January 31, 2013
BTG plc: Interim Management Statement
London, UK, 31 January 2013
BTG plc (LSE: BTG), the specialist healthcare company, provides the following update for the period from 1 October 2012 to 31 January 2013.
The Group’s trading during the period has been strong, with a particularly good performance from the Group’s acute care products. The Board currently anticipates that full year revenues for the year to 31 March 2013 will be around the top end of its guidance of £205m to £215m.
Whilst delivering strong financial results, the Group has also made good operational progress.
A New Drug Application seeking approval of Varisolve® (polidocanol endovenous microfoam (PEM)) as a comprehensive treatment for varicose veins will be submitted to the US Food & Drug Administration (FDA) within the next few days.
BTG’s interventional medicine business has made good progress. Humanitarian Use Device (HUD) designation was granted in the US in June 2012 for PRECISION Bead® and in December 2012 for PARAGON Bead®. HUD designation establishes that a medical device is intended to benefit patients in the treatment of a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year and it affords sponsors a faster review time and additional support from FDA reviewers.During H1 2013, BTG plans to submit Humanitarian Device Exemption (HDE) applications for both PARAGON Bead® and PRECISION Bead®, seeking authority to market both actively as drug-eluting bead treatments for intrahepatic cholangiocarcinoma and uveal melanoma with hypervascularised hepatic metastases respectively.
Good progress was also made with our partnered programmes. During the period, Zytiga®received US and EU label extensions to treat men with metastatic castration-resistant prostate cancer who have not received prior chemotherapy. In addition, Sanofi and its subsidiary Genzyme announced that the FDA had accepted for standard review a supplemental Biologics License Application (sBLA) file seeking approval of Lemtrada™ (alemtuzumab) for the treatment of relapsing multiple sclerosis. An FDA response on the application is expected during H2 2013. An EU regulatory opinion from the Committee for Medicinal Products for Human Use (CHMP)on Lemtrada™ for the treatment of relapsing multiple sclerosis is expected during Q2 2013.
Louise Makin, Chief Executive of BTG plc, said, “We have continued to make excellent operational and financial progress and now expect full year revenues to be around the top end of previous guidance. With the imminent submission of the Varisolve® NDA and the good progress in our beads business, we are on track with our strategic priorities and focused on executing our growth strategy.”
For further information contact:
Andy Burrows, Director of Investor Relations
+44 (0)20 7575 1741; Mobile: +44 (0)7990 530605
Rolf Soderstrom, Chief Financial Officer
+44 (0)20 7575 0000
+44 (0)20 7831 3113
BTG is an international specialist healthcare company that is developing and commercialising products targeting critical care, cancer and other disorders. 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.