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Unaudited Preliminary Results for the year ended 31 December 2009

Farnham, UK, 18 March 2010:Biocompatibles International plc (LSE:BII), the medical technology company, today announces its unaudited preliminary results for the year ended 31 December 2009.

Highlights

  • Total revenue increase of 50% to £26.6m (2008: £17.7m). Increase of 29% at constant currency.
  • Bead Products revenue increase of 100% to £12.0m (2008: £6.0m). Increase of 73% at constant currency.
  • Gross profit increase of 48% to £20.8m (2008: £14.0m).
  • Operating loss increase of 141% to £7.6m (2008: £3.2m). Current year figure includes an asset impairment charge of £2.5m (2008: £nil) and prior year figure includes a significant one-off item of income. Adjusting for these items, the loss decreased.
  • Net funds at 31 December 2009 of £30.5m (2008: £33.6m).
  • CE Mark Approval for Cosmetic Dermal Filler Bead (announced 18 March 2009).
  • Five pence per share dividend paid (announced 24 March 2009).
  • Eisai licences Drug-Eluting Bead products in Japan (announced 28 July 2009).
  • Acquisition of Cancer Diagnostic Product and Related Intellectual Property (announced 12 November 2009).
  • AstraZeneca and Biocompatibles agree to initiate Clinical Trial Programme (announced 6 December 2009).
  • Clinical activity:
  • Clinical Trial in UK in Liver Metastases from Colorectal Cancer (announced 17 February 2009).
  • Drug-Eluting Bead data presented at ASCO GI (announced 17 February 2009).
  • Update on US Drug-Eluting Bead Cancer Trials (announced 27 April 2009).
  • Positive Data from Combination Therapy Trial in Primary Liver Cancer (announced 3 November 2009).

 

Post Period Highlights

  • First Volunteer treated in Clinical Trial for Type II Diabetes Drug (announced 17 February 2010).
  • First patient treated in trial in China to support the DC Bead Regulatory submission.
  • 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.
  • Encouraging start to EU launch of Novabel.
  • Financial guidance reaffirmed.

 

Principal 2010 Operating Goals:

Operating

  • Complete recruitment in the CM31 Phase I clinical trials in Type 2 Diabetes.
  • Commence recruitment in the CM3 Phase II clinical trial.
  • File regulatory submission (PMA) for the DC Bead in Japan.
  • Complete recruitment in the clinical trial supporting the DC Bead regulatory submission for China.
  • Updates from our principal Drug-Eluting Bead clinical trials, which include SPACE, PARAGON II and PARAGON Louisville.

 

Financial

  • Revenue in the range £28m to £32m.
  • Pay a dividend of 6.25 pence per share in May.
  • Closing cash of £25m after payment of the dividend of £2.5m.

 

- Ends -

An analysts' presentation will be held on 18 March 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, for details please call Olga Holme at Piper Jaffray on +44 (0)20 3142 8769.

Contact:

Biocompatibles
Crispin Simon, Chief Executive
Ian Ardill, Finance Director

+44 (0)1252 732706

Anna Keeble

+44 (0)7879 818876

Full-Year Results PDF

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.