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11/19/2013 9:22:02 AM
Chippenham, UK – 19 November 2013: Vectura Group plc (LSE: VEC) (“Vectura”), which specialises in developing products for the treatment of airway-related diseases, today announces its unaudited interim results for the six months ended 30 September 2013.
- Revenues of £17.0m (H1: 2012/13 - £17.0m; FY: 2012/13 - £30.5m)
- Positive EBITDA of £2.3m (H1: 2012/13 - £2.6m; FY: 2012/13 - negative £3.4m)
- Loss before tax of £1.2m (H1: 2012/13 - £1.1m; FY: 2012/13 - £10.4m)
- EPS loss of 0.1p (H1: 2012/13 - profit of 0.3p; FY: 2012/13 - loss of 1.8p)
- Robust balance sheet with cash and cash equivalents of £65.5m (£70.1m at 31 March 2013)
Approval of Novartis’ Ultibro® Breezhaler® (indacaterol/glycopyrronium, QVA149) in Europe and approval of Ultibro® Inhalation Capsules in Japan
- Following a positive CHMP opinion, the European Commission approved Ultibro® Breezhaler®, triggering a $10m (£6.2m) milestone
- Japanese approval for once-daily Ultibro® Inhalation Capsules, triggering a $2.5m (£1.6m) milestone
- US filing for QVA149 expected late 2014
- Post period event:
- Launched by Novartis in the Netherlands and Germany
Collaboration with UCB announced
- Development of an innovative biologic immunomodulatory product in the area of severe respiratory disease
- Co-development structure aims to bring asset through to clinical proof of concept
- Further validation of Vectura’s development capability and technology platform, and adds a novel early stage asset to the pipeline
VR315 (asthma/COPD), VR632 (asthma/COPD) and VR506 (asthma)
- Focus continues on high-value, non-commodity products
- Announcement of US guidelines on inhaled generic drugs was a positive development for Vectura
- Clinical trial programme underway for VR506
- Positive readout on clinical trial 002 (post period)
- Ongoing clinical trial (004), due to report data in H1 2014
- Discussions underway with potential development/commercialisation partners
Joint venture established in China (Kinnovata)
- Non-cash investment for 35% share in JV that will develop and commercialise products in fast-growing Asian markets
- Worldwide rights to Clickhaler® technology and Asian rights to Duohaler® technology
- Access to Vectura’s approved European Clickhaler® regulatory dossiers
- Clickhaler® and Duohaler® fixed assets
- Final local Government approval expected in 2014 upon which a non-cash gain of approximately £13.5m will be recognised
New Board appointment
- We are delighted to highlight the appointment of Bruno Angelici to the Board as an Independent Non-executive Director and Non-executive Chairman Designate (see post period press release on 14 November 2013). Bruno Angelici will join the Board on 1 December 2013 and will become Non-executive Chairman on 1 February 2014, the date on which current Chairman, Jack Cashman, will retire from the Board of Vectura.
Dr Chris Blackwell, Chief Executive of Vectura:
“The first half of the financial year has been another important period for Vectura, marked by significant development achievements. In September, Novartis received approval in Europe for Ultibro® Breezhaler® and Ultibro® Inhalation Capsules in Japan, the first ever approval of a LABA/LAMA combination.
These events represent a significant de-risking of our interests in this late-stage clinical asset. Novartis continues to roll out the commercialisation of both Seebri® Breezhaler® and Ultibro® Breezhaler® in Europe and Japan. Seebri® Breezhaler® launch is underway and we anticipate growing royalties as the launch of Ultibro® Breezhaler® is initiated by Novartis.
Vectura has maintained its financial discipline, exercising continued tight cost control whilst also leveraging non-core assets in emerging markets through the establishment of Kinnovata, our joint venture in China. Furthermore, our co-development collaboration with UCB highlights our on-going commitment to applying our development and technological strengths to innovative biological assets for airway-related diseases.
We would also like to welcome Bruno Angelici, following the recent announcement that he will join the Board of Vectura. Bruno brings a wealth of experience and we look forward to working with him as Vectura embarks on its next stage of growth.”
Chris Blackwell, Chief Executive and Paul Oliver, Chief Financial Officer, will host an analyst/investor briefing today at 9.30 a.m. GMT 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.
Vectura Group plc +44 (0)1249 667700
Chris Blackwell, Chief Executive
Paul Oliver, Chief Financial Officer
Karl Keegan, Corporate Development Director
FTI Consulting +44 (0)20 7831 3113
Vectura Group plc and its subsidiaries (“Vectura” or the “Group”) is a product development company that focuses on the development of pharmaceutical therapies for the treatment of airway-related 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 six revenue generating 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 KingYork Group Company Limited (KingYork).
Vectura seeks to develop certain products itself where this will optimise value. Vectura’s formulation and inhalation technologies are available to other pharmaceutical companies on an out-licensing basis where this complements Vectura’s business strategy. For further information, please visit Vectura’s website at www.vectura.com.
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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