|
Article Excerpt
Original Source: FD (FAIR DISCLOSURE) WIRE
FRANK CONDELLA, CEO, SKYEPHARMA PLC: Well, good morning. I think we're ready to get started. I'm Frank Condella, Chief Executive of Skyepharma and we're here for the first half results presentation for 2008. Everyone's aware of this disclaimer, I'm sure you've read and memorized it by now. It's there for your reference in the pack so you can spend time reading it throughout the presentation.
Key messages of this presentation, first of all, is that our revenues are up 44% year on year. So we've made very good progress on our revenues and that is falling to the bottom line with a substantial reduction of losses. Peter will be up here soon to give you more flavor and detail around the numbers.
Also, we've made very good progress on the development of Flutiform, our late stage Phase III product. And we're still on track for a filing in early next year, that's 2009, and we expect that to continue on that track. And Ken will be up here in just a few moments to tell you much more about the progress of Flutiform.
Also, we -- this year is the year of further growth from approvals and launches of other products and we'll be getting more into that into the operating review as well. And finally, I'd like to say that we made very good progress on the negotiation of the convertible bonds and we expect to be able to give you an announcement and an update very shortly.
So, just looking at our achievements. The significant progress on Flutiform development, I wont go into the details because I'll leave that for Ken, but its fair to say that we have a product here that's met all of its primary end points at this point, its continuing on its timelines and it will be filed by Abbott in the first quarter of 2009 and quite honestly, I think its very exciting and hopefully soon people will start to realize how important this progress is.
We also completed the out licensing of Flutiform to Kyorin for Japan. And that is the last of the major three pharmaceutical markets. We've got of course Abbott in the United States and Mundipharma in Europe and now Kyorin in Japan.
And will it will take some time to develop Flutiform for Japan, it's a very good deal for us because Kyorin will be paying for substantially all of the development costs. Along the way, the first of this year, we've had the approvals and launches of Requip XL in the United States. Requip, called one today in Europe is now available in 23 countries in Europe.
Sular, the new formulation has been launched in the United States and I think Ken will give a little bit more flavor in terms of how well that's going. And then, finally, Pulmicort MDI-HFA, which is marketed by AstraZeneca in Europe has further rolled out to additional countries.
Our partnership with Dr. Reddy's on SKP2045, which we have not named what that product is, but uses two of our proprietary technologies is continuing to move along and we're happy with that partnership so far.
And finally, just to reiterate that we have made good progress on convertible bonds. We do expect an announcement shortly and that's about all we're going to be able to say about this today and I'll repeat that a couple times, that that's about all we can say about this today.
So, on the top line numbers then, revenues up to GBP28.4 million for the first half, that's a 44% increase year on year. R&D spend is down year on year, but still quite significant given the cost of Flutiform and Peter again will give some more flavor as to how the R&D spend looks for the future.
And finally, our operating loss was only GBP2.2 million and then finally, after financing costs, amortization, et cetera. our net loss after tax was GBP6.8 million. An improvement from close to GBP20 million last year. So with that, I'll hand it over to Ken Cunningham.
KEN CUNNINGHAM, COO, SKYEPHARMA PLC: Thanks Frank, and good morning, everyone. Well we now have 12 approved products and we believe these do validate our technology. We -- as Frank's already mentioned, we've seen two new approvals this year, Sular, which was a vital approval for Sciele.
We manufacture this product and it's had a successful launch and now has over 80% of new prescriptions. So the conversion has gone really very well indeed and there have been no significant problems with the manufacturing.
Requip, we were very pleased to ultimately get U.S. approval in June and the product was launched in July. It's also, this year, been approved and launched in the UK, Germany and France.
And remember, we regard this version of Requip as actually not just delivering some improvement perhaps in convenience in taking it, but there are some real clinical benefits including speed of dose titration, reduction in side effects and improvements in efficacy. So, this is a product that despite there now being some generics out there, we believe, and Glaxo believes, will do well.
I think also like to bring your attention to Foradil. For some significant time now Novartis has been reviewing its commercial strategy and then it started to look at out licensing to a third party. But from about the spring of this year, we have been given the responsibility of identifying a licensee and we're making good progress on that front and we're in some talks so we hope we can move things forward.
And that's a product that, in the U.S., is ready to go. We have the approval. We have the manufacturing lined up to be able to launch it next year. So we're quite excited about the possibilities of that moving forward.
Word or two about Solaraze. Solaraze is our [only] topical product, but a couple of significant things have actually happened this year. One is that Almirall has taken over the product from [Shire] in Europe and certain other...
|
