Ann: FLLYR: PEB: FY Preliminary Results

• Release Date: 30/05/13 16:39
• Summary: FLLYR: PEB: FY Preliminary Results
• Price Sensitive: No
• Download Document  13.46KB

					

PEB
30/05/2013 14:39
FLLYR

REL: 1439 HRS Pacific Edge Limited

FLLYR: PEB: FY Preliminary Results

PRELIMINARY FULL YEAR DISCLOSURE
Pacific Edge Limited
Year End 31 March 2013

FY2013 Results Summary
- Sales and marketing of Cxbladder launched in the USA - the world's largest
healthcare market
- Regulatory approval for USA laboratory facilities in March 2013
- Four laboratories - in Europe, USA, Australia and NZ - now certified by
Pacific Edge to commercially run Cxbladder tests
- Patent granted in China for gastric cancer diagnostic tool

The 2012-13 financial year has been a landmark year for the Company with
major milestones being achieved in the commercialisation of the Company's
intellectual property portfolio.

Significant resources have been invested in the last 12 months in
infrastructure and people to achieve regulatory approval and begin the
roll-out of the Company's lead product, Cxbladder, in the United States, the
world's largest healthcare market. This has required the completion and
regulatory approval of a purpose built laboratory facility in Pennsylvania
and the appointment of highly skilled senior executives, technical and sales
staff to gain traction for Cxbladder with medical practitioners across the
USA.

 A significant proportion of the Company's expenditure for the 2013 financial
year has been on the commercial process development and commercial rollout of
the bladder cancer product Cxbladder to the new US business, our commercial
laboratory in New Zealand and those of our licensed partners. As a result,
the Company has recorded an unaudited net loss of $6,949,878 for the year
ended 31 March 2013, compared to a budgeted loss of $7,148,661. This compares
to a recorded net loss of $4,079,234 for the year ended 31 March 2012.

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 Cxbladder detection test is now
commercially available and any further expenditure on this product is
expected to be capitalised. The Company over this period has made further
significant investment in intellectual property protection and product
development of Cxbladder and its new follow-on products targeted on other
clinical needs for urologists.

Update on Commercialisation of Cxbladder
The Company's subsidiary, Pacific Edge Diagnostics USA Limited, PEDUSA has
been created specifically to build the business to service the world's
largest healthcare market, the USA. Its complexity is challenging but the
Company is confident that in PEDUSA it has the people at Board, executive and
technical levels with the right depth of experience in launching biomedical
products in the United States. During the year Jackie Walker was appointed as
CEO and Bruce Nogales to the Board of Directors of PEDUSA. Both are
outstanding professionals experienced in biomedical commercialisation in the
USA.  Key appointments have also been made to the roles of Laboratory
Director, Medical Director and Technical Supervisor, in particular to meet
the regulatory requirements. Recruitment of key sales and marketing staff is
now underway.

The build and fit-out of the new laboratory infrastructure in Hershey,
Pennsylvania has also been completed, to enable the Company to begin the
sales and marketing phase of this new product. This facility was completed on
time, to specification and within budget and provides the Company with a
dedicated, state-of-the-art laboratory facility for Cxbladder.

The regulatory approval process was completed as planned in March 2013 with
registration by the USA regulatory agency CLIA. The capability to build this
business opportunity in the USA off the back of the New Zealand business has
been a significant factor in enabling this market channel to be delivered
quickly and very cost-effectively.

The USA market has a comprehensive understanding of the clinical applications
and advantages that can be, and are being, achieved from new molecular
diagnostic and prognostic tests.  Clinicians and healthcare providers
understand that significant cost savings and enhanced patient wellbeing, from
changes to clinical procedures, will come as a direct result of the adoption
of these technologies. Management retains the expectation that Pacific Edge
will reach the 200,000 tests per annum throughput target for the laboratory
by the end of the 5th year of trading.
Update on the US market

A recent trend in the US is for urologists to cluster into Large Urology
Group practices (LUGs) to enable specialisation and to leverage buying power.
PEDUSA is actively targeting LUGs, as well as the large managed healthcare
organisations to provide a focused start to the Company's USA based sales and
marketing program. There are approximately 10,500 practising urologists in
the USA and approximately 10% are aggregated into LUG's.

Significant change is underway within the USA healthcare system under the
much-publicised 'Obamacare' (Affordable Care Act) and there is renewed focus
on shifting healthcare from a cost plus mentality to a value based approach.
This change is heralded by many as an exciting opportunity for new
technologies to be able to be recognised for their ability to increase
efficacy and lower overall costs. Where this is the case, greater value could
otherwise be expected to flow from these technologies. 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 USA there are expected to be in excess of 1,000,000 people
presenting to their healthcare provider this year with blood in their urine
(haematuria). It is anticipated that the USA healthcare system could invest
in excess of $1 billion this year in investigating haematuria.

Cxbladder's sales in the USA have made a minimal impact on Pacific Edge
revenues in this current financial year as we bring the sales and marketing
resources to bear and invest strongly in getting the message, clinical value
proposition and product out to the clinicians. Building the market awareness
of the product opportunity is a substantial process that we will continue
aggressively in the coming financial year and revenue from the USA is
expected to develop progressively over FY14 as our sales teams build
relationships with clinicians.

Update on other markets
The launch of Cxbladder in the United States follows licensing agreements
with Oryzon in Spain (Spain has the highest incidence of bladder cancer of
any country in the world), and Healthscope Pathology in Australia. Taking
Cxbladder to the market in New Zealand and Australia is seen by the Company
as an integral part of our commercialisation strategy. Our local market
provides the Company with an excellent opportunity to develop and fine-tune
the commercial processes and to refine the logistics prior to launching the
test in other markets and countries.

Urologists and general practitioners in New Zealand and Australia are showing
keen interest in using Cxbladder, with a significant number of them
undergoing in-practice evaluations of Cxbladder to determine how Cxbladder
can best work in their practices. This has been a notable feature of the
commercial rollout during the year and is expected by the Company to
translate into a full commercial relationship with the urologists that have
embarked on the 'User Program'. Cxbladder is expected to be widely used as an
adjunct to cystoscopy for patients presenting with haematuria and returning
to the clinic for on-going monitoring. Sales this year have been steady but
small in number and are expected to increase steadily off the back of these
'user-programs' during the coming year.

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. 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
Limited, using its diagnostic laboratory based in Dunedin. As part of the
progressive launch of Cxbladder, Pacific Edge has signed Labtests in 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.

Pacific Edge is pleased to have Oryzon in Spain as a partner providing the
initial entry point for Pacific Edge into the European market. 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 has successfully completed the technical transition to enable their
laboratory to process tests. The expectation is for Oryzon to start
commercial activity this year. Oryzon's laboratory is the fourth laboratory
globally that has the capability to process Cxbladder, including PE
Diagnostics NZ Limited in Dunedin, PEDUSA in Hershey, Pennsylvania, and
Healthscope's Melbourne based laboratory.

Pacific Edge's Product Pipeline
The Company continues to progress the development of the other products in
the product pipeline and the Company achieved another significant milestone
with a patent issued for the detection of gastric cancer in China. This now
provides issued patent coverage for the Detection of Gastric Cancer in
Europe, Australia, New Zealand and China. Investment in intellectual property
is a significant annual investment for the Company and underpins the
commercial capability of the Company's products. Steady progress is being
made with the expected issue of patents as they reach final examination in
various geographies around the world.

Chris Swann   David Darling
Chairman       Chief Executive Officer

ABOUT PACIFIC EDGE
Pacific Edge Limited (NZX: PEB) is a New Zealand based cancer diagnostic
company specialising in the discovery and commercialisation of diagnostic and
prognostic technology for the early detection and monitoring of cancer.
Products in development and in clinical trials are accurate and simple to use
genomic and proteomic tools for the earlier detection, improved
characterisation and better management of gastric, bladder, colorectal
cancers and melanoma. The Company has recently completed and released its
first product for the detection of bladder cancer, Cxbladder, and is actively
marketing the product to urologists in New Zealand, Australia and soon to be
Spain and the USA.

www.pacificedge.co.nz

ABOUT PACIFIC EDGE DIAGNOSTICS
Pacific Edge takes its exciting cancer detection tests to market through its
wholly owned subsidiaries, Pacific Edge Diagnostics NZ Limited and Pacific
Edge Diagnostics USA Limited, and selected commercial partners in Australia
and Spain, Healthscope Pathology and Oryzon respectively.

www.pacificedgedx.com

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 published, Journal of Urology in September 2012,
multi-centre international clinical study recruited 485 patients from
Australia and New Zealand. Results show that Cxbladder out-performed all
other benchmark technologies in the clinical trial and detected nearly all of
the tumours of concern to a urologist; At 85% specificity the test sees 100%
of T1, T2, T3, Tis and greater than 95% of high grade tumours.

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 on 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 twice the incidence of bladder cancer over non
fire fighters. Smoking is a significant contributing factor (over 50% in
males and 33% in females, and approximately one of every two 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 and
chemical engineers. 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 50%-70% with
up to 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:00236869 For:PEB    Type:FLLYR      Time:2013-05-30 14:39:33