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GEN News Highlights : Feb 5, 2014
China Sales Declines Dent GSK Results Despite Drug Approvals
GlaxoSmithKline (GSK) reported mixed fourth-quarter and full year 2013 earnings results, with its core operating profit dipping 8% (1% at constant exchange rates) to £2.088 billion ($3.397 billion) on core revenue that rose 2% (5% at CER) to £6.906 billion ($11.237 billion).
The company fared slightly better over the full year, with operating profit flat (up 1% at CER) to £8.015 billion ($13.042 billion) on core revenue that decreased 3% (but stayed flat at CER) to £26.505 billion ($43.149 billion).
GSK trumpeted its R&D performance during 2013, in which it won approvals for six major products and completed five additional regulatory filings, helping to drive its estimated R&D internal rate of return up to 13%. Two of those approvals were for melanoma drugs Tafinlar and Mekinist, which according to GSK have around 60% combined share of prescriptions in the v600 targeted therapy market in the United States. The company expects even stronger sales this year, since the products were approved for use in combination in January, and GSK also received FDA breakthrough designation for Tafinlar in non-small cell lung cancer in the same month.
Another two of those approvals, Breo and Anoro, were for respiratory drugs—GSK is preparing to enter the COPD bronchodilator market this year by launching Anoro as the first dual agent available in the United States—while the company also has seven potential new products in late-stage development. GSK is intent on maintaining sales in respiratory drugs as its longtime best-selling product in the category Advair has seen sales slip due to competing products from several other biopharmas, notably AstraZeneca and Merck & Co.
“We are confident in the strength and future prospects of this broader portfolio of products and in our ability to maintain our leadership in respiratory well into the next decade,” GSK CEO Sir Andrew Witty said in a statement.
Overall, Witty said, the company has about 40 NMEs in Phase II/III clinical development, and this year and next GSK expects to have Phase III readouts for six of the NMEs. GSK is also planning to start Phase III trials for around 10 new products in key drug categories that include respiratory, oncology, and immuno-inflammation, he said.
A key challenge GSK faced last year, Witty acknowledged, was the loss of sales due to China’s investigation of alleged bribery by company representatives of physicians and government officials.
Sales of pharmaceuticals and vaccines fell 18% in China for full-year 2013, driven primarily by declines in respiratory and hepatitis products. China’s sales declines lowered the overall Emerging Markets Asia Pacific (EMAP) pharmaceuticals and vaccines sales gain to 1%, to £4.698 billion ($7.650 billion) in 2013; that gain was 5% outside of China.
During the fourth quarter, EMAP pharmaceuticals and vaccines sales rose 5% to £1.306 billion ($2.127 billion) with China results included, and jumped 11% excluding Chinese results. Within China, Q4 sales fell 29% from Q4 2012, with hepatitis and respiratory products especially affected, GSK said.
One example: respiratory sales in EMAP grew 5% during the quarter, despite a 22% decline in China that was primarily driven by Seretide, which was down 20%. Excluding China, EMAP respiratory sales grew 13%, with Seretide up 17% and Ventolin up 8%.
During 2013, respiratory sales in EMAP grew 4%, but would have grown 9% excluding China. The top-performing drug, Seretide, grew its sales 4% to £429 million ($698.6 million), but would have recorded a 12% gain had Chinese results not been included.
Sales of antivirals were also affected by China, finishing the year down 6% to £667 million ($1.086 billion) as increased shipments of Relenza to Japan could only partially make up for lower sales of Zeffix and Hepsera in China. However, Relenza shipments accounted for a 10% jump in Q4 antiviral sales, to £202 million, despite a decline in China.
For 2014, GSK projected core earnings per share growth of 4 to 8% at constant exchange rates, on revenue growth it expects will reach “around” 2% at CER.
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