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Revenue ahead of expectations
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Recruitment complete in first phase I trial of CM3
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Dividend record date 7 May 2010
Farnham UK, 13 May 2010: Biocompatibles International plc (LSE:BII), the medical technology company, is pleased to publish its Interim Management Statement (“IMS”) relating to the period from 1 January 2010 to 12 May 2010.
Financial update
Revenue is ahead of Board expectations. Bead Products are performing strongly and, within Licensing, there is good growth in sales of the Novabel®1 cosmetic dermal filler bead. In addition, Sterling weakness has contributed to sales in both divisions.
The Company generated £2.2m of cash during the four months ended 30 April 2010, closing with cash of £35.2m (31 Dec 2009: £33.0m). The €4.3m, second instalment of a schedule of payments of €8.8m, first announced by Biocompatibles on 22 December 2008, was paid by AstraZeneca in January 2010. The final instalment is €1.0m and is due on the delivery of the reports of the pre-clinical and clinical activities; not expected in 2010.
The Company has provided guidance on 2010 revenue in the range £28m to £32m; and on closing cash of £25m. It is the Company’s policy not to change guidance early in the year.
The Board has approved a dividend of 6.25 pence per share which will be paid on Friday 28 May 2010 to shareholders on the register at the close of business on Friday 7 May 2010.
Operational update
In the Oncology Products Division, we were pleased to announce on 18 March the initiation of PARAGON Germany, a trial studying the Drug-Eluting Bead delivering irinotecan in combination with Cetuximab. This is the third trial to combine Drug-Eluting Bead therapy with a systemically-delivered drug marketed by a major pharmaceutical company.
Mr Graeme Poston, Chairman, and Chairman of Surgery, of the Liverpool, Mersey and North Cheshire Hepatobiliary Cancer Network will make a presentation on the PARAGON II clinical trial at the 2010 Annual Meeting of the American Society of Clinical Oncology (ASCO), June 4-8, 2010, Chicago. PARAGON II is an MHRA-approved, Phase II study evaluating DEBIRI2 in patients with liver metastases from colo-rectal cancer, who are eligible for surgical resection. Professor Riccardo Lencioni , Chief, Division of Diagnostic Imaging and Intervention, Department of Liver Transplantation, Hepatology and Infectious Diseases, Pisa University School of Medicine, will also make a presentation at ASCO on the design of the SPACE trial.
In the Licensing Division, the Company announced on 18 February 2010 the treatment of the first volunteer in the first Phase I clinical trial for CM3, a type II diabetes drug, under development with AstraZeneca. This trial is the first of four planned to commence in the year and has now finished recruitment. The Company plans to start the second Phase II clinical trial in late June. The clinical trial programme consists of these two Phase I and two Phase II trials.
On 30 March 2010, the Company announced the award of a €6.2M grant for the development of CellBeadsTM for the treatment of Cardiovascular Diseases. The project aims to deliver the data package to then enable First-In-Man studies in AMI (acute myocardial infarction, or heart attack) and CHF (congestive heart failure). The award has been made by the BioMedical Materials program (BMM), a public-private partnership subsidised by the Dutch government.
Commenting on the first quarter of 2010, Crispin Simon, Chief Executive of Biocompatibles said: “The Company has had a strong start to the year, with four growth drivers all making good progress: sales of Drug-Eluting Beads, sales of Novabel, the CM3 programme and the SPACE clinical trial. We are pleased with the operational and financial progress in the first quarter and look forward to paying our second annual dividend in May.”
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Contact:
Biocompatibles
Crispin Simon, Chief Executive
Ian Ardill, Finance Director |
+44 (0)1252 732706 |
Anna Keeble |
+44 (0)7879 818876 |
Biocompatibles International plc (www.biocompatibles.com)
Biocompatibles International plc
Biocompatibles International plc is a leading medical technology company in the field of drug-device combination products.
The Oncology Products Division supplies medical devices from facilities in Farnham, UK and Oxford, CT. These include Drug-Eluting Bead Products which are used in more than 40 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. We have a clinical collaboration agreement with Bayer Healthcare Pharmaceuticals Inc.
Our Licensing Division includes CellMed, in Alzenau, Germany, which is developing a Drug-Eluting Bead product for the treatment of stroke, based on proprietary stem cell technology; a GLP-1 analogue for the treatment of diabetes and obesity partnered with AstraZeneca; and a cosmetic Dermatology Bead partnered with Merz Pharmaceuticals GmbH. We also have a PC Licensing agreement with Medtronic Inc. in the field of Drug-Eluting Stents.
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.
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