Chippenham, UK – 21 May 2013: Vectura Group plc (LSE: VEC) (“Vectura”), which specialises in developing inhaled therapies, principally for the treatment of airway diseases, announces today its preliminary results for the year ended 31 March 2013.
Financial Highlights
· Revenues slightly ahead of expectations at £30.5m (2011/12: £33m)
· EBITDA loss improves to £3.4m (2011/12: £4.2m)
· Loss before tax decreased by 21% to £10.4m (2011/12: £13.2m)
· Balance sheet strength maintained with cash and cash equivalents of £70.1m (£75.5m at 31 March 2012)
Operational Highlights
Significant regulatory and clinical progress made throughout the year
Seebri® Breezhaler® (glycopyrronium bromide/NVA237 (COPD))
Product now launched in some European countries and Japan
· Novartis’ Seebri® Breezhaler® approved in the EU for maintenance treatment of COPD by the European Commission
· Approval for once-daily Seebri® Inhalation Capsules as maintenance COPD treatment in Japan
· EU and Japanese approvals triggered two milestone payments from Novartis of $10m (£6.2m) and $2.5m (£1.5m) respectively
· Seebri® Breezhaler® has been launched by Novartis in UK and Ireland, Germany and other countries, and Seebri® Inhalation Capsules in Japan
· US NDA filing for NVA237 expected in early 2014
QVA149 (COPD)
European and Japanese filings completed
· QVA149 is being investigated by Novartis for the maintenance treatment of COPD in the Phase III IGNITE clinical trial programme
· IGNITE is one of the largest international clinical trial programs in COPD comprising 10 studies in total (ILLUMINATE, SHINE, BRIGHT, ENLIGHTEN, SPARK, BLAZE, ARISE, BEACON, RADIATE, LANTERN) with more than 7,000 patients across 42 countries
· Phase III data presented by Novartis at the European Respiratory Society (ERS) Annual Congress in September 2012
· Novartis filed QVA149 for marketing authorisation in Europe in October 2012, and a separate filing in Japan in November 2012
· The EU filing triggered a $5m (£3.1m) milestone payment to Vectura
· US NDA filing expected at the end of 2014
VR315 (asthma/COPD), VR632 (asthma/COPD) and VR506 (asthma)
· Development programme continue to progress
· First development milestone of $3m (£1.9m) earned from new US partner on VR315
· Eligible to receive up to a further $32m upon achievement of future pre-determined development milestones
· VR506 development on-going with two multi-centre, international clinical trials currently in progress; one expected to report in Q4, 2013 and the second in Q1, 2014
Post-period events
· Chinese JV, Kinnovata, formed to develop and commercialise products in fast-growing Asian markets
· US approval of GSK’s BREOTM ELLIPTATM signals new additional royalty stream
· As is the subject of a separate announcement, Anne Hyland will be stepping down as Chief Financial Officer and Board Director on 30 June 2013. Paul Oliver, currently Financial Controller, will be appointed as her successor, with effect from 1 July 2013.
Dr Chris Blackwell, Chief Executive of Vectura:
“The past year has been very significant for Vectura, driven by the tremendous progress made by our partners and we continue to preserve our balance sheet strength through a combination of existing royalty streams and disciplined investment in R&D. As Novartis continues its roll out of Seebri® Breezhaler®, we will build on our royalty income and should also benefit from additional near-term development milestones from products in our pipeline. These additional income streams will provide a platform from which we can generate the next phase of Vectura’s growth. To achieve this, we will actively seek and evaluate suitable late-stage development and commercial opportunities, whilst carefully prioritising development and exercising tight control over expenses to manage our cash resources prudently. We are also delighted with the announcement post-period of the establishment of our joint venture in China, Kinnovata. This marks our first step into emerging markets and is an example of how we strive to leverage our assets in a cash efficient manner”.
Chris Blackwell, Chief Executive and Anne Hyland, Chief Financial Officer, will host an analyst/investor briefing today at 9.30 a.m. BST at the offices of FTI Consulting, Holborn Gate, 26 Southampton Buildings, London, WC2A 1PB. For further details please contact Victoria Foster- Mitchell on +44(0)20 3077 0486.
Enquiries
Vectura Group plc +44 (0)1249 667700
Chris Blackwell, Chief Executive
Anne Hyland, Chief Financial Officer
Karl Keegan, Corporate Development Director
FTI Consulting +44 (0)20 7831 3113
John Dineen / Ben Atwell / Simon Conway
About Vectura
Vectura Group plc is a product development company that focuses on the development of pharmaceutical therapies for the treatment of airway diseases. This growing market includes asthma and chronic obstructive pulmonary disease (COPD) and is estimated to be worth in excess of $30 billion worldwide.
Vectura has seven products marketed by its partners and a portfolio of drugs in clinical development, a number of which have been licensed to major pharmaceutical companies. Vectura has development collaborations and licence agreements with several pharmaceutical companies, including Novartis, Sandoz (the generics arm of Novartis), Baxter, GlaxoSmithKline (GSK) and Tianjin King York Group Company Limited (KingYork).
Vectura seeks to develop certain programmes itself where this will optimise value. Vectura’s formulation and inhalation technologies are available to other pharmaceutical companies on an outlicensing basis where this complements Vectura’s business strategy. For further information, please visit Vectura’s website at www.vectura.com.
Forward-looking statements
This press release contains forward-looking statements, including statements about the discovery, development and commercialisation of products. Various risks may cause Vectura's actual results to differ materially from those expressed or implied by the forward-looking statements, including: adverse results in clinical development programmes; failure to obtain patent protection for inventions; commercial limitations imposed by patents owned or controlled by third parties; dependence upon strategic alliance partners to develop and commercialise products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from development efforts; the requirement for substantial funding to conduct research and development and to expand commercialisation activities; and product initiatives by competitors. As a result of these factors, prospective investors are cautioned not to rely on any forward-looking statements. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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