Skyepharma PLC (SKYEF) – Interim Management Statement
10/10/2013 7:58:22 AM
LONDON, UK, 10 October, 2013 – Skyepharma PLC (LSE: SKP), the expert oral and inhalation drug delivery company, today publishes its Interim Management Statement for the period 1 July 2013 to 9 October 2013 and provides an update on key events since the half-year results announced on 15 August 2013.
As anticipated, revenue in the second half of 2013 has benefitted from a milestone of several million U.S. Dollars which has been received following the approval of flutiform® in Japan on 20 September 2013. A further milestone of €3 million (£2.5 million at current rates) is payable when flutiform® is launched in France, which is anticipated to take place in 2014. Now that launch stocks have been supplied for many markets, revenues from the supply of flutiform® are expected to be lower in the second half of the year compared with the first six months of 2013.
As previously announced, as at 30 June 2013 the Group had £18.8 million of cash. As anticipated, despite the receipt of milestones following the launch of flutiform® in countries including Japan and Italy, the Board expects that there will be a net cash outflow in the second half of the year due to debt and interest payments and the continuing investment in working capital and scaling up of the manufacturing processes for flutiform®.
Pipeline and product updates
Update on flutiform®
flutiform® combines, for the first time in Europe, the fast acting LABA (Long-Acting Beta Agonist), formoterol, and the most widely prescribed ICS (Inhaled Corticosteroid), fluticasone.
In Europe, flutiform® has been approved in 21 countries and launched in 12: Germany, the UK, Italy, Belgium, Cyprus, Denmark, Finland, Ireland, the Netherlands, Norway, Slovakia and Sweden. Skyepharma’s licensee, Mundipharma International Corporation Limited (“Mundipharma”), which is responsible for the development and commercialisation of flutiform® in Europe and most of the rest of the world outside Japan and the Americas, anticipates further launches during 2013/14, once pricing and reimbursement processes are concluded.
Mundipharma management has stated that uptake and sales of flutiform® continue to be in line with their expectations. According to Mundipharma, in-market sales* of flutiform® from launch (which commenced in September 2012) to the end of July 2013 totalled €8.2 million* (£6.9 million at current rates). When compared with the most recent launch of a new non-generic combination brand in the ICS/LABA market segment, flutiform® continues to track in-market value of total sales for the same period post launch across those countries where available. Mundipharma has achieved a “share of voice”† in this segment similar to that of the category leaders, and market research shows that flutiform® messages and key data are being well received. (*Source: IMS Health, IMS MIDAS. July MAT 2013. †Note: “Share of voice” represents the proportion of discussions recalled by prescribers based on independent surveys).
In September 2013, Mundipharma commenced an international clinical trial of flutiform® for the treatment of Chronic Obstructive Pulmonary Disease (“COPD”).
Mundipharma has filed marketing authorisation applications for flutiform® in a number of international markets outside Europe, and flutiform® has been approved for the treatment of bronchial asthma in Australia, Hong Kong and Israel.
As announced on 20 September 2013, the Japanese Ministry of Health, Labour and Welfare has given official administrative marketing authorisation for flutiform® for the treatment of adult patients with bronchial asthma in Japan, the world’s second largest pharmaceutical market. Following this approval, a milestone of several million U.S. Dollars has been received by the Group.
The Group’s partner, Kyorin Pharmaceutical Co. (“Kyorin”), is responsible for the development, marketing and distribution of flutiform® in Japan and intends to launch the product as soon as possible once pricing and reimbursement has been finalised, which is anticipated in the next few months.
In Latin America, the Group’s licensee, Sanofi, has made its first New Drug Applications (“NDAs”) for flutiform®.
Licences to GlaxoSmithKline (“GSK”)
One of the Group’s proprietary dry powder formulation technologies has been incorporated in two of GSK’s new inhalation products - BREO™ ELLIPTA™/RELVAR™ ELLIPTA™ and ANORO™ ELLIPTA™. Skyepharma is entitled to a low single-digit royalty on net sales of products using the licensed technology capped at a maximum amount of £3.0 million per annum for each chemical entity for the life of the relevant patents. BREO™ ELLIPTA™ and ANORO™ ELLIPTA™ together involve three new chemical entities, with total potential income of up to £9.0 million per annum.
As previously announced, BREO™ ELLIPTA™ (fluticasone furoate/vilanterol 100/25mcg) has been approved for the treatment of COPD in the United States and Canada. In September 2013, the same product, under the brand name RELVAR™ ELLIPTA™ (100/25 mcg and 200/25 mcg), was approved in Japan for the treatment of bronchial asthma, and the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion recommending its authorisation for the treatment of asthma and COPD in Europe.
NDAs for ANORO™ ELLIPTA™ (umeclidinium bromide/vilanterol) have been filed for approval in a number of countries including the United States, Europe and Japan. In September 2013, a Food and Drug Administration (“FDA”) Advisory Committee of the Pulmonary-Allergy Drugs Division recommended approval of ANORO™ ELLIPTA™ in the United States for the treatment of COPD and the Prescription Drug User Fee Act (“PDUFA”) target date for the FDA to complete its review is 18 December 2013. This medicine is not approved or licensed anywhere in the world.
Skyepharma has received encouraging advice from the FDA on the regulatory pathway for SKP-1052, an oral investigational product applying the Group’s proprietary Geoclock™ chronotechnology for the treatment of nocturnal, insulin-induced hypoglycaemia in patients with diabetes mellitus. Skyepharma is actively seeking a partner to fund further development.
Aenova – Lyon Facility
In July 2011, Skyepharma Production SAS leased its pharmaceutical manufacturing business (“Manufacturing Business”) and premises at Saint Quentin-Fallavier, Lyon (together the “Facility”), to Aenova France SAS (“Aenova”). The leasing arrangements were entered into for an initial period of two years which ended on 30 June 2013, following which certain termination or renewal rights apply. Aenova has initiated a process to ascertain if it has the right to terminate the lease of the Facility on 60 days’ notice. Skyepharma does not believe that Aenova has such a right to terminate in which case Skyepharma has the right to renew the lease agreement for the remaining period to 30 June 2016 at a rental of €2 million (£1.7 million at current rates) per annum. In accordance with the leasing arrangements, the matter is now being referred to be determined by an independent expert. Aenova continues to be obliged to manage and be responsible for the financial performance of the Facility on a day-to-day basis.
Appointment of CFO
As announced on 22 August 2013, Andrew Derodra has been recruited as Chief Financial Officer. He is expected to join the Company and Board in November 2013.
Peter Grant, Chief Executive Officer of Skyepharma, commented:
"Positive momentum has continued since we announced our interim results in August, including the approval of flutiform in Japan, its continued roll out in European markets and the decision by our marketing partner, Mundipharma, to initiate a clinical study for the treatment of COPD. The approvals of GSK’s BREO ELLIPTA/RELVAR ELLIPTA in the U.S., Canada and Japan have further strengthened the expected flow of royalties from Skyepharma’s inhalation technologies. We look forward to continued progress with flutiform in a number of key markets, including work to complete pricing discussions in France and Kyorin’s planned launch in Japan.
“With six major product approvals and launches in the last 18 months, Skyepharma has a strong platform for future growth from which to generate new development opportunities, both organically and with industry partners.”
For further information please contact:
Peter Grant, Chief Executive Officer +44 207 881 0524
Julia Phillips/Susan Stuart/Natalie Garland-Collins +44 207 831 3113
Shaun Dobson/Jennifer Wyllie +44 207 496 3000
Skyepharma combines proven scientific expertise with validated proprietary drug delivery technologies to develop innovative oral and inhalation pharmaceutical products. The Group receives revenues from 14 approved products in the areas of inhalation, oral, topical and injectable drug delivery as well as generating income from the development of further products and technology licenses. The products developed by the Group are marketed throughout the world by big pharma as well as speciality pharmaceutical companies. For more information, visit www.Skyepharma.com
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