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2010 Half-Yearly Results

Farnham, UK, 26 August 2010: Biocompatibles (LSE:BII), the medical technology company, today announces its unaudited half-yearly results for the period ended 30 June 2010.

Revenue growth was strong and the Company traded profitably. The directors expect it to continue to do so.

Financial summary:

  • Bead Products revenue increase of 38% to £9.3m (H1 2009: £6.7m). Increase of 41% at constant currency.
  • Total revenue increase of 22% to £17.0m (H1 2009: £14.0m). Increase of 24% at constant currency.
  • Net profit of £1.2m (H1 2009: Net loss of £0.7m).
  • Cash, cash equivalents and held to maturity financial assets at 30 June 2010 of £33.4m (31 December 2009: £33.0m).
  • Announcement of expectation of sustainable profitability and increased 2010 revenue guidance of £31-34m and year-end cash guidance of £26m (announced 16 June 2010).
  • Net profit guidance for 2010 of around £1.5m.


Operational summary:

  • First volunteer treated in a clinical trial for CM3, our Type 2 diabetes drug (announced 17 February 2010).
  • First patient treated in trial in China to support the DC Bead® Regulatory submission (announced 18 March 2010).
  • Initiation of PARAGON Germany (Drug-Eluting Bead together with Cetuximab), the third trial to combine Drug-Eluting Bead therapy with a systemically-delivered drug marketed by a major pharmaceutical company (announced 18 March 2010).
  • Award of a €6.2m grant to the Company/University collaborative team for the development of CellBeadsTM for the treatment of cardiovascular diseases (announced 30 March 2010).
  • Payment of 6.25p per share dividend on 28 May 2010 (announced 15 April 2010)
  • Temporary suspension of shipment of Novabel® cosmetic dermal filler bead by our marketing partner, Merz Pharmaceuticals GmbH (announced 30 June 2010)
  • Acquisition of the Bead Technology Patents for $4.5m (£3m), which removed the obligation to pay future royalties (announced 6 July 2010).


Post period highlights:

  • Promising data in liver metastases clinical trial (PARAGON Louisville) and FDA approval for randomised Phase IIb stage of the trial.
  • First volunteers treated in the second Phase I clinical trial for the diabetes drug, CM3.


Commenting on results, Crispin Simon, Chief Executive of Biocompatibles International plc, said: “Revenue growth has been strong for the first half of the year. We are pleased to have moved into profit and intend to remain there whilst maintaining our commitment to developing and growing innovative medical therapies.”

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An analysts' presentation will be held on 26 August 2010 at 9.30am at the offices of Piper Jaffray, One South Place, London, EC2M 2RB. For those unable to attend a dial-in facility is available for analysts, please call Olga Holme of Piper Jaffray for details on +44 (0) 20 3142 8769.

Contact:

Biocompatibles +44 (0) 1252 732706
Crispin Simon, Chief Executive  
Ian Ardill, Finance Director  
   
Anna Keeble +44 (0) 7879 818876

Biocompatibles International plc (www.biocompatibles.com)

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.

Notes to Editors:
Biocompatibles’ products are being evaluated in more than 15 clinical trials, including the following:

Trial name Location Indication Primary Endpoint Patient numbers
SPACE (in collaboration with Bayer) Multi-centre Worldwide Primary liver cancer Time to progression Over 300
PARAGON
Louisville
Multi-centre US Liver metastases from colo-rectal cancer Tumour response 70
CM3 Programme (four Phase I and II trials) Germany Type 2 Diabetes Safety and tolerability. Efficacy circa 200
in four trials

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Regulatory notices and product safety data

Worldwide (excluding USA)

Bead Block™ is CE marked and indicated for the treatment of a variety of hypervascular tumours (including Uterine Fibroids) and arteriovenous malformations (AVMs). For full prescribing information please refer to Bead Block instructions for use.

DC Bead® is CE marked and is indicated for the treatment of malignant hypervascular tumours and loading with doxorubicin drug. DC Bead® is also indicated for loading with irinotecan for the treatment of metastatic colorectal cancer (mCRC). Both indications may not be available in your territory. For full prescribing information please refer to DC Bead instructions for use.

DC BeadM1™ is indicated for loading with irinotecan for the treatment of metastatic colorectal cancer (mCRC). For full prescribing information please refer to DC Bead M1 instructions for use.

USA

In the USA, Bead Block™ is indicated for the treatment of hypervascular tumors and arteriovenous malformations (AVMs). For full prescribing information please refer to Bead Block USA Instructions for use.

LC Bead™ is cleared by the FDA for the embolization of hypervascular tumors and arteriovenous malformations (AVMs). For full prescribing information please refer to LC Bead instructions for use.

LC Bead M1™ is cleared by the FDA for the embolization of hypervascular tumors and arteriovenous malformations (AVMs). For full prescribing information please refer to LC Bead M1 instructions for use.

DC Bead is not currently available for sale or distribution in the USA. Both indications may not be available in your territory. 

DC Bead M1 is not currently available for sale or distributions in the USA. 

Canada

DC Bead® with doxorubicin is indicated for trans-arterial chemoembolization (TACE) of unresectable hepatocellular carcinoma (HCC). DC Bead are also intended to be loaded with irinotecan for the purpose of embolization of vessels supplying malignant colorectal cancer metastasised to the liver (mCRC), and delivery of a local, controlled, sustained dose of irinotecan to the mCRC. For full prescribing information please refer to DC Bead Canada Instructions for Use 

DC BeadM1 is primarily intended as an embolic agent to treat vessels supplying malignant colorectal cancer metastasised to the liver (mCRC). DC BeadM1 is also compatible with irinotecan, which can be loaded prior to embolisation and then, as a secondary action, elute a local, controlled and sustained dose to the mCRC after embolisation. For full prescribing information please refer to DC BeadM1 Canada Instructions for Use  

Tawain

DC Bead is approved by the Department of Health and is intended to be loaded with Mayne (Hospira) doxorubicin HCI for the purpose of embolisation of vessels supplying malignant hypervascularised tumour(s), and delivery of a local, controlled, sustained dose of doxorubicin.  DC Bead is also indicated for the embolisation of nidus vessels without medication.  Approved size ranges in Taiwan are 300-500µm and 500-700µm.

Hong Kong

PRECISION Bead™ is indicated for the delivery of Doxorubicin, a chemotherapeutic agent for the treatment of malignant hypervascular tumours, where Trans Arterial Embolisation (TAE) is not contraindicated.