Media Release
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`Basel, 30 January 2014
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`Roche delivers strong 2013 results
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` Group sales rise 6%1 to 46.8 billion Swiss francs
` Pharmaceuticals sales 7% higher, driven by HER2 breast cancer franchise, Avastin,
`MabThera/Rituxan, Actemra/RoActemra and Lucentis. Diagnostics sales up 4% on strong
`Professional Diagnostics performance
` Core EPS growth ahead of sales, up 10% to 14.27 Swiss francs
` Positive regulatory decisions for Kadcyla, Perjeta and Herceptin SC strengthen HER2
`franchise and US approval of Gazyva supports hematology franchise
` Significant progress of R&D pipeline: 15 new molecular entities in late-stage development
` Board proposes dividend increase of 6% to 7.80 Swiss francs, 27th consecutive year of
`dividend growth
` Outlook for 2014: Sales expected to grow low- to mid-single digit, at constant exchange
`rates. Core earnings per share targeted to grow (at CER) ahead of sales. Roche expects to
`further increase its dividend
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`1 Unless otherwise stated, all growth rates are at constant exchange rates (CER). The percentage changes at CER are calculated using
`simulations by reconsolidating both the 2013 and 2012 results at constant currencies (the average rates for the year ended 31
`December 2012).
`
`
`
`
`F. Hoffmann-La Roche Ltd
`
`4070 Basel
`Switzerland
`
`Group Communications
`Roche Group Media Relations
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`Tel. +41 61 688 88 88
`Fax +41 61 688 27 75
`www.roche.com
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`IMMUNOGEN 2346, pg. 1
`Phigenix v. Immunogen
`IPR2014-00676
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`% change
`CER*
`
`CHF
`
`USD
`
`45,499
`35,232
`10,267
`
`17,160
`16,135
`9,660
`13.49
`
`100
`78
`22
`
`38.3
`35.0
`24.3
`
`
`100
`77
`23
`
`37.7
`35.5
`21.2
`
`
`+6
`+7
`+4
`
`+8
`+5
`+22
`+10
`
`+3
`+3
`+2
`
`+4
`+2
`+18
`+6
`
`+4
`+4
`+3
`
`
`
`
`
`
`
`
`Key figures 2013
`
`Group Sales
`Pharmaceuticals Division
`Diagnostics Division
`
`In millions of CHF As % of sales
`2013
`2012
`2013
`2012
`
`46,780
`36,304
`10,476
`
`17,904
`Core operating profit
`16,381
`Operating free cash flow
`IFRS2 Net income
`11,373
`14.27
`Core earnings per share
`* Constant exchange rates (average full-year 2012)
`
`Roche’s CEO Severin Schwan: “2013 was a very good year for Roche. We exceeded our financial targets with
`strong demand for our existing products and positive uptake of recently launched medicines and diagnostics.
`With the launch of Perjeta and Kadcyla we have added a new generation of treatments for women with a
`particularly aggressive type of breast cancer. Another highlight was the launch of Gazyva for chronic
`lymphocytic leukemia (CLL), in the United States. In Diagnostics we introduced a range of new instruments
`and tests that further strengthen our position as market leader, including the cobas 8100 and a new HPV test
`for cervical cancer. With our strong product pipeline we are well positioned for future success."
`
`Strong performance in 2013
`Group sales rose 6% to 46.8 billion Swiss francs in 2013 as a result of strong demand for Roche’s biologic
`medicines in the area of oncology, immunology and ophthalmology as well as for its clinical laboratory
`diagnostic products, especially immunoassays. This sales performance contributed significantly to an 8%
`increase in the Group’s core operating profit and, combined with lower financing costs, a 10% rise in core
`earnings per share. IFRS net income rose 22% to 11.4 billion Swiss francs as a result of lower restructuring
`costs and the reversal of previous impairment charges.
`
`Strong sales growth
`Sales of the Pharmaceuticals Division grew 7% to 36.3 billion Swiss francs due to the continued strength of
`established and new medicines for cancer (HER2 franchise, Avastin and MabThera/Rituxan) as well as good
`growth in medicines for rheumatoid arthritis (Actemra/RoActemra) and eye diseases (Lucentis). Sales
`growth was strongest in the United States (+10%) and emerging markets (+12%)3, which grew faster than
`Europe (+2%) and Japan (+2%).
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`
`2 International Financial Reporting Standards.
`3 E7 emerging markets: Brazil, China, India, Mexico, Russia, South Korea and Turkey.
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`The Diagnostics Division grew ahead of the in vitro market4, as all regions contributed to sales growth of 4%.
`Sales reached 10.5 billion Swiss francs with the most important contribution coming from continued strong
`demand for tests and instruments used in clinical laboratories, especially from Professional Diagnostics
`(+8%). As expected, the market environment for Diabetes Care (-3%) remained challenging in 2013 and
`Roche is continuing the restructuring measures that were initiated in 2012. Sales growth in Diagnostics was
`strongest in Asia-Pacific (+14%) and Latin America (+13%), and lower in mature markets: Europe (+2%),
`North America (+1%) and Japan (+2%).
`
`The Swiss franc rose against a number of currencies in 2013, mainly the Japanese yen and the US dollar,
`while falling against the euro. Overall, this led to a negative impact on the results reported in Swiss francs.
`
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`Core operating profit further improved
`Driven by the strong sales performance, the Group’s core operating profit increased by 8% (+4% in Swiss
`francs) to 17.9 billion Swiss francs. Higher operating costs were recorded for research and development, as
`well as for marketing and distribution to support growth in key markets such as the United States and China.
`Core operating profit in the Pharmaceuticals Division grew 7% to 16.1 billion Swiss francs and Diagnostics
`core operating profit increased by 4% to 2.2 billion Swiss francs.
`
`Roche’s core earnings per share, which excludes non-core items such as global restructuring charges and
`amortisation and impairment of goodwill and intangible assets, rose 10% to 14.27 Swiss francs per share.
`This was driven by the strong operating performance and lower financing costs, due to lower interest
`payments following progressive repayment of the debt incurred for the Genentech transaction. IFRS net
`income rose 22% to 11.4 billion Swiss francs (+18% in Swiss francs) as a result of lower restructuring costs
`and the reversal of previous impairment charges.5
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`Strong operating free cash flow and improved net debt position
`The Group’s operating free cash flow grew by 5% (+2% in Swiss francs) to 16.4 billion Swiss francs, enabling
`Roche to further reduce the Group’s debt position: by the end of the year, 67% of the debt incurred to finance
`the Genentech transaction in 2009 had been repaid. The net debt position of the Group at year-end 2013 was
`6.7 billion Swiss francs, a decrease of 3.9 billion Swiss francs from year-end 2012. At 31 December 2013, the
`net debt to asset ratio was 11%.
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`Significant progress in pharmaceutical R&D pipeline
`During 2013 Roche’s pharmaceutical R&D pipeline made significant progress both in oncology and in the
`
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`4 Market estimates from an independent IVD consultancy; data as of end Q3 2013.
`5 As part of a broader initiative to expand production capacity of biologic medicines, Roche put back into service a discontinued
`production unit in Vacaville (USA). This resulted in a reversal of previously incurred impairment charges of 0.5 bn Swiss francs.
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`areas of ophthalmology and immunology. The pipeline currently has 66 new molecular entities in clinical
`development of which 15 are in late-stage development. Based on promising mid-stage data Roche selected
`eight new compounds to progress to late-stage development during 2013: six compounds in oncology (anti-
`CD79b ADC, pan-PI3Ki, beta-sparing PI3Ki, alectinib (ALKi), Bcl-2i, anti-PDL1), etrolizumab for
`inflammatory bowel disease, lampalizumab for the eye disease geographic atrophy (an advanced form of dry
`AMD). In addition, Roche licensed-in oral octreotide, a treatment for the growth disorder, acromegaly.6
`
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`Proposals for the Annual General Meeting 2014
`In light of the company’s strong performance in 2013, the Board of Directors is proposing an 6% dividend
`increase to 7.80 Swiss francs per share and non-voting equity security (2012: 7.35 Swiss francs), making this
`the 27th consecutive year of dividend growth.
`
`The Board of Directors proposes that Christoph Franz, who has served as a non-executive Director on the
`Roche Board since 2011, be elected as Chairman of the Board.
`
`In March 2013 a majority of Swiss citizens voted in a referendum in favour of a set of changes to the Swiss
`constitution regarding governance regulations of publicly quoted companies. Roche has decided to
`implement the new regulations earlier than required and will propose changes to the company’s Articles of
`Incorporation at the AGM on 4 March 2014: as of this year, the Chairman of the Board, all members of the
`Board of Directors and the members of the Remuneration Committee will be elected annually by the
`shareholders and binding votes on remuneration will be proposed to be implemented in 2014, ahead of the
`mandatory date of 2015.
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`Outlook for 2014
`In 2014, Roche expects low- to mid-single digit growth in Group sales at constant exchange rates. Core EPS is
`targeted to grow (at CER) ahead of sales. Roche expects to further increase its dividend.
`
`
`6 In February 2013, Roche signed an agreement with Chiasma, a privately held biopharma company, to develop and commercialise
`Octreolin.
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`Pharmaceuticals Division
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`Pharmaceuticals Division:
`In millions of
`CHF
`Key figures - 2013
`36,304
` Sales - Pharmaceuticals Division
`15,097
` United States
`9,254
` Europe
`3,405
` Japan
`8,548
` International
`16,108
`Core operating profit
`14,976
`Operating free cash flow
`7,683
`Research and development
`* Constant exchange rates (average full-year 2012)
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`
`
`% change at
`CER*
`+7
`+10
`+2
`+2
`+8
`+7
`+5
`+5
`
`% change in
`CHF
`+3
`+9
`+3
`-17
`+3
`+4
`+2
`+2
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`As % of sales
`
`100
`42
`25
`9
`24
`44.4
`41.3
`21.2
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`Strong sales growth in the United States and emerging markets
`Pharmaceuticals sales were driven by growth for oncology products in the United States (+10%) and the E7
`emerging markets (+12%), especially China (+21%) and Brazil (+9%). Sales in Europe grew 2%, despite
`ongoing pricing pressure in key markets. In Japan sales increased 2%, despite the loss of sales following the
`termination of a co-marketing agreement for Evista, an osteoporosis treatment; excluding this impact, sales
`in Japan grew 7%.
`
`Oncology: dynamic growth and important product approvals
`Sales of the HER2 breast cancer franchise, which consists of Herceptin, Perjeta and Kadcyla, rose 14% to 6.6
`billion Swiss francs. In 2013 Roche received several important product approvals for the HER2 franchise in
`key markets: Kadcyla was approved in the United States and the EU and Perjeta was approved in the EU for
`late-stage cancer. In October Perjeta was also approved for use in treatment of HER2-positive breast cancer
`prior to surgery (neoadjuvant setting) in the United States. The HER2 franchise was further strengthened by
`EU approval of the subcutaneous formulation of Herceptin.
`
`Sales of Avastin, which is used to treat a number of different types of cancer, increased 13% to 6.3 billion
`Swiss francs due to strong demand for the treatment of advanced ovarian cancer in Europe, and colorectal
`cancer in the United States and Europe. During 2013 Avastin was approved in Japan to treat ovarian cancer,
`as well as glioblastoma, a type of brain tumour.
`
`Sales of Roche’s blood cancer and rheumatoid arthritis medicine MabThera/Rituxan increased 6% to 7.0
`billion Swiss francs. The outlook for the Group’s hematology franchise was enhanced by US approval of
`Gazyva to treat chronic lymphocytic leukemia (CLL), one of the most common forms of blood cancer. Late-
`stage trials investigating Gazyva in non-Hodgkin’s lymphoma (NHL), the most common cancer of the
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`lymphatic system, are ongoing. Roche also reported encouraging phase I data on its Bcl-2 inhibitor.7
`
`In 2013, based on promising mid-stage data, we selected six new oncology compounds to progress to late
`stage development: anti-CD79b ADC (blood cancers), pan-PI3Ki (breast cancer and other solid tumours),
`beta-sparing PI3Ki (breast cancer and other solid tumours), alectinib ALKi (lung cancer and other solid
`tumours), Bcl-2i (blood cancers) and anti-PDL1 (lung cancer and other solid tumours).
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`Immunology and ophthalmology: product growth and promising pipeline
`The rheumatoid arthritis drug Actemra/RoActemra recorded a 30% increase in sales and achieved sales of
`more than 1 billion Swiss francs for the first time in 2013. The subcutaneous formulation of
`Actemra/RoActemra was approved in the United States in October and has also received a positive
`recommendation from Europe’s regulatory agency. Roche’s immunology pipeline includes etrolizumab for
`inflammatory bowel disease and lebrikizumab for severe asthma.
`
`Sales of Lucentis, which is used in the treatment of a number of eye diseases, rose 15% to 1.7 billion Swiss
`francs. Roche has made further progress in strengthening its ophthalmology pipeline with lampalizumab
`which showed promising phase II clinical trial results in the treatment of geographic atrophy, an advanced
`form of dry age-related macular degeneration.
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`Neuroscience pipeline
`In January 2014 Roche announced that two bitopertin trials for schizophrenia did not meet their primary
`endpoints. Another four studies with bitopertin are ongoing, for which results are expected during 2014.
`Diseases of the nervous system have a very high unmet need and pose some of the greatest challenges for
`society. Neuroscience remains a focus area of research and development at Roche, with a total of 12 new
`compounds in clinical development, including late-stage compounds for Alzheimer’s (gantenerumab) and
`multiple sclerosis (ocrelizumab).
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`Cardiovascular/metabolism pipeline
`In July 2013 Roche announced the discontinuation of aleglitazar trials in diabetes. As a result, the company
`no longer has any cardiovascular/metabolism compounds in its late-stage pipeline and has decided to pursue
`partnering opportunities for the remaining compounds in its early development pipeline.
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`7 GDC 199/ABT-199 in collaboration with AbbVie.
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`Total
`
`United States
`
`Europe
`
`Japan
`
`CHF m %*
`
`
`6,951
`6%
`
`CHF m %*
`
`
`3,329
`8%
`
`CHF m %*
`
`
`1,918
`3%
`
`CHF m %*
`
`
`249
`6%
`
`International
`**
`CHF m %*
`
`
`1,455
`6%
`
`6,254
`6,079
`1,689
`1,509
`1,339
`1,312
`1,037
`
`2,575
`13%
`1,787
`6%
`1,689
`15%
`616
`2%
`604
`4%
`-19% 307
`30%
`314
`
`1,919
`5%
`2,191
`9%
`-
`15%
`315
`0%
`343
`7%
`-43% 356
`32%
`360
`
`717
`14%
`294
`-1%
`-
`-
`107
`-4%
`99
`-5%
`-11% 52
`27%
`197
`
`1,043
`15%
`1,807
`8%
`-
`-
`471
`4%
`293
`10%
`-21% 597
`21%
`166
`
`30%
`11%
`-
`8%
`8%
`-3%
`49%
`
`
`Pharmaceuticals
`Division:
`Product Sales 2013
`Top selling products
`MabThera/
`Rituxan
`Avastin
`Herceptin
`Lucentis
`Xeloda
`Tarceva
`Pegasys
`Actemra/
`RoActemra
`CellCept
`Xolair
`
`874
`790
`
`354
`326
`234
`75
`3
`
`204
`-2%
`790
`13%
`
`
`123
`52%
`498% 219
`-
`222
`161% 66
`-
`3
`
`238
`21%
`-
`13%
`
`
`194
`11%
`311% 68
`-
`9
`132% 8
`-
`-
`
`-12% 68
`-
`-
`
`
`65%
`-
`***
`23
`-
`-
`-
`-
`-
`-
`
`10%
`-
`
`-
`-
`-
`-
`-
`
`364
`-
`
`37
`16
`3
`1
`-
`
`-7%
`-
`
`***
`***
`-
`-
`-
`
`Recent launches
`Zelboraf
`Perjeta
`Kadcyla
`Erivedge
`Gazyva
`* Constant exchange rates.
`**Asia–Pacific, EEMEA (Eastern Europe, Middle East and Africa), Latin America, Canada, Others.
`*** Over +500%.
`
`Key products
` MabThera/Rituxan (+6%), for blood cancers, specifically non-Hodgkin’s lymphoma (NHL), chronic
`lymphocytic leukemia (CLL), and for rheumatoid arthritis, as well as granulomatosis with polyangiitis
`(GPA) and microscopic polyangiitis (MPA), which are two types of ANCA (anti-neutrophil cytoplasmic
`antibody) associated vasculitis. Global sales rose 6% largely due to higher sales in the United States (+8%)
`driven by increased use across all oncology and rheumatoid arthritis indications. In January 2014 the
`subcutaneous formulation of MabThera for NHL secured a positive recommendation from Europe’s
`regulatory agency (CHMP).
`
` Avastin (+13%), for advanced colorectal, breast, lung, kidney and ovarian cancer, and relapsed
`glioblastoma (a type of brain tumour). Global sales rose 13% due to increased use in established
`indications (colorectal and lung cancer) as well as the recently approved indication, ovarian cancer. Sales
`rose 14% in Europe as a result of growing use in ovarian and colorectal cancer. In the United States sales
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`increased 5% due to expanded use in colorectal cancer. Demand was strong in several International
`markets (overall +30%), especially China (+62%, in particular for colorectal cancer). In 2013 Roche filed
`for approval of Avastin for advanced non-small cell lung cancer (NSCLC) in China based on
`encouraging phase III data in Chinese patients. Lung cancer is the most common type of cancer and the
`biggest cause of cancer-related death in China.
`
` Herceptin (+6%), for HER2-positive breast cancer and HER2-positive metastatic (advanced) gastric
`cancer. Herceptin sales rose 6% largely due to good sales growth in the United States (+9%) and strong
`sales in the International region (+11%). Growth was especially strong in China (+40%), due to patient
`access programmes and ongoing testing initiatives and in Brazil (+10%), where Herceptin is now
`available on the national public healthcare system. The subcutaneous (SC) formulation of Herceptin has
`performed well since its approval in Europe in June 2013 and is now available in many markets in
`Europe, including Germany and the UK.
`
` Lucentis (+15%, US market only), for eye conditions specifically wet age-related macular degeneration
`(wAMD), macular edema following retinal vein occlusion (RVO) and diabetic macular edema (DME).
`Sales of Lucentis rose 15% as a result of growth in the RVO and DME indications and steady growth for
`the treatment of wAMD. Since receiving FDA approval in August 2012, Lucentis is the only anti-vascular
`endothelial growth factor medicine approved for DME in the United States. In February Roche received
`FDA approval to update the Lucentis label to include a less frequent dosing regimen in wAMD.
`
` Pegasys (-19%), for hepatitis B and C. Global sales of Pegasys fell in 2013, especially in the United States
`(-43%) and several markets within Europe (-11%) as doctors in these regions awaited the launch of
`interferon-free combination therapies. There is continued demand for Pegasys in several emerging
`markets, where first-generation triple combination therapies are being introduced.
`
` Actemra/RoActemra (+30%), for rheumatoid arthritis (RA), systemic juvenile idiopathic arthritis and
`polyarticular juvenile idiopathic arthritis. Sales continued to grow in all regions and reached 1 billion
`Swiss francs for the first time in 2013. The subcutaneous formulation for adults with moderately to
`severely active rheumatoid arthritis was approved in March in Japan, and in October in the United
`States. In December this formulation secured a positive recommendation from Europe’s regulatory
`agency (CHMP).
`
`Recently launched products
` Zelboraf (354 million Swiss francs), for BRAF V600 mutation-positive metastatic melanoma. Zelboraf is
`now the standard of care for BRAF mutation-positive metastatic melanoma in the United States and
`Europe. Zelboraf is now approved in 81 countries. Data from the coBRIM phase III combination study of
`Zelboraf and the MEK inhibitor cobimetinib in BRAF V600 mutation-positive metastatic melanoma is
`expected in 2014.
`
` Perjeta (326 million Swiss francs), for neoadjuvant HER2-positive breast cancer and first line HER2-
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`positive metastatic breast cancer. Perjeta is combined with Herceptin and chemotherapy to provide a
`more comprehensive blockade of HER2 signaling pathways. The Perjeta regimen has been shown to
`significantly extend overall survival and progression-free survival in patients with previously untreated
`HER2-positive mBC. Perjeta is now approved for this use in the United States, the EU (approval received
`in March 2013), Switzerland, Japan and 37 other countries. In October Perjeta received accelerated
`approval in the United States for neoadjuvant treatment (therapy before surgery) in patients with high-
`risk HER2-positive early stage breast cancer. Perjeta is performing well in the United States and has also
`been strong in several European countries, especially Germany and the UK.
`
` Kadcyla (234 million Swiss francs), for HER2-positive metastatic breast cancer in patients who have
`already been treated with Herceptin and taxane-based chemotherapy. Kadcyla is the first antibody drug
`conjugate (ADC) approved to treat HER2-positive breast cancer. An ADC is a targeted cancer medicine
`that can attach to certain types of cancer cells and deliver chemotherapy directly to them, resulting in a
`highly potent treatment that also has fewer adverse side effects. Kadcyla received regulatory approval in
`the United States in February, in Japan in September and in Europe in November. US demand has been
`strong and reimbursement discussions are currently underway in Europe and Japan.
`
` Gazyva (3 million Swiss francs), for chronic lymphocytic leukemia (CLL). Gazyva was given
`Breakthrough Therapy Designation by the FDA due to the significance of the positive progression-free
`
`survival (PFS) results from the Phase III CLL11 trial. The trial also showed that Gazyva, when combined
`
`with chlorambucil, significantly reduced the risk of disease worsening or death compared to the current
`
`standard of care, MabThera/Rituxan. Roche received regulatory approval in the United States in
`
`November and Gazyva was subsequently included in the CLL treatment guidelines of the National
`
`Comprehensive Cancer Network. Roche has also submitted marketing applications to other regulatory
`
`authorities, including the European Medicines Agency (EMA).
`
`
`
`Major clinical and regulatory news flow up to the end January 2014
`
`Compound
`Actemra subcutaneous
`Actemra subcutaneous
`RoActemra
`subcutaneous
`Actemra
`RoActemra
`aleglitazar
`
`Indication
`rheumatoid arthritis
`rheumatoid arthritis
`rheumatoid arthritis
`
`Milestone
`Japanese approval
`US approval
`CHMP positive opinion
`
`polyarticular juvenile idiopathic arthritis US approval
`polyarticular juvenile idiopathic arthritis EU approval
`Diabetes
`aleglitazar trials
`discontinued
`US approval
`
`metastatic colorectal cancer TML
`
`Avastin
`
`
`
`
`Q1 
`Q4 
`Q4 
`
`Q1 
`Q2 
`Q3 
`
`Q1 
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`Japanese approval
`
`newly diagnosed and relapsed
`glioblastoma
`newly diagnosed glioblastoma
`advanced cervical cancer
`
`ovarian cancer
`adjuvant HER2-positive breast cancer
`advanced basal cell carcinoma
`chronic lymphocytic leukemia
`
`EU filing (AVAglio)
`phase III study results
`(GOG240)
`Japanese approval
`phase III study
`conditional EU approval
`phase III study results
`(CLL11)
`US approval
`chronic lymphocytic leukemia
`Gazyva
`EU approval
`Herceptin subcutaneous HER2-positive breast cancer
`Kadcyla
`HER2-positive metastatic breast cancer US approval
`Kadcyla
`HER2-positive metastatic breast cancer
`phase III study results
`(TH3RESA)
`Japanese approval
`HER2-positive metastatic breast cancer
`EU approval
`HER2-positive metastatic breast cancer
`less frequent dosing regimen for wAMD US approval
`active GPA and MPA
`EU approval
`NHL (follicular lymphoma and diffuse
`CHMP positive opinion
`large B-cell lymphoma)
`chronic hepatitis C in children
`HER2-positive metastatic breast cancer
`HER2-positive metastatic breast cancer
`HER2-positive neoadjuvant breast
`cancer
`EGFR mutation-positive non-small cell
`lung cancer (first line)
`
`Avastin
`
`Avastin
`Avastin
`
`Avastin
`Avastin
`Erivedge
`Gazyva
`
`Kadcyla
`Kadcyla
`Lucentis
`MabThera
`MabThera
`subcutaneous
`Pegasys
`Perjeta
`Perjeta
`Perjeta
`
`Tarceva
`
`EU approval
`EU approval
`Japanese approval
`US approval
`
`US approval
`
`Tarceva
`
`non-small cell lung cancer adjuvant
`
`Xolair
`
`chronic idiopathic urticaria
`
`phase III study results
`(RADIANT)
`
`phase III study results
`(ASTERIA II)
`
`
`
`
`
`Q2 
`
`Q2 
`Q2 
`
`Q4 
`Q4 
`Q3 
`Q1 
`
`Q4 
`Q3 
`Q1 
`Q2 
`
`Q3 
`Q4 
`Q1 
`Q2 
`2014
`Q1 
`Q1 
`Q1 
`Q2 
`Q3 
`
`Q1 
`
`Q4 
`
`Q1 
`
`10/32
`
`IMMUNOGEN 2346, pg. 10
`Phigenix v. Immunogen
`IPR2014-00676
`
`

`

`
`Upcoming clinical news flow and pending regulatory decisions
`
`Compound
`bitopertin
`
`Indication
`schizophrenia
`
`Gazyva
`Kadcyla and Perjeta
`
`MabThera
`subcutaneous
`RoActemra
`subcutaneous
`Tarceva and
`onartuzumab
`Zelboraf and
`cobimetinib
`
`
`chronic lymphocytic leukemia
`metastatic HER2-positive breast cancer
`(first line)
`NHL (follicular lymphoma and diffuse
`large B-cell lymphoma)
`rheumatoid arthritis
`
`non-small cell lung cancer
`
`BRAF V600 mutation-positive
`metastatic melanoma
`
`Milestone
`phase III study results
`(SunLyte, TwiLyte, MoonLyte,
`NightLyte)
`EU approval
`phase III study results
`(MARIANNE)
`EU approval
`
`EU approval
`
`phase III study results
`(MetLung)
`phase III study results
`(co-BRIM)
`
`
`
`11/32
`
`IMMUNOGEN 2346, pg. 11
`Phigenix v. Immunogen
`IPR2014-00676
`
`

`

`% change in
`CHF
`+2
`+5
`-4
`-1
`+5
`+2
`-1
`+12
`+4
`-17
`0
`+4
`
`As %
`of sales
`100
`56
`23
`15
`6
`46
`25
`16
`8
`5
`20.8
`18.7
`
`In millions of
`CHF
`10,476
`5,740
`2,459
`1,612
`665
`4,825
`2,611
`1,746
`802
`492
`2,177
`1,962
`
`% change at
`CER*
`+4
`+8
`-3
`+2
`+7
`+2
`+1
`+14
`+13
`+2
`+4
`+9
`
`
`Diagnostics Division
`
`Diagnostics Division:
`Key figures - 2013
` Sales - Diagnostics Division
` Business
`Professional Diagnostics
` Areas
`Diabetes Care
`Molecular Diagnostics
`Tissue Diagnostics
` Regions Europe, Middle East, Africa
`North America
`Asia–Pacific
`Latin America
`Japan
` Core operating profit
` Operating free cash flow
`* Constant exchange rates
`
`The Diagnostics Division again grew ahead of the global in vitro diagnostics market8 with a 4% increase in
`sales to 10.5 billion Swiss francs in 2013. This was mainly due to strong demand from customers at clinical
`laboratories for products, especially from the Professional Diagnostics business area, which posted an 8%
`increase in sales. Diabetes Care sales decreased 3% as a result of the challenging market environment and
`reimbursement changes in blood glucose monitoring in some key markets, notably the United States.
`Molecular Diagnostics grew 2% and Tissue Diagnostics sales increased 7%.
`
`All regions contributed to growth: the main growth drivers were Asia–Pacific (+14%), EMEA (+2%,
`accounting for almost half of total Division sales) and Latin America (+13%).
`
`
`Professional Diagnostics (+8%). The business area further extended its position as market leader based on
`strong growth from the immunoassay (+14%) and clinical chemistry (+6%) businesses, while coagulation
`patient self-monitoring (+7%) and hematology (+9%) also supported this good performance. Asia–Pacific
`(+17%) and Latin America (+17%) were the main regional contributors to growth. The immunoassay
`business, which accounts for almost a quarter of total Division sales, includes tests for tumours, thyroid
`function, cardiac and women’s health and infectious disease markers. Sales of the vitamin D test, launched in
`the third quarter of 2012, grew over 50% in 2013. A key milestone for Professional Diagnostics was the
`launch of the new cobas 8100 pre- and post-analytics instrument. The system is available in all markets
`
`
`8 Market estimates from an independent IVD consultancy; data as of end Q3 2013
`
`
`
`12/32
`
`IMMUNOGEN 2346, pg. 12
`Phigenix v. Immunogen
`IPR2014-00676
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`

`except the United States, and uptake has been positive since its launch in September.
`
`In July 2013 Roche acquired US-based Constitution Medical Investors, Inc. (CMI). CMI is the developer of a
`highly innovative hematology testing system, which is designed to provide faster and more accurate diagnosis
`of blood-related diseases. This acquisition demonstrates Roche’s commitment to hematology testing. The
`business is reported as part of Professional Diagnostics.
`
`
`Diabetes Care (-3%). Sales decreased as a result of reimbursement cuts for blood glucose monitoring
`supplies, especially in North America (-15%), and ongoing price pressure in other key markets. Sales were
`stable in EMEA and declined in Japan (-3%) but increased in Asia–Pacific (+4%) and in Latin America
`(+2%).
`
`Demand for newer and more sophisticated products, such as Accu-Chek Mobile (+41%), remained strong,
`while sales of Accu-Chek Nano SmartView in the United States almost doubled. Sales of insulin delivery
`systems grew 1%. The next-generation Accu-Chek Active Meter and the next-generation no-code Accu-Chek
`Aviva/Performa Meter were launched in 2013 in all markets except the United States, where the no-code
`Accu-Chek Nano SmartView meter and test strips have been available since 2012. The Accu-Chek Aviva
`Expert system received FDA clearance in the United States in 2013.
`
`
`Molecular Diagnostics (+2%). The underlying sales growth of the Molecular Diagnostics business was 6%
`(excluding sequencing sales). The main growth contributors were tests for the human papilloma virus (HPV)
`(+90%), nucleic acid purification (NAP)/real-time PCR (qPCR) reagents and systems in the life sciences
`market (+6%), as well as products for blood screening (+2%). Demand for oncology companion diagnostic
`tests also showed significant growth (+70%). Sales growth was reported by all regions.
`
`
`Tests for sexually transmitted diseases (Chlamydia trachomatis/Neisseria gonorrhoeae) received a label
`expansion for the US market, while marketing clearance (CE Mark) in Europe was obtained for the
`microbiology portfolio (MRSA, MSSA and herpes simplex virus 1 and 2).
`
`
`Tissue Diagnostics (+7%). Sales growth was largely driven by advanced staining reagents, which grew 4%.
`All regions recorded strong sales growth except North America, where sales increased 1% due to US national
`reimbursement changes and new laboratory guidelines. The Ventana HER2 test label has been expanded to
`include Roche’s recently launched breast cancer medicines, Perjeta and Kadcyla, in markets outside the
`United States. Revenues from external personalised healthcare partners and sales of companion tests
`continued to grow. Tissue Diagnostics contributed to Roche’s existing cervical cancer testing portfolio with
`the CINtec Histology test (+31%) which is used to identify precancerous cervical lesions. In addition, the
`CINtec PLUS Cytology test, a fully automated cell based assay used in cervical cancer screening, obtained the
`
`
`
`13/32
`
`IMMUNOGEN 2346, pg. 13
`Phigenix v. Immunogen
`IPR2014-00676
`
`

`

`CE Mark in December 2013.
`
`With the cobas HPV test for screening, the CINtec p16 Histology test, and the CINtec PLUS Cytology test,
`Roche has the most complete cervical cancer screening and diagnosis portfolio to help women and healthcare
`professionals identify and manage cervical cancer early and avoid cases that could be missed by Pap smear
`screening alone.
`
`Diagnostics Division: Key product launches in 2013
`
`
`Area
`
`Product name
`
`Description
`
`Instruments/devices
`
`Laboratories
`
`cobas 8100
`
`next-generation modular pre- and post- analytics
`
`
`
`Accu-Chek Active
`
`next-generation blood glucose meter with maltose
`independent test strips
`
`Life sciences
`
`Tests/assays
`
`GS FLX+ long
`amplicons
`
`software for long-read targeted sequencing for DNA
`variant detection
`
`Oncology
`
`Calcitonin
`
`proGRP
`
`EGFR
`
`ER
`
`medullary thyroid cancer diagnosis and monitoring
`(immunoassay)
`
`diagnosis of small cell lung cancer (immunoassay)
`
`therapy selection for non-small cell lung cancer (PCR)
`
`breast cancer diagnosis (IHC tissue test)
`
`CINtec PLUS
`Cytology
`
`diagnosis of cervical precancer (immunocytochemistry
`test)
`
`HC