`
`
`
`
`Basel, 16 October 2014
`
`Roche delivers solid sales growth for the first nine months of 2014
`
`
`
` Group sales up 5% at CER1, stable in Swiss francs
` 4% higher sales in Pharmaceuticals Division, with strong growth of oncology portfolio, as well as
`
`Actemra for rheumatoid arthritis and Xolair for asthma and chronic hives
` 6% higher sales in Diagnostics Division, driven by strong Professional Diagnostics’ performance
` Acquisition of InterMune completed, FDA approval of Esbriet
` New generation of fully-automated PCR testing systems launched
` Full year outlook confirmed
`
`Nine months’ sales
`Jan–Sept
`
`In millions of CHF
`
`As % of sales
`
`% change
`
`2014
`
`2013
`
`2014
`
`2013 At CER1
`
`In CHF
`
`0
`
`-1
`
`1 2
`
`-3
`-6
`
`1
`
`5
`
`4
`5
`3
`7
`3
`
`6
`
`Group Sales
`
`Pharmaceuticals Division
` US
`
`Europe
`
`Japan
`
`International*
`
`Diagnostics Division
`
`34,757
`
`34,867
`
`100
`
`100
`
`26,965
`11,528
`7,070
`2,406
`5,961
`
`27,190
`11,429
`6,952
`2,492
`6,317
`
`7,792
`
`7,677
`
`78
`33
`20
`7
`18
`
`22
`
`78
`33
`20
`7
`18
`
`22
`
`* Asia–Pacific, EEMEA (Eastern Europe, Middle East, Africa), Latin America, Canada, Others
`
`
`
`Commenting on the nine month results, Roche CEO Severin Schwan said: “Demand for our products is
`
`strong in both divisions and we are well on track to reach our full-year targets. We have had positive news
`
`from our product pipeline, including study results for Perjeta in breast cancer and a new combination
`
`
`1 Unless otherwise stated, all growth rates in this document are in constant exchange rates CER (average full-year 2013).
`
`
`
`
`F. Hoffmann-La Roche Ltd
`
`4070 Basel
`Switzerland
`
`Group Communications
`Roche Group Media Relations
`
`
`
`
`
`Tel. +41 61 688 88 88
`Fax +41 61 688 27 75
`www.roche.com
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`1/12
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`therapy with Zelboraf in melanoma. The InterMune acquisition has also strengthened our portfolio with a
`
`new medicine, Esbriet for idiopathic pulmonary fibrosis, which has now been approved by the FDA. In
`
`Diagnostics, growth continues to be driven by the immunodiagnostics business and we have strengthened
`
`our molecular diagnostics portfolio with a new generation of testing systems.”
`
`
`
`Group nine months overview
`
`Group sales were 34.8 billion Swiss francs, 5% higher at constant exchange rates and stable in Swiss francs for
`
`the nine months ended 30 September 2014. A number of currencies remained weaker against the Swiss franc
`
`throughout the year, most notably the US dollar, as well as all Latin American currencies and the Japanese
`
`yen.
`
`
`
`Both divisions saw good sales growth for the nine months, with Pharmaceuticals up 4% and Diagnostics up
`
`6%. Growth in the Pharmaceuticals Division was driven by the oncology portfolio, in particular the
`
`medicines for HER2-positive breast cancer, Herceptin, Perjeta and Kadcyla, whilst growth in Diagnostics
`
`mainly stemmed from a continued strong performance in Professional Diagnostics.
`
`
`
`Recent highlights included new approvals for Avastin in cervical cancer in the United States and platinum-
`
`resistant ovarian cancer in Europe, and of Gazyvaro in Europe for chronic lymphocytic leukemia. In
`
`Diagnostics, the cobas 6800 and cobas 8800 integrated laboratory testing instruments were launched. The
`
`Diagnostics division also launched a global access programme for HIV viral load testing in resource
`
`constrained countries, in partnership with a number of organisations, including UNAIDS, the Clinton
`
`Access Initiative and the President’s Emergency Plan for AIDS relief. Another achievement was Roche being
`
`named the Group Leader for the Pharmaceuticals, Biotechnology and Life Sciences Industry in the Dow
`
`Jones Sustainability Indices for the sixth year running.
`
`
`
`Acquisition of InterMune
`
`The acquisition of InterMune was completed in September, adding a new medicine for idiopathic pulmonary
`
`fibrosis, Esbriet which was approved by the FDA in October 2014. Idiopathic pulmonary fibrosis is a
`
`progressive disease, which causes scarring of the lungs and has a survival rate of 2 to 3 years from diagnosis.
`
`Esbriet has the potential to make a considerable difference to the treatment of patients with this debilitating
`
`disease. Roche has successfully issued bonds to the value of 5.75 billion US dollars to finance the transaction.
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`2/12
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`Pipeline update
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`At the European Society for Medical Oncology (ESMO) annual congress in September, Roche presented final
`
`overall survival data from the Phase III CLEOPATRA study of Perjeta in HER2-positive metastatic breast
`
`cancer. The results showed that in combination with Herceptin and chemotherapy, Perjeta extended overall
`
`survival by 15.7 months, compared with Herceptin and chemotherapy alone. Results of the Phase III coBRIM
`
`study, testing the combination of Zelboraf and the Roche investigational MEK inhibitor, cobimetinib, in
`
`patients with malignant melanoma were also presented. The data showed that treatment with the
`
`combination halved the risk of the disease worsening. Other highlights at ESMO included encouraging data
`
`from early phase trials of an investigational cancer immunotherapy medicine, anti-PDL1 (MPDL3280A) in
`
`bladder cancer, a disease for which the drug has received FDA Breakthrough Therapy Designation. There
`
`was also positive early data for anti-PDL1 in combination with Avastin in renal cell carcinoma and other
`
`solid tumours. Cancer immunotherapy is a new approach that aims to enable the body’s immune system to
`
`fight cancer.
`
`
`
`Other positive pipeline news came in two Phase III studies (IMELDA and TANIA) for Avastin in treatment
`
`for HER2-negative breast cancer, the most common form of breast cancer, showing significant
`
`improvements in progression-free survival. Phase III trials for lampalizumab, the first potential treatment for
`
`geographic atrophy, were initiated in September. Geographic atrophy is an advanced form of age-related
`
`macular degeneration, a progressive condition that can lead to blindness. In Japan, Alecensa (alectinib) was
`
`approved for the treatment of ALK-positive non-small cell lung cancer in July, based on the results of a
`
`Japanese trial. The FDA has granted Breakthrough Therapy Designation for alectinib and global studies are
`
`ongoing.
`
`
`
`Full-year outlook confirmed
`
`For the full year 2014, Roche expects low- to mid-single digit growth in Group sales at constant exchange
`
`rates. Core EPS is targeted to grow ahead of sales. Roche expects to further increase its dividend.
`
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`3/12
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`Pharmaceuticals Division
`
`
`Top-selling
`pharmaceuticals and
`recent launches Jan–
`Sept 2014
`
`MabThera/Rituxan
`Avastin
`Herceptin
`Lucentis
`Tarceva
`Actemra/RoActemra
`Pegasys
`Xolair
`Perjeta
`Xeloda
`Recent launches
`Kadcyla
`Zelboraf
`Erivedge
`Gazyva/Gazyvaro
`
`Total
`
`US
`
`Europe
`
`Japan
`
`International**
`
`CHF m
`
`%*
`
`CHF m
`
`%*
`
`CHF m
`
`%*
`
`3%
`5,124
`6%
`4,749
`7%
`4,679
`5%
`1,260
`0%
`971
`24%
`897
`-17%
`811
`24%
`701
`633 255%
`623
`-43%
`
`371 148%
`230
`-8%
`90
`93%
`32
`-
`
`2,483
`2,002
`1,451
`1,260
`486
`292
`167
`701
`380
`171
`
`213
`53
`57
`30
`
`0%
`5%
`10%
`5%
`7%
`31%
`-34%
`24%
`190%
`-63%
`
`46%
`-42%
`29%
`-
`
`1,517
`1,472
`1,696
`-
`229
`320
`194
`-
`157
`76
`
`111
`145
`29
`1
`
`6%
`3%
`3%
`-
`-11%
`22%
`-29%
`-
`319%
`-68%
`
`***
`2%
`***
`-
`
`%*
`
`CHF
`m
`2%
`165
`519 11%
`200
`4%
`-
`-
`73 17%
`156 23%
`49 37%
`-
`-
`58
`***
`67
`-8%
`
`
`21
`-
`-
`-
`-
`-
`-
`-
`
`CHF
`m
`959
`756
`1,332
`-
`183
`129
`401
`-
`38
`309
`
`26
`32
`4
`1
`
`%*
`
`6%
`10%
`9%
`-
`-10%
`17%
`-4%
`-
`***
`-8%
`
`***
`69%
`***
`-
`
`* At constant exchange rates (CER) ** Asia–Pacific, EEMEA (Eastern Europe, Middle East, Africa), Latin America, Canada, Others *** >500%
`
`
`Sales in the Pharmaceuticals Division grew 4%, with a significant contribution from medicines to treat
`
`HER2-positive breast cancer, Herceptin, Perjeta and Kadcyla, which together increased 21%. This more than
`
`outweighed lower sales of oral chemotherapy drug Xeloda following the entry of generic competitors in key
`markets.
`
`
`In the United States, sales were 5% higher, with medicines for HER2-positive breast cancer, as well as
`
`Avastin driving growth. This more than offset declines in sales of Xeloda and Pegasys, a medicine for
`
`hepatitis B and C, which is facing competition from a new generation of hepatitis C treatment. Demand for
`
`Xolair increased after FDA approval of the medicine for a form of chronic hives, in addition to its existing
`
`use in allergic asthma.
`
`
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`4/12
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`In Europe 3% higher sales were driven by strong growth in Germany, particularly in sales of HER2 breast
`
`cancer medicines, as well as MabThera/Rituxan; and in the UK with sales of HER2 breast cancer medicines
`
`and stockpiling of Tamiflu. These increases were partially offset by on-going pricing pressure in a number of
`
`markets. There were significantly lower sales of Xeloda.
`
`
`
`Following a further acceleration of growth in the third quarter, sales for the International region were 3%
`
`higher, with strong growth in Latin America, in particular Argentina, Venezuela and Brazil. In the Middle
`
`East, sales were impacted by political unrest, whilst in China sales were stable, with continued strong growth
`
`for key products such as the HER2 breast cancer medicine portfolio, MabThera/Rituxan and
`
`Actemra/RoActemra. Sales of a number of mature products including Tarceva, Xeloda and Madopar, were
`
`lower in China, mainly as a result of increased competition. Sales of Tamiflu in China were significantly
`
`lower.
`
`
`
`In Japan, 7% higher sales were driven by strong demand for HER2 breast cancer medicines, as well as
`
`Avastin and Actemra/RoActemra. In the osteoporosis segment, there was solid sales growth for Edirol, as
`
`well as Bonviva.
`
`
`
`Key products
` Herceptin, Perjeta, Kadcyla (+21%), for HER2-positive breast cancer and Herceptin for HER2-positive
`metastatic (advanced) gastric cancer. Herceptin (+7%) sales growth was driven mainly by the United
`
`States (+10%), with increased use in breast cancer treatment in combination with Perjeta. There was also
`
`strong growth in the International region (+9%), with significant increases in China and Brazil. In
`
`Europe, sales increased 3%, with strong demand in Germany, Spain and the UK. In Japan, sales were 4%
`
`higher, with increased usage in combination with Perjeta in breast cancer, as well as in gastric cancer.
`
`Perjeta (633 million Swiss francs) showed continued strong growth in the United States and in Europe,
`
`especially in France and the UK. Kadcyla (371 million Swiss francs) is an antibody-drug conjugate that
`
`can attach to HER2-positive cancer cells and deliver potent chemotherapy directly to the cancer cell. This
`
`helps patients avoid some of the side effects of conventional chemotherapy. Uptake of this medicine has
`
`been very strong in the United States and Europe, in particular Germany and UK.
` MabThera/Rituxan (+3%), for common forms of blood cancers, non-Hodgkin’s lymphoma and chronic
`lymphocytic leukemia; and for rheumatoid arthritis and certain types of ANCA-associated vasculitis.
`
`Sales grew strongly in Europe (+6%), driven by increased market share in follicular lymphoma, as well as
`
`first line treatment for chronic lymphocytic leukemia. Sales were stable in the United States. In
`
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`5/12
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`IMMUNOGEN 2270, pg. 5
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`International markets, sales rose by 6%, driven by strong growth in Latin America.
` Avastin (+6%), for advanced colorectal, breast, lung, kidney, cervical and ovarian cancer, as well as
`glioblastoma (a type of brain tumour). Sales in the United States rose by 5% with growing demand in
`
`colorectal and lung cancer treatment. In Europe, 3% higher sales were driven by increased use in ovarian
`
`and breast cancer. In the International region, sales were 10% higher, driven by launches for ovarian
`
`cancer and uptake in colorectal cancer. In Japan (+11%), growth was driven by increased demand in
`
`breast cancer, as well as by ovarian cancer and malignant glioma, which are both new indications that
`
`were approved in 2013.
` Lucentis (+5%, United States only), for the eye conditions, wet age-related macular degeneration,
`macular edema following retinal vein occlusion and diabetic macular edema. Growth was driven largely
`
`by increased adoption of Lucentis in treating diabetic macular edema.
` Actemra/RoActemra (+24%), for rheumatoid arthritis, systemic juvenile idiopathic arthritis and
`polyarticular juvenile idiopathic arthritis. Sales growth was strong in all major markets (United States
`
`+31%; Europe +22%; International region +17%; Japan +23%) driven by strong demand for
`
`monotherapy in rheumatoid arthritis. It has now also been approved for use in earlier treatment of
`
`rheumatoid arthritis in Europe. Sales of the new subcutaneous formulation of the medicine are also
`
`growing well in the United States and Europe.
` Zelboraf (-8%), for BRAF V600 mutation-positive metastatic melanoma. Zelboraf is currently facing
`significant competition in the US (-42%), whilst in Europe sales were 2% higher. Phase III results from
`
`the pivotal coBRIM trial, comparing the combination of cobimetinib (Roche’s investigational MEK
`
`inhibitor) with Zelboraf, versus Zelboraf alone were presented at ESMO and published in the New
`
`England Journal of Medicine in September. The data showed that combination treatment halved the risk
`
`of the disease worsening and the data has been submitted to the European Medicines Agency. The FDA
`
`has granted Fast Track Designation for the combination and a US filing will follow later this year.
` Gazyva/Gazyvaro (32 million Swiss francs), for frontline treatment of chronic lymphocytic leukemia
`(CLL). Gazyva was approved in the United States in November 2013 with an FDA Breakthrough Therapy
`
`Designation, and in Europe in July 2014. Initial uptake in Europe, where it is sold under the brand name
`
`Gazyvaro, has been very positive. It is also approved in Switzerland and is expected to be approved in a
`
`number of key markets later in 2014.
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`6/12
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`Major clinical and regulatory news flow up to mid-October 2014
`
`Indication
`NHL (follicular lymphoma and diffuse
`large B-cell lymphoma)
`
`Milestone
`EU approval
`
`FDA approval
`Phase IIb study results
`(LUTE, VERSE)
`Phase III study results
`(MetLung)
`EU approval
`
`chronic idiopathic urticaria
`severe uncontrolled asthma
`
`non-small cell lung cancer
`
`rheumatoid arthritis
`
`metastatic bladder cancer
`
`bacterial infections
`schizophrenia
`ALK-positive non-small cell lung cancer
`chronic lymphocytic leukemia
`early rheumatoid arthritis
`cervical cancer
`platinum-resistant recurrent ovarian
`cancer
`glioblastoma
`BRAF V600 mutation-positive
`metastatic melanoma
`
`HER2-positive breast cancer (neo-
`adjuvant)
`metastatic HER2-positive breast cancer
`(first line)
`
`diabetic retinopathy
`idiopathic pulmonary fibrosis
`
`
`Q1
`
`Q1
`Q1
`
`Q1
`
`Q2
`
`Q2
`
`Q3
`Q3
`
`Q3
`
`Q3
`
`Q3
`Q3
`
`7/12
`
`Phase I study results led to
`FDA Breakthrough
`Therapy Designation
`FDA fast track designation Q2
`Q3
`Phase III study results
`Q3
`Japanese approval
`Q3
`EU approval
`Q3
`EU approval
`Q3
`FDA approval
`Q3
`EU approval
`
`EU approval
`Phase III study results
`(co-BRIM) filed in EU, fast
`track designation in US
`Phase II (NEOSPHERE)
`study results filed in EU
`Final overall survival data
`from Phase III
`(CLEOPATRA)
`FDA priority review
`FDA approval
`
`Compound
`MabThera
`(subcutaneous
`formulation)
`Xolair
`Lebrikizumab
`
`Onartuzumab and
`Tarceva
`RoActemra
`(subcutaneous
`formulation)
`Anti-PDL1
`
`LptD antibiotic
`Bitopertin
`Alectinib
`Gazyvaro
`RoActemra
`Avastin
`Avastin
`
`Avastin
`Cobimetinib and
`Zelboraf
`
`Perjeta
`
`Perjeta
`
`Lucentis
`Esbriet
`
`
`
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`
`IMMUNOGEN 2270, pg. 7
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`Diagnostics Division
`
`Diagnostics Division
`Sales
`Jan – Sept 2014
`Division
`Business areas
`
`Regions
`
`In millions
`of CHF
`
`% change
`At CER*
`
`In CHF
`
`As %
`of sales
`
`7,792
`4,397
`1,721
`1,165
`509
`3,586
`1,929
`1,386
`558
`333
`
`6
`8
`1
`5
`10
`3
`6
`15
`12
`3
`
`1
`3
`-3
`0
`6
`1
`1
`9
`-3
`-7
`
`100
`56
`22
`15
`7
`46
`25
`18
`7
`4
`
`Professional Diagnostics
`Diabetes Care
`Molecular Diagnostics
`Tissue Diagnostics
`Europe, Middle East, Africa
`North America
`Asia–Pacific
`Latin America
`Japan
`
`* At constant exchange rates (CER)
`
`
`
`The Diagnostics Division recorded a strong sales increase of 6% to 7.8 billion Swiss francs. Professional
`
`Diagnostics (+ 8%) was the main contributor, led by the immunodiagnostics business (+12%). Molecular
`
`Diagnostics’ sales increased 5%, Tissue Diagnostics 10% and Diabetes Care 1%.
`
`All regions contributed to growth, which was primarily driven by the Asia–Pacific (+15%), EMEA (Europe,
`
`Middle East and Africa, +3%) and the North America (+6%) regions. Sales increased 12% in Latin America
`
`and 3% in Japan.
`
`
`
`Ten key products were launched in the first nine months, including the new cobas 6800 and cobas 8800
`
`systems for fully automated PCR testing. Sales of companion tests for personalised healthcare and revenues
`
`from external development agreements for such tests continued to grow strongly, especially tests for targeted
`
`cancer therapies.
`
`
`
`Professional Diagnostics (+8%). This business continues to outperform the market, with very strong growth
`
`in the immunodiagnostics business (+12%) and the clinical chemistry business (+8%). Sales increases were
`
`recorded in all regions, in Asia-Pacific (+18%), especially China; North America (+7%), in the EMEA region
`
`(+4%), Latin America (+13%) and Japan (+8%).
`
` A
`
` new anti-Müllerian hormone (AMH) blood test was launched in September. This is the first fully-
`
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`8/12
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`automated AMH test for assessing a woman’s ovarian reserve for in-vitro fertilisation. This test can be
`
`incorporated into routine clinical practice for faster and more reliable results.
`
`
`
`Diabetes Care (+1%). Overall sales increased despite a challenging market environment. Sales of products
`
`for blood glucose monitoring were up 1%, outperforming the global market. The premium product Accu-
`
`Chek Mobile generated a sales increase of 22% and Accu-Chek Aviva/ Performa sales were up 6%. However
`
`reimbursement changes and declining sales for products approaching the late stage of their life-cycle
`
`continued to impact overall sales performance. Sales of insulin delivery systems grew 5%, driven by infusion
`
`systems. Roche launched the Accu-Chek Insight insulin pump and blood glucose monitoring system and
`
`more recently its Accu-Chek Connect system which offers connectivity to mobile applications via
`
`smartphones and web-based platforms.
`
`
`
`Roche Diabetes Care continued to implement restructuring activities, which will enable the business to focus
`
`on the market changes and drive efficiencies.
`
`
`
`Molecular Diagnostics (+5%). Sales in the underlying molecular businesses (excluding genome sequencing),
`
`increased 7%, driven by tests for viral infections (+7%) and blood screening (+5%) as well as the cobas HPV
`
`Test (+57%) for cervical cancer screening. Further growth came from nucleic acid purification (NAP)/real-
`
`time PCR (qPCR) reagents (+8%). This sales growth was partly offset by a decline in the genome sequencing
`
`business. In North America, the cobas HPV Test showed continued high, double-digit growth following
`
`regulatory approvals for primary cervical cancer screening in the US and Canada.
`
`
`
`Roche launched the next generation of mid and high volume, fully automated, molecular testing instruments,
`
`the cobas 6800 and the cobas 8800 systems, along with three next-generation assays for donor blood
`
`screening. These systems produce test results faster and have a higher testing capacity than other molecular
`
`instrumentation currently available.
`
`
`
`Molecular Diagnostics also launched three tests in Europe: a test for the herpes-simplex-virus (HSV) and two
`
`tests which identify hospital acquired infections; the MRSA/SA2 and the C-difficile (Clostridium difficile)
`
`tests. The cobas Strep A nucleic acid test received CE mark designation, allowing its commercialisation in the
`
`EU and in all markets that recognise the CE mark. This new test joins an already approved cobas Flu A/B
`
`nucleic acid test and will run on the cobas Liat, a point-of-care molecular diagnostic platform developed by
`
`
`2 MRSA/SA: methicillin-resistant Staphylococcus aureus and Staphylococcus aureus
`
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`IQuum which was acquired by Roche earlier in 2014. The company has also acquired Genia Technologies,
`
`Inc., which is developing the next generation of sequencing technology, a single-molecule, semi-conductor
`
`based DNA sequencing platform using nanopore technology.
`
` new global access programme for HIV viral load testing was launched in September. This programme was
`
` A
`
`created in partnership with UNAIDS, the joint United Nations Program on HIV/AIDS, the Clinton Health
`
`Access Initiative (CHAI), the President’s Emergency Plan For AIDS Relief (PEPFAR) and the Global Fund to
`
`fight AIDS, TB and Malaria. This access initiative for HIV testing aims at improving laboratory capacity to
`
`ensure that all people living with HIV can be linked to effective, high-quality HIV treatment services.
`
`
`
`Tissue Diagnostics (+10%). Sales were driven by 8% growth in advanced staining, in particular
`
`immunohistochemistry reagents. Sales of CINtec histology tests and the fully automated CINtec PLUS test
`
`grew by 13% and 33% respectively. Both tests complement Roche’s portfolio of cervical cancer screening
`
`Market
`
`WW*
`
`EU
`
`EU
`
`WW*
`
`EU
`
`EU
`
`US
`
`WW*
`
`10/12
`
`products.
`
`
`
`Growth was strong in the EMEA and Asia–Pacific regions. Revenues from personalised healthcare
`
`partnerships with external pharmaceutical companies continued to grow strongly.
`
`Diagnostics Division: Key product launches planned for 2014
`Area
`Product name
`Description
`
`Instruments/devices
`
`cobas 6800/8800 next generation molecular (PCR) system
`
`cobas m511
`
`fully integrated/automated hematology system
`
`cobas 6500
`
`automated urinalysis work area
`
`Connect-V
`
`Accu-Chek
`Insight
`
`Accu-Chek
`Connect
`
`middleware providing connectivity to hospital information
`systems
`
`next generation insulin pump & blood glucose monitoring
`system
`
`bG meter with connectivity to smartphones, mobile applications
`and cloud
`
`MPX 2.0
`
`next generation blood screening multiplex test
`
`MPX (HIV, HCV, full NAT blood screening menu for cobas 6800/8800
`
`
`
`Laboratories
`
`
`Diabetes
`Care
`
`Tests/ assays
`
`
`
`
`
`IMMUNOGEN 2270, pg. 10
`Phigenix v. Immunogen
`IPR2014-00676
`
`
`
`
`Blood
`screening /
`infectious
`diseases
`
`HBV), HEV,
`DPX1, WNV2
`
`HIV, HBV,
`HCV, CMV
`
`HSV
`
`virology tests for cobas 6800/8800
`
`herpes simplex virus detection on cobas 4800
`
`
`
`Microbiology
`
`
`Women’s
`health
`
`Syphilis
`
`treponema pallidum detection (immunoassay)
`
`MRSA/SA
`
`next generation assay on cobas 4800
`
`C-difficile
`
`diagnosis of infections and associated diarrhea
`
`AMH
`
`assessment of ovarian reserve for fertility
`
`PE Prognosis
`
`short-term prediction of pre-eclampsia in pregnancy (claim
`extension)
`
`WW*
`
`EU
`
`EU
`
`EU
`
`EU
`
`EU
`
`EU
`
`1 Parvovirus B19 and hepatitis A virus.
`2 West Nile virus.
`*excluding US
`
`
`
`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, immunology, infectious diseases, ophthalmology and neuroscience. Roche is also the world leader in in
`
`vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s
`
`personalised healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in
`
`the health, quality of life and survival of patients. Founded in 1896, Roche has been making important contributions
`
`to global health for more than a century. Twenty-four medicines developed by Roche are included in the World
`
`Health Organisation Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and
`
`chemotherapy.
`
`
`
`In 2013 the Roche Group employed over 85,000 people worldwide, invested 8.7 billion Swiss francs in R&D and
`
`posted sales of 46.8 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche
`
`Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit
`
`www.roche.com.
`
`All trademarks used or mentioned in this release are protected by law.
`
`
`
`
`
`11/12
`
`IMMUNOGEN 2270, pg. 11
`Phigenix v. Immunogen
`IPR2014-00676
`
`
`
`
`
`
`Additional information
` Media Release including full set of tables: http://www.roche.com/med-cor-2014-10-16.htm
` Sustainable Development at Roche: www.roche.com/corporate_responsibility
` Roche Annual Report 2013 (includes Corporate Responsibility Report): www.roche.com/annual_reports
` Dow Jones Sustainability Indexes: www.sustainability-indexes.com
` SAM: www.sam-group.com
`
`
`
`Roche Group Media Relations
`
`Phone: +41 -61 688 8888 / e-mail: roche.mediarelations@roche.com
`
`- Nicolas Dunant (Head)
`
`- Ulrike Engels-Lange
`- Štěpán Kráčala
`‐ Claudia Schmitt
`- Nina Schwab-Hautzinger
`
`
`
`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.
`
`12/12
`
`
`
`
`
`IMMUNOGEN 2270, pg. 12
`Phigenix v. Immunogen
`IPR2014-00676