The UK's Shire Pharmaceuticals saw a big drop in its net income for the second quarter of the year, from just under $110 million in 2005 to little over $61 million, as impressive earnings from its star hyperactivity drug Adderall XR failed to offset the increased investment in R&D and new products. But investors seemed relatively unconcerned and the company's share price shifted little on the day.
Overall, product sales jumped 7% to $376 million, while total revenues were lifted just 3% to $439 million, versus major growth spurts of 28% and 23% in the previous 2006 quarter. This, says Shire, relates in the main to wholesaler de-stocking and says the half-year revenue growth figure of 12% is a better predictor of its performance, as well as being in line with its sales growth forecasts of low double digits for the full year.
Having been criticised for being over-reliant on its Adderall franchise, which pulled in $220 million during the quarter, up 7%, Shire is investing heavily in new product development and received a boon recently following the launch of its Daytrana ADHD patch - which it says has been well received - as well as the approval earlier last week of Elaprase (idursulfase), the first drug to be cleared for the rare genetic condition Hunter syndrome in the USA and which is also anticipating a green light in Europe in December.
And next up to buoy Shire is NRP104 - its new ADHD therapy - which is slated for US approval on October 6, followed later that month by Mesavance (mesalamine) for ulcerative colitis. Its ADHD focus, which has proved so profitable, is certainly not waning for Shire, with two additional compounds in development in this arena and rapidly approaching the marketplace: SPD465, for adult ADHD, was filed with the Food and Drug Administration last month, while SPD503 for paediatric ADHD will be submitted to the US drug regulators in the third quarter.
Meanwhile, investors are also hopeful of an out-of-court settlement between Shire and generics manufacturer Barr Labs after the UK firm revealed “discussions are progressing” concerning a copycat version of Adderall XR and suggested it hopes to settle the patent litigation before the case is scheduled to begin at the end of October. Shire filed a Citizen's Petition last year seeking to delay generic competition to Adderall XR by asking that generic companies be asked to supply more robust bioequivalence data in order to secure approval.