BIOCOMPATIBLES INTERNATIONAL PLC
("Biocompatibles" or the "Company")
Trading statement
Farnham UK, 8 January 2010: Biocompatibles International plc (LSE:BII), the
medical technology company, is pleased to provide an update on 2009 trading.
The key points are as follows:
2009 Results:
* Revenue of £26.6m, representing growth of 50% on 2008 (29% on a constant
currency basis, hereafter referred to as "CC") and compared with previous
guidance of between £24m and £26m.
* Year-end net funds of £30.5m compared with previous guidance of £28m.
Principal 2010 Operating Goals:
* Complete recruitment in the CM3(1) 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.
2010 Guidance:
* Revenue in the range of £28m to £32m (13% increase on 2009 at the
mid-point; 21% CC).
* Pay a dividend of 6.25 pence per share in May; an increase of 25%.
* Closing cash of £25m after payment of the dividend of £2.5m.
2009 Results
Revenue increased by 50% to £26.6m (29% CC) - ahead of our expectations at the
start of the year.
Bead sales grew 100% (73% CC) to £12.0m and BrachySciences' sales were £6.1m.
BrachySciences' sales grew by 24% (4% CC) over 2008 including the pre
acquisition period. PC Licensing revenue decreased by 44% (-52% CC) to £4.6m
due to the absence of the one-off milestone received in H1 2008 and CellMed
revenue increased by 239% (202% CC) to £3.9m driven by the AstraZeneca
agreement.
Year end net funds were £30.5m compared with previous guidance of £28m and £
33.6m at 1 January 2009. The net funds comprised cash of £33.0m less a
financial liability of £2.5m, which is funding received from our marketing
partner, Merz Pharmaceuticals GmbH, to establish sufficient manufacturing
capacity for the NovabelTM product. Our cash position benefited significantly
from our strong sales in 2009 together with lower than anticipated operating
expenses.
We had five principal operating goals for 2009:
1. First patient treated in Bayer's "SPACE" trial (Drug-Eluting Bead +/-
Nexavar in HCC). This goal was achieved. The trial is currently recruiting
patients and we will report on any information released by Bayer.
2. Launch of DC Bead in China. This goal was not achieved. We announced on 7
August 2009 that our marketing partner, SciClone Pharmaceuticals Inc. had
reported that a small trial was required in China and that regulatory
approval was not expected until the second half of 2010.
3. Presentation of data from the Drug-Eluting Bead Surgical Registry at The
American Hepato-Pancreato-Billiary Association (AHPBA) Annual Meeting
(12-15 March, Miami Beach, Florida). This goal was achieved. Dr Robert
Martin presented positive data at the AHPBA meeting.
4. AstraZeneca programme update. This goal was achieved. We were delighted to
announce on 7 December 2009 that AstraZeneca had agreed to initiate the
clinical trial phase. The first treatment of a patient in a Phase I trial
is planned for early 2010.
5. Completion of recruitment in the CellBeadsTM stroke trial. This goal was
not achieved. Six patients have been recruited and the trial is not
expected to complete recruitment of the remaining 14 until the end of 2010.
A full review of the goals will be provided with the Preliminary Results
statement which is scheduled for release on 18 March 2010.
2010 Financial Guidance
The Company expects to achieve consolidated revenue for 2010 in the range of £
28m to £32m, the mid point of which represents growth of 13% over 2009 (21%
CC). - This growth will be generated by the Oncology Products Division. In
addition to unfavourable foreign exchange impacts, the Company's overall growth
rate is held back by flat revenues from the lower growth components of our
sales mix, namely the Medtronic ENDEAVOR® Drug-Eluting Stent royalty and
revenues recognised from the AstraZeneca development agreement.
The Company expects cash to be £25m at 31 December 2010. The outflow of £8.0m
results from an expected operating utilisation of £5.5m and the proposed
dividend payment of £2.5m. The operating utilisation includes capital
expenditure of around £3.5m, a significant part of which is for the Novabel
manufacturing facility at CellMed. The majority of this expenditure is funded
by our marketing partner, Merz Pharmaceuticals GmbH, the cash having been
received in 2009.
Ian Ardill, Finance Director of Biocompatibles, commented:
"The Company had an excellent year in 2009. Our Oncology Products Division
delivered strong sales growth and partnered with Eisai for the DC Bead in
Japan. Elsewhere in the Company, payment of our maiden dividend and
AstraZeneca's agreement to take the CM3 protein into the clinic were
highlights. We look forward to maintaining our progress in 2010 and the
confidence of the Board in the outlook for the Company is reflected in the
proposed increase in the dividend."
(1) CM3 is a GLP-1 drug for Type 2 diabetes which is under development with
AstraZeneca
-Ends-
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 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. 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 the Editors
Trial Indication End-Point(s) Concept Status
SPACE Intermediate Progression-free Randomised Recruiting
Stage HCC survival Controlled patients; Target
Trial 350
Control:
DEBDOX
Test:
DEBDOX +
Nexavar
PARAGON II Colorectal Tumour Single arm: Recruiting
liver resectability at Feasibility patients; Target
metastases surgery 20
DEBIRI mono
First-line, Correlation of therapy
resectable histopathology
(neo
and radiological adjuvant)
response
PARAGON Colorectal Progression-free Randomised Recruiting
liver survival controlled patients; Target
Louisville metastases trial 70
First-line, Control:
non-resectable FOLFOX +
Avastin
Test:
FOLFOX +
Avastin
+ DEBIRI