On April 27, 2017 Ipsen, a global specialty-driven pharmaceutical group, reported sales for the first quarter of 2017 (Press release, Ipsen, APR 27, 2017, View Source [SID1234518698]).

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2017 first quarter sales

In the first quarter of 2017, Consolidated Group sales grew 19.1% to €438.0 million driven by Specialty Care growth of 25.4%1 including growth of 86.3%1 from North America.

Commenting on the first quarter 2017 performance, David Meek, Chief Executive Officer of Ipsen said: "In the first quarter, Specialty Care continued to drive remarkable organic top-line growth for Ipsen, led by the outstanding performance of Somatuline, both in the United States and Europe, as well as a strong acceleration for Dysport. We continue to face headwinds in certain emerging markets for our Consumer Healthcare business." David Meek continued, "After the successful closing of the Onivyde transaction, our largest acquisition to date, we are focused on the successful execution of the Onivyde and Cabometyx launches. These two important products strengthen our presence in Oncology and will contribute meaningfully to our top-line growth and profitability in the coming years."

Ipsen confirms its financial targets for 2017, with Specialty Care sales growth year-on-year greater than +18.0%1, Consumer Healthcare sales growth year-on-year greater than +4.0%1 and Core Operating margin greater than 24% of net sales.

In addition, Ipsen announces the change in name of its Primary Care division to Consumer Healthcare. This reflects the evolution over the last two years of the promotional model from classical prescription-based to a combination of prescription and over-the-counter (OTx) in select countries with gastrointestinal portfolios. The transaction announced in February to acquire a portfolio of select consumer healthcare assets from Sanofi will strengthen the evolution of the Consumer Healthcare portfolio in France and Central Europe with the strategic intent to further develop the OTx model in most geographies.

View Ipsen’s full Q1 report at View Source

On April 26, 2017 GlaxoSmithKline reported another quarter of continued progress (Press release, GlaxoSmithKline, APR 26, 2017, View Source [SID1234518697]).

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Q1 sales of £7.4 billion, +19% AER, + 5% CER
Total EPS of 21.4p >100% AER, >100% CER; Adjusted EPS of 25.0p, +31% AER, +9% CER

View full Q1 2017 results (PDF): View Source

Summary:

Financial highlights

Sales growth across all three businesses: Pharmaceuticals £4.2 billion, +17% AER, +4% CER; Vaccines £1.2 billion, +31% AER, +16% CER; Consumer Healthcare £2.0 billion, +16% AER, +2% CER
Improved Group operating margin reflecting leverage from sales growth, focus on costs and benefits of restructuring. Pharmaceuticals 34.4%; Vaccines 29.6%; Consumer Healthcare 17.2%
Net cash flow from operations of £1.1 billion (Q1 2016: £0.5 billion). Free cash flow of £0.7 billion
(Q1 2016: £0.2 billion outflow), primarily reflecting improved operating performance and the net benefit of exchange rate movements
19p dividend declared for Q1 2017. Continue to expect 80p for FY 2017
2017 Adjusted CER earnings per share guidance maintained
Product and pipeline highlights

New product sales of £1.4 billion +72% AER, +52% CER. On track to deliver £6 billion (CER) sales in 2018
Results from MUSCA study demonstrate Nucala significantly improves quality of life and lung function in patients with severe asthma
Positive SWORD study presented for two-drug regimen of dolutegravir and rilpivirine for treatment of HIV
Positive results reported in-house from ZOSTER-048 study of Shingrix in individuals previously vaccinated with Zostavax*
Flonase Sensimist launched in US; second Rx to OTC switch in 3 years
Outlook assumptions and cautionary statements

Assumptions related to 2017 guidance and 2016-2020 outlook

In outlining the expectations for 2017 and the five-year period 2016-2020, the Group has made certain assumptions about the healthcare sector, the different markets in which the Group operates and the delivery of revenues and financial benefits from its current portfolio, pipeline and restructuring programmes.

For the Group specifically, over the period to 2020 GSK expects further declines in sales of Seretide/Advair. The introduction of a generic alternative to Advair in the US has been factored into the Group’s assessment of its future performance. The Group assumes no premature loss of exclusivity for other key products over the period. The Group’s expectation of at least £6 billion of revenues per annum on a CER basis in 2018 from products launched since 2013 includes contributions from the current pipeline asset Shingrix. The Group also expects volume demand for its products
to increase, particularly in Emerging Markets.

The assumptions for the Group’s revenue and earnings expectations assume no material interruptions to supply of the Group’s products and no material mergers, acquisitions, disposals, litigation costs or share repurchases for the Company; and no change in the Group’s shareholdings in ViiV Healthcare or Consumer Healthcare. They also assume no material changes in the macro-economic and healthcare environment.

The Group’s expectations assume successful delivery of the Group’s integration and restructuring plans over the period 2016-2020. Material costs for investment in new product launches and R&D have been factored into the expectations given. The expectations are given on a constant currency basis and assume no material change to the Group’s effective tax rate.

Assumptions and cautionary statement regarding forward-looking statements

The Group’s management believes that the assumptions outlined above are reasonable, and that the aspirational targets described in this report are achievable based on those assumptions. However, given the longer term nature of these expectations and targets, they are subject to greater uncertainty, including potential material impacts if the above assumptions are not realised, and other material impacts related to foreign exchange fluctuations, macroeconomic activity, changes in regulation, government actions or intellectual property protection, actions by our competitors, and other risks inherent to the industries in which we operate.

This document contains statements that are, or may be deemed to be, “forward-looking statements”. Forward-looking statements give the Group’s current expectations or forecasts of future events. An investor can identify these statements by the fact that they do not relate strictly to historical or current facts. They use words such as ‘anticipate’, ‘estimate’, ‘expect’, ‘intend’, ‘will’, ‘project’, ‘plan’, ‘believe’, ‘target’ and other words and terms of similar meaning in connection with any discussion of future operating or financial performance. In particular, these include statements relating to future actions, prospective products or product approvals, future performance or results of current and anticipated products, sales efforts, expenses, the outcome of contingencies such as legal proceedings, and financial results. Other than in accordance with its legal or regulatory obligations (including under the UK Listing Rules and the Disclosure and Transparency Rules of the Financial Conduct Authority), the Group undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. The reader should, however, consult any additional disclosures that the Group may make in any documents which it publishes and/or files with the SEC. All readers, wherever located, should take note of these disclosures. Accordingly, no assurance can be given that any particular expectation will be met and investors are cautioned not to place undue reliance on the forward-looking statements.

On April, 27 2017 Roche reported a good start in 2017 (Press release, Hoffmann-La Roche, APR 27, 2017, View Source [SID1234518708]).

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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

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.

Clinical trial results support key new indications for Roche medicines
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.a