Roche reports further accelerated sales growth in third quarter
Full-year outlook raised, new Group management team appointed
- Group sales up 3.1 billion to 36.4 billion Swiss francs in first nine months, an increase of 11% in local currencies (9% in Swiss francs); both divisions grow significantly faster than their respective markets1
- Genentech integration progressing successfully
- New Group leadership appointed
| Nine months ended 30. Sep | % change | ||||
|---|---|---|---|---|---|
| 2009 | 2008 | In CHF | In LC* | In USD | |
| Pharmaceuticals Division | 29,034 | 26,193 | 11 | 12 | 6 |
| Europe/Rest of World | 14,387 | 13,869 | 4 | 13 | -1 |
| United States | 11,157 | 10,090 | 11 | 6 | 6 |
| Japan | 3,490 | 2,234 | 56 | 34 | 49 |
| Diagnostics Division | 7,365 | 7,112 | 4 | 8 | -1 |
| Roche Group | 36,399 | 33,305 | 9 | 11 | 4 |
* LC= local currencies
See appendix to this media release for details of quarterly sales growth
Full-year outlook raised
- Roche now expects at least high single-digit full-year sales growth for Pharmaceuticals Division; full-year 2009 sales in both divisions expected to grow well ahead of market
- Roche confirms target of double-digit Core EPS growth in 2009 and 2010 (at constant exchange rates)
Pharmaceuticals Division sustains growth at twice the market average
- Pharma sales grow 12% (11% in Swiss francs) driven by continued strong performance of leading anticancer medicines, Lucentis, Pegasys and Mircera
- Strong demand for Tamiflu continues in third quarter: full-year sales expectation raised from 2.0 to around 2.7 billion francs in 2009 and from 400 million to about 700 million francs in 2010
- MabThera receives EU approval for the treatment of relapsed or refractory chronic lymphocytic leukemia
- Avastin receives US FDA approval for kidney cancer and broader EU approval for breast cancer
- Positive market response to ongoing rollout of RoActemra in EU, market penetration of Actemra in Japan progressing well
Diagnostics Division significantly outperforms the market
- Divisional sales grow 8% (4% in Swiss francs) — more than twice as fast as the global IVD market — driven by all Business Areas, especially Professional Diagnostics
- cobas 8000 modular analyser series receives CE Mark certification for high-throughput clinical chemistry and immunoassay testing
Commenting on the Group’s nine-month sales figures, Roche CEO Severin Schwan said: ‘The Roche Group continued to perform very strongly in the third quarter. Sales by both the Pharmaceuticals and Diagnostics divisions are significantly outgrowing their respective markets. Based on this performance, we expect another very good full-year result. I’m particularly pleased with the excellent progress we’re making in joining forces with Genentech. The new leadership structure we announced recently will ensure that we continue to translate excellent science into innovative medicines for patients.’
Roche Group
Strong sales growth in third quarter
The Roche Group recorded sustained strong sales growth in the first nine months of 2009. Group sales grew 11% in local currencies (9% in Swiss francs; 4% in US dollars) to 36.4 billion Swiss francs. The Pharmaceuticals Division’s sales increased 12% in local currencies (11% in Swiss francs; 6% in US dollars) to 29.0 billion Swiss francs, maintaining growth at twice the global market rate. The Diagnostics Division also continued to outpace market growth, with sales up 8% in local currencies (4% in Swiss francs; -1% in US dollars) to 7.4 billion Swiss francs.
Genentech integration on track, new leadership structure announced
Following the merger agreement with Genentech in March of this year and the rapid completion of the transaction, integration activities have been proceeding successfully and are already yielding substantial productivity gains. The integration will be largely complete by the end of the year. As announced in September, from January 2010 a newly structured Corporate Executive Committee will continue to implement Roche’s focused strategy built around the combination of pharmaceuticals and diagnostics. The broader leadership structure will ensure a diversity of approaches and help drive innovation in the key areas of research and early development. In addition, the integration of Genentech and Roche will enhance the Group’s innovative capabilities by facilitating knowledge transfer within the Group. Combining the two companies’ late-stage product development, manufacturing and commercial operations will enable the Roche Group to leverage its global scale, as well as achieving efficiencies.
Outlook
Based on the sales results of the nine months, Roche has raised its full-year outlook for 2009. The Group now expects full-year sales in both divisions to grow well ahead of the market, with at least high single-digit sales growth for the Pharmaceuticals Division. The Group is aiming for double-digit Core EPS growth in both 2009 and 2010 (at constant exchange rates). Given the rapid progress in integrating Genentech, Roche expects to see further productivity gains next year. By 2011 the Group aims to achieve pre-tax annual synergies of approximately 1 billion Swiss francs. Based on the strong operating free cash flow, Roche expects to reduce debt progressively and to return to a net cash position by 2015 while maintaining its dividend outlook.
Pharmaceuticals Division
Sales continue to grow at twice the global market rate
| Total | US | Japan | Europe/RoW* | |||||
|---|---|---|---|---|---|---|---|---|
| CHF m | %** | CHF m | %** | CHF m | %** | CHF m | %** | |
| Avastin | 4,684 | 26 | 2,544 | 18 | 284 | 90 | 1,856 | 33 |
| MabThera/Rituxan | 4,606 | 8 | 2,312 | 5 | 177 | 4 | 2,117 | 11 |
| Herceptin | 3,972 | 9 | 1,207 | 4 | 257 | 36 | 2,508 | 10 |
| Tamiflu | 2,004 | 362 | 506 | 34 | 651 | 3186 | 847 | 1753 |
| CellCept | 1,289 | -14 | 515 | -30 | 37 | 13 | 737 | 1 |
| Pegasys | 1,280 | 11 | 317 | 10 | 96 | 22 | 867 | 10 |
| NeoRecormon, Epogin | 1,180 | -9 | - | - | 377 | -2 | 803 | -12 |
| Tarceva | 962 | 10 | 379 | 1 | 48 | 30 | 535 | 16 |
| Xeloda | 952 | 11 | 355 | 14 | 52 | 35 | 545 | 7 |
| Lucentis | 869 | 21 | 869 | 21 | - | - | - | - |
*Rest of World
**Local growth rates versus YTD September 2008
Sales by the Pharmaceuticals Division in the first nine months rose 12% in local currencies (11% in Swiss francs, 6% in US dollars) to 29.0 billion Swiss francs, or double the global pharmaceuticals market growth rate (6%)2. Excluding Tamiflu, the division’s sales increased 6%, in line with global market growth, driven by strong demand for Avastin, Herceptin, MabThera/Rituxan, Lucentis, Pegasys and Mircera. The worldwide spread of the pandemic A (H1N1) 2009 influenza virus led to exceptionally strong demand for Tamiflu in the second and third quarters.
The division recorded above-market sales increases in all regions, led by Japan and Europe/Rest of World3 (RoW). Solid growth of Avastin, Lucentis and other key products, together with strong growth of Tamiflu, more than offset lower sales of CellCept and Boniva in the United States and the impact of the voluntary withdrawal of Raptiva from the US market in 2009. Sales by Chugai in Japan increased strongly due to demand for Tamiflu, Avastin, Herceptin and Actemra. Sales in Europe/RoW were driven by demand for Tamiflu, Avastin, Herceptin and MabThera/Rituxan.
Global sales of the antiinfluenza medicine Tamiflu (oseltamivir) totalled 2.0 billion Swiss francs in the first nine months, an increase of 362%, or 1,576 million francs, over the same period last year. This exceptional growth was driven by substantially increased demand in the second and third quarters from governments and in the retail pharmacy sector during the current pandemic A (H1N1) 2009 influenza virus (‘swine flu’) outbreak. Sales for pandemic stockpiling amounted to 1,380 million francs in the first nine months. Sales of Tamiflu in the third quarter totalled 994 million francs, compared with 101 million francs in the third quarter of 2008. Based on current estimates, Roche expects full-year sales of Tamiflu of around 2.7 billion francs in 2009 and about 700 million francs in 2010. This is, however, difficult to predict and will depend on levels of infection due to the pandemic A (H1N1) virus and seasonal influenza strains in the coming northern hemisphere winter, as well as government orders in the fourth quarter. Roche is working with the World Health Organization and governments worldwide to support pandemic preparedness and supply Tamiflu to patients in need.
The Roche Group’s key cancer medications continued to show solid growth through the third quarter. Nine-month sales of Avastin (bevacizumab), for advanced colorectal, breast, lung and kidney cancer, and for relapsed glioblastoma (a type of brain tumour), rose 26% to 4.7 billion Swiss francs. Sustained growth in all regions was driven primarily by continued uptake in colorectal, breast and lung cancer. Uptake in Japan, where Avastin is currently approved for advanced colorectal cancer, remains particularly strong. Rollout of Avastin in the United States in the recently approved indications relapsed glioblastoma and advanced renal cell carcinoma is progressing according to plan. Herceptin (trastuzumab), for HER2-positive breast cancer, is experiencing particularly strong growth in Japan and emerging markets. Sales in the first nine months advanced 9% to 4.0 billion Swiss francs. Overall sales (oncology and autoimmune diseases) of MabThera/Rituxan (rituximab), for non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL) and rheumatoid arthritis (RA), rose 8% to 4.6 billion Swiss francs. Growth in the oncology segment is being driven by uptake in CLL following approval in the EU earlier in the year. Sales in the RA segment are being driven mainly by increasing use of MabThera/Rituxan in patients with an inadequate response to a single tumour necrosis factor (TNF) inhibitor in the EU and multiple TNF inhibitors in the US. Sales of Xeloda (capecitabine) and Tarceva (erlotinib) increased 11% and 10%, respectively, to 952 million and 962 million Swiss francs. Sales of Xeloda, for colorectal, stomach and breast cancer, were driven primarily by strong gains in the United States, Japan and China. Sales of Tarceva, for advanced lung and pancreatic cancer, were driven by strong growth in Western Europe and Japan, with additional contributions from CEMAI 4 and Asia–Pacific countries.
US sales of Lucentis (ranibizumab), for wet age-related macular degeneration (AMD), increased 21% to 869 million Swiss francs compared with the prior-year period. Solid growth was driven primarily by an increase in the number of Lucentis injections administered to patients in the first and second year of treatment, growth in the number of patients treated for wet AMD and continued improvement in market conditions compared with the first nine months of 2008.
Sales of Pegasys (peginterferon alfa-2a), for hepatitis B and C, rose 11% to 1.3 billion Swiss francs. Growth was driven by continued demand in emerging markets and market-share gains worldwide.
In a highly competitive, price-sensitive market, sales of the renal anemia medication Mircera (methoxy polyethylene glycol-epoetin beta), which is now available in more than 80 countries worldwide, rose 296% to 123 million Swiss francs in the first nine months. Growth is being driven primarily by the success of the product in the predialysis segment. Combined sales of the Group’s established anemia medicines, Roche’s NeoRecormon and Chugai’s Epogin (epoetin beta), declined 9% to 1.2 billion Swiss francs. The decline in NeoRecormon sales of 12% was due mainly to price erosion. The more moderate reduction in sales of Epogin in Japan (-2%) reflects stabilisation of the product’s market share despite continued strong competition.
Sales of CellCept (mycophenolate mofetil), for the prevention of solid organ transplant rejection, decreased 14% compared with the year-earlier period to 1.3 billion Swiss francs. As expected, in the second and third quarters sales fell sharply year-on-year as a result of the expiry of the product’s US patent in May. The erosion of US sales through generic competition was partly offset by continued solid growth elsewhere, especially in Latin America and China.
Sales uptake of the novel rheumatoid arthritis (RA) medicine RoActemra (tocilizumab, known as Actemra outside Europe) in its initial European launch markets has been strong, and the response from physicians is very encouraging. Actemra/RoActemra is now available in eight EU countries, including Germany, as well as Switzerland, India, Brazil and several other countries worldwide. RoActemra is scheduled for launch in additional key EU markets by the end of the year. In Japan, where Actemra was approved for RA in adults and for related pediatric indications in April 2008, market penetration is progressing well.
Product development highlights
In the third quarter of 2009 the Pharmaceuticals Division gained a number of major regulatory approvals and filed important new marketing applications. In July the EU authorities approved the use of Avastin in combination with docetaxel, a commonly used chemotherapy, in the first-line treatment of metastatic breast cancer. The expanded indication, which follows EU approval for combined Avastin and paclitaxel in 2007, means that more patients can benefit from Avastin-based treatment options. In August the US Food and Drug Administration (FDA) approved Avastin in combination with interferon alfa-2a for the treatment of metastatic renal cell carcinoma, the most common type of kidney cancer. In September Roche received EU approval for the use of MabThera in patients with relapsed or refractory chronic lymphocytic leukemia (CLL), the most common form of the disease in adults. In July the FDA designated for priority review two supplemental Biologics License Applications (sBLAs) submitted by Genentech and Biogen Idec, for approval of Rituxan plus standard chemotherapy in previously untreated or treated CLL. In September Chugai received approval in Japan for additional indications for Xeloda and Avastin. Xeloda can now be used in combination with oxaliplatin chemotherapy, with or without Avastin, in the first- or second-line treatment of patients with metastatic colorectal cancer.
In July the FDA accepted Roche’s resubmission for its US marketing application for Actemra for rheumatoid arthritis. This follows the FDA’s complete response in September 2008 and subsequent discussions with Roche. The FDA has designated a six-month review timeline for the resubmission. Also in July, Chugai filed a marketing application with the Japanese authorities for approval of Mircera (currently known in Japan by its project code, RG744) for renal anemia. In September Roche filed an application with the EU’s European Medicines Agency to expand the marketing authorisation for RoActemra to include inhibition of the progression of joint damage and improvement of physical function in patients with rheumatoid arthritis. The filing follows positive two-year data from the phase III LITHE trial.
Also in September Roche submitted an application to the EU health authorities to expand approval for Herceptin to include treatment of advanced HER2-positive stomach cancer. The filing is based on the results of the international phase III ToGA trial. In mid-September Chugai filed a marketing application in Japan for approval of Tarceva in the additional indication of pancreatic cancer.
So far this year the division has reported positive results from nine major phase III clinical trials with the potential to significantly expand the use of key products. In July the Group announced the results of two phase III studies, BRAVO and CRUISE, which showed that Lucentis improved vision in patients with swelling in the retina (macular edema) due to branch retinal vein and central retinal vein occlusion, respectively. The data will be used to support a planned supplemental Biologics License Application to the US FDA for Lucentis in retinal vein occlusion.
In September Roche, Genentech and Biogen Idec announced results from an international phase III study (PRIMA), showing that MabThera/Rituxan maintenance therapy can significantly increase the time until the disease progresses in newly-treated patients with advanced follicular lymphoma, a common type of non-Hodgkin’s lymphoma. Because PRIMA met its endpoint during a pre-planned interim analysis, the study was stopped early on the recommendation of an independent data and safety monitoring board. Data from the trial will be filed with EU and US health authorities to extend the current label for MabThera/Rituxan.
In addition, two new studies published in September reported increased survival rates in patients with avian flu (H5N1) and severe seasonal flu who were treated with Tamiflu: in the first of these observational studies 53% of patients with H5N1 infection survived when treated with Tamiflu, compared with 12% of untreated patients; the second trial showed that the death rate was reduced by 37% in high-risk patients with severe seasonal flu who received Tamiflu, compared with no treatment.
R&D pipeline
As of 30 September 2009 the Pharmaceuticals Division’s research and development pipeline (phase I to III/registration) included 63 new molecular entities and 61 additional indications. In the third quarter of 2009 four projects entered phase II development. Portfolio prioritisations led to the discontinuation of one phase I and one phase II project.
Diagnostics Division
Sales continue to grow significantly faster than the market
| In millions of CHF | % change in CHF | % change in local currencies | As % of sales | |
|---|---|---|---|---|
| Diagnostics Divsion | 7,365 | 4 | 8 | 100 |
| - Professional Diagnostics | 3,363 | 4 | 9 | 46 |
| - Diabetes Care | 2,158 | -2 | 4 | 29 |
| - Molecular Diagnostics | 882 | 3 | 5 | 12 |
| - Applied Science | 616 | 11 | 12 | 8 |
| - Tissue Diagnostics | 346 | 33 | 30 | 5 |
In the first nine months of 2009 sales by Roche’s Diagnostics Division, the leader in in vitro diagnostics (IVDs), increased 8% in local currencies (4% in Swiss francs, -1% in US dollars) to 7.4 billion Swiss francs. This was more than twice global IVD market growth, which is estimated at 3%.5 All five business areas helped drive growth, with Professional Diagnostics again making the biggest contribution. Divisional sales grew ahead of the market in all regions except Japan, where price cuts led to a slight decline in sales. Nine-month sales in the emerging seven (E7) markets (Brazil, Russia, India, China, Korea, Mexico and Turkey) grew 25% and accounted for over 10% of divisional sales.
Roche Professional Diagnostics’ nine-month sales grew roughly twice as fast as the market, rising 9% to 3,363 million Swiss francs. The immunoassay business gained additional market share on sales growth of 19%, driven by new placements of cobas analysers and strong sales of assays for cardiac markers and hepatitis C virus. Coagulation monitoring sales increased 24%, strengthening Roche’s leadership in this segment. Clinical chemistry sales rose 5%, in line with growth in this more mature market. The cobas 8000 modular analyser series for high-throughput laboratories — the largest laboratory customer segment by sales — received CE Mark certification in August. The rollout of this new flagship serum work area platform commenced with the high-speed c701 clinical chemistry module, now available in several configurations in the EU and other markets recognising CE Marking. Four cobas 8000 clinical chemistry and immunoassay modules will be available worldwide in a total of 38 configurations by the end of 2010.
Roche Diabetes Care’s sales rose 4% to 2,158 million Swiss francs. Sales of blood glucose (BG) monitoring systems continued to show single-digit growth (4%) despite the economic downturn. Accu-Chek Aviva and Accu-Chek Performa remained the primary growth drivers, with the new Accu-Chek Aviva Nano and Mobile monitoring systems introduced earlier this year also contributing to sales. Insulin delivery systems contributed positively to growth, helped by strong uptake of the new Accu-Chek Combo interactive insulin pump/BG meter combination, which was launched in an additional five European markets in the third quarter. Promising preliminary results from the Accu-Chek 360° View Outcome study were presented at the recent European Diabetes Congress. They suggest that structured BG testing can contribute to a better understanding of metabolic fluctuations and improved glycemic control in type 2 diabetes.
Roche Molecular Diagnostics’ sales rose 5% to 882 million Swiss francs. Blood screening remained the primary growth driver, with sales up 8% for the period. The unit maintained its leadership in virology with 4% sales growth, slightly below anticipated market growth. In September Molecular Diagnostics launched the new, fully automated cobas 4800 platform with tests for Chlamydia trachomatis and Neisseria gonorrhoeae in Australia and New Zealand. Further launches, with an expanded test menu including a new human papillomavirus screening test that can simultaneously identify high-risk genotypes 16 and 18, are planned for the fourth quarter in Europe and other markets that accept CE Mark certification.
Roche Applied Science’s sales totalled 616 million Swiss francs, an above-market increase of 12% over the year-earlier period. The MagNA Pure and LightCycler systems (nucleic acid purification and PCR analysis) were again the biggest contributors to growth (24%), helped by strong demand for instruments and reagents for pandemic influenza testing and surveillance. The RealTime ready Influenza A/H1N1 test, launched for research use in May, just weeks after the new virus was detected, has generated very strong sales; a filing for approval for clinical use in emergency situations was submitted to the US Food and Drug Administration in September. Sales of DNA sequencing systems were up 12% despite a decline in research funding, notably in the US. In September Applied Science launched MagNA Pure 96, a fully automated high-throughput nucleic acid purification system tailored to the needs of the pharmaceutical industry and academic researchers.
Roche Tissue Diagnostics’ sales totalled 346 million Swiss francs, a 30% increase over the eight months’ sales consolidated in the year-earlier period following the Ventana acquisition in February 2008. On a comparable basis, sales rose 20%, significantly outpacing the market. Advanced tissue staining remained the primary growth driver, with immunohistochemistry reagents and advanced staining instruments like the BenchMark Ultra fuelling robust 29% growth in this segment. In the high-volume primary staining market sales were up 47%, driven by instruments and reagents for hematoxylin/eosin staining. In September the business area launched its INFORM MET DNA Probe, a CE-marked probe to detect genomic gain (extra copies) of the MET gene in non-small cell lung cancer and gastric cancer.
About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2008, Roche had over 80’000 employees worldwide and invested almost 9 billion Swiss francs in R&D. The Group posted sales of 45.6 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.
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1) Unless otherwise stated, all growth rates are in local currencies Barring unforeseen events.
2) Pharmaceutical market growth according to IMS (to end of June 2009)
3) Roche defines Europe/Rest of World as covering Europe and all other countries except Japan and the United States
4) CEMAI: Central and Eastern Europe, Middle East, Africa, Central Asia, Indian Subcontinent
5) Estimated IVD market growth rates based on company estimates and various industry reports.
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 any current or future period will necessarily match or exceed the historical published earnings or earnings per share of Roche.