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July 2011
Pacific EdgeCapital Raising to Deliver Cxbladder® to the US
Important Notice
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The Offer referred to in this presentation is being made pursuant to a simplified disclosure prospectus dated 29 July 2012 (“Offer Document”). A copy of the Offer Document may be obtained free of charge from 1 August 2011 by calling the Pacific Edge shareholder information line on 0800 868 996.
Pacific Edge Limited (Pacific Edge) is undertaking a placement to institutional and habitual investors and a pro rata renounceable entitlement offer to eligible shareholders in New Zealand. Any new shares attributable to rights not taken up will be offered via a bookbuild to institutional and other eligible investors. No action has been or will be taken by Pacific Edge which would permit an offer of new shares to eligible shareholders outside New Zealand or the offer of new shares under the bookbuild to eligible investors outside New Zealand, or to permit possession or distribution of any offering material, in any country or jurisdiction where action for that purpose is required (other than New Zealand).
This presentation is intended for use only in connection with the Offer and does not constitute an offer or invitation in any place in which, or to any person to whom, it would not be lawful to make such an offer or invitation. Pacific Edge is not licensed to provide financial product advice in relation to the new shares. The information provided in this presentation is not financial product advice and is not intended to be relied upon as advice to investors or potential investors. This presentation has been prepared without taking into account the financial situation, investment objectives or particular needs of any particular person.
There are statements in this presentation that are “forward looking statements”. As these forward-looking statements are predictive in nature, they are subject to a number of risks and uncertainties relating to Pacific Edge. As a result, actual results and conditions may differ materially from those expressed or implied in this presentation. Given these uncertainties, you should not place undue reliance on any forward-looking statements in this presentation. Under no circumstances should you regard the inclusion of such forward-looking statements in this presentation as a representation or warranty by any member of the Pacific Edge group or any of their respective directors, officers or employees or any other person as to the achievement of the results expressed or implied by such statements or that the assumptions underlying such forward-looking statements will in fact be correct. Pacific Edge, and its respective directors, officers and employees disclaim any responsibility to update any such risk factors or publicly announce the result of any revisions to the forward-looking statements contained in this presentation to reflect future developments or events, other than where required to do so by the Securities Act 1978, the Securities Regulations 2009, the Financial Reporting Act 1993 or the NZSX Listing Rules.
None of Pacific Edge, the Lead Manager, nor their respective directors, officers or employees nor any other person warrants or guarantees the new shares to be issued pursuant to the Offer or the future performance of the new shares or any return on any investment made pursuant to the Offer. No person is authorised to give any information or to make any representation in connection with the Offer which is not contained in this presentation or the Offer Document. Any information or representation in connection with the Offer not contained in this presentation or the Offer Document may not be relied upon as having been authorised by Pacific Edge, the Lead Manager or any of their respective directors, officers, employees, or associates.
Acceptance of this presentation constitutes acceptance of the terms set out above in this Important Notice. This Offer is supplied only to persons whose principal business is the investment of money or who, in the course of and for the purposes of their business, habitually invest money.
This presentation has been prepared solely to assist the person to whom it is given by Pacific Edge to determine for himself or herself whether to subscribe for shares in Pacific Edge. It may not be used for any other purpose. Prospective investors are expected to come to their own conclusions on the suitability of investing in the Company for their own purposes, after consulting their own tax and other professional advisors.
Contents
Executive Summary 4Business Overview and Strategy 6Cxbladder® 11Delivering Cxbladder® to the United States 17Economics of US Delivery 23Offer Overview 29
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Executive Summary
Capital raising to deliver Cxbladder® to the US
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Pacific Edge is seeking to raise ~NZ$20 million to deliver Cxbladder® through a CLIA laboratory1 to the largest and most lucrative potential market for Cxbladder®, the US
1. Clinical Laboratory Improvement Amendments (CLIA) are United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States.
2. TERP is calculated as the weighted average of 171,945,075 existing shares at NZ$0.24, 23,000,000 placement shares at $0.22 and 83,547,889 new shares at NZ$0.19.3. An application has been made to NZX for permission to quote the rights and all requirements of NZX relating to such quotation that can be complied with on or before the date of this
presentation have been duly complied with. The NZSX is a registered market, regulated under the Securities Markets Act 1988.
Purpose
Funds will enable Pacific Edge to rollout its bladder cancer diagnostic and prognostic product, Cxbladder®, in the US, by establishing a CLIA laboratory in Pennsylvania. The CLIA laboratory will provide the infrastructure to deliver Pacific Edge’s other leading products to the US marketplace when they are market ready
Offer Size Total equity raising of approximately NZ$21m
Offer Structure
There are two components to the capital raising:
1. Placement to institutional and habitual investors of 23,000,000 shares at NZ$0.22 to raise $5.1m • Placement shares eligible to participate in the Entitlement Offer
2. 3 for 7 entitlement offer to all shareholders at NZ$0.19 to raise a maximum of NZ$15.9 million• Rights offer price at 15% discount to TERP(2)
• Traditional rights issue, with rights trading(3), followed by a bookbuild for the shares attributable to the rights not, or not able to be, taken up after the close of rights trading period
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Business Overview and Strategy
Pacific Edge’s mandate is to commercialise its cutting edge technologyPacific Edge develops and commercialises diagnostic and prognostic tests for the detection and management of cancer• Pacific Edge's commercial objectives are to discover, develop and commercialise new, simple-to-use
diagnostic and prognostic tools for the earlier detection, improved characterisation and better management of a targeted set of cancers
• Utilizes proprietary genetic databases as the discovery engine for identifying diagnostic biomarkers
• Develops these biomarkers, genetic biomarkers from RNA and immunoassays from protein antigens, into commercial products
• Pacific Edge has four products in late stage development1
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Current Product Offering and Pipeline
Application Bladder cancer detection and diagnosis
Colorectal cancer prognosis
Gastric cancer diagnosis and prognosis
Melanoma diagnosis and prognosis
Product Cxbladder® Cxcolorectal™ TBD Immunoassay TBD RT qPCR
StageCompleted trials in February 2010; released commercially in Aus/NZ
Completed the retrospective European clinical trial in February 2010
Pre-clinical Pre-clinical
1. The CLIA laboratory will provide the infrastructure to deliver Pacific Edge’s other leading products to the US marketplace when they are market ready
Pacific Edge’s product benefits are compelling
Pacific Edge’s products seek to address a number of important current shortcomings in cancer detection and management, including the need for:
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Earlier DetectionPacific Edge is seeking biomarker suites that characterise early stage cancer. Early diagnosis means treatment of cancer in its early stages, which is usually more effective than late-stage treatment and thus improves patient outcomes
Better CharacterisationHigh specificity and sensitivity tests, such as those Pacific Edge is developing, result in more certain diagnoses and greater surety of the best treatment methodology, resulting in better patient outcomes
Lower CostPacific Edge’s RNA and protein tests provide a lower cost relative to such tests routinely used such as cystoscopy. Low cost tests result in more frequent screening and monitoring, leading to improved diagnosis for patients
Non-Invasive TestingRNA and protein assays, which Pacific Edge uses, are done on body fluids such as urine or blood and are thus minimally invasive. Existing tests are often highly invasive, deterring patients from seeking screening
Greater AccuracyPacific Edge is developing multiple biomarker assays which have higher levels of accuracy than existing tests, as well as the ability to assay for multiple disease states or precursors. In contrast, the majority of products currently on the market rely on single biomarkers with attendant lack of accuracy
Greater Utility: Pacific Edge is developing single tests which provide multiple pieces of information, for exampleCxbladder® achieves both diagnosis and identification of superficial vs. invasive tumours
Note: Diagnostic tests, RNA or protein analysis mostly use fluids e.g. blood, whereas prognostics utilise tissue samples
Pacific Edge’s commercialisation programme is gaining momentum
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2011
March: Pacific Edge and Healthscope sign an agreement to market Cxbladder® in Australia
May: Pacific Edge and Spanish company Oryzon S.A sign an exclusive license agreement to market Cxbladder® in Spain and Portugal
June: Cxbladder® kits receive registration under the TGA1, permitting Pacific Edge and Healthscope to market and sell Cxbladder®
kits to all segments of the Australian market
1. Therapeutic Goods Administration
TBD: CLIA laboratory built and licensed. Cxbladder® launched in the US
2011/12
Recently announced commercialisation milestones…
Cxbladder® is now on the market in NZ and Australia and later this year in Spain and PortugalPacific Edge and its commercial partners Healthscope and Oryzon are introducing Cxbladder® to clinicians and physicians in these markets• In March 2011, Pacific Edge signed up leading Australian pathology and healthcare provider Healthscope
Pathology to take Cxbladder® to the Australian market
• Healthscope operates in every Australian state and territory as well as in Asia. It is the second largest Australian private hospital provider.
• Healthscope also operates a leading pathology business with facilities in Australia, NZ, Singapore, Vietnam and Malaysia.
• Following the Healthscope arrangement, Pacific Edge exclusively licensed Oryzon to provide Cxbladder® to urologists and GPs in Spain and Portugal
• Considered the fastest growing biotechnology and molecular diagnostics company in Spain, Oryzonspecialises in the commercialisation of biomarkers and biomarker tests for diagnostic and therapeutic applications in oncology
• Spain and Portugal are key entry points in the European market for Pacific Edge, at roughly four times the size of the NZ and Australian markets combined
• Spain has the world’s highest incidence of bladder cancer per head of population – around 200,000 of Spains 46 million population will present to their GP with haematuria (blood in the urine) per annum, leading to the identification of around 13,000 new cases of bladder cancer per annum.(1)
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(1) Source: European Network of Cancer Registries
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Cxbladder®
Cxbladder® is a fast, non-invasive test for bladder cancer
Cxbladder® is a fast, inexpensive, and non-invasive assay that quantitatively measures the expression of five genes in a small sample of patient urine• Provides general practitioners and urologists with a quick, cost effective and accurate measure of the
presence of the cancer
• Provides urologists with the opportunity to reduce reliance on invasive tests such as cystoscopy1
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.
1. Cystoscopy is endoscopy of the bladder via the urethra and is invasive2. Specificity is expected to be higher in a monitoring for recurrence setting3. US$768 is the estimated total “supported” cost for Cxbladder® using composite CPT coding for CMS patients. Reimbursement by insurers in the US generally occurs at 70% to 80%
of the composite CPT code, or US$550 - US$630 per test
Cxbladder® AdvantagesAccurate 100% sensitivity at 85% specificity(2) in detecting late stage bladder cancer
Non-Invasive Non-invasive sample collection (urine sample) versus other tests (cystoscopies, etc.)
High Utility Can detect bladder cancer accurately; andCan differentiate between high grade and low grade cancer
Robust Robust to urine sample contamination from blood and infection
Fast Quick turnaround time (3 - 5 days)
High Commercial Value
RRP of US$250 in Aus/NZ, €200 in Europe, and US$768(3) in the U.S. (composite CPT codes) versus US$600 - US$1000 for flexible cystoscopiesand US$2,500 - US$3,000 for rigid cystoscopies
The clinical validity of Cxbladder® is independently proven
The clinical study for Cxbladder® entailed a multicentre, prospective cohort study of 467 patients with a recent history of gross haematuria, who were undergoing cystoscopicinvestigation for possible urological cancer
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Study Results1
Cxbladder® NMP22 BladderChek NMP22 ELISA Cytology
Stage SensitivityTIS 100% 0% 0% 100%Ta 77% 39% 32% 29%T1 100% 43% 71% 50%T2 100% 13% 57% 100%Overall Sensitivity
81% 35% 45% 46%Specificity
85% 96% 88% 96%
1. Eligible consenting patients provided a freshly voided mid-stream urine sample prior to cystoscopy, for Cxbladder® the NMP22 tests and urine cytology analysis. Comparator tests; NMP22 ELISA and urine cytology were analysed independently at Southern Community Laboratories, Dunedin. The NMP22 BladderChek test was conducted at each clinical site. The presence of urinary tract TCC (transitional cell carcinoma) was determined by biopsy and histopathological examination within a 3 month period following study registration.
Cxbladder® is significantly more accurate than other commercially available tests
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Approximate Sensitivity of Cxbladder® for Stage 1 TCC1 compared with other commercially available bladder tests
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
NMP22 ELISACytology
NMP22 B-Chek
100%
71%
50%
43%
Sens
itivi
ty (%
)
Significant increase in performance of Cxbladder® is relative to the commercially available tests that were used as benchmarks in the clinical study.Source: USANZ, 24 February 2010
Cxbladder®
1. Transitional Cell Carcinoma
As a molecular diagnostic test Cxbladder®’s has market leading performance
The Cxbladder® clinical study met its primary clinical end point of identifying bladder cancer significantly more accurately than other commercially available tests benchmarked in the trial
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Cxbladder® outperformed all comparators1 in the accurate detection of all stages of TCC
Cxbladder® correctly identified 3 cases of bladder cancer at one year follow-up that were missed by the initial cystoscopy
Cxbladder® detected nearly all tumours of significance to a urologist – 100% T1, 100% T2, 100% Tis and 96% of high grade tumours
Cxbladder ®identified all cases of bladder cancer detected by cytology
Cxbladder® detected 20 cases of bladder cancer that were not identified by cytology during the clinical work-up
1. NMP22 BladderChek, NMP22 ELISA and cytology
Cxbladder® is a high value proposition to the clinician
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Cxbladder® is positioned in the market to meet several clinical needs
DETECTION: expected to successfully triage out-patients who would normally progress through from the general practitioner to the urologist and who would otherwise receive a more expensive and invasive cystoscopy
MONITORING: positioned to replace cytology as an adjunct to cystoscopy and to replace a number of cystoscopies over the patient's monitoring regime
FAST RESULTS: significantly quicker turnaround time when compared to the time involved in the scheduling and performance of cytology, where the urine sample is sent out to a contracted laboratory
ACCURATE DIFFERENTIATION: more accurate differentiation of low-grade from high-grade, late stage tumors, enables more aggressive treatment for later-stage and high-grade cancers
• particularly important in the case of bladder cancer, where between 50% to 70% of cancers recur and of those approximately 30% of recurrence is in the form of a later-stage cancer
PATIENT COMPLIANCE: non-invasive nature is more compelling for the patient and likely to lead to an overall higher compliance to the monitoring regimen than is currently achieved with cystoscopy alone
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Delivering Cxbladder® to the United States
Proven strategy for commercialisation in the US
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Pacific Edge’s market entry strategy is to deliver Cxbladder® as a Laboratory Developed Test1(LDT) to US clinicians performed in a CLIA certified laboratory• Pacific Edge is in late stage negotiations to establish a headquarters in Hershey, Pennsylvania
• Operations will include a CLIA laboratory and requisite staffing to carry out laboratory, reimbursement, sales, and marketing activities
1. Laboratory Developed Tests (LDTs) are tests developed, evaluated and validated in a single CLIA laboratory - because LDTs are not marketed to multiple laboratories and health care facilities, they do not require FDA approval
Location of proposed CLIA Lab – Hershey, PA Advantages of location
Attractive State of Pennsylvania incentive package:• US$1.5m contribution to CLIA lab fit-out• US$0.5m occupancy grant
58 million people on the Eastern seaboard
1.5 hour proximity (average) to large markets
Close proximity to Penn State Medical and new Integrated Caner Research Facilities
Proximity to Fedex hub in York, Pennsylvania
Fastest route to commercialisation…
Commercialising its products as LDTs performed in CLIA laboratories allows Pacific Edge to avoid the time-consuming process of getting approval from the FDA, since CLIA labs are regulated by state governments• Many high value molecular diagnostic tests offered via the certified laboratory model in the US• This is a well validated commercialisation route e.g. Myriad Genetics, Genomic Health, XDx, CardioDx• Pacific Edge anticipates that the first test will be ready for commercial sale within 12 months of funding
commitments for the CLIA laboratory to be built in the US
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1. By the American Medical Association
Established Commercialisation Pathway
CLIA Laboratory Fit-out Completed
Pennsylvania filing, inspection and
licence
Confirm Composite CPT code1 assigned
to Cxbladder®
Coverage determination obtained from
Medicare / Medicaid
Coverage determination
obtained from private insurers
First Cxbladder® testavailable for
commercial sale
Publication of clinical performance of
Cxbladder® in a peer reviewed scientific journal in the US
…demonstrated by Genomic Health
Genomic Health successfully used the CLIA laboratory pathway to commercialise its breast cancer assay, Oncotype DX
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0
100
200
300
400
500
600
700
800
900
Sep 05 Sep 06 Sep 07 Sep 08 Sep 09 Sep 10
Mar
ket C
apita
lisat
ion
($US
m)
Sep 05: IPO raises US$60m
Jan 07: Oncotype DX receives UnitedHealthcaresupport
Jan 08: Oncotype DX is included on the National Breast Cancer Treatment Guidelines
Jun 11: Current market capitalisation of US$763m
Genomic Health’s Market CapitalisationGenomic Health’s Commercialisation Pathway
January 2004: CLIA certifies the Genomic Health clinical laboratory to perform and offer the company's
first breast cancer assay, Oncotype DX
December 2004: Oncotype DX reports positive results from a B20 chemotherapy benefit study. Results in the
company receiving up to 200 calls per day and the number of breast cancer assays orders tripling
January 2006: Oncotype DX receives Medicare support
Proceeds of capital raising to fund US business
Proceeds from Pacific Edge’s capital raising will be allocated as follows (figures are net of State of Pennsylvania incentives):
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Proposed Use of Proceeds: 2011 to 2013
Set up CLIA laboratory NZ$4.5m
Staff recruitment, salaries, costs NZ$7.5m
Operational expenditure NZ$8.0m
Gross proceeds NZ$20m
Indicative US timeline
Pacific Edge anticipates the first Cxbladder® test will be ready for commercial sale within 12-20 months of funding commitments for the CLIA laboratory to be built in the US(1)
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(1) Subject to slippage if key timing milestones are not met or if State licensing processes suffer delays
Complete Capital Raising
CLIA Laboratory
Agreement with State of Pennsylvania
Build out lab to Pacific Edge specs
Hire key staff
LIMS selection, installation, validation
Transfer technology
Write lab SOPs
Validate Cxbladder
CLIA Licence
PA filing, inspection, license
NY, FL, RI and MD licenses
Developed marketing material
Launch test in Pennsylvania
FEB MAR
2013
AUG SEPT OCT NOV JANDEC
2012
MAY JUN
2011
NOV DEC JAN FEB MAR APRJUL AUG SEPT OCT JUL
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Economics of US Delivery
27.123.6
16.914.7
24.19.5
5.4
15.5
12.87.9
3.844
4.15.4
4.92.2
6.42.71.7
4.6
2.61.8
1.41.1
1 South Central AsiaSouth East AsiaChinaJapanWestern Asia
Australia/NZ
Central AmericaSouth AmericaNorth America
Eastern EuropeNorthern EuropeWestern EuropeSouthern Europe
Bladder cancer – the issues and the opportunity
Bladder cancer is the fourth most expensive cancer to treat and incurs the highest total medical cost per patient of all cancers: ~US$200,000 from diagnosis to death(1)
• In the US, bladder cancer is the sixth most prevalent (8% of male cancers and 2% of female)(2)
• Patients with bladder cancer receive the diagnosis after they present with macro or microscopic haematuria (presence of blood in the urine)
• In the US, US$1 billion will be spent this year investigating haematuria(2)
• Recurrence rate for bladder cancer ranges from 50% to 70% over a five year period(2)
• Early detection of bladder cancer can reduce mortality
• Following diagnosis, NCCN(2) guidelines say patients will be monitored for 5 years and are recommended to receive 12 cystoscopies
• Compliance by patients an issue as recurring tumours restart the monitoring
1. National Cancer Institute 2. National Comprehensive Cancer Network 3. European Cancer Observatory
Age Standardised Incidence of Bladder Cancer Per 100,000(3)
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Economics of delivering Cxbladder® to the US are compelling(1)
In the US, Pacific Edge will be seeking US reimbursement using a composite CPT code with the longer term intention of obtaining a test-specific CPT code• Total “supported” price for Cxbladder® using composite CPT coding for CMS patients is expected to be
approximately US$786 per test• Reimbursement by insurers in the US routinely occurs at a minimum of 70% to 80% of the composite CPT
code, or US$550 - US$630 per test for Cxbladder®
• Pacific Edge estimates the cost (COGS) of producing each Cxbladder® test which is sold in the US will be approximately US$100
• This provides an indicative gross margin of US$450 - US$530 per test
251. All figures are based on Pacific Edge estimates
Cxbladder® is significantly more cost effective for insurers than current best practice diagnosis/prognosis toolsBladder cancer has the highest total per patient medical costs of any cancer• In the United States, 1,000,000 patients per year present to their GP with haematuria(1)
• Patients with haematuria are routinely evaluated for bladder cancer – this generates testing and screening procedures that cost US $1 billion per year(1)
• Cytology is the most common test used by general practitioners to triage patients with haematuria• If cytology indicates the possibility of cancer, the patient is referred to a urologist to confirm the
diagnosis• Urologists primarily use cystoscopy to confirm the diagnosis of bladder cancer• Cystoscopy is an invasive and expensive test that entails inserting a scope to examine the bladder for
the presence of tumors• On confirmation of a positive diagnosis, the patient will be treated and monitored extensively, often by
cystoscopy, for five years to monitor for any recurrence• Flexible cystoscopies are routinely used and cost between US$600 and US$1,000(2)• For patients diagnosed with invasive disease, a rigid cystoscopy is often used and costs as much as
US $2,500 to US $3,000(2)
• Cxbladder® can replace cytology as the dominant initial, non-invasive diagnostic tool for bladder cancer
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1.Ploeg, M., Aben, K. K. & Kiemeney, L. A. The present and future burden of urinary bladder cancer in the world. World J. Urol. 27, 289-293 (2009).2. Jemal, A., Siegel, R., Xu, J. & Ward, E. Cancer statistics, 2010. CA Cancer J. Clin. 60, 277-300 (2010).
The annual market for Cxbladder® in the US is large
The annual potential(1) US market for Cxbladder® tests is approximately 1.8m tests
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Annual Market for Bladder Cancer Assays in the US(3)
• In the United States, 1,000,000 patients per year present to their GP with haematuria
• 68,800 patients are diagnosed each year with bladder cancer1 -NCCN Clinical Practice Guidelines in Oncology specify that patients receive 12 monitoring cystoscopies in the five year monitoring period – 4 in the year of diagnosis and 2 in each following year(2)
1. Pacific Edge makes no representation as to its ability to penetrate the US market for bladder cancer assays 2. Jemal A, Siegel R, Ward E, et al. Cancer statistics, 2008. CA Cancer3. Figures do not take into account patients who experience recurrence of bladder cancer . Recurrence rate for bladder cancer ranges from 50% to 70% over a five year period.
Total US Assay Market (Haematuria & Bladder Cancer) Year 1 Year 2 Year 3 Year 4 Year 5
New patients presenting with Haematuria 1,000,000 1,000,000 1,000,000 1,000,000 1,000,000New patients diagnosed with bladder cancer 68,800 68,800 68,800 68,800 68,800receive 4 follow up cystoscopies in the 68,800 68,800 68,800 68,800 68,800first year following diagnosis 68,800 68,800 68,800 68,800 68,800
68,800 68,800 68,800 68,800 68,800Two cystoscopies per annum in year 2 68,800 68,800 68,800 68,800 68,800
68,800 68,800 68,800 68,800 68,800Two cystoscopies per annum in year 3 68,800 68,800 68,800 68,800 68,800
68,800 68,800 68,800 68,800 68,800Two cystoscopies per annum in year 4 68,800 68,800 68,800 68,800 68,800
68,800 68,800 68,800 68,800 68,800Two cystoscopies per annum in year 5 68,800 68,800 68,800 68,800 68,800
68,800 68,800 68,800 68,800 68,800
Total Assays Required 1,825,600 1,825,600 1,825,600 1,825,600 1,825,600
Market penetration will drive profitability in the US
Cxbladder® could successfully penetrate the US market for bladder cancer detection, because:
Cxbladder® offers superior performance
Cxbladder® represents a high value proposition for the clinician
Cxbladder® offers significant cost advantages for health insurers
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Market Penetration Drives Profitability (US$)
Total annual US assay market 1,825,600 1,825,600 1,825,600 1,825,600 1,825,600Potential market penetration 0.5% 2.0% 5.0% 10.0% 12.5%Number of tests carried out 9,128 36,512 91,280 182,560 228,200Price per test (at low end of indicative range) $550 $550 $550 $550 $550
Revenue $5,020,400 $20,081,600 $50,204,000 $100,408,000 $125,510,000COGS (at US$100 per test) ($912,800) ($3,651,200) ($9,128,000) ($18,256,000) ($22,820,000)Gross Margin $4,107,600 $16,430,400 $41,076,000 $82,152,000 $102,690,000
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Offer Overview
Capital Raising Overview
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Up-front Placement
Maximum new Shares to be issued 23,000,000 new Shares
Issue price $0.22
Capital raised $5.1 million
Shares issued “cum-entitlement” Placement shares are eligible to participate in the Entitlement Offer
Eligible investors Institutional and habitual investors
Entitlement OfferEntitlement ratio 3 New Shares for every 7 existing Shares
Maximum New Shares to be issued 83,547,889 million (subject to rounding)
Application price $0.19
Offer discount 15% to TERP
Total equity to be raised $15.9 million (maximum)
Ranking New Shares issued on completion of the Offer will rank equally with existing Shares and will be quoted on the NZSX
Rights The Offer is renounceable - rights that are not taken up may be sold on the NZSX
Entitlement Offer Structure
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Entitlement Offer
Eligible Shareholders will be sent an Offer Document with a personalised Entitlement and Acceptance Form in the week ending 5 August 2011
Each Eligible Shareholder may choose to:
• Take up all or part of their Rights by 5pm (NZ time) on 31 August 2011• Sell all or part of their Rights• Do nothing
Oversubscription Facility
Eligible Shareholders who accept their entitlement in full may also apply for an additional number of New Shares up to 25% of their original entitlement at the same Application Price through the Oversubscription Facility
The number of New Shares available under the Oversubscription Facility will equal the number of New Shares for which valid applications are not received by the Closing Date
Shortfall Bookbuild
New Shares attributable to Rights not taken up, including those of IneligibleShareholders, will be offered to institutional and habitual investors via aShortfall Bookbuild
Bookbuild process to be conducted on 2 September 2011
If the proceeds under the Shortfall Bookbuild on a per Share basis exceed the Application Price, the Premium will be returned to those shareholders who do not, or cannot, take up their Rights
Timetable
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Trading halt, Simplified Disclosure Prospectus registered Friday, 29 July 2011
Up-front placement to institutional and habitual investors Friday, 29 July 2011
PEB shares quoted “ex-entitlements” on the NZSX Tuesday, 9 August 2011
Rights trading commences Tuesday, 9 August 2011
Rights issue offer period commences Tuesday, 9 August 2011
Record Date for determining entitlements Thursday, 11 August 2011
Offer documentation mailed to shareholders Friday, 12 August 2011
Rights trading ceases Thursday, 25 August 2011
Rights issue offer period closes Wednesday, 31 August 2011
Shortfall bookbuild for new Shares attributable to Rights not taken up Friday, 2 September 2011
New Shares allotted and quoted on NZSX Wednesday, 7 September 2011
The key dates in respect of Pacific Edge’s capital raising are as follows:
Glossary of Terms
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Assay: Chemical reactions that allow detection or quantification of substances or biomarkers in samples
Biomarker: A characteristic that is objectively measured and evaluated as an indicator of normal biologic or pathogenic processes
Clinical Trial: A single statistically significant trial for patients with disease
CLIA: Clinical Laboratory Improvement Amendments (CLIA) are United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States
Cystoscopy: Endoscopy of the urinary bladder via the urethra
Cytology: The study of cell structure and the way cells interact with their environment
Endoscopy: Visual inspection of body cavities by use of an endoscope
FDA: Food and Drug Administration. US Government agency responsible for approval of drugs and medical devices
Molecular diagnostics: Diagnostics based on genetic and epigenetic information
Oncology: The branch of medicine that studies tumours (cancer) and seeks to understand their development, diagnosis, treatment and prevention
Prognosis: Prediction of how a patient’s disease will progress , and hence chance of recoverySensitivity: The measure of a test’s ability to accurately detect the presence of a disease. For example, a sensitivity of 90% means that out of 100 patients who actually have the disease, on average 90 are correctly diagnosed
Specificity: The measure for a test’s ability to exclude a disease if it is not present. For example, a specificity of 90% means that out of 100 healthy people, 10 are falsely identified as having the disease
Urologist: Specialist clinicians for urological diseases and disorders
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www.pacificedge.co.nzwww.cxbladder.com