Investor Update
`
`
`
`
`
`
`Basel, 1 February 2017
`
`Roche reports good results in 2016
`
` 
`
` Group sales increase 4%1 at constant exchange rates, 5% in Swiss francs
` Pharmaceuticals Division sales up 3%, mainly driven by cancer medicines Perjeta and Herceptin as well
`as Actemra/RoActemra
` Diagnostics Division sales grow 7%, driven primarily by immunodiagnostic solutions
` Successful launches of four new medicines; five US FDA breakthrough therapy designations granted
` Emicizumab prophylaxis shows positive results in people with haemophilia A in pivotal trial
` Successful launch of new immunochemistry instrument cobas e 801
` Core earnings per share up 5% at constant exchange rates, 8% in Swiss francs
` Board proposes dividend increase to CHF 8.20
` Outlook for 2017: sales expected to grow low- to mid-single digit, at constant exchange rates. Core
`earnings per share targeted to grow broadly in line with sales, at constant exchange rates. Roche expects
`
`to further increase its dividend in Swiss francs.
`
`
`
`Key figures 2016
`
`CHF millions
`
`% change
`
`
`Group sales
`
`Pharmaceuticals Division
`
`Diagnostics Division
`
`Core operating profit
`
`Core EPS - diluted (CHF)
`
`IFRS net income
`
`
`
`
`
`
`
`
`
`2016
`
`50,576
`
`39,103
`
`11,473
`
`18,420
`
`
`
`14.53
`
`
`
`9,733
`
`2015
`
`CER1
`
`CHF
`
`48,145
`
`37,331
`
`10,814
`
`17,542
`
`
`
`13.49
`
`
`
`9,056
`
`+4
`
`+3
`
`+7
`
`+4
`
`
`
`+5
`
`
`
`+7
`
`+5
`
`+5
`
`+6
`
`+5
`
`
`
`+8
`
`
`
`+7
`
`
`1 Unless otherwise stated, all growth rates in this document are at constant exchange rates (CER: average 2015).
`
`
`
`
`
`F. Hoffmann-La Roche Ltd
`
`4070 Basel
`Switzerland
`
`Investor Relations
`email:
`investor.relations@roche.com
`
`Tel. +41 61 68-88880
`Fax +41 61 69-10014
`www.roche.com
`
`
`
`APOTEX EX. 1063-001
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`

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`Commenting on the Group’s results, Roche CEO Severin Schwan said: «I am pleased that we have again
`
`reached all our financial targets while our product portfolio has made significant progress. We brought four
`
`new medicines to market in less than a year, including our first cancer immunotherapy Tecentriq. In
`
`Diagnostics, we launched an immunodiagnostic instrument, the cobas e 801, which represents a major step
`
`forward in realising the connected laboratory. We again look forward to a number of important clinical read-
`
`outs and regulatory milestones for Roche medicines this year, reflecting our broad and innovative product
`
`pipeline.»
`
`Group results
`
`Good performance in both divisions
`
`Group sales rose 4% to CHF 50.6 billion. Despite high investments in the launch of new products and
`
`product development, core EPS grew faster than sales (+5%). Core EPS growth reflects the good underlying
`
`business performance and an impact from changes to the Group's Swiss pension plans. IFRS net income was
`
`up 7% at constant exchange rates and in Swiss francs.
`
`
`
`Sales in the Pharmaceuticals Division rose 3% to CHF 39.1 billion, driven by growth of Perjeta, Herceptin
`
`and Actemra/RoActemra, partially offset by lower sales of Pegasys, Tarceva and Lucentis.
`
`
`
`In the US, Pharmaceuticals sales advanced 3%, led by the respiratory medicines Xolair and Esbriet. The
`
`recently launched medicines Tecentriq and Alecensa contributed to the growth as well. Sales of eye drug
`
`Lucentis and cancer medicines Avastin and Tarceva declined due to growing use of other therapeutic
`
`options. In Europe, sales growth of 4% was driven by Perjeta, Actemra/RoActemra and MabThera/Rituxan.
`
`In Japan, sales grew 1% despite the biennial price cuts and a special price reduction rule for best-selling
`
`medicines. Tamiflu, Alecensa and Actemra/RoActemra were key sales contributors. In the International
`
`region, sales gained 4%, driven by the Asia-Pacific and Latin America subregions.
`
`
`
`Diagnostics divisional sales increased 7% to CHF 11.5 billion – above market growth. Centralised and Point
`
`of Care Solutions2 was the main contributor, led by its immunodiagnostics business.
`
`
`
`In the EMEA3 (+2%) and North America (+3%) regions, the division’s largest markets, the sales increases
`
`were led by Centralised and Point of Care Solutions. Sales growth in North America was partially offset by a
`
`decline in Diabetes Care business, which faced continued pricing pressure. The sales increase in Asia-Pacific
`
`(+16%) was mainly driven by China. In Latin America, sales advanced 18%. Sales growth in Japan (+2%) was
`
`also led by the Centralised and Point of Care Solutions business.
`
`
`
`
`2 Formerly Roche Professional Diagnostics
`3 EMEA= Europe, Middle East, Africa
`
`
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`APOTEX EX. 1063-002
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`
`High number of launches in Pharmaceuticals
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`Roche recently launched four new medicines: Cotellic (advanced melanoma), Alecensa (lung cancer),
`
`Venclexta (chronic lymphocytic leukemia; jointly commercialised with AbbVie) and Tecentriq (bladder and
`
`lung cancer). In addition, five FDA breakthrough therapy designations were granted for Roche medicines in
`
`2016. A major highlight was the US launch of Roche’s cancer immunotherapy medicine Tecentriq in May. It
`
`is the first FDA-approved treatment for people with a specific type of bladder cancer in more than 30 years.
`
`Furthermore, in October the FDA cleared Tecentriq for use in previously treated metastatic non-small cell
`
`lung cancer (NSCLC). The pivotal Oak trial showed that people with this form of lung cancer who received
`
`Tecentriq live significantly longer, regardless of their PD-L1 status, compared with those receiving
`
`chemotherapy. Additional data presented at the ECTRIMS4 congress in September showed that Roche’s
`
`ocrelizumab increased disease control in both relapsing and primary progressive multiple sclerosis (RMS and
`
`PPMS). Roche is seeking regulatory approval for this medicine in RMS and PPMS in the US and the EU. The
`
`US FDA’s action date for a decision is March 28, 2017.
`
`
`
`Roche also presented other important clinical results in 2016. A pivotal study in a group of people with
`
`haemophilia A (Haven 1) showed that prophylaxis with emicizumab led to a significant reduction in the
`
`number of bleeds over time. A phase III study by Chugai (J-Alex) found that first-line treatment with
`
`Alecensa significantly reduced the risk of disease worsening or death compared to crizotinib, the current
`
`standard of care, in people with ALK-positive NSCLC. While Gazyva/Gazyvaro showed positive results in a
`
`major clinical trial (Gallium) in follicular lymphoma, a separate trial (Goya) of the medicine in diffuse large
`
`B-cell lymphoma, did not reach its primary study goal. Also in 2016, Roche presented data from the largest
`
`clinical trial ever conducted in giant cell arteritis (GCA), a serious inflammatory disease of blood vessels.
`
`Initially combined with a steroid regimen, Actemra/RoActemra more effectively sustained remission
`
`compared to a steroid-only regimen in people with newly diagnosed and relapsing GCA.
`
`
`
`Further broadening the Diagnostics portfolio
`
`During 2016, Roche added nine key instruments and tests to its comprehensive portfolio, further improving
`
`decision-making in healthcare, and supporting laboratories’ efforts to increase efficiency. Among the new
`
`instruments are the cobas e 801 immunoassay module, the CoaguChek INRange system to monitor vitamin
`
`K antagonist therapy, and the Accu-Chek Guide, a next-generation blood glucose monitoring system.
`
`
`
`The US-FDA approved two accompanying diagnostics: the Ventana PD-L1 (SP142) test is a complementary
`
`diagnostic which determines PD-L1 status of patients with bladder and lung cancer. The cobas EGFR
`
`Mutation test v2 is a companion diagnostic for lung cancer medicine Tarceva. The FDA also granted
`
`
`4 European Committee for Treatment and Research in Multiple Sclerosis
`
`
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`3/24
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`APOTEX EX. 1063-003
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`

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`premarket clearance and a CLIA5 waiver for the cobas Liat Influenza A/B & RSV test. This is the first point-
`
`of-care test that extends molecular testing on the Liat system beyond influenza A/B and Streptococcus A to
`
`include respiratory syncytial virus (RSV). The FDA also approved Roche tests for the detection of Zika virus.
`
`
`
`Outlook for 2017
`
`In 2017, Roche expects sales to grow low- to mid-single digit, at constant exchange rates. Core earnings per
`
`share are targeted to grow broadly in line with sales, at constant exchange rates. Roche expects to further
`
`increase its dividend in Swiss francs.
`
`
`
`Dividend proposal
`
`The Board of Directors proposes a dividend increase to CHF 8.20 per share and non-voting equity security.
`
`Subject to approval by the Annual General Meeting of shareholders on 14 March 2017, this will be Roche’s
`
`30th consecutive annual dividend increase.
`
`
`
`
`Pharmaceuticals Division
`Key figures 2016
`In millions of CHF
`
`As % of sales
`
`% change
`
`
`Pharmaceuticals Division
`
`United States
`
`Europe
`
`Japan
`
`International*
`
`2016
`
`2015
`
`39,103
`
`37,331
`
`18,594
`
`17,616
`
`9,159
`
`3,711
`
`7,639
`
`8,734
`
`3,224
`
`7,757
`
`2016
`
`100
`
`49
`
`23
`
`9
`
`19
`
`2015 At CER
`
`In CHF
`
`100
`
`47
`
`23
`
`9
`
`21
`
`+3
`
`+3
`
`+4
`
`+1
`
`+4
`
`+5
`
`+6
`
`+5
`
`+15
`
`-2
`
`*Asia–Pacific, EEMEA (Eastern Europe, Middle East and Africa), Latin America, Canada,
`Others
`
`
`
`
`
`Key pharmaceutical products in 2016
`
`
`
`
`
`
`
`
`
`Herceptin, Perjeta and Kadcyla (combined +8%). For HER2-positive breast cancer and HER2-positive
`
`metastatic gastric cancer (Herceptin only). Herceptin sales were up 4%, helped by additional reimbursement
`
`approvals in China and continued growth in the US due to longer duration of treatment in combination with
`
`Perjeta. Perjeta sales (+26%) advanced particularly strongly in Europe and the US, where the medicine was
`
`approved for use before surgery in early breast cancer. Kadcyla sales (+7%) were fuelled by increasing
`
`demand in the International region, due mainly to expanded access in countries in which the medicine was
`
`newly launched.
`
`
`
`
`
`
`5 CLIA= Clinical Laboratory Improvement Amendments
`
`
`
`4/24
`
`APOTEX EX. 1063-004
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`

`

`MabThera/Rituxan (+3%). For common forms of blood cancer, rheumatoid arthritis and certain types of
`
`vasculitis. Sales continued to rise despite competitive pressure. Increasing demand was mainly seen in China,
`
`the US and Europe. Growth in China was supported by expanded regional access, largely in diffuse large B-
`
`cell lymphoma.
`
`
`
`Avastin (0%). For advanced colorectal, breast, lung, kidney, cervical and ovarian cancer, and relapsed
`
`glioblastoma (a type of brain tumour). Sales continued to grow strongly in the International region (+18%),
`
`especially China, following the approval of the lung cancer indication in 2015. Sales in the US, where Avastin
`
`is already broadly used in its approved indications, declined 5%, largely due to growing use of new
`
`immunotherapy agents in the lung cancer setting.
`
`
`
`Actemra/RoActemra (+16%). For rheumatoid arthritis and forms of juvenile idiopathic arthritis. Increasing
`
`use of Actemra/RoActemra as a single agent and of the subcutaneous formulation remained key growth
`
`drivers globally.
`
`
`
`Esbriet (+34%). For idiopathic pulmonary fibrosis (IPF). Sales continued to expand, mostly due to increasing
`
`use in people with moderate and progressive disease. Roche is stepping up its efforts in various markets to
`
`improve disease awareness and inform patients and caregivers of the need for early and sustained treatment
`
`of IPF.
`
`
`
`Gazyva/Gazyvaro (+52%). For chronic lymphocytic leukaemia (CLL) and rituximab-refractory follicular
`
`lymphoma. Sales expanded in the US and Europe despite increasing competition in CLL. Gazyva/Gazyvaro is
`
`now approved for CLL in more than 60 countries. Following US and EU approval of the medicine in
`
`previously treated follicular lymphoma in the first half of 2016, early uptake in this indication has been
`
`encouraging.
`
`
`
`Recently launched medicines showed good sales performance. Alecensa (CHF 182 million) is for people with
`
`ALK-positive advanced NSCLC whose disease has progressed on, or who are intolerant to crizotinib. There
`
`was very good uptake in the US, driven by strong demand in the previously treated patient population. Sales
`
`growth remained strong in Japan, where the medicine was launched in 2014 for a broader patient population,
`
`including people who have not received prior treatment with crizotinib. Following FDA approval of
`
`Tecentriq (CHF 157 million) in bladder and lung cancer, in May and October respectively, market uptake in
`
`the US has been strong. Cotellic (CHF 45 million) plus Zelboraf for BRAF-mutated metastatic melanoma
`
`showed good sales uptake, especially in major markets such as France and the US.
`
`
`
`
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`5/24
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`APOTEX EX. 1063-005
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`

`

`Top-selling
`
`Total sales
`
`United States
`
`Europe
`
`Japan
`
`International*
`
`pharmaceuticals
`
`CHF m % CHF m % CHF m % CHF m % CHF m %
`
`MabThera/Rituxan
`
`Avastin
`
`Herceptin
`
`Perjeta
`
`Actemra/RoActemra
`
`Xolair
`
`Lucentis
`
`7,300
`
`6,783
`
`6,782
`
`1,846
`
`1,697
`
`1,498
`
`1,406
`
`3
`
`0
`
`4
`
`26
`
`16
`
`15
`
`3,911
`
`2,964
`
`2,509
`
`905
`
`647
`
`1,498
`
`2
`
`-5
`
`3
`
`10
`
`15
`
`15
`
`-10
`
`1,406
`
`16
`
`1,062
`
`-10
`
`17
`
`1,879
`
`1,841
`
`2,055
`
`628
`
`558
`
`-
`
`-
`
`-
`
`3
`
`0
`
`2
`
`44
`
`18
`
`-
`
`-
`
`-
`
`291
`
`834
`
`309
`
`108
`
`284
`
`-
`
`-
`
`-
`
`11
`
`-2
`
`4
`
`12
`
`13
`
`-
`
`-
`
`-
`
`1,219
`
`1,144
`
`1,909
`
`205
`
`208
`
`-
`
`-
`
`46
`
`4
`
`18
`
`6
`
`74
`
`18
`
`-
`
`-
`
`3
`
`Activase/TNKase
`
`Tarceva
`
`Kadcyla
`
`1,108
`
`1,024
`
`831
`
`-15
`
`7
`
`560
`
`316
`
`-14
`
`0
`
`174
`
`331
`
`-22
`
`2
`
`104
`
`75
`
`-1
`
`13
`
`186
`
`109
`
`-17
`
`46
`
`* Asia-Pacific, EEMEA (Eastern Europe, Middle East and Africa), Latin America, Canada, Others.
`
`
`
`
`
`
`
`
`
`Diagnostics Division
`
`Key figures 2016
`
`
`Sales – Diagnostics Division
`
`Business
`areas
`
`Centralised and Point of
`Care Solutions
`
`Diabetes Care
`
`Molecular Diagnostics
`
`Tissue Diagnostics
`
`Europe, Middle East, Africa
`
`North America
`
`Regions
`
`Asia-Pacific
`
`Latin America
`
`Japan
`
`CHF
`millions
`
`% change
`
`CER
`
`CHF
`
`As % of
`sales
`
`11,473
`
`6,698
`
`2,016
`
`1,845
`
`914
`
`4,637
`
`3,007
`
`2,559
`
`792
`
`478
`
`+7
`
`+9
`
`-4
`
`+7
`
`+14
`
`+2
`
`+3
`
`+16
`
`+18
`
`+2
`
`+6
`
`+8
`
`-5
`
`+7
`
`+15
`
`+2
`
`+5
`
`+14
`
`+4
`
`+16
`
`100
`
`58
`
`18
`
`16
`
`8
`
`40
`
`26
`
`23
`
`7
`
`4
`
`
`
`
`
`
`
`
`
`6/24
`
`APOTEX EX. 1063-006
`
`

`

`Centralised and Point of Care Solutions (+9%) was the largest contributor to the division’s sales
`
`performance, led by the Asia-Pacific region, with continued strong growth in China (+23%).
`
`Its Integrated Serum Work Area solutions, comprising the immunodiagnostics (+13%) and clinical
`
`chemistry (+6%) segments, were the main drivers of this growth.
`
`
`
`In Molecular Diagnostics, including sequencing, sales rose 7%, led by the Asia-Pacific region. In virology,
`
`with its portfolio for the diagnosis and monitoring of hepatitis and HIV load, sales were up 9%. HPV
`
`(human papillomavirus) screening sales advanced 8%. The blood screening business grew 5%, supported by
`
`tender wins in many countries.
`
`
`
`Tissue Diagnostics sales increased 14%, strongly driven by sales in North America. Sales in the advanced
`
`staining portfolio and in primary staining were up 9% and 21% respectively. Companion diagnostic sales
`
`showed continued strong growth (+46%).
`
`
`
`The strong sales performance of the laboratory business was based on the combination of Roche’s rich
`
`portfolio of modern instrumentation, very broad test menu, integrated IT solutions and wide range of
`
`services for laboratories. The launch of next-generation instruments and a number of new tests further
`
`expanded this base.
`
`
`
`Diabetes Care sales decreased 4%, predominantly due to continued price pressure in the US. Higher sales
`
`were recorded in Latin America; sales in the Asia-Pacific region were stable, and they were down in EMEA
`
`and Japan.
`
`
`
`Roche’s Full Year Results 2016 – Presentation in London and live video webcast
`
`The Roche Full Year Results 2016 presentation takes place in London today. Further details are available
`
`here. A live video webcast will be available on http://ir.roche.com.
`
`
`
`About Roche
`
`Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve
`
`people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche
`
`the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best
`
`way possible.
`
`
`
`Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology,
`
`infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader
`
`in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
`
`
`
`7/24
`
`APOTEX EX. 1063-007
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`

`

`Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make
`
`a sustainable contribution to society. The company also aims for improving patient access to medical
`
`innovations by working with all relevant stakeholders. Twenty-nine medicines developed by Roche are
`
`included in the World Health Organization Model Lists of Essential Medicines, among them life-saving
`
`antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in
`
`sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry eight years in a row by the
`
`Dow Jones Sustainability Indices (DJSI).
`
`
`
`The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2016 employed
`
`more than 94,000 people worldwide. In 2016, Roche invested CHF 9.9 billion in R&D and posted sales of
`
`CHF 50.6 billion. 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.
`
`
`
`Additional information
`– Full Year 2016 Presentation: http://www.roche.com/irp170201-a.pdf
`– Full Year 2016 Presentation with appendix: http://www.roche.com/irp170201.pdf
`– Pharmaceuticals: major clinical and regulatory news flow in 2016:
`http://www.roche.com/pharmaar16e.pdf
`– Diagnostics: key diagnostics product launches in 2016: http://www.roche.com/diaar16e.pdf
`– Annual Report 2016 (includes corporate responsibility report): http://www.roche.com/annual_reports
`– Dow Jones Sustainability Indices: http://www.sustainability-indices.com/
`
`
`
`Roche Investor Relations
`
`Dr. Karl Mahler
`Phone: +41 61 68-78503
`e-mail: karl.mahler@roche.com
`
`Dr. Bruno Eschli
`Phone: +41 61 68-75284
`e-mail: bruno.eschli@roche.com
`
`Dr. Birgit Masjost
`Phone: +41 61 68-84814
`e-mail: birgit.masjost@roche.com
`
`
`
`
`
`Dr. Sabine Borngräber
`Phone: +41 61 68-88027
`e-mail: sabine.borngraeber@roche.com
`
`Dr. Tamer Farhan
`Phone: +41 61 68-82552
`e-mail: tamer.farhan@roche.com
`
`Dr. Susann Weissmüller
`Phone: +41 61-68-75619
`e-mail: susann.weissmueller@roche.com
`
`8/24
`
`APOTEX EX. 1063-008
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`

`

`Investor Relations North America
`
`Neera Dahiya Ravindran, MD
`Phone: +1 650 491 5281
`e-mail: ravindran.neera@gene.com
`
`Loren Kalm
`Phone: +1 650 225 3217
`e-mail: kalm.loren@gene.com
`
`
`
`Disclaimer: Cautionary statement regarding forward-looking statements
`This document contains certain forward-looking statements. These forward-looking statements may be identified by words such as
`‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of,
`among other things, strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from
`those reflected in forward-looking statements contained in this document, among others: (1) pricing and product initiatives of
`competitors; (2) legislative and regulatory developments and economic conditions; (3) delay or inability in obtaining regulatory
`approvals or bringing products to market; (4) fluctuations in currency exchange rates and general financial market conditions; (5)
`uncertainties in the discovery, development or marketing of new products or new uses of existing products, including without
`limitation negative results of clinical trials or research projects, unexpected side effects of pipeline or marketed products; (6)
`increased government pricing pressures; (7) interruptions in production; (8) loss of or inability to obtain adequate protection for
`intellectual property rights; (9) litigation; (10) loss of key executives or other employees; and (11) adverse publicity and news
`coverage. The statement regarding earnings per share growth is not a profit forecast and should not be interpreted to mean that
`Roche’s earnings or earnings per share for 2015 or any subsequent period will necessarily match or exceed the historical published
`earnings or earnings per share of Roche.
`
`
`
`9/24
`
`APOTEX EX. 1063-009
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`

`

`Appendix: Tables
`
`
`Sales January to December 2016 and 2015 ........................................................................................................................................................................................................................... 11
`1.
`2. Quarterly sales and constant exchange rate sales growth by Division in 2016 and 2015 ............................................................................................................................................... 12
`3.
`Pharmaceuticals Division ........................................................................................................................................................................................................................................................ 13
`4.
`Top 20 Pharmaceuticals Division product sales and constant exchange rate growth 2016 vs. 2015 ........................................................................................................................... 14
`5.
`Top 20 Pharmaceuticals Division quarterly product sales and quarterly constant exchange rate sales growth ........................................................................................................ 15
`6.
`Top 20 Pharmaceuticals Division quarterly product sales and quarterly constant exchange rate sales growth United States ................................................................................ 16
`7.
`Top 20 Pharmaceuticals Division quarterly product sales and quarterly constant exchange rate sales growth Europe........................................................................................... 17
`8.
`Top 20 Pharmaceuticals Division quarterly product sales and quarterly constant exchange rate sales growth Japan ............................................................................................. 18
`9.
`Top 20 Pharmaceuticals Division quarterly product sales and quarterly constant exchange rate sales growth International* .............................................................................. 19
`1.
`Roche Group consolidated income statement for the twelve months ended 31 December 2016 ................................................................................................................................ 20
`2.
`Roche Group core results reconciliation – Full Year 2016 ................................................................................................................................................................................................. 21
`3. Divisional core results reconciliation – Full Year 2016 ...................................................................................................................................................................................................... 22
`4.
`Roche Group consolidated balance sheet ............................................................................................................................................................................................................................. 23
`Roche Group consolidated statement of cash flows ............................................................................................................................................................................................................ 24
`5.
`
`
`
`
`10/24
`
`APOTEX EX. 1063-010
`
`

`

`1. Sales January to December 2016 and 2015
`
`CHF millions
`
`31 December
`
`Twelve months ended
`
`% change
`
`2016
`
`2015
`
`At CER
`
`In CHF
`
`Pharmaceuticals Division
`
`39,103
`
`37,331
`
`United States
`
`18,594
`
`17,616
`
`Europe
`
`Japan
`
`International*
`
`9,159
`
`3,711
`
`7,639
`
`8,734
`
`3,224
`
`7,757
`
`Diagnostics Division
`
`11,473
`
`10,814
`
`Roche Group
`
`50,576
`
`48,145
`
`3
`
`3
`
`4
`
`1
`
`4
`
`7
`
`4
`
`5
`
`6
`
`5
`
`15
`
`-2
`
`6
`
`5
`
`* Asia–Pacific, EEMEA (Eastern Europe, Middle East and Africa), Latin America, Canada, Others
`
`
`
`
`
`
`
`
`
`11/24
`
`APOTEX EX. 1063-011
`
`

`

`2. Quarterly sales and constant exchange rate sales growth by Division in 2016 and 2015
`
`
`
`% change
`
`
`
`% change
`
`
`
`% change
`
`
`
`% change
`
`
`
`% change
`
`CHF millions
`
`Q4 2015
`
`vs.
`
`Q1 2016
`
`vs.
`
`Q2 2016
`
`vs.
`
`Q3 2016
`
`vs.
`
`Q4 2016
`
`vs.
`
`
`
`Q4 2014
`
`
`
`Q1 2015
`
`
`
`Q2 2015
`
`
`
`Q3 2015
`
`
`
`Q4 2015
`
`Pharmaceuticals Division
`
`9,641
`
`United States
`
`4,569
`
`3
`
`3
`
`9,800
`
`4,716
`
`4
`
`3
`
`9,660
`
`4,557
`
`2,320
`
`5
`
`5
`
`6
`
`9,680
`
`4,577
`
`2,277
`
`2
`
`1
`
`5
`
`9,963
`
`4,744
`
`2,243
`
`3
`
`3
`
`2
`
`Europe
`
`Japan
`
`International*
`
`Diagnostics Division
`
`Roche Group
`
`2,258
`
`883
`
`1,931
`
`2,979
`
`12,620
`
`5
`
`2
`
`2
`
`7
`
`4
`
`2,319
`
`853
`
`1,912
`
`2,614
`
`12,414
`
`5
`
`4
`
`4
`
`5
`
`4
`
`903
`
`1,880
`
`2,948
`
`12,608
`
`1
`
`5
`
`8
`
`6
`
`934
`
`1,892
`
`2,803
`
`12,483
`
`-3
`
`1,021
`
`2
`
`8
`
`3
`
`1,955
`
`3,108
`
`13,071
`
`3
`
`3
`
`5
`
`3
`
`*Asia–Pacific, EEMEA (Eastern Europe, Middle East and Africa), Latin America, Canada, Others
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`12/24
`
`APOTEX EX. 1063-012
`
`

`

`3. Pharmaceuticals Division
`
`Top-selling pharmaceuticals
`and recent new launches
`
`Total
`
`United States
`
`Europe
`
`Japan
`
`International*
`
`January - December 2016
`
`CHF m
`
`%
`
`CHF m
`
`MabThera/Rituxan
`
`Avastin
`
`Herceptin
`
`Perjeta
`
`7,300
`
`6,783
`
`6,782
`
`1,846
`
`3
`
`0
`
`4
`
`26
`
`3,911
`
`2,964
`
`2,509
`
`905
`
`%
`
`2
`
`-5
`
`3
`
`10
`
`CHF m
`
`%
`
`CHF m
`
`1,879
`
`1,841
`
`2,055
`
`628
`
`3
`
`0
`
`2
`
`44
`
`291
`
`834
`
`309
`
`108
`
`%
`
`11
`
`-2
`
`4
`
`12
`
`CHF m
`
`1,219
`
`1,144
`
`1,909
`
`205
`
`%
`
`4
`
`18
`
`6
`
`74
`
`Actemra/RoActemra
`
`Xolair
`
`Lucentis
`
`Activase/TNKase
`
`Tarceva
`
`1,697
`
`1,498
`
`1,406
`
`1,108
`
`1,024
`
`16
`
`15
`
`-10
`
`16
`
`-15
`
`647
`
`1,498
`
`1,406
`
`1,062
`
`560
`
`15
`
`15
`
`-10
`
`17
`
`-14
`
`0
`
`558
`
`-
`
`-
`
`-
`
`174
`
`331
`
`18
`
`-
`
`-
`
`-
`
`-22
`
`2
`
`284
`
`-
`
`-
`
`-
`
`104
`
`75
`
`13
`
`-
`
`-
`
`-
`
`-1
`
`13
`
`208
`
`-
`
`-
`
`46
`
`186
`
`109
`
`18
`
`-
`
`-
`
`3
`
`-17
`
`46
`
`Kadcyla
`
`
`
`
`
`
`
`Recent new launches
`
`Esbriet
`
`Zelboraf
`
`Erivedge
`
`
`
`831
`
`
`
`768
`
`213
`
`203
`
`
`
`7
`
`
`
`34
`
`0
`
`21
`
`316
`
`
`
`569
`
`47
`
`134
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`44
`
`8
`
`12
`
`
`
`179
`
`118
`
`53
`
`
`
`17
`
`-7
`
`38
`
`
`
`-
`
`3
`
`-
`
`
`
`-
`
`-32
`
`-
`
`
`
`20
`
`45
`
`16
`
`27
`
`
`
`-17
`
`18
`
`58
`
`-8
`
`Gazyva
`
`Alecensa
`
`Tecentriq
`
`Cotellic
`
`196
`
`182
`
`157
`
`45
`
`52
`
`159
`
`-
`
`**
`
`116
`
`74
`
`154
`
`14
`
`49
`
`**
`
`-
`
`**
`
`53
`
`1
`
`2
`
`30
`
`148
`
`-
`
`-
`
`**
`
`-
`
`107
`
`-
`
`-
`
`-
`
`48
`
`-
`
`-
`
`* Asia–Pacific, EEMEA (Eastern Europe, Middle East and Africa), Latin America, Canada, Others
`
`** Over 500%
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`-
`
`1
`
`1
`
`
`
`
`
`-
`
`-
`
`-
`
`13/24
`
`APOTEX EX. 1063-013
`
`

`

`
`
`4. Top 20 Pharmaceuticals Division product sales and constant exchange rate growth 2016 vs. 2015
`
`CHF millions
`
`MabThera/Rituxan
`
`Avastin
`
`Herceptin
`
`Perjeta
`
`Total
`
`United States
`
`Europe
`
`Japan
`
`International*
`
`CHF m
`
`%
`
`CHF m
`
`7,300
`
`6,783
`
`6,782
`
`1,846
`
`3
`
`0
`
`4
`
`26
`
`3,911
`
`2,964
`
`2,509
`
`905
`
`%
`
`2
`
`-5
`
`3
`
`10
`
`CHF m
`
`%
`
`CHF m
`
`1,879
`
`1,841
`
`2,055
`
`628
`
`3
`
`0
`
`2
`
`44
`
`291
`
`834
`
`309
`
`108
`
`%
`
`11
`
`-2
`
`4
`
`12
`
`CHF m
`
`1,219
`
`1,144
`
`1,909
`
`205
`
`%
`
`4
`
`18
`
`6
`
`74
`
`Actemra/RoActemra
`
`Xolair
`
`Lucentis
`
`Activase/TNKase
`
`Tarceva
`
`1,697
`
`1,498
`
`1,406
`
`1,108
`
`1,024
`
`16
`
`15
`
`-10
`
`16
`
`-15
`
`647
`
`1,498
`
`1,406
`
`1,062
`
`560
`
`15
`
`15
`
`-10
`
`17
`
`-14
`
`0
`
`558
`
`-
`
`-
`
`-
`
`174
`
`331
`
`18
`
`-
`
`-
`
`-
`
`-22
`
`2
`
`284
`
`-
`
`-
`
`-
`
`104
`
`75
`
`13
`
`-
`
`-
`
`-
`
`-1
`
`13
`
`208
`
`-
`
`-
`
`46
`
`186
`
`109
`
`18
`
`-
`
`-
`
`3
`
`-17
`
`46
`
`Kadcyla
`
`Tamiflu
`
`Esbriet
`
`CellCept
`
`Pulmozyme
`
`Mircera
`
`831
`
`794
`
`768
`
`741
`
`685
`
`512
`
`7
`
`10
`
`34
`
`-6
`
`4
`
`2
`
`316
`
`467
`
`569
`
`172
`
`474
`
`-
`
`-14
`
`44
`
`-16
`
`2
`
`-
`
`101
`
`179
`
`176
`
`122
`
`87
`
`**
`
`17
`
`-2
`
`7
`
`-1
`
`122
`
`-
`
`71
`
`-
`
`219
`
`64
`
`-
`
`13
`
`-
`
`2
`
`10
`
`104
`
`20
`
`322
`
`89
`
`206
`
`284
`
`16
`
`-17
`
`-5
`
`15
`
`3
`
`-10
`
`Xeloda
`
`NeoRecormon/Epogin
`
`Valcyte/Cymevene
`
`Rocephin
`
`Madopar
`
`506
`
`328
`
`306
`
`298
`
`290
`
`-3
`
`-9
`
`-17
`
`7
`
`6
`
`79
`
`-
`
`77
`
`1
`
`-
`
`38
`
`-
`
`-15
`
`-
`
`-
`
`32
`
`141
`
`116
`
`37
`
`99
`
`-26
`
`-9
`
`-24
`
`-2
`
`2
`
`111
`
`47
`
`-
`
`30
`
`16
`
`-12
`
`-
`
`-12
`
`-5
`
`140
`
`113
`
`230
`
`175
`
`* Asia–Pacific, EEMEA (Eastern Europe, Middle East and Africa), Latin America, Canada, Others
`
`
`
`
`
`
`
`
`
`
`
`
`
`-9
`
`-9
`
`11
`
`9
`
`14/24
`
`
`
`
`
`APOTEX EX. 1063-014
`
`

`

`5. Top 20 Pharmaceuticals Division quarterly product sales and quarterly constant exchange rate sales growth
`
`CHF millions
`
`Q4 2015
`
`vs.
`
`Q1 2016
`
`vs.
`
`Q2 2016
`
`vs.
`
`Q3 2016
`
`vs.
`
`Q4 2016
`
`vs.
`
`
`
`% change
`
`
`
`% change
`
`
`
`% change
`
`
`
`% change
`
`
`
`% change
`
`MabThera/Rituxan
`
`Avastin
`
`
`
`Q4 2014
`
`
`
`Q1 2015
`
`
`
`Q2 2015
`
`
`
`Q3 2015
`
`
`
`Q4 2015
`
`1,777
`
`1,716
`
`1,659
`
`4
`
`9
`
`10
`
`1,825
`
`1,706
`
`1,725
`
`3
`
`4
`
`4
`
`1,877
`
`1,724
`
`1,709
`
`5
`
`4
`
`5
`
`1,782
`
`1,684
`
`1,691
`
`0
`
`-3
`
`4
`
`1,816
`
`1,669
`
`1,657
`
`2
`
`-4
`
`0
`
`Herceptin
`
`Perjeta
`
`Actemra/RoActemra
`
`Xolair
`
`Lucentis
`
`Activase/TNKase
`
`410
`
`390
`
`345
`
`378
`
`259
`
`50
`
`25
`
`22
`
`-17
`
`36
`
`439
`
`386
`
`356
`
`355
`
`276
`
`258
`
`33
`
`14
`
`22
`
`-13
`
`21
`
`-14
`
`467
`
`428
`
`375
`
`349
`
`261
`
`262
`
`35
`
`21
`
`17
`
`-10
`
`17
`
`-17
`
`473
`
`433
`
`389
`
`373
`
`270
`
`245
`
`24
`
`15
`
`13
`
`-1
`
`12
`
`-18
`
`467
`
`450
`
`378
`
`329
`
`301
`
`259
`
`14
`
`14
`
`8
`
`-14
`
`15
`
`-11
`
`Tarceva
`
`Kadcyla
`
`Tamiflu
`
`Esbriet
`
`CellCept
`
`Pulmozyme
`
`287
`
`211
`
`170
`
`177
`
`203
`
`180
`
`-9
`
`36
`
`-67
`
`296
`
`13
`
`8
`
`201
`
`367
`
`178
`
`189
`
`160
`
`11
`
`-6
`
`96
`
`-4
`
`7
`
`207
`
`43
`
`180
`
`184
`
`177
`
`123
`
`10
`
`5
`
`24
`
`-5
`
`10
`
`7
`
`208
`
`93
`
`213
`
`186
`
`167
`
`134
`
`5
`
`-23
`
`35
`
`-5
`
`0
`
`-16
`
`215
`
`291
`
`197
`
`182
`
`181
`
`137
`
`2
`
`72
`
`10
`
`-10
`
`1
`
`23
`
`Mircera
`
`Xeloda
`
`NeoRecormon/Epogin
`
`Valcyte/Cymevene
`
`Rocephin
`
`Madopar
`
`106
`
`129
`
`94
`
`99
`
`73
`
`71
`
`-1
`
`-9
`
`-6
`
`-41
`
`-1
`
`-9
`
`118
`
`111
`
`79
`
`78
`
`82
`
`71
`
`0
`
`-17
`
`-14
`
`-21
`
`5
`
`20
`
`119
`
`82
`
`82
`
`75
`
`69
`
`-5
`
`-8
`
`-6
`
`18
`
`-4
`
`120
`
`83
`
`67
`
`75
`
`74
`
`-6
`
`-7
`
`-18
`
`18
`
`4
`
`156
`
`84
`
`79
`
`66
`
`76
`
`18
`
`-7
`
`-20
`
`-9
`
`6
`
`15/24
`
`
`
`
`
`APOTEX EX. 1063-015
`
`

`

`6. Top 20 Pharmaceuticals Division quarterly product sales and quarterly constant exchange rate sales growth United States
`
`
`
`% change
`
`
`
`% change
`
`
`
`% change
`
`
`
`% change
`
`
`
`% change
`
`CHF millions
`
`Q4 2015
`
`vs.
`
`Q1 2016
`
`vs.
`
`Q2 2016
`
`vs.
`
`Q3 2016
`
`vs.
`
`Q4 2016
`
`vs.
`
`
`
`Q4 2014
`
`
`
`Q1 2015
`
`
`
`Q2 2015
`
`
`
`Q3 2015
`
`
`
`Q4 2015
`
`MabThera/Rituxan
`
`Avastin
`
`Herceptin
`
`938
`
`772
`
`599
`
`7
`
`11
`
`13
`
`978
`
`775
`
`651
`
`0
`
`-2
`
`4
`
`1,023
`
`763
`
`630
`
`6
`
`0
`
`6
`
`932
`
`723
`
`617
`
`-3
`
`-9
`
`0
`
`978
`
`703
`
`611
`
`222
`
`3
`
`-10
`
`1
`
`1
`
`Perjeta
`
`Actemra/RoActemra
`
`Xolair
`
`Lucentis
`
`Activase/TNKase
`
`Tarceva
`
`217
`
`153
`
`345
`
`378
`
`246
`
`160
`
`31
`
`32
`
`22
`
`-17
`
`36
`
`1
`
`224
`
`145
`
`356
`
`355
`
`265
`
`136
`
`15
`
`12
`
`22
`
`-13
`
`21
`
`-15
`
`230
`
`164
`
`375
`
`349
`
`250
`
`141
`
`16
`
`23
`
`17
`
`-10
`
`18
`
`-17
`
`229
`
`165
`
`389
`
`373
`
`258
`
`135
`
`8
`
`13
`
`13
`
`-1
`
`12
`
`-16
`
`173
`
`378
`
`329
`
`289
`
`148
`
`78
`
`11
`
`8
`
`-14
`
`16
`
`-8
`
`-2
`
`Kadcyla
`
`Tamiflu
`
`Esbriet
`
`CellCept
`
`Pulmozyme
`
`Mircera
`
`79
`
`121
`
`124
`
`54
`
`128
`
`-
`
`12
`
`-74
`
`*
`
`29
`
`19
`
`-
`
`79
`
`251
`
`127
`
`45
`
`112
`
`-
`
`-2
`
`-15
`
`145
`
`0
`
`6
`
`-
`
`80
`
`12
`
`134
`
`43
`
`121
`
`-
`
`7
`
`-45
`
`32
`
`-18
`
`7
`
`-
`
`79
`
`63
`
`158
`
`46
`
`116
`
`-
`
`-1
`
`-39
`
`38
`
`-13
`
`0
`
`-
`
`-21
`
`141
`
`150
`
`38
`
`125
`
`-
`
`52
`
`16
`
`19
`
`-31
`
`-4
`
`-
`
`312
`
`Xeloda
`
`NeoRecormon/Epogin
`
`Valcyte/Cymevene
`
`Rocephin
`
`Madopar
`
`* Ov