On July 26, 2018 Roche reported very strong performance in the first half of 2018(Press release, Hoffmann-La Roche, JUL 26, 2018, View Source [SID1234528785])
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Group sales increase 7%1 at constant exchange rates and in Swiss francs
Pharmaceuticals Division sales up 7%, driven mainly by Ocrevus, Perjeta, Alecensa and Tecentriq
Diagnostics Division sales grow 6%, primarily due to demand for immunodiagnostic solutions
Core earnings per share grow ahead of sales at 19%, or 8% excluding the effect of the US tax reform
On IFRS basis, net income increases 33% due to the strong underlying results and lower impairments of intangible assets compared to 2017
Approvals in the second quarter: European Commission approves Perjeta for adjuvant treatment of HER2-positive early breast cancer at high risk of recurrence; FDA approves new indications for existing medicines: subcutaneous formulation of Actemra/RoActemra for a form of juvenile idiopathic arthritis; MabThera/Rituxan for pemphigus vulgaris; Avastin for a form of ovarian cancer
Outlook raised for 2018: Roche expects mid-single digit sales growth, at constant exchange rates. Core earnings per share are targeted to grow in the mid-teen digits, at constant exchange rates. Excluding the US tax reform impact, core earnings per share are targeted to grow broadly in line with sales.
Commenting on the Group’s results, Roche CEO Severin Schwan said: "In the first half of the year, both our Pharmaceuticals and Diagnostics Divisions achieved very strong results. Given the very good, continuously growing uptake of our new medicines, we are well on track to rejuvenate our portfolio. The growth of our business will continue, also beyond the current year. Based on the performance in the first half of the year, we are increasing the outlook for the full-year 2018 to mid-single digit sales growth, and targeting core earnings per share to grow in the mid-teen digits, at constant exchange rates."
Group results
Very strong performance in both divisions
In the first half of 2018, Group sales rose 7% to CHF 28.1 billion and core EPS grew 19%. Excluding the effect of the US tax reform, core EPS grew 8%, ahead of sales. Core EPS growth reflects the strong underlying business performance. IFRS net income increased 33%, due to the underlying core results and lower impairment of intangible assets compared to 2017.
Sales in the Pharmaceuticals Division increased 7% to CHF 21.8 billion. Key growth drivers were the recently launched medicines Ocrevus, used to treat two forms of multiple sclerosis, and cancer medicines Perjeta, Alecensa and Tecentriq. Tamiflu contributed with high sales at the beginning of the year due to a severe flu season. As expected, the strong growth reported for the Pharmaceuticals Division was partially offset by lower sales of MabThera/Rituxan and of Tarceva.
In the US, sales increased 15%, led by Ocrevus, Herceptin and Perjeta. Ocrevus sales were supported by continued strong new patient demand. The 27% sales increase of Perjeta was driven by its use for adjuvant (after surgery) treatment of patients with HER2-positive early breast cancer at high risk of recurrence.2
In Europe (-8%), strong launches of our new medicines Ocrevus, Tecentriq and Alecensa, especially in Germany, partially offset declining sales of MabThera/Rituxan (-47%), which were affected by biosimilar impact. Perjeta sales continued to grow, specifically in the metastatic and neoadjuvant settings. In the International region, sales grew 5%, led by the Latin America and Asia–Pacific subregions. In Japan, sales were stable, despite government price cuts.
Diagnostics Division sales increased 6% to CHF 6.3 billion. Centralised and Point of Care Solutions (+6%) was the main contributor, led by the growth of its immunodiagnostics business (+9%). Sales increased in all business areas. In regional terms, growth was driven by Asia-Pacific (+14%) and North America (+7%). Sales increased 1% in EMEA3 and 6% in Latin America. In Japan, sales decreased 2% due to lower sales in the molecular diagnostics business.
Core operating profit increased 11% in the Pharmaceuticals Division while it remained stable in the Diagnostics Division. The IFRS results include lower intangible asset impairment charges of CHF 0.3 billion compared to CHF 1.5 billion in the first half of 2017.
Milestones for Roche medicines
In the second quarter, health authorities granted several approvals for Roche medicines. The European Commission approved Perjeta in combination with Herceptin and chemotherapy for post-surgery (adjuvant) treatment of adult patients with HER2-positive early breast cancer (eBC) at high risk of recurrence. This approval is based on results from the phase III Aphinity study.
The US Food and Drug Administration (FDA) approved the subcutaneous formulation of Actemra for the treatment of active polyarticular juvenile idiopathic arthritis in patients two years of age and older.
MabThera/Rituxan received FDA approval for the treatment of adults with moderate to severe pemphigus vulgaris, a rare, serious, life-threatening condition characterised by progressive painful blistering of the skin and mucous membranes. This is the first biologic therapy approved by the FDA for pemphigus vulgaris and the first major advancement in the treatment of the disease in more than 60 years.
Approval was granted by the FDA for Venclexta in combination with Rituxan/MabThera for the treatment of people with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma, with or without 17p deletion, who have received at least one prior therapy. Venclexta is being developed by AbbVie and Roche. It is jointly commercialised with AbbVie in the US and commercialised solely by AbbVie outside of the US. Sales of Venclexta are reported by AbbVie.
The FDA granted Priority Review for Roche medicines including Hemlibra for adults and children with haemophilia A without factor VIII inhibitors. This decision is based on data from the phase III Haven 3 study. Priority Review was also granted for Tecentriq, in combination with Avastin, paclitaxel and carboplatin (chemotherapy), for the initial (first-line) treatment of people with metastatic non-squamous non-small cell lung cancer (NSCLC).
Breakthrough Therapy Designation was granted by the FDA for the combination of Tecentriq and Avastin as an initial (first-line) treatment for people with advanced or metastatic hepatocellular carcinoma (HCC), the most common form of liver cancer.
The FDA granted Priority Review for baloxavir marboxil as a single-dose, oral treatment for acute, uncomplicated influenza in patients 12 years and older. Baloxavir marboxil is a first-in-class, single-dose, investigational oral medicine with a novel proposed mechanism of action designed to target the flu virus, including oseltamivir-resistant strains and avian strains (H7N9, H5N1).4
Clinical trial results on Roche medicines
Results from a number of late-stage studies were announced during the second quarter, with Tecentriq in particular continuing its news flow with six positive out of seven readouts during the quarter. These represent important achievements in a highly competitive and dynamic environment.
The phase III IMpower132 study met its co-primary endpoint of progression-free survival (PFS) and demonstrated that the combination of Tecentriq plus chemotherapy (cisplatin or carboplatin plus pemetrexed) reduced the risk of disease worsening or death (PFS) compared to chemotherapy alone in the initial (first-line) treatment of advanced non-squamous non-small cell lung cancer (NSCLC). While a numerical improvement for the co-primary endpoint of overall survival (OS) was observed, statistical significance was not met at this interim analysis, and the study will continue as planned with final OS results expected next year.
The phase III IMpassion130 study met its co-primary endpoint of PFS. Results demonstrated that the combination of Tecentriq plus nab-paclitaxel, as an initial (first-line) treatment, significantly reduced the risk of disease worsening or death (PFS) in the intention-to-treat and PD-L1-positive population with metastatic or unresectable locally advanced triple negative breast cancer (TNBC). Overall survival was encouraging in the PD-L1 positive population at this interim analysis, and follow up will continue until the next planned analysis. Currently, Roche has seven ongoing phase III studies investigating Tecentriq in TNBC, an aggressive disease with limited treatment options.
The phase III IMpower133 study met its co-primary endpoints of OS and PFS at its first interim analysis. The study demonstrated that initial (first-line) treatment with the combination of Tecentriq plus chemotherapy (carboplatin and etoposide) helped people with extensive-stage small cell lung cancer (ES-SCLC) live significantly longer compared to chemotherapy alone. The Tecentriq-based combination also reduced the risk of disease worsening or death (PFS) compared to chemotherapy alone. There has been limited treatment progress for people with ES-SCLC in the past 20 years.
Results from the phase III IMpower131 study showed Tecentriq plus chemotherapy (carboplatin and albumin-bound paclitaxel) reduced the risk of disease worsening or death (PFS) by 29 percent compared with chemotherapy (carboplatin and nab-paclitaxel) alone in the initial (first-line) treatment of people with advanced squamous non-small cell lung cancer (NSCLC) (median PFS=6.3 vs. 5.6 months).
The phase III IMpower130 study met its co-primary endpoints of OS and PFS. The combination of Tecentriq plus chemotherapy (carboplatin and albumin-bound paclitaxel; nab-paclitaxel) helped people live significantly longer compared to chemotherapy alone in the initial (first-line) treatment of advanced non-squamous NSCLC. In addition, the Tecentriq combination reduced the risk of disease worsening or death (PFS) compared with chemotherapy alone.
Positive OS results were announced from the phase III IMpower150 study of Tecentriq and Avastin plus carboplatin and paclitaxel (chemotherapy) for the initial (first-line) treatment of chemotherapy-naïve people with metastatic non-squamous NSCLC. This interim analysis showed that Tecentriq and Avastin plus carboplatin and paclitaxel helped people live significantly longer compared with Avastin plus carboplatin and paclitaxel (median OS = 19.2 versus 14.7 months).
The phase III IMblaze370 study evaluating the combination of Tecentriq and Cotellic did not meet its primary endpoint of OS compared to regorafenib. The study evaluated the combination in people with difficult-to-treat, locally advanced or metastatic colorectal cancer whose disease progressed or who were intolerant to at least two systemic chemotherapy regimens.
Follow-up data from the phase III Alex study revealed that Alecensa helped people with ALK-positive metastatic non-small cell lung cancer to live a median of almost three years without their disease worsening or death (PFS).
The phase III Capstone-2 study assessing the safety and efficacy of baloxavir marboxil in people at high risk of complications from the flu met the study’s primary objective, and showed superior efficacy in the primary endpoint of time to improvement of influenza symptoms versus placebo.
Advancing personalised healthcare
Roche and Foundation Medicine (FMI), Inc., US, have entered into a definitive merger agreement. A tender offer was launched on 2 July 2018 and the closing of the transaction is expected to take place in the second half of 2018, subject to a majority of FMI’s outstanding shares not already held by the Group being tendered and other customary conditions. This transaction broadens Roche’s personalised healthcare strategy and aims to further advance molecular insights and the broad availability of high-quality comprehensive genomic profiling, both key enablers for the development of new cancer treatments and optimal patient care.
New tools for Alzheimer’s diagnosis and diabetes management
The FDA granted Breakthrough Device Designation to Roche’s Elecsys ß-Amyloid (1-42) CSF and Elecsys Phospho-Tau (181P) CSF assays. These in vitro diagnostic immunoassays are for the measurement of the ß-Amyloid (1-42) and Phospho-Tau concentrations in cerebral spinal fluid (CSF) in adult subjects with mild cognitive impairment being evaluated for Alzheimer’s disease (AD) and other causes of dementia. Roche was one of the first companies to use biomarkers in clinical trials and will continue to explore high-performing diagnostic and disease-monitoring solutions for AD.
Roche’s new small, tube-free Accu-Chek Solo micropump obtained the CE mark. The micropump offers people with diabetes the option of dosing insulin either directly from the pump or from the dedicated handheld, as well as enabling them to detach and re-attach the pump without wasting insulin. It also complements Roche’s digital health solutions contributing to a more effective and personalised diabetes management. Roche signed a collaboration agreement and investment in Care Innovations. mySugr, one of Roche´s digital diabetes management solutions, will become the integrated personalised diabetes and population health management offering to Care Innovations’ broad range of customers based in the US and Canada.
Next generation of the founding families for the Board of Directors
Dr Andreas Oeri (69) has informed the Board of Directors that he will not stand for re-election as a member of the Board of Directors at the Annual General Meeting 2020. This will conclude his 24-year term of office. Dr Joerg Duschmalé (34), a fifth-generation descendant of the founder of Roche, has confirmed his interest in standing for election as a member of the Board of Directors in 2020.
Outlook increased again for 2018
Roche expects sales to grow mid-single digit, at constant exchange rates. Core earnings per share are targeted to grow in the mid-teen digits, at constant exchange rates. Excluding the US tax reform impact, core earnings per share are targeted to grow broadly in line with sales. Roche expects to further increase its dividend in Swiss francs.