Investor Update
`
`
`
`
`
`
`
`Basel, 27 April 2017
`
`
`
`Roche reports a good start in 2017
`
` 
`
` Group sales increase 4%1 at constant exchange rates and in Swiss francs
` Pharmaceuticals Division sales up 3%, driven mainly by Tecentriq and Perjeta
` Diagnostics Division sales grow 6%, primarily due to immunodiagnostic solutions
` US FDA approves Ocrevus to treat two forms of multiple sclerosis
` EU approves Alecensa for the treatment of a specific form of lung cancer
` Successful phase III Aphinity study of Perjeta treatment regimen in early breast cancer
` Outlook for 2017 confirmed
`
`
`
`
`Sales
`
`
`
`
`
`
`
`
`
`
`
`
`
`CHF millions
`
`As % of sales
`
`% change
`
`January - March 2017
`
`2017
`
`2016
`
`2017
`
`2016
`
`Group sales
`
`
`Pharmaceuticals Division
`
`United States
`
`Europe
`
`12,942
`
`
`10,177
`
`5,070
`
`2,273
`
`12,414
`
`
`9,800
`
`4,716
`
`2,319
`
`100
`
`
`79
`
`39
`
`18
`
`100
`
`
`79
`
`38
`
`19
`
`At
`CER
`
`In
`CHF
`
`+4
`
`
`+3
`
`+6
`
`+1
`
`+4
`
`
`+4
`
`+8
`
`-2
`
`Japan
`
`International*
`
`
`
`856
`
`1,978
`
`
`
`853
`
`1,912
`
`
`
`Diagnostics Division
`
`2,765
`
`2,614
`
`7
`
`15
`
`
`
`21
`
`*Asia–Pacific, EEMEA (Eastern Europe, Middle East and Africa), Latin America, Canada, Others
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`0
`
`+3
`
`
`
`+6
`
`7
`
`15
`
`
`
`21
`
`-2
`
`+1
`
`
`
`+6
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`1 Unless otherwise stated, all growth rates in this document are at constant exchange rates (CER: average 2016).
`
`
`
`
`
`F. Hoffmann-La Roche Ltd
`
`
`
`
`
`4070 Basel
`Switzerland
`
`Investor Relations
`investor.relations@roche.com
`
`Tel. +41 61 68-88880
`www.roche.com
`
`1/19
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`Commenting on the Group’s results, Roche CEO Severin Schwan said: «We have started the year with good
`
`growth in both our Pharmaceuticals and Diagnostics Divisions and with important positive clinical study
`
`results. A highlight of the first quarter was the US approval of our medicine Ocrevus for the treatment of
`
`multiple sclerosis (MS). Ocrevus is the first and only FDA approved medicine for both relapsing and primary
`
`progressive forms of MS and represents a new era for the treatment of this disease. We are well on track to
`
`meet our full-year targets.»
`
`
`Group results
`Good sales growth in both divisions
`
`Group sales rose 4% to CHF 12.9 billion. Sales in the Pharmaceuticals Division increased 3% to CHF 10.2
`
`billion, driven by very good early uptake of Tecentriq and continued strong growth of Perjeta and partially
`
`offset by lower sales of Tamiflu. In the US, sales advanced 6%, led by the recently launched medicines
`
`Tecentriq and Alecensa, as well as Xolair and MabThera/Rituxan. Sales of Tamiflu declined due to
`
`competition from generics. In Europe (+1%), Perjeta, Actemra/RoActemra and Herceptin were the main
`
`contributors to sales growth. In the International region, sales advanced 1%, led by the Latin America and
`Asia–Pacific subregions. In Japan (-2%), sales were impacted by government price reductions in April 2016.
`
`
`Diagnostics Division sales increased 6% to CHF 2.8 billion. Centralised and Point of Care Solutions2 was the
`
`main contributor, led by the growth of its immunodiagnostics business (+13%). In regional terms, growth
`was driven in particular by Asia–Pacific (+13%) and Latin America (+21%). In EMEA3 (+2%) and Japan
`(+4%), sales increases were led by Centralised and Point of Care Solutions, and in North America (+4%) by
`
`Tissue Diagnostics.
`
`
`
`Important new product approvals in Pharmaceuticals
`
`The US Food and Drug Administration (FDA) approved Ocrevus for the treatment of two forms of multiple
`
`sclerosis (MS); relapsing MS (RMS) and primary progressive MS (PPMS). Ocrevus is an important new
`
`treatment option for people with RMS, and due to the favourable benefit-risk profile has the potential to
`
`change disease course. It is also the first and only medicine approved to treat PPMS, a particularly disabling
`form of MS. Multiple sclerosis, for which there is currently no cure,4 is a chronic disease that affects an
`estimated 2.3 million people around the world. The European Commission granted Alecensa a conditional
`marketing authorisation as monotherapy for adult patients with ALK5-positive advanced non-small cell lung
`
`cancer (NSCLC) previously treated with crizotinib.
`
`
`
`2 Formerly Roche Professional Diagnostics
`3 EMEA = Europe, Middle East and Africa
`4 Multiple Sclerosis International Federation. (2013). Atlas of MS 2013. Available at: http://www.msif.org/about-us/advocacy/atlas/.
`5 ALK = anaplastic lymphoma kinase
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`Clinical trial results support key new indications for Roche medicines
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`Roche communicated important clinical results in the first quarter of 2017. The phase III Aphinity study
`
`with Roche’s Perjeta regimen met its primary endpoint. It showed that adjuvant (after surgery) treatment
`
`with the combination of Perjeta, Herceptin and chemotherapy achieved a statistically significant reduction in
`
`the risk of recurrence of invasive disease or death in people with HER2-positive early breast cancer compared
`
`with Herceptin and chemotherapy alone. Encouraging results from the Tecentriq phase II study IMmotion
`
`150 were presented: the study compared Tecentriq plus Avastin as well as Tecentriq monotherapy to the
`
`treatment with sunitinib in people with previously untreated, locally advanced or metastatic renal cell
`
`carcinoma.
`
`The phase III Alur study met its primary endpoint, showing that Alecensa significantly improved
`
`progression-free survival (PFS) in people with ALK-positive advanced NSCLC who had progressed following
`
`treatment with platinum-based chemotherapy and crizotinib, compared with chemotherapy. In addition, in
`
`early April Roche announced that the phase III Alex study met its primary endpoint, showing that Alecensa
`
`as initial (first-line) treatment significantly improved PFS compared with crizotinib in people with ALK-
`
`positive NSCLC.
`
`
`
`The US FDA accepted Roche’s supplemental Biologics License Application and granted priority review for
`
`Actemra/RoActemra for giant cell arteritis (GCA), a form of vasculitis. The FDA also granted breakthrough
`
`therapy designation for MabThera/Rituxan, in pemphigus vulgaris, a rare skin disease.
`
`
`
`New generation of diagnostics products
`The cobas HPV DNA test for cobas 6800/8800 systems was launched in the EU and other markets accepting
`
`the CE-mark, and the US FDA cleared the CINtec Histology test to aid in the diagnosis of cervical pre-
`
`cancer. These tests are a key part of Roche’s cervical cancer prevention portfolio. Human papillomavirus
`
`(HPV) is the cause of almost all cases of cervical cancer, a leading cause of death in women.
`
`
`
`The cobas Liat PCR system was launched in markets accepting the CE-mark. This real-time PCR system
`
`covers four assays, including a test for the rapid detection of Clostridium difficile. Timely and accurate
`
`diagnosis of this infection is important because it can quickly become life-threatening. In the US, the FDA
`
`approved Roche's cobas e 801 module for high-volume immunology testing. The Accu-Chek Instant system
`
`for effortless, reliable and affordable blood glucose monitoring was introduced in various markets in the EU.
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`Outlook for 2017 confirmed
`
`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.
`
`Pharmaceuticals Division
`
`Top-selling
`
`Pharmaceuticals
`January - March
`2017
`
`MabThera/Rituxan
`
`Herceptin
`
`Avastin
`
`Perjeta
`
`Total
`
`United States
`
`Europe
`
`Japan
`
`International*
`
`CHFm
`
`%
`
`CHFm
`
`%
`
`CHFm
`
`%
`
`CHFm
`
`%
`
`CHFm
`
`%
`
`1,899
`
`1,756
`
`1,684
`
`524
`
`4
`
`2
`
`-2
`
`19
`
`15
`
`1,045
`
`680
`
`765
`
`257
`
`177
`
`6
`
`3
`
`-2
`
`14
`
`21
`
`465
`
`522
`
`446
`
`176
`
`147
`
`1
`
`3
`
`-3
`
`21
`
`17
`
`62
`
`67
`
`181
`
`26
`
`64
`
`-3
`
`-4
`
`-8
`
`7
`
`4
`
`327
`
`487
`
`292
`
`65
`
`57
`
`4
`
`0
`
`7
`
`47
`
`7
`
`Actemra/RoActemra
`
`Xolair
`
`Lucentis
`
`Activase/TNKase
`
`Tamiflu
`
`Kadcyla
`
`445
`
`437
`
`392
`
`316
`
`270
`
`222
`
`22
`
`9
`
`13
`
`-27
`
`11
`
`437
`
`392
`
`305
`
`156
`
`89
`
`22
`
`9
`
`14
`
`-39
`
`11
`
`0
`
`0
`
`0
`
`13
`
`84
`
`0
`
`0
`
`0
`
`-30
`
`5
`
`0
`
`0
`
`0
`
`65
`
`16
`
`0
`
`0
`
`0
`
`5
`
`-9
`
`0
`
`0
`
`11
`
`36
`
`33
`
`0
`
`0
`
`0
`
`-4
`
`49
`
`* Asia–Pacific, EEMEA (Eastern Europe, Middle East and Africa), Latin America, Canada, Others
`
`
`
`
`
`
`
`
`Key pharmaceutical products in 2017
`
`Herceptin, Perjeta and Kadcyla (combined +6%). For HER2-positive breast cancer and HER2-positive
`
`metastatic gastric cancer (Herceptin only). Herceptin sales were up 2%, led by growth in Brazil and the US
`
`and helped by additional reimbursement approvals and broader use in China. Perjeta (+19%) experienced
`
`strong sales growth in Europe and the US. Sales of Kadcyla (+11%) were fuelled by increasing uptake in
`
`International region countries where the medicine was recently launched and in the US.
`
`
`
`MabThera/Rituxan (+4%). For common forms of blood cancer, rheumatoid arthritis and certain types of
`
`vasculitis. Sales continued to rise despite competitive pressure. Increasing sales were seen mainly in the US
`
`and the International region. Growth in China was supported by additional reimbursement approvals and
`
`expanded regional access, mainly in diffuse large B cell lymphoma.
`
`
`
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`

`

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`
`
`
`Avastin (-2%). For advanced colorectal, breast, lung, kidney, cervical and ovarian cancer, and relapsed
`
`glioblastoma (a type of brain tumour). Sales continued to grow in the International region (+7%). In the US,
`
`where Avastin is already broadly used in its approved indications, sales declined 2%, largely due to growing
`
`use of new cancer immunotherapy agents in lung cancer.
`
`
`
`Actemra/RoActemra (+15%). For rheumatoid arthritis and forms of juvenile idiopathic arthritis. Increasing
`
`use of Actemra/RoActemra as a single agent (monotherapy) and of the subcutaneous formulation of the
`
`medicine remained a key growth driver globally. Actemra/RoActemra remains the leader in monotherapy in
`
`the five largest EU markets.
`
`
`
`Esbriet (+13%). For idiopathic pulmonary fibrosis (IPF). Sales continued to expand, mostly due to increasing
`
`use in people with moderate and progressive disease.
`
`
`
`Gazyva/Gazyvaro (+48%). For chronic lymphocytic leukaemia (CLL) and rituximab-refractory follicular
`
`lymphoma. Sales expanded in all regions where this product has been launched, despite increasing
`
`competition in CLL.
`
`
`
`Recently launched Roche medicines recorded good sales performance in the first quarter. Tecentriq sales
`
`totalled CHF 113 million; following FDA approval of the medicine in bladder and lung cancer in 2016,
`
`market uptake in the US has been very good. Alecensa (CHF 68 million), for people with ALK-positive
`
`advanced NSCLC whose disease has progressed on, or who are intolerant to crizotinib, showed very good
`
`uptake in the US and sales growth remained strong in Japan.
`
`
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`
`
`Diagnostics Division
`
`Sales
`
`January - March 2017
`
`Diagnostics Division
`
`
`Business Areas:
`Centralised and Point of Care Solutions
`
`Diabetes Care
`
`Molecular Diagnostics
`
`Tissue Diagnostics
`
`CHF millions
`
`As % of sales
`
`% change
`
`2017
`
`2016
`
`2017
`
`2016
`
`At CER
`
`In CHF
`
`2,765
`
`2,614
`
`
`
`
`
`1,641
`
`1,519
`
`447
`
`441
`
`236
`
`443
`
`446
`
`206
`
`100
`
`
`
`59
`
`16
`
`16
`
`9
`
`100
`
`
`
`58
`
`17
`
`17
`
`8
`
`
`
`+6
`
`
`
`+9
`
`+1
`
`-2
`
`+15
`
`
`
`+6
`
`
`
`+8
`
`+1
`
`-1
`
`+15
`
`
`
`
`Regions:
`Europe, Middle East, Africa
`
`North America
`
`Asia–Pacific
`
`Latin America
`
`Japan
`
`
`
`
`
`
`
`
`1,126
`
`1,130
`
`740
`
`594
`
`203
`
`102
`
`703
`
`529
`
`157
`
`95
`
`
`
`41
`
`27
`
`21
`
`7
`
`4
`
`43
`
`27
`
`20
`
`6
`
`4
`
`+2
`
`+4
`
`+13
`
`+21
`
`+4
`
`0
`
`+5
`
`+12
`
`+29
`
`+7
`
`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%).
`
`Integrated Serum Work Area solutions, comprising the immunodiagnostics (+13%) and clinical chemistry
`
`(+3%) segments, were the main drivers of this growth. Already available in the EU and markets accepting
`
`the CE-mark, the cobas e 801 module, for immunodiagnostics, was approved in the US. The new system
`
`doubles the currently available immunochemistry testing capacity over the same floor space, requires only
`
`low sample volume, and delivers fast results. The recently launched cobas m 511 integrated haematology
`
`analyser has been very well received by customers.
`
`
`
`Sales in Molecular Diagnostics, including sequencing, declined 2%. HPV screening sales advanced 3%. In
`
`virology, which includes Roche’s portfolio for the diagnosis and monitoring of hepatitis B, hepatitis C and
`
`HIV, sales declined 6%, impacted by the phasing of certain testing programmes by non-government
`
`organisations and a base effect from prior year strong HCV sales. Sales in the blood screening business (-4%)
`
`were affected by the timing of tender renewals in several markets.
`
`
`
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`
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`6/19
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`APOTEX EX. 1064-006
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`
`
`The cobas HPV DNA test adds to the growing CE-IVD menu on the cobas 6800/8800 systems and enables
`
`laboratories to run HPV DNA testing simultaneously with our portfolio of other previously released cobas
`
`assays. The cobas Liat System for point-of-care testing includes Europe’s first real-time PCR test for
`
`suspected infections with Clostridium difficile and provides results in less than 20 minutes.
`
`
`
`Tissue Diagnostics sales increased 15%, driven strongly by sales in North America and EMEA. Sales in the
`
`advanced staining portfolio and in primary staining were up 11% and 14%, respectively. The companion
`
`diagnostics business grew 40%. The CINtech Histology test, now approved by the FDA, completes the
`
`cervical cancer testing portfolio in the US.
`
`
`
`Roche’s unique combination of molecular, cellular and tissue-based diagnostic tests for screening and
`
`diagnosis of HPV infection provides healthcare professionals with important information to help them make
`
`patient care decisions and minimise unnecessary treatment.
`
`
`
`Diabetes Care sales increased 1%, supported by the launch of the Accu-Chek Guide and the Accu-Chek
`
`Instant systems for strip-based blood glucose testing and management. Higher sales were recorded in Latin
`
`America. Sales were stable in the EMEA and North America regions, and declined in Asia–Pacific and Japan.
`
`
`Roche’s First Quarter Sales 2017 Conference Call
`
`There will be a conference call for investors and analysts today, Thursday, 27 April at 2:00 pm CEST.
`
`Please dial in to the conference call 10-15 min. prior to the scheduled start, using the following numbers:
`
`
`
`
`
`
`
`+41 (0) 58 310 5000 (Europe and ROW)
`
`+44 (0) 203 059 5862 (UK)
`
`+1 (1) 631 570 5613 (USA)
`
`Alternatively a live audio webcast can be accessed via 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.
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`
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`7/19
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`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.
`
`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.
`
`First Quarter 2017 Sales Presentation with appendix: www.roche.com/irp1q17.pdf
`
`All trademarks used or mentioned in this release are protected by law.
`
`
`Additional information
`–
`–
`First Quarter 2017 Sales Presentation: www.roche.com/irp1q17-a.pdf
`– Diagnostics: key product launches in 2017: www.roche.com/diaq117.pdf
`– Annual Report 2016: www.roche.com/annual_reports
`– Dow Jones Sustainability Indices: 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. 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
`
`
`
`
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`8/19
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`APOTEX EX. 1064-008
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`
`
`
`Dr. Birgit Masjost
`Phone: +41 61 68-84814
`e-mail: birgit.masjost@roche.com
`
`Investor Relations North America
`
`Neera Dahiya Ravindran, MD
`Phone: +1 650 491 5281
`e-mail: ravindran.neera@gene.com
`
`Dr. Susann Weissmüller
`Phone: +41 61-68-75619
`e-mail: susann.weissmueller@roche.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 2016 or any subsequent period will necessarily match or exceed the historical published
`earnings or earnings per share of Roche.
`
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`9/19
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`

`
`Appendix: Tables
`
`
`
`
`1.
`
`Sales January to March 2017 and 2016 ......................................................................................................................................................................................................11
`
`2. Quarterly sales and constant exchange rate sales growth by Division in 2017 and 2016 ...................................................................................................................12
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`8.
`
`9.
`
`
`
`
`
`Pharmaceuticals Division ............................................................................................................................................................................................................................13
`
`Top 20 Pharmaceuticals Division product sales and constant exchange rate growth Q1 2017 vs. Q1 2016 ...................................................................................14
`
`Top 20 Pharmaceuticals Division quarterly product sales and quarterly constant exchange rate sales growth .............................................................................15
`
`Top 20 Pharmaceuticals Division quarterly product sales and quarterly constant exchange rate sales growth United States .....................................................16
`
`Top 20 Pharmaceuticals Division quarterly product sales and quarterly constant exchange rate sales growth Europe ................................................................17
`
`Top 20 Pharmaceuticals Division quarterly product sales and quarterly constant exchange rate sales growth Japan...................................................................18
`
`Top 20 Pharmaceuticals Division quarterly product sales and quarterly constant exchange rate sales growth International* ....................................................19
`
`
`
`10/19
`
`APOTEX EX. 1064-010
`
`

`

`
`
`1. Sales January to March 2017 and 2016
`
`
`
`
`
`
`
`
`
`
`
`CHF millions
`
`31 March
`
`Three months ended
`
`Pharmaceuticals Division
`
`United States
`
`Europe
`
`Japan
`
`International*
`
`Diagnostics Division
`
`2017
`
`10,177
`
`5,070
`
`2,273
`
`856
`
`1,978
`
`2,765
`
`2016
`
`9,800
`
`4,716
`
`2,319
`
`853
`
`1,912
`
`2,614
`
`Roche Group
`
`12,942
`
`12,414
`
`% change
`
`At CER
`
`In CHF
`
`3
`
`6
`
`1
`
`-2
`
`1
`
`6
`
`4
`
`4
`
`8
`
`-2
`
`0
`
`3
`
`6
`
`4
`
`* Asia–Pacific, EEMEA (Eastern Europe, Middle East and Africa), Latin America, Canada, Others
`
`
`
`
`
`
`
`
`
`
`
`11/19
`
`APOTEX EX. 1064-011
`
`

`

`
`
`2. Quarterly sales and constant exchange rate sales growth by Division in 2017 and 2016
`
`
`
`CHF millions
`
`Q1 2016
`
`vs.
`
`Q2 2016
`
`vs.
`
`Q3 2016
`
`vs.
`
`Q4 2016
`
`vs.
`
`Q1 2017
`
`vs.
`
`
`
`% change
`
`
`
`% change
`
`
`
`% change
`
`
`
`% change
`
`
`
`% change
`
`
`
`Q1 2015
`
`
`
`Q2 2015
`
`
`
`Q3 2015
`
`
`
`Q4 2015
`
`
`
`Q1 2016
`
`Pharmaceuticals Division
`
`United States
`
`9,800
`
`4,716
`
`4
`
`3
`
`9,660
`
`4,557
`
`5
`
`5
`
`9,680
`
`4,577
`
`2
`
`1
`
`5
`
`9,963
`
`4,744
`
`2,243
`
`3
`
`3
`
`2
`
`10,177
`
`5,070
`
`2,273
`
`3
`
`6
`
`1
`
`Europe
`
`Japan
`
`International*
`
`Diagnostics Division
`
`Roche Group
`
`2,319
`
`853
`
`1,912
`
`2,614
`
`12,414
`
`5
`
`4
`
`4
`
`5
`
`4
`
`2,320
`
`903
`
`1,880
`
`2,948
`
`12,608
`
`6
`
`1
`
`5
`
`8
`
`6
`
`2,277
`
`934
`
`1,892
`
`2,803
`
`12,483
`
`-3
`
`2
`
`8
`
`3
`
`1,021
`
`1,955
`
`3,108
`
`13,071
`
`3
`
`3
`
`5
`
`3
`
`856
`
`1,978
`
`2,765
`
`12,942
`
`-2
`
`1
`
`6
`
`4
`
`*Asia–Pacific, EEMEA (Eastern Europe, Middle East and Africa), Latin America, Canada, Others
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`12/19
`
`APOTEX EX. 1064-012
`
`

`

`
`
`3. Pharmaceuticals Division
`
`Top-selling pharmaceuticals
`and recent new launches
`
`
`
`Total
`
`United States
`
`Europe
`
`Japan
`
`International*
`
`January - March 2017
`
`CHF m
`
`MabThera/Rituxan
`
`Herceptin
`
`Avastin
`
`1,899
`
`1,756
`
`1,684
`
`%
`
`4
`
`2
`
`-2
`
`CHF m
`
`1,045
`
`680
`
`765
`
`%
`
`6
`
`3
`
`-2
`
`CHF m
`
`465
`
`522
`
`446
`
`%
`
`1
`
`3
`
`-3
`
`CHF m
`
`62
`
`67
`
`181
`
`%
`
`-3
`
`-4
`
`-8
`
`CHF m
`
`327
`
`487
`
`292
`
`65
`
`%
`
`4
`
`0
`
`7
`
`47
`
`Perjeta
`
`Actemra/RoActemra
`
`Xolair
`
`Lucentis
`
`Activase/TNKase
`
`524
`
`445
`
`437
`
`392
`
`316
`
`19
`
`15
`
`22
`
`9
`
`13
`
`257
`
`177
`
`437
`
`392
`
`305
`
`14
`
`21
`
`22
`
`9
`
`14
`
`176
`
`147
`
`-
`
`-
`
`-
`
`21
`
`17
`
`-
`
`-
`
`-
`
`26
`
`64
`
`-
`
`-
`
`-
`
`7
`
`4
`
`-
`
`-
`
`-
`
`57
`
`-
`
`-
`
`11
`
`36
`
`7
`
`-
`
`-
`
`0
`
`-4
`
`Tamiflu
`
`Kadcyla
`
`
`
`
`
`
`
`Recent new launches
`
`Esbriet
`
`270
`
`222
`
`
`
`202
`
`
`
`-27
`
`11
`
`
`
`13
`
`
`
`156
`
`89
`
`
`
`153
`
`
`
`-39
`
`11
`
`
`
`19
`
`
`
`13
`
`84
`
`
`
`42
`
`-30
`
`5
`
`
`
`
`
`
`
`-2
`
`65
`
`16
`
`
`
`-
`
`
`
`5
`
`-9
`
`
`
`-
`
`
`
`
`
`33
`
`
`
`7
`
`49
`
`
`
`10
`
`-
`
`Tecentriq
`
`Alecensa
`
`Gazyva
`
`Cotellic
`
`113
`
`68
`
`67
`
`14
`
`-
`
`124
`
`48
`
`37
`
`109
`
`36
`
`38
`
`4
`
`-
`
`244
`
`27
`
`87
`
`2
`
`1
`
`17
`
`9
`
`-
`
`-
`
`59
`
`5
`
`-
`
`29
`
`-
`
`-
`
`-
`
`50
`
`-
`
`-
`
`2
`
`2
`
`12
`
`1
`
`-
`
`160
`
`-
`
`* Asia–Pacific, EEMEA (Eastern Europe, Middle East and Africa), Latin America, Canada, Others
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`13/19
`
`APOTEX EX. 1064-013
`
`

`

`
`
`
`
`
`4. Top 20 Pharmaceuticals Division product sales and constant exchange rate growth Q1 2017 vs. Q1 2016
`
`CHF millions
`
`MabThera/Rituxan
`
`Herceptin
`
`Avastin
`
`Perjeta
`
`Total
`
`United States
`
`Europe
`
`Japan
`
`International*
`
`CHF m
`
`1,899
`
`1,756
`
`1,684
`
`524
`
`%
`
`4
`
`2
`
`-2
`
`19
`
`CHF m
`
`1,045
`
`680
`
`765
`
`257
`
`%
`
`6
`
`3
`
`-2
`
`14
`
`CHF m
`
`465
`
`522
`
`446
`
`176
`
`%
`
`1
`
`3
`
`-3
`
`21
`
`CHF m
`
`62
`
`67
`
`181
`
`26
`
`%
`
`-3
`
`-4
`
`-8
`
`7
`
`CHF m
`
`327
`
`487
`
`292
`
`65
`
`%
`
`4
`
`0
`
`7
`
`47
`
`Actemra/RoActemra
`
`Xolair
`
`Lucentis
`
`Activase/TNKase
`
`Tamiflu
`
`445
`
`437
`
`392
`
`316
`
`270
`
`15
`
`22
`
`9
`
`13
`
`-27
`
`177
`
`437
`
`392
`
`305
`
`156
`
`21
`
`22
`
`9
`
`14
`
`-39
`
`11
`
`147
`
`-
`
`-
`
`-
`
`13
`
`84
`
`17
`
`-
`
`-
`
`-
`
`-30
`
`5
`
`64
`
`-
`
`-
`
`-
`
`65
`
`16
`
`4
`
`-
`
`-
`
`-
`
`5
`
`-9
`
`57
`
`-
`
`-
`
`11
`
`36
`
`33
`
`7
`
`-
`
`-
`
`0
`
`-4
`
`49
`
`Kadcyla
`
`Tarceva
`
`Esbriet
`
`Pulmozyme
`
`CellCept
`
`Mircera
`
`222
`
`211
`
`202
`
`175
`
`170
`
`115
`
`11
`
`-19
`
`13
`
`9
`
`-10
`
`-4
`
`89
`
`109
`
`153
`
`125
`
`33
`
`-
`
`-21
`
`19
`
`10
`
`-26
`
`-
`
`37
`
`42
`
`32
`
`43
`
`22
`
`-22
`
`-2
`
`10
`
`3
`
`3
`
`22
`
`-
`
`-
`
`17
`
`43
`
`-
`
`-4
`
`-
`
`-
`
`9
`
`-6
`
`-
`
`43
`
`7
`
`18
`
`77
`
`50
`
`2
`
`-18
`
`10
`
`3
`
`-11
`
`-5
`
`-
`
`Tecentriq
`
`Xeloda
`
`Madopar
`
`NeoRecormon/Epogin
`
`Rocephin
`
`113
`
`104
`
`86
`
`77
`
`74
`
`-
`
`-7
`
`18
`
`-3
`
`-9
`
`109
`
`6
`
`-
`
`-
`
`-
`
`-
`
`30
`
`-
`
`-
`
`-
`
`2
`
`6
`
`23
`
`32
`
`13
`
`-
`
`-28
`
`0
`
`-8
`
`-3
`
`25
`
`4
`
`10
`
`6
`
`-3
`
`-2
`
`-6
`
`-15
`
`67
`
`59
`
`35
`
`55
`
`-8
`
`30
`
`4
`
`-10
`
`* Asia–Pacific, EEMEA (Eastern Europe, Middle East and Africa), Latin America, Canada, Others
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`14/19
`
`APOTEX EX. 1064-014
`
`

`

`
`
`
`5. Top 20 Pharmaceuticals Division quarterly product sales and quarterly constant exchange rate sales growth
`
`CHF millions
`
`Q1 2016
`
`vs.
`
`Q2 2016
`
`vs.
`
`Q3 2016
`
`vs.
`
`Q4 2016
`
`vs.
`
`Q1 2017
`
`vs.
`
`
`
`% change
`
`
`
`% change
`
`
`
`% change
`
`
`
`% change
`
`
`
`% change
`
`MabThera/Rituxan
`
`Herceptin
`
`
`
`Q1 2015
`
`
`
`Q2 2015
`
`
`
`Q3 2015
`
`
`
`Q4 2015
`
`
`
`Q1 2016
`
`1,825
`
`1,725
`
`1,706
`
`3
`
`4
`
`4
`
`1,877
`
`1,709
`
`1,724
`
`5
`
`5
`
`4
`
`1,782
`
`1,691
`
`1,684
`
`0
`
`4
`
`-3
`
`1,816
`
`1,657
`
`1,669
`
`2
`
`0
`
`-4
`
`1,899
`
`1,756
`
`1,684
`
`4
`
`2
`
`-2
`
`Avastin
`
`Perjeta
`
`Actemra/RoActemra
`
`Xolair
`
`Lucentis
`
`Activase/TNKase
`
`439
`
`386
`
`356
`
`355
`
`276
`
`33
`
`14
`
`22
`
`-13
`
`21
`
`467
`
`428
`
`375
`
`349
`
`261
`
`43
`
`35
`
`21
`
`17
`
`-10
`
`17
`
`5
`
`473
`
`433
`
`389
`
`373
`
`270
`
`93
`
`24
`
`15
`
`13
`
`-1
`
`12
`
`-23
`
`467
`
`450
`
`378
`
`329
`
`301
`
`291
`
`14
`
`14
`
`8
`
`-14
`
`15
`
`72
`
`524
`
`445
`
`437
`
`392
`
`316
`
`270
`
`19
`
`15
`
`22
`
`9
`
`13
`
`-27
`
`Tamiflu
`
`Kadcyla
`
`Tarceva
`
`Esbriet
`
`Pulmozyme
`
`CellCept
`
`367
`
`201
`
`258
`
`178
`
`160
`
`189
`
`-6
`
`11
`
`-14
`
`96
`
`7
`
`-4
`
`207
`
`262
`
`180
`
`177
`
`184
`
`10
`
`-17
`
`24
`
`10
`
`-5
`
`208
`
`245
`
`213
`
`167
`
`186
`
`134
`
`5
`
`-18
`
`35
`
`0
`
`-5
`
`-16
`
`215
`
`259
`
`197
`
`181
`
`182
`
`137
`
`2
`
`-11
`
`10
`
`1
`
`-10
`
`23
`
`222
`
`211
`
`202
`
`175
`
`170
`
`115
`
`11
`
`-19
`
`13
`
`9
`
`-10
`
`-4
`
`Mircera
`
`Tecentriq
`
`Xeloda
`
`Madopar
`
`NeoRecormon/Epogin
`
`Rocephin
`
`118
`
`-
`
`111
`
`71
`
`79
`
`82
`
`0
`
`-
`
`-17
`
`20
`
`-14
`
`5
`
`123
`
`19
`
`119
`
`69
`
`82
`
`75
`
`7
`
`-
`
`-5
`
`-4
`
`-8
`
`18
`
`58
`
`120
`
`74
`
`83
`
`75
`
`-
`
`-6
`
`4
`
`-7
`
`18
`
`80
`
`156
`
`76
`
`84
`
`66
`
`-
`
`18
`
`6
`
`-7
`
`-9
`
`113
`
`104
`
`86
`
`77
`
`74
`
`-
`
`-7
`
`18
`
`-3
`
`-9
`
`
`
`
`
`
`
`15/19
`
`APOTEX EX. 1064-015
`
`

`

`
`
`
`6. Top 20 Pharmaceuticals Division quarterly product sales and quarterly constant exchange rate sales growth United States
`
`CHF millions
`
`Q1 2016
`
`vs.
`
`Q2 2016
`
`vs.
`
`Q3 2016
`
`vs.
`
`Q4 2016
`
`vs.
`
`Q1 2017
`
`vs.
`
`
`
`% change
`
`
`
`% change
`
`
`
`% change
`
`
`
`% change
`
`
`
`% change
`
`
`
`Q1 2015
`
`
`
`Q2 2015
`
`
`
`Q3 2015
`
`
`
`Q4 2015
`
`
`
`Q1 2016
`
`MabThera/Rituxan
`
`Herceptin
`
`Avastin
`
`978
`
`651
`
`775
`
`0
`
`4
`
`-2
`
`1,023
`
`630
`
`763
`
`6
`
`6
`
`0
`
`932
`
`617
`
`723
`
`-3
`
`0
`
`-9
`
`978
`
`611
`
`703
`
`3
`
`1
`
`-10
`
`1,045
`
`680
`
`765
`
`6
`
`3
`
`-2
`
`14
`
`Perjeta
`
`Actemra/RoActemra
`
`Xolair
`
`Lucentis
`
`Activase/TNKase
`
`Tamiflu
`
`224
`
`145
`
`356
`
`355
`
`265
`
`251
`
`15
`
`12
`
`22
`
`-13
`
`21
`
`-15
`
`230
`
`164
`
`375
`
`349
`
`250
`
`12
`
`16
`
`23
`
`17
`
`-10
`
`18
`
`-45
`
`229
`
`165
`
`389
`
`373
`
`258
`
`63
`
`8
`
`13
`
`13
`
`-1
`
`12
`
`-39
`
`222
`
`173
`
`378
`
`329
`
`289
`
`141
`
`1
`
`11
`
`8
`
`-14
`
`16
`
`16
`
`257
`
`177
`
`437
`
`392
`
`305
`
`156
`
`89
`
`21
`
`22
`
`9
`
`14
`
`-39
`
`11
`
`Kadcyla
`
`Tarceva
`
`Esbriet
`
`Pulmozyme
`
`CellCept
`
`Mircera
`
`79
`
`136
`
`127
`
`112
`
`45
`
`-
`
`-2
`
`-15
`
`145
`
`6
`
`0
`
`-
`
`80
`
`141
`
`134
`
`121
`
`43
`
`-
`
`7
`
`-17
`
`32
`
`7
`
`-18
`
`-
`
`79
`
`135
`
`158
`
`116
`
`46
`
`-
`
`-1
`
`-16
`
`38
`
`0
`
`-13
`
`-
`
`78
`
`148
`
`150
`
`125
`
`38
`
`-
`
`-2
`
`-8
`
`19
`
`-4
`
`-31
`
`-
`
`-
`
`109
`
`153
`
`125
`
`33
`
`-
`
`109
`
`-21
`
`19
`
`10
`
`-26
`
`-
`
`-
`
`Tecentriq
`
`Xeloda
`
`Madopar
`
`NeoRecormon/Epogin
`
`Rocephin
`
`* Over 500%
`
`-
`
`5
`
`-
`
`-
`
`-
`
`-
`
`-71
`
`-
`
`-
`
`-
`
`19
`
`12
`
`-
`
`-
`
`-
`
`-
`
`-24
`
`-
`
`-
`
`-
`
`57
`
`10
`
`-
`
`-
`
`1
`
`-
`
`-21
`
`-
`
`-
`
`-
`
`78
`
`52
`
`-
`
`-
`
`-
`
`312
`
`-
`
`-
`
`-
`
`6
`
`-
`
`-
`
`-
`
`30
`
`-
`
`-
`
`-
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`16/19
`
`APOTEX EX. 1064-016
`
`

`

`
`
`
`7. Top 20 Pharmaceuticals Division quarterly product sales and quarterly constant exchange rate sales growth Europe
`
`CHF millions
`
`Q1 2016
`
`vs.
`
`Q2 2016
`
`vs.
`
`Q3 2016
`
`vs.
`
`Q4 2016
`
`vs.
`
`Q1 2017
`
`vs.
`
`
`
`% change
`
`
`
`% change
`
`
`
`% change
`
`
`
`% change
`
`
`
`% change
`
`MabThera/Rituxan
`
`Herceptin
`
`
`
`Q1 2015
`
`
`
`Q2 2015
`
`
`
`Q3 2015
`
`
`
`Q4 2015
`
`
`
`Q1 2016
`
`479
`
`525
`
`471
`
`5
`
`2
`
`2
`
`482
`
`523
`
`473
`
`5
`
`3
`
`4
`
`468
`
`521
`
`458
`
`4
`
`4
`
`-1
`
`450
`
`486
`
`439
`
`-1
`
`-2
`
`-4
`
`465
`
`522
`
`446
`
`1
`
`3
`
`-3
`
`Avastin
`
`Perjeta
`
`Actemra/RoActemra
`
`Xolair
`
`Lucentis
`
`Activase/TNKase
`
`149
`
`131
`
`-
`
`-
`
`-
`
`65
`
`17
`
`-
`
`-
`
`-
`
`161
`
`143
`
`-
`
`-
`
`-
`
`11
`
`56
`
`21
`
`-
`
`-
`
`-
`
`*
`
`163
`
`142
`
`-
`
`-
`
`-
`
`7
`
`42
`
`18
`
`-
`
`-
`
`-
`
`*
`
`155
`
`142
`
`-
`
`-
`
`-
`
`63
`
`22
`
`14
`
`-
`
`-
`
`-
`
`*
`
`176
`
`147
`
`-
`
`-
`
`-
`
`13
`
`21
`
`17
`
`-
`
`-
`
`-
`
`-30
`
`Tamiflu
`
`Kadcyla
`
`Tarceva
`
`Esbriet
`
`Pulmozyme
`
`CellCept
`
`20
`
`83
`
`48
`
`45
`
`31
`
`43
`
`78
`
`13
`
`-18
`
`36
`
`6
`
`-3
`
`84
`
`44
`
`41
`
`30
`
`46
`
`2
`
`-27
`
`9
`
`5
`
`2
`
`83
`
`43
`
`49
`
`30
`
`43
`
`22
`
`1
`
`-19
`
`33
`
`10
`
`-1
`
`0
`
`81
`
`39
`
`44
`
`31
`
`44
`
`22
`
`-6
`
`-25
`
`-4
`
`6
`
`-4
`
`4
`
`84
`
`37
`
`42
`
`32
`
`43
`
`22
`
`5
`
`-22
`
`-2
`
`10
`
`3
`
`3
`
`Mircera
`
`Tecentriq
`
`Xeloda
`
`Madopar
`
`NeoRecormon/Epogin
`
`Rocephin
`
`21
`
`-
`
`9
`
`24
`
`36
`
`13
`
`-7
`
`-
`
`-31
`
`-1
`
`-10
`
`-13
`
`22
`
`-
`
`8
`
`25
`
`35
`
`7
`
`-2
`
`-
`
`-17
`
`2
`
`-11
`
`-13
`
`1
`
`8
`
`25
`
`36
`
`6
`
`-
`
`-23
`
`2
`
`-7
`
`2
`
`1
`
`7
`
`25
`
`34
`
`11
`
`-
`
`-30
`
`5
`
`-8
`
`26
`
`2
`
`6
`
`23
`
`32
`
`13
`
`-
`
`-28
`
`0
`
`-8
`
`-3
`
`
`
`
`
`
`
`17/19
`
`APOTEX EX. 1064-017
`
`

`

`
`
`
`8. Top 20 Pharmaceuticals Division quarterly product sales and quarterly constant exchange rate sales growth Japan
`
`CHF millions
`
`Q1 2016
`
`vs.
`
`Q2 2016
`
`vs.
`
`Q3 2016
`
`vs.
`
`Q4 2016
`
`vs.
`
`Q1 2017
`
`vs.
`
`
`
`% change
`
`
`
`% change
`
`
`
`% change
`
`
`
`% change
`
`
`
`% change
`
`
`
`Q1 2015
`
`
`
`Q2 2015
`
`
`
`Q3 2015
`
`
`
`Q4 2015
`
`
`
`Q1 2016
`
`MabThera/Rituxan
`
`Herceptin
`
`62
`
`67
`
`12
`
`5
`
`7
`
`72
`
`79
`
`206
`
`12
`
`4
`
`-2
`
`77
`
`79
`
`213
`
`9
`
`2
`
`-6
`
`80
`
`84
`
`223
`
`11
`
`7
`
`-5
`
`62
`
`67
`
`181
`
`-3
`
`-4
`
`-8
`
`Avastin
`
`Perjeta
`
`Actemra/RoActemra
`
`Xolair
`
`Lucentis
`
`Activase/TNKase
`
`192
`
`23
`
`60
`
`-
`
`-
`
`-
`
`18
`
`14
`
`-
`
`-
`
`-
`
`27
`
`70
`
`-
`
`-
`
`-
`
`10
`
`13
`
`-
`
`-
`
`-
`
`*
`
`27
`
`75
`
`-
`
`-
`
`-
`
`12
`
`4
`
`10
`
`-
`
`-
`
`-
`
`*
`
`31
`
`79
`
`-
`
`-
`
`-
`
`46
`
`17
`
`14
`
`-
`
`-
`
`-
`
`243
`
`26
`
`64
`
`-
`
`-
`
`-
`
`65
`
`7
`
`4
`
`-
`
`-
`
`-
`
`5
`
`Tamiflu
`
`Kadcyla
`
`Tarceva
`
`Esbriet
`
`Pulmozyme
`
`CellCept
`
`60
`
`17
`
`22
`
`-
`
`-
`
`15
`
`4
`
`27
`
`0
`
`-
`
`-
`
`11
`
`4
`
`20
`
`27
`
`-
`
`-
`
`18
`
`20
`
`3
`
`-
`
`-
`
`16
`
`18
`
`27
`
`-
`
`-
`
`18
`
`4
`
`-9
`
`-
`
`-
`
`12