EXHIBIT 99.1
Appendix 4C
Quarter Ended 30 September 2016
San Diego, California and Sydney, Australia (Friday, 28 October 2016, AEDT) – REVA Medical, Inc. (ASX: RVA) (“REVA” or the “Company”) is pleased to provide the attached Appendix 4C Quarterly Report for the quarter ended 30 September 2016. The Appendix 4C is unaudited.
Third Quarter Highlights
The Company completed an application for CE Marking of its Fantom scaffold in August 2016, continues to collect data from its clinical trials, and is preparing for commercialization. Fantom is a bioresorbable drug-eluting scaffold that utilizes REVA’s advanced proprietary polymer to allow thinner strut thickness and enhanced deliverability, while offering its unique property of being visible under x-ray.
During the first quarter of 2016, the Company completed enrollment of the FANTOM II clinical trial with a total of 240 patients enrolled. During the second quarter of 2016, the Company completed the primary endpoint of an imaging assessment at a six-month time point on patients in Cohort A of the trial and released positive data from those patients. During the third quarter of 2016, the Company achieved the following:
| • | Finalized data analyses on patients in the FANTOM II clinical trial through the six-month primary endpoint and completed the application for regulatory approval to commercialize under the CE Mark in Europe. The endpoint data was obtained from the 117 patients in Cohort A of the trial and showed favorable results, including a Major Adverse Cardiac Events rate of 2.56% and a Late Lumen Loss of 0.25mm (±0.40mm) in scaffold and 0.17mm (±0.34mm) in segment. Low late loss is a desirable result that historically corresponds to positive long-term outcomes; permanent drug-eluting stents and competitive bioresorbable scaffolds generally have late loss values in the range of 0.20mm to 0.40mm. | |
| • | Initiated primary nine-month endpoint assessments on the remaining 123 patients enrolled in trial and began analyzing and compiling that data. Patients are scheduled to complete the nine-month imaging assessments in January 2017. | |
| • | Continued to prepare manufacturing operations for commercialization, which includes refining the processes, conducting verification on the processes, and other commercial preparation aspects for Fantom. | |
| • | Successfully completed the first of two on-site audits required for the CE Marking process in August, with no audit findings. The independent notified body conducted the second on-site audit this week and results are pending. In addition to these audits, the Company expects to receive the initial response to the data and other documentation submitted with the application by early December, with the possibility of receiving CE Mark by year end. | |
HEAD OFFICE: 5751 Copley Drive, San Diego, CA 92111 • +1 (858) 966-3000 • +1 (858) 966-3099 (FAX) • www.revamedical.com
AUSTRALIAN OFFICE: Suite 4, Level 14, 6 O’Connell Street, Sydney NSW 2000 • +61 2 9237 2800
ARBN 146 505 777 • REVA Medical, Inc., is a foreign company incorporated in Delaware, USA, whose stockholders have limited liability
REVA Medical, Inc. – ASX AnnouncementPage 2
| • | Continued to identify and pursue sources of follow-on financing to secure additional capital. In addition to evaluating these options, the Company continues to support its plan to pursue a listing of its securities on NASDAQ or another U.S. exchange no later than 30 June 2017. | |
Appendix 4C
As of 30 September 2016, the Company’s cash balance was US$11,553,000. The current quarter end cash balance reflects a decrease of US$4,996,000 from the 30 June 2016 balance of US$16,549,000. This decrease reflects US$4,742,000 in disbursements related to normal operating activities and capital equipment purchases of US$254,000.
The Company currently plans to file its Form 10-Q Quarterly Report with the U.S. Securities and Exchange Commission and with the Australian Securities Exchange on or before the due date of 10 November 2016. The Quarterly Report provides financial statements, along with Management’s Discussion and Analysis of Financial Condition and Results of Operations for the quarter ended 30 September 2016.
About REVA
REVA is a clinical stage medical device company located in San Diego, California, USA, that is working to commercialize its proprietary bioresorbable scaffolds, as an alternative to metal stents, to treat coronary artery disease. Scaffolds provide restoration of blood flow, support the artery through the healing process, then disappear (or “resorb”) from the body over a period of time. This resorption allows the return of natural movement and function of the artery, a result not attainable with permanent metal stents. The Company’s Fantom® scaffold has been designed to offer an ideal balance of thinness and strength, with distinct ease-of-use features including complete scaffold visibility under x-ray, expansion with one continuous inflation, and no procedural time limitations. REVA will require regulatory approval before it can commercialize Fantom or any other product.
Forward-Looking Statements
This announcement contains or may contain forward-looking statements that are based on management's beliefs, assumptions and expectations and on information currently available to management. All statements that are not statements of historical fact, including those statements that address future operating performance and events or developments that we expect or anticipate will occur in the future, are forward-looking statements, such as those statements regarding our ability to obtain regulatory approvals, timely and successfully complete our clinical trials, protect our intellectual property position, commercialize our products if and when approved, develop and commercialize new products, recruit and retain our key personnel, and estimates regarding our capital requirements and financial performance. You should not place undue reliance on forward-looking statements. Although management believes forward-looking statements are reasonable as and when made, forward-looking statements are subject to a number of risks and uncertainties that may cause our actual results to vary materially from those expressed in forward-looking statements, including the risks and uncertainties that are described in the "Risk Factors" section of our Annual Report on Form 10-K filed with the US Securities and Exchange Commission (the “SEC”) on March 10, 2016, and as may be updated in our periodic reports thereafter. Any forward-looking statements in this announcement speak only as of the date when made. REVA does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
| | | |
| United States | Australia | Australia |
| Investor & Media Enquiries: | Investor Enquiries: | Media Enquiries: |
| REVA Medical, Inc. | Inteq Limited | Buchan Consulting |
| Cheryl Liberatore | Kim Jacobs | Rebecca Wilson |
| Director, Communications | +61 438 217 279 | +61 3 9866 4722 |
| +1 858-966-3045 | Andrew Cohen | |
| | +61 408 333 452 | |
HEAD OFFICE: 5751 Copley Drive, San Diego, CA 92111 • +1 (858) 966-3000 • +1 (858) 966-3099 (FAX) • www.revamedical.com
AUSTRALIAN OFFICE: Suite 4, Level 14, 6 O’Connell Street, Sydney NSW 2000 • +61 2 9237 2800
ARBN 146 505 777 • REVA Medical, Inc., is a foreign company incorporated in Delaware, USA, whose stockholders have limited liability
Appendix 4C
Quarterly report for entities
admitted on the basis of commitments
Rule 4.7B
Appendix 4C
Quarterly report
for entities admitted
on the basis of commitments
Introduced 31/03/00 Amended 30/09/01, 24/10/05, 17/12/10
|
Name of entity |
REVA Medical, Inc. |
| | |
ABN | | Quarter ended (“current quarter”) |
ARBN 146 505 777 | | 30 September 2016 |
Consolidated statement of cash flows
| | | |
Cash flows related to operating activities | Current Quarter (Q3) $’000 USD | Year to date (9 months) $’000 USD |
1.1 | Receipts from customers | 0 | 0 |
| | | |
1.2 | Payments for(a) staff costs (b) advertising and marketing (c) research and development (d) leased assets (e) other working capital | (1,995) 0 (2,317) 0 (431) | (6,568) 0 (7,841) 0 (1,740) |
1.3 | Dividends received | 0 | 0 |
1.4 | Interest and other items of a similar nature received | 1 | 3 |
1.5 | Interest and other costs of finance paid | 0 | 0 |
1.6 | Income taxes paid | 0 | 0 |
1.7 | Other (provide details if material) | 0 | 0 |
| Net operating cash flows | (4,742) | (16,146) |
+ See chapter 19 for defined terms.
17/12/2010Appendix 4C Page 1
Appendix 4C
Quarterly report for entities
admitted on the basis of commitments
| | | |
| | | |
| | Current Quarter (Q3) $’000 USD | Year to date (9 months) $’000 USD |
1.8 | Net operating cash flows (carried forward) | (4,742) | (16,146) |
| Cash flows related to investing activities | | |
1.9 | Payment for acquisition of: (a) businesses (item 5) (b) equity investments (c) intellectual property (d) physical non-current assets (e) other non-current assets | 0 0 0 (254) 0 | 0 0 0 (624) 0 |
1.10 | Proceeds from disposal of: (a) businesses (item 5) (b) equity investments (c) intellectual property (d) physical non-current assets (e) other non-current assets | 0 0 0 0 0 | 0 0 0 0 0 |
1.11 | Loans to other entities | 0 | 0 |
1.12 | Loans repaid by other entities | 0 | 0 |
1.13 | Other: Maturities of Certificates of Deposit | 0 | 0 |
| Net investing cash flows | (254) | (624) |
1.14 | Total operating and investing cash flows | (4,996) | (16,770) |
| Cash flows related to financing activities | | |
1.15 | Proceeds from issues of shares, options, etc. | 0 | 11,428 |
1.16 | Proceeds from sale of forfeited shares | 0 | 0 |
1.17 | Proceeds from borrowings | 0 | 0 |
1.18 | Repayment of borrowings | 0 | 0 |
1.19 | Dividends paid | 0 | 0 |
1.20 | Other (costs of financing transaction) | 0 | 0 |
| Net financing cash flows | 0 | 11,428 |
| Net increase (decrease) in cash held | (4,996) | (5,342) |
1.21 | Cash at beginning of quarter/year to date | 16,549 | 16,895 |
1.22 | Exchange rate adjustments to item 1.20 | 0 | 0 |
1.23 | Cash at end of quarter | 11,553 | 11,553 |
+ See chapter 19 for defined terms.
Appendix 4C Page 217/12/2010
Appendix 4C
Quarterly report for entities
admitted on the basis of commitments
Payments to directors of the entity and associates of the directors
Payments to related entities of the entity and associates of the related entities
| | |
| Current Quarter (Q3) $’000 USD |
1.24 | Aggregate amount of payments to the parties included in item 1.2 | 86 |
1.25 | Aggregate amount of loans to the parties included in item 1.11 | 0 |
1.26 | Explanation necessary for an understanding of the transactions |
| Australian Director fees (2 non-executive directors) 25 U.S./British Director fees (5 non-executive directors) 61 |
Non-cash financing and investing activities
| |
2.1 | Details of financing and investing transactions which have had a material effect on consolidated assets and liabilities but did not involve cash flows |
| N/A |
| |
2.2 | Details of outlays made by other entities to establish or increase their share in businesses in which the reporting entity has an interest |
| N/A |
Financing facilities available
Add notes as necessary for an understanding of the position.
| | | |
| | Amount available $’000 USD | Amount used $’000 USD |
3.1 | Loan facilities | 0 | 0 |
3.2 | Credit standby arrangements | 0 | 0 |
+ See chapter 19 for defined terms.
17/12/2010Appendix 4C Page 3
Appendix 4C
Quarterly report for entities
admitted on the basis of commitments
Reconciliation of cash
| | | |
Reconciliation of cash at the end of the quarter (as shown in the consolidated statement of cash flows) to the related items in the accounts is as follows. | Current Quarter (Q3) $’000 USD | Previous Quarter (Q2) $’000 USD |
4.1 | Cash on hand and at bank | 23 | 90 |
4.2 | Deposits at call (including time deposits) | 11,530 | 16,459 |
4.3 | Bank overdraft | 0 | 0 |
4.4 | Other (provide details) | 0 | 0 |
| Total: cash at end of quarter (item 1.23) | 11,553 | 16,549 |
Acquisitions and disposals of business entities
| | | |
| Acquisitions (Item 1.9(a)) | Disposals (Item 1.10(a)) |
5.1 | Name of entity | N/A | N/A |
5.2 | Place of incorporation or registration | | |
5.3 | Consideration for acquisition or disposal | | |
5.4 | Total net assets | | |
5.5 | Nature of business | | |
Compliance statement
1 | This statement has been prepared under accounting policies which comply with accounting standards as defined in the Corporations Act (except to the extent that information is not required because of note 2) or other standards acceptable to ASX. |
2 | This statement does give a true and fair view of the matters disclosed. |
Sign here: ../s/ Katrina L. Thompson............................. | Date: 28 October 2016 |
(Chief Financial Officer/Company Secretary)
Print name: Katrina L. Thompson
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 wanting to disclose additional information is encouraged to do so, in a note or notes attached to this report. |
2. | The definitions in, and provisions of, AASB 107: Statement of Cash Flows apply to this report except for any additional disclosure requirements requested by AASB 107 that are not already itemised in this report. |
3. | Accounting Standards. ASX will accept, for example, the use of International Financial Reporting Standards for foreign entities. If the standards used do not address a topic, the Australian standard on that topic (if any) must be complied with. |
+ See chapter 19 for defined terms.
Appendix 4C Page 417/12/2010
