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1. |
BASIS OF PRESENTATION |
Vical Incorporated, or the Company, a Delaware corporation, was incorporated in April 1987 and has devoted substantially all of its resources since that time to its research and development programs. The Company researches and develops biopharmaceutical products, including those based on its patented DNA delivery technologies, for the prevention and treatment of serious or life-threatening diseases.
All of the Company’s potential products are in research and development phases. No revenues have been generated from the sale of any such products, nor are any such revenues expected for at least the next several years. The Company earns revenue from research and development agreements with pharmaceutical collaborators and grant and contract arrangements with government entities. Most of the Company’s product candidates will require significant additional research and development efforts, including extensive preclinical and clinical testing. All product candidates that advance to clinical testing will require regulatory approval prior to commercial use, and will require significant costs for commercialization. There can be no assurance that the Company’s research and development efforts, or those of its collaborators, will be successful. The Company expects to continue to incur substantial losses and not generate positive cash flows from operations for at least the next several years. No assurance can be given that the Company can generate sufficient product revenue to become profitable or generate positive cash flows from operations.
The unaudited financial statements at September 30, 2015, and for the three and nine months ended September 30, 2015 and 2014, have been prepared in accordance with the rules and regulations of the Securities and Exchange Commission, or SEC, and with accounting principles generally accepted in the United States applicable to interim financial statements. These unaudited financial statements have been prepared on the same basis as the audited financial statements included in the Company’s Annual Report on Form 10-K and include all adjustments, consisting of only normal recurring accruals, which in the opinion of management are necessary to present fairly the Company’s financial position as of the interim date and results of operations for the interim periods presented. Interim results are not necessarily indicative of results expected for a full year or future periods. The preparation of financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ materially from those estimates. These unaudited financial statements should be read in conjunction with the Company’s audited financial statements for the year ended December 31, 2014, included in its Annual Report on Form 10-K filed with the SEC.
Cash, Cash Equivalents and Marketable Securities
Cash and cash equivalents consist of cash and highly liquid securities with original maturities at the date of acquisition of ninety days or less and can be liquidated without prior notice or penalty. Investments with an original maturity of more than ninety days are considered marketable securities and have been classified by management as available-for-sale. These investments are classified as current assets, even though the stated maturity date may be one year or more beyond the current balance sheet date which reflects management’s intention to use the proceeds from sales of these securities to fund its operations, as necessary. Such investments are carried at fair value, with unrealized gains and losses included as a separate component of stockholders’ equity. Realized gains and losses from the sale of available-for-sale securities or the amounts, net of tax, reclassified out of accumulated other comprehensive income (loss), if any, are determined on a specific identification basis.
Restricted Cash
The Company is required to maintain a letter of credit securing an amount equal to twelve months of the current monthly installment of base rent for the term of its primary facilities lease, which ends in August 2017. Under certain circumstances, the Company may be able to eliminate the need for the letter of credit. As of September 30, 2015, and December 31, 2014, restricted cash of $3.2 million was pledged as collateral for this letter of credit.
Revenue Recognition
Revenue is recognized when the four basic criteria of revenue recognition are met: (1) persuasive evidence of an arrangement exists; (2) delivery has occurred or services rendered; (3) the fee is fixed or determinable; and (4) collectability is reasonably assured. Certain portions of the Company’s revenue are generated through manufacturing contracts and stand-alone license agreements.
Multiple-element arrangements
The Company has entered into multiple-element arrangements. In order to account for the multiple-element arrangements, the Company identifies the deliverables included within the agreement and evaluates which deliverables represents separate units of accounting. Analyzing the arrangement to identify deliverables requires the use of judgment, and each deliverable may be an obligation to deliver services, a right or license to use an asset, or another performance obligation. The delivered item(s) must have value to the customer on a standalone basis and, if the arrangement includes a general right of return relative to the delivered item, delivery or performance of the undelivered item(s) is considered probable and substantially in the Company’s control.
A delivered item is considered a separate unit of accounting when the delivered item has value to the partner on a standalone basis based on the consideration of the relevant facts and circumstances for each arrangement. Factors considered in this determination include the research capabilities of the partner and the availability of research expertise in this field in the general marketplace. Arrangement consideration is allocated at the inception of the agreement to all identified units of accounting based on their relative selling price. The relative selling price for each deliverable is determined using vendor specific objective evidence, or VSOE, of selling price or third-party evidence of selling price if VSOE does not exist. If neither VSOE nor third-party evidence of selling price exists, the Company uses its best estimate of the selling price for the deliverable. The amount of allocable arrangement consideration is limited to amounts that are fixed or determinable. The consideration received is allocated among the separate units of accounting, and the applicable revenue recognition criteria are applied to each of the separate units. Changes in the allocation of the sales price between delivered and undelivered elements can impact revenue recognition but do not change the total revenue recognized under any agreement. If facts and circumstances dictate that the license has standalone value from the undelivered items, which generally include research and development services and the manufacture of drug products, the license is identified as a separate unit of accounting and the amounts allocated to the license are recognized upon the delivery of the license, assuming the other revenue recognition criteria have been met. However, if the amounts allocated to the license through the relative selling price allocation exceed the upfront license fee, the amount recognized upon the delivery of the license is limited to the upfront fee received. If facts and circumstances dictate that the license does not have standalone value, the transaction price, including any upfront license fee payments received, are allocated to the identified separate units of accounting and recognized as those items are delivered.
The terms of the Company’s partnership agreements provide for milestone payments upon achievement of certain regulatory and commercial events. Under the Milestone Method, the Company recognizes consideration that is contingent upon the achievement of a milestone in its entirety as revenue in the period in which the milestone is achieved only if the milestone is substantive in its entirety. A milestone is considered substantive when it meets all of the following criteria: 1) The consideration is commensurate with either the entity’s performance to achieve the milestone or the enhancement of the value of the delivered item(s) as a result of a specific outcome resulting from the entity’s performance to achieve the milestone, 2) The consideration relates solely to past performance, and 3) The consideration is reasonable relative to all of the deliverables and payment terms within the arrangement. A milestone is defined as an event (i) that can only be achieved based in whole or in part on either the entity’s performance or on the occurrence of a specific outcome resulting from the entity’s performance, (ii) for which there is substantive uncertainty at the date the arrangement is entered into that the event will be achieved and (iii) that would result in additional payments being due to the Company.
Contract Services, Grant and Royalty Revenue
The Company recognizes revenues from contract services and federal government research grants during the period in which the related expenditures are incurred and related payments for those services are received or collection is reasonably assured. Royalties to be received based on sales of licensed products by the Company’s partners incorporating the Company’s licensed technology are recognized when received.
Manufacturing and Production Costs
Manufacturing and production costs include expenses related to manufacturing contracts and expenses for the production of plasmid DNA for use in the Company’s research and development efforts. Manufacturing expenses related to manufacturing contracts are deferred and expensed when the related revenue is recognized. Production expenses related to the Company’s research and development efforts are expensed as incurred.
Net Loss Per Share
Basic and diluted net loss per share has been computed using the weighted-average number of shares of common stock outstanding during the period. The weighted average number of shares used to compute diluted loss per share excludes any assumed exercise of stock options and any assumed issuance of common stock under restricted stock units as the effect would be antidilutive. Common stock equivalents of 0.1 million and 0.4 million for the three months ended September 30, 2015 and 2014, respectively, were excluded from the calculation because of their antidilutive effect. Common stock equivalents of 0.4 million and 0.5 million for the nine months ended September 30, 2015 and 2014, respectively, were excluded from the calculation because of their antidilutive effect.
Stock-Based Compensation
The Company records its compensation expense associated with stock options and other forms of equity compensation based on their fair value at the date of grant using the Black-Scholes-Merton option pricing model. Stock-based compensation includes amortization related to stock option awards based on the estimated grant date fair value. Stock-based compensation expense related to stock options includes an estimate for forfeitures and the portion that is ultimately expected to vest is recognized ratably over the vesting period of the option. In addition, the Company records expense related to RSUs granted based on the fair value of those awards on the grant date. The fair value related to the RSUs is amortized to expense over the vesting term of those awards. Stock-based compensation expense related to RSUs includes an estimate for forfeitures and the portion expected to vest is recognized ratably over the requisite service period. The expected forfeiture rate of all equity-based compensation is based on observed historical patterns of the Company’s employees and is estimated to be 8.75% and 11.2% annually for each of the nine months ended September 30, 2015 and 2014, respectively.
Stock-based compensation expense for a stock-based award with a performance condition is recognized when the achievement of such performance condition is determined to be probable. If the outcome of such performance condition is not determined to be probable or is not met, no compensation expense is recognized and any recognized compensation expense is reversed.
Recent Accounting Pronouncements
In May 2014, the FASB issued guidance that outlines a single comprehensive model for entities to use in accounting for revenue arising from contracts with customers and supersedes most current revenue recognition guidance, including industry-specific guidance. The guidance provides that an entity recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. This guidance also requires additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments, and assets recognized from costs incurred to obtain or fulfill a contract. The guidance allows for either full retrospective or modified retrospective adoption and will become effective for the Company in the first quarter of 2019. The Company is evaluating the alternative transition methods and the potential effects of the adoption of this update on its financial statements.
In August 2014, the FASB issued an amendment to the accounting guidance related to the evaluation of an entity to continue as a going concern. The amendment establishes management’s responsibility to evaluate whether there is substantial doubt about an entity’s ability to continue as a going concern in connection with preparing financial statements for each annual and interim reporting period. The amendment also gives guidance to determine whether to disclose information about relevant conditions and events when there is substantial doubt about an entity’s ability to continue as a going concern. The amended guidance is effective prospectively for fiscal years beginning after December 15, 2016. The new guidance will not have an impact on the Company’s financial position, results of operations or cash flows.
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2. |
STOCK-BASED COMPENSATION |
Total stock-based compensation expense was allocated to research and development, manufacturing and production and general and administrative expense as follows (in thousands):
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Three Months Ended |
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Nine Months Ended |
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September 30, |
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September 30, |
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2015 |
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2014 |
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2015 |
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2014 |
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Research and development |
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$ |
93 |
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$ |
186 |
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$ |
309 |
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$ |
628 |
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Manufacturing and production |
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42 |
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56 |
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123 |
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177 |
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General and administrative |
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302 |
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488 |
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1,102 |
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1,646 |
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Total stock-based compensation expense |
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$ |
437 |
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$ |
730 |
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$ |
1,534 |
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$ |
2,451 |
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During the nine months ended September 30, 2015 and 2014, the Company granted stock-based awards with a total estimated value of $1.9 million and $2.3 million, respectively. At September 30, 2015, total unrecognized estimated compensation expense related to unvested stock-based awards granted prior to that date was $1.7 million, which is expected to be recognized over a weighted-average period of 1.4 years. Stock-based awards granted during the nine months ended September 30, 2015 and 2014, were equal to 3.3% and 3.0%, respectively, of the outstanding shares of common stock at the end of the applicable period.
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3. |
MARKETABLE SECURITIES, AVAILABLE FOR SALE |
The following is a summary of available-for-sale marketable securities (in thousands):
September 30, 2015 |
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Amortized Cost |
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Unrealized Gain |
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Unrealized Loss |
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Market Value |
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U.S. treasuries |
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$ |
5,030 |
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$ |
5 |
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$ |
— |
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$ |
5,035 |
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Government-sponsored enterprise securities |
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2,000 |
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— |
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— |
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2,000 |
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Corporate bonds |
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2,005 |
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— |
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— |
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2,005 |
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Certificates of deposit |
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10,824 |
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— |
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— |
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10,824 |
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$ |
19,859 |
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$ |
5 |
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$ |
- |
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$ |
19,864 |
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December 31, 2014 |
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Amortized Cost |
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Unrealized Gain |
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Unrealized Loss |
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Market Value |
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U.S. treasuries |
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$ |
5,558 |
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$ |
— |
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$ |
1 |
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$ |
5,557 |
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Government-sponsored enterprise securities |
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7,499 |
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— |
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6 |
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7,493 |
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Corporate bonds |
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2,025 |
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— |
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5 |
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2,020 |
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Certificates of deposit |
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8,429 |
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— |
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— |
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8,429 |
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$ |
23,511 |
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$ |
- |
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$ |
12 |
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$ |
23,499 |
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At September 30, 2015, $0.5 million of these securities were scheduled to mature outside of one year. The Company did not realize any gains or losses on sales of available-for-sale securities for the nine months ended September 30, 2015. As of September 30, 2015, none of the securities had been in a continuous material unrealized loss position longer than one year.
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4. |
OTHER BALANCE SHEET ACCOUNTS |
Accounts payable and accrued expenses consisted of the following (in thousands):
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September 30, |
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December 31, |
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2015 |
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2014 |
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Employee compensation |
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$ |
1,850 |
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$ |
2,471 |
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Clinical trial accruals |
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206 |
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1,686 |
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Accounts payable |
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316 |
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227 |
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Deferred rent |
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480 |
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432 |
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Other accrued liabilities |
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512 |
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385 |
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Total accounts payable and accrued expenses |
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$ |
3,364 |
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$ |
5,201 |
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5. |
LONG-TERM INVESTMENTS |
As of September 30, 2015, the Company held an auction rate security with a par value of $2.5 million. This auction rate security has not experienced a successful auction since the liquidity issues experienced in the global credit and capital markets in 2008. As a result, the security is classified as a long-term investment as it is scheduled to mature in 2038. The security was rated A- by Standard and Poor’s as of September 30, 2015. The security continues to pay interest according to its stated terms.
The valuation of the Company’s auction rate security is subject to uncertainties that are difficult to predict. The fair value of the security is estimated utilizing a discounted cash flow analysis. The key drivers of the valuation model include the expected term, collateral underlying the security investment, the creditworthiness of the counterparty, the timing of expected future cash flows, discount rates, liquidity and the expected holding period. The security was also compared, when possible, to other observable market data for securities with similar characteristics. As of September 30, 2015, the inputs used in the Company’s discounted cash flow analysis assumed an interest rate of 1.39%, an estimated redemption period of five years and a discount rate of 1.50%. Based on the valuation of the security, the Company has recognized cumulative losses of $0.5 million as of September 30, 2015, none of which were realized during the three months ended September 30, 2015. The losses when recognized are included in investment and other income. The market value of the security has partially recovered. Included in other comprehensive income (loss) are unrealized gains (losses) of $106,000 and $(43,000) for the nine months ended September 30, 2015 and 2014, respectively. As of September 30, 2015, the Company had recorded cumulative unrealized gains of $0.3 million. The resulting carrying value of the auction rate security at September 30, 2015, was $2.1 million. Any future decline in market value may result in additional losses being recognized.
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6. |
FAIR VALUE MEASUREMENTS |
The Company measures fair value as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. Fair value measurements are based on a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows:
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Level 1: Observable inputs such as quoted prices in active markets; |
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· |
Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and |
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Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions. |
Cash equivalents, marketable securities and long-term investments measured at fair value are classified in the table below in one of the three categories described above (in thousands):
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Fair Value Measurements |
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September 30, 2015 |
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Level 1 |
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Level 2 |
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Level 3 |
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Total |
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Certificates of deposit |
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$ |
10,824 |
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$ |
— |
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$ |
— |
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$ |
10,824 |
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U.S. treasuries |
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5,035 |
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|
|
— |
|
|
|
— |
|
|
|
5,035 |
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Corporate bonds |
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— |
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2,005 |
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|
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— |
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2,005 |
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Government-sponsored enterprise securities |
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— |
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2,000 |
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|
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— |
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2,000 |
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Auction rate securities |
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— |
|
|
|
— |
|
|
|
2,077 |
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|
|
2,077 |
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|
|
$ |
15,859 |
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$ |
4,005 |
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|
$ |
2,077 |
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$ |
21,941 |
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Fair Value Measurements |
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December 31, 2014 |
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Level 1 |
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Level 2 |
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Level 3 |
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Total |
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Certificates of deposit |
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$ |
8,674 |
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$ |
— |
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$ |
— |
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$ |
8,674 |
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Money market funds |
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|
169 |
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|
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— |
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|
|
— |
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|
|
169 |
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U.S. treasuries |
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5,557 |
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|
|
— |
|
|
|
— |
|
|
|
5,557 |
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Corporate bonds |
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— |
|
|
|
2,020 |
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|
|
— |
|
|
|
2,020 |
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Government-sponsored enterprise securities |
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|
— |
|
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7,493 |
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|
|
— |
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|
|
7,493 |
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Auction rate securities |
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— |
|
|
|
— |
|
|
|
1,971 |
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|
|
1,971 |
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|
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$ |
14,400 |
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$ |
9,513 |
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$ |
1,971 |
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$ |
25,884 |
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The Company’s investments in U.S. treasury securities, certificates of deposit and money market funds are valued based on publicly available quoted market prices for identical securities as of September 30, 2015. The Company determines the fair value of corporate bonds and other government-sponsored enterprise related securities with the aid of valuations provided by third parties using proprietary valuation models and analytical tools. These valuation models and analytical tools use market pricing or similar instruments that are both objective and publicly available, including matrix pricing or reported trades, benchmark yields, broker/dealer quotes, issuer spreads, two-sided markets, benchmark securities, bids and/or offers. The Company validates the valuations received from its primary pricing vendors for its level 2 securities by examining the inputs used in that vendor’s pricing process and determines whether they are reasonable and observable. The Company also compares those valuations to recent reported trades for those securities. The Company did not adjust any of the valuations received from these independent third parties with respect to any of its level 2 securities at September 30, 2015. The Company did not transfer any investments between level categories during the three and nine months ended September 30, 2015. The valuation of the Company’s investments in auction rate securities, which includes significant unobservable inputs, is more fully described in Note 5.
Activity for assets measured at fair value using significant unobservable inputs (Level 3) is presented in the table below (in thousands):
Balance at December 31, 2014 |
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$ |
1,971 |
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Total unrealized gains, excluding tax impact, included in other comprehensive loss |
|
|
106 |
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Balance at September 30, 2015 |
|
$ |
2,077 |
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Total gains or losses for the period included in net loss attributable to the change in unrealized gains or losses relating to assets still held at the reporting date |
|
$ |
— |
|
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7. |
COMMITMENTS AND CONTINGENCIES |
In late October and early November 2013, following the Company’s announcement of the results of its Phase 3 trial of Allovectin® and the subsequent decline of the price of its common stock, two putative securities class action complaints were filed in the U.S. District Court for the Southern District of California against the Company and certain of its current and former officers. On February 26, 2014, the two cases were consolidated into one action and a lead plaintiff and lead counsel were appointed, or Consolidation Order. On May 12, 2014, the lead plaintiff filed a first amended consolidated complaint alleging that the defendants violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 by making materially false and misleading statements regarding the Company’s business prospects and the prospects for Allovectin®, thereby artificially inflating the price of its common stock. On June 9, 2014, the defendants filed a motion to dismiss the first amended complaint and a motion to strike certain allegations in the amended complaint. On March 9, 2015, the Court granted defendants’ motion to dismiss the first amended complaint and terminated as moot defendants’ motion to strike, or Order. The Lead plaintiff was granted leave to amend his first amended complaint on or before March 25, 2015. The lead plaintiff chose not to amend his complaint and instead stipulated to an entry of judgment. On April 28, 2015, the Court entered final judgment dismissing the action, or Judgment. On May 28, 2015, the lead plaintiff appealed the Order and Judgment to the U.S. Court of Appeals for the Ninth Circuit. That same day, another group of the Company’s stockholders, that had previously moved for appointment as lead plaintiff, or the Vical Investor Group, also appealed the Order and Judgment, as well as the Consolidation Order, to the U.S. Court of Appeals for the Ninth Circuit. On August 3, 2015, the Vical Investor Group voluntarily dismissed its appeal. On October 8, 2015, the lead plaintiff-appellant filed an opening brief in support of his appeal. The Defendants’ answering brief is currently due on November 9, 2015.
In the ordinary course of business, the Company may become a party to additional lawsuits involving various matters. The Company is unaware of any such lawsuits presently pending against it which, individually or in the aggregate, are deemed to be material to the Company’s financial condition or results of operations.
The Company prosecutes its intellectual property vigorously to obtain the broadest valid scope for its patents. Due to uncertainty of the ultimate outcome of these matters, the impact on future operating results or the Company’s financial condition is not subject to reasonable estimates.
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8. |
ASTELLAS OUT-LICENSE AGREEMENTS |
In July 2011, the Company entered into license agreements with Astellas Pharma Inc., or Astellas, granting Astellas exclusive, worldwide, royalty-bearing licenses under certain of the Company's know-how and intellectual property to develop and commercialize certain products containing plasmids encoding certain forms of cytomegalovirus, glycoprotein B and/or phosphoprotein 65, including ASP0113 (TransVax™) but excluding CyMVectin™.
Under the terms of the agreements, the Company is performing research and development services and manufacturing services which are being paid for by Astellas. During the three months ended September 30, 2015 and 2014, the Company recognized $4.4 million and $3.0 million, respectively, of revenue related to these contract services. During the nine months ended September 30, 2015 and 2014, the Company recognized $12.4 million and $9.1 million, respectively, of revenue related to these contract services. The Company also recognized $1.5 million and $1.1 million in license revenue under the Astellas agreements during the nine months ended September 30, 2015 and 2014, respectively.
9. |
ASTELLAS IN-LICENSE AGREEMENTS |
In March 2015, the Company entered into license and stock purchase agreements with Astellas, granting Vical exclusive worldwide license to develop and commercialize a novel antifungal, VL-2397, formally known as ASP2397. VL-2397 is a potential therapeutic for invasive fungal infections, including invasive aspergillosis. Astellas received 861,216 shares of unregistered Vical common stock and $250,000 in cash. The $250,000 cash payment and the fair value of the common stock issued of $775,094 were included in research and development expenses during the nine months ending September 30, 2015. Astellas will also be eligible to receive up to $100 million in aggregate milestone payments, the vast majority of which are commercial and sales milestones, and single-digit royalties on net sales of commercial products.
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Cash, Cash Equivalents and Marketable Securities
Cash and cash equivalents consist of cash and highly liquid securities with original maturities at the date of acquisition of ninety days or less and can be liquidated without prior notice or penalty. Investments with an original maturity of more than ninety days are considered marketable securities and have been classified by management as available-for-sale. These investments are classified as current assets, even though the stated maturity date may be one year or more beyond the current balance sheet date which reflects management’s intention to use the proceeds from sales of these securities to fund its operations, as necessary. Such investments are carried at fair value, with unrealized gains and losses included as a separate component of stockholders’ equity. Realized gains and losses from the sale of available-for-sale securities or the amounts, net of tax, reclassified out of accumulated other comprehensive income (loss), if any, are determined on a specific identification basis.
Restricted Cash
The Company is required to maintain a letter of credit securing an amount equal to twelve months of the current monthly installment of base rent for the term of its primary facilities lease, which ends in August 2017. Under certain circumstances, the Company may be able to eliminate the need for the letter of credit. As of September 30, 2015, and December 31, 2014, restricted cash of $3.2 million was pledged as collateral for this letter of credit.
Revenue Recognition
Revenue is recognized when the four basic criteria of revenue recognition are met: (1) persuasive evidence of an arrangement exists; (2) delivery has occurred or services rendered; (3) the fee is fixed or determinable; and (4) collectability is reasonably assured. Certain portions of the Company’s revenue are generated through manufacturing contracts and stand-alone license agreements.
Multiple-element arrangements
The Company has entered into multiple-element arrangements. In order to account for the multiple-element arrangements, the Company identifies the deliverables included within the agreement and evaluates which deliverables represents separate units of accounting. Analyzing the arrangement to identify deliverables requires the use of judgment, and each deliverable may be an obligation to deliver services, a right or license to use an asset, or another performance obligation. The delivered item(s) must have value to the customer on a standalone basis and, if the arrangement includes a general right of return relative to the delivered item, delivery or performance of the undelivered item(s) is considered probable and substantially in the Company’s control.
A delivered item is considered a separate unit of accounting when the delivered item has value to the partner on a standalone basis based on the consideration of the relevant facts and circumstances for each arrangement. Factors considered in this determination include the research capabilities of the partner and the availability of research expertise in this field in the general marketplace. Arrangement consideration is allocated at the inception of the agreement to all identified units of accounting based on their relative selling price. The relative selling price for each deliverable is determined using vendor specific objective evidence, or VSOE, of selling price or third-party evidence of selling price if VSOE does not exist. If neither VSOE nor third-party evidence of selling price exists, the Company uses its best estimate of the selling price for the deliverable. The amount of allocable arrangement consideration is limited to amounts that are fixed or determinable. The consideration received is allocated among the separate units of accounting, and the applicable revenue recognition criteria are applied to each of the separate units. Changes in the allocation of the sales price between delivered and undelivered elements can impact revenue recognition but do not change the total revenue recognized under any agreement. If facts and circumstances dictate that the license has standalone value from the undelivered items, which generally include research and development services and the manufacture of drug products, the license is identified as a separate unit of accounting and the amounts allocated to the license are recognized upon the delivery of the license, assuming the other revenue recognition criteria have been met. However, if the amounts allocated to the license through the relative selling price allocation exceed the upfront license fee, the amount recognized upon the delivery of the license is limited to the upfront fee received. If facts and circumstances dictate that the license does not have standalone value, the transaction price, including any upfront license fee payments received, are allocated to the identified separate units of accounting and recognized as those items are delivered.
The terms of the Company’s partnership agreements provide for milestone payments upon achievement of certain regulatory and commercial events. Under the Milestone Method, the Company recognizes consideration that is contingent upon the achievement of a milestone in its entirety as revenue in the period in which the milestone is achieved only if the milestone is substantive in its entirety. A milestone is considered substantive when it meets all of the following criteria: 1) The consideration is commensurate with either the entity’s performance to achieve the milestone or the enhancement of the value of the delivered item(s) as a result of a specific outcome resulting from the entity’s performance to achieve the milestone, 2) The consideration relates solely to past performance, and 3) The consideration is reasonable relative to all of the deliverables and payment terms within the arrangement. A milestone is defined as an event (i) that can only be achieved based in whole or in part on either the entity’s performance or on the occurrence of a specific outcome resulting from the entity’s performance, (ii) for which there is substantive uncertainty at the date the arrangement is entered into that the event will be achieved and (iii) that would result in additional payments being due to the Company.
Contract Services, Grant and Royalty Revenue
The Company recognizes revenues from contract services and federal government research grants during the period in which the related expenditures are incurred and related payments for those services are received or collection is reasonably assured. Royalties to be received based on sales of licensed products by the Company’s partners incorporating the Company’s licensed technology are recognized when received.
Manufacturing and Production Costs
Manufacturing and production costs include expenses related to manufacturing contracts and expenses for the production of plasmid DNA for use in the Company’s research and development efforts. Manufacturing expenses related to manufacturing contracts are deferred and expensed when the related revenue is recognized. Production expenses related to the Company’s research and development efforts are expensed as incurred.
Net Loss Per Share
Basic and diluted net loss per share has been computed using the weighted-average number of shares of common stock outstanding during the period. The weighted average number of shares used to compute diluted loss per share excludes any assumed exercise of stock options and any assumed issuance of common stock under restricted stock units as the effect would be antidilutive. Common stock equivalents of 0.1 million and 0.4 million for the three months ended September 30, 2015 and 2014, respectively, were excluded from the calculation because of their antidilutive effect. Common stock equivalents of 0.4 million and 0.5 million for the nine months ended September 30, 2015 and 2014, respectively, were excluded from the calculation because of their antidilutive effect.
Stock-Based Compensation
The Company records its compensation expense associated with stock options and other forms of equity compensation based on their fair value at the date of grant using the Black-Scholes-Merton option pricing model. Stock-based compensation includes amortization related to stock option awards based on the estimated grant date fair value. Stock-based compensation expense related to stock options includes an estimate for forfeitures and the portion that is ultimately expected to vest is recognized ratably over the vesting period of the option. In addition, the Company records expense related to RSUs granted based on the fair value of those awards on the grant date. The fair value related to the RSUs is amortized to expense over the vesting term of those awards. Stock-based compensation expense related to RSUs includes an estimate for forfeitures and the portion expected to vest is recognized ratably over the requisite service period. The expected forfeiture rate of all equity-based compensation is based on observed historical patterns of the Company’s employees and is estimated to be 8.75% and 11.2% annually for each of the nine months ended September 30, 2015 and 2014, respectively.
Stock-based compensation expense for a stock-based award with a performance condition is recognized when the achievement of such performance condition is determined to be probable. If the outcome of such performance condition is not determined to be probable or is not met, no compensation expense is recognized and any recognized compensation expense is reversed.
Recent Accounting Pronouncements
In May 2014, the FASB issued guidance that outlines a single comprehensive model for entities to use in accounting for revenue arising from contracts with customers and supersedes most current revenue recognition guidance, including industry-specific guidance. The guidance provides that an entity recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. This guidance also requires additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments, and assets recognized from costs incurred to obtain or fulfill a contract. The guidance allows for either full retrospective or modified retrospective adoption and will become effective for the Company in the first quarter of 2019. The Company is evaluating the alternative transition methods and the potential effects of the adoption of this update on its financial statements.
In August 2014, the FASB issued an amendment to the accounting guidance related to the evaluation of an entity to continue as a going concern. The amendment establishes management’s responsibility to evaluate whether there is substantial doubt about an entity’s ability to continue as a going concern in connection with preparing financial statements for each annual and interim reporting period. The amendment also gives guidance to determine whether to disclose information about relevant conditions and events when there is substantial doubt about an entity’s ability to continue as a going concern. The amended guidance is effective prospectively for fiscal years beginning after December 15, 2016. The new guidance will not have an impact on the Company’s financial position, results of operations or cash flows.
|
Total stock-based compensation expense was allocated to research and development, manufacturing and production and general and administrative expense as follows (in thousands):
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
||||||||||
|
|
September 30, |
|
|
September 30, |
|
||||||||||
|
|
2015 |
|
|
2014 |
|
|
2015 |
|
|
2014 |
|
||||
Research and development |
|
$ |
93 |
|
|
$ |
186 |
|
|
$ |
309 |
|
|
$ |
628 |
|
Manufacturing and production |
|
|
42 |
|
|
|
56 |
|
|
|
123 |
|
|
|
177 |
|
General and administrative |
|
|
302 |
|
|
|
488 |
|
|
|
1,102 |
|
|
|
1,646 |
|
Total stock-based compensation expense |
|
$ |
437 |
|
|
$ |
730 |
|
|
$ |
1,534 |
|
|
$ |
2,451 |
|
|
The following is a summary of available-for-sale marketable securities (in thousands):
September 30, 2015 |
|
Amortized Cost |
|
|
Unrealized Gain |
|
|
Unrealized Loss |
|
|
Market Value |
|
||||
U.S. treasuries |
|
$ |
5,030 |
|
|
$ |
5 |
|
|
$ |
— |
|
|
$ |
5,035 |
|
Government-sponsored enterprise securities |
|
|
2,000 |
|
|
|
— |
|
|
|
— |
|
|
|
2,000 |
|
Corporate bonds |
|
|
2,005 |
|
|
|
— |
|
|
|
— |
|
|
|
2,005 |
|
Certificates of deposit |
|
|
10,824 |
|
|
|
— |
|
|
|
— |
|
|
|
10,824 |
|
|
|
$ |
19,859 |
|
|
$ |
5 |
|
|
$ |
- |
|
|
$ |
19,864 |
|
December 31, 2014 |
|
Amortized Cost |
|
|
Unrealized Gain |
|
|
Unrealized Loss |
|
|
Market Value |
|
||||
U.S. treasuries |
|
$ |
5,558 |
|
|
$ |
— |
|
|
$ |
1 |
|
|
$ |
5,557 |
|
Government-sponsored enterprise securities |
|
|
7,499 |
|
|
|
— |
|
|
|
6 |
|
|
|
7,493 |
|
Corporate bonds |
|
|
2,025 |
|
|
|
— |
|
|
|
5 |
|
|
|
2,020 |
|
Certificates of deposit |
|
|
8,429 |
|
|
|
— |
|
|
|
— |
|
|
|
8,429 |
|
|
|
$ |
23,511 |
|
|
$ |
- |
|
|
$ |
12 |
|
|
$ |
23,499 |
|
|
Accounts payable and accrued expenses consisted of the following (in thousands):
|
|
September 30, |
|
|
December 31, |
|
||
|
|
2015 |
|
|
2014 |
|
||
Employee compensation |
|
$ |
1,850 |
|
|
$ |
2,471 |
|
Clinical trial accruals |
|
|
206 |
|
|
|
1,686 |
|
Accounts payable |
|
|
316 |
|
|
|
227 |
|
Deferred rent |
|
|
480 |
|
|
|
432 |
|
Other accrued liabilities |
|
|
512 |
|
|
|
385 |
|
Total accounts payable and accrued expenses |
|
$ |
3,364 |
|
|
$ |
5,201 |
|
|
Cash equivalents, marketable securities and long-term investments measured at fair value are classified in the table below in one of the three categories described above (in thousands):
|
|
Fair Value Measurements |
|
|||||||||||||
September 30, 2015 |
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
||||
Certificates of deposit |
|
$ |
10,824 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
10,824 |
|
U.S. treasuries |
|
|
5,035 |
|
|
|
— |
|
|
|
— |
|
|
|
5,035 |
|
Corporate bonds |
|
|
— |
|
|
|
2,005 |
|
|
|
— |
|
|
|
2,005 |
|
Government-sponsored enterprise securities |
|
|
— |
|
|
|
2,000 |
|
|
|
— |
|
|
|
2,000 |
|
Auction rate securities |
|
|
— |
|
|
|
— |
|
|
|
2,077 |
|
|
|
2,077 |
|
|
|
$ |
15,859 |
|
|
$ |
4,005 |
|
|
$ |
2,077 |
|
|
$ |
21,941 |
|
|
|
Fair Value Measurements |
|
|||||||||||||
December 31, 2014 |
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
||||
Certificates of deposit |
|
$ |
8,674 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
8,674 |
|
Money market funds |
|
|
169 |
|
|
|
— |
|
|
|
— |
|
|
|
169 |
|
U.S. treasuries |
|
|
5,557 |
|
|
|
— |
|
|
|
— |
|
|
|
5,557 |
|
Corporate bonds |
|
|
— |
|
|
|
2,020 |
|
|
|
— |
|
|
|
2,020 |
|
Government-sponsored enterprise securities |
|
|
— |
|
|
|
7,493 |
|
|
|
— |
|
|
|
7,493 |
|
Auction rate securities |
|
|
— |
|
|
|
— |
|
|
|
1,971 |
|
|
|
1,971 |
|
|
|
$ |
14,400 |
|
|
$ |
9,513 |
|
|
$ |
1,971 |
|
|
$ |
25,884 |
|
Activity for assets measured at fair value using significant unobservable inputs (Level 3) is presented in the table below (in thousands):
Balance at December 31, 2014 |
|
$ |
1,971 |
|
Total unrealized gains, excluding tax impact, included in other comprehensive loss |
|
|
106 |
|
Balance at September 30, 2015 |
|
$ |
2,077 |
|
Total gains or losses for the period included in net loss attributable to the change in unrealized gains or losses relating to assets still held at the reporting date |
|
$ |
— |
|
|
|
|
|
|
|
|
|
|
|
|
|