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London, UK, 05 April 2018
BTG plc (LSE: BTG), the global healthcare company, provides the following update for the year ended 31 March 2018.
BTG has delivered a good financial performance for the year, with revenue in line with expectations.
Very good growth in Interventional Medicine product sales reflects mid-teens CER1 growth in the oncology and vascular portfolios, which together represent >90% of revenue in this business. Sales of the earlier-stage Interventional Medicine assets were broadly flat at CER, where growth in Varithena® sales was offset by lower sales of the PneumRx Coils®. In the Pharmaceuticals business, product sales have grown around mid-single digits at CER. Licensing has performed well, with single-digit revenue growth at CER.
During the year we continued to make strong progress in clinical development, geographic expansion and product innovation. Enrolment was completed into the TheraSphere® STOP-HCC liver cancer trial. The first patients were treated with TheraSphere® in Latin America, Taiwan and Israel, and the first patients in Europe were treated with the novel radiopaque chemo-embolising bead, DC Bead LUMI™. Visual-ICE MRI, a new cryoablation system and needles from Galil Medical that are compatible with all Magnetic Resonance Imaging (MRI) scanners, received 510(k) and CE Mark regulatory clearances, and the first systems have been installed with customers. One-year data from the OPTALYSE PE trial reinforced the safety and efficacy of shorter, lower-dose EKOS® therapy for pulmonary embolism, showing continued improvement in right ventricular / left ventricular ratios and in quality of life.
Lower sales of the PneumRx® Coils reflect that market development, including securing appropriate levels of reimbursement, is taking longer than expected. We believe there is a significant long-term opportunity for the Coils and are taking action to focus resources on key activities to build long-term value. These include initiating the ELEVATE clinical study to generate additional data to support market development, and progressing the Premarket Approval application in the US, where an Advisory Committee Panel meeting is expected during the summer with potential approval by the end of 2018. Market development including accessing reimbursement will also take time in the US. As a consequence of this, and of prioritising European patients into the ELEVATE study, we do not expect material revenues from this product over the next two years. We have therefore reassessed the fair value of this asset, and our financial results for 2017/18 will include an impairment charge of approximately £150m. In addition, our 2018/19 results will include a one-off restructuring charge of up to £10m.
The introduction of new reimbursement codes for Varithena® in the US in January 2018 has led to renewed physician interest in the product. However, as previously noted, it will take time to see the impact of the codes on physician and insurer practice. We expect to have a better understanding of physician ordering and reordering patterns by the end of 2018.
During the period, growth in the Pharmaceuticals business was driven by strong performances from CroFab® and Voraxaze®. In Licensing, royalties from Zytiga®(abiraterone) grew significantly following new data that supported earlier use in patients with advanced prostate cancer.
BTG’s Final Results will be published on 15 May 2018, together with guidance for the year ending 31 March 2019.
Louise Makin, BTG’s CEO, commented:
“We have delivered a good performance during the year. With sustainable and diverse revenue streams, we are continuing to invest in innovation, geographic expansion, indication expansion and acquisitions. We are well positioned to continue building our Interventional Medicine business and delivering these strong growth rates, and to continue developing leadership positions in attractive growth markets.”
For further information contact:
Andy Burrows, VP Corporate & Investor Relations
+44 (0)20 7575 1741; Mobile: +44 (0)7990 530 605
Stuart Hunt, Investor Relations Manager
+44 (0)20 7575 1582; Mobile: +44 (0)7815 778 536
Chris Sampson, Corporate Communications Director
+44 (0)20 7575 1595; Mobile: +44 (0)7773 251 178
Ben Atwell/Simon Conway
+44 (0)20 3727 1000
BTG is a global healthcare company focused on Interventional Medicine. Our innovative medical technology helps physicians treat their patients through minimally invasive procedures. We have a growing portfolio of products that advance the treatment of cancer, vascular conditions and severe emphysema. BTG’s Pharmaceuticals business provides products that help patients overexposed to certain medications or toxins. To learn more about BTG, please visit: btgplc.com.
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