Document_and_Entity_Informatio
Document and Entity Information | 9 Months Ended | |
Sep. 30, 2013 | Nov. 01, 2013 | |
Document and Entity Information | ' | ' |
Entity Registrant Name | 'REVA Medical, Inc. | ' |
Entity Central Index Key | '0001496268 | ' |
Document Type | '10-Q | ' |
Document Period End Date | 30-Sep-13 | ' |
Amendment Flag | 'false | ' |
Current Fiscal Year End Date | '--12-31 | ' |
Entity Current Reporting Status | 'Yes | ' |
Entity Filer Category | 'Accelerated Filer | ' |
Entity Common Stock, Shares Outstanding | ' | 33,250,053 |
Document Fiscal Year Focus | '2013 | ' |
Document Fiscal Period Focus | 'Q3 | ' |
Consolidated_Balance_Sheets
Consolidated Balance Sheets (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
In Thousands, unless otherwise specified | ||
Current Assets: | ' | ' |
Cash and cash equivalents | $25,966 | $38,876 |
Short-term investments | 1,243 | 5,223 |
Prepaid expenses and other current assets | 288 | 417 |
Total Current Assets | 27,497 | 44,516 |
Property and equipment, net | 3,500 | 2,821 |
Other assets | 60 | 60 |
Total Assets | 31,057 | 47,397 |
Current Liabilities: | ' | ' |
Accounts payable | 1,121 | 656 |
Accrued expenses and other current liabilities | 1,915 | 1,537 |
Total Current Liabilities | 3,036 | 2,193 |
Long-term liabilities | 514 | 578 |
Total Liabilities | 3,550 | 2,771 |
Commitments and Contingencies (Note 5) | ' | ' |
Stockholders' Equity: | ' | ' |
Undesignated preferred stock - $0.0001 par value; 5,000,000 shares authorized; no shares issued or outstanding | ' | ' |
Additional paid-in capital | 221,260 | 218,210 |
Deficit accumulated during the development stage | -193,756 | -173,587 |
Total Stockholders' Equity | 27,507 | 44,626 |
Total Liabilities and Stockholders' Equity | 31,057 | 47,397 |
Common stock | ' | ' |
Stockholders' Equity: | ' | ' |
Common stock | 3 | 3 |
Class B common stock | ' | ' |
Stockholders' Equity: | ' | ' |
Common stock | ' | ' |
Consolidated_Balance_Sheets_Pa
Consolidated Balance Sheets (Parenthetical) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
Undesignated preferred stock, par value (in dollars per share) | $0.00 | $0.00 |
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 |
Common stock | ' | ' |
Common stock, par value (in dollars per share) | $0.00 | $0.00 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 33,250,053 | 33,132,203 |
Common stock, shares outstanding | 33,250,053 | 33,132,203 |
Class B common stock | ' | ' |
Common stock, par value (in dollars per share) | $0.00 | $0.00 |
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_Ope
Consolidated Statements of Operations and Comprehensive Loss (USD $) | 3 Months Ended | 9 Months Ended | 184 Months Ended | ||
In Thousands, except Share data, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 |
Operating Expense: | ' | ' | ' | ' | ' |
Research and development | $5,088 | $3,928 | $13,867 | $11,751 | $117,411 |
General and administrative | 2,094 | 1,921 | 6,324 | 5,769 | 42,254 |
Loss from operations | -7,182 | -5,849 | -20,191 | -17,520 | -159,665 |
Other Income (Expense): | ' | ' | ' | ' | ' |
Interest income | 7 | 20 | 26 | 74 | 1,401 |
Related party interest expense | ' | ' | ' | ' | -21,113 |
Interest expense | ' | ' | ' | ' | -952 |
Interest from amortization of notes payable premium | ' | ' | ' | ' | 2,283 |
Change in fair value of preferred stock rights and warrant liabilities | ' | ' | ' | ' | 1,795 |
Loss on extinguishment of notes payable | ' | ' | ' | ' | -13,285 |
Other expense | -16 | -5 | -4 | -1 | -47 |
Net Loss | -7,191 | -5,834 | -20,169 | -17,447 | -189,583 |
Cumulative dividends and deemed dividends on Series H convertible preferred stock | ' | ' | ' | ' | -10,695 |
Net Loss Attributable to Common Stockholders | -7,191 | -5,834 | -20,169 | -17,447 | -200,278 |
Net Loss Per Common Share: | ' | ' | ' | ' | ' |
Net loss per share, basic and diluted (in dollars per share) | ($0.22) | ($0.18) | ($0.61) | ($0.53) | ' |
Shares used to compute net loss per share, basic and diluted (in shares) | 33,136,368 | 33,092,768 | 33,116,561 | 33,063,980 | ' |
Other Comprehensive Loss: | ' | ' | ' | ' | ' |
Net loss | -7,191 | -5,834 | -20,169 | -17,447 | -189,583 |
Foreign currency translation adjustments | ' | ' | ' | -1 | ' |
Comprehensive Loss | -7,191 | -5,834 | -20,169 | -17,448 | -189,583 |
Cumulative dividends and deemed dividends on Series H convertible preferred stock | ' | ' | ' | ' | -10,695 |
Comprehensive Loss Attributable to Common Stockholders | ($7,191) | ($5,834) | ($20,169) | ($17,448) | ($200,278) |
Consolidated_Statements_of_Cas
Consolidated Statements of Cash Flows (USD $) | 9 Months Ended | 184 Months Ended | |
In Thousands, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 |
Cash Flows from Operating Activities: | ' | ' | ' |
Net loss | ($20,169) | ($17,447) | ($189,583) |
Non-cash adjustments to reconcile net loss to net cash used for operating activities: | ' | ' | ' |
Depreciation and amortization | 635 | 490 | 4,605 |
Loss on property and equipment disposal and impairment | 1 | ' | 586 |
Stock-based compensation | 3,031 | 2,580 | 11,646 |
Interest on notes payable | ' | ' | 8,562 |
Repayment premium on notes payable | ' | ' | 11,100 |
Loss on change in fair value of preferred stock warrant liability | ' | ' | 970 |
Gain on change in fair value of preferred stock rights liability | ' | ' | -2,765 |
Loss on extinguishment of notes payable | ' | ' | 13,285 |
Other non-cash expenses | 13 | 100 | 163 |
Changes in operating assets and liabilities: | ' | ' | ' |
Prepaid expenses and other current assets | 129 | 702 | -288 |
Other assets | ' | ' | -60 |
Accounts payable | 345 | -126 | 1,001 |
Accrued expenses and other current liabilities | 365 | 315 | 1,822 |
Long-term liabilities | -64 | 64 | 455 |
Net cash used for operating activities | -15,714 | -13,322 | -138,501 |
Cash Flows from Investing Activities: | ' | ' | ' |
Purchases of property and equipment | -1,195 | -1,824 | -8,738 |
Sales of property and equipment | ' | ' | 167 |
Purchases of investments | -1,243 | -1,493 | -26,344 |
Maturities of investments | 5,223 | 1,494 | 25,101 |
Net cash provided by (used for) investing activities | 2,785 | -1,823 | -9,814 |
Cash Flows from Financing Activities: | ' | ' | ' |
Proceeds from issuances of convertible preferred stock, net of costs | ' | ' | 68,917 |
Proceeds from issuances of common stock | 19 | 322 | 85,307 |
Initial public offering costs | ' | ' | -8,068 |
Proceeds from exercises of warrants | ' | ' | 263 |
Repurchases of stock | ' | ' | -638 |
Proceeds from issuances of notes payable | ' | ' | 28,600 |
Repayments of notes payable | ' | ' | -100 |
Net cash provided by financing activities | 19 | 322 | 174,281 |
Effect of foreign exchange rates | ' | -1 | ' |
Net increase (decrease) in cash and cash equivalents | -12,910 | -14,824 | 25,966 |
Cash and cash equivalents at beginning of period | 38,876 | 59,161 | ' |
Cash and cash equivalents at the end of period | 25,966 | 44,337 | 25,966 |
Supplemental Cash and Non-Cash information | ' | ' | ' |
Cash paid for interest | ' | ' | 126 |
Non-cash conversions of notes payable, accrued interest, note premiums and discounts, preferred stock, non-voting common stock, preferred warrants, and common warrants upon initial public offering in December 2010 | ' | ' | 120,349 |
Non-cash property and equipment purchases in accounts payable | $120 | ' | $120 |
Background_and_Basis_of_Presen
Background and Basis of Presentation | 9 Months Ended |
Sep. 30, 2013 | |
Background and Basis of Presentation | ' |
Background and Basis of Presentation | ' |
1. Background and Basis of Presentation | |
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 are currently developing proprietary designs and biomaterial technologies that will be used primarily for a bioresorbable stent to treat vascular disease in humans. We initiated the first human clinical trial of our bioresorbable stent during 2007, enrolled patients in a second clinical trial between December 2011 and July 2012, and initiated a third and larger clinical trial in the first quarter of 2013 in which we continue to enroll patients. | |
In December 2010, we completed an initial public offering (the “IPO”) of our common stock in Australia. We issued 7,727,273 shares of common stock for gross proceeds of $84.3 million. Our stock is traded in the form of CHESS Depository Interests (“CDIs”) on the Australian Securities Exchange; each share of our common stock is equivalent to ten CDIs. Our trading symbol is “RVA.” | |
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 Securities and Exchange Commission (“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 for the year ended December 31, 2012. | |
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. The consolidated balance sheet as of September 30, 2013, the consolidated statements of operations and comprehensive loss and of cash flows for the three and nine months ended September 30, 2012 and 2013 and the period from June 3, 1998 (inception) through September 30, 2013 are unaudited. 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 and nine months ended September 30, 2013 are not necessarily indicative of the results to be expected for the year ending December 31, 2013 or for any other interim period. | |
Development Stage and Capital Resources: We are considered a “development stage” enterprise, as we have not yet generated revenue from the sale of products. Although we have been researching and developing new technologies and product applications and are conducting clinical trials of our bioresorbable stents, we do not anticipate having a product available for sale until after we receive regulatory approval to commercialize in Europe (“CE Marking”) or other regulatory approval, which we expect will be late 2014 at the earliest. Until revenue is generated from a saleable product, and for a period of time thereafter until we achieve sufficient sales volumes and operating margins, we expect to continue to incur substantial operating losses and experience significant net cash outflows. We believe that we have sufficient capital to fund our operations at least through the next 12 months from the remaining IPO proceeds. | |
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 operating expense accruals, including preclinical and clinical expenses, and stock-based compensation. Actual results could differ from our estimates. | |
Balance_Sheet_Details
Balance Sheet Details | 9 Months Ended | ||||||||||
Sep. 30, 2013 | |||||||||||
Balance Sheet Details | ' | ||||||||||
Balance Sheet Details | ' | ||||||||||
2. Balance Sheet Details | |||||||||||
Investments: We invest excess cash in high-quality marketable securities. Our investments are classified as either short- or long-term based on their maturity dates; investments with a maturity of less than one year are classified as short-term and all others are classified as long-term. We have categorized the investments as “held-to-maturity” based on our intent and ability to hold to maturity. Our investments are stated at cost; their fair value is determined each reporting period through quoted market prices of similar instruments in active markets, which is a Level 2 category in the fair value hierarchy according to GAAP. During the reporting period there were no declines in fair value that were deemed to be other than temporary and no transfers between hierarchy levels. Our marketable security investment balances, grouped as time deposits, are as follows: | |||||||||||
Cost | Gross | Fair Value | |||||||||
Unrealized | |||||||||||
Losses | |||||||||||
(in thousands) | |||||||||||
As of December 31, 2012: | |||||||||||
Time deposits due in one year or less | $ | 5,223 | $ | (8 | ) | $ | 5,215 | ||||
As of September 30, 2013: | |||||||||||
Time deposits due in one year or less | $ | 1,243 | $ | (4 | ) | $ | 1,239 | ||||
Components of our property and equipment and accrued expenses and other current liabilities are as follows: | |||||||||||
December 31, | September 30, | ||||||||||
2012 | 2013 | ||||||||||
(in thousands) | |||||||||||
Property and equipment: | |||||||||||
Furniture, office equipment, and software | $ | 569 | $ | 657 | |||||||
Laboratory equipment | 3,816 | 4,678 | |||||||||
Leasehold improvements | 1,838 | 2,198 | |||||||||
6,223 | 7,533 | ||||||||||
Accumulated depreciation and amortization | (3,402 | ) | (4,033 | ) | |||||||
$ | 2,821 | $ | 3,500 | ||||||||
Accrued expenses and other current liabilities: | |||||||||||
Accrued salaries and other employee costs | $ | 1,123 | $ | 1,059 | |||||||
Accrued operating expenses | 288 | 745 | |||||||||
Accrued use taxes and other | 126 | 111 | |||||||||
$ | 1,537 | $ | 1,915 | ||||||||
Income_Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2013 | |
Income Taxes | ' |
Income Taxes | ' |
3. Income Taxes | |
We have reported net losses for all periods through September 30, 2013; therefore, no provision for income taxes has been recorded since our inception. The net operating 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 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. | |
StockBased_Compensation
Stock-Based Compensation | 9 Months Ended | |||||||||||||
Sep. 30, 2013 | ||||||||||||||
Stock-Based Compensation | ' | |||||||||||||
Stock-Based Compensation | ' | |||||||||||||
4. Stock-Based Compensation | ||||||||||||||
The Plan: Our 2010 Equity Incentive Plan was a follow-on to our 2001 Stock Option/Stock Issuance Plan and the two plans are collectively referred to as the “Plan.” The Plan provides for restricted stock awards as well as 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. 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, 2013, an additional 993,966 shares were reserved for issuance under the Plan. An aggregate of 6,654,684 shares are reserved for issuance under the Plan as of September 30, 2013. | ||||||||||||||
The term of the options granted under the Plan may not exceed ten years. The majority of options granted prior to 2010 vest over five years, with 20 percent vesting on each annual anniversary of the vesting commencement date. Beginning in 2010, with the adoption of the 2010 Equity Incentive Plan, the option grants vest over four years, with 25 percent vesting on the one-year anniversary of the vesting commencement date and the remaining 75 percent vesting in equal monthly installments thereafter. All vesting is subject to continued service to the Company. All of our stock 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. | ||||||||||||||
Option activity under the Plan is as follows: | ||||||||||||||
Weighted | ||||||||||||||
Average | ||||||||||||||
Options | Exercise | |||||||||||||
Outstanding | Price | |||||||||||||
Balance at December 31, 2011 | 3,304,000 | $ | 6.99 | |||||||||||
Granted | 544,000 | $ | 5.95 | |||||||||||
Cancelled | (9,300 | ) | $ | 12.64 | ||||||||||
Exercised | (288,700 | ) | $ | 1.11 | ||||||||||
Balance at December 31, 2012 | 3,550,000 | $ | 7.3 | |||||||||||
Granted | 489,500 | $ | 5.31 | |||||||||||
Cancelled | (42,500 | ) | $ | 2 | ||||||||||
Exercised | (30,350 | ) | $ | 0.61 | ||||||||||
Balance at September 30, 2013 | 3,966,650 | $ | 7.16 | |||||||||||
Prior to 2011, we had not awarded any restricted stock under the Plan. During 2011 we awarded 5,000 shares of restricted stock; 50 percent of the award vested in May 2011, 25 percent vested in May 2012, and the remaining 25 percent vested in May 2013. During July 2012, January 2013, and May 2013, we awarded 33,000, 40,000, and 47,500 shares, respectively, of restricted stock; 25 percent of these awards vest on each annual anniversary date of award. | ||||||||||||||
No tax benefits arising from stock-based compensation have been recognized in the consolidated statements of operations and comprehensive loss through September 30, 2013. | ||||||||||||||
Stock Options and Restricted Stock to Employees: We account for option grants and restricted stock 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 vesting period on a straight-line basis. We include non-employee directors as employees for this purpose. | ||||||||||||||
Expense recorded for employee options and awards under the Plan is as follows (dollars in thousands): | ||||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||
September 30, | September 30, | |||||||||||||
2012 | 2013 | 2012 | 2013 | |||||||||||
Research and development | $ | 248 | $ | 267 | $ | 656 | $ | 801 | ||||||
General and administrative | 656 | 747 | 1,890 | 2,217 | ||||||||||
Total stock-based compensation | $ | 904 | $ | 1,014 | $ | 2,546 | $ | 3,018 | ||||||
The fair values of options granted were estimated using the following weighted average assumptions: | ||||||||||||||
Nine Months Ended | ||||||||||||||
September 30, | ||||||||||||||
2012 | 2013 | |||||||||||||
Risk-free interest rate | 1.03 | % | 1.38 | % | ||||||||||
Expected volatility of common stock | 62.1 | % | 60.1 | % | ||||||||||
Expected life — years | 6.25 | 6.25 | ||||||||||||
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 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 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. 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 nine months ended September 30, 2013 had a weighted average grant date fair value of $2.98. | ||||||||||||||
The fair value of our restricted stock awards is calculated using the closing market price on the date of award. | ||||||||||||||
The aggregate intrinsic value of options exercised during the nine months ended September 30, 2012 and 2013 was $1.4 million and $142,000, respectively. | ||||||||||||||
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. During September 2009, consultants were granted options to purchase 50,000 shares of common stock. Stock-based compensation expense arising from these options, which was recorded to research and development, totaled $17,000 and $9,000 for the three months ended September 30, 2012 and 2013, respectively, and $34,000 and $13,000 for the nine months ended September 30, 2012 and 2013, respectively. The fair value of unvested consultant options at September 30, 2012 and 2013 was estimated to be $5.92 and $4.21 per share, respectively, based on the following assumptions: | ||||||||||||||
Nine Months Ended | ||||||||||||||
September 30, | ||||||||||||||
2012 | 2013 | |||||||||||||
Risk-free interest rate | 1.04 | % | 1.71 | % | ||||||||||
Expected volatility of common stock | 62.1 | % | 60.1 | % | ||||||||||
Expected life — years | 6.96 | 5.96 | ||||||||||||
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 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. | ||||||||||||||
Commitments_and_Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2013 | |
Commitments and Contingencies. | ' |
Commitments and Contingencies | ' |
5. Commitments and Contingencies | |
We have licensed certain patents and other intellectual property rights related to the composition of our bioresorbable stent and our other biomaterial products. Terms of these licenses include provisions for royalty payments on 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 $2,200,000 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 amounts 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; the $175,000 for 2013 was paid and recorded to research and development expense during the first quarter of 2013. 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, and payment of patent filing, maintenance, and defense fees. The license terms remain in effect until the last patent expires. | |
Net_Loss_Per_Common_Share
Net Loss Per Common Share | 9 Months Ended |
Sep. 30, 2013 | |
Net Loss Per Common Share | ' |
Net Loss Per Common Share | ' |
6. Net Loss Per Common Share | |
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 and are included in the calculation of diluted net loss per share only when their effect is dilutive. For the nine months ended September 30, 2012 and 2013, common stock options totaling 3,550,000 and 3,966,650 shares, respectively, and restricted stock subject to forfeiture totaling 34,250 and 112,250 shares, respectively, were excluded from the computation of diluted net loss per share because including them would have been antidilutive. | |
Background_and_Basis_of_Presen1
Background and Basis of Presentation (Policies) | 9 Months Ended |
Sep. 30, 2013 | |
Background and Basis of Presentation | ' |
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 Securities and Exchange Commission (“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 for the year ended December 31, 2012. | |
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. The consolidated balance sheet as of September 30, 2013, the consolidated statements of operations and comprehensive loss and of cash flows for the three and nine months ended September 30, 2012 and 2013 and the period from June 3, 1998 (inception) through September 30, 2013 are unaudited. 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 and nine months ended September 30, 2013 are not necessarily indicative of the results to be expected for the year ending December 31, 2013 or for any other interim period. | |
Development Stage and Capital Resources | ' |
Development Stage and Capital Resources: We are considered a “development stage” enterprise, as we have not yet generated revenue from the sale of products. Although we have been researching and developing new technologies and product applications and are conducting clinical trials of our bioresorbable stents, we do not anticipate having a product available for sale until after we receive regulatory approval to commercialize in Europe (“CE Marking”) or other regulatory approval, which we expect will be late 2014 at the earliest. Until revenue is generated from a saleable product, and for a period of time thereafter until we achieve sufficient sales volumes and operating margins, we expect to continue to incur substantial operating losses and experience significant net cash outflows. We believe that we have sufficient capital to fund our operations at least through the next 12 months from the remaining IPO proceeds. | |
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 operating expense accruals, including preclinical and clinical expenses, and stock-based compensation. Actual results could differ from our estimates. |
Balance_Sheet_Details_Tables
Balance Sheet Details (Tables) | 9 Months Ended | ||||||||||
Sep. 30, 2013 | |||||||||||
Balance Sheet Details | ' | ||||||||||
Schedule of marketable security investment balances grouped as time deposits | ' | ||||||||||
Cost | Gross | Fair Value | |||||||||
Unrealized | |||||||||||
Losses | |||||||||||
(in thousands) | |||||||||||
As of December 31, 2012: | |||||||||||
Time deposits due in one year or less | $ | 5,223 | $ | (8 | ) | $ | 5,215 | ||||
As of September 30, 2013: | |||||||||||
Time deposits due in one year or less | $ | 1,243 | $ | (4 | ) | $ | 1,239 | ||||
Schedule of components of property and equipment | ' | ||||||||||
December 31, | September 30, | ||||||||||
2012 | 2013 | ||||||||||
(in thousands) | |||||||||||
Property and equipment: | |||||||||||
Furniture, office equipment, and software | $ | 569 | $ | 657 | |||||||
Laboratory equipment | 3,816 | 4,678 | |||||||||
Leasehold improvements | 1,838 | 2,198 | |||||||||
6,223 | 7,533 | ||||||||||
Accumulated depreciation and amortization | (3,402 | ) | (4,033 | ) | |||||||
$ | 2,821 | $ | 3,500 | ||||||||
Schedule of components of accrued expenses and other current liabilities | ' | ||||||||||
Accrued expenses and other current liabilities: | |||||||||||
Accrued salaries and other employee costs | $ | 1,123 | $ | 1,059 | |||||||
Accrued operating expenses | 288 | 745 | |||||||||
Accrued use taxes and other | 126 | 111 | |||||||||
$ | 1,537 | $ | 1,915 | ||||||||
StockBased_Compensation_Tables
Stock-Based Compensation (Tables) | 9 Months Ended | |||||||||||||
Sep. 30, 2013 | ||||||||||||||
Stock-Based Compensation | ' | |||||||||||||
Schedule of the option activity under the plan | ' | |||||||||||||
Weighted | ||||||||||||||
Average | ||||||||||||||
Options | Exercise | |||||||||||||
Outstanding | Price | |||||||||||||
Balance at December 31, 2011 | 3,304,000 | $ | 6.99 | |||||||||||
Granted | 544,000 | $ | 5.95 | |||||||||||
Cancelled | (9,300 | ) | $ | 12.64 | ||||||||||
Exercised | (288,700 | ) | $ | 1.11 | ||||||||||
Balance at December 31, 2012 | 3,550,000 | $ | 7.3 | |||||||||||
Granted | 489,500 | $ | 5.31 | |||||||||||
Cancelled | (42,500 | ) | $ | 2 | ||||||||||
Exercised | (30,350 | ) | $ | 0.61 | ||||||||||
Balance at September 30, 2013 | 3,966,650 | $ | 7.16 | |||||||||||
Schedule of the expense recorded for employee options and awards under the plan | ' | |||||||||||||
Expense recorded for employee options and awards under the Plan is as follows (dollars in thousands): | ||||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||
September 30, | September 30, | |||||||||||||
2012 | 2013 | 2012 | 2013 | |||||||||||
Research and development | $ | 248 | $ | 267 | $ | 656 | $ | 801 | ||||||
General and administrative | 656 | 747 | 1,890 | 2,217 | ||||||||||
Total stock-based compensation | $ | 904 | $ | 1,014 | $ | 2,546 | $ | 3,018 | ||||||
Options Granted | ' | |||||||||||||
Stock-Based Compensation | ' | |||||||||||||
Schedule of the weighted-average assumptions used to estimate fair value of options granted | ' | |||||||||||||
Nine Months Ended | ||||||||||||||
September 30, | ||||||||||||||
2012 | 2013 | |||||||||||||
Risk-free interest rate | 1.03 | % | 1.38 | % | ||||||||||
Expected volatility of common stock | 62.1 | % | 60.1 | % | ||||||||||
Expected life — years | 6.25 | 6.25 | ||||||||||||
Dividend yield | 0 | % | 0 | % | ||||||||||
Stock Options to Consultants | ' | |||||||||||||
Stock-Based Compensation | ' | |||||||||||||
Schedule of the weighted-average assumptions used to estimate fair value of options granted | ' | |||||||||||||
Nine Months Ended | ||||||||||||||
September 30, | ||||||||||||||
2012 | 2013 | |||||||||||||
Risk-free interest rate | 1.04 | % | 1.71 | % | ||||||||||
Expected volatility of common stock | 62.1 | % | 60.1 | % | ||||||||||
Expected life — years | 6.96 | 5.96 | ||||||||||||
Dividend yield | 0 | % | 0 | % | ||||||||||
Background_and_Basis_of_Presen2
Background and Basis of Presentation (Details) (USD $) | 1 Months Ended |
Dec. 31, 2010 | |
Basis of Presentation | ' |
Common stock to CDIs conversion ratio | $10 |
Common stock | ' |
Basis of Presentation | ' |
Common Stock issued | 7,727,273 |
Gross proceed of common stock | $84,300,000 |
Balance_Sheet_Details_Details
Balance Sheet Details (Details) (USD $) | 9 Months Ended | 12 Months Ended |
In Thousands, unless otherwise specified | Sep. 30, 2013 | Dec. 31, 2012 |
Balance Sheet Details | ' | ' |
Cost, one year or less | $1,243 | $5,223 |
Gross Unrealized loss | -4 | -8 |
Fair Value | $1,239 | $5,215 |
Balance_Sheet_Details_Details_
Balance Sheet Details (Details 2) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
In Thousands, unless otherwise specified | ||
Property and equipment: | ' | ' |
Property and equipment, gross | $7,533 | $6,223 |
Accumulated depreciation and amortization | -4,033 | -3,402 |
Property and equipment, net | 3,500 | 2,821 |
Furniture, office equipment, and software | ' | ' |
Property and equipment: | ' | ' |
Property and equipment, gross | 657 | 569 |
Laboratory equipment | ' | ' |
Property and equipment: | ' | ' |
Property and equipment, gross | 4,678 | 3,816 |
Leasehold improvements | ' | ' |
Property and equipment: | ' | ' |
Property and equipment, gross | $2,198 | $1,838 |
Balance_Sheet_Details_Details_1
Balance Sheet Details (Details 3) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
In Thousands, unless otherwise specified | ||
Accrued expenses and other current liabilities: | ' | ' |
Accrued salaries and other employee costs | $1,059 | $1,123 |
Accrued operating expenses | 745 | 288 |
Accrued use taxes and other | 111 | 126 |
Accrued expenses and other current liabilities, total | $1,915 | $1,537 |
Income_Taxes_Details
Income Taxes (Details) (USD $) | 9 Months Ended |
Sep. 30, 2013 | |
Income Taxes | ' |
Provision for income taxes | $0 |
Deferred tax assets | 0 |
Deferred tax liability | $0 |
StockBased_Compensation_Detail
Stock-Based Compensation (Details) (USD $) | 9 Months Ended | 12 Months Ended | 1 Months Ended | 12 Months Ended | 1 Months Ended | 9 Months Ended | ||||||||
Sep. 30, 2013 | Sep. 30, 2013 | Sep. 30, 2013 | Sep. 30, 2013 | Dec. 31, 2012 | 31-May-13 | 31-May-12 | 31-May-11 | Dec. 31, 2011 | 31-May-13 | Jan. 31, 2013 | Jul. 31, 2012 | Sep. 30, 2013 | Sep. 30, 2013 | |
Options | Plan | Plan | Plan | Plan | Plan | Plan | Plan | Plan | Plan | Plan | Plan | 2001 Stock Option/Stock Issuance Plan | Our 2010 Equity Incentive Plan | |
item | Maximum | Options | Options | Restricted Stock - First award | Restricted Stock - First award | Restricted Stock - First award | Restricted Stock - First award | Restricted Stock - Subsequent awards | Restricted Stock - Subsequent awards | Restricted Stock - Subsequent awards | ||||
Share-based Compensation Arrangement by Share-based Payment Award | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Number of plans covered under stock-based compensation arrangement | ' | 2 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Increment in the number of shares reserved under the Plan annually (as a percent) | ' | ' | 3.00% | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Number of shares added in reserve | ' | 993,966 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Total number of shares in reserve with additional shares under the Plan | ' | 6,654,684 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Term of options granted under the plan | '10 years | ' | '10 years | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Vesting periods | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | '5 years | '4 years |
Vesting percentage | ' | ' | ' | ' | ' | 25.00% | 25.00% | 50.00% | ' | ' | ' | ' | 20.00% | 25.00% |
Percentage of remaining option grants vesting in equal monthly installments after the one-year anniversary of the vesting commencement date | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 75.00% |
Options Outstanding | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Balance at the beginning of period (in shares) | ' | ' | ' | 3,550,000 | 3,304,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Granted (in shares) | ' | ' | ' | 489,500 | 544,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Cancelled (in shares) | ' | ' | ' | -42,500 | -9,300 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Exercised (in shares) | ' | ' | ' | -30,350 | -288,700 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Balance at the end of period (in shares) | ' | ' | ' | 3,966,650 | 3,550,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Weighted Average Exercise Price | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Balance at the beginning of period (in dollars per share) | ' | ' | ' | $7.30 | $6.99 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Granted (in dollars per share) | ' | ' | ' | $5.31 | $5.95 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Cancelled (in dollars per share) | ' | ' | ' | $2 | $12.64 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Exercised (in dollars per share) | ' | ' | ' | $0.61 | $1.11 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Balance at the end of period (in dollars per share) | ' | ' | ' | $7.16 | $7.30 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Number of shares awarded | ' | ' | ' | ' | ' | ' | ' | ' | 5,000 | 47,500 | 40,000 | 33,000 | ' | ' |
Annual vesting percent | ' | ' | ' | ' | ' | ' | ' | ' | ' | 25.00% | 25.00% | 25.00% | ' | ' |
Tax benefits from stock based compensation | ' | $0 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
StockBased_Compensation_Detail1
Stock-Based Compensation (Details 2) (Stock Awards and Option Grants, USD $) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | |
Stock Options and Restricted Stock to Employees | ' | ' | ' | ' |
Total stock-based compensation | $1,014,000 | $904,000 | $3,018,000 | $2,546,000 |
Research and development | ' | ' | ' | ' |
Stock Options and Restricted Stock to Employees | ' | ' | ' | ' |
Total stock-based compensation | 267,000 | 248,000 | 801,000 | 656,000 |
General and administrative | ' | ' | ' | ' |
Stock Options and Restricted Stock to Employees | ' | ' | ' | ' |
Total stock-based compensation | $747,000 | $656,000 | $2,217,000 | $1,890,000 |
StockBased_Compensation_Detail2
Stock-Based Compensation (Details 3) (USD $) | 9 Months Ended | 1 Months Ended | 9 Months Ended | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2009 | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | |
Options Granted | Options Granted | Stock Options to Consultants | Stock Options to Consultants | Stock Options to Consultants | Stock Options to Consultants | Stock Options to Consultants | Stock Options to Consultants | Stock Options to Consultants | |
Research and development | Research and development | Research and development | Research and development | ||||||
Additional information related to fair values of options granted | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Risk-free interest rate (as a percent) | 1.38% | 1.03% | ' | 1.71% | 1.04% | ' | ' | ' | ' |
Expected volatility of common stock (as a percent) | 60.10% | 62.10% | ' | 60.10% | 62.10% | ' | ' | ' | ' |
Expected life | '6 years 3 months | '6 years 3 months | ' | '5 years 11 months 16 days | '6 years 11 months 16 days | ' | ' | ' | ' |
Dividend yield (as a percent) | 0.00% | 0.00% | ' | 0.00% | 0.00% | ' | ' | ' | ' |
Expiration term | '10 years | ' | ' | ' | ' | ' | ' | ' | ' |
Weighted average grant date fair value (in dollars per share) | $2.98 | ' | ' | $4.21 | $5.92 | ' | ' | ' | ' |
Intrinsic value of options exercised | $142,000 | $1,400,000 | ' | ' | ' | ' | ' | ' | ' |
Granted (in shares) | ' | ' | 50,000 | ' | ' | ' | ' | ' | ' |
Total stock-based compensation | ' | ' | ' | ' | ' | $9,000 | $17,000 | $13,000 | $34,000 |
Commitments_and_Contingencies_
Commitments and Contingencies (Details) (USD $) | 9 Months Ended | 3 Months Ended | ||
Sep. 30, 2013 | Sep. 30, 2013 | Sep. 30, 2013 | Mar. 31, 2013 | |
Minimum | Maximum | Research and development | ||
Commitment and Contingencies | ' | ' | ' | ' |
Royalty payment per unit (in dollar per unit) | ' | 25 | 100 | ' |
License provisions for escalating minimum royalties | $2,200,000 | ' | ' | ' |
Milestone amounts paid to the licensors (as a percent) | ' | ' | 40.00% | ' |
Annual licensing payment | 175,000 | ' | ' | ' |
Annual licensing payments made and recorded | ' | ' | ' | 175,000 |
Other payments of royalty agreement occur during commercialization | 950,000 | ' | ' | ' |
Payment due to change in control of ownership | $350,000 | ' | ' | ' |
Net_Loss_Per_Common_Share_Deta
Net Loss Per Common Share (Details) | 9 Months Ended | |
Sep. 30, 2013 | Sep. 30, 2012 | |
Common stock options | ' | ' |
Net Income Loss Per Common Share | ' | ' |
Securities excluded from the computation of diluted net loss per share (in shares) | 3,966,650 | 3,550,000 |
Restricted Stock | ' | ' |
Net Income Loss Per Common Share | ' | ' |
Securities excluded from the computation of diluted net loss per share (in shares) | 112,250 | 34,250 |