January 29, 2014
BTG plc: Interim Management Statement
London, UK, 29 January 2014
BTG plc (LSE: BTG), the specialist healthcare company, provides the following update for the period from 1 October 2013 to 28 January 2014.
Trading overall during the period and in the year to date has been in line with expectations. The Company reiterates its guidance of revenue in the range £275m to £285m for the current financial year ending 31 March 2014.
There was good progress in Interventional Medicine during the period. BTG achieved a significant goal in November 2013 by securing regulatory approval of Varithena™ (polidocanol injectable foam) from the US Food and Drug Administration (FDA) for the treatment of patients with incompetent veins and visible varicosities of the great saphenous vein system. Preparations continue ahead of a planned product launch in the US during Q2 2014. These include the formation of a dedicated specialist sales force focused on private vein clinics that conduct the majority of reimbursed varicose veins procedures in the US. Preparations also continue to explore other market opportunities, including expanding the use of Varithena™ into the self-pay segment in the US, and expanding into additional geographic markets.
In November 2013, the combined LC Bead™ and TheraSphere® US sales force commenced selling both products to healthcare professionals involved in the interventional treatment of liver tumours. Activities are on track and BTG expects the financial impact of combining the sales forces to be evident in the financial year commencing April 2014. Activities also continued to expand and accelerate the three ongoing TheraSphere® Phase III trials in people with hepatocellular carcinoma or metastatic liver tumours from colorectal cancer (mCRC).
Sales of EKOS Corporation’s devices to treat severe blood clots continued to grow as new customers were acquired and reorders grew, in line with expectations. In January 2014, encouraging data were published from the ULTIMA study, exploring the potential use of the EkoSonic® Endovascular System in patients with sub-massive pulmonary embolism.
In Specialty Pharmaceuticals trading showed a continuation of the first-half performance; with the snake-biting season over, promotional activities focused on DigiFab® and Voraxaze® rather than CroFab®.
In the Licensing segment, sales of Johnson and Johnson’s Zytiga™ (abiraterone acetate) continued to grow, generating increased royalties to BTG. Sanofi/Genzyme’s Lemtrada™ (alemtuzumab) received regulatory approval in Canada and Australia as a treatment for multiple sclerosis, following EU approval in September 2013. In December 2013, Genzyme received a Complete Response Letter from the FDA, indicating that the application is not ready for approval in the US. Genzyme commented that the FDA’s conclusion is related to the design of the completed Phase 3 active comparator studies of Lemtrada™ and that FDA has taken the position that one or more additional active comparator clinical trials are needed prior to potential approval. Genzyme plans to appeal the decision.
Louise Makin, Chief Executive of BTG plc, said, “BTG has made strong progress in 2013. The acquisitions of TheraSphere® and EKOS Corporation, together with the recent approval of Varithena™, give us the platform to become a commercial and scientific leader in Interventional Medicine. With the continued strong financial underpin from our Specialty Pharmaceuticals and Licensing segments, we will continue to execute our commercial and development plans to deliver sustainable and profitable long-term growth.”
For further information please contact:
Andy Burrows, Corporate and Investor Relations
+44 (0)20 7575 1741; Mobile: +44 (0)7990 53060
Rolf Soderstrom, Chief Financial Officer
+44 (0)20 7575 0000
Ben Atwell/Simon Conway
+44 (0)20 7831 3113
BTG is an international specialist healthcare company that is developing and commercializing 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.