July 16, 2014BTG plc: Interim Management Statement and Annual General Meeting
London, UK, 16 July 2014
BTG plc (LSE: BTG), the specialist healthcare company, today announces its interim management statement for the period 1 April 2014 to 15 July 2014 ahead of the Company's Annual General Meeting, which will be held today at 10.30 am at the offices of Stephenson Harwood LLP, 1 Finsbury Circus, London, EC2M 7SH.
Trading during the period has been in line with the Board’s expectations across all business segments. Full year revenue is expected to be in the £330m to £345m range as previously guided, despite the recent weakening of the US dollar versus sterling. Operating developments during the period are as follows.
In the Interventional Medicine segment, the controlled US launch of the varicose veins treatment Varithena® (polidocanol injectable foam) continues on track. More than 85% of vein clinic physicians have been contacted and the first 96 physicians are currently being qualified to use Varithena®. The first commercial patient treatments have been pre-authorised by insurance companies and are expected to be conducted during Q3 2014. Qualification of additional physicians will continue through the financial year.
An increase in the number of US hospitals using the EKOS blood clot treatment products, together with the recent US Food and Drug Administration (FDA) clearance of the EkoSonic®endovascular system for the treatment of pulmonary embolism, have helped the continued strong growth in this business.
Interventional oncology revenues overall are in line with expectations. Activities to expand the geographic availability of these products are continuing. In Europe, the sales force for TheraSphere®, BTG’s Yttrium 90 liver cancer radiation therapy, is being increased to 25-30 representatives to expand direct sales within the five major markets. In Asia, a direct sales team has been established in Taiwan and a regulatory and medical hub is being established in Hong Kong. This will provide regional support for both TheraSphere® and DC Bead® (used in trans-arterial chemoembolisation of malignant hypervascular tumours in the liver). In the US, the number of TheraSphere® users is increasing as expected following the merger of the sales forces for TheraSphere® and LC Bead® (used in the embolisation of hypervascularised tumours and arteriovenous malformations).
BTG has received a subpoena from the US Department of Justice, seeking documents in relation to an investigation they have commenced regarding LC Bead®, covering the period since 2003. BTG is cooperating fully with this investigation and at this time is unable to predict its scope, duration or outcome.
A good performance in the Specialty Pharmaceuticals segment during the period reflects hospital ordering patterns for CroFab®, the US snakebite antivenin, and steady demand for BTG’s other antidote products, DigiFab® and Voraxaze®. Wellstat Therapeutics Corporation continues progress towards a New Drug Application for uridine triacetate in the US for 5-FU overexposure.
In the Licensing segment, Sanofi/Genzyme have resubmitted the supplemental Biologics License Application for Lemtrada™ (alemtuzumab) as a treatment for relapsing remitting multiple sclerosis in the US, with an FDA action expected in Q4 2014. Lemtrada™ was also recommended for reimbursed use on the National Health Service by the UK’s National Institute for Health and Care Excellence.
Louise Makin, BTG’s CEO commented: “We have made a good start to the financial year, with revenues across the business growing as expected. The controlled launch of Varithena® in the US reimbursed sector is progressing well and the first patients are scheduled for treatment this quarter. We are implementing plans to expand direct sales of TheraSphere® and the EKOS products in Europe and to expand the availability of the interventional oncology products in Asia. These activities, together with the continued contribution from our specialty pharmaceuticals business and the financial underpin from our royalties, means we are well positioned to deliver sustainable profitable growth.”
For further information please contact:
Andy Burrows, VP Corporate and Investor Relations
+44 (0)20 7575 1741; Mobile: +44 (0)7990 530605
Ben Atwell/Simon Conway
+44 (0)20 3727 1000
BTG is a growing international specialist healthcare company that is developing and commercialising products targeting acute care, cancer and vascular diseases. The company has diversified revenues from sales of its own marketed products and from royalties on partnered products, and is seeking to acquire new programmes and products to develop and market to specialist physicians.