%). Oncology:
US launch of Avastin contributes to accelerated growth Sales of MabThera/Rituxan
(US: +21%; Japan: +177%; Europe/RoW: +56%) continued to grow strongly, driven by increased use in the
first-line treatment of aggressive and indolent non-Hodgkin’s lymphoma (NHL). In Europe 60% of patients
with aggressive NHL and 34% of patients with indolent NHL are already being started on MabThera as first-line
therapy. Herceptin continued to deliver strong growth (+27%), particularly in Europe/RoW
(+39%) and Japan (+28%). Herceptin combined with Taxotere has been shown to significantly improve survival
in patients with an aggressive form of breast cancer. The data have been submitted to the European authorities
to support a label extension for this drug combination. Xeloda, for breast and colorectal
cancer, continued to make a steadily growing contribution to the oncology franchise, posting sales growth
of 34% in Europe, Latin America and Asia. Sales in the United States were down 49% for the first quarter,
primarily due to changing wholesaler inventory levels and buying patterns; this trend should correct
itself over the course of the year, however, as US prescriptions continue to grow at a strong +19% rate.
In the supportive cancer care segment, the division has begun rolling out Bondronat
across Europe for use in patients with metastatic bone disease. Kytril, Roche’s anti-emetic for controlling
nausea and vomiting associated with cancer therapy, continues to show strong growth (+28%) in all major
markets. The first quarter was also marked by the approval and launch of Avastin in the
United States for first-line treatment with chemotherapy in patients with advanced cancer of the colon
or rectum. Filings for Avastin, the first anti-angiogenesis agent for cancer, have been granted priority
review status in Switzerland, Australia and Canada. An application for European marketing authorisation
was filed in December 2003. Virology: Pegasys
and Copegus drive growth Pegasys and Copegus, Roche’s combination therapy for hepatitis
C, continued to show dynamic growth and gain market share, with combined sales of these two products
rising to 391 million Swiss francs worldwide. In the last 12 months Pegasys and Copegus have posted
sales of over 1 billion Swiss francs. Pegasys strengthened its market leadership in the United States
(57%) during the first quarter. Programmes to develop Pegasys for additional indications are under way.
In February, for example, Roche announced the results of a large-scale trial of the product in patients
co-infected with HIV and HCV. Liver disease is the leading cause of hospital admissions and death in
HIV/HCV co-infected patients. The trial patients who received Pegasys plus Copegus had the highest sustained
virological response rate ever achieved in this patient population. Sales
of the anti-HIV drug Fuzeon, the world’s first fusion inhibitor, were up by nearly one-third from the
previous quarter and are expected to increase further now that the product has also been launched in
the key Spanish and Italian markets. Reimbursement negotiations in several other EU countries are ongoing,
as are programmes to increase acceptance of subcutaneous self-injection of the medicine. Anemia:
NeoRecormon and Epogin maintain their market position NeoRecormon and Epogin, the
leading treatments for anemia in patients with renal disease and cancer, posted 5% growth. Sales were
affected by price erosion, which has resulted in flattening growth rates in the anti-anemia market,
and by slow growth in the oncology segment early in the quarter. However, NeoRecormon sales in the oncology
segment are expected to improve further thanks to the recent approval and launch of a more convenient
and cost-effective pre-filled syringe for once-weekly dosing in patients with lymphoid cancers. An
extensive programme of phase III clinical trials with the newly developed anemia treatment CERA in patients
with renal disease has commenced in Europe and the United States. Transplantation:
strong double-digit growth CellCept (+23%), Roche’s low-toxicity immunosuppressant
for kidney, liver and heart transplantation and the top-selling branded immunosuppressant in the United
States, continued to achieve impressive sales increases in the United States and all other key markets.
Combined sales of Valcyte and Cymevene were up 38%. This strong growth was driven primarily
by the launch of Valcyte in a number of countries, following EU and US approval of the product in 2003
for the prevention of CMV disease in transplant patients. Other
major products Sales of Xenical have stabilised (+1%). In March the European authorities
approved an extension to Xenical’s prescribing label based on the XENDOS study. The label now includes
information on Xenical’s ability to reduce the risk of developing type 2 diabetes. In addition, Sweden’s
reinstatement of reimbursement for the product has helped stimulate sales in Europe. Tamiflu
sales remained strong in Japan in the first quarter. Growing concerns about the avian flu and the potential
for a pandemic in the coming years have led to intense discussions with the WHO and a number of government
agencies. A once-daily oral formulation of Bonviva/Boniva, a medicine for the prevention
and treatment of osteoporosis, was approved by the European authorities in February 2004. Moreover,
results from a new phase III trial indicate that once-monthly oral dosing of the drug is at least as
effective as a once-a-day regimen, while at the same time promising to increase patient acceptance and
enhance treatment compliance. Publication of the final results and submission of approval applications
to the European and US regulatory authorities are planned for this year. Rocephin sales
grew 4% in the first quarter. Strong sales were reported in North America because of the flu outbreak
there. Sales erosion in Europe/RoW was less than anticipated due to the absence of generic competition
in Italy. Consumer Health: above-market growth In
the first quarter of 2004 sales of non-prescription (OTC) medicines, including sales by Chugai in Japan,
grew 5% in local currencies (+7% in CHF) to 429 million Swiss francs. Excluding Chugai, the Group’s
consumer health sales grew by 8% in local currencies, significantly outpacing the market as a whole.
This strong growth was fuelled by sales of the Group’s most important OTC brands, which were up 10%
in local currencies, and particularly by increased sales in the core markets of Spain (+19%), the United
Kingdom (+14%), Brazil (+30%) and Turkey (+25%). As previously announced, Roche is reviewing
various strategic options for Roche Consumer Health. A decision is expected in the course of this year. Diagnostics
Division
Roche Diagnostics continued to grow significantly
faster than the market in the first quarter of 2004. Divisional sales totalled 1.9 billion Swiss francs,
a 10% increase over last year’s first quarter results in local currencies (+11% in CHF). The first-quarter
sales figures are substantially better than those of other leading diagnostics companies.
All
regions once again contributed to growth. Double-digit sales gains were posted in Asia–Pacific, Latin
America, Iberia and Japan. In Latin America sales benefited from the region’s economic recovery. The
market slowdown seen last year in the United States continued in the first quarter of 2004. After adjusting
for special items (sale of product lines), however, Roche Diagnostics once again outpaced the US market
by a significant margin. Worldwide sales growth was driven primarily by insulin pump sales, diabetes
monitoring products, immunodiagnostics and the molecular diagnostics business. Sales gains in Europe
were in the high single-digit range despite the cost containment measures implemented in a number of
countries. Diabetes Care: new products well
received in the marketplace Roche Diabetes Care extended its market leadership
as sales rose 15% (+15 in CHF) compared with the very strong results posted a year earlier. Roche Diabetes
Care is confident of its ability to maintain above-market growth worldwide. The Accu-Chek
Compact system is expected to continue delivering steady growth. In the first quarter Accu-Chek Go was
launched in France and Austria, and Accu-Chek Advantage III was rolled out on schedule in the United
States and Germany. Both devices offer users enhanced convenience. The FDA is expected
to conduct a re-inspection of Disetronic’s Burgdorf facility in the third quarter of 2004, after issuing
an advisory letter last year regarding production processes and documentation at the site. Near
Patient Testing: Urisys launched in United States; OMNI S available worldwide While
Roche Near Patient Testing posted a 1% decline in overall sales for the quarter (+0% in CHF), revenues
in this business area show a 3% gain (+4% in CHF) if special items (sale of the OPTI product line and
drugs-of-abuse testing business) are taken into account. In the primary care and patient self-testing
segments, sales of coagulation meters and Accutrend cholesterol testing products showed double-digit
growth. As part of a global market rollout, the Urisys 1100 was launched in the United States, strengthening
Roche Diagnostics’ position in the automated urinalysis segment. The global rollout of the OMNI S blood
gas and electrolyte analyser continues and is making a major contribution to consolidating Roche’s leading
position in this segment. The launch of Cobas IT 1000, an innovative data management
software package for use at the point of care, is planned for the second quarter of 2004. This Internet-based
solution will create additional incentives for customers to draw on the broad portfolio of products
supplied by Near Patient Testing and will help Roche Diagnostics to extend its lead in the hospital
point of care segment. A contract signed in the first quarter of this year with Novation,
one of the largest healthcare group purchasing organisations in the United States, will generate additional
sales momentum. Centralized Diagnostics: immunochemistry
drives growth Overall, sales by Roche Centralized Diagnostics increased 5% (+8%
in CHF). Sales of immunodiagnostic products grew well ahead of the market, increasing by 24% (+27% in
CHF). The completed acquisition of Igen has created additional potential for growth in the immunodiagnostics
market, the single largest diagnostics segment, currently worth over 8 billion Swiss francs. Mounting
demand for tools designed to optimise laboratory workflow is expected to provide an additional stimulus
for growth. Systems like Modular Pre-Analytics open up additional growth opportunities for Roche Centralized
Diagnostics, the leading supplier of integrated analytical systems. The business area expanded its broad
menu of cardiac diagnostic tests by licensing in a highly sensitive immunoassay.
Molecular
Diagnostics: women’s health and blood screening the most important growth segments Roche
Molecular Systems increased its sales by 14% in the first quarter (+13% in CHF). The blood screening
and women’s health segments were the biggest contributors to growth. Sales of screening
tests to ensure the safety of blood products were fuelled by the signing of new contracts in expanding
markets and by the introduction of additional tests. Roche Diagnostics strengthened its leading position
in the Asia–Pacific region and Japan, for example, by expanding its partnership with Asian blood banks.
The Cobas AmpliScreen HIV-1 Test was approved in the United States for testing blood plasma and donor
organs. Preparations for filing an application for AmpliChip CYP 450 as an in vitro
diagnostic are moving ahead as planned. Roche intends to submit applications to the US and European
authorities this year. European approval is expected in the middle of 2004. The European
launch of an HPV test in April of this year is an important landmark in the development of Roche’s women’s
health portfolio. It is the first PCR-based test for detecting HPV and is capable of identifying all
13 high-risk subtypes of the virus. Following a decline in 2003, sales to industrial
customers were up 14% (+5% in CHF) for the first quarter. Applied
Science: return to growth Following last year’s noticeable downturn, the biotechnology
market returned to healthy growth, with Roche Applied Science posting a 10% rise in sales in this segment
(+9% in CHF). The introduction of additional components for the LightCycler 2.0 system, offering an
even wider range of applications for PCR technology, and a focus on genomics and life science research
will contribute to further growth. 1 Oncology portfolio:
MabThera/Rituxan, Herceptin, Xeloda, Bondronat, Kytril, Furtulon, Neupogen, NeoRecormon (25%), Roferon-A
(85%), Neutrogin, Picibanil, Avastin. 2 Unless otherwise noted, all percentage changes
are based on results in local currencies. 3 Source: IMS, Moving Annual Total February
2003 - January 2004 Annex 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 onditions; (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. |
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