pacific edge capital raising to deliver cxbladder to the us · pdf filepacific edge’s...

34
July 2011 Pacific Edge Capital Raising to Deliver Cxbladder ® to the US

Upload: vanphuc

Post on 09-Mar-2018

216 views

Category:

Documents


4 download

TRANSCRIPT

Page 1: Pacific Edge Capital Raising to Deliver Cxbladder to the US · PDF filePacific Edge’s mandate is to commercialise its cutting edge technology Pacific Edge develops and commercialises

July 2011

Pacific EdgeCapital Raising to Deliver Cxbladder® to the US

Page 2: Pacific Edge Capital Raising to Deliver Cxbladder to the US · PDF filePacific Edge’s mandate is to commercialise its cutting edge technology Pacific Edge develops and commercialises

Important Notice

2

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.

Page 3: Pacific Edge Capital Raising to Deliver Cxbladder to the US · PDF filePacific Edge’s mandate is to commercialise its cutting edge technology Pacific Edge develops and commercialises

Contents

Executive Summary 4Business Overview and Strategy 6Cxbladder® 11Delivering Cxbladder® to the United States 17Economics of US Delivery 23Offer Overview 29

3

Page 4: Pacific Edge Capital Raising to Deliver Cxbladder to the US · PDF filePacific Edge’s mandate is to commercialise its cutting edge technology Pacific Edge develops and commercialises

4

Executive Summary

Page 5: Pacific Edge Capital Raising to Deliver Cxbladder to the US · PDF filePacific Edge’s mandate is to commercialise its cutting edge technology Pacific Edge develops and commercialises

Capital raising to deliver Cxbladder® to the US

5

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

Page 6: Pacific Edge Capital Raising to Deliver Cxbladder to the US · PDF filePacific Edge’s mandate is to commercialise its cutting edge technology Pacific Edge develops and commercialises

6

Business Overview and Strategy

Page 7: Pacific Edge Capital Raising to Deliver Cxbladder to the US · PDF filePacific Edge’s mandate is to commercialise its cutting edge technology Pacific Edge develops and commercialises

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

7

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

Page 8: Pacific Edge Capital Raising to Deliver Cxbladder to the US · PDF filePacific Edge’s mandate is to commercialise its cutting edge technology Pacific Edge develops and commercialises

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:

8

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

Page 9: Pacific Edge Capital Raising to Deliver Cxbladder to the US · PDF filePacific Edge’s mandate is to commercialise its cutting edge technology Pacific Edge develops and commercialises

Pacific Edge’s commercialisation programme is gaining momentum

9

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… 

Page 10: Pacific Edge Capital Raising to Deliver Cxbladder to the US · PDF filePacific Edge’s mandate is to commercialise its cutting edge technology Pacific Edge develops and commercialises

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)

10

(1) Source: European Network of Cancer Registries

Page 11: Pacific Edge Capital Raising to Deliver Cxbladder to the US · PDF filePacific Edge’s mandate is to commercialise its cutting edge technology Pacific Edge develops and commercialises

11

Cxbladder®

Page 12: Pacific Edge Capital Raising to Deliver Cxbladder to the US · PDF filePacific Edge’s mandate is to commercialise its cutting edge technology Pacific Edge develops and commercialises

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

12

.

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

Page 13: Pacific Edge Capital Raising to Deliver Cxbladder to the US · PDF filePacific Edge’s mandate is to commercialise its cutting edge technology Pacific Edge develops and commercialises

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

13

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.

Page 14: Pacific Edge Capital Raising to Deliver Cxbladder to the US · PDF filePacific Edge’s mandate is to commercialise its cutting edge technology Pacific Edge develops and commercialises

Cxbladder® is significantly more accurate than other commercially available tests

14

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

Page 15: Pacific Edge Capital Raising to Deliver Cxbladder to the US · PDF filePacific Edge’s mandate is to commercialise its cutting edge technology Pacific Edge develops and commercialises

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

15

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

Page 16: Pacific Edge Capital Raising to Deliver Cxbladder to the US · PDF filePacific Edge’s mandate is to commercialise its cutting edge technology Pacific Edge develops and commercialises

Cxbladder® is a high value proposition to the clinician

16

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

Page 17: Pacific Edge Capital Raising to Deliver Cxbladder to the US · PDF filePacific Edge’s mandate is to commercialise its cutting edge technology Pacific Edge develops and commercialises

17

Delivering Cxbladder® to the United States

Page 18: Pacific Edge Capital Raising to Deliver Cxbladder to the US · PDF filePacific Edge’s mandate is to commercialise its cutting edge technology Pacific Edge develops and commercialises

Proven strategy for commercialisation in the US

18

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

Page 19: Pacific Edge Capital Raising to Deliver Cxbladder to the US · PDF filePacific Edge’s mandate is to commercialise its cutting edge technology Pacific Edge develops and commercialises

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

19

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

Page 20: Pacific Edge Capital Raising to Deliver Cxbladder to the US · PDF filePacific Edge’s mandate is to commercialise its cutting edge technology Pacific Edge develops and commercialises

…demonstrated by Genomic Health

Genomic Health successfully used the CLIA laboratory pathway to commercialise its breast cancer assay, Oncotype DX

20

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

Page 21: Pacific Edge Capital Raising to Deliver Cxbladder to the US · PDF filePacific Edge’s mandate is to commercialise its cutting edge technology Pacific Edge develops and commercialises

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):

21

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

Page 22: Pacific Edge Capital Raising to Deliver Cxbladder to the US · PDF filePacific Edge’s mandate is to commercialise its cutting edge technology Pacific Edge develops and commercialises

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)

22

(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

Page 23: Pacific Edge Capital Raising to Deliver Cxbladder to the US · PDF filePacific Edge’s mandate is to commercialise its cutting edge technology Pacific Edge develops and commercialises

23

Economics of US Delivery

Page 24: Pacific Edge Capital Raising to Deliver Cxbladder to the US · PDF filePacific Edge’s mandate is to commercialise its cutting edge technology Pacific Edge develops and commercialises

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)

24

Page 25: Pacific Edge Capital Raising to Deliver Cxbladder to the US · PDF filePacific Edge’s mandate is to commercialise its cutting edge technology Pacific Edge develops and commercialises

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

Page 26: Pacific Edge Capital Raising to Deliver Cxbladder to the US · PDF filePacific Edge’s mandate is to commercialise its cutting edge technology Pacific Edge develops and commercialises

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

26

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).

Page 27: Pacific Edge Capital Raising to Deliver Cxbladder to the US · PDF filePacific Edge’s mandate is to commercialise its cutting edge technology Pacific Edge develops and commercialises

The annual market for Cxbladder® in the US is large

The annual potential(1) US market for Cxbladder® tests is approximately 1.8m tests

27

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

Page 28: Pacific Edge Capital Raising to Deliver Cxbladder to the US · PDF filePacific Edge’s mandate is to commercialise its cutting edge technology Pacific Edge develops and commercialises

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

28

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

Page 29: Pacific Edge Capital Raising to Deliver Cxbladder to the US · PDF filePacific Edge’s mandate is to commercialise its cutting edge technology Pacific Edge develops and commercialises

29

Offer Overview

Page 30: Pacific Edge Capital Raising to Deliver Cxbladder to the US · PDF filePacific Edge’s mandate is to commercialise its cutting edge technology Pacific Edge develops and commercialises

Capital Raising Overview

30

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

Page 31: Pacific Edge Capital Raising to Deliver Cxbladder to the US · PDF filePacific Edge’s mandate is to commercialise its cutting edge technology Pacific Edge develops and commercialises

Entitlement Offer Structure

31

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

Page 32: Pacific Edge Capital Raising to Deliver Cxbladder to the US · PDF filePacific Edge’s mandate is to commercialise its cutting edge technology Pacific Edge develops and commercialises

Timetable

32

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: 

Page 33: Pacific Edge Capital Raising to Deliver Cxbladder to the US · PDF filePacific Edge’s mandate is to commercialise its cutting edge technology Pacific Edge develops and commercialises

Glossary of Terms

33

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

Page 34: Pacific Edge Capital Raising to Deliver Cxbladder to the US · PDF filePacific Edge’s mandate is to commercialise its cutting edge technology Pacific Edge develops and commercialises

34

www.pacificedge.co.nzwww.cxbladder.com