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Media Release Basel, 27 July 2017 Roche reports strong performance in the first half of 2017 Group sales increase 5% 1 at constant exchange rates and in Swiss francs Pharmaceuticals Division sales up 5%,
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Media Release Basel, 27 July 2017 Roche reports strong performance in the first half of 2017 Group sales increase 5% 1 at constant exchange rates and in Swiss francs Pharmaceuticals Division sales up 5%, driven mainly by Tecentriq, Ocrevus and Perjeta Diagnostics Division sales grow 5%, primarily due to immunodiagnostics Core earnings per share growing ahead of sales at 6% In the second quarter, the US FDA approves Tecentriq for certain people with metastatic urothelial carcinoma, Rituxan Hycela for subcutaneous injection, Actemra/RoActemra for giant cell arteritis and Lucentis for diabetic retinopathy In July, the European CHMP recommends EU approval for Tecentriq in a specific type of metastatic lung and two types of metastatic bladder cancer. Further, CHMP recommends EU approvals of Actemra/RoActemra for the treatment of giant cell arteritis as well as Gazyvaro for people with previously untreated advanced follicular lymphoma Outlook for 2017 raised Key figures CHF millions % change January - June At CER 1 In CHF Group sales 26,344 25, Pharmaceuticals Division 20,521 19, Diagnostics Division 5,823 5, Core operating profit 10,135 9, Core EPS - diluted (CHF) IFRS net income 5,577 5, 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 Group Communications Roche Group Media Relations Tel /26 Commenting on the Group s results, Roche CEO Severin Schwan said: In the first half of the year, both our Pharmaceuticals and Diagnostics Divisions showed strong performance, very much driven by new product launches. Particularly pleasing is the very successful launch of Ocrevus for the treatment of two forms of multiple sclerosis. Based on our half-year performance, we raised the outlook for the full-year to mid-single digit sales growth. Group results Strong performance in both divisions In the first half of 2017, Group sales rose 5% to CHF 26.3 billion. Core EPS grew 6%, ahead of sales. Core EPS growth reflects the strong underlying business performance. IFRS net income increased 2%. Sales in the Pharmaceuticals Division increased 5% to CHF 20.5 billion. The recently launched medicines Tecentriq, Ocrevus and Alecensa contributed CHF 0.5 billion of new sales, which represents half of the division s growth. Perjeta continued its strong sales increase. This growth was partially offset by lower sales of Tarceva, Tamiflu and Pegasys. In the US, sales advanced 8%, led by Tecentriq, Xolair, MabThera/Rituxan and Ocrevus, recently launched for the treatment of relapsing and primary progressive forms of multiple sclerosis. In Europe, sales were stable. Growth of Perjeta and Actemra/RoActemra sales was offset by lower sales of Avastin. In the International region, sales grew by 5%, led by the Latin America and Asia Pacific subregions. In Japan, sales were stable. Growth of Alecensa sales (+42%) was partially offset by Avastin (-3%), which was negatively affected by the biannual government price cuts in April Diagnostics Division sales increased 5% to CHF 5.8 billion. Centralised and Point of Care Solutions (+8%) 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%), with continued strong growth in China (+20%). Sales increased 3% in EMEA 2, 8% in Latin America, 1% in North America, and 2% in Japan. Core operating profit increased by 3% in the Pharmaceuticals Division and by 5% in the Diagnostics Division. The growth rates of both divisions were impacted by the base effect of income in 2016 from changes to the Group s Swiss pension plans, partially offset by income from older medicine divestments in the first half of EMEA = Europe, Middle East and Africa 2/26 Core EPS increased by 6% and net income on an IFRS basis increased by 2%. IFRS net income was impacted by impairments of intangible assets. These increased by CHF 0.7 billion net of taxes, notably from the partial impairment of the Esbriet product intangible. Important new product approvals in Pharmaceuticals In the second quarter of this year health authorities approved several new medicines: In April, Tecentriq received accelerated approval from the US Food and Drug Administration (FDA) for the treatment of people with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin chemotherapy. In the same month, Lucentis was approved by the FDA for the monthly treatment of all forms of diabetic retinopathy. In May, Actemra/RoActemra subcutaneous injection was approved by the FDA for the treatment of giant cell arteritis. This is a chronic and severe autoimmune condition that has not seen any new treatments in more than 50 years. In June, the FDA approved Rituxan Hycela (rituximab and hyaluronidase human) for subcutaneous injection, for the treatment of adults with specific forms of blood cancer. This new formulation combines the monoclonal antibody used in intravenous MabThera/Rituxan with hyaluronidase, an enzyme that enables injection of the medicine under the skin. Also in June, a new tablet formulation of Esbriet was approved by the European Commission for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF), following approval by the FDA in early In July, the Australian Therapeutic Goods Administration approved Ocrevus for the treatment of relapsing forms of multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). Clinical trial results support Roche medicines The primary analysis of the phase III Haven 1 study in adults and adolescents and interim analysis of the phase III Haven 2 study showed positive data. The studies evaluated once-weekly subcutaneous emicizumab prophylaxis for the treatment of adults and adolescents or children with haemophilia A and inhibitors to factor VIII. The primary endpoint was treated bleeds, and results showed a statistically significant and clinically meaningful reduction in bleed rate of 87% (Haven 1) with emicizumab prophylaxis compared with on-demand treatment with bypassing agents. 3 3 Presented at the International Society on Thrombosis and Hemostasis Congress 2017, 8 13 July, Berlin, Germany 3/26 New data from additional analyses of the pivotal phase III Gallium study in people with previously untreated follicular lymphoma confirmed that the improvement in progression-free survival (PFS) with Gazyva/Gazyvaro-based treatment over MabThera/Rituxan-based treatment was sustained, irrespective of chemotherapy regimen. 4 This updated analysis includes a further six months of follow-up. Data presented at EAN 5 showed Ocrevus significantly reduced disease activity and disability progression in patients with RMS and PPMS, as measured by No Evidence of Progression or Active Disease (NEPAD), a novel composite endpoint in MS. Ocrevus significantly reduced the risk of RMS and PPMS patients requiring mobility aids versus comparators. In patients with PPMS, Ocrevus reduced the risk of more severe forms of disability progression versus placebo. The phase III Aphinity study showed adjuvant (after surgery) treatment with the combination of Perjeta, Herceptin and chemotherapy (the Perjeta-based regimen) significantly reduced the risk of breast cancer recurrence or death in people with HER2-positive early breast cancer compared to Herceptin and chemotherapy alone. 6, 7 At the time of the primary analysis, with median follow-up of 45.4 months, the reduction in risk of invasive breast cancer recurrence with the Perjeta-based regimen was greatest in people with lymph node-positive or hormone receptor-negative disease. The phase III Alex study showed Alecensa reduced the risk of disease worsening or death (progression-free survival, PFS) by more than half (53%) compared to crizotinib when given as initial (first-line) treatment for people with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). 8 Clinical study updates The phase III IMvigor211 study that evaluated Tecentriq in people with locally advanced or metastatic urothelial cancer whose disease progressed during or after treatment with a platinum-based chemotherapy (previously treated) did not meet its primary endpoint of overall survival compared to chemotherapy. 4 Presented at the 22nd European Hematology Association (EHA) annual congress, June, Madrid, Spain 5 3rd Congress of the European Academy of Neurology (EAN), June 2017, Amsterdam, Netherlands 6 Minckwitz G, et al. APHINITY trial. American Society of Clinical Oncology Annual Meeting; 2017 Jun 2-6; Chicago. IL, USA. Abstract #LBA N Engl J Med 2017; 377: July 13, 2017DOI: /NEJMoa Shaw AT, et al. Alectinib versus crizotinib in treatment-naïve advanced ALK-positive non-small cell lung cancer (NSCLC): Primary results of the global phase III ALEX study. Presented at: ASCO Annual Meeting; 2017 Jun 2-6; Chicago, IL, USA. Abstract #LBA /26 The results observed in people treated with Tecentriq in IMvigor211 were generally consistent with those observed in a similar group of people in the Phase II IMvigor210 study. In July, the EU Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Tecentriq as a monotherapy for the treatment of adults with locally advanced or metastatic NSCLC after they have been previously treated with chemotherapy. People with EGFR activating mutations or ALK positive tumour mutations should also have received targeted therapy before receiving Tecentriq. This positive recommendation is based on results from the large randomised phase III Oak study and the randomised phase II Poplar study. The CHMP also adopted a positive opinion for the use of Tecentriq as a monotherapy for the treatment of adults with locally advanced or metastatic urothelial carcinoma who have been previously treated with a platinum based chemotherapy or who are considered ineligible for cisplatin chemotherapy. This positive opinion is based on results from the randomised phase III IMvigor211 study and cohorts 1 and 2 from the single-arm phase II IMvigor210 study. New generation of diagnostics products The cobas MRSA/SA nucleic acid test for use on the cobas Liat System for the qualitative detection and differentiation of methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA) is now available in countries accepting the CE mark and ideal for use at the point of care. This menu expansion serves specific needs of European markets. This is the first real-time PCR test that simultaneously detects MRSA and SA with one sample in less than 30 minutes. MRSA and SA are both significant sources of healthcare- and community-associated infections. Also introduced to the markets were the Avenio ctdna (ctdna - circulating tumour DNA) analysis kits for oncology research. These are the first blood-based distributed oncology tests and provide accurate insights into different stages and types of cancer. They represent a portfolio of three next-generation sequencing (NGS) liquid biopsy assay kits for oncology research: the Avenio ctdna Targeted Kit, Expanded Kit and Surveillance Kit. The kits include all reagents, bioinformatics and software to make ctdna-testing accessible to all NGS laboratories. Roche launched the Avenio Millisect System, which utilises an automated, digitally assisted process to reliably and efficiently isolate clinically relevant cells from tissue biopsies for diagnostic testing in the US and countries accepting the CE mark. It allows for efficient tissue dissection and maximises medical value for all molecular downstream applications. 5/26 The Elecsys HIV combi PT assay was approved by the FDA. This highly sensitive and specific assay further expands Roche's broad testing menu for infectious diseases in the US. With the addition of this assay, laboratories will be able to screen for common co-infections, such as hepatitis C and syphilis, which can be tested simultaneously with HIV, reducing the need for sample splitting and additional analysers. The FDA also granted approval for the cobas CMV (cytomegalovirus) test for use on the fully automated cobas 6800 and cobas 8800 systems. Healthcare professionals use the CMV test to assess how transplant patients on therapy are responding to treatment. Outlook for 2017 raised In 2017, Roche now expects sales to grow 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 Sales CHF millions As % of sales % change January - June At CER In CHF Pharmaceuticals Division 20,521 19, United States 10,185 9, Europe 4,539 4, Japan 1,771 1, International* 4,026 3, *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 3%, led by growth in the US and Brazil, as well as by additional reimbursement approvals and broader use in China. Perjeta (+17%) sales grew in all regions following increased demand in the neoadjuvant and metastatic settings, notably in Europe, the US and the International region. Sales of Kadcyla increased 9%, led by the International region (+47%). 6/26 MabThera/Rituxan (+3%). For forms of blood cancer, rheumatoid arthritis and certain types of vasculitis. Sales continued to rise, driven by growth in the oncology as well as in the immunology segments. The largest sales increases were recorded in the US and the International region. Growth in China was supported by additional reimbursement approvals and expanded regional access. Avastin (-1%). For advanced colorectal, breast, lung, kidney, cervical and ovarian cancer, and relapsed glioblastoma (a type of brain tumour). In the US, where Avastin is already broadly used in its approved indications, sales declined 3%, largely due to growing use of cancer immunotherapy medicines in lung cancer. Sales continued to grow in the International region (+11%), in particular in China, where sales increased due to broader market penetration in the lung and colorectal cancer setting. Sales in Europe (-5%) were impacted by the removal of the reimbursement for breast cancer in France. Actemra/RoActemra (+13%). For rheumatoid arthritis, forms of juvenile idiopathic arthritis and giant cell arteritis. Sales growth was reported in all regions, notably in the US (+16%) and Europe (+15%). In Japan, sales increased by 7% due to steady growth in demand for the subcutaneous formulation. Increasing use of Actemra/RoActemra as a single agent (monotherapy) and of the subcutaneous formulation remained key growth drivers globally. In June, the FDA approved Actemra for the treatment of giant cell arteritis (GCA), a chronic and potentially life-threatening autoimmune condition. In July, the CHMP recommended EU-approval of Actemra/RoActemra for the treatment of GCA. This is its sixth approved indication. Actemra/RoActemra remains the leading RA monotherapy in the five largest EU markets. Esbriet (+16%). For idiopathic pulmonary fibrosis (IPF), sales continued to expand, driven by growth in the US (+19%) and the International region (+34%). Increased investments in patient education about urgency to treat, is a key area in the US and the EU and resulted in growth driven by penetration into moderate and mild patient segments. In June, a new tablet formulation was approved by the European Commission following approval by the FDA in early The tablet formulation makes therapy easier for patients, who now have the option taking only one tablet three times a day compared to three capsules three times a day. 7/26 Gazyva/Gazyvaro (+44%). 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. In July, the CHMP recommended the EU approval of Gazyvaro in combination with chemotherapy, followed by Gazyvaro maintenance in people achieving a response, as a new treatment option for previously untreated advanced follicular lymphoma. This recommendation is based on results from the phase III Gallium study. Recently launched Roche medicines recorded strong sales performance in the first half year. Tecentriq sales totalled CHF 237 million, driven mainly by uptake in the US in metastatic bladder cancer and in metastatic non-small cell lung cancer (NSCLC). Ocrevus (CHF 192 million), launched in the US in April 2017, met strong demand in both indications, relapsing and primary progressive multiple sclerosis. Ocrevus is being used across various stages of these diseases and is a key growth driver in the US. Alecensa (CHF 148 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. Top-selling Total United States Europe Japan International* pharmaceuticals CHFm % CHFm % CHFm % CHFm % CHFm % MabThera/ Rituxan 3, , Herceptin 3, , , Avastin 3, , Perjeta 1, Actemra/ RoActemra Xolair Lucentis Activase/TNKase Kadcyla Tarceva * Asia Pacific, EEMEA (Eastern Europe, Middle East and Africa), Latin America, Canada, Others 8/26 Diagnostics Division Sales CHF millions As % of sales % change January - June Diagnostics Division 5,823 5, Business Areas Regions At CER Centralised and Point of Care Solutions 3,456 3, Diabetes Care Molecular Diagnostics Tissue Diagnostics Europe, Middle East, Africa 2,330 2, North America 1,507 1, Asia Pacific 1,341 1, Latin America Japan In CHF Centralised and Point of Care Solutions (+8%) was the largest contributor to the division s sales performance, led by the Asia-Pacific region. Integrated Serum Work Area solutions, comprising the immunodiagnostics (+13%) and clinical chemistry (+3%) segments, were the main drivers of growth. The cobas e 801 module, for immunodiagnostics, was launched in the US. A core element of the integrated laboratory, cobas e 801 doubles the currently available immunochemistry testing capacity over the same floor space, requires only low sample volume, and delivers fast results. The cobas e 801 has been very well received by customers and contributes to the strong performance of this business area. Sales in Molecular Diagnostics increased 1%, with 2% growth in the underlying molecular business and a decrease in the sequencing business. Regional growth was driven by North America and EMEA. Sales in the blood screening and HPV screening businesses grew 3% and 2% respectively. In virology, which includes Roche s portfolio for diagnosis and monitoring of hepatitis B, hepatitis C and HIV, sales declined 1%, impacted by a base effect from prior-year strong HCV sales. 9/26 Tissue Diagnostics sales increased 13%, driven by strong sales in North America and EMEA. Sales in the advanced staining and primary staining portfolios were up 9% and 15% respectively. The companion diagnostics business grew 40%. The CINtec Histology and CINtec PLUS Cytology tests recorded continued good growth (+18%), also supported by the recent US launch of the CINtec Histology 510(k) product. Diabetes Care sales decreased 4%, impacted by challenging market conditions in North America (-18%). Sales grew 3% in Latin America but declined 1% in EMEA, 5% in the Asia-Pacific and 5% in Japan. Rollout of the Accu-Chek Guide system, Roche s new blood glucose monitoring platform first launched in 2016, extended into additional major markets, including the US and Germany. With the acquisition of mysugr Roche is further building its platform for digital diabetes management. This is a new patient-centred digital health service in diabetes care, which helps healthcare providers ut
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