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IMPEDIMED LIMITED — Interim / Quarterly Report 2017
Jul 23, 2017
65135_rns_2017-07-23_420c1377-3c87-4234-8f59-13f5a57950f1.pdf
Interim / Quarterly Report
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24 July 2017
ASX ANNOUNCEMENT
– APPENDIX 4C Quarter Ended 30 June 2017
Brisbane, Australia - ImpediMed Limited (ASX: IPD) a global provider of medical technology to non-invasively measure, monitor and manage fluid status and body composition, today released its Appendix 4C – Quarterly cash flow report for the period ended 30 June 2017.
Total revenue for the period was $1.3 million, including lymphoedema sales of $0.9 million and SOZO[TM ] sales of $0.1 million. Net operating cash outflow for the quarter was $7.1 million. Cash receipts from customers for the quarter were $1.3 million and cash on hand as of 30 June 2017 was $54.9 million.
Highlights for the past quarter include:
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CE Mark obtained for SOZO™ for multiple indications, including fluid status monitoring for heart failure patients and L-Dex® for lymphoedema monitoring;
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Commenced commercial sales of SOZO™, with shipments of $0.1 million in the week following CE Mark being obtained on 21 June 2017;
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Trained 22 new L-Dex® accounts in the US in Q2 of CY2017; with 38 of the total 72 new L-Dex® accounts targeted for CY2017 trained in the first two quarters of the second year since initial US commercial launch;
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993 of 1,100 patients enrolled to date in PREVENT, the randomised lymphoedema (LE) post-approval clinical trial, with first data expected in 2HCY2017;
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Commencement of Macquarie University SOZO™ trial to determine the best practices for at-home lymphoedema monitoring;
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Announced data from a new independent 596 patients, 6-year L-Dex® study showing substantial reduction in clinical lymphoedema through prospective monitoring and intervention with L-Dex®;
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Commencement of Vanderbilt University School of Nursing at-home study for lymphoedema;
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Ms Judith Downes, appointed to the Board of Directors.
“We are building an impressive foundation for our L-Dex® business in the US. A total of 110 leading sites in the US have now signed and trained for using L-Dex®. These top-tier cancer centers across the US are currently using our U400 system in their high-risk patient programs. We anticipate that following regulatory clearance for SOZO[TM] later this year, these facilities will start to broaden the use of L-Dex® within their facilities," said Richard Carreon, Managing Director and CEO of ImpediMed.
“We are also very pleased to have obtained a CE Mark for SOZO[TM] in late June, for multiple indications, including fluid status monitoring for heart failure patients, enabling us to commence sales and marketing of SOZO[TM] in EU and AU. The initial enquiry and demand for SOZO[TM] out of both EU and AU is highly encouraging and we have
already shipped our first $100k of units into those markets following the CE Mark being obtained. This puts us in a very strong position for the roll-out in Europe and Australia as we look to the remainder of the calendar year.”
“We have also made some great progress on our regulatory program for SOZO[TM] in the US, with the latest of filing our 510(k) for SOZO[TM] for lymphoedema within weeks of obtaining our CE Mark. We are very much looking forward to the filing of multiple 510(k) applications for SOZO[TM] for the remainder of the financial year,” added Mr Carreon.
Investor Conference Call
Investors are invited to join a conference call with Managing Director and CEO, Richard Carreon, at 9.15am AEST on Monday 24[th] July.
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: 511314
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 CE Marked medical devices, including SOZO[TM] , 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 Quarter ended (“current quarter”) 65 089 705 144 30 June 2017 |
|
| 65 089 705 144 | 30 June 2017 |
| Consolidated statement of cash flows Current quarter $A’000 Year to date (12 months) $A’000 1. Cash flows from operating activities 1,331 5,460 1.1 Receipts from customers 1.2 Payments for (1,221) (5,305) (a) research and development (b) product manufacturing and operating costs (921) (2,477) (c) advertising and marketing (238) (1,295) (d) leased assets - (3) (e) staff costs (3,829) (17,471) (f) administration and corporate costs (2,370) (7,658) 1.3 Dividends received (see note 3) - - 1.4 Interest received 102 375 1.5 Interest and other costs of finance paid - - 1.6 Income taxes paid - - 1.7 Government grants and tax incentives - 2,778 1.8 Other (provide details if material) 4 30 1.9 Net cash from / (used in) operating activities (7,142) (25,566) |
|
| 2. Cash flows from investing activities (96) (335) 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 (27) (27) |
- 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 | (12 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 | (123) | (362) |
| 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 | 154 | 751 |
| 3.4 | Transaction costs related to issues of | (4) | (31) |
| 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 | 150 | 720 |
| 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 | 62,228 | 82,254 | |
| 4.2 | Net cash from / (used in) operating | (7,142) | (25,566) |
| activities (item 1.9 above) | |||
| 4.3 | Net cash from / (used in) investing activities | (123) | (362) |
| (item 2.6 above) | |||
| 4.4 | Net cash from / (used in) financing activities | 150 | 720 |
| (item 3.10 above) | |||
| 4.5 | Effect of movement in exchange rates on | (229) | (2,162) |
| cash held | |||
| 4.6 | Cash and cash equivalents at end of | 54,884 | 54,884 |
| quarter |
- See chapter 19 for defined terms 1 September 2016
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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 | 7,668 | 5,485 |
| 5.2 | Call deposits | 47,216 | 56,743 |
| 5.3 | Bank overdrafts | - | - |
| 5.4 | Other (provide details) | - | - |
| 5.5 | Cash and cash equivalents at end of | 54,884 | 62,228 |
| 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 | 153 |
| 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 and year-to-date. These figures include only Non-Executive Directors. At 30 June 2017, there were nil Directors’ fees accrued and unpaid.
| 7. Payments to related entities of the entity and their associates 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 |
Current quarter $A'000 - - |
-
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 | Total facility amount | Total facility amount | 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 | (1,000) | ||||||
| 9.2 | Product manufacturing and operating costs | (1,100) | ||||||
| 9.3 | Advertising and marketing | (200) | ||||||
| 9.4 | Leased assets | - | ||||||
| 9.5 | Staff costs | (5,200) | ||||||
| 9.6 | Administration and corporate costs | (1,800) | ||||||
| 9.7 | Other (receipt of R&D Tax Incentive offsetting R&D | (100) | ||||||
| expense outlays) | ||||||||
| 9.8 | Total estimated cash outflows | (9,400) | ||||||
| 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
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1 This statement has been prepared in accordance with accounting standards and policies which comply with Listing Rule 19.11A.
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2 This statement gives a true and fair view of the matters disclosed.
Sign here: ............................................................ Date: 24 July 2017 (Company secretary)
Print name: Leanne Ralph
Notes
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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.
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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.
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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.
-
See chapter 19 for defined terms 1 September 2016
Page 5