Background and Basis of Presentation | 1. Background : REVA Medical, Inc. (“REVA” or the “Company”) was incorporated in California in 1998 under the name MD3, Inc. In March 2002, we changed our name to REVA Medical, Inc. In October 2010, we reincorporated in Delaware. We established a non-operating wholly owned subsidiary, REVA Germany GmbH, in 2007. In these notes the terms “us,” “we,” or “our” refer to REVA and our consolidated subsidiary unless context dictates otherwise. We do not yet have a product available for sale; our product(s) will become available for sale following application for, and receipt of, regulatory approval with data from our clinical studies. We are currently in the clinical testing phase of a drug-eluting bioresorbable stent to treat vascular disease in humans. This stent, which we have named Fantom Fantom In December 2010 we completed an initial public offering (the “IPO”) of our common stock in Australia and registered with the U.S. Securities and Exchange Commission (“SEC”) and, consequently, became an SEC filer. Our stock is traded in the form of CHESS Depositary Interests (“CDIs”) on the Australian Securities Exchange (“ASX”); each share of our common stock is equivalent to ten CDIs. Our trading symbol is “RVA.AX.” Under an agreement with the current holders of our convertible notes, during the remainder of 2016 we intend to pursue a listing of our common stock on NASDAQ or another exchange approved by our noteholders, with the intention to be accepted for listing no later than June 30, 2017. Basis of Presentation : We have prepared the accompanying consolidated financial statements in accordance with U.S. generally accepted accounting principles (“GAAP”) and the rules and regulations of the SEC for reporting of interim financial information and, therefore, certain information and footnote disclosures normally included in annual financial statements have been omitted. Accordingly, these interim financial statements should be read in conjunction with Management’s Discussion and Analysis of Financial Condition and Results of Operations contained in this report and with the audited financial statements and accompanying footnotes included in our Annual Report on Form 10-K (“Form 10-K”) for the year ended December 31, 2015. Our consolidated financial statements include the accounts of REVA and our wholly owned subsidiary. All intercompany transactions and balances, if any, have been eliminated in consolidation. These interim consolidated financial statements are unaudited; the consolidated balance sheet as of December 31, 2015 was derived from the Company’s audited financial statements included in our Form 10-K for the year ended December 31, 2015. The interim financial statements have been prepared on the same basis as our annual financial statements and, in our opinion, all adjustments, consisting only of normal recurring accruals, considered necessary for a fair statement of the results of these interim periods have been included. The results of operations for the three-month and six-month periods ended June 30, 2016 are not necessarily indicative of the results to be expected for the year ending December 31, 2016 or for any other interim period. Restatement : We have restated our balance sheet as of June 30, 2016 to classify our convertible notes payable (“Notes”), and the related accrued interest on the Notes, as current liabilities. This restatement was made to reflect a provision of the Notes that provides the noteholders a one-time option for cash redemption on June 30, 2017, if the Notes have not previously been converted or redeemed, for the face value plus accrued interest. The face value of the Notes is $25,000,000. We account for the Notes at fair value and determined their fair value to be $96,206,000 as of June 30, 2016. This restatement did not impact any reporting periods other than June 30, 2016. 1. (continued) Restatement (continued) : A summary of the restatement is as follows: June 30, 2016 As Reported Adjustments As Restated (in thousands) Current Liabilities: Accounts payable $ 827 $ — $ 827 Accrued expenses and other current liabilities 2,004 — 2,004 Convertible notes payable — 96,206 96,206 Accrued interest on convertible notes payable — 3,162 3,162 Total current liabilities 2,831 99,368 102,199 Long-Term Liabilities: Convertible notes payable 96,206 (96,206 ) — Common stock warrant liability — — — Other long-term liabilities 3,274 (3,162 ) 112 Total long-term liabilities 99,480 (99,368 ) 112 Total Liabilities 102,311 — 102,311 Liquidity : We have experienced recurring losses and negative cash flows from operating activities since our inception and, as of June 30, 2016, we had an accumulated deficit of $380,493,000 and current liabilities of $102,199,000. While we anticipate initiating commercial operations by mid-2017, until we generate revenue, and at a level to support our cost structure, we expect to continue to incur substantial operating losses and net cash outflows. We had cash of $16,549,000 at June 30, 2016, which reflects the receipt of $11,407,000 in cash proceeds from warrant exercises on February 12, 2016. Based on our current operating plans and projections, we believe this cash balance will be sufficient to fund our operating and capital needs into, and possibly through, the first fiscal quarter of 2017. These conditions, combined with the uncertainty of the timing of receipt of future financings, if any, raise substantial doubt about our ability to continue as a going concern. A total of $99,368,000 of the current liabilities as of June 30, 2016 relate to our convertible notes payable (the “Notes”), which contain a one-time option for cash redemption at face value, plus accrued interest, on June 30, 2017, if the Notes are not otherwise converted or redeemed prior to that time. As discussed in Note 3 below, the Notes automatically convert to equity if and when we achieve the three conditions to automatic conversion. While we believe we would be able to cause the conversion of the Notes to equity prior to June 30, 2017, if the noteholders were to exercise their one-time option to request cash redemption on June 30, 2017, there can be no assurance that we will be successful prior to June 30, 2017 in triggering the automatic conversion of the Notes. Because we believe the Notes will be converted to equity prior to the time we would be requested to redeem their $25 million face value, plus accrued interest, we do not currently anticipate requiring additional capital to redeem them. Although we currently have no set financing plans, until we can sustain positive cash flows from our operations, we intend to fund our future needs by raising additional capital through equity or debt issuances. There can be no assurance that we will be successful in raising additional capital or that such capital, if available, will be on terms that are acceptable to us. If we are unable to raise sufficient additional capital, we may be compelled to reduce the scope of our operations and planned capital expenditures or sell certain assets, including intellectual property assets. Even if we do attain revenue, we may never become profitable and even if we do attain profitable operations, we may not be able to sustain that profitability or positive cash flows on a recurring basis. The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. Use of Estimates : In order to prepare our financial statements in conformity with GAAP, we are required to make estimates and assumptions that affect the reported amounts in the financial statements and accompanying notes. Our most significant estimates relate to, or have related to, the fair value of our convertible notes payable, the fair value of our warrant liability, our operating expense accruals, including clinical study expenses, and our stock-based compensation. Actual results could differ from our estimates. |