REVA Medical : Q3 2018 Quarterly Report on Form 10Q

Q3 2018 Quarterly Report on Form 10-Q

San Diego, California and Sydney, Australia (Tuesday, 6 November 2018, AEDT) - REVA Medical, Inc. (ASX: RVA) ("REVA" or the "Company") is pleased to present the attached Quarterly Report on Form 10-Q, as filed with the Securities and Exchange Commission today. The Form 10-Q includes the Company's unaudited Financial Statements for the three and nine months ended 30 September 2018 and other required disclosures. The financial statements included in the Form 10-Q were prepared in accordance with accounting principles generally accepted in the United States ("GAAP") and are denominated in United States dollars.

About REVA Medical

REVA Medical is a medical device company focused on the development and commercialization of bioresorbable polymer technologies for vascular applications. The Company's lead products are the Fantom and Fantom Encore bioresorbable vascular scaffolds for the treatment of coronary artery disease. REVA is currently selling Fantom in Germany, Switzerland, Austria, the Netherlands, Belgium, Luxembourg, Italy and Turkey. REVA is based in San Diego, California, and employs 45 people in the U.S. and Europe.

Fantom, Fantom Encore, MOTIV and Tyrocore are trademarks of REVA Medical, Inc.

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 plans or performance and events or developments that may occur in the future, are forward-looking statements, such as those statements regarding the projections and timing surrounding commercial operations and sales, clinical trials, pipeline product development, and future financings. No undue reliance should be placed 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 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 7, 2018, and as 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.

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

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

• ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

  For the quarterly period ended September 30, 2018

  or

• ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission file number: 000-54192

REVA MEDICAL, INC.

(Exact name of registrant as specified in its charter)

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☑ No ☐

Indicate by check mark whether the registrant has submitted electronically, every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or such shorter period that the registrant was required to submit such files). Yes ☑ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of "large accelerated filer," "accelerated filer," "non-accelerated filer," "smaller reporting company," and "emerging growth company" in Rule 12b-2 of the Exchange Act. (Check one):

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☑

As of November 1, 2018, 41,479,877 shares of the registrant's common stock, $0.0001 par value per share, were outstanding.

REVA MEDICAL, INC.

FORM 10-Q -- QUARTERLY REPORT For the Quarter Ended September 30, 2018

Table of Contents

Page

PART I. FINANCIAL INFORMATION 1

Item 1. Financial Statements 1

Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations 18

Item 3. Quantitative and Qualitative Disclosures about Market Risk 28

Item 4. Controls and Procedures 28

PART II. OTHER INFORMATION 28

Item 1. Legal Proceedings 28

Item 1A. Risk Factors 28

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 31

Item 3. Defaults upon Senior Securities 31

Item 4. Mine Safety Disclosures 31

Item 5. Other Information 31

Item 6. Exhibits 32

SIGNATURES 33

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REFERENCES

Corporate Information

Our principal executive offices are located at 5751 Copley Drive, Suite B, San Diego, CA 92111, U.S.A., and our telephone number is (858) 966-3000. Our website address iswww.revamedical.com. The information on, or accessible through, our website is not part of this report. Unless the context implies otherwise, references in this report and in the information incorporated herein by reference to "REVA Medical," "REVA," the "Company," "we," "us," and "our" refer to REVA Medical, Inc. and its consolidated subsidiary.

Currency

Unless indicated otherwise in this report, all references to "$" or "dollars" refer to United States dollars, the lawful currency of the United States of America. References to "A$" refer to Australian dollars, the lawful currency of the Commonwealth of Australia.

Trademarks

Our product name Fantom® is a registered trademark in the United States, Australia and the European Union. We have pending applications to register the mark in Brazil, China and Japan. The names Fantom Encore, Tyrocore™ and MOTIV™ are also our trademarks. We have pending applications to register Tyrocore and MOTIV in the United States. All other trademarks, trade names, and service marks appearing in this report are the property of their respective owners. Use or display by us of other parties' trademarks, trade dress, or service marks is not intended to and does not imply a relationship with, or endorsement or sponsorship of, us by the owner thereof.

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PART I. FINANCIAL INFORMATIONItem 1. Financial Statements

REVA Medical, Inc. Consolidated Balance Sheets

(Unaudited)

(in thousands, except share and per share amounts)

September 30, 2018

Assets

Current assets:

Cash and cash equivalents Investment securities Accounts receivable, net Inventory

Prepaid expenses and other current assets

Total current assets

Property and equipment, net Other non-current assets

$

Total assets

7,094$ 18,544

-1,470

11563

831627

685438

8,72521,142

1,8781,492

2327

Liabilities and Stockholders' Deficit

Current liabilities:

Accounts payable

Accrued expenses and other current liabilities Deferred revenue

Total current liabilities Convertible notes

Accrued interest on convertible notes Common stock warrant liability Other long-term liabilities

Total liabilities

$

1,010$ 756

1,5441,737

383158

2,9372,651

66,21199,368

13,4658,779

4704,176

813500

83,896

Commitments and contingencies (Note 9)

Stockholders' deficit:

Common stock ― $0.0001 par value; 100,000,000 shares authorized; 41,479,877 and 41,245,820 shares issued and outstanding, respectively, at September 30, 2018 and December 31, 2017 Additional paid-in capital

Accumulated other comprehensive loss Accumulated deficit

Total stockholders' deficit

Total liabilities and stockholders' deficit

$

The accompanying notes are an integral part of these financial statements.

-1-

4

292,651

(2 )

(3 6 5 ,9 2 3 )

December 31, 2017

115,474

4

289,342

(2 )

(3 8 2 ,1 5 7 )

(7 3 ,2 7 0 )

(9 2 ,8 1 3 )

10,626$

22,661