Skyepharma Plc (SKP.L, SKYE), a specialist drug delivery company, Monday reported that three-month revenue continued to grow significantly over last year's, mainly on higher royalty income and manufacturing revenues combined with increased contract research and development activities.
In its Interim Management statement for the trading period July 1-September 30, the company noted, "As in the first half of the year, revenues since 1 July 2008 continue to show significant growth compared with the 2007 run rate, primarily driven by increases in contract research and development, an increase in royalty income following the launches of Pulmicort HFA-MDI, Sular, and Requip Once-a-day, and higher manufacturing revenues, mainly from Sular."
The company further stated that as Flutiform Phase III program for the New Drug Application draws to a close, its research & development costs, as expected, are falling, with administration expenses remaining same as the first half. Again, the strengthening of the U.S. dollar against sterling has considerably reduced the unrealized exchange gain from that reported in the first six-month period.
Regarding its products and pipeline, Skyepharma noted that in Europe the Flutiform development program continues to make good progress. The extra higher dose strength efficacy trial is now ongoing and the company still expects to file the European Marketing Authorization Application in the third quarter of 2009.
For the U.S. launch of its approved drug Foradil Certihaler in 2009, discussions are in progress with a potential marketing and distribution partner. For Lodotra, Nitec Pharma AG now expects to obtain European approvals within a few months, and thereafter its launch in Germany by Merck KGaA shortly afterwards. Further, Nitec is working on a program for U.S. registration for which the FDA filing is expectedly to take place in 2010.
The company stated that generic erosion to its Paxil CR has been quite fast rapid, following the launch by Mylan Pharmaceuticals Inc.'s generic version of Skye's drug. Around 80% of new prescriptions and about 75% of total prescriptions at August end were being written for the generic form of the product, the company added. Requip Once-a-day has now been launched in the U.S. as Requip XL and also in most European countries, with GBP 15 million in sales reported for the third quarter.
The company also said that based on the current sales level of Zyflo CR and the release of additional supplies in August and September 2008, Critical Therapeutics estimates that wholesale distributors and retail pharmacies would have a sufficient inventory of this drug throughout the fourth quarter. Work on the previously announced collaborative feasibility project, SKP-2045, with Dr. Reddy's has been stopped pending further assessment. Progress continues to be made in line with the Board's expectations on the development of the sleep maintenance product, SKP-1041.
Commenting on its third-quarter performance, Ken Cunningham, chief executive officer, said, "This has been a period of significant progress for SkyePharma during which we have completed a successful fund raising and restructured our finances. Last week we announced excellent top line results from the final Phase III efficacy study for Flutiform and we look forward to the NDA filing in the United States in Q1 2009."
Looking ahead, SkyePharma said growing revenues from across its portfolio and declining costs for the development of Flutiform will enable the company to move towards long-term profitable growth.
SKYE closed Friday's regular trading on Nasdaq at $25.55.
On the LSE, SKP.L is currently trading at 190.00 pence, down 2.00 pence, or 1.04%, with a volume of 128,504 shares.
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