On July 21, 2016 Roche reported continued growth in the first half of 2016 (Press release, Hoffmann-La Roche , JUL 21, 2016, View Source [SID:1234513980]).
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Group sales increased by 5%1 at constant exchange rates, 6% in Swiss francs
Pharmaceuticals Division sales up 4%, driven by oncology and immunology medicines
Diagnostics Division sales grew 6%, driven primarily by immunodiagnostic products; challenging market conditions in Diabetes Care
Core earnings per share grew slightly faster than sales at 5% at constant exchange rates, 7% in Swiss francs
OCREVUS filed in US and EU for relapsing and primary progressive forms of multiple sclerosis; FDA granted priority review
Cancer immunotherapy medicine Tecentriq received accelerated FDA approval in bladder cancer in the US
cobas e801 immunodiagnostic module launched for high-volume testing
Outlook for 2016 confirmed
Key figures January – June
In millions of CHF % change
2016
2015
CER1
CHF
Group sales
25,022
23,585
+5
+6
Pharmaceuticals Division
19,460
18,350
+4
+6
Diagnostics Division
5,562
5,235
+6
+6
Core operating profit
9,854
9,236
+5
+7
Core EPS-diluted (CHF)
7.74
7.22
+5
+7
IFRS net income
5,467
5,249
+3
+4
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 good growth across all regions. The launch of our first cancer immunotherapy medicine Tecentriq is off to a strong start. We also completed the US and EU filings of OCREVUS, which brings us an important step closer toward launching this promising multiple sclerosis medicine. Based on our half year performance, I am confident that we will meet our full-year targets for 2016.”
Group
Strong performance in both divisions
In the first half of 2016, Group sales rose 4.8% at constant exchange rates to CHF 25.0 billion. Core EPS grew 5.2% at constant exchange rates, slightly faster than sales. Core EPS growth reflects the good underlying business performance, investments into the launch of new products and the product pipeline, the one-off accounting impact of changes to the Group’s Swiss pension plans, as well as an early bond redemption.
IFRS net income was up 3% at constant exchange rates and 4% in Swiss francs. The positive currency effect was driven by the weakening of the Swiss franc against the US dollar, the yen and the euro, partly offset by a strengthening of Latin American currencies.
Sales in the Pharmaceuticals Division were up 4% to CHF 19.5 billion, driven by demand for oncology and immunology medicines. Sales in the US increased 4%, led by immunology treatments Xolair and Esbriet, as well as Herceptin and Perjeta against HER2-positive breast cancer. There was high demand for Alecensa, which was recently launched in the US for a specific type of lung cancer. Sales of Lucentis and Tarceva declined due to the continued impact of competition. In Europe (+5%), Perjeta, MabThera/Rituxan and Actemra/RoActemra recorded strong sales growth, especially in Germany and France. In the International region (+4%), growth was driven by HER2 medicines, Avastin and MabThera/Rituxan. This growth was partly offset by lower Pegasys sales due to competition from a new generation of hepatitis C treatments. In Japan, sales rose 2% driven by HER2 medicines, Alecensa and Actemra/RoActemra.
Sales in the Diagnostics Division grew 6% to CHF 5.6 billion. All regions contributed to this growth, particularly Asia-Pacific (+17%). Professional and Tissue Diagnostics grew strongly. Diabetes Care sales were impacted by continued challenging market conditions, especially in North America.
Regulatory approvals
In the second quarter, Roche achieved several key regulatory milestones. In April, Venclexta (venetoclax) received accelerated approval in the US for a specific form of leukemia. This medicine was jointly developed with AbbVie. In May, the FDA granted cancer immunotherapy Tecentriq (atezolizumab) accelerated approval in the US for a specific type of bladder cancer. Also in May, the subcutaneous formulation of MabThera/Rituxan received approval in the EU for people with chronic lymphocytic leukaemia. In June, the European Commission approved Gazyva/Gazyvaro plus bendamustine for the second-line treatment of follicular lymphoma. The EU authorities also approved the combination of Avastin and Tarceva for the treatment of people with a specific type of lung cancer.
Strong Pharma pipeline
Roche made significant progress in late-stage development. In June, the European Medicines Agency (EMA) and the FDA confirmed that the data submission for OCREVUS (ocrelizumab) is complete, and the marketing applications for both relapsing and progressive multiple sclerosis are being reviewed. In addition, the FDA granted priority review for the US application with an action date of 28 December 2016.
In the same month, the largest clinical trial ever conducted in giant cell arteritis (GCA), a serious inflammatory disease of blood vessels, showed positive results. Initially combined with a six-month steroid regimen, Actemra/RoActemra more effectively sustained remission through one year compared to a 6- or 12-month steroid-only regimen in people with newly diagnosed and relapsing GCA.
At the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in June, Roche presented an updated clinical analysis for Tecentriq in previously treated lung cancer. Overall survival benefit was seen regardless of Programmed Death-Ligand 1 (PD-L1) expression compared to chemotherapy. In addition, Roche shared encouraging results from clinical trials with Tecentriq in combination with chemotherapy, targeted anti-cancer medicines and other cancer immunotherapy agents in several tumour types.
In May, a phase III study (J-ALEX) by Chugai found that Alecensa significantly reduced the risk of disease worsening or death compared to crizotinib. This trial in a Japanese patient population with advanced or recurrent ALK-positive non-small cell lung cancer was stopped early after a pre-planned interim analysis.
Roche recently provided an update on the phase III study of Gazyva/Gazyvaro in previously untreated diffuse large B-cell lymphoma (GOYA). The study did not meet its primary goal of extending the time patients live without their disease advancing. In May, another phase III study of Gazyva/Gazyvaro (GALLIUM) was stopped early after a pre-planned interim analysis showed positive results in the first-line treatment of follicular lymphoma. In both studies, Gazyva/Gazyvaro plus chemotherapy was tested head-to-head with MabThera/Rituxan combined with chemotherapy. The GALLIUM data will be submitted to health authorities for approval consideration. Gazyva/Gazyvaro is already approved for previously treated follicular lymphoma.
Portfolio progress in Diagnostics
In May, Roche launched the CoaguChek INRange, the first Bluetooth enabled home device, allowing patients and their healthcare providers greater control over their coagulation status. In June, Roche launched the cobas e801 module in countries accepting the CE Mark. As part of the cobas 8000 analyzer, this module provides increased immunochemistry testing capacity and an extensive test menu to laboratories with high testing volumes. Also in June, the cobas liquid biopsy test for the detection of specific mutations of the epidermal growth factor receptor (EGFR) gene became the first FDA approved liquid biopsy test. It can support therapy guidance in non-small cell lung cancer (NSCLC) via the analysis of a simple blood sample; and it complements the existing tissue-based EGFR test.