Interim Management Statement Q1 2009
17/04/2009
• Revenue ahead of expectations
• Metastatic Breast Cancer data to be presented in September
• Dividend record date 1st May 2009
Biocompatibles International plc (LSE:BII) is pleased to publish its Interim Management Statement (“IMS”) relating to the three month period ended 31 March 2009.
Financial update
Revenue is ahead of Board expectations, as a result of the benefit of sterling weakness and stronger than budgeted sales of Drug-Eluting Beads.
The Company generated a small positive cash flow in the quarter, closing with cash and cash equivalents of £33.9m (31 Dec 2008: £33.6m). A payment by AstraZeneca was received, in accordance with the terms of the agreements announced on 22nd December 2008.
The Company has provided guidance on 2009 revenue in the range £22m to £24m; and on closing net funds of £27m. It is the Company’s policy not to change guidance early in the year.
The Board has approved a dividend of five pence per share which will be paid on Friday 22nd May 2009 to shareholders on the register at the close of business on Friday 1st May 2009.
Clinical Trials Reporting
Data has been presented from the Drug-Eluting Bead “Surgical Registry” at a number of conferences including the annual meetings of the Society of Surgical Oncology (SSO) and the American Hepato-Pancreato-Biliary Association (AHPBA). A summary of the key points is as follows:
1 A sub-set of 15 patients with hepatic breast cancer metastases was identified and the safety and efficacy data analysed. The results will be presented no later than in September, where the location would be the annual meeting of the Cardiovascular and Interventional Society of Europe (CIRSE). A paper has been accepted for publication later in 2009; and the Company is now discussing the design of an appropriate Phase II study with experts in this field.
2 A sub-set of 55 patients with hepatic colorectal metastases was identified - who had been judged to be not suitable candidates for intra-arterial chemotherapy (too unlikely to respond to treatment given the toxicity-related side effects).
a. A response to Drug-Eluting Bead treatment at six months was recorded in 66% of these patients 1. This compared with the 12% response that would have been expected from intra-arterial chemotherapy.
b. Patients were recruited into the trial because they were considered to be ineligible for surgical resection or other potentially curative treatments. Following Drug-Eluting Bead treatment, 20% of these patients subsequently received a surgical resection or another curative treatment.
3 A sub-set of 60 patients with HCC was identified, where local disease control was more than 95% 2. Concurrent sorafenib treatment was safely administered to 15 of these patients, providing data in support of the combination DC Bead + sorafenib therapy being evaluated in the SPACE trial (see below).
Doctors have now presented the results of the treatment with Drug-Eluting Beads of a cumulative 1,319 patients in 35 clinical trials. This represents a substantial body of safety and efficacy data and is important to the reputation and growth of the Company’s products.
Clinical Trials Recruiting
There are six larger trials in which Biocompatibles’ products are being evaluated. An outline of these trials’ designs is shown in the Notes to Editors. Data from these trials are expected in the 2009-2012 time-frame and, when presented, to contribute to further growth in sales. At this time, the Company considers the SPACE trial and the Surgical Registry to have the greatest near and medium term commercial importance.
The SPACE trial is managed by Bayer Pharmaceuticals Inc. Biocompatibles will make announcements of any material information put into the public domain by Bayer.
The Surgical Registry has now recruited 363 patients. Several papers have been submitted for publication and further trials are being designed in indications identified in the Registry.
PARAGON Louisville investigators have now received FDA conditional approval to start the trial. The investigators expect to recruit the first patient during the course of the second quarter of 2009.
PARAGON I investigators are screening patients at three centres and the first patient was treated on 8th April.
PARAGON II investigators have now treated three patients. The first patient has also safely undergone liver resection - in accordance with the trial’s protocol.
The CellBeads Stroke trial has now recruited four patients. Two further hospitals are preparing documentation that would enable them to participate in the trial.
1 Data first reported in company announcement on 17th February 2009
2 Objective response and Stable Disease combined
- Ends -
Contact Us
Biocompatibles International plc:
Biocompatibles International plc is a leading medical technology company in the field of drug-device combination products.
The Oncology Products Division conducts the marketing of Biocompatibles’ approved oncology products, supplied from facilities in Farnham, UK and Oxford, CT. These include Drug-Eluting Bead products which are used in more than 35 countries for the treatment of primary liver cancer (HCC), liver metastases from colorectal cancer, and other cancers; and Brachytherapy products (Radiation-Delivering Seeds) which are used in the treatment of prostate cancer. Our distribution partners include AngioDynamics Inc., Terumo Corporation and Eisai Co. Ltd.
Our R&D Facilities are engaged in licensing and in new product development, based on the company’s core drug delivery technologies. The Drug Delivery Division, in Farnham, UK is developing new products for oncology. CellMed, in Alzenau, Germany, is developing a Drug-Eluting Bead product for the treatment of stroke, based on proprietary stem cell technology; and a GLP-1 analogue for the treatment of diabetes and obesity partnered with AstraZeneca. We also have collaborative agreements with Bayer Healthcare Pharmaceuticals Inc., Medtronic Inc. and Merz Pharmaceuticals GmbH.
Further information is available at www.biocompatibles.com
This news release contains forward-looking statements that reflect Biocompatibles’ current expectation regarding future events. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors including the success of Biocompatibles’ research strategy, the applicability of the discoveries made therein, the successful and timely completion of clinical studies and the uncertainties related to the regulatory and commercialisation processes.
Notes to Editors:
There are six larger trials in which Biocompatibles’ products are being evaluated.