PEB
25/05/2012 16:21
FLLYR
REL: 1621 HRS Pacific Edge Limited
FLLYR: PEB: Preliminary Full Year Result: Year ended 31 March 2012
PRELIMINARY FULL YEAR DISCLOSURE
Pacific Edge Limited
Year End 31 March 2012
Commercialisation of Cxbladder has been the focal point for Pacific Edge
Limited ("the Company") during the financial year. Significant progress has
been achieved and major milestones reached. The Company has licensed partners
in Australia and Spain, has created new licensees in New Zealand and has
begun the rollout of the Company's US business in Hershey, Pennsylvania.
The Company progressed the commercial rollout of Cxbladder to reach into the
world's largest healthcare market, the US, with the successful raising of
NZ$20 million in New Zealand during the year. These funds are anticipated to
provide the Company with the cash resources to establish the business and
progress to significant revenue over the next two years.
The PEDUSA business has been created specifically to service the large US
market. The new laboratory, under construction in Pennsylvania has a planned
capacity of up to 200,000 tests per annum. It is on track for completion of
the build-out in September 2012, and for commencement of business operations
in March 2013, following an anticipated successful completion of the
regulatory process administered by the Clinical Laboratory Improvements
Amendment (CLIA). The Company hopes to be able to be in a position to
achieve a throughput target for the US laboratory by the end of the 5th year
of trading which would give the company the potential to generate gross
revenue in excess of $100 million at that time.
The US healthcare market is the largest healthcare market in the world. The
market has an advanced understanding of the clinical applications and
advantages that can and are being achieved from new molecular diagnostic and
prognostic tests. Several companies are now established in the market with
significant revenues. Recent developments in the US show that some urologists
are clustering into Large Urology Group practices (LUGs) to enable
specialisation and to leverage buying power. These LUGs, in conjunction with
the large Managed Healthcare organisations, provide the Company with a
focussed start to the US based sales and marketing program. There are
approximately 15,000 practising urologists in the USA and approximately 10%
are aggregated into LUG's.
Treatment of bladder cancer incurs the highest total medical costs of any
cancer. In the United States this figure is approaching US$200,000 per
patient from detection until death. In the US there are expected to be in
excess of 1,000,000 people presenting to their healthcare provider this year
with blood in their urine. It is anticipated that the US healthcare system
could invest in excess of $1 billion this year in investigating haematuria.
Cxbladder is expected to replace cytology for patients presenting to
clinicians with haematuria and be used to complement cystoscopy in the
clinical care of patients following treatment where patients are being
monitored for a recurrence of the disease.
The Company has continued to advance the rollout of Cxbladder to the markets
in Australia and New Zealand. During the year the Cxbladder laboratory
processes and operating technology has been successfully transitioned into
the Healthscope laboratory in Melbourne, Australia. The laboratory has now
been signed off by Pacific Edge and is capable of running the Cxbladder test
in a commercial environment. This transition enabled Pacific Edge to test
features of the technology support and commercial systems needed to enable
this franchised process to operate. Healthscope completed the training
seminars for all sales staff, enabling them to roll out the business
opportunity in all states in Australia.
Pacific Edge is delighted to have Healthscope Pathology as our key partner in
Australia, giving Cxbladder a strong market presence. Healthscope was the
first of Pacific Edge's targeted partners to take a license for the Company's
turnkey solution for bladder cancer, Cxbladder. Under the terms of our
agreement, Healthscope Pathology will market and offer laboratory services to
urologists and general practitioners (GPs) for the detection of bladder
cancer using Cxbladder in Australia.
Pacific Edge has retained the commercial rights to provide services to New
Zealand urologists and GPs through its subsidiary Pacific Edge Diagnostics NZ
Ltd, with its diagnostic laboratory based in Dunedin. As part of the
progressive launch of Cxbladder Pacific Edge has signed Labtests of Auckland
for an exclusive sales and marketing agreement that will see the Labtests
sales team focus on urologists and GPs in the Auckland and Northland regions,
which account for approximately 40% of the NZ market.
Further commercial applications are envisaged for this technology to monitor
the recurrence of bladder tumours in patients already diagnosed with bladder
cancer. A number of in-market studies have started during the year to enable
clinicians to understand how the Cxbladder technology will interface with the
clinical practice of key urologists.
Taking Cxbladder to the market in New Zealand and Australia is an integral
part of our commercialisation strategy. This local market provides the
Company with an excellent opportunity to develop the commercial processes and
to refine the logistics prior to commercialising the test in other countries.
Pacific Edge was delighted to sign Oryzon in Spain as its second partner.
Oryzon will market and offer laboratory services to urologists and general
practitioners for the detection of bladder cancer using Cxbladder in Spain
and Portugal. Oryzon is expected to have its laboratory validated by Pacific
Edge in July this year with the expectation of starting to offer commercial
services shortly after that.
The Company continues to progress the development of the other products in
the product pipeline and the Company achieved another significant milestone
with patents issued for Europe, Australia, and New Zealand in relation to the
Company's technology for the detection of gastric cancer. Investment in
intellectual property is a significant annual investment for the Company and
underpins the commercial capability for the Company's products. Steady
progress is being made with the issue of patents as they reach final
examination in various geographies around the world.
The Company has recorded a net loss of $4,072,897 for the year ended 31 March
2012, compared to a budgeted loss of $3,691,893 for the year ended 31 March
2012. This compares to a recorded net loss of $3,146,652 for the year ended
31 March 2011. The Company has made a significant forward investment in the
commercial rollout of Cxbladder in the US as a result of the successful
fundraising during the year. The unbudgeted spend on advancing the US
commercialisation was $389,825 (9.6%). A significant proportion of the
Company's expenditure for the 2012 financial year has been on the commercial
process development and commercial rollout of the bladder cancer product
Cxbladder to our commercial laboratory, and those of our licensed partners,
of the technology including the Company's proprietary sample collection kit
and the new diagnostic laboratory. The earnings per share for the current
year has remained constant at negative $0.18. No returns to shareholders have
been made in the last financial year.
As a matter of policy, the Company continues to write off all research and
development expenditure until the point at which products or projects provide
reasonable certainty of cost recovery. The Company over this period has made
further significant investment in intellectual property protection and
product development.
Chris Swann David Darling
Chairman Chief Executive Officer
ABOUT Cxbladder
Cxbladder is a non-invasive, accurate test that enables the early detection
of bladder cancer from a small volume of urine. It provides general
practitioners and urologists with a quick, cost effective and accurate
measure of the presence of the cancer, and provides urologists with the
opportunity to reduce their reliance on the need for invasive tests such as
cystoscopy. The recently completed multi-centre international clinical study
recruited 467 patients from Australia and New Zealand. Results show that
Cxbladder outperforms all of the benchmark technologies in the trial and
detected nearly all of the tumours of concern to a urologist; greater than
95% of all late stage and high grade tumours.
The Company's recently completed international, multicentre clinical trial
has been accepted for publication by the Journal of Urology and is scheduled
to be published in September 2012. Results show that Cxbladder is
significantly more accurate than other bladder cancer urine tests in common
usage. Cxbladder? technology sees 100% of late stage tumours and 95% of
high-grade tumours. These are the tumours of concern to the urologist. These
results show that Cxbladder? provides a significant step change increase in
performance over the other technologies benchmarked in the trial. It is
proposed that Cxbladder? will provide for clinicians and physicians a
replacement for cytology and will be the preferred complement to cystoscopy
in the patient's urological work-up - a significant market, given that all
patients that present to their healthcare professionals will receive between
1 to 3 cytologies in that work-up.
www.cxbladder.com
ABOUT BLADDER CANCER
Globally, bladder cancer has the 9th highest incidence and the 4th highest
incidence for men. One of the early symptoms of bladder cancer is the
presence of blood in the urine, haematuria. People with haematuria often
present to their general practitioner before being referred to a urologist.
There are a number of 'at risk' occupations that have shown a much higher
incidence of bladder cancer. Fire fighters and fire control officers have
shown in a US study to have a 2x incidence of bladder cancer over non fire
fighters. Smoking is a significant contributing factor (over 50% in males
and 33% in females, approximately 1 of every 2 new incidences of bladder
cancer is linked to smoking). Exposure to certain industrial chemicals or
carcinogens increases risks for some occupations e.g. hairdressers, painters,
printers, fire fighters and metal workers, chemical engineers. Finally,
incidence increases with age so the older you are, the greater the potential
for bladder cancer.
Bladder cancer has a very high recurrence rate of approximately 70%, with 30%
of these recurring as later stage tumours. This is a higher recurrence than
for skin cancer! However, bladder cancers are highly treatable, especially
if detected in the early stages. If diagnosed early there is a much higher
probability of survival for early stage tumours relative to later stage
tumours. This makes timely and regular surveillance and monitoring of this
cancer a key element of the clinical process and of the individual's annual
healthcare plan.
End CA:00223280 For:PEB Type:FLLYR Time:2012-05-25 16:21:19
