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IMPEDIMED LIMITED Interim / Quarterly Report 2018

Oct 24, 2017

65135_rns_2017-10-24_a9aafd92-5655-4382-b021-11499cd5c12c.pdf

Interim / Quarterly Report

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25 October 2017

ASX ANNOUNCEMENT

APPENDIX 4C Quarter Ended 30 September 2017

Brisbane, Australia - ImpediMed Limited (ASX: IPD) a global provider of medical technology to non-invasively measure, monitor and manage tissue composition and fluid status, today released its Appendix 4C – Quarterly cash flow report for the period ended 30 September 2017.

Total revenue for the period was $1.0 million, including medical sales of $0.8 million, as the company focused on the launch of its next generation SOZO[TM] device, which received its first FDA clearance on 14 August 2017. Net operating cash outflow for the quarter was $6.1 million. Cash receipts from customers for the quarter were $1.1 million and cash on hand as of 30 September 2017 was $47.7 million.

Highlights include:

  • Announced the issuance by the US Food and Drug Administration (FDA) of a 510(k) clearance to market SOZO™ to aid in the clinical assessment of unilateral lymphoedema in the United States on 14 August 2017, after the submission of the application on 17 July 2017;

  • Heart failure 510(k) application submitted for SOZO[TM] to FDA;

  • Announced publication of a 206-patient independent clinical study using L- Dex[®] for early detection of subclinical lymphoedema, which reported superior clinical outcomes utilizing L-Dex[®] ;

  • Announced first patient enrollment in SOZO™ Chronic Heart Failure (CHF) Trial at Scripps Health;

  • CHF trial to commence with the Mayo Clinic, Lancaster General and Atlantic Health;

  • L-Dex[®] recommended in American Physical Therapy Association Guidelines;

  • • 1,054 of 1,100 patients enrolled to date in randomised lymphoedema (LE) post-approval clinical trial;

  • Announced the appointment of Scott Ward the role of Chair, replacing Dr Cherrell Hirst, who is retiring from the Board after 12 years (including six as Chair) immediately after the company’s Annual General Meeting on 15 November 2017; and

  • Announced the appointment of Professor Robert Graham of the Victor Chang Institute to the Board.

“We were extremely pleased to receive FDA clearance for SOZO™ for use in the assessment of unilateral lymphoedema, within a month of filing our submission. This enabled us to bring forward our plans for market launch in the U.S. We have already undertaken our first SOZO™ shipments to customers in the US as announced earlier this week," said Richard Carreon, Managing Director and CEO of ImpediMed.

Investor Conference Call

Investors are invited to join a conference call with CEO and Managing Director, Richard Carreon, at 9.15am AEDT on Wednesday 25[th] October.

For those who have pre-registered for the call please use the PIN number that has been provided.

Alternatively, the following dial in details may be used:

Conference ID Number: 493650

Australia Toll Free: 1 800 558 698 Alternate Australia Toll Free: 1 800 809 971 Australia Local: 02 9007 3187 New Zealand Toll Free: 0800 453 055 Belgium: 0800 72 111 Canada: 1855 8811 339 France: 0800 913 848 Germany: 0800 182 7617 Hong Kong: 800 966 806 India: 0008 0010 08443 Indonesia: 001 803 019 3275 Ireland: 1800 948 625 Italy: 800 793 500 Japan: 0053 116 1281 Malaysia: 1800 816 294 Singapore: 800 101 2785 United Kingdom: 0800 051 8245 United States: (855) 881 1339

Richard Carreon Managing Director & CEO

For further information, contact:

Richard Carreon, ImpediMed Managing Director & CEO Morten Vigeland, ImpediMed CFO T: +1 (760) 585-2100

Media and Investor Contacts:

In Australia:

Kyahn Williamson, WE Buchan T: +61 3 9866 4722 E: [email protected]

About ImpediMed

Founded and headquartered in Brisbane, Australia with U.S. offices in Carlsbad, Calif. and Bloomington, Minn., and a European office in Thessaloniki, Greece, ImpediMed is the world leader in the design and manufacture of medical devices employing bioimpedance spectroscopy (BIS) technologies for use in the non-invasive clinical assessment and monitoring of tissue composition and fluid status.

ImpediMed was the first company to receive FDA clearance in the U.S. to aid healthcare professionals to clinically assess unilateral lymphoedema of the arm and leg in women and the leg in men, for its L-Dex[®] device. In addition, ImpediMed produces a family of FDA cleared and CE Marked medical devices, including SOZO™, sold in select markets globally.

For more information, visit www.impedimed.com.

Appendix 4C Quarterly report for entities subject to Listing Rule 4.7B

+Rule 4.7B

Appendix 4C

Quarterly report for entities subject to Listing Rule 4.7B

Introduced 31/03/00 Amended 30/09/01, 24/10/05, 17/12/10, 01/09/16

Name of entity

ImpediMed Limited
ABN
65 089 705 144
Quarter ended (“current quarter”)
65 089 705 144 30 September 2017
Consolidated statement of cash flows
Current quarter
$A’000
Year to date
(3 months)
$A’000
1.
Cash flows from operating activities
1,109
1,109
1.1
Receipts from customers
1.2
Payments for
(774)
(774)
(a) research and development
(b) product manufacturing and operating
costs
(1,169)
(1,169)
(c) advertising and marketing
(88)
(88)
(d) leased assets
-
-
(e) staff costs
(5,829)
(5,829)
(f)
administration and corporate costs
(1,919)
(1,919)
1.3
Dividends received (see note 3)
-
-
1.4
Interest received
107
107
1.5
Interest and other costs of finance paid
-
-
1.6
Income taxes paid
-
-
1.7
Government grants and tax incentives
2,463
2,463
1.8
Other (provide details if material)
-
-
1.9
Net cash from / (used in) operating
activities
(6,100)
(6,100)
2.
Cash flows from investing activities
(35)
(35)
2.1
Payments to acquire:
(a) property, plant and equipment
(b) businesses (see item 10)
-
-
(c) investments
-
-
(d) intellectual property
-
-
(e) other non-current assets
-
-
    • See chapter 19 for defined terms

1 September 2016

Page 1

Appendix 4C Quarterly report for entities subject to Listing Rule 4.7B

Consolidated statement of cash flows Consolidated statement of cash flows Current quarter Year to date
$A’000 (3 months)
$A’000
2.2 Proceeds from disposal of:
(a) property, plant and equipment - -
(b) businesses (see item 10) - -
(c) investments - -
(d) intellectual property - -
(e) other non-current assets - -
2.3 Cash flows from loans to other entities - -
2.4 Dividends received (see note 3) - -
2.5 Other (provide details if material) - -
2.6 Net cash from / (used in) investing (35) (35)
activities
3. Cash flows from financing activities
3.1 Proceeds from issues of shares - -
3.2 Proceeds from issue of convertible notes - -
3.3 Proceeds from exercise of share options 17 17
3.4 Transaction costs related to issues of (5) (5)
shares, convertible notes or options
3.5 Proceeds from borrowings - -
3.6 Repayment of borrowings - -
3.7 Transaction costs related to loans and - -
borrowings
3.8 Dividends paid - -
3.9 Other (provide details if material) - -
3.10 Net cash from / (used in) financing 12 12
activities
4. Net increase / (decrease) in cash and
cash equivalents for the period
4.1 Cash and cash equivalents at beginning of
quarter/year to date 54,884 54,884
4.2 Net cash from / (used in) operating (6,100) (6,100)
activities (item 1.9 above)
4.3 Net cash from / (used in) investing activities (35) (35)
(item 2.6 above)
4.4 Net cash from / (used in) financing activities 12 12
(item 3.10 above)
4.5 Effect of movement in exchange rates on (1,063) (1,063)
cash held
4.6 Cash and cash equivalents at end of 47,698 47,698
quarter
  • See chapter 19 for defined terms 1 September 2016

Page 2

Appendix 4C Quarterly report for entities subject to Listing Rule 4.7B

5. Reconciliation of cash and cash Current quarter Previous quarter
equivalents $A’000 $A’000
at the end of the quarter (as shown in the
consolidated statement of cash flows) to the
related items in the accounts
5.1 Bank balances 5,921 7,668
5.2 Call deposits 41,777 47,216
5.3 Bank overdrafts - -
5.4 Other (provide details) - -
5.5 Cash and cash equivalents at end of 47,698 54,884
quarter (should equal item 4.6 above)
6. Payments to directors of the entity and their associates Current quarter
$A'000
6.1 Aggregate amount of payments to these parties included in item 1.2 147
6.2 Aggregate amount of cash flow from loans to these parties included -
in item 2.3
6.3 Include below any explanation necessary to understand the transactions included in
items 6.1 and 6.2

Item 6.1: Payments to directors consist of Directors’ salaries and superannuation and Directors’ fees for the quarter. These figures include only Non-Executive Directors. At 30 September 2017, there were nil Directors’ fees accrued and unpaid.

7. Payments to related entities of the entity and their Current quarter
associates $A'000
7.1 Aggregate amount of payments to these parties included in item 1.2 -
7.2 Aggregate amount of cash flow from loans to these parties included -
in item 2.3
7.3 Include below any explanation necessary to understand the transactions included in
items 7.1 and 7.2
  • See chapter 19 for defined terms 1 September 2016

Page 3

Appendix 4C Quarterly report for entities subject to Listing Rule 4.7B

8. Financing facilities available Total facility amount Amount drawn at
Add notes as necessary for an at quarter end quarter end
understanding of the position $A’000 $A’000
8.1 Loan facilities - -
8.2 Credit standby arrangements - -
8.3 Other (please specify) - -
8.4 Include below a description of each facility above, including the lender, interest rate and
whether it is secured or unsecured. If any additional facilities have been entered into or are
proposed to be entered into after quarter end, include details of those facilities as well.
9. Estimated cash outflows for next quarter $A’000
9.1 Research and development (900)
9.2 Product manufacturing and operating costs (1,000)
9.3 Advertising and marketing (200)
9.4 Leased assets -
9.5 Staff costs (4,000)
9.6 Administration and corporate costs (1,700)
9.7 Other (receipt of R&D Tax Incentive offsetting R&D (100)
expense outlays)
9.8 Total estimated cash outflows (7,900)
10. Acquisitions and disposals of Acquisitions Disposals
business entities
(items 2.1(b) and 2.2(b) above)
10.1 Name of entity N/A N/A
10.2 Place of incorporation or N/A N/A
registration
10.3 Consideration for acquisition or N/A N/A
disposal
10.4 Total net assets N/A N/A
10.5 Nature of business N/A N/A
  • See chapter 19 for defined terms 1 September 2016

Page 4

Appendix 4C Quarterly report for entities subject to Listing Rule 4.7B

Compliance statement

  • 1 This statement has been prepared in accordance with accounting standards and policies which comply with Listing Rule 19.11A.

  • 2 This statement gives a true and fair view of the matters disclosed.

Sign here:

............................................................ (Director/Company secretary)

Date: .............................................

Print name: .........................................................

Notes

  1. The quarterly report provides a basis for informing the market how the entity’s activities have been financed for the past quarter and the effect on its cash position. An entity that wishes to disclose additional information is encouraged to do so, in a note or notes included in or attached to this report.

  2. If this quarterly report has been prepared in accordance with Australian Accounting Standards, the definitions in, and provisions of, AASB 107: Statement of Cash Flows apply to this report. If this quarterly report has been prepared in accordance with other accounting standards agreed by ASX pursuant to Listing Rule 19.11A, the corresponding equivalent standard applies to this report.

  3. Dividends received may be classified either as cash flows from operating activities or cash flows from investing activities, depending on the accounting policy of the entity.

  4. See chapter 19 for defined terms 1 September 2016

Page 5