Skyepharma PLC AGM Trading Update
LONDON, ENGLAND, 12 May 2015 – Skyepharma PLC (LSE: SKP), the expert oral and inhalation drug development company, provides a trading update ahead of its Annual General Meeting (AGM) being held today.
Current trading
The Group is currently trading overall in line with the Board’s expectations for the full financial year.
The Group is experiencing growth in demand for flutiform® and steps are being taken to expand manufacturing capacity. This product is now available in 26 countries and has been approved in a further 10 with applications for marketing authorisations under review in 14 countries.
Combined U.S. sales in the first quarter of 2015 of Solaraze® and its authorised generic as reported by the Group’s U.S. license partner Fougera Pharmaceuticals Inc. (part of Sandoz), were significantly ahead of expectations due to manufacturing issues at a competitor. Skyepharma is currently eligible for a royalty of 20 per cent on net sales of these products, which will reduce to a low-teens percentage after all relevant licensed patents expire.
On 30 April, GlaxoSmithKline (GSK) announced that the U.S. Food and Drug Administration (FDA) has approved Breo® Ellipta® (fluticasone furoate/vilanterol [FF/VI]) for the once-daily treatment of asthma (but not for the relief of acute bronchospasm) in patients aged 18 years and older. Breo® Ellipta® has already been approved and launched by GSK in the U.S. for Chronic Obstructive Pulmonary Disease (COPD). On 6 May, GSK reported total Q1 2015 sales of Breo®/Relvar® Ellipta®, Anoro® Ellipta® and Incruse® Ellipta® of £54 million, up from £49 million in Q4 2014. Skyepharma has the potential to earn significant royalty income of up to £9.0 million per annum from the license of inhalation technologies to GSK used in these products.
On 30 April, Pacira announced sales of EXPAREL® of U.S.$56.0 million for Q1 2015, an increase of 63 per cent compared with the first quarter of 2014. In February 2015, Pacira announced resolution of matters with the FDA Office of Prescription Drug Promotion (OPDP) pertaining to certain promotional aspects of EXPAREL®. On 16 April, Pacira announced that it had received a subpoena from the U.S. Department of Justice requiring the production of a broad range of documents related to marketing and promotional practices for EXPAREL®. On 30 April, Pacira announced that, given the current lack of visibility on EXPAREL® sales resulting from the combined impact of recent regulatory developments and the government investigation, it is not currently giving guidance for sales of EXPAREL® for 2015. EXPAREL® sales in 2014 totalled U.S.$188.5 million. The Group receives 3 per cent of net sales (on a cash received basis) of EXPAREL®. In addition, based on current consensus forecasts by analysts covering Pacira, the trigger of U.S.$250 million annual net sales (on a cash received basis) for a U.S.$8.0 million (£6.3 million) sales milestone to become payable to Skyepharma is predicted to be achieved in 2015.
Revolving Credit Facility (“RCF”)
With a stronger balance sheet the Group is in a position to consider corporate opportunities in appropriate circumstances as they arise. In order to provide greater funding flexibility to complement the existing net cash position and strong cash flow, Skyepharma signed a £25 million five year unsecured multi-currency RCF in April 2015 with Barclays Bank PLC, with an accordion option to extend the facility to up to £35 million during the term. The cost of borrowing under the facility is 1.30 per cent above the relevant LIBOR/EURIBOR reference rate, which is significantly lower than the costs of recently repaid secured debt. There are no current plans to draw down on the facility.
Peter Grant, Chief Executive Officer of Skyepharma, commented:
“Our business has made a good start to the year, building on the strong momentum reported for 2014 and we remain confident of the outlook for the full year.”
Skyepharma will hold its Annual General Meeting today at 10.30am at the offices of FTI Consulting, 200 Aldersgate Street, London EC1A 4HD.
- Ends -
For further information please contact:
Skyepharma PLC
Peter Grant, Chief Executive Officer
Andrew Derodra, Chief Financial Officer
+44 (0)20 7881 0524
Jonathan Birt, Investor and Media Relations
+44 (0)7860 361746
N+1 Singer
Shaun Dobson/Jen Boorer
+44 (0)20 7496 3000
FTI Consulting
Julia Phillips/Rob Winder/Natalie Garland-Collins
+44 (0)20 3727 1000
About Skyepharma PLC
Skyepharma combines proven scientific expertise with validated proprietary technologies to develop innovative oral and inhalation pharmaceutical products. The Group’s licenses cover 16 approved inhalation, oral, topical and injectable products, which generate milestones, recurring royalties, and in some cases, product supply revenues. The Group also earns milestones and contract development revenues from new product developments. Products developed by Skyepharma are marketed by some of the world’s most respected pharmaceutical companies. For more information, visit www.skyepharma.com
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Current trading
The Group is currently trading overall in line with the Board’s expectations for the full financial year.
The Group is experiencing growth in demand for flutiform® and steps are being taken to expand manufacturing capacity. This product is now available in 26 countries and has been approved in a further 10 with applications for marketing authorisations under review in 14 countries.
Combined U.S. sales in the first quarter of 2015 of Solaraze® and its authorised generic as reported by the Group’s U.S. license partner Fougera Pharmaceuticals Inc. (part of Sandoz), were significantly ahead of expectations due to manufacturing issues at a competitor. Skyepharma is currently eligible for a royalty of 20 per cent on net sales of these products, which will reduce to a low-teens percentage after all relevant licensed patents expire.
On 30 April, GlaxoSmithKline (GSK) announced that the U.S. Food and Drug Administration (FDA) has approved Breo® Ellipta® (fluticasone furoate/vilanterol [FF/VI]) for the once-daily treatment of asthma (but not for the relief of acute bronchospasm) in patients aged 18 years and older. Breo® Ellipta® has already been approved and launched by GSK in the U.S. for Chronic Obstructive Pulmonary Disease (COPD). On 6 May, GSK reported total Q1 2015 sales of Breo®/Relvar® Ellipta®, Anoro® Ellipta® and Incruse® Ellipta® of £54 million, up from £49 million in Q4 2014. Skyepharma has the potential to earn significant royalty income of up to £9.0 million per annum from the license of inhalation technologies to GSK used in these products.
On 30 April, Pacira announced sales of EXPAREL® of U.S.$56.0 million for Q1 2015, an increase of 63 per cent compared with the first quarter of 2014. In February 2015, Pacira announced resolution of matters with the FDA Office of Prescription Drug Promotion (OPDP) pertaining to certain promotional aspects of EXPAREL®. On 16 April, Pacira announced that it had received a subpoena from the U.S. Department of Justice requiring the production of a broad range of documents related to marketing and promotional practices for EXPAREL®. On 30 April, Pacira announced that, given the current lack of visibility on EXPAREL® sales resulting from the combined impact of recent regulatory developments and the government investigation, it is not currently giving guidance for sales of EXPAREL® for 2015. EXPAREL® sales in 2014 totalled U.S.$188.5 million. The Group receives 3 per cent of net sales (on a cash received basis) of EXPAREL®. In addition, based on current consensus forecasts by analysts covering Pacira, the trigger of U.S.$250 million annual net sales (on a cash received basis) for a U.S.$8.0 million (£6.3 million) sales milestone to become payable to Skyepharma is predicted to be achieved in 2015.
Revolving Credit Facility (“RCF”)
With a stronger balance sheet the Group is in a position to consider corporate opportunities in appropriate circumstances as they arise. In order to provide greater funding flexibility to complement the existing net cash position and strong cash flow, Skyepharma signed a £25 million five year unsecured multi-currency RCF in April 2015 with Barclays Bank PLC, with an accordion option to extend the facility to up to £35 million during the term. The cost of borrowing under the facility is 1.30 per cent above the relevant LIBOR/EURIBOR reference rate, which is significantly lower than the costs of recently repaid secured debt. There are no current plans to draw down on the facility.
Peter Grant, Chief Executive Officer of Skyepharma, commented:
“Our business has made a good start to the year, building on the strong momentum reported for 2014 and we remain confident of the outlook for the full year.”
Skyepharma will hold its Annual General Meeting today at 10.30am at the offices of FTI Consulting, 200 Aldersgate Street, London EC1A 4HD.
- Ends -
For further information please contact:
Skyepharma PLC
Peter Grant, Chief Executive Officer
Andrew Derodra, Chief Financial Officer
+44 (0)20 7881 0524
Jonathan Birt, Investor and Media Relations
+44 (0)7860 361746
N+1 Singer
Shaun Dobson/Jen Boorer
+44 (0)20 7496 3000
FTI Consulting
Julia Phillips/Rob Winder/Natalie Garland-Collins
+44 (0)20 3727 1000
About Skyepharma PLC
Skyepharma combines proven scientific expertise with validated proprietary technologies to develop innovative oral and inhalation pharmaceutical products. The Group’s licenses cover 16 approved inhalation, oral, topical and injectable products, which generate milestones, recurring royalties, and in some cases, product supply revenues. The Group also earns milestones and contract development revenues from new product developments. Products developed by Skyepharma are marketed by some of the world’s most respected pharmaceutical companies. For more information, visit www.skyepharma.com
Help employers find you! Check out all the jobs and post your resume.