Interim Management Statement
22/04/2008
Biocompatibles International plc (LSE:BII) is pleased to publish its first Interim Management Statement (“IMS”). This IMS relates to the three month period ended 31 March 2008 and contains information up to the publication of this IMS (“the period”).
The overall performance of the business during the period has been in line with the Board’s expectations. Details are described below.
Business developments
In our Drug Delivery business, two key events occurred in the period.
Firstly, the FDA approved Medtronic’s Endeavor® Drug-Eluting Stent and Medtronic launched the product onto the market, both events happening in February. The product launch entitled the Company to a milestone payment from Abbott which was received in the period. Biocompatibles receives a 1.5% royalty on Medtronic’s worldwide sales of Endeavor®.
Secondly, we received regulatory approval from the FDA for a clinical trial for the PARAGON Bead™ which is loaded with the chemotherapy drug, Irinotecan. This study will recruit 70 patients with hepatic colo-rectal metastases. The trial is part of a programme that is designed to deliver US regulatory approval for the PARAGON Bead™. We are targeting the recruitment of the first patient around the middle of this year.
In CellMed, recruitment completed in the Dermal Filler Bead trial. This trial is managed by CellMed’s partner, Merz Pharmaceuticals and is designed to deliver CE Mark approval; targeted for the first half of 2009.
These events represent three of our five principal goals for 2008. The statuses of the remaining two goals are as follows; presentation of the randomised PRECISION V data at CIRSE is on track for September; and completion of recruitment in the CellBeads™ stroke trial where we still await recruitment of the first patient.
Financial update
The Company generated a positive cash flow of £2.7m in the quarter to 31 March, closing with cash and cash equivalents of £37.0m. This was helped by the receipt of the second Abbott milestone, relating to Medtronic’s first US commercial sale of the Endeavor® stent.
Revenue is in line with our expectations at this point in the year and we continue to expect full year revenue in the range £12m to £15m.
Crispin Simon, Chief Executive of Biocompatibles commented, “We have made good progress in the first three months of 2008. We have benefited from two products achieving their US regulatory goals of product or clinical trial approval and a third achieving its first clinical milestone of patient recruitment. We look forward to the further progress of these three programmes.”
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