AI assistant
IMPEDIMED LIMITED — Capital/Financing Update 2012
May 9, 2012
65135_rns_2012-05-09_f71e032a-21bd-4430-9a88-84d93a44b579.pdf
Capital/Financing Update
Open in viewerOpens in your device viewer
==> picture [81 x 92] intentionally omitted <==
10 May 2012
ASX RELEASE
ASX ANNOUNCEMENT – RETAIL OFFER BOOKLET
Brisbane, Australia - On 3 May 2012, ImpediMed Limited ( ASX:IPD ) ( ImpediMed or the Company ) announced the details of a 1 for 4 pro-rata accelerated non-renounceable entitlement offer of ordinary shares to raise up to approximately A$13.7 million, consisting of an offer to eligible institutional and sophisticated shareholders and an offer to eligible retail shareholders ( Retail Entitlement Offer ).
The Retail Offer Booklet relating to the Retail Entitlement Offer, together with a personalised entitlement and acceptance form, will be despatched to eligible retail holders today. A copy of the booklet and a sample entitlement and acceptance form are attached.
Yours faithfully IMPEDIMED LIMITED
==> picture [102 x 45] intentionally omitted <==
_____ Steve Denaro - Company Secretary
ENDS
For further information contact:
Greg Brown, ImpediMed CEO T: 61-7-3860-3700 Mobile/Cell: +61408281127
6655809/1ImpediMed Limited Unit 50 Parker Court Pinkenba, QLD 4008 Phone : +6-3860-3700
ImpediMed Limited ABN 65 089 705 144 Website: www.impedimed.com.au
L-Dex[®] is a trademark of ImpediMed Limited.
The L-Dex scale is a tool to assist in the clinical assessment of unilateral lymphoedema of arm and leg in women and the leg in men by a medical provider. The L-Dex scale is not intended to diagnose or predict lymphoedema of an extremity.
Important Notice
This announcement is not an offer or an invitation to acquire securities. In particular this release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities in the United States or to, for the amount or benefit of, any U.S. Person. This announcement may not be released or distributed in the United States or to any U.S. Person. Any securities described in this announcement have not been and will not be registered under the U.S. Securities Act or the securities laws of any other jurisdiction, and may not be offered or sold in the United States, or to, or for the account or benefit of, any U.S. Person.
6655809/1ImpediMed Limited Unit 50 Parker Court Pinkenba, QLD 4008 Phone : +6-3860-3700
ImpediMed Limited ABN 65 089 705 144 Website: www.impedimed.com.au
==> picture [135 x 94] intentionally omitted <==
ImpediMed Limited
ABN 65 089 705 144
Retail Offer Booklet
Pro-rata accelerated non-renounceable entitlement offer of 1 New Share for every 4 Shares held at an issue price of $0.35 per New Share
Retail Entitlement Offer closes 5.00pm (Brisbane time) on 24 May 2012
This is an important document that requires your immediate attention. Please read this document carefully and call your professional adviser if you have any queries. This document is provided for information purposes and is not a prospectus or disclosure document under the Corporations Act.
NOT FOR DISTRIBUTION OR RELEASE IN THE UNITED STATES OR TO US PERSONS
Joint Lead Managers
==> picture [77 x 69] intentionally omitted <==
==> picture [168 x 33] intentionally omitted <==
Contents
| Key offer dates | Page 2 |
|---|---|
| Chairman’s letter | Page 3 |
| ASX announcement and investor presentation | Page 6 |
| How to apply | Page 28 |
| Important information | Page 32 |
| Definitions | Page 37 |
Corporate Directory
Registered Office
Unit 1 50 Parker Court Pinkenba Qld 4008 Phone: (07) 3860 3700 Website: www.impedimed.com.au ASX code: IPD
Board of Directors
Joint Lead Managers
Wilson HTM Corporate Finance Ltd
Level 38, Riparian Plaza 71 Eagle Street Brisbane Qld 4000 Phone: (07) 3212 1333
RBS Morgans Corporate Limited
Level 29, 123 Eagle Street Brisbane Qld 4000 Phone: (07) 3334 4888
Dr Cherrell Hirst, AO, Chairman
Greg Brown, Chief Executive Officer & Managing Director
Mel Bridges, Non-Executive Director
Martin Kriewaldt, Non-Executive Director
Jim Hazel, Non-Executive Director
Legal Adviser
Corrs Chambers Westgarth Level 35, Waterfront Place 1 Eagle Street Brisbane Qld 4000 Phone: (07) 3228 9333
Dr Michael Panaccio, Non-Executive Director
Share registry
Link Market Services Limited Level 15, 324 Queen Street Brisbane Qld 4000
Phone: 1300 554 474 (within Australia) +61 2 8280 7454 (outside Australia) Email: [email protected]
6576210/15
page 1
Key offer dates
| Event | Date |
|---|---|
| Announcement Date Record Date (7.00pm Brisbane time) Retail Entitlement Offer opens Retail Entitlement Offer closes (5.00pm Brisbane time) Settlement of New Shares under the Retail Entitlement Offer Despatch of holding statements New Shares issued under the Retail Entitlement Offer commence trading on ASX |
3 May 2012 4 May 2012 10 May 2012 24 May 2012 31 May 2012 1 June 2012 4 June 2012 |
Eligible Retail Shareholders are encouraged to submit their Entitlement and Acceptance Forms as soon as possible after the Retail Entitlement Offer opens. ImpediMed reserves the right, subject to the Corporations Act, the Listing Rules and applicable laws to vary the dates of the Retail Entitlement Offer, including extending the Closing Date or accepting late applications, either generally or in particular cases, without notice.
Enquiries
If you have any questions, please call ImpediMed on (07) 3860 3700 (within Australia) or +617 3860 3700 (outside Australia) at any time between 8.30am and 5.30pm (Brisbane time) on any business day until the Closing Date, or consult your stockbroker, accountant or other professional adviser.
page 2
1 Chairman’s letter
10 May 2012
Dear Shareholder
ImpediMed Limited Retail Entitlement Offer
On behalf of ImpediMed Limited ( ImpediMed or the Company ), I am pleased to invite you to participate in a 1 for 4 pro-rata accelerated non-renounceable entitlement offer of ImpediMed ordinary shares. The New Shares are being offered at an issue price of $0.35 per New Share, which represents a discount of approximately 15.5% to the theoretical ex-rights price of $0.41 ( TERP )[1] and a 18.6% discount to the closing price of ImpediMed’s shares of $0.43 on 30 April 2012.
On 3 May 2012, ImpediMed announced its intention to raise up to $13.7 million through the Entitlement Offer. Wilson HTM and RBS Morgans are Joint Lead Managers to the Entitlement Offer.
ImpediMed has already raised approximately $7.8 million (before offer costs) from institutional investors as part of the Entitlement Offer.
Settlement of the New Shares issued under the Institutional Entitlement Offer will occur in two tranches with approximately $7.8 million to be completed on the first settlement date of 14 May 2012.
The Company’s largest shareholder, funds managed by Allan Gray Australia (formerly Orbis Investment Management (Australia)) has committed to the Entitlement Offer and will continue to hold approximately 19.9% of the Company’s issued shares post completion of the Entitlement Offer.
This Retail Offer Booklet relates to the retail component of the Entitlement Offer which provides Eligible Retail Shareholders with the same opportunity offered to those investors who participated in the Institutional Entitlement Offer to acquire New Shares. The Retail Entitlement Offer, which is not underwritten, will raise up to $5.9 million before offer costs. Eligible Retail Shareholders may apply for New Shares in excess of their entitlement. However, ImpediMed may scale back applications for Additional New Shares in its absolute discretion.
The proceeds of the Entitlement Offer will be used:
-
to expand reimbursement support;
-
for sales, marketing and training;
-
for instrument development and in particular to continue the commercialisation of the UB500;
1 TERP is the theoretical price at which shares should trade immediately after the ex-date for the Entitlement Offer assuming 100% take-up of the Entitlement Offer. The theoretical ex-rights price is a theoretical calculation only and the actual price at which shares trade immediately after the ex-date for the Entitlement Offer will depend on many factors and may not be equal to the theoretical ex-rights price.
page 3
-
for clinical trial support;
-
for inventory growth; and
-
for general working capital purposes.
This Retail Offer Booklet contains a number of important parts and documents, including:
-
an investor presentation and ASX announcement, which were released to ASX on 3 May 2012, providing information on ImpediMed and risk factors for you to consider;
-
instructions on “How to apply” setting out how to accept all or part of your Entitlement in the Retail Entitlement Offer if you choose to do so; and
-
important legal information.
With this booklet you will also find your Entitlement and Acceptance Form which details your Entitlement, to be completed in accordance with the instructions provided on the form and the instructions on “How to apply” in section 3 .
The Retail Entitlement Offer closes at 5.00pm (Brisbane time) on Thursday 24 May 2012. To participate, you need to ensure that your completed Entitlement and Acceptance Form and Application Money is received by ImpediMed before this time and date OR you have paid your Application Money via BPAY®[2] pursuant to the instructions that are set out on the Entitlement and Acceptance Form. Please refer to the instructions on “How to apply” in section 3 for further information.
Entitlements are non-renounceable and will not be tradeable on ASX or otherwise transferable. Shareholders who do not take up their Entitlements in full will not receive any value in respect of those Entitlements they do not take up and their percentage shareholding in ImpediMed will be reduced following the issue of all New Shares under the Entitlement Offer.
You should obtain any professional advice you require to evaluate whether to participate in the Retail Entitlement Offer.
For further information regarding the Retail Entitlement Offer, please call ImpediMed on (07) 3860 3700 (within Australia) or +617 3860 3700 (outside Australia) or visit our website at www.impedimed.com.au.
On behalf of the Board of ImpediMed, I thank you for your continued support as an ImpediMed shareholder and I invite you to consider this investment opportunity.
Yours sincerely
==> picture [105 x 60] intentionally omitted <==
Dr Cherrell Hirst, AO Chairman
2 Registered to BPAY Pty Ltd
page 4
Important Information
This booklet contains forward-looking statements, opinions and estimates regarding ImpediMed’s business. These forward-looking statements are not guarantees or predictions of future performance, and involve known and unknown risks, uncertainties and other factors, many of which are beyond our control, and which may cause actual results to differ materially from those expressed in the statements contained in this booklet. You should not place undue reliance on these forward-looking statements. These forward-looking statements are based on information available to ImpediMed as of the date of this booklet. Except as required by law or regulation (including the Listing Rules) ImpediMed undertakes no obligation to update these forward-looking statements.
This booklet does not constitute an offer to sell, or the solicitation of an offer to buy, any securities in the United States or to, or for the account or benefit of, any US Person (as defined in Regulation S under the Securities Act, as amended). Shares may not be offered or sold in the United States or to, or for the account or benefit of, any US Person absent registration or an exemption from registration. This booklet has been prepared for publication only in Australia and New Zealand, and may not be released elsewhere.
page 5
==> picture [425 x 313] intentionally omitted <==
----- Start of picture text -----
2 ASX investor presentation and announcement
ImpediMed Limited
Investor Presentation
May 2012
1
----- End of picture text -----
==> picture [425 x 295] intentionally omitted <==
----- Start of picture text -----
Disclaimer
This presentation has been produced by ImpediMed Limited (“ImpediMed”) only and may contain forward-looking statements that are based on management’s
current expectations and beliefs and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in
the forward-looking statements. The forward-looking statements contained in this presentation include statements about future financial and operating results,
status of our regulatory submissions, possible or assumed future growth opportunities and risks and uncertainties that could affect ImpediMed’s product and
products under development. These statements are not guarantees of future performance, involve certain risks, uncertainties and assumptions that are difficult to
predict, and are based upon assumptions as to future events that may not prove accurate. Therefore, actual outcomes and results may differ materially from what
is expressed herein. In any forward-looking statement in which ImpediMed expresses an expectation or belief as to future results, such expectation or belief is
expressed in good faith and believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will result or be
achieved or accomplished. We are not under any duty to update forward-looking statements unless required by law.
This investor presentation is not an offer of the sale of securities.
ImpediMed and their respective directors, employees, associates, affiliates or agents, make no:
(a) representations or warranties, express or implied, in relation to this presentation or the accuracy, reliability or completeness of any information in it or the
performance of ImpediMed;
(b) accept no responsibility for the accuracy or completeness of this presentation and the information contained in it; and
(c) make no recommendation as to whether you should participate in the proposed ImpediMed capital raising.
This presentation is intended to provide background information only and does not constitute or form part of an offer of securities or a solicitation or invitation to buy
or apply for securities, nor may it or any part of it form the basis of, or be relied on in any connection with any contract or commitment whatsoever. The information
in this presentation does not take into account the objectives, financial situation or particular needs of any person. Nothing contained in this presentation
constitutes investment, legal, tax or other advice. Potential investors should make their own decision whether to participate in the capital raising based on their own
enquiries. Potential investors are advised to seek appropriate independent advice, if necessary, to determine the suitability of this investment. This presentation
does not, and does not purport to, contain all the information prospective investors in ImpediMed would desire or require in reaching an investment decision.
To the maximum extent permitted by law, none of ImpediMed , their officers, directors, employees, associates, affiliates or agents, nor any other person accepts
any liability for any loss, claim, damages, costs or expenses of whatever nature (whether or not foreseeable), including, without limitation, any liability arising from
fault or negligence on the part of any of them or any other person, for any loss arising from the use of this presentation or its contents or otherwise arising in
connection with it or any errors or omissions in it.
The distribution of this presentation in jurisdictions outside Australia may be restricted by law and you should observe any such restrictions. This presentation has
not been filed, lodged, registered or approved in any jurisdiction and recipients of this presentation should keep themselves informed of and comply with and
observe all applicable legal and regulatory requirements. This presentation is made only to sophisticated or professional investors under the Corporations Act.
2
----- End of picture text -----
page 6
3
Presenters – IPD senior management
==> picture [38 x 42] intentionally omitted <==
Greg Brown, Chief Executive Officer (CEO) – B.Sc. / MBA
-
Director since December 2001, and CEO from February 2004.
-
Over 25 years of international business experience in the healthcare industry including in Australia, Switzerland, England, Germany and the US.
-
Held the roles of Vice President, Global Marketing for Digene Corporation (US & UK); Sales and Marketing Director for Baxter Diagnostics in the UK; and Senior Global Marketing Manager for Roche Molecular Systems (NY).
Peggy Brooker, Chief Operating Officer and Chief Financial Officer – CPA
-
Former Partner of E&Y LLP in the US and a Principal of E&Y Australia.
-
Peggy has been the CFO of an insurance broker in Los Angeles and Vice President of Finance of an aerospace manufacturer.
-
Bachelor of Science Degree in Business/Accounting from USC and licensed CPA in the State of California. Member of American Institute of Certified Public Accountants (AICPA).
Medical device company – First to market opportunity
==> picture [38 x 43] intentionally omitted <==
==> picture [434 x 227] intentionally omitted <==
----- Start of picture text -----
Targeting a sustainable, protected
and profitable franchise
• Unmet clinical • Limit • Fluid status • Unique and first • Unique code
need competition applications wave FDA reimbursement
clearance
• Lymphoedema • 31 families • Strong breast • Appropriate • Unique code for
arm and legs Patent / cancer data clearance for limbs
• Venous Insufficiency • applicationsBuilding TM • lymphoedemaBuilding data for assessment supports value creation • Target attractive payment and
collateral L-Dex legs coverage
Hurdles to entry – franchise protection Critical drivers of the business – sales/market share
Hurdles to entry – franchise protection
4
Regulatory
First to market
Clinical Validation
Intellectual Property
Reimbursement
----- End of picture text -----
page 7
Lymphoedema – Major unmet clinical need
==> picture [38 x 43] intentionally omitted <==
The current ‘gold standard’ for the detection of lymphoedema is water displacement. A 200ml difference can be too late, as irreversible changes may have already occurred.
==> picture [241 x 137] intentionally omitted <==
==> picture [132 x 148] intentionally omitted <==
Presently diagnosed when patients can already have irreversible changes Successful treatment and potential prevention can occur with early detection (compression sleeve)
5
Critical difference – Time of assessment
==> picture [38 x 43] intentionally omitted <==
==> picture [427 x 238] intentionally omitted <==
----- Start of picture text -----
ImpediMed’s L-Dex [®] U400 can detect lymphoedema at a sub-clinical stage when swelling
is not visible
L-Dex [®] U400 prospective readings
Identified at a sub-clinical stage
when swelling is not visible Sub clinical
Current standard
Identified at clinically evident
stage (>10% change) when
swelling is visible
Stage I Stage II Stage III
6
----- End of picture text -----
page 8
IPD platform - Bioimpedance Spectroscopy (BIS)
==> picture [38 x 43] intentionally omitted <==
ImpediMed utilises BIS technology in its medical devices for the detection of lymphoedema
==> picture [426 x 210] intentionally omitted <==
----- Start of picture text -----
ImpediMed’s BIS technology directly measures extracellular fluid
At low frequency At high frequency
Cell membrane
Intracellular fluid
Extracellular fluid
ImpediMed’s BIS Technique
7
----- End of picture text -----
ImpediMed’s L-Dex[®] U400
==> picture [38 x 43] intentionally omitted <==
- ImpediMed’s L-Dex[®] U400 is FDA cleared and can aid a surgeon or radiation oncologist in clinically assessing the early changes associated with lymphoedema
==> picture [147 x 127] intentionally omitted <==
-
Direct measure for extracellular fluid (ECF) differences of the limbs to aid in clinical assessment
-
Pathophysiology of lymphoedema shows ECF is a direct measure of early changes. In chronic state ECF levels can decrease
==> picture [179 x 200] intentionally omitted <==
==> picture [4 x 5] intentionally omitted <==
----- Start of picture text -----
8
----- End of picture text -----
page 9
True Innovation - Current detection methods are sub-optimal
==> picture [38 x 43] intentionally omitted <==
==> picture [428 x 235] intentionally omitted <==
----- Start of picture text -----
FDA clearance for
Direct or indirect measurement,
Detection Method volume or ECW lymphoedema Reproducibility/Accuracy
assessment
Tape measure
Volumetric calculation of limb by Non-standardised and
measuring diameter at prescribed No
intervals subjective measurement
Water displacement
Non-standardised and
Volumetric calculation of limb using No subjective measurement
‘Archimedes’ principal
Perometer
Standardised and objective
Volumetric calculation 80% of limb No measurement for volume only
using an infrared scan
BIS
Standardised and objective
Direct measure of relevant measurement specific for
compartment - the extracellular Yes lymphoedema changes
fluid differences between limbs
9
----- End of picture text -----
Our opportunity and approach – staged target markets entry
==> picture [38 x 43] intentionally omitted <==
ImpediMed is currently focused on the US breast cancer market with the L-Dex U400. ImpediMed’s UB500 is targeted for use into the larger pelvic cancer market with legs
==> picture [427 x 213] intentionally omitted <==
----- Start of picture text -----
Today & Near Term
Breast Cancer market – Entry Pelvic Cancer - Expansion
TGA, FDA, and CE cleared TGA, FDA, and CE cleared (Uni only)
Est. - US$120m to $250m annually Est. - US$400m to $700m annually
Targeting $65 to $85 per reading Targeting $65 to $85 per reading
Fluid
Status
Fluid Status Market
Technology
platform
Dialysis market Oedema market – New market expansion
Fluid status monitoring in Venous insufficiency
dialysis patients Pelvic cancers - differentiation of
lymphoedema / oedema
Future
10
----- End of picture text -----
page 10
Targeting a consumable based business model
==> picture [38 x 43] intentionally omitted <==
==> picture [418 x 230] intentionally omitted <==
----- Start of picture text -----
Physician pays ImpediMed for the consumables associated with the test and bills the
patient’s insurance company for reimbursement
Illustrative Device Economics Illustrative charge per reading (USD) Doctor supplied device free of charge
Illustrative Device Economics
Insurance reimburses doctor/clinic for a Doctor bills insurance company a fee
Average $250
reading for the reading service
IPD charges doctor/clinic per reading Targeting up to $85 One use consumable is IPD revenue
per reading charged to the doctor
Reimbursement and consumable amounts are targets - indicative only
Net doctor/clinic profit per reading Estimate of $165 Doctor’s profit per service
Reimbursement and consumable amounts are indicative targets
Clinical Protocols
Major HMO recommendations - 8 tests in first 3 years
NAPBC recommendations - 17 tests in first 5 years
First reading may take place during a scheduled consultation with the physician
----- End of picture text -----*
==> picture [8 x 5] intentionally omitted <==
----- Start of picture text -----
11
----- End of picture text -----
Illustrative only - Potential based on adoption of targeted protocols
==> picture [38 x 43] intentionally omitted <==
Two possible protocols could be (1) in line with HMO guidelines, or (2) NAPBC recommendations
==> picture [302 x 216] intentionally omitted <==
----- Start of picture text -----
Launch year Year 1 Year 2 Year 3 Year 4 Year 5
No. of tests each year from launch yr 1 cohort 6 1 1 0 0
No. of tests each yr from launch yr 2 cohort 6 1 1 0
No. of tests each yr from launch yr 3 cohort 6 1 1
No. of tests each yr from launch yr 4 cohort 6 1
No. of tests each yr from launch yr 5 cohort 6
Cumulative number of tests /yr 6 7 8 8 8
Launch year Year 1 Year 2 Year 3 Year 4 Year 5
No.of tests each yr from launch yr 1 cohort 4 4 4 3 2
No. of tests each yr from launch yr 2 cohort 4 4 4 3
No. of tests each yr from launch yr 3 cohort 4 4 4
No. of tests each yr from launch yr 4 cohort 4 4
No. of tests each yr from launch yr 5 cohort 4
Cumulative number of tests /yr 4 8 12 15 17
----- End of picture text -----
HMO illustration assumptions:
-
Assumes 8 tests in 3 years
-
Assumes 1 new patient/year
-
Assumes 100% compliance
-
Assumes patient has access to instrument and readings
-
Assume no positive result
NAPBC Recommendation:
-
Assumes 17 test in 5 years
-
Assumes 1 new patient/year
-
Assumes 100% compliance
-
Assumes patient has access to instrument and readings
-
Assumes no positive result
12
page 11
==> picture [38 x 43] intentionally omitted <==
==> picture [376 x 231] intentionally omitted <==
----- Start of picture text -----
Our target markets for driving sales
ImpediMed sells to three groups of customers
• Estimate top 1000 targets treat 45% of patients
Breast Surgeons • Direct sales and marketing
• Coverage critical driver for sales
• Co-marketing strategies with key chains
Radiation Oncologists • Co-market to both payer programs and surgeons
• Positioned for servicing non breast cancer patients
• Direct Managed Care team
Payers • Medicare local carriers and insurance companies
• Clinical and Economic compendium
----- End of picture text -----
==> picture [8 x 6] intentionally omitted <==
----- Start of picture text -----
13
----- End of picture text -----
US reimbursement overview – Critical to drive sales
==> picture [38 x 43] intentionally omitted <==
==> picture [414 x 190] intentionally omitted <==
----- Start of picture text -----
All three components are critical for reimbursement. Coverage often needs to meet a break-
even point before a doctor introduces testing for all patients in a practice
Coding Payment Coverage
CPT codes Clinician fee schedule National & local
I,III or Miscellaneous Medicare & private payers
A product that can deliver the following key characteristics is well positioned to build unique coding, coverage and
payment support:
True innovation – targeting an unmet need
High economic value
Clinician and patient acceptance and demand
First to market
----- End of picture text -----
==> picture [8 x 5] intentionally omitted <==
----- Start of picture text -----
14
----- End of picture text -----
page 12
Payment and coverage – Delivered through US healthcare payers
==> picture [329 x 234] intentionally omitted <==
----- Start of picture text -----
ImpediMed is targeting major insurance groups in the US
United Uninsured
Humana 6% 16% others
3% 4%
Aetna
5%
Wellpoint
BCBS
12%
33%
Cigna
3%
Kaiser CMS
3% 15%
Source: Harvard University, ‘Health Care Delivery Covered Lives – Summary of Findings’, 2007
----- End of picture text -----
==> picture [38 x 43] intentionally omitted <==
==> picture [8 x 6] intentionally omitted <==
----- Start of picture text -----
15
----- End of picture text -----
==> picture [451 x 313] intentionally omitted <==
----- Start of picture text -----
Our progress – L-Dex placements in the US as of 31 December 2011
ImpediMed has 178 devices placed in the US
Key:
15+ L-Dex placements
10 – 14 L-Dex placements
5 – 9 L-Dex placements
1 – 4 L-Dex placements
Source: ImpediMed data
No L-Dex placements 16
----- End of picture text -----
page 13
Significant risk to cancer patients - Incidence rates
==> picture [38 x 43] intentionally omitted <==
There are approximately 250,000 new breast cancer patients in the US each year
==> picture [393 x 138] intentionally omitted <==
----- Start of picture text -----
Incidence of Lymphedema in Cancer Survivors Expected New Patients
US Breast [9]
250,000
----- End of picture text -----
Source: Reference slide page 28 - Numbers 1 to 8 and 16 to 19.
Source: American Cancer Society, Datamonitor, Onkos, ROW - Rest of World (JPN, FRA, GER, ESP, UK)
-
US breast cancer incidence ~250,000 cases/year (American Cancer Society)
-
US breast cancer survivors ~2.5 million people
17
Third party validation – Early detection/intervention & outcomes
==> picture [38 x 43] intentionally omitted <==
Insurers typically review for a new diagnostic test on three principle grounds
| 18 3. Outcomes Data? Early Treatment: Campisi 2002 (RCT) Boccardo 2009 (RCT) LaComba 2010 (RCT) Stout 2008 Reactive Care: Dini 1999 (RCT) Johansson 2010 2. Diagnostic Performance? Hayes 2005, 2008 Schmitz/Hayes 2011 Cornish 1996, 2001 Ward 2002, 2009, 2011 Warren 2007 1. Technical Performance? Van Loan 1993 Van Loan 1999 (RCT) Cornish 1994,1996, 1998 Ward 2008 Czerniec 2009, 2010 Hayes 2008 Outcome Trials Detection Follow-Up Control Arm Treatment Arm Stout (Observational) Perometry >3% difference 196 patients – 1.5 years N/A 22% Dx subclinical All returned baseline Campisi (RCT) Lymphoscintigraphy 50 patients – 5 years 36% 8% Boccado (RCT) Lymphoscintigraphy 55 patients – 2 years 33% 8% LaComba (RCT) Prophylaxis vs educate 120 patients – 1 year 25% 7% Johansson (Observational) Water displacement (8%) 292 patients – 5 /10yrs treated N/A 38% Dx (111 pts) /no return |
18 3. Outcomes Data? Early Treatment: Campisi 2002 (RCT) Boccardo 2009 (RCT) LaComba 2010 (RCT) Stout 2008 Reactive Care: Dini 1999 (RCT) Johansson 2010 2. Diagnostic Performance? Hayes 2005, 2008 Schmitz/Hayes 2011 Cornish 1996, 2001 Ward 2002, 2009, 2011 Warren 2007 1. Technical Performance? Van Loan 1993 Van Loan 1999 (RCT) Cornish 1994,1996, 1998 Ward 2008 Czerniec 2009, 2010 Hayes 2008 Outcome Trials Detection Follow-Up Control Arm Treatment Arm Stout (Observational) Perometry >3% difference 196 patients – 1.5 years N/A 22% Dx subclinical All returned baseline Campisi (RCT) Lymphoscintigraphy 50 patients – 5 years 36% 8% Boccado (RCT) Lymphoscintigraphy 55 patients – 2 years 33% 8% LaComba (RCT) Prophylaxis vs educate 120 patients – 1 year 25% 7% Johansson (Observational) Water displacement (8%) 292 patients – 5 /10yrs treated N/A 38% Dx (111 pts) /no return |
18 3. Outcomes Data? Early Treatment: Campisi 2002 (RCT) Boccardo 2009 (RCT) LaComba 2010 (RCT) Stout 2008 Reactive Care: Dini 1999 (RCT) Johansson 2010 2. Diagnostic Performance? Hayes 2005, 2008 Schmitz/Hayes 2011 Cornish 1996, 2001 Ward 2002, 2009, 2011 Warren 2007 1. Technical Performance? Van Loan 1993 Van Loan 1999 (RCT) Cornish 1994,1996, 1998 Ward 2008 Czerniec 2009, 2010 Hayes 2008 Outcome Trials Detection Follow-Up Control Arm Treatment Arm Stout (Observational) Perometry >3% difference 196 patients – 1.5 years N/A 22% Dx subclinical All returned baseline Campisi (RCT) Lymphoscintigraphy 50 patients – 5 years 36% 8% Boccado (RCT) Lymphoscintigraphy 55 patients – 2 years 33% 8% LaComba (RCT) Prophylaxis vs educate 120 patients – 1 year 25% 7% Johansson (Observational) Water displacement (8%) 292 patients – 5 /10yrs treated N/A 38% Dx (111 pts) /no return |
18 3. Outcomes Data? Early Treatment: Campisi 2002 (RCT) Boccardo 2009 (RCT) LaComba 2010 (RCT) Stout 2008 Reactive Care: Dini 1999 (RCT) Johansson 2010 2. Diagnostic Performance? Hayes 2005, 2008 Schmitz/Hayes 2011 Cornish 1996, 2001 Ward 2002, 2009, 2011 Warren 2007 1. Technical Performance? Van Loan 1993 Van Loan 1999 (RCT) Cornish 1994,1996, 1998 Ward 2008 Czerniec 2009, 2010 Hayes 2008 Outcome Trials Detection Follow-Up Control Arm Treatment Arm Stout (Observational) Perometry >3% difference 196 patients – 1.5 years N/A 22% Dx subclinical All returned baseline Campisi (RCT) Lymphoscintigraphy 50 patients – 5 years 36% 8% Boccado (RCT) Lymphoscintigraphy 55 patients – 2 years 33% 8% LaComba (RCT) Prophylaxis vs educate 120 patients – 1 year 25% 7% Johansson (Observational) Water displacement (8%) 292 patients – 5 /10yrs treated N/A 38% Dx (111 pts) /no return |
18 3. Outcomes Data? Early Treatment: Campisi 2002 (RCT) Boccardo 2009 (RCT) LaComba 2010 (RCT) Stout 2008 Reactive Care: Dini 1999 (RCT) Johansson 2010 2. Diagnostic Performance? Hayes 2005, 2008 Schmitz/Hayes 2011 Cornish 1996, 2001 Ward 2002, 2009, 2011 Warren 2007 1. Technical Performance? Van Loan 1993 Van Loan 1999 (RCT) Cornish 1994,1996, 1998 Ward 2008 Czerniec 2009, 2010 Hayes 2008 Outcome Trials Detection Follow-Up Control Arm Treatment Arm Stout (Observational) Perometry >3% difference 196 patients – 1.5 years N/A 22% Dx subclinical All returned baseline Campisi (RCT) Lymphoscintigraphy 50 patients – 5 years 36% 8% Boccado (RCT) Lymphoscintigraphy 55 patients – 2 years 33% 8% LaComba (RCT) Prophylaxis vs educate 120 patients – 1 year 25% 7% Johansson (Observational) Water displacement (8%) 292 patients – 5 /10yrs treated N/A 38% Dx (111 pts) /no return |
|---|---|---|---|---|
| Outcome Trials | Detection | Follow-Up | Control Arm | |
| Stout (Observational) | Perometry >3% difference | 196 patients – 1.5 years | N/A | 22% Dx subclinical All returned baseline |
| Campisi (RCT) | Lymphoscintigraphy | 50 patients – 5 years | 36% | 8% |
| Boccado (RCT) | Lymphoscintigraphy | 55 patients – 2 years | 33% | 8% |
| LaComba (RCT) | Prophylaxis vs educate | 120 patients – 1 year | 25% | 7% |
| Johansson (Observational) | Water displacement (8%) | 292 patients – 5 /10yrs treated |
N/A | 38% Dx (111 pts) /no return |
page 14
US 5 Year early detection/intervention trial
==> picture [38 x 43] intentionally omitted <==
==> picture [388 x 115] intentionally omitted <==
----- Start of picture text -----
A NIH study shows that intervention with sleeve resulted in reversal of symptoms in all
patients
National Institutes of Health (NIH) Funded Study – 2008
5 year study assessing lymphoedema in breast cancer patients (196 patients)
Preoperative, 1, 3, 6, 9, and 12 month assessment post surgery (Perometer)
22% (43 patients) identified with sub-clinical lymphoedema
----- End of picture text -----*
- Source: Reference slide page 28 - Number 10.
==> picture [427 x 108] intentionally omitted <==
----- Start of picture text -----
NIH 5 Year Preliminary Data At 1 year(NIH) At 5 years(NIH) Armer 2011
(n=196) (n=86) (n=236)
Sub-clinical: 22% 38% 0%
Stage I/II 11%* 55% (42% to 90%)
“Post-Breast Cancer Lymphedema: Incidence Increases From 12 TO 30 TO 60 Months” - Lymphology 43 (2010) 118 127. This study
aimed to describe lymphoedema occurrence over time among breast cancer survivors using four diagnostic criteria based on three
measurement techniques.
19
----- End of picture text -----
Support building for prospective care in US
==> picture [38 x 43] intentionally omitted <==
-
Support for BIS is snowballing in the US with physicians, advocacy groups and survivors
-
National Accreditation Program for Breast Centers (NAPBC) clinical Standard 2.15 “Support and Rehabilitation”
-
This standard strongly recommends lymphoedema management and risk reduction practices for the treatment of all breast cancer patients. The NAPBC clinical Standard was updated and published in the “2011 Breast Center Standards Manual”
-
Under this standard, it references the National Lymphedema Network (NLN) supporting guideline document, which supports baseline testing at baseline and every subsequent visit for the life of the patient
-
Avon Foundation White paper – calls for prospective care with BIS/Perometry
-
Key opinion leaders support
-
Clinical based Economic Model – gives clinical and economic potential benefits
-
UPMC and Major HMO (Top 7 Insurer) adoption of BIS in prospective care
==> picture [8 x 5] intentionally omitted <==
----- Start of picture text -----
20
----- End of picture text -----
page 15
Social media – lymphconnect.com and international.l-dex.com
==> picture [38 x 43] intentionally omitted <==
Targeting support for prospective care in US market with physicians, advocacy groups and survivors
==> picture [203 x 131] intentionally omitted <==
==> picture [164 x 137] intentionally omitted <==
-
Lymphconnect.com website launched in December 2011 to support lymphoedema sufferers with information and a space to share their story
-
L-Dex.com is a Company website helping newly diagnosed breast cancer patients with information about L-Dex and where the test is offered in their area
21
Our progress - Key milestones and events
==> picture [38 x 43] intentionally omitted <==
ImpediMed is focused on building coverage to support effective reimbursement
==> picture [422 x 174] intentionally omitted <==
----- Start of picture text -----
September 2010 January 2011 CPT June 2009July 2011 November 2011 December 2011 March 2012
MCO contracts announced Category III code active 45 L-Dex dAvon Whit e vices in Paper FDA claim for limbs UPMC covers 23 million covered lives
cleared
NIH 5 year data
2010 2011 2012
October 2010 May 2011
March 2012
IMS health NLN position paper
economic model September 2011 Major HMO adopts clinical guidelines
Red Journal article review
paper
July 2011 February 2012
First coverage statement Stanford registry
starts enrolling
----- End of picture text -----
==> picture [8 x 5] intentionally omitted <==
----- Start of picture text -----
22
----- End of picture text -----
page 16
Next generation consumable for breast and pelvic cancer
==> picture [38 x 43] intentionally omitted <==
==> picture [429 x 239] intentionally omitted <==
----- Start of picture text -----
The UB500 will allow ImpediMed to protect and build the larger consumable revenue
potential in the pelvic cancer market
UB500 Beta II prototype
Active electrode system
Consumables model
Commercialisation continues with
pre-production units
23
----- End of picture text -----
Offer summary
==> picture [38 x 43] intentionally omitted <==
==> picture [430 x 234] intentionally omitted <==
----- Start of picture text -----
1 for 4 accelerated non-renounceable rights issue to raise up to approximately $13.7 million
Offer structure Up to approximately 39.1 million new ImpediMed ordinary shares to be issued (25% of existing
shares on issue)
$0.35 per share
Offer price 18.6% discount to ImpediMed’s closing price on 30 April 2012 of $0.43
15.5% discount to theoretical ex-rights price (TERP) of $0.41
Institutional offer Opens at 10am (Sydney time) 1 May 2012 and closes 4:00pm (Sydney time) on 1 May 2012
Retail offer Opens at 9:00am (Sydney time) 10 May 2012 and closes 5:00pm (Sydney time) 24 May 2012
JLMs Wilson HTM and RBS Morgans are acting as Joint Lead Managers
24
----- End of picture text -----
page 17
Expected use of funds
==> picture [38 x 43] intentionally omitted <==
-
Sales, marketing and training
-
Expand reimbursement support
-
Instrument development - continue commercialisation of the UB500
-
Clinical trial support
-
Inventory growth
-
General working capital purposes
25
Indicative rights issue timetable
==> picture [38 x 43] intentionally omitted <==
| Timetable* | |||
|---|---|---|---|
| Institutional Offer period (under trading halt) | 1 - 2 May 2012 | ||
| Institutional bookbuild opens | 1 May 2012 | ||
| Institutional bookbuild closes | 1 May 2012 | ||
| Ordinary shares recommence trading | 3 May 2012 | ||
| Record date | 4 May 2012 | ||
| Retail offer opens | 10 May 2012 | ||
| Retail Offer Booklet despatched to Eligible Retail Shareholders | 10 May 2012 | ||
| Institutional settlement | 14 May 2012 | ||
| Institutional Offer allotment and trading date | 15 May 2012 | ||
| Retail Offer closes – 5pm Sydney, Australia time | 24 May 2012 | ||
| Retail Offer settlement date | 31 May 2012 | ||
| Retail allotment date | 1 June 2012 | ||
| Retail trading date | 4 June 2012 |
- Indicative dates only subject to change at ImpediMed’s discretion
26
page 18
Risk factors
==> picture [38 x 43] intentionally omitted <==
Early stage company with limited revenue
- ImpediMed is at an early stage in its commercialisation of it’s L-Dex medical device. To date, it has operated at a loss and has an operating history of losses. ImpediMed’s ability to generate sufficient revenue in the future depends on a number of factors, including: (i) reimbursement of its L-Dex product, especially in in the US; (ii) the company meeting its timeline for next generation product launch; (iii) the ability to obtain all necessary regulatory marketing approvals in a timely manner; (iv) the ability to manufacture sufficient quantities of products to the required standard and at acceptable cost levels; and (v) the success of ImpediMed’s clinical trials. There is a risk that ImpediMed will continue to incur losses from its operations and may not achieve or maintain profitability. ImpediMed expects its expenses to increase in the short term in connection with the commercialisation of L-Dex, regulatory approval processes, along with the continuing of research and development projects and clinical trials. Over the longer term, ImpediMed’s costs will fluctuate, primarily dependant on commercialisation expenses (direct reimbursement team and sales and marketing), regulatory authorizations, the number, type and size of clinical trials.
Regulatory approvals
- The clinical development, testing, manufacturing, sales and marketing of ImpediMed products are subject to extensive regulation by regulatory authorities in the U.S., the E.U., Australia and elsewhere. To receive regulatory authorisation for the commercial sale of any product, ImpediMed must complete pre-clinical development and extensive clinical trials to demonstrate safety and efficacy and then apply for clearance/approval to the relevant regulatory authorities. The process to obtain regulatory authorisation is expensive, complex, lengthy and the outcomes uncertain. ImpediMed may not be able to obtain marketing authorisations for all its targeted claims, including the approval/clearance of the L-Dex UB500 for bilateral legs or venous insufficiency. Another possibility is that the targeted claims may be delayed or subject to significant limitations (narrower claims), warnings, precautions or contra-indications with respect to conditions of use.
Pricing and reimbursement – Payment levels, pricing support and category I code success
-
The commercial success of ImpediMed’s approved products is substantially dependent on achieving acceptable payment levels to medical providers to support pricing strategies for L-Dex. Whether acceptable third-party coverage and reimbursement levels are available from government bodies, private health insurers and other third-parties will be reliant on clinical data and health economic arguments. The company is intending to submit the category III code for upgrade to category I. The process of obtaining payment for a category I code for L-Dex is time consuming and the outcome is uncertain. Timing of this process and the outcome of payment for the category I code will relate to how successful the company is in (i) clinical trials, (ii) obtaining regulatory approvals, (iii) obtaining the direct support for our code from clinical governing society’s around the disorders we target, (iv) supporting an argument for wide spread adoption of the technology by establishing many users of our products, and v) maintaining a payment under the present category III code to support our present pricing targets.
-
Government bodies, national health authorities and other third-parties are increasingly seeking to contain healthcare costs by delaying reimbursement for, and limiting both the coverage and the level of reimbursement of new products and, as a result, they may not cover or provide adequate payment for ImpediMed’s products. Even if products receive acceptable pricing and reimbursement, pricing and reimbursement levels are subject to change under healthcare reforms to reduce costs.
27
Risk factors
==> picture [38 x 43] intentionally omitted <==
Sales and marketing
- There is a risk that ImpediMed’s direct sales and marketing efforts may not be successful. ImpediMed has a direct sales and marketing capability to Surgeons, Radiation Oncologists and major insurance companies (Managed Care team). Third party options for distribution maybe limited due to the first to market nature of the business. Co-marketing programs, with key radiation oncology chains, could have a material impact on pricing if the test is used as a loss leader to leverage other radiation product billable revenue. Marketing partners that do not pursue the reimbursement strategy of coverage under the technology code, could impact on our ability to build coverage and to establish appropriate payment levels to support the pricing strategy for the L-Dex U400.
Market acceptance of products and patient population
- There is a risk that the L-Dex U400 and future products (UB500) may not gain adequate market acceptance. The degree of market acceptance will depend on a variety of factors, including: (i) regulatory claims; (ii) the clinical trial outcomes, (iii) the level of support from target markets; (iv) the level of reimbursement coverage and payment; (iv) the timing of new market introductions; (v) clinical profile of conventional competitive products; and (vi) the success of marketing & sales efforts. Additionally, there is a risk that market estimates do not accurately reflect the number of patients in the target markets.
Change in laws and healthcare policy
- ImpediMed’s business and the business of the third parties with which it operates are subject to the laws and regulations in a number of jurisdictions. Unforeseen changes in laws and government policy both in Australia, the EU, the U.S. and elsewhere, including material and unforeseen changes to licensing and approval requirements or regulations relating to clinical trials, manufacturing, product approval and pricing could materially impact ImpediMed’s operations, assets, contracts and profitability. To date, the Affordable Care Act (Obama Care) in the United States has had a material impact in changing dramatically how healthcare has been administered/managed (Accountable Care Organisations). Higher entry hurdles in clinical utility validation, outcomes evidence and code requirements has impacted on coverage development as a result of Obama Care.
Dividends
- ImpediMed has never paid a dividend and does not intend on paying dividends in the foreseeable future which means that holders of shares may not receive any return on their investment from dividends.
Dependence on breast cancer market
- Although ImpediMed has a pipeline of market targets for its platform, it’s success is currently substantially dependent on completion of development, regulatory approval and successful commercialisation of L-Dex for secondary lymphoedema and other applications in all key markets in a timely manner.
28
page 19
Risk factors
==> picture [38 x 43] intentionally omitted <==
Ongoing regulatory issues
-
Even after medical devices receive regulatory clearance, ImpediMed may still face developmental and ongoing regulatory compliance difficulties. Regulatory agencies subject a marketed device, its manufacturer and the manufacturer’s facilities to continual review and periodic inspections. Potentially costly followups or post-marketing clinical studies may be required and previously unknown problems may result in restrictions on the marketing of the device and could include product withdrawal. If ImpediMed fails to comply with applicable regulatory requirements, a regulatory agency may: (i) issue warning letters; (ii) impose civil or criminal penalties; (iii) suspend ImpediMed’s regulatory authorisation or restrict or change the approved indications for use or impose additional safety reporting requirements; (iv) suspend any of ImpediMed’s ongoing clinical trials; (v) refuse to approve pending applications or supplements to approved applications filed; (vi) impose restrictions on ImpediMed’s operations, including closing ImpediMed’s or its contract manufacturers’ facilities or terminating its licenses to manufacture Good Manufacturing Practice; or (vii) seize or detain devices or require a product recall.
-
In addition, the law or regulatory policies governing medical devices may change. New regulatory requirements or additional regulations may be enacted that could prevent or delay regulatory approval of ImpediMed’s products or that may otherwise impact on ImpediMed‘s ability to market, distribute and sell devices and or consumables. ImpediMed cannot predict the likelihood, nature or extent of adverse government regulation that may arise.
Clinical trials
- To receive regulatory approvals for the commercial sale of products, ImpediMed must complete pre-clinical development and clinical trials to demonstrate safety and efficacy of the device on humans. Clinical trials are expensive, time consuming, subject to delay and their outcome uncertain. There are numerous factors that could affect the timing of the commencement, continuation and completion of clinical trials which may delay the clinical trials or prevent ImpediMed from completing these trials successfully. Due to our reliance on contract research organizations, hospitals and investigators to conduct clinical trials, ImpediMed is unable to directly control the timing, conduct and expense of our clinical trials. Ongoing and future clinical trials may not show sufficient safety or efficacy to obtain regulatory and reimbursement acceptance. Success in pre-clinical and early clinical trials is not a guarantee of future results nor does it ensure that later large scale trials will be successful. Additional clinical trials of UB500 for the diagnosis of leg lymphoedema in men and women may also be required in order to obtain FDA approval. The outcome of these trials are uncertain and there is a risk that they may not be successful and may not demonstrate sufficient safety or efficacy to obtain regulatory clearance.
Clinical development
- ImpediMed cannot be certain that the clinical development of any of its product in pre-clinical testing or clinical development will be successful. Significant delays in clinical development could materially increase costs, delay receipt of revenue or allow competitors to bring products to market before ImpediMed. ImpediMed uses third parties to provide research and development services and may therefore be unable to directly control of the timing, conduct and expense of certain research. If development activities are unsuccessful, significant monies and time invested may be rendered unproductive and worthless
29
Risk factors
==> picture [38 x 43] intentionally omitted <==
Manufacturing
- ImpediMed, or its contract manufacturers and suppliers, may fail to achieve and maintain required manufacturing standards which could result in device recalls or withdrawals, product shortages, delays or failures in product testing or delivery or other problems that could seriously harm ImpediMed’s business. ImpediMed may be impacted by industrial action or operating equipment and facilities may not operate as intended or be available as a result of unanticipated failures or other events outside of ImpediMed’s control such as fires or catastrophic breakdowns or deliberate acts of destruction which may restrict ImpediMed’s ability to supply product, profitability and ability to operate. ImpediMed’s and its contract manufacturers may not be able to obtain and maintain all licenses and approvals required to maintain manufacturing operations. Any interruption to ImpediMed’s manufacturing capability could result in the cancellation of shipments and loss of product, resulting in delays and additional costs.
Competition
- ImpediMed conducts business in a highly regulated industry. The medical device industry there are a number of well established companies that could develop a competing product. There can be no assurances given in respect of ImpediMed’s ability to compete.
Product liability claims and insurance
- ImpediMed faces product liability exposure with respect to its devices and consummables. This exposure is likely to increase as ImpediMed increases commercial sales. Regardless of merit or eventual outcome, liability claims may result in: (i) decreased demand for ImpediMed’s products; (ii) injury to ImpediMed’s reputation; (iii) withdrawal of clinical trial participants; (iv) costly litigation; (v) substantial monetary awards to physicians or patients and others; (vii) loss of revenues; and (viii) an inability to commercialise ImpediMed’s products. ImpediMed may not be able to maintain insurance coverage at a reasonable cost nor obtain suitable or reasonable insurance coverage in respect of any liability that may arise and any claim for damages could be substantial.
Patents and trade secrets
- ImpediMed uses patents or trade marks to try and protect its technology and applications from unauthorised use by third parties. The term of patents may expire or may be challenged, invalidated or circumvented. There can be no assurances that ImpediMed’s patents will afford it significant commercial protection for its devices.
30
page 20
Risk factors
==> picture [38 x 43] intentionally omitted <==
Enforcement and infringement of intellectual property
-
Third parties may own or control patents or patent applications that ImpediMed may be required to license to commercialise product, that IMpediMed may infringe, or, that could result in litigation that would be costly and time consuming. As a result of intellectual property infringement claims, or to avoid potential claims, ImpediMed might be: (i) prohibited from selling or licensing a product; (ii) required to expend considerable amounts of money in defending the claim; (iii) required to pay substantial royalties or license fees; (iv) required to pay substantial monetary damages; or (v) required to redesign a product so it does not infringe, which may not be possible or could require substantial funds and time.
-
Litigation
-
There has been substantial litigation and other proceedings in the biotechnology and medical device industries. Defending against litigation and other third party claims would be costly and time consuming and would divert management’s attention from our business, which could lead to delays in our development or commercialization efforts. If third parties are successful in their claims, ImpediMed might have to pay substantial damages or take other actions that are adverse to the ImpediMed business.
Resources
-
The loss of services of one or more of our members of key personnel or the inability to recruit and retain high calibre staff could delay or compromise the successful commercialisation of products. ImpediMed will need to increase the size of its organisation, and it may experience difficulties in managing growth.
-
Capital requirements
-
ImpediMed may require substantial additional funds which may be dilutive or that may not be available to ImpediMed on favourable terms or at all. If ImpediMed is unable to obtain additional funds when required, ImpediMed may be forced to delay, reduce the scope or eliminate one or more clinical trials or research and development programs or future commercialisation efforts.
General economic factors
- Material adverse changes in the general domestic and international economic climate may have an adverse effect on ImpediMed’s performance. These factors may include fluctuations in foreign exchange rates ( ImpediMed has no formal hedge policy, uses a natural hedging process), does business in many countries and most overheads are now in USD. inflation, interest rates, rate of economic growth, taxation laws, consumer spending, unemployment rates, government fiscal, monetary and regulatory policies and consumer and business sentiment. Any of these factors have the potential to cause costs to increase or revenues to decline.
31
Risk factors
==> picture [38 x 43] intentionally omitted <==
Share price
-
The market price of ImpediMed’s shares historically has been, and ImpediMed expects will continue to be, subject to significant fluctuations over short periods of time. These fluctuations may be due to factors specific to ImpediMed, to changes in analysts’ recommendations and earnings estimates, to changes in exchange rates or to factors affecting the biopharmaceutical industry or the securities markets in general. These factors include: (i) adverse or inconclusive results or delays in clinical trial programs; (ii) unforeseen safety issues or adverse side effects resulting from clinical trials or the commercial use of any ImpediMed products; (iii) regulatory actions in respect of any ImpediMed products or the products of any of its competitors; (iv) failure or delay of any of ImpediMed products obtaining regulatory authorisations in key markets or limitations on the indications or other conditions on any regulatory authorisations given; failure to obtain and maintain satisfactory pricing, payment and reimbursement coverage for L-Dex; (v) failure of any ImpediMed products to achieve commercial success; (vi) inability to manufacture sufficient products to the necessary standard and disruptions to supply arrangements; (vii) announcements of the introduction of new products by ImpediMed or possible competitors; (viii) market conditions, including market conditions in the Biotech and medical device sectors; (ix) increases in the Company’s costs or decreases in revenues due to unfavourable movements in foreign currency exchange rates; (x) developments or litigation concerning patents, licenses and other intellectual property rights; (xi) litigation or public concern about the safety of potential products; (xii) changes in recommendations or earnings estimates by securities analysts; (xiii) actual and anticipated fluctuations in ImpediMed’s quarterly operating results; (xiv) deviations in operating results from the estimates of securities analysts; (xv) additions or departures of key personnel; and (xvi) changes in third-party reimbursement policies.
-
ImpediMed may experience a material decline in the market price of its shares, regardless of operating performance. No assurances can be given that the New Shares will trade at or above the Offer Price. None of ImpediMed, its Board or any other person guarantees the market performance of the New Shares.
32
page 21
33
Reference Information
==> picture [38 x 43] intentionally omitted <==
-
Warren A, Bronson H, Borud L, and Slavin S, Lymphedema: A Comprehensive Review, Annals of Plastic Surgery • Volume 59, Number 4, 2007
-
Francis WP, Abghari P, Du W, Rymal C, Suna M, Kosir MA. Improving surgical outcomes: standardizing the reporting of incidence and severity of acute lymphedema after sentinel lymph node biopsy and axillary lymph node dissection. Am J Surg 2006;192(5):636-9. Available from http://www.ncbi. .nlm.nih.gov/entrez/query.fcgi? cod=Retrieve&db=PubMed&dopt=Citation &list_uids=17071198 http://www.ncbi.nlm. nih.gov/entrez/query.fcgi?cmd=Retrieve&db= PubMed&dopt=Citation&list_uids=17071198
-
Armer J, Fu MR, Wainstock JM, Zagar E, Jacobs LK. Lymphedema following breast cancer treatment, including sentinel lymph node biopsy. Lymphology 2004;37(2):73-91. Available from PM:15328760
-
Leidenius M, Leivonen M, Vironen J, von Smitten K. The consequences of long-time arm morbidity in node-negative breast cancer patients with sentinel node biopsy or axillary clearance. J.Surg.Oncol. 2005;92(1):23-31. Available from PM:16180231
-
Langer I, Guller U, Berclaz G, Koechli OR, Schaer G, Fehr MK, et al. Morbidity of sentinel lymph node biopsy (SLN) alone versus SLN and completion axillary lymph node dissection after breast cancer surgery: a prospective Swiss multicenter study on 659 patients. Ann Surg 2007;245(3):452-61.
-
Clark B, Sitzia J, Harlow W. Incidence and risk of arm oedema following treatment for breast cancer: a three-year follow-up study. QJM. 2005;98(5):343-48. Available from PM:15820971
-
Umberto Veronesi, M.D., Giovanni Paganelli, M.D., Giuseppe Viale, F.R.C.Path., Alberto Luini, M.D., Stefano Zurrida, M.D., Viviana Galimberti, M.D., Mattia Intra, M.D., Paolo Veronesi, M.D., Chris Robertson, Ph.D., Patrick Maisonneuve, Eng., Giuseppe Renne,M.D.,Concetta De Cicco, M.D., Francesca De Lucia, M.D. and Roberto Gennari, M.D.: A Randomized Comparison of Sentinel-Node Biopsy with Routine Axillary Dissection in Breast Cancer. N Engl J Med Volume 349;6:546-553 August 7, 2003
-
Haid et al: Morbidity of Breast Cancer Patients Following Complete Axillary Dissection or Sentinel Node Biopsy Only: A Comparative Evaluation. Breast Cancer Research and Treatment Volume 73, Number 1 / May, 2002
-
American Cancer Society. Cancer Facts & Figures 2008. Atlanta: American Cancer Society; 2008.
-
Gergich N, Washington F, Pfalzer L, Soballe P and McGarvey C: Preoperative assessment enables the early diagnosis and successful treatment of lymphedema. Cancer, June 2008, Vol 112, pp 2809-2819
Did not use numbers 11 to 15.
-
16 Werngren-Elgstrom M, Lidman D. Lymphedema of the lower extremities after surgery and radiotherapy for cancer of the cervix. Scand J Plast Reconstr Surg Hand Surg 1994;28:289-93.
-
Nunns D, Williamson K, Swaney L, et al. The morbidity of surgery and adjuvant radiotherapy in the management of endometrial carcinoma. Int J Gynecol Cancer 2000;10:233-8.
-
Fujiwara K, Kigawa J, Hasegawa K, et al. Effect of simple omentoplasty and omentopexy in the prevention of complications after pelvic lymphadenectomy. Int J Gynecol Cancer 2003;13:61-6.
-
Carlson J, Kauderer J, Walker J, Gold M, O’Malley D, Tuller E, Clarke-Pearson D. Phase III trial of Tisseel to reduce lymphedema after inguinal lymph node dissection: a Gynecologic Oncology Group study. The 38th Annual Meeting on Women’s Cancer. March 3-7, 2007. San Diego, CA. Abstract #228.
page 22
==> picture [454 x 646] intentionally omitted <==
page 23
==> picture [454 x 648] intentionally omitted <==
page 24
==> picture [454 x 643] intentionally omitted <==
page 25
==> picture [454 x 641] intentionally omitted <==
page 26
==> picture [454 x 642] intentionally omitted <==
page 27
3 How to apply
3.1 Please read this booklet carefully
The Retail Entitlement Offer is being made in accordance with rules under the Corporations Act that allow rights issues to be offered by providing certain confirmations to the market without the need for a prospectus. Consequently, before accepting your Entitlement, you should carefully read and understand the publicly available information on ImpediMed and the Entitlement Offer, including the materials in this booklet, ImpediMed’s interim and annual reports and other announcements that have been made available at www.asx.com.au.
3.2 Consider the Retail Entitlement Offer in light of your particular investment objectives and circumstances
If you have any queries or are uncertain about any aspects of the Retail Entitlement Offer, consult with your stockbroker, accountant or other professional adviser. Please ensure that you review carefully the “Risk Factors” section of the investor presentation in section 2 .
3.3 Complete and return the accompanying Entitlement and Acceptance Form
If you decide to take up all or part of your Entitlement, complete and return the Entitlement and Acceptance Form with your payment or pay your Application Money via BPAY according to the instructions that are set out on the Entitlement and Acceptance Form.
Entitlements are non-renounceable and will not be tradeable on ASX or otherwise transferable. Shareholders who do not take up their Entitlements in full will not receive any value in respect of those Entitlements they do not take up and their percentage shareholding in ImpediMed will be reduced following the issue of all New Shares under the Entitlement Offer.
Your Entitlement is set out on the accompanying Entitlement and Acceptance Form and has been calculated as 1 New Share for every 4 Shares you held as at the Record Date, rounded up to the nearest whole Share. If you have more than one holding of Shares you will receive more than one Entitlement and Acceptance Form and you will have separate Entitlements for each holding.
Eligible Retail Shareholders may also apply for New Shares in excess of their Entitlement ( Additional New Shares ). Please note that Additional New Shares will only be allocated to Eligible Retail Shareholders if and to the extent that ImpediMed determines to do so, in its absolute discretion, having regard to circumstances as at the time of the close of the Retail Entitlement Offer. ImpediMed may scale back any application for Additional New Shares in its absolute discretion, but will not scale back any Entitlement.
ImpediMed will treat you as applying for as many New Shares as your payment will pay for in full, subject to any scale-back it may determine to implement in its absolute discretion in respect of Additional New Shares. Amounts received by ImpediMed in excess of the Application Money for your Entitlement ( Excess
page 28
Amount ) may be treated as an application to apply for as many Additional New Shares as your Excess Amount will pay for in full. If you are paying by BPAY, please make sure to use the specific Biller Code and unique Customer Reference Number ( CRN ) on your personalised Entitlement and Acceptance Form. If you receive more than one personalised Entitlement and Acceptance Form, please only use the CRN specific to the Entitlement on that form. If you inadvertently use the same CRN for more than one of your Entitlements, you will be deemed to have applied only for Additional New Shares over and above the Entitlement to which that CRN applies.
If you accept and pay for all or part of your Entitlement before the close of the Retail Entitlement Offer at 5.00pm (Brisbane time) on Thursday 24 May 2012, you will be allotted your New Shares on Thursday 31 May 2012.
If you take no action you will not be allocated any New Shares and your Entitlement will lapse.
3.4 Acceptance of the Entitlement Offer
By completing and returning your personalised Entitlement and Acceptance Form with the requisite Application Money or making a payment by BPAY, you:
-
(a) agree to be bound by the terms of this booklet and the provisions of ImpediMed’s constitution;
-
(b) authorise ImpediMed to register you as the holder(s) of the New Shares allotted to you;
-
(c) declare that all details and statements made in the Entitlement and Acceptance Form are complete and accurate;
-
(d) declare that you are over 18 years of age and have full legal capacity and power to perform all your rights and obligations under the Retail Entitlement Offer;
-
(e) acknowledge that once ImpediMed receives the Entitlement and Acceptance Form or your payment by BPAY, you may not withdraw it except as allowed by law;
-
(f) agree to apply for, and be issued with up to, the number of New Shares that you apply for at the Issue Price;
-
(g) authorise ImpediMed and its officers or agents to do anything on your behalf necessary for the New Shares to be issued to you, including to act on instructions of ImpediMed’s share registry upon using the contact details set out in the Entitlement and Acceptance Form;
-
(h) declare that you were the registered holder(s) at the Record Date (defined in section 4.3 below) of the Shares indicated on the Entitlement and Acceptance Form as being held by you on the Record Date;
-
(i) acknowledge that the information contained in this booklet is not investment advice or a recommendation that New Shares are suitable for you, given your investment objectives, financial situation or particular needs;
page 29
-
(j) represent and warrant that the law of any place (other than Australia and New Zealand) does not prohibit you from being given this booklet or making an application for New Shares; and
-
(k) represent and warrant that you are an Eligible Retail Shareholder and have read and understood this booklet and the Entitlement and Acceptance Form and that you acknowledge the matters, and make the warranties and representations and agreements contained in this booklet and the Entitlement and Acceptance Form.
By completing and returning your personalised Entitlement and Acceptance Form with the requisite Application Money or making a payment by BPAY, you will also be deemed to have acknowledged, represented and warranted on behalf of each person on whose account you are acting that:
-
(a) you are not in the United States and are not a US Person and are not acting for the account or benefit of, a US Person and are not otherwise a person to whom it would be illegal to make an offer or issue New Shares under the Retail Entitlement Offer;
-
(b) you acknowledge that the Entitlements and the New Shares have not been, and will not be, registered under the US Securities Act or the securities laws of any state or other jurisdiction in the United States, or in any other jurisdiction outside Australia or New Zealand, and accordingly, the Entitlements may not be taken up, and the New Shares may not be offered, sold or otherwise transferred except in accordance with an available exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and any other applicable securities laws; and
-
(c) you have not and will not send any materials relating to the Retail Entitlement Offer to any person in the United States or that is a US Person, or is acting for the account or benefit of a US Person.
Payment by cheque, bank draft or money order
Should you wish to pay by cheque, bank draft or money order, this should accompany your completed Entitlement and Acceptance Form.
Your cheque, bank draft or money order must be:
-
in Australian currency, made payable to “ImpediMed Limited” and crossed “Not Negotiable”;
-
in respect of the full Application Money (being the Issue Price multiplied by the number of New Shares applied for); and
-
drawn on an Australian branch of a financial institution.
ImpediMed will treat you as applying for as many New Shares and Additional New Shares as your cheque, bank draft or money order will pay for. Any amount received by ImpediMed in excess of your final allocation of New Shares and Additional New Shares will be refunded and no interest will be paid on any Application Money received or refunded.
page 30
Payment by BPAY
Should you wish to pay by BPAY:
-
Please follow the instructions on the Entitlement and Acceptance Form. Your BPAY payment must be received by no later than 5.00pm (Brisbane time) on Thursday 24 May 2012. You should be aware that your own financial institution may implement earlier cut off times with regards to electronic payment, and should therefore take this into consideration when making payment. It is your responsibility to ensure that funds submitted through BPAY are received by this time;
-
For payment by BPAY, you do not need to lodge your Entitlement and Acceptance Form, however, by making a payment through BPAY, you will be deemed to have made the declarations set out in this booklet and in the Entitlement and Acceptance Form; and
-
ImpediMed will treat you as applying for as many New Shares and Additional New Shares as your BPAY payment will pay for. Any amount received by ImpediMed in excess of your final allocation of New Shares and Additional New Shares will be refunded and no interest will be paid on any Application Money received or refunded.
Cash payments will not be accepted. Receipts for payment will not be issued.
3.5 Mail or delivery
To participate in the Retail Entitlement Offer, your payment must be received no later than 5.00pm (Brisbane time) on Thursday 24 May 2012. If not paying by BPAY, your completed Entitlement and Acceptance Form, together with Application Money, should be mailed or hand delivered to the address shown on your Entitlement and Acceptance Form.
page 31
4 Important information
This booklet has been prepared by ImpediMed. You should read it carefully and in its entirety before deciding whether to invest in New Shares. In particular, you should consider the risk factors outlined in the “Risk Factors” section of the investor presentation in section 2 .
4.1
Overview of the Entitlement Offer
The Entitlement Offer is an offer of approximately 39.1 million New Shares at $0.35 per New Share to raise up to $13.7 million (before offer costs).
Funds raised under the Entitlement Offer will be used;
-
to expand reimbursement support;
-
for sales, marketing and training;
-
for instrument development and in particular to continue the commercialisation of the UB500;
-
for clinical trial support;
-
for inventory growth; and
-
for general working capital purposes.
The Entitlement Offer has two components:
-
(a) an initial offer to eligible institutional and sophisticated Shareholders identified by ImpediMed and the Joint Lead Managers; and
-
(b) an offer to remaining eligible Shareholders.
4.2
Institutional Entitlement Offer
- ImpediMed has already raised approximately $7.8 million (before offer costs) from institutional and sophisticated investors as part of the Entitlement Offer.
4.3
Eligible Retail Shareholders
This booklet contains an offer of New Shares to Eligible Retail Shareholders in Australia and New Zealand.
Eligible Retail Shareholders are those holders of Shares who:
-
are registered as a holder of Shares as at 7.00pm (Brisbane time) on 4 May 2012 (the Record Date );
-
have a registered address in Australia or New Zealand;
-
are not in the United States;
-
were not an institutional or sophisticated shareholder who participated under the Institutional Entitlement Offer; and
-
are eligible under all applicable securities laws to receive an offer under the Retail Entitlement Offer.
page 32
ImpediMed may (in its absolute discretion) extend the Retail Entitlement Offer to any institutional or sophisticated Shareholder in foreign jurisdictions which did not participate in the Institutional Entitlement Offer (subject to compliance with applicable laws).
4.4 Additional New Shares
Eligible Retail Shareholders may apply for New Shares in excess of their Entitlement.
Any Additional New Shares will be limited to the extent that there are sufficient New Shares from Eligible Retail Shareholders who do not take up their full Entitlements or from New Shares that would have been offered to Ineligible Retail Shareholders if they had been entitled to participate in the Retail Entitlement Offer.
If you apply for Additional New Shares then, subject to ImpediMed’s absolute discretion to scale back your application for Additional New Shares (in whole or part), you will be issued those Additional New Shares. ImpediMed’s decision on the number of Additional New Shares to be allocated to you will be final.
New Shares and Additional New Shares issued under the Retail Entitlement Offer will rank equally with existing Shares.
4.5 No cooling off rights
Cooling off rights do not apply to an investment in New Shares or Additional New Shares. You cannot withdraw your application or payment once it has been accepted.
4.6 No Entitlements trading
Entitlements are non-renounceable and will not be tradeable on the ASX or otherwise transferable. Shareholders who do not take up their Entitlement in full will not receive any value in respect of those Entitlements that they do not take up.
ImpediMed has applied for the quotation of the New Shares on ASX.
4.7 Discretion to deal with shortfall
To the extent there is any shortfall in subscriptions for New Shares and Additional New Shares under the Entitlement Offer, the Directors reserve the right to allocate top up Shares or place any shortfall at their discretion within three months after the close of the Retail Entitlement Offer.
4.8
Minimum subscription
There is no minimum subscription for the Retail Entitlement Offer.
4.9 No underwriting
The Retail Entitlement Offer is not underwritten.
page 33
4.10 Broker Handling Fee
A Broker Handling Fee of 1.25% (plus GST) of the value of successful Applications pursuant to an Entitlement and Acceptance Form application or BPAY application will be payable by the Joint Lead Managers, subject to the following conditions:
-
a) the Broker Handling Fee will be limited to $250 in respect of any one Entitlement and Acceptance Form;
-
b) where an Eligible Retail Shareholder lodges more than one Entitlement and Acceptance Form, the fee is only payable on one Entitlement and Acceptance Form;
-
c) if an individual is applying on behalf of more than one beneficial holder, a list of beneficial holders must be provided in order to receive the Broker Handling Fee in relation to each beneficial holder;
-
d) Broker Handling Fees will only be paid to participating organisations of ASX (being those entities recognised as full service brokers or nonadvisory brokers by ASX);
-
e) Broker Handling Fees will only be paid on applications where a Broker Handling Fee claim form and schedule is submitted to the Share Registry no later than 5.00pm (Brisbane time) on 1 June 2012. The Broker Handling Fee claim form and schedule (including details of how to submit this form) is available from the Share Registry; and
-
f) if ImpediMed scales back applications for Additional New Shares, the Broker Handling Fee will be payable on the value of the Shares issued under the scaleback.
4.11 Not investment advice
The Retail Entitlement Offer complies with the requirements of section 708AA of the Corporations Act as notionally modified by ASIC Class Order 08/35.
This booklet is not a prospectus under the Corporations Act and has not been lodged with ASIC. It is also not financial product advice and has been prepared without taking into account your investment objectives, financial circumstances or particular needs. ImpediMed is not licensed to provide financial product advice in respect of the New Shares.
This booklet does not purport to contain all the information that you may require to evaluate a possible application for New Shares and does not take into account the investment objectives, financial situation or needs of you or any particular investor. You should conduct your own independent review, investigation and analysis of Shares the subject of the Retail Entitlement Offer. You should obtain any professional advice you require to evaluate the merits and risks of an investment in ImpediMed before making any investment decision based on your investment objectives.
page 34
4.12 Shareholders outside Australia and New Zealand
General restrictions
This booklet and the accompanying Entitlement and Acceptance Form do not constitute an offer in any place in which, or to any person to whom, it would not be lawful to make such an offer.
No action has been taken to register or qualify the New Shares or to otherwise permit an offering of New Shares outside Australia and New Zealand.
Return of the Entitlement and Acceptance Form or your BPAY payment will be taken by ImpediMed as a representation by you that there has been no breach of any such laws. Eligible Retail Shareholders who are nominees, trustees or custodians are advised to seek independent advice as to how to proceed.
New Zealand
Shares are offered to Eligible Retail Shareholders with registered addresses in New Zealand in reliance on the Securities Act (Overseas Companies) Exemption Notice 2002 (NZ). This booklet is not an investment statement or prospectus under New Zealand law, and may not contain all the information that an investment statement or prospectus under New Zealand law is required to contain.
United States
This is not an offer to sell nor a solicitation of an offer to buy securities in the United States. New Shares may not be offered or sold in the United States or to, or for the account or benefit of, US Persons in the absence of registration or an exemption from registration.
The New Shares have not been, and will not be, registered under the Securities Act, or the securities laws of any state of the United States and accordingly, the New Shares may only be offered and sold: (i) within the United States or to, or for the account or benefit of, any US Person, to a limited number of approved institutional investors that are “qualified institutional buyers” (as defined in Rule 144A under the Securities Act), in transactions exempt from, or not subject to, the registration requirements of the Securities Act; or (ii) outside the United States, to persons that are not US Persons and are not acting for the account or benefit of US Persons in offshore transactions in compliance with Regulation S under the Securities Act.
The distribution of this document outside Australia and New Zealand may be restricted by law. In particular, this document or any copy of it must not be taken into or distributed or released in the United States or distributed or released to any US Person. Persons who come into possession of this document should seek advice on and observe any such restrictions. Any failure to comply with such restrictions may constitute a violation of applicable shares laws.
page 35
4.13 Taxation
Taxation implications will vary depending upon the individual circumstances of individual Eligible Retail Shareholders. Eligible Retail Shareholders should obtain their own professional advice before deciding whether to invest.
4.14
Governing law
This booklet, the Retail Entitlement Offer and the contracts formed on acceptance of an application for New Shares are governed by the laws applicable in Queensland, Australia.
4.15 Future performance and forward looking statements
Except as required by law, and only to the extent so required, no person warrants or guarantees the future performance of the Company or any return on any investment made pursuant to the Entitlement Offer.
Past Share price performance of the Company provides no guidance as to its future Share price performance.
An investment in New Shares is subject to investment and other known and unknown risks, some of which are beyond the control of ImpediMed. ImpediMed does not guarantee any particular rate of return or the performance of ImpediMed nor does it guarantee the repayment of capital from ImpediMed or any particular tax treatment. You should also have regard to the “Risk Factors” section of the investor presentation in section 2 .
4.16 Rounding of Entitlements
Where fractions arise in the calculation of Entitlements, they will be rounded up to the nearest whole number of New Shares.
4.17 Disclaimer of representations
No person is authorised to give any information, or to make any representation, in connection with the Retail Entitlement Offer that is not contained in this booklet.
Any information or representation that is not in this booklet may not be taken as having been authorised by ImpediMed or its related bodies corporate in connection with the Retail Entitlement Offer. Except as required by law, and only to the extent so required, none of ImpediMed, or any other person, warrants or guarantees the future performance of ImpediMed or any return on any investment made pursuant to this booklet.
4.18
Interpretation
Some capitalised words and expressions used in this booklet have meanings which are explained in section 5 .
A reference to time in this booklet is to the local time in Brisbane, Australia, unless otherwise stated. All financial amounts in this booklet are expressed in Australian dollars, unless otherwise stated.
page 36
5 Definitions
| Additional New Shares | New Shares applied for by Eligible Retail Shareholders in |
|---|---|
| excess of their Entitlement | |
| Application | The submission of an Entitlement and Acceptance Form |
| accompanied by the relevant Application Money or arranging | |
| for payment of the relevant Application Money through BPAY | |
| in accordance with the instructions on the Entitlement and | |
| Acceptance Form | |
| Application Money | Money payable by Eligible Retail Shareholders for New |
| Shares and Additional New Shares | |
| ASIC | The Australian Securities and Investments Commission |
| ASX | ASX Limited ACN 008 624 691 or the Australian Securities |
| Exchange, as applicable | |
| Board | The Board of Directors of the Company |
| Broker Handling Fee | The stamping fee payable by the Joint Lead Managers to |
| stockbrokers who submit a valid claim on successful | |
| Applications | |
| Closing Date | 24 May 2012 |
| Company or | ImpediMed Limited ABN 65 089 705 144 |
| ImpediMed | |
| Corporations Act | Corporations Act 2001(Cth) |
| Director | A Director of the Company |
| Eligible Retail | A Shareholder described insection 4.3 |
| Shareholder | |
| Entitlement | The entitlement to one New Share for every four Shares held |
| at 7.00 pm (Brisbane time) on the Record Date. The | |
| entitlement of each Eligible Retail Shareholder is shown on | |
| the Entitlement and Acceptance Form | |
| Entitlement Offer | The pro-rata accelerated non-renounceable entitlement offer |
| announced by the Company on 3 May 2012 | |
| Entitlement and | The entitlement and acceptance form accompanying this |
| Acceptance Form | Retail Entitlement Offer |
| Ineligible Retail | A Shareholder who is not an Eligible Retail Shareholder (and |
| Shareholder | has not already participated in the institutional component of |
| the Entitlement Offer) | |
| Institutional Entitlement | The institutional component of the Entitlement Offer described |
| Offer | insection 4.2 |
page 37
| Issue Price | $0.35 per New Share |
|---|---|
| Joint Lead Managers | RBS Morgans and Wilson HTM |
| Listing Rules | The official listing rules of ASX, as amended or waived by |
| ASX from time to time | |
| New Shares | Shares offered under the Entitlement Offer |
| RBS Morgans | RBS Morgans Corporate Limited |
| Record Date | 4 May 2012 |
| Register | The register of Shareholders required to be kept under the |
| Corporations Act | |
| Retail Entitlement Offer | The offer to Eligible Retail Shareholders made in this booklet |
| Share | A fully paid ordinary share in the Company |
| Share Registry | Link Market Services Limited |
| Shareholder | A holder of Shares |
| US or United States | United States of America, its territories and possessions, any |
| State of the United States of America and the District of | |
| Columbia | |
| US person | The meaning given in Regulation S under the US Securities |
| Act | |
| US Securities Act | The_United States Securities Act of 1933_, as amended |
| Wilson HTM | Wilson HTM Corporate Finance Ltd |
page 38
All Registry communications to: Link Market Services Limited Locked Bag A14 Sydney South NSW 1235 Australia Telephone: 1300 554 474 From outside Australia: +61 2 8280 7454 ASX Code: IPD Website: www.linkmarketservices.com.au
ImpediMed Limited
ABN 65 089 705 144
==> picture [55 x 58] intentionally omitted <==
SRN/HIN:
Entitlement Number:
Number of Eligible Shares held as at the Record Date, 7:00pm (Brisbane time) on 4 May 2012:
Entitlement to New Shares (on a 1 New Share for 4 basis):
Amount payable on full acceptance at A$0.35 per Share:
==> picture [199 x 30] intentionally omitted <==
----- Start of picture text -----
|||
|---|---|
|Offer Closes|
|5:00pm (Brisbane time):|24 May 2012|
----- End of picture text -----
ENTITLEMENT AND ACCEPTANCE FORM
[[[®]]] you do NOT need to pay[[®]] before 5:00pm (Brisbane time) pay[[®]] 24 May 2012. pay[[® ]] you will Telephone & Internet Banking – Bpaypay[[®]] Biller Code: 585984 Ref: ® Registered to Bpay Pty Ltd ABN 69 079 137 518Bpay Pty Ltd ABN 69 079 137 518pay Pty Ltd ABN 69 079 137 518 Pty Ltd ABN 69 079 137 518
As an Eligible Shareholder you are entitled to acquire 1 New Share for every 4 Existing Shares that you hold on the Record Date, at an Offer Price of A$0.35 per New Share. You may also apply for New Shares in excess of your Entitlement, at the Offer Price. This is an important document and requires your immediate attention. If you do not understand it or you are in doubt as how to deal with it, you should contact your accountant, stockbroker, solicitor or other professional adviser. IMPORTANT: The offer is being made under the Retail Offer Booklet dated 10 May 2012. The Retail Offer Booklet contains information about investing in the New Shares. Before applying for New Shares, you should carefully read the Retail Offer Booklet. This Entitlement and Acceptance Form should be read in conjunction with the Retail Offer Booklet.
If you do not have a paper copy of the Retail Offer Booklet, you can obtain a paper copy at no charge, by calling ImpediMed Limited on 07 3860 3700.
PAYMENT OPTIONS
If you wish to take up all or part of your Entitlement (as shown above), or take up all of your Entitlement and apply for additional New Shares, you have two payment options detailed below.
OPTION 1: PAyINg by BpayBpaypay[[[®]]]
OPTION 1: PAyINg by BpayBpaypay[[[®]]] OPTION 2: PAyINg by ChEquE, bANk dRAfT OR MONEy ORdER If paying by Bpay[®] , refer to the instructions overleaf. you do NOT need to If paying by cheque, bank draft or money order, complete and return the return the acceptance slip below if you elect to make payment by acceptance slip below with your Application Monies. No signature is Bpay[®] . Payment must be received via Bpay[[®]] before 5:00pm (Brisbane time) required on the acceptance slip. The acceptance slip with your Application on 24 May 2012. You should check the processing cut off-time for Bpay[[®]] Monies must be received by the Registry before 5:00pm (Brisbane time) on transactions with your bank, credit union or building society to ensure your 24 May 2012. payment will be received by the Registry in time. By paying by Bpay[[® ]] you will have deemed to have completed an Application Form for the number of Shares subject of your application payment.
==> picture [513 x 284] intentionally omitted <==
----- Start of picture text -----
Telephone & Internet Banking – Bpaypay [[®]]
Biller Code: 585984 Contact your bank or financial institution to make this payment from your cheque,
Ref: savings, debit or transaction account. More info: www.bpay.com.au
® Registered to Bpay Pty Ltd ABN 69 079 137 518Bpay Pty Ltd ABN 69 079 137 518pay Pty Ltd ABN 69 079 137 518 Pty Ltd ABN 69 079 137 518
See overleaf for details and further instructions on how to complete and lodge this Entitlement and Acceptance Form.
THIS IS A PERSONALISED FORM FOR THE SOLE USE OF THE SHAREHOLDER AND HOLDING RECORDED ABOVE.
Please detach and enclose with payment
ImpediMed Limited
ABN 65 089 705 144 SRN/hIN:
9999999 Entitlement Number:
A Number of New Shares accepted (being not B Number of additional New Shares C Total number of New Shares accepted (add
more than your Entitlement shown above) Boxes A and B)
+ =
D PLEASE INSERT ChEquE, bANk dRAfT OR MONEy ORdER dETAILS – Cheques, bank drafts or money orders must be drawn on an Australian
branch of a financial institution in Australian currency, made payable to “ImpediMed Limited” and crossed “Not Negotiable”.
Drawer Cheque Number BSB Number Account Number Amount of Cheque
A$
E CONTACT dETAILS – Telephone Number Telephone Number – After Hours Contact Name
( ) ( )
----- End of picture text -----*
Contact your bank or financial institution to make this payment from your cheque, savings, debit or transaction account. More info: www.bpay.com.au
IMPEDIMED LIMITED
2. If PAyINg by ChEquE, bANk dRAfT OR MONEy ORdER
The offer to which this Entitlement and Acceptance Form relates is not being made to investors located or resident outside of Australia and New Zealand. In particular, the offer is not being made to any person in the U.S. or to a U.S. person. The Retail Offer Booklet and Entitlement and Acceptance Form do not constitute an offer or invitation to acquire Shares in any place in which, or to any person to whom, it would be unlawful to make such an offer or invitation.
-
Complete all relevant sections of the Entitlement and Acceptance Form USING BLOCK LETTERS. These instructions are cross referenced to each section of the Entitlement and Acceptance Form.
-
A. Acceptance of New Shares
-
Enter into section A the number of New Shares you wish to apply for. The number of New Shares must be equal to or less than your Entitlement, which is set out overleaf.
ACCEPTANCE Of ENTITLEMENT OffER
By either returning the Entitlement and Acceptance Form with payment to the Registry, or making payment received by Bpay[®] :
b. Application for Additional New Shares
-
You can apply for more New Shares than your Entitlement. Please enter the number of additional New Shares above your Entitlement for which you wish to apply into Box B. Your Application for additional New Shares may not be successful (wholly or partially). The decision of ImpediMed Limited on the number of New Shares to be allocated to you will be final. No interest will be paid on any Application Monies received or returned.
-
you represent and warrant that you have read and understood the Retail Offer Booklet and that you acknowledge the matters, and make the warranties and representations;
-
you provide authorisation to be registered as the holder of New Shares acquired by you and agree to be bound by the Constitution of ImpediMed Limited.
-
C. Total Number of New Shares Subscribed for
-
To calculate total number of New Shares subscribed for, add Box A and Box B and enter this in Box C.
hOw TO APPLy fOR NEw ShARES
1. If PAyINg by Bpay[®] (AvAILAbLE TO ShAREhOLdERS wITh AN AuSTRALIAN bANk ACCOuNT ONLy)
d. Cheque, bank draft or money order details pay[[®]] you must contact your bank bank draft or money order will pay for. E. Contact details your acceptance of New Shares, if necessary.
-
d. Cheque, bank draft or money order details
-
Enter your cheque, bank draft or money order details in section D. Cheques, bank drafts or money orders must be drawn on an Australian branch of a financial institution in Australian currency, made payable to “ImpediMed Limited” and crossed “Not Negotiable”. Please ensure sufficient cleared funds are held in your account, as your cheque will be banked as soon as it is received. If you provide a cheque or money order for the incorrect amount, ImpediMed Limited may treat you as applying for as many New Shares and Additional New Shares as your cheque, bank draft or money order will pay for.
If you elect to make payment using Bpay[[®]] you must contact your bank or financial institution to make this payment from your cheque, savings, debit or transaction account. For more information on paying by Bpay[®] : www.bpay.com.au
Work out the total amount payable by you. To calculate the total amount, multiply the number of New Shares you wish to apply for by A$0.35.
Refer overleaf for the Biller Code and Reference Number. The Reference Number is used to identify your holding. If you have multiple holdings you will have multiple Reference Numbers. You must use the Reference Number shown on each personalised Entitlement and Acceptance Form when paying for any New Shares that you wish to apply for in respect of that holding.
Enter your contact telephone number where we may contact you regarding your acceptance of New Shares, if necessary.
3. hOw TO LOdgE yOuR ENTITLEMENT ANd ACCEPTANCE fORM
A reply paid envelope is enclosed for your use. No postage stamp is required if it is posted in Australia. Alternatively, if you have lost the reply paid envelope, or you have obtained the Retail Offer Booklet electronically, your completed Entitlement and Acceptance Form with the payment for New Shares may be mailed to the postal address, or delivered by hand to the delivery address, set out below. If paying by Bpay[® ] you do not need to complete or return the Entitlement and Acceptance form. You should check the processing cut off-time for Bpay[®] transactions with your bank, credit union or building society to ensure your payment will be received by the Registry by the close of the offer.
| Mailing Address | hand delivery |
|---|---|
| ImpediMed Limited | ImpediMed Limited |
| C/- Link Market Services Limited | C/- Link Market Services Limited |
| Locked Bag 3415 | Level 15, 324 Queen Street |
| Brisbane QLD 4001 | Brisbane QLD 4000(Please do not use this address for mailing purposes) |
Make sure you send your Acceptance Slip and application payment allowing enough time for mail delivery, so Link Market Services Limited receives them no later than 5:00pm (Brisbane time) on 24 May 2012. Please ensure sufficient cleared funds are held in your account, as your cheque will be banked as soon as it is received. ImpediMed Limited reserves the right not to process any Acceptance Slips and cheques received after the Closing Date.
If you require further information on how to complete this Entitlement and Acceptance form, please contact ImpediMed Limited on 07 3860 3700 between 8:30am and 5:30pm (brisbane time) Monday to friday.