Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2016 | Aug. 01, 2016 | |
Document And Entity Information [Abstract] | ||
Entity Registrant Name | REVA Medical, Inc. | |
Entity Central Index Key | 1,496,268 | |
Document Type | 10-Q/A | |
Document Period End Date | Jun. 30, 2016 | |
Amendment Flag | true | |
Amendment Description | This Amendment No. 1 (“Form 10-Q/A”) to our Quarterly Report on Form 10-Q for the quarter ended June 30, 2016 (“Original Filing”), filed with the U.S. Securities and Exchange Commission (“SEC”) on August 9, 2016, is being filed for the purpose of restating our unaudited consolidated financial statements as of June 30, 2016 and to make corresponding revisions to certain disclosures in the Original Filing. As disclosed in our Form 8-K filed on November 7, 2016, the restatement is the result of a misclassification our Convertible Notes Payable, and related interested payable on the Convertible Notes, as long-term liabilities. Based on our reassessment of relevant accounting guidelines, we have corrected the error and characterized our Convertible Notes Payable, and related interest payable on the Convertible Notes, as current liabilities, rather than long-term liabilities. Our management has determined that there was a control deficiency in our internal control over financial reporting that constitutes a material weakness, as discussed in Part I – Item 4 of this Form 10-Q/A. A material weakness is a deficiency, or combination of control deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the annual or interim consolidated financial statements will not be prevented or detected on a timely basis. For a discussion of management’s consideration of our disclosure controls and procedures and the material weakness identified, see Part I – Item 4 included in this Form 10-Q/A. This Form 10-Q/A amends and restates in its entirety each section of the Original Filing impacted as a result of the change in presentation, but each section that has been restated has been updated solely to reflect the change in classification to current liability from long-term liability. This Form 10-Q/A has not been updated to reflect events occurring after August 9, 2016, the date of the Original Filing. Therefore, this Form 10-Q/A should be read in conjunction with filings we have made with the SEC subsequent to August 9, 2016. | |
Current Fiscal Year End Date | --12-31 | |
Trading Symbol | RVA | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 42,704,486 | |
Document Fiscal Year Focus | 2,016 | |
Document Fiscal Period Focus | Q2 |
Consolidated Balance Sheets (Un
Consolidated Balance Sheets (Unaudited) - USD ($) | Jun. 30, 2016 | Dec. 31, 2015 |
Current Assets: | ||
Cash and cash equivalents | $ 16,549,000 | $ 16,895,000 |
Prepaid expenses and other current assets | 287,000 | 397,000 |
Total current assets | 16,836,000 | 17,292,000 |
Non-Current Assets: | ||
Property and equipment, net | 2,575,000 | 2,719,000 |
Other non-current assets | 60,000 | 60,000 |
Total non-current assets | 2,635,000 | 2,779,000 |
Total Assets | 19,471,000 | 20,071,000 |
Current Liabilities: | ||
Accounts payable | 827,000 | 1,054,000 |
Accrued expenses and other current liabilities | 2,004,000 | 2,242,000 |
Convertible notes payable | 96,206,000 | |
Accrued interest on convertible notes payable | 3,162,000 | |
Total current liabilities | 102,199,000 | 3,296,000 |
Long-Term Liabilities: | ||
Convertible notes payable | 75,365,000 | |
Common stock warrant liability | 19,622,000 | |
Other long-term liabilities | 112,000 | 2,352,000 |
Total long-term liabilities | 112,000 | 97,339,000 |
Total Liabilities | 102,311,000 | 100,635,000 |
Commitments and contingencies (Note 7) | ||
Stockholders' Deficit | ||
Common stock | 4,000 | 4,000 |
Undesignated preferred stock ― $0.0001 par value; 5,000,000 shares authorized; no shares issued or outstanding | ||
Additional paid-in capital | 297,649,000 | 254,572,000 |
Accumulated deficit | (380,493,000) | (335,140,000) |
Total Stockholders' Deficit | (82,840,000) | (80,564,000) |
Total Liabilities and Stockholders' Deficit | 19,471,000 | 20,071,000 |
Class B common stock | ||
Stockholders' Deficit | ||
Common stock |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2016 | Dec. 31, 2015 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 42,704,486 | 38,155,986 |
Common stock, shares outstanding | 42,704,486 | 38,155,986 |
Undesignated preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Undesignated preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Undesignated preferred stock, shares issued | 0 | 0 |
Undesignated preferred stock, shares outstanding | 0 | 0 |
Class B common stock | ||
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 25,000,000 | 25,000,000 |
Common stock, shares issued | 0 | 0 |
Common stock, shares outstanding | 0 | 0 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Operating Expense: | ||||
Research and development | $ 4,665 | $ 4,067 | $ 9,953 | $ 7,331 |
General and administrative | 2,366 | 1,566 | 4,559 | 3,155 |
Loss from operations | (7,031) | (5,633) | (14,512) | (10,486) |
Other Income (Expense): | ||||
Interest income | 1 | 3 | 2 | 6 |
Interest expense | (505) | (470) | (1,010) | (935) |
Gain (loss) on change in fair value of convertible notes payable and warrant liability | 2,966 | 11,970 | (29,798) | (6,131) |
Other income (expense) | 14 | (16) | (35) | 43 |
Other income (expense) | 2,476 | 11,487 | (30,841) | (7,017) |
Net Income (Loss) and Comprehensive Income (Loss) | $ (4,555) | $ 5,854 | $ (45,353) | $ (17,503) |
Net Income (Loss) Per Common Share: | ||||
Basic | $ (0.11) | $ 0.17 | $ (1.09) | $ (0.52) |
Diluted | $ (0.11) | $ (0.12) | $ (1.09) | $ (0.52) |
Shares Used to Compute Net Income (Loss) per Share: | ||||
Basic | 42,569,166 | 33,561,959 | 41,520,092 | 33,490,314 |
Diluted | 42,569,166 | 49,056,892 | 41,520,092 | 33,490,314 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
Cash Flows from Operating Activities: | ||
Net loss | $ (45,353) | $ (17,503) |
Non-cash adjustments to reconcile net loss to net cash used for operating activities: | ||
Depreciation and amortization | 564 | 530 |
Stock-based compensation | 3,070 | 1,385 |
Interest on convertible notes payable | 1,010 | 935 |
Loss on change in fair value of convertible notes payable and warrant liability | 29,798 | 6,131 |
Other non-cash expenses | 10 | 10 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 110 | 35 |
Accounts payable | (277) | 230 |
Accrued expenses and other current liabilities | (248) | (1,112) |
Other long-term liabilities | (88) | (78) |
Net cash used for operating activities | (11,404) | (9,437) |
Cash Flows from Investing Activities: | ||
Purchases of property and equipment | (370) | (508) |
Net cash used for investing activities | (370) | (508) |
Cash Flows from Financing Activities: | ||
Proceeds from issuances of common stock | 11,428 | 62 |
Costs of issuing convertible notes payable and warrants | (50) | |
Net cash provided by financing activities | 11,428 | 12 |
Net decrease in cash and cash equivalents | (346) | (9,933) |
Cash and cash equivalents at beginning of period | 16,895 | 25,814 |
Cash and Cash Equivalents at End of Period | 16,549 | 15,881 |
Supplemental Non-Cash Information: | ||
Property and equipment in accounts payable at end of period | 100 | $ 6 |
Warrant liability transferred to equity upon exercise | $ 28,579 |
Background and Basis of Present
Background and Basis of Presentation | 6 Months Ended |
Jun. 30, 2016 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
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. |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2016 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 2. We measure the fair value of our financial and non-financial assets and liabilities at each reporting date in accordance with the fair value hierarchy according to GAAP, which requires that f air value measurements be classified and disclosed in one of the following three categories: Level 1 – Quoted market prices for identical assets or liabilities in active markets at the measurement date; Level 2 – Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities in active or non-active markets, or other inputs that can be corroborated by observable market data for substantially the full term of an asset or liability; and, Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of an asset or liability, including management’s best estimate of the factors that market participants would use in pricing an asset or liability at the measurement date. We carry our convertible notes payable and, until February 12, 2016 when the warrants were exercised in full, our common stock warrant liability at fair value. We carry our other financial instruments at amortized cost, which we consider to be reasonable estimates of their respective fair values due to their short-term nature and, therefore, fair value information is not provided in the following table; these other financial instruments include cash and cash equivalents, accounts payable, and accrued expenses. Utilizing the lowest level inputs available under the measurement hierarchy, the fair values of our measured financial instruments, which consist only of liabilities, are as follows: Level 3 (in thousands) Fair Value of Liabilities at December 31, 2015: Convertible notes payable $ 75,365 Common stock warrant liability 19,622 $ 94,987 Fair Value of Liabilities at June 30, 2016: Convertible notes payable $ 96,206 Common stock warrant liability — $ 96,206 We had no Level 1 or Level 2 financial instruments through June 30, 2016. Our Level 3 financial liabilities, which are recurring, consist of convertible notes payable (the “Notes”) and, until they were exercised in full, warrants for the purchase of common stock, all of which were issued in November 2014. The fair values of the Notes were determined utilizing a least squares Monte Carlo simulation model and valuation of the warrants was determined utilizing a Black-Scholes valuation model. Both models require use of unobservable inputs that are determined by management, with the assistance of independent experts. These inputs represent our best estimates, but involve certain inherent uncertainties. We used the market value of the underlying stock, a life equal to the contractual life of the financial instrument, incremental borrowing rates and bond yields that correspond to instruments of similar credit worthiness and the instrument’s remaining life, an estimate of volatility based on the historical prices of our trading securities, and we made assumptions as to our abilities to test and commercialize our product(s), to obtain future financings when and if needed, and to comply with the terms and conditions of our Notes. A summary of the weighted-average assumptions used to value the Notes and warrants is as follows: June 30, June 30, 2015 2016 Market price per share of common stock $3.62 $8.22 Risk-free interest rate 2.2% 1.5% Expected volatility of common stock 84.6% 74.6% Expected life – years 4.37 3.42 Bond yield of equivalent securities 29.2% 27.0% 2. (continued) A significant change in the market price per share, expected volatility, or bond yield of equivalent securities, in isolation, would result in significantly higher or lower fair value measurements. In combination, changes in these inputs could result in a significantly higher or lower fair value measurement if the input changes were to be aligned, or could result in a minimally higher or lower fair value measurement if the input changes were of a compensating nature. We recorded a total of $11,970,000 and $2,966,000 in unrealized gains during the three-month periods, and a total of $6,131,000 and $29,798,000 in unrealized losses during the six-month periods, ended June 30, 2015 and 2016, respectively, that arose from the change in fair value on our Level 3 financial liabilities. Our Level 3 fair value activity through June 30, 2016 is as follows: Level 3 (in thousands) Balance at December 31, 2015 $ 94,987 Losses from Change in Fair Value: Convertible notes payable 23,807 Common stock warrant liability 8,957 Transfer to additional paid-in capital upon exercise of warrants (28,579 ) Balance at March 31, 2016 99,172 Gain from Change in Fair Value: Convertible notes payable (2,966 ) Balance at June 30, 2016 $ 96,206 |
Convertible Notes Payable and W
Convertible Notes Payable and Warrants to Purchase Common Stock | 6 Months Ended |
Jun. 30, 2016 | |
Convertible Notes Payable And Warrants To Purchase Common Stock Disclosure [Abstract] | |
Convertible Notes Payable and Warrants to Purchase Common Stock | 3. Convertible Notes Payable and Warrants to Purchase Common Stock In November 2014, we issued 250 convertible notes payable, each with a face value of $100,000, for total cash proceeds of $25,000,000. The Notes are convertible into 11,506,155 shares of common stock, which is a conversion rate of $2.17275 per share. The Notes are convertible at any time at the holders’ election; the Notes automatically convert in the case where we have received CE Mark approval of our Fantom Following an analysis of the embedded and derivative features of the Notes upon their issuance in 2014, and a projection of the volatility of their effective interest rates under the cost method, we made an irrevocable election to utilize fair value accounting for the Notes. Management believed the fair value method of accounting would provide a more appropriate presentation of these liabilities than would be provided under the cost method. The fair values of the Notes as of December 31, 2015 and June 30, 2016 was calculated to be $50,365,000 and $71,206,000, respectively, higher than the unpaid principal balance of the Notes of $25,000,000. The increases of $5,270,000 and $20,841,000 in the fair value of the Notes during the six months ended June 30, 2015 and 2016, respectively, were recorded as losses in the consolidated statement of operations. In connection with the issuance of the Notes in November 2014, we issued warrants to the noteholders to purchase up to 8,750,000 shares of common stock. In October 2015, a total of 4,375,000 warrants were exercised for $9,506,000 cash proceeds and on February 12, 2016 the remaining 4,375,000 warrants were exercised for $11,407,000 cash proceeds. The fair value of the warrants on the February 12, 2016 exercise date was calculated to be $28,579,000. The increases of $861,000 and $8,957,000 in fair value of the warrant liability during the six months ended June 30, 2015 and the period from December 31, 2015 to February 12, 2016, respectively, were recorded as losses in the consolidated statement of operations. |
Balance Sheet Details
Balance Sheet Details | 6 Months Ended |
Jun. 30, 2016 | |
Balance Sheet Related Disclosures [Abstract] | |
Balance Sheet Details | 4. Property and Equipment and Accrued Expenses : Components of our property and equipment and accrued expenses and other current liabilities are as follows: December 31, June 30, 2015 2016 (in thousands) Property and Equipment: Furniture, office equipment, and software $ 650 $ 658 Laboratory equipment 5,952 6,361 Leasehold improvements 2,386 2,386 8,988 9,405 Accumulated depreciation and amortization (6,269 ) (6,830 ) $ 2,719 $ 2,575 Accrued Expenses and Other Current Liabilities: Accrued salaries and other employee costs $ 1,311 $ 993 Accrued operating expenses 745 829 Accrued use taxes and other 186 182 $ 2,242 $ 2,004 |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2016 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 5. We have reported tax net operating losses since our inception through June 30, 2016; therefore, no provision for income taxes has been recorded since our inception. The net operating tax loss carryforwards arising from our net losses may be available to offset future taxable income for income tax purposes; however, under Internal Revenue Code (“IRC”) Sections 382 and 383, use of the net operating tax loss carryforwards, as well as our research tax credit carryforwards, may be limited based on cumulative changes in ownership. We have established a valuation allowance against our net deferred tax assets due to the uncertainty surrounding the realization of those assets and we, therefore, have no deferred asset or liability balance for any reporting period. We periodically evaluate the recoverability of the deferred tax assets and, when it is determined that it is more-likely-than-not that the deferred tax assets are realizable, the valuation allowance will be reduced. Due to our valuation allowance, future changes in our unrecognized tax benefits will not impact our effective tax rate. |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2016 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-Based Compensation | 6. The Plan : Our 2010 Equity Incentive Plan, as amended (the “Plan”), provides for grants of incentive and non-qualified stock options for purchase of our common stock at a price per share equal to the closing market price on the date of grant and for awards of restricted stock units and restricted stock for no consideration payable by the recipient. The number of shares reserved for issuance under the Plan may be increased annually by up to three percent of the outstanding stock of the Company and on January 1, 2016, an additional 550,000 shares were reserved for issuance under the Plan. An aggregate of 8,422,445 shares are reserved for issuance under the Plan as of June 30, 2016. All stock issuances under the Plan are made with new shares from our authorized but unissued common stock. The term of grants and awards under the Plan may not exceed ten years. Employees, non-employee directors, and consultants are eligible to participate in the Plan. For purposes of determining stock-based compensation expense, we include non-employee directors with employees; we account for consultant compensation expense separately. 6. (continued) Option activity under the Plan is as follows: Weighted Average Options Exercise Outstanding Price Balance at December 31, 2014 4,243,425 $7.01 Granted 2,152,500 $4.50 Cancelled (232,292 ) $2.85 Exercised (251,208 ) $2.27 Balance at December 31, 2015 5,912,425 $6.46 Granted 546,500 $8.19 Exercised (13,500 ) $1.56 Balance at June 30, 2016 6,445,425 $6.62 Vesting periods of stock and unit awards and option grants are determined by the Company’s board of directors. The majority of options granted by the Company vest over four years, with 25 percent vesting on the one-year anniversary of the vesting commencement date and 75 percent vesting in equal monthly installments thereafter. A majority of those options are exercisable at any time but, if exercised, are subject to a lapsing right of repurchase by us at the exercise price until fully vested. During March 2015, we granted a total of 316,000 options that vest based on certain performance milestones of the Company. We estimated the vesting term for each performance objective on the date of grant, and on each reporting date thereafter, based on our internal timelines and operating projections. Our estimates of vesting ranged from approximately nine to 30 months, with a weighted average vesting term of 8.0 months remaining as of June 30, 2016. A total of 30 percent of these options had vested through June 30, 2016 and none had been cancelled. During July 2012, January 2013, and May 2013 we awarded 33,000 shares, 40,000 shares, and 47,500 shares, respectively, of restricted stock; 25 percent of each award vests on each annual anniversary date of the award. Through June 30, 2016, none of the restricted stock had been cancelled. During March 2015, we awarded 824,200 restricted stock units (“RSUs”) to employees. These RSUs vest based on certain performance milestones of the Company. We estimated the vesting term for each performance objective on the award date, and on each reporting date thereafter, based on our internal timelines and operating projections. Our estimates of vesting ranged from approximately 21 to 30 months, with a weighted average vesting term of 8.2 months remaining as of June 30, 2016. None of these RSUs had vested or been cancelled as of June 30, 2016. During May 2015, we awarded 160,000 RSUs to employee and non-employee directors; these RSUs vested on May 24, 2016. During May 2016, we awarded 35,200 RSUs to non-employee directors; these RSUs vest on the earlier of May 25, 2017 or one day prior to our 2017 annual stockholder meeting. Each RSU entitles the recipient to one share of our common stock upon vesting. Through June 30, 2016, none of these RSUs had been cancelled. No tax benefits arising from stock-based compensation have been recognized in the consolidated statements of operations and comprehensive loss through June 30, 2016. 6. (continued) Grants and Awards to Employees : We account for option grants, restricted stock awards, and RSU awards to employees based on their estimated fair values on the date of grant or award, with the resulting stock-based compensation recorded over the requisite service period on a straight-line basis. For the options and RSUs that vest upon performance milestones, we estimate the probability that the performance milestones will be met and record the related stock-based compensation expense. During the three months ended March 31, 2016, we determined that two of the three performance targets for our performance-based awards were probable of being achieved and, therefore, recorded expense for those awards only. During the three months ended June 30, 2016, we determined that all three of the performance targets were probable of being achieved, and, therefore, recorded cumulative expense of $583,000 for the third performance target, as well as recording straight-line quarterly expense of $140,000 for those awards, during the second quarter of 2016. Stock-based compensation arising from employee options and awards under the Plan is as follows: Three Months Ended Six Months Ended June 30, June 30, 2015 2016 2015 2016 (in thousands) (in thousands) Employee Stock-Based Compensation: Research and development expense $ 418 $ 800 $ 714 $ 1,164 General and administrative expense 413 1,075 644 1,866 $ 831 $ 1,875 $ 1,358 $ 3,030 The fair value of restricted stock and RSU awards is equal to the closing market price of our common stock on the date of award. The fair value of options granted was estimated on the date of grant using the following weighted- average assumptions: Six Months Ended June 30, 2015 2016 Risk-free interest rate 1.7% 1.6% Expected volatility of common stock 56.4% 57.5% Expected life in years 5.86 6.17 Dividend yield 0% 0% The assumed risk-free interest rate was based on the implied yield on a U.S. Treasury zero-coupon issue with a remaining term equal to the expected life of the option. The assumed volatility was calculated based on the historical market prices of a selected group of publicly traded companies considered to be our peers; we use peer group data due to the fact that we have limited historical trading data but adjusted the 2016 volatility upward by approximately eight percent to allow us to move toward using our trading history, which is more volatile than our peer group. For options that vest based on passage of time, the expected option life was calculated using the simplified method under the accounting standard for stock compensation and a ten-year option expiration; we use the simplified method because we do not yet have adequate history as a public company to establish a reasonable expected life. For options that vest based on performance achievements, the expected life was calculated based on the requisite service periods estimated by management and a ten-year option expiration. The expected dividend yield of zero reflects that we have not paid cash dividends since inception and do not intend to pay cash dividends in the foreseeable future. The options granted to employees during the six months ended June 30, 2016 had a weighted average grant date fair value of $4.48. The aggregate intrinsic value of options exercised during the six months ended June 30, 2015 and 2016 was $135,000 and $92,000, respectively. 6. (continued) Stock Options to Consultants : We account for stock options granted to consultants at their fair value. Under this method, the fair value is estimated at each reporting date during the vesting period using the Black-Scholes option-pricing model. The resulting stock-based compensation expense, or income if the fair value declines in a reporting period, is recorded over the consultant’s service period. Fully vested options to purchase 7,500 shares of common stock were granted to consultants during the six months ended June 30, 2016; no options were granted to consultants during the six months ended June 30, 2015. Stock-based compensation expense arising from consultant options granted under the Plan is as follows: Six Months Ended June 30, 2015 2016 (in thousands) Consultant Stock-Based Compensation: Research and development expense $ — $ 40 General and administrative expense 27 — $ 27 $ 40 We did not record any stock-based compensation expense during the three month periods ended June 30, 2015 and 2016 for consultant options. The fair value of the options granted to consultants during the six months ended June 30, 2016 was estimated to be $5.30 per share based on weighted-average assumptions of a risk-free interest rate of 2.02 percent, volatility of 57.4 percent, an option life of ten years, and a dividend yield of zero percent. The assumed risk-free interest rate was based on the implied yield on a U.S. Treasury zero-coupon issue with a remaining term equal to the expected life of the option. The assumed volatility was calculated from the historical market prices of a selected group of publicly traded companies considered to be our peers; we use peer group data due to the fact that we have limited historical trading data. The expected option life is the remaining term of the option. The expected dividend yield of zero reflects that we have not paid cash dividends since inception and do not intend to pay cash dividends in the foreseeable future. There were no unvested consultant options at either June 30, 2015 or June 30, 2016. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2016 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 7. Commitments and Contingencies We have licensed certain patents and other intellectual property rights related to the composition and coating of our bioresorbable stent and our other biomaterial products. Terms of these licenses include provisions for royalty payments on any future sales of products, if any, utilizing this technology, with provisions for minimum royalties once product sales begin. The amount of royalties varies depending upon type of product, use of product, stage of product, location of sale, and ultimate sales volume, and ranges from a minimum of approximately $25 per unit to a maximum of approximately $100 per unit sold, with license provisions for escalating minimum royalties that could be as high as $2.2 million per year. Additionally, in the event we sublicense the technology and receive certain milestone payments, the licenses require that up to 40 percent of the milestone amount be paid to the licensors. Additional terms of the technology licenses include annual licensing payments of $175,000 until the underlying technology has been commercialized. Terms of the licenses also include other payments to occur during commercialization that could total $950,000, payment of $350,000 upon a change in control of ownership, payments of up to $300,000 annually to extend filing periods related to certain technology, and payment of patent filing, maintenance, and defense fees. The license terms remain in effect until the last patent expires. |
Net Income (Loss) Per Common Sh
Net Income (Loss) Per Common Share | 6 Months Ended |
Jun. 30, 2016 | |
Earnings Per Share [Abstract] | |
Net Income (Loss) Per Common Share | 8. Basic net loss per common share is calculated by dividing the net loss attributable to common stockholders by the weighted average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted average number of common share equivalents outstanding for the period determined using the treasury-stock method and the if-converted method, as applicable. For purpose of this calculation, common stock options and restricted stock subject to forfeiture are considered to be common stock equivalents; common share equivalents are included in the calculation of diluted net loss per share only when their effect is dilutive. Basic earnings per share reconciles to fully diluted earnings per share as follows (dollars in thousands): Three Months Ended Six Months Ended June 30, June 30, 2015 2016 2015 2016 Net Loss Used for Diluted EPS: Net income (loss) used for basic earnings per share $ 5,854 $ (4,555 ) $ (17,503 ) $ (45,353 ) Interest expense 470 — — — Gain on change in fair value of convertible notes payable and warrant liability (11,970 ) — — — $ (5,646 ) $ (4,555 ) $ (17,503 ) $ (45,353 ) Weighted Average Shares Used for Diluted EPS: Weighted average shares used for basic EPS 33,561,959 42,569,166 33,490,314 41,520,092 Weighted average common share equivalents 15,494,933 — — — 49,056,892 42,569,166 33,490,314 41,520,092 The following weighted average shares were excluded from the computations of diluted net loss per share because including them would have been antidilutive. Three Months Ended Six Months Ended June 30, June 30, 2015 2016 2015 2016 Weighted Average Shares Excluded from EPS: Options to purchase common stock 4,488,583 6,414,854 4,404,804 6,300,137 Unvested restricted stock 67,819 37,693 70,679 40,562 Restricted stock units 885,738 931,699 550,048 957,949 Warrants to purchase common stock — — 8,750,000 1,009,615 Common share equivalents of convertible notes — 11,506,156 11,506,156 11,506,156 5,442,140 18,890,402 25,281,687 19,814,419 |
Background and Basis of Prese14
Background and Basis of Presentation (Policies) | 6 Months Ended |
Jun. 30, 2016 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Basis of Presentation | 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 | 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 | 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 | 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. |
Background and Basis of Prese15
Background and Basis of Presentation (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Summary of Restatement | 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 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Fair Value Disclosures [Abstract] | |
Schedule of fair values of investments and liabilities, determined from level 2 and 3 inputs | Level 3 (in thousands) Fair Value of Liabilities at December 31, 2015: Convertible notes payable $ 75,365 Common stock warrant liability 19,622 $ 94,987 Fair Value of Liabilities at June 30, 2016: Convertible notes payable $ 96,206 Common stock warrant liability — $ 96,206 |
Summary of weighted-average assumptions used to value the Notes and warrants | June 30, June 30, 2015 2016 Market price per share of common stock $3.62 $8.22 Risk-free interest rate 2.2% 1.5% Expected volatility of common stock 84.6% 74.6% Expected life – years 4.37 3.42 Bond yield of equivalent securities 29.2% 27.0% |
Summary of fair value of financial liabilities determined from "Level 3" inputs | Level 3 (in thousands) Balance at December 31, 2015 $ 94,987 Losses from Change in Fair Value: Convertible notes payable 23,807 Common stock warrant liability 8,957 Transfer to additional paid-in capital upon exercise of warrants (28,579 ) Balance at March 31, 2016 99,172 Gain from Change in Fair Value: Convertible notes payable (2,966 ) Balance at June 30, 2016 $ 96,206 |
Balance Sheet Details (Tables)
Balance Sheet Details (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Balance Sheet Related Disclosures [Abstract] | |
Schedule of Property and Equipment | Property and Equipment and Accrued Expenses : Components of our property and equipment and accrued expenses and other current liabilities are as follows: December 31, June 30, 2015 2016 (in thousands) Property and Equipment: Furniture, office equipment, and software $ 650 $ 658 Laboratory equipment 5,952 6,361 Leasehold improvements 2,386 2,386 8,988 9,405 Accumulated depreciation and amortization (6,269 ) (6,830 ) $ 2,719 $ 2,575 Accrued Expenses and Other Current Liabilities: Accrued salaries and other employee costs $ 1,311 $ 993 Accrued operating expenses 745 829 Accrued use taxes and other 186 182 $ 2,242 $ 2,004 |
Schedule of Accrued Expenses and Other Current Liabilities | December 31, June 30, 2015 2016 (in thousands) Property and Equipment: Furniture, office equipment, and software $ 650 $ 658 Laboratory equipment 5,952 6,361 Leasehold improvements 2,386 2,386 8,988 9,405 Accumulated depreciation and amortization (6,269 ) (6,830 ) $ 2,719 $ 2,575 Accrued Expenses and Other Current Liabilities: Accrued salaries and other employee costs $ 1,311 $ 993 Accrued operating expenses 745 829 Accrued use taxes and other 186 182 $ 2,242 $ 2,004 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Schedule of the option activity under the plan | Employees, non-employee directors, and consultants are eligible to participate in the Plan. For purposes of determining stock-based compensation expense, we include non-employee directors with employees; we account for consultant compensation expense separately. Option activity under the Plan is as follows: Weighted Average Options Exercise Outstanding Price Balance at December 31, 2014 4,243,425 $7.01 Granted 2,152,500 $4.50 Cancelled (232,292 ) $2.85 Exercised (251,208 ) $2.27 Balance at December 31, 2015 5,912,425 $6.46 Granted 546,500 $8.19 Exercised (13,500 ) $1.56 Balance at June 30, 2016 6,445,425 $6.62 |
Equity awards to employees | |
Schedule of stock-based compensation expense | Three Months Ended Six Months Ended June 30, June 30, 2015 2016 2015 2016 (in thousands) (in thousands) Employee Stock-Based Compensation: Research and development expense $ 418 $ 800 $ 714 $ 1,164 General and administrative expense 413 1,075 644 1,866 $ 831 $ 1,875 $ 1,358 $ 3,030 |
Options Granted | |
Schedule of the weighted-average assumptions used to estimate fair value of options granted | The fair value of restricted stock and RSU awards is equal to the closing market price of our common stock on the date of award. The fair value of options granted was estimated on the date of grant using the following weighted- average assumptions: Six Months Ended June 30, 2015 2016 Risk-free interest rate 1.7% 1.6% Expected volatility of common stock 56.4% 57.5% Expected life in years 5.86 6.17 Dividend yield 0% 0% |
Equity awards to consultants | |
Schedule of stock-based compensation expense | Stock-based compensation expense arising from consultant options granted under the Plan is as follows: Six Months Ended June 30, 2015 2016 (in thousands) Consultant Stock-Based Compensation: Research and development expense $ — $ 40 General and administrative expense 27 — $ 27 $ 40 |
Net Income (Loss) Per Common 19
Net Income (Loss) Per Common Share (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Earnings Per Share [Abstract] | |
Schedule of basic earnings per share reconciles to fully diluted earnings per share | Basic earnings per share reconciles to fully diluted earnings per share as follows (dollars in thousands): Three Months Ended Six Months Ended June 30, June 30, 2015 2016 2015 2016 Net Loss Used for Diluted EPS: Net income (loss) used for basic earnings per share $ 5,854 $ (4,555 ) $ (17,503 ) $ (45,353 ) Interest expense 470 — — — Gain on change in fair value of convertible notes payable and warrant liability (11,970 ) — — — $ (5,646 ) $ (4,555 ) $ (17,503 ) $ (45,353 ) Weighted Average Shares Used for Diluted EPS: Weighted average shares used for basic EPS 33,561,959 42,569,166 33,490,314 41,520,092 Weighted average common share equivalents 15,494,933 — — — 49,056,892 42,569,166 33,490,314 41,520,092 |
Schedule of weighted average shares excluded from the computation of diluted net loss per share | The following weighted average shares were excluded from the computations of diluted net loss per share because including them would have been antidilutive. Three Months Ended Six Months Ended June 30, June 30, 2015 2016 2015 2016 Weighted Average Shares Excluded from EPS: Options to purchase common stock 4,488,583 6,414,854 4,404,804 6,300,137 Unvested restricted stock 67,819 37,693 70,679 40,562 Restricted stock units 885,738 931,699 550,048 957,949 Warrants to purchase common stock — — 8,750,000 1,009,615 Common share equivalents of convertible notes — 11,506,156 11,506,156 11,506,156 5,442,140 18,890,402 25,281,687 19,814,419 |
Background and Basis of Prese20
Background and Basis of Presentation (Details) | Feb. 12, 2016USD ($) | Jun. 30, 2016USD ($)itemCountryPatient | Dec. 31, 2015USD ($) | Jun. 30, 2015USD ($) | Dec. 31, 2014USD ($) | Nov. 14, 2014USD ($) | Dec. 31, 2010 |
Organization Consolidation And Basis Of Presentation Of Financial Statements [Line Items] | |||||||
Number of patients enrolled in a clinical trial of bioresorbable stent product | item | 247 | ||||||
Number of countries | Country | 8 | ||||||
Number of patients data used | Patient | 117 | ||||||
Common Stock Conversion Rate | 10 | ||||||
Convertible notes payable | $ 96,206,000 | ||||||
Restatement description | 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. | ||||||
Retained earnings (Accumulated deficit) | $ (380,493,000) | $ (335,140,000) | |||||
Current liabilities | 102,199,000 | 3,296,000 | |||||
Cash | 16,549,000 | $ 16,895,000 | $ 15,881,000 | $ 25,814,000 | |||
Proceeds from warrant exercises | $ 11,407,000 | ||||||
Convertible Notes Payable | |||||||
Organization Consolidation And Basis Of Presentation Of Financial Statements [Line Items] | |||||||
Face Amount | $ 100,000 | ||||||
Current liabilities | 99,368,000 | ||||||
Convertible Notes Payable | Principal Balance | |||||||
Organization Consolidation And Basis Of Presentation Of Financial Statements [Line Items] | |||||||
Face Amount | $ 25,000,000 |
Background and Basis of Prese21
Background and Basis of Presentation (Details 1) - USD ($) | Jun. 30, 2016 | Feb. 12, 2016 | Dec. 31, 2015 |
Current Liabilities: | |||
Accounts payable | $ 827,000 | $ 1,054,000 | |
Accrued expenses and other current liabilities | 2,004,000 | 2,242,000 | |
Convertible notes payable | 96,206,000 | ||
Accrued interest on convertible notes payable | 3,162,000 | ||
Total current liabilities | 102,199,000 | 3,296,000 | |
Long-Term Liabilities: | |||
Common stock warrant liability | $ 28,579,000 | 19,622,000 | |
Other long-term liabilities | 112,000 | 2,352,000 | |
Total long-term liabilities | 112,000 | 97,339,000 | |
Total Liabilities | 102,311,000 | $ 100,635,000 | |
As Reported | |||
Current Liabilities: | |||
Accounts payable | 827,000 | ||
Accrued expenses and other current liabilities | 2,004,000 | ||
Total current liabilities | 2,831,000 | ||
Long-Term Liabilities: | |||
Convertible notes payable | 96,206,000 | ||
Other long-term liabilities | 3,274,000 | ||
Total long-term liabilities | 99,480,000 | ||
Total Liabilities | 102,311,000 | ||
Adjustments | |||
Current Liabilities: | |||
Convertible notes payable | 96,206,000 | ||
Accrued interest on convertible notes payable | 3,162,000 | ||
Total current liabilities | 99,368,000 | ||
Long-Term Liabilities: | |||
Convertible notes payable | (96,206,000) | ||
Other long-term liabilities | (3,162,000) | ||
Total long-term liabilities | $ (99,368,000) |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |||||
Jun. 30, 2016 | Mar. 31, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | Feb. 12, 2016 | Dec. 31, 2015 | |
Common stock warrant liability | $ 28,579,000 | $ 19,622,000 | |||||
Weighted Average Assumptions: | |||||||
Market price per share of common stock | $ 8.22 | $ 3.62 | $ 8.22 | $ 3.62 | |||
Risk-free interest rate | 1.50% | 2.20% | |||||
Expected volatility of common stock | 74.60% | 84.60% | |||||
Expected life – years | 3 years 5 months 1 day | 4 years 4 months 13 days | |||||
Bond yield of equivalent securities | 27.00% | 29.20% | |||||
Changes in unrealized gain (loss) on instruments held at the end of period, financial liabilities | $ 2,966,000 | $ 11,970,000 | $ (29,798,000) | $ (6,131,000) | |||
Losses/(Gain) from Change in Fair Value: | |||||||
Transfer out upon exercise of warrants | (28,579,000) | ||||||
Level 3 | |||||||
Convertible notes payable | 96,206,000 | 96,206,000 | 75,365,000 | ||||
Common stock warrant liability | 19,622,000 | ||||||
Liabilities | 96,206,000 | $ 99,172,000 | 96,206,000 | 94,987,000 | |||
Weighted Average Assumptions: | |||||||
Changes in unrealized gain (loss) on instruments held at the end of period, financial liabilities | 2,966,000 | $ 11,970,000 | (29,798,000) | $ (6,131,000) | |||
Financial Liabilities Fair Value Disclosure | |||||||
Liabilities | 96,206,000 | 99,172,000 | 96,206,000 | 94,987,000 | |||
Losses/(Gain) from Change in Fair Value: | |||||||
Convertible notes payable | (2,966,000) | 23,807,000 | |||||
Common stock warrant liability | 8,957,000 | ||||||
Transfer out upon exercise of warrants | (28,579,000) | ||||||
Liabilities | $ 96,206,000 | $ 99,172,000 | $ 96,206,000 | $ 94,987,000 |
Convertible Notes Payable and23
Convertible Notes Payable and Warrants to Purchase Common Stock (Details) | Feb. 12, 2016USD ($)shares | Oct. 01, 2015USD ($)shares | Nov. 14, 2014USD ($)item$ / sharesshares | Feb. 12, 2016USD ($) | Jun. 30, 2016USD ($) | Jun. 30, 2015USD ($) | Dec. 31, 2015USD ($) |
Number of convertible notes payable | item | 250 | ||||||
Cash proceeds from Notes payable and warrants | $ 25,000,000 | ||||||
Convertible notes excluding unpaid principal balance | $ 71,206,000 | $ 50,365,000 | |||||
Proceeds from warrant exercises | $ 11,407,000 | ||||||
Common stock warrant liability | $ 28,579,000 | $ 28,579,000 | $ 19,622,000 | ||||
Warrants to purchase common stock | |||||||
Warrants issued to purchase common stock (in shares) | shares | 8,750,000 | ||||||
Warrant exercised | shares | 4,375,000 | 4,375,000 | |||||
Proceeds from warrant exercises | $ 11,407,000 | $ 9,506,000 | |||||
Change in fair value of Warrants | $ 8,957,000 | $ 861,000 | |||||
Convertible Notes Payable | |||||||
Face Amount | $ 100,000 | ||||||
Number of converted shares of common stock | shares | 11,506,155 | ||||||
Convertible rate into common stock | $ / shares | $ 2.17275 | ||||||
Consecutive trading days | 20 days | ||||||
Interest rate (as a percent) accrued on notes | 7.54% | ||||||
Increase (decrease) in fair value of notes | $ 20,841,000 | $ 5,270,000 | |||||
Minimum | Convertible Notes Payable | |||||||
Market trading price | $ / shares | $ 0.60 |
Balance Sheet Details (Details)
Balance Sheet Details (Details) - USD ($) $ in Thousands | Jun. 30, 2016 | Dec. 31, 2015 |
Property and Equipment: | ||
Property and equipment, gross | $ 9,405 | $ 8,988 |
Accumulated depreciation and amortization | (6,830) | (6,269) |
Property and equipment, net | 2,575 | 2,719 |
Accrued Expenses and Other Current Liabilities: | ||
Accrued salaries and other employee costs | 993 | 1,311 |
Accrued operating expenses | 829 | 745 |
Accrued use taxes and other | 182 | 186 |
Accrued expenses and other current liabilities, total | 2,004 | 2,242 |
Furniture, office equipment, and software | ||
Property and Equipment: | ||
Property and equipment, gross | 658 | 650 |
Laboratory equipment | ||
Property and Equipment: | ||
Property and equipment, gross | 6,361 | 5,952 |
Leasehold improvements | ||
Property and Equipment: | ||
Property and equipment, gross | $ 2,386 | $ 2,386 |
Income Taxes (Details)
Income Taxes (Details) | 6 Months Ended |
Jun. 30, 2016USD ($) | |
Income Tax Disclosure [Abstract] | |
Provision for income taxes | $ 0 |
Deferred tax assets | 0 |
Deferred tax liability | $ 0 |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details) - USD ($) | May 24, 2016 | Jan. 01, 2016 | May 31, 2016 | May 31, 2015 | Mar. 31, 2015 | May 31, 2013 | Jan. 31, 2013 | Jul. 31, 2012 | Jun. 30, 2016 | Jun. 30, 2015 | Mar. 31, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | Dec. 31, 2015 |
Stock-Based Compensation | ||||||||||||||
Vesting periods | 4 years | |||||||||||||
Options, granted (in shares) | 546,500 | 2,152,500 | ||||||||||||
Share-based Compensation Award, Tranche One | ||||||||||||||
Stock-Based Compensation | ||||||||||||||
Vesting percentage | 25.00% | |||||||||||||
Share-based Compensation Award, Tranche Two | ||||||||||||||
Stock-Based Compensation | ||||||||||||||
Vesting percentage | 75.00% | |||||||||||||
Equity awards to employees | ||||||||||||||
Stock-Based Compensation | ||||||||||||||
Term of options granted under the plan | 10 years | |||||||||||||
Vesting percentage | 30.00% | |||||||||||||
Options, granted (in shares) | 316,000 | |||||||||||||
Options cancelled (in shares) | 0 | |||||||||||||
Stock-based compensation expense | $ 1,875,000 | $ 831,000 | $ 3,030,000 | $ 1,358,000 | ||||||||||
Percentage of volatility upward adjustment | 8.00% | |||||||||||||
Dividend yield (as a percent) | 0.00% | |||||||||||||
Weighted average grant date fair value (in dollars per share) | $ 4.48 | |||||||||||||
Intrinsic value of options exercised | $ 92,000 | $ 135,000 | ||||||||||||
Performance-based awards | ||||||||||||||
Stock-Based Compensation | ||||||||||||||
Stock-based compensation expense | 140,000 | $ 583,000 | ||||||||||||
Equity awards to consultants | ||||||||||||||
Stock-Based Compensation | ||||||||||||||
Options, granted (in shares) | 7,500 | 0 | ||||||||||||
Stock-based compensation expense | $ 0 | $ 0 | $ 40,000 | $ 27,000 | ||||||||||
Dividend yield (as a percent) | 0.00% | |||||||||||||
Weighted average grant date fair value (in dollars per share) | $ 5.30 | |||||||||||||
Risk-free interest rate (as a percent) | 2.02% | |||||||||||||
Expected volatility of common stock (as a percent) | 57.40% | |||||||||||||
Expected life | 10 years | |||||||||||||
Unvested stock option (in shares) | 0 | 0 | 0 | 0 | ||||||||||
2010 Equity Incentive Plan | ||||||||||||||
Stock-Based Compensation | ||||||||||||||
Number of shares added in reserve | 550,000 | |||||||||||||
Total number of shares in reserve with additional shares under the Plan | 8,422,445 | 8,422,445 | ||||||||||||
Tax benefits from stock based compensation | $ 0 | |||||||||||||
2010 Equity Incentive Plan | Restricted stock | ||||||||||||||
Stock-Based Compensation | ||||||||||||||
Annual vesting percent | 25.00% | 25.00% | 25.00% | |||||||||||
Shares of restricted stock awarded | 47,500 | 40,000 | 33,000 | |||||||||||
Shares of restricted stock cancelled | 0 | |||||||||||||
2010 Equity Incentive Plan | Restricted stock units | ||||||||||||||
Stock-Based Compensation | ||||||||||||||
Shares of restricted stock cancelled | 0 | |||||||||||||
Number of shares awarded | 35,200 | 160,000 | 824,200 | |||||||||||
Employee share of common stock upon vesting | 1 | |||||||||||||
Shares of restricted stock vested | 160,000 | 0 | ||||||||||||
Maximum | Equity awards to employees | ||||||||||||||
Stock-Based Compensation | ||||||||||||||
Vesting periods | 30 months | |||||||||||||
Maximum | 2010 Equity Incentive Plan | ||||||||||||||
Stock-Based Compensation | ||||||||||||||
Increment in the number of shares reserved under the Plan annually (as a percent) | 3.00% | |||||||||||||
Term of options granted under the plan | 10 years | |||||||||||||
Maximum | 2010 Equity Incentive Plan | Restricted stock units | ||||||||||||||
Stock-Based Compensation | ||||||||||||||
Vesting periods | 30 months | |||||||||||||
Weighted Average [Member] | Equity awards to employees | ||||||||||||||
Stock-Based Compensation | ||||||||||||||
Vesting periods | 8 months | |||||||||||||
Weighted Average [Member] | 2010 Equity Incentive Plan | Restricted stock units | ||||||||||||||
Stock-Based Compensation | ||||||||||||||
Vesting periods | 8 months 6 days | |||||||||||||
Minimum | Equity awards to employees | ||||||||||||||
Stock-Based Compensation | ||||||||||||||
Vesting periods | 9 months | |||||||||||||
Minimum | 2010 Equity Incentive Plan | Restricted stock units | ||||||||||||||
Stock-Based Compensation | ||||||||||||||
Vesting periods | 21 months |
Stock-Based Compensation (Det27
Stock-Based Compensation (Details 1) - $ / shares | 6 Months Ended | 12 Months Ended |
Jun. 30, 2016 | Dec. 31, 2015 | |
Options Outstanding | ||
Options outstanding, balance at the beginning of period (in shares) | 5,912,425 | 4,243,425 |
Options, granted (in shares) | 546,500 | 2,152,500 |
Options, cancelled (in shares) | (232,292) | |
Options, exercised (in shares) | (13,500) | (251,208) |
Options outstanding, balance at the end of period (in shares) | 6,445,425 | 5,912,425 |
Weighted Average Exercise Price | ||
Weighted average exercise price, balance at the beginning of period (in dollars per share) | $ 6.46 | $ 7.01 |
Weighted average exercise price, granted (in dollars per share) | 8.19 | 4.50 |
Weighted average exercise price, cancelled (in dollars per share) | 2.85 | |
Weighted average exercise price, exercised (in dollars per share) | 1.56 | 2.27 |
Weighted average exercise price, balance at the end of period (in dollars per share) | $ 6.62 | $ 6.46 |
Stock-Based Compensation (Det28
Stock-Based Compensation (Details 2) - Equity awards to employees - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Employee Stock-Based Compensation: | ||||
Total stock-based compensation | $ 1,875 | $ 831 | $ 3,030 | $ 1,358 |
Research and development expense | ||||
Employee Stock-Based Compensation: | ||||
Total stock-based compensation | 800 | 418 | 1,164 | 714 |
General and administrative expense | ||||
Employee Stock-Based Compensation: | ||||
Total stock-based compensation | $ 1,075 | $ 413 | $ 1,866 | $ 644 |
Stock-Based Compensation (Det29
Stock-Based Compensation (Details 3) - Employee Stock Option | 6 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
Additional information related to fair values of options granted | ||
Risk-free interest rate (as a percent) | 1.60% | 1.70% |
Expected volatility of common stock (as a percent) | 57.50% | 56.40% |
Expected life | 6 years 2 months 1 day | 5 years 10 months 10 days |
Dividend yield (as a percent) | 0.00% | 0.00% |
Stock-Based Compensation (Det30
Stock-Based Compensation (Details 4) - Equity awards to consultants - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Employee Stock-Based Compensation: | ||||
Total stock-based compensation | $ 0 | $ 0 | $ 40,000 | $ 27,000 |
Research and development expense | ||||
Employee Stock-Based Compensation: | ||||
Total stock-based compensation | $ 40,000 | |||
General and administrative expense | ||||
Employee Stock-Based Compensation: | ||||
Total stock-based compensation | $ 27,000 |
Commitments and Contingencies (
Commitments and Contingencies (Details) | 6 Months Ended |
Jun. 30, 2016USD ($)$ / item | |
Commitment And Contingencies [Line Items] | |
Annual licensing payment | $ 175,000 |
Other payments of royalty agreement occur during commercialization | 950,000 |
Contingent license fee payable only upon a change in ownership of licensee | $ 350,000 |
Minimum | |
Commitment And Contingencies [Line Items] | |
Royalty payment per unit (in dollar per unit) | $ / item | 25 |
Maximum | |
Commitment And Contingencies [Line Items] | |
Royalty payment per unit (in dollar per unit) | $ / item | 100 |
License provisions for escalating minimum royalties | $ 2,200,000 |
Milestone amounts paid to the licensors (as a percent) | 40.00% |
Annual payments to extend filing periods related to certain technology | $ 300,000 |
Net Income (Loss) Per Common 32
Net Income (Loss) Per Common Share (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Earnings per share reconciliation | ||||
Net income (loss) used for basic earnings per share | $ (4,555) | $ 5,854 | $ (45,353) | $ (17,503) |
Interest expense | 470 | |||
Gain on change in fair value of convertible notes payable and warrant liability | (11,970) | |||
Net Loss Used for Diluted EPS | $ (4,555) | $ (5,646) | $ (45,353) | $ (17,503) |
Weighted average shares used for basic EPS | 42,569,166 | 33,561,959 | 41,520,092 | 33,490,314 |
Weighted average common share equivalents | 15,494,933 | |||
Weighted Average Shares Used for Diluted EPS | 42,569,166 | 49,056,892 | 41,520,092 | 33,490,314 |
Weighted Average Shares Excluded from EPS: | ||||
Total weighted average shares excluded | 18,890,402 | 5,442,140 | 19,814,419 | 25,281,687 |
Options to purchase common stock | ||||
Weighted Average Shares Excluded from EPS: | ||||
Total weighted average shares excluded | 6,414,854 | 4,488,583 | 6,300,137 | 4,404,804 |
Unvested restricted stock | ||||
Weighted Average Shares Excluded from EPS: | ||||
Total weighted average shares excluded | 37,693 | 67,819 | 40,562 | 70,679 |
Restricted stock units | ||||
Weighted Average Shares Excluded from EPS: | ||||
Total weighted average shares excluded | 931,699 | 885,738 | 957,949 | 550,048 |
Warrants to purchase common stock | ||||
Weighted Average Shares Excluded from EPS: | ||||
Total weighted average shares excluded | 1,009,615 | 8,750,000 | ||
Common share equivalents from convertible notes | ||||
Weighted Average Shares Excluded from EPS: | ||||
Total weighted average shares excluded | 11,506,156 | 11,506,156 | 11,506,156 |