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IMPEDIMED LIMITED Interim / Quarterly Report 2016

Oct 25, 2016

65135_rns_2016-10-25_599db14d-a203-40f9-bc40-d640f4f95312.pdf

Interim / Quarterly Report

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26 October 2016

ASX ANNOUNCEMENT

APPENDIX 4C Quarter Ended 30 September 2016

Brisbane, Australia - ImpediMed Limited (ASX: IPD) a global provider of medical technology to measure, monitor and manage fluid status and body composition, today released its Appendix 4C – Quarterly cash flow report for the period ended 30 September 2016.

Total revenue for the period was $1.7 million, including lymphoedema sales of $1.2 million. Net operating cash outflow for the quarter was $6.9 million. Cash receipts from customers for the quarter were $1.5 million and cash on hand as of 30 September 2016 was $73.4 million.

Highlights for the past quarter include:

  • Trained 22 new L-Dex accounts in Q3 and have now signed and trained 55 L- Dex® accounts for CY2016, surpassing the 50 targeted L-Dex accounts for CY2016 in the first nine-months since commercial launch;

  • The Centers for Medicare and Medicaid Services (CMS) published the proposed outpatient payment rates for calendar year 2017, which includes an increased payment rate for code 93702 when billed by a hospital outpatient facility to $US 127.42, an increase of 13.1%;

  • Study on efficacy of L-Dex in routine clinical practice published, which demonstrates the impact L-Dex can have on patients at-risk for breast cancer related lymphoedema;

  • Announced SOZO™, the first product on the company’s new population health platform that allows patients and clinicians to measure and track their fluid status and body composition;

  • Entered into a three-year joint development agreement with the Mayo Clinic to advance new solutions for ImpediMed’s fluid status and body composition monitoring technology;

  • Partnered with Redox to expand the capabilities of electronic health record (EHR) integration for ImpediMed’s next generation device, SOZO;

  • Partnered with Vanderbilt University for a series of patient and clinician human factors testing using SOZO;

  • Scripps Health, the operator of one of the top cardiovascular hospitals in the US, will use SOZO in a validation study for monitoring patients with heart failure who are currently being tracked using pulmonary artery pressure monitoring;

  • The US Food and Drug Administration (FDA) issued new guidance surrounding digital health, which allows manufacturers of medical devices to use Real-World Evidence to support their application for submission to FDA for clearance and/or approval;

  • The FDA released their guidance document “General Wellness: Policy for Low Risk Devices”, which states that the agency does not intend to examine low

risk, general wellness products. Devices and apps marketed to promote healthy behaviors have been exempted by the FDA;

  • Appointed Mr Gary Goetzke to the Board of Directors and Mr David Adams to the position of Senior VP of Ventures, Licensing and Corporate Development;

  • • Receipt of $0.8 million tax refund for the 2015 financial year, as part of AusIndustry’s R&D Tax Incentive program.

Highlights subsequent to the quarter end include:

  • Mayo Clinic, together with the Atlantic Health System, will use the SOZO device in a feasibility study for monitoring patients with heart failure, to provide real-world data necessary for the final design of the pivotal trial;

  • Receipt of $2.0 million tax refund for the 2016 financial year, as part of AusIndustry’s R&D Tax Incentive program.

“It was a very productive quarter as we announced the pre-launch of SOZO and several key partnerships. Partnering with institutions such as the Mayo Clinic, Scripps Health and Vanderbilt University for studies using SOZO will allow us to gather important patient and clinical data from our digital health technology platform.”

“In addition, I am very pleased with the progress of L-Dex during the quarter, as we have now surpassed the 50 initial targeted L-Dex accounts for the calendar year, laying the foundation for future revenue growth,” said Richard Carreon, Managing Director and CEO of ImpediMed.

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 Contacts:

In Australia:

Kyahn Williamson, 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., ImpediMed is the world leader in the development and distribution of medical devices employing bioimpedance spectroscopy (BIS) technologies for use in the non-invasive clinical assessment and monitoring of fluid status and body composition in patients. 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”)
30 September 2016
Consolidated statement of cash flows
1.
Cash flows from operating activities
1.1
Receipts from customers
1.2
Payments for
(a) research and development
(b) product manufacturing and operating
costs
(c) advertising and marketing
(d) leased assets
(e) staff costs
(f)
administration and corporate costs
1.3
Dividends received (see note 3)
1.4
Interest received
1.5
Interest and other costs of finance paid
1.6
Income taxes paid
1.7
Government grants and tax incentives
1.8
Other (provide details if material)
1.9
Net cash from / (used in) operating
activities
Current quarter
$A’000
Year to date
(3 months)
$A’000
1,457
1,457
(1,019)
(1,019)
(440)
(440)
(425)
(425)
(1)
(1)
(5,372)
(5,372)
(1,963)
(1,963)
-
-
91
91
-
-
-
-
750
750
16
16
(6,906)
(6,906)
2.
Cash flows from investing activities
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
(136)
(136)
-
-
-
-
-
-
-
-
  • 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 (136) (136)
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 173 173
3.4 Transaction costs related to issues of (9) (9)
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 164 164
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 82,254 82,254
4.2 Net cash from / (used in) operating (6,906) (6,906)
activities (item 1.9 above)
4.3 Net cash from / (used in) investing activities (136) (136)
(item 2.6 above)
4.4 Net cash from / (used in) financing activities 164 164
(item 3.10 above)
4.5 Effect of movement in exchange rates on (1,937) (1,937)
cash held
4.6 Cash and cash equivalents at end of 73,439 73,439
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 3,495 2,586
5.2 Call deposits 69,944 79,668
5.3 Bank overdrafts - -
5.4 Other (provide details) - -
5.5 Cash and cash equivalents at end of 73,439 82,254
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 1.2 110
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.

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 (1,900)
9.2 Product manufacturing and operating costs (1,350)
9.3 Advertising and marketing (300)
9.4 Leased assets -
9.5 Staff costs (3,850)
9.6 Administration and corporate costs (1,400)
9.7 Other (provide details if material) (100)
9.8 Total estimated cash outflows (8,900)
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: Date: 26/10/2016 (Company secretary)

Print name: LEANNE RALPH

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