Osmetech is a fast developing, international healthcare diagnostics business, targeting the high growth, near patient
testing sector serving small to medium sized hospitals.
Highlights:
- Sales for the 8 month period of £5.59m (12 months ended 30 April 2005 - £5.83m) – increase of 78% on
the corresponding 8 month period
- Critical Care Division sales for calendar year 2005 increase by 64% to $14.79m (2004 calendar year -
$9.04m)
- Substantial growth in sales of Critical Care Division’s blood-gas analysers and consumables to both human
and veterinary (IDEXX) markets
- Operating losses for the 8 month period of £5.09m before share compensation charges of £0.5m (12
months ended 30 April 2005 – operating losses of £2.15m before exceptional operating costs of £0.83m)
- Loss after tax for the 8 month period of £5.22m (12 months ended 30 April 2005 - £2.72m)
- Acquisition of Clinical Micro Sensors Inc. (CMS) in July 2005 strengthens the Group’s presence in the fast
growing molecular diagnostics market
- FDA clearance received for eSensor Cystic Fibrosis screening test
- Three molecular diagnostics products, eSensor, OPTI GENE and OPTI TUBE on schedule for launch in H1
2006
- Worldwide roll out of new Critical Care products, OPTI LION and OPTI R
- Excellent growth prospects in the small to medium sized hospital market
James White, Chief Executive, Osmetech plc said:
‘Our investment in the Critical Care Division since it was acquired from Roche in 2003 is being realised with a
substantial increase in sales during the period. We expect further profitable growth in 2006 from both new products
and the expansion of our veterinary business through IDEXX.'
‘The acquisition of CMS has enhanced our growing reputation in the rapidly developing molecular diagnostics
market. We have recently received FDA clearance for a Cystic Fibrosis test run on the eSensor instrument which
will be launched in the first half of 2006 together with the OPTI GENE and OPTI TUBE products.
‘The growing and reliable OPTI business gives us a valuable development, manufacturing, sales and distribution
infrastructure, providing a strong platform for growth and level of credibility as a successful commercial organisation
as we look to exploit the considerable opportunities in the field of molecular diagnostics.’
For further information:
Osmetech plc
James White / David Sandilands 020 7593 4000
madano partnership
Mark Way / Matthew Moth 020 7593 4000
2
Chairman’s statement
Osmetech has adopted a December year end in order to bring its management and reporting cycle more into line
with its commercial partners. The 8 month period to 31 December 2005 saw two areas of significant progress for
the Group – the acquisition of Clinical Micro Sensors, Inc., (“CMS”) from Motorola to further strengthen our
molecular diagnostics business and the substantial sales growth achieved by our Critical Care Division through the
OPTI range of blood gas analysers and consumables.
Strong growth in Critical Care
I am pleased to report that our Critical Care Division has reported exceptionally strong growth in the 8 month period
with sales of £5,588,000, up by 78% (2004 – corresponding 8 month period: £3,145,000). We are now benefiting
from both the new product investment made since the business was acquired from Roche in 2003 and the strong
sales of VetStat by our veterinary distribution partner, IDEXX Laboratories, Inc. (“IDEXX”). We expect to see further
growth in both of these areas in 2006.
Greater presence in molecular diagnostics
Osmetech is creating a strong Molecular Diagnostics Division to address the considerable potential that exists in
this fast growing market.
CMS was acquired in July 2005 providing us with the eSensor product to complement our existing OPTI GENE and
OPTI TUBE business which targets simple, rapid near patient testing. On the back of our recent FDA clearance for
a Cystic Fibrosis assay using the eSensor instrument platform we remain on target to launch all three of these
products during the first half of 2006.
Summary and outlook
The Group is building a strong presence in the important field of molecular diagnostics which is underpinned by a
solid and profitable OPTI business with a proven commercial infrastructure and worldwide distribution network.
Osmetech is developing a strong reputation for acquiring and developing underexploited assets and non-core
businesses. Under experienced management, considerable progress has now been made with all three of our
recent acquisitions. New products and the IDEXX veterinary business have enabled us to broadly double the size of
the Critical Care Division in a little over 2 years and now, within 6 months of the acquisition of CMS, we have gained
FDA approval for a Cystic Fibrosis carrier detection test using the eSensor DNA detection instrument.
This progress is expected to continue as the Group strengthens its position in the fast growing near patient
diagnostics testing market serving small to medium sized hospitals.
Gordon Hall
Chairman
21 March 2006
Chief Executive Officer’s review
Introduction
Osmetech’s operations now comprise two US based divisions: Critical Care based in Atlanta and Molecular
Diagnostics located in Boston and Pasadena. The Group’s overall business model of selling instruments leading to
ongoing consumable sales has resulted in excellent growth for our Critical Care Division. The Molecular
Diagnostics Division has made excellent progress in developing a pipeline of products which is expected to start
generating revenues in 2006 based upon a similar business model of instruments and proprietary consumable
sales.
Critical Care Division
Based upon the OPTI product line of blood gas and electrolyte instruments and proprietary consumables, this
profitable division has reported substantial growth in 2005. Sales for the 8 month period were up by 73% in constant
currency terms compared to the equivalent period in 2004, while for 2005 as a whole, sales totalled $14.8m and
were ahead by 64% compared to the calendar year 2004.
Sales of both OPTI instruments and consumables grew strongly throughout the period boosted by increased sales
of the new touchscreen version of the long established OPTI Critical Care Analyser (“CCA”). Business in China was
particularly strong as our distributors build their market share in this increasingly important market.
Approximately half of the revenue growth in 2005 was due to sales to our veterinary distribution partner, IDEXX. The
VetStat blood gas and electrolyte analyser launched by IDEXX this year has proved very successful with a large
number of instruments already placed and in full use.
We continue to make good progress with IDEXX to create a new platform for measuring critical care parameters
based on OPTI’s proprietary optical fluorescence technology and we remain confident that product sales will
commence in the short to medium term. We are also broadening our test menu for new critical care parameters to
enhance both our competitiveness and revenue streams.
The international launch programme for the new OPTI LION and OPTI R instruments will be completed in 2006.
Incorporating similar technology to our highly reliable CCA instrument, the OPTI LION is a low cost electrolyte
analyser whereas the OPTI R targets the higher usage customer offering a highly competitive price per test through
the use of reusable consumables.
Osmetech Molecular Diagnostics
Molecular diagnostics is the fastest growing sector of the global diagnostics market and continues to develop
rapidly. The Human Genome Project is regularly discovering new information linking disease with genetic markers.
In turn, this is fuelling the demand for increased genetic diagnostic testing and intervention therapies in order to
improve healthcare and manage costs. Innovative technology such as Osmetech’s is expected to continue to
facilitate cost effective and simpler testing to enable wider adoption.
Against this exciting market backdrop, Osmetech’s Molecular Diagnostics Division is focused on decentralised
testing by providing practical, cost effective molecular diagnostic technologies and tools that enable a broader range
of hospitals and laboratories to offer molecular diagnostic services for improved patient care. Our strategy has been
to design low cost products specifically for the diagnostics market rather than by adapting complicated high cost
research products. During the first half of 2006, Osmetech plans to launch its first three products in this field.
Product launches
1) CMS eSensor - launch date: April 2006
The eSensor system targets relatively complex molecular tests which require the analysis of multiple genetic
information. Combining universal platform design and a patented advanced electrochemical detection technology,
the eSensor System can detect and identify many different targets at once. The technology is protected by strong
intellectual property comprising over 70 international patents which had benefited from an investment of
approximately $100m by Motorola during its period of ownership.
In January 2006 Osmetech received 510(k) clearance from the US Food & Drug Administration (‘FDA’) for its Cystic
Fibrosis (‘CF’) carrier detection test and its eSensor™4800 DNA Detection instrument platform. This FDA approval
is a first for a combined instrument and consumable CF assay. The system qualitatively assesses the carrier status
for Cystic Fibrosis for all adult couples contemplating pregnancy. In the clinical trials, very favourable comparison
studies were made against DNA sequencing. The overall agreement of the 486 samples was 98.8% (or 99.6%
omitting samples which produced a no-call result). Of these samples, 11,178 genetic mutations were analysed
producing an agreement of 99.0% (or 99.98% omitting no-calls).
The instrument platform and microarray consumable forming part of this approval will also be used for future
assays. Our facility in Pasadena has now also received an FDA California State License to manufacture product
and we remain on target to launch product in April 2006.
2) OPTI TUBE - launch date: May 2006
The OPTI TUBE product line consists of plastic tubes and ergonomically designed sealing caps and carousel for
use in the Roche LightCycler as a replacement for the Roche glass capillaries, sealing cap and carousel. OPTI
TUBE is a cost effective, robust alternative solution that eliminates the dangers of glass breakage and minimises
the risk of laboratory personnel being exposed to potentially dangerous samples and glass shards. There are an
estimated 50m glass capillaries sold each year for use on the LightCycler. The same plastic technology has been
incorporated into consumables to be supplied for use with Osmetech’s OPTI GENE instrument.
Osmetech has also granted a worldwide non-exclusive license with Roche Diagnostics for the manufacture and sale
of plastic consumable vials using this proprietary plastic tube technology.
3) OPTI GENE - launch date: June 2006
The OPTI GENE is a fast and flexible system for the detection of DNA and RNA targets using technologically
proven PCR or RT-PCR based assays suitable for simple molecular tests. It is a compact, self-contained
instrument that employs a graphics driven touch-screen user interface and a conveniently packaged OPTI TUBE
consumable. The system provides independent thermal controls for each sample position, as well as random
access for each of the three 4-sample cassettes.
Osmetech will initially be launching this instrument with thrombophilia assays. A recent study of 237 patient samples
at Bristol University in the UK, demonstrated that the OPTI GENE Factor V Leiden thrombophilia test was 100%
concordant with an established Roche LightCycler assay kit. The study showed that the test was simple to perform,
rapid and robust with excellent sensitivity, specificity and reproducibility.
Future products
The next Osmetech molecular test targeted for FDA submission will be our Cytochrome P450 (“CYP 450”)
pharmacogenomics assay which is currently in development. The CYP450 family of enzymes provides relevant
genetic information for drug metabolism, with the first FDA approved test having recently been launched by Roche
Diagnostics at more than $500 per test.
In general, pharmacogenomics is expected to become a very important area for the molecular diagnostics industry
over the coming years with the prospect of high product sales margins. Healthcare providers and pharmaceutical
companies now have both economic drivers and statutory obligations to determine the safety and efficacy of drug
effectiveness and dosage rates for patients by reference to their metabolic characteristics.
There are further assays in development for the OPTI GENE utilising the HyBeacons DNA probe technology
licensed from LGC Limited.
The combination of the OPTI GENE and eSensor products should enable both simple and more complex molecular
diagnostic tests to be performed accurately by hospitals in a cost effective and easy to use format. Unlike many
competing products, both Osmetech products combine both an instrument platform and proprietary assay-specific
consumables. These products were exhibited in November 2005 at two major international shows in the US (AMP)
and Europe (Medica) and generated a significant level of pre-launch interest both from potential commercial
partners and end customers.
In addition, both products have significant potential in other markets, such as veterinary, environmental and
forensics, which we would look to exploit through strategic partnerships. We have also seen through the $230m
acquisition of GeneOhm by Beckton Dickinson that the larger players are looking to aggressively extend their
molecular diagnostics presence through acquisition.
Acquisition of CMS
CMS was acquired cash and debt free on 26 July 2005 for a consideration satisfied by the issue of warrants that
entitle Motorola to subscribe for 7,811,428 ordinary shares at 17.5 pence per share. The Black-Scholes model for
pricing such a warrant indicates a fair value of the warrants of £923,000 which has been used to value the
consideration of the acquisition of CMS.
Fund raising
At the same time as the acquisition of CMS in July 2005, a placing of 62.9m new ordinary shares raised £11.0m
gross (£10.2m net of expenses) at a price of 17.5 pence per share.
Whilst we continue to believe that the net proceeds of the funding will be sufficient for the completion of
development and the launch of both the OPTI GENE and CMS Cystic Fibrosis products Osmetech will require
further funding later this year. In the meantime, we continue to progress our business model and hence, build value
within the Group.
Financial review
Sales revenues for the 8 month period to 31 December 2005 totalled £5,588,000 ($9,943,000) which represented a
78% increase over the corresponding 8 month period for previous year.
OPTI sales accounted for all Group revenues with new instrument sales representing 42% of the total. The relatively
high proportion of lower margin instrument sales and the growth in the IDEXX business was reflected in the gross
profit margin of 39% (year ended 30 April 2005: 42%) although the overall profitability of the Critical Care Division
benefitted from these additional sales.
As expected, following the CMS acquisition in July 2005 operating losses increased in the 8 month period to
£5,089,000 before share compensation charges of £512,000 (year ended 30 April 2005: £2,152,000 before
exceptional items of £827,000 and share compensation charges of £nil). CMS losses of £2,874,000 accounted for
the majority of the overall Group loss.
We anticipate that losses will increase in the coming year reflecting the full year effect of CMS’s operations.
However the expected sales growth from OPTI in 2006 should contribute to a further improvement in the profitability
of the Critical Care Division. The leveraging of our manufacturing cost base and planned product cost savings will
also drive us towards profitability. We expect to continue to operate with minimal sales and marketing costs through
the use of distributors for international and veterinary market sales.
Outlook
We anticipate further growth for the Critical Care Division in 2006 although this is not expected to match the
exceptionally strong growth rates achieved in 2005. IDEXX sales should continue to increase significantly and we
also expect good growth in our core human market with an important growing contribution coming from sales of our
new OPTI R and OPTI LION instruments. The high proportion of instrument sales in 2005 and growing installed
base of over 5,000 instruments in the human market alone should lead to a growth in high quality, reliable
consumable sales revenues in 2006 and beyond. In turn, this will enhance the profitability of the division.
Our Molecular Diagnostics Division has progressed significantly in the current period. There are clear markets for
the new OPTI GENE and OPTI TUBE products and we have demonstrated the compatibility of the HyBeacons DNA
probe technology as a foundation chemistry from which to develop further diagnostic tests. The CMS business has
been quickly integrated into the Group and the eSensor DNA Detection instrument platform now has FDA approval
for its first assay.
Both of these new molecular diagnostics instruments together with OPTI TUBE will be launched by mid 2006 and
will enhance our growing reputation in this rapidly developing market as well as installing instruments to provide the
basis of future revenues by introducing a wider range of tests. Through experienced management, proven
technology and a strong intellectual property position, we have already created a significant asset base and expect
to be able to strengthen our market position through future commercial partnerships and licensing agreements.
We expect Osmetech to build on its recent strong progress in fulfilling its strategy to develop a medical devices and
diagnostics business in the fast growing near patient testing market, principally serving small to medium sized
hospitals. In addition, we will continue to search for other opportunities to grow the business and leverage our
operations further through acquisition. The growing and reliable OPTI business gives us a valuable development,
manufacturing, sales and distribution infrastructure, providing a strong platform for growth and level of credibility as
a successful commercial organisation, as we look to exploit the considerable opportunities in the field of molecular
diagnostics.
James White
Chief Executive Officer
21 March 2006
To see the Consolidated Profit and Loss Account, Consolidated Balance Sheet, and Consolidated Cash Flow Statement please down the PDF version of this document.
Preliminary Results for the 8 months to 31st of December 2005 - [118 KB]
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