VICAL INC, 10-Q filed on 5/10/2013
Quarterly Report
Document and Entity Information
3 Months Ended
Mar. 31, 2013
Apr. 22, 2013
Document and Entity Information [Abstract]
 
 
Entity Registrant Name
VICAL INC 
 
Entity Central Index Key
0000819050 
 
Document Type
10-Q 
 
Document Period End Date
Mar. 31, 2013 
 
Amendment Flag
false 
 
Document Fiscal Year Focus
2013 
 
Document Fiscal Period Focus
Q1 
 
Current Fiscal Year End Date
--12-31 
 
Entity Filer Category
Accelerated Filer 
 
Entity Common Stock, Shares Outstanding
 
86,448,194 
Balance Sheets (Unaudited) (USD $)
In Thousands, unless otherwise specified
Mar. 31, 2013
Dec. 31, 2012
Current assets:
 
 
Cash and cash equivalents
$ 47,026 
$ 43,159 
Marketable securities, available-for-sale
25,352 
37,639 
Restricted cash
3,059 
3,059 
Receivables and other assets
2,390 
2,152 
Total current assets
77,827 
86,009 
Long-term investments
2,197 
2,225 
Property and equipment, net
5,042 
5,284 
Intangible assets, net
2,742 
2,813 
Other assets
191 
191 
Total assets
87,999 
96,522 
Current liabilities:
 
 
Accounts payable and accrued expenses
5,109 
5,629 
Deferred revenue
167 
150 
Total current liabilities
5,276 
5,779 
Long-term liabilities:
 
 
Deferred rent
1,569 
1,657 
Commitments and contingencies
   
   
Stockholders' equity:
 
 
Preferred stock, $0.01 par value, 5,000 shares authorized, none issued and outstanding
   
   
Common stock, $0.01 par value, 160,000 shares authorized, 86,311 and 86,136 shares issued and outstanding at March 31, 2013 and December 31, 2012, respectively
863 
861 
Additional paid-in capital
437,276 
435,915 
Accumulated deficit
(357,219)
(347,937)
Accumulated other comprehensive income
234 
247 
Total stockholders' equity
81,154 
89,086 
Total liabilities and stockholders' equity
$ 87,999 
$ 96,522 
Balance Sheets (Unaudited) (Parenthetical) (USD $)
In Thousands, except Per Share data, unless otherwise specified
Mar. 31, 2013
Dec. 31, 2012
Balance Sheets [Abstract]
 
 
Preferred stock, par value
$ 0.01 
$ 0.01 
Preferred stock, shares authorized
5,000 
5,000 
Preferred stock, shares issued
   
   
Preferred stock, shares outstanding
   
   
Common stock, par value
$ 0.01 
$ 0.01 
Common stock, shares authorized
160,000 
160,000 
Common stock, shares, issued
86,311 
86,136 
Common stock, shares outstanding
86,311 
86,136 
Statements of Operations (Unaudited) (USD $)
In Thousands, except Per Share data, unless otherwise specified
3 Months Ended
Mar. 31, 2013
Mar. 31, 2012
Revenues:
 
 
Contract and grant revenue
$ 1,136 
$ 1,221 
License and royalty revenue
438 
10,239 
Total revenues
1,574 
11,460 
Operating expenses:
 
 
Research and development
3,650 
6,428 
Manufacturing and production
3,713 
2,472 
General and administrative
3,518 
2,700 
Total operating expenses
10,881 
11,600 
Loss from operations
(9,307)
(140)
Other income (expense):
 
 
Investment and other income, net
25 
384 
Net income (loss)
$ (9,282)
$ 244 
Basic net income (loss) per share
$ (0.11)
$ 0.00 
Diluted net income (loss) per share
$ (0.11)
$ 0.00 
Weighted average shares used in computing basic net income (loss) per share
86,638 
84,519 
Weighted average shares used in computing diluted net income (loss) per share
86,638 
86,124 
Statements of Comprehensive Loss (Unaudited) (USD $)
In Thousands, unless otherwise specified
3 Months Ended
Mar. 31, 2013
Mar. 31, 2012
Statements of Comprehensive Loss [Abstract]
 
 
Net income (loss)
$ (9,282)
$ 244 
Unrealized (losses) gains on available-for-sale and long-term marketable securities:
 
 
Unrealized (losses) gains arising during holding period
(13)
196 
Less: Reversal of unrealized losses in accumulated other comprehensive loss upon the sale of long-term marketable securities included in investment and other income
 
(590)
Other comprehensive loss
(13)
(394)
Total comprehensive loss
$ (9,295)
$ (150)
Statements of Cash Flows (Unaudited) (USD $)
In Thousands, unless otherwise specified
3 Months Ended
Mar. 31, 2013
Mar. 31, 2012
Cash flows from operating activities:
 
 
Net income (loss)
$ (9,282)
$ 244 
Adjustments to reconcile net income (loss) to net cash used in operating activities:
 
 
Depreciation and amortization
506 
493 
Write-off of abandoned patents
81 
20 
Gain on sale of property and equipment
   
(6)
Compensation expense related to stock options and awards
1,138 
920 
Changes in operating assets and liabilities:
 
 
Receivables and other assets
(238)
(10,412)
Accounts payable and accrued expenses
(535)
889 
Deferred revenue
17 
(99)
Deferred rent
(72)
(57)
Net cash used in operating activities
(8,385)
(8,008)
Cash flows from investing activities:
 
 
Proceeds from the sale of marketable securities
   
3,750 
Maturities of marketable securities
12,594 
5,261 
Purchases of marketable securities
(293)
(17,659)
Purchases of property and equipment
(164)
(135)
Proceeds from the sale of property and equipment
   
Patent expenditures
(110)
(97)
Net cash provided by (used in) investing activities
12,027 
(8,874)
Cash flows from financing activities:
 
 
Net proceeds from issuance of common stock
328 
48,770 
Payment of withholding taxes for net settlement of restricted stock units
(103)
(109)
Net cash provided by financing activities
225 
48,661 
Net increase in cash and cash equivalents
3,867 
31,779 
Cash and cash equivalents at beginning of period
43,159 
38,696 
Cash and cash equivalents at end of period
$ 47,026 
$ 70,475 
General
GENERAL

1.       GENERAL

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 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 March 31, 2013, and for the three months ended March 31, 2013 and 2012, 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 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 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, 2012, 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. 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, 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 March 31, 2013, and December 31, 2012, restricted cash of $3.1 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 of the Company’s revenue is generated through manufacturing contracts and stand-alone license agreements.

 

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 represent 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. 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 three 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.

Net Income (Loss) Per Share

Basic and diluted net income (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 net loss per share excludes any assumed exercise of stock options and warrants, and any assumed issuance of common stock under restricted stock units, or RSUs, as the effect would be antidilutive. Common stock equivalents totaling 1.6 million shares for the three months ended March 31, 2013, were excluded from the calculation of diluted net loss per share because of their antidilutive effect. Common stock equivalents totaling 1.6 million shares for the three months ended March 31, 2012, were included in the calculation of diluted net income per share.

 

Recent Accounting Pronouncement

Effective January 1, 2013, the Company adopted Accounting Standards Update (“ASU”) No. 2013-02, “Reporting of Amounts Reclassified Out of Accumulated Other Comprehensive Income.” The adoption of ASU No. 2013-02 concerns presentation and disclosure only and did not have an impact on the Company’s financial position or results of operations. The Company elected to present the information required by ASU No. 2013-02 in the Statements of Comprehensive Loss.

Stock-Based Compensation
STOCK-BASED COMPENSATION

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):

 

                 
    Three Months Ended
March 31,
 
        2013             2012      

Research and development

  $ 312     $ 287  

Manufacturing and production

    68       49  

General and administrative

    758       584  
   

 

 

   

 

 

 

Total stock-based compensation expense

  $ 1,138     $ 920  
   

 

 

   

 

 

 

During the three months ended March 31, 2013 and 2012, the Company granted stock-based awards with a total estimated value of $3.1 million and $3.6 million, respectively. At March 31, 2013, total unrecognized estimated compensation expense related to unvested stock-based awards granted prior to that date was $4.3 million, which is expected to be recognized over a weighted-average period of 1.5 years. Stock-based awards granted during the three months ended March 31, 2013 and 2012, were equal to 1.8% and 1.9%, respectively, of outstanding shares of common stock at the end of the applicable period.

Other Balance Sheet Accounts
OTHER BALANCE SHEET ACCOUNTS

3.       OTHER BALANCE SHEET ACCOUNTS

Accounts payable and accrued expenses consisted of the following (in thousands):

 

                 
    March 31,
2013
    December 31,
2012
 

Employee compensation

  $ 2,392     $ 3,858  

Post-termination benefit accrual

    463       —    

Clinical trial accrual

    708       660  

Accounts payable

    645       377  

Deferred rent

    322       307  

Other accrued liabilities

    579       427  
   

 

 

   

 

 

 

Total accounts payable and accrued expenses

  $ 5,109     $ 5,629  
   

 

 

   

 

 

 

 

Marketable Securities, Available For Sale
MARKETABLE SECURITIES, AVAILABLE-FOR-SALE

4.       MARKETABLE SECURITIES, AVAILABLE FOR SALE

The following is a summary of available-for-sale marketable securities (in thousands):

 

                                 

March 31, 2013

  Amortized
Cost
    Unrealized
Gain
    Unrealized
Loss
    Market
Value
 

U.S. treasuries

  $ 7,574     $ 2     $ —       $ 7,576  

Government-sponsored enterprise securities

    7,751       —         —         7,751  

Corporate bonds

    9,246       —         6       9,240  

Certificates of deposit

    785       —         —         785  
   

 

 

   

 

 

   

 

 

   

 

 

 
    $ 25,356     $ 2     $ 6     $ 25,352  
   

 

 

   

 

 

   

 

 

   

 

 

 

 

                                 

December 31, 2012

  Amortized
Cost
    Unrealized
Gain
    Unrealized
Loss
    Market
Value
 

U.S. treasuries

  $ 10,135     $ 1     $ —       $ 10,136  

Government-sponsored enterprise securities

    15,507       —         1       15,506  

Corporate bonds

    11,509       —         8       11,501  

Certificates of deposit

    496       —         —          496  
   

 

 

   

 

 

   

 

 

   

 

 

 
    $ 37,647     $ 1     $ 9     $ 37,639  
   

 

 

   

 

 

   

 

 

   

 

 

 

At March 31, 2013, $7.8 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 three months ended March 31, 2013. As of March 31, 2013, none of the securities had been in a continuous unrealized loss position longer than one year.

Long-Term Investments
LONG TERM INVESTMENTS

5.       LONG-TERM INVESTMENTS

In March 2012, the Company sold two auction rate securities classified as long-term investments with a par value of $4.0 million. Included in interest and other income for the three months ended March 31, 2012, is a gain of $0.3 million related to the sale.

As of March 31, 2013, 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 BBB by Standard and Poor’s as of March 31, 2013. 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, collateralization 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. Based on the valuation of the security, the Company has recognized cumulative losses of $0.5 million as of March 31, 2013, none of which were recognized during the three months ended March 31, 2013. 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 are unrealized losses of $17,000 and $6,000 for the three months ended March 31, 2013 and 2012, respectively. As of March 31, 2013, the Company had recorded cumulative unrealized gains of $0.4 million. The resulting carrying value of the auction rate security at March 31, 2013, was $2.2 million. Any future decline in market value may result in additional losses being recognized.

 

Fair Value Measurements
FAIR VALUE MEASUREMENTS

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:

 

   

Level 1: Observable inputs such as quoted prices in active markets;

 

   

Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and

 

   

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):

 

                                 
    Fair Value Measurements  

March 31, 2013

  Level 1     Level 2     Level 3     Total  

Certificates of deposit

  $ 785     $ —       $ —       $ 785  

Money market funds

    19,816       —         —         19,816  

U.S. treasuries

    7,576       —         —         7,576  

Corporate bonds

    —         9,240       —         9,240  

Government-sponsored enterprise securities

    —         7,751       —         7,751  

Auction rate securities

    —         —         2,197       2,197  
   

 

 

   

 

 

   

 

 

   

 

 

 
    $ 28,177     $ 16,991     $ 2,197     $ 47,365  
   

 

 

   

 

 

   

 

 

   

 

 

 

 

                                 
    Fair Value Measurements  

December 31, 2012

  Level 1     Level 2     Level 3     Total  

Certificates of deposit

  $ 496     $ —       $ —       $ 496  

Money market funds

    18,500       —         —         18,500  

U.S. treasuries

    10,136       —         —         10,136  

Corporate bonds

    —         11,501       —         11,501  

Government-sponsored enterprise securities

    —         15,506       —         15,506  

Auction rate securities

    —         —         2,225       2,225  
   

 

 

   

 

 

   

 

 

   

 

 

 
    $ 29,132     $ 27,007     $ 2,225     $ 58,364  
   

 

 

   

 

 

   

 

 

   

 

 

 

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 March 31, 2013. 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 March 31, 2013. The Company did not reclassify any investments between level categories during the three months ended March 31, 2013. 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):

 

         
    Three Months
Ended

March  31, 2013
 

Balance at December 31, 2012

  $ 2,225  

Total net unrealized losses included in other comprehensive income

    (28
   

 

 

 

Balance at March 31, 2013

  $ 2,197  
   

 

 

 

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

  $ —    
   

 

 

 
Commitments and Contingencies
COMMITMENTS AND CONTINGENCIES

7.       COMMITMENTS AND CONTINGENCIES

The Company prosecutes its intellectual property estate vigorously to obtain the broadest valid scope for its patents. Due to uncertainty of the ultimate outcome of patent enforcement actions, their impact on future operating results or the Company’s financial condition is not subject to reasonable estimates.

In the ordinary course of business, the Company may become a party to 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.

Stockholders' Equity
STOCKHOLDERS' EQUITY

8.       STOCKHOLDERS’ EQUITY

In January 2012, the Company sold 13,333,334 shares of its common stock in a public offering at a price to the public of $3.75 per share. In February 2012, the Company sold an additional 576,358 shares pursuant to a partial exercise of the underwriters’ overallotment option at a price to the public of $3.75 per share. Net proceeds from the offering, after deducting underwriting discounts and commissions and other offering expenses payable by the Company, totaled $48.7 million. All of the shares of common stock were offered pursuant to two effective shelf registration statements.

In November 2012, the Company entered into an At-The-Market Equity Offering Sales Agreement, or Sales Agreement, with Stifel, Nicolaus & Company, Incorporated, or Stifel, under which the Company may issue and sell up to $50,000,000 of shares of its common stock from time to time. Under the Sales Agreement, the Company will set the parameters for the sale of shares, including the number of shares to be issued and any minimum price below which sales may not be made. Subject to the terms and conditions of the Sales Agreement, shares may be sold through Stifel acting as sales agent or directly to Stifel acting as principal, by means of ordinary brokers’ transactions on the Nasdaq Global Select Market, in privately negotiated transactions or otherwise at market prices prevailing at the time of sale, at prices related to prevailing market prices or at negotiated prices.

Astellas Agreements
ASTELLAS AGREEMENTS

9.       ASTELLAS 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, or CMV, glycoprotein B and/or phosphoprotein 65, including TransVax™ but excluding CyMVectin™.

Under the terms of the license agreements, Astellas paid a nonrefundable upfront license fee of $25.0 million in 2011. The Company also received a $10.0 million milestone payment in March 2012 upon finalization of the general trial design for a Phase 3 registration trial of TransVax™ in hematopoietic stem cell transplant recipients. The Company recognized $0.1 million and $10.1 million in license revenue under the Astellas agreements during the three months ended March 31, 2013 and 2012, respectively.

Under the terms of the agreements, the Company is also performing research and development services which are being paid for by Astellas. During the three months ended March 31, 2013 and 2012, the Company recognized $1.1 million and $1.0 million, respectively, of revenue related to these contract services.

In August 2012, the Company amended its license and supply agreements with Astellas to, among other things, extend the time period that the Company is obligated to supply licensed products for commercial use to Astellas, at Astellas’ expense, modify the allocation of $95.0 million of milestone payments among certain milestones through commercial launch and modify the structure of the royalties on net sales from a fixed double digit royalty to tiered double digit royalties.

General (Policies)

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. 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, 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 March 31, 2013, and December 31, 2012, restricted cash of $3.1 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 of the Company’s revenue is generated through manufacturing contracts and stand-alone license agreements.

 

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 represent 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. 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 three 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.

Net Income (Loss) Per Share

Basic and diluted net income (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 net loss per share excludes any assumed exercise of stock options and warrants, and any assumed issuance of common stock under restricted stock units, or RSUs, as the effect would be antidilutive. Common stock equivalents totaling 1.6 million shares for the three months ended March 31, 2013, were excluded from the calculation of diluted net loss per share because of their antidilutive effect. Common stock equivalents totaling 1.6 million shares for the three months ended March 31, 2012, were included in the calculation of diluted net income per share.

Recent Accounting Pronouncement

Effective January 1, 2013, the Company adopted Accounting Standards Update (“ASU”) No. 2013-02, “Reporting of Amounts Reclassified Out of Accumulated Other Comprehensive Income.” The adoption of ASU No. 2013-02 concerns presentation and disclosure only and did not have an impact on the Company’s financial position or results of operations. The Company elected to present the information required by ASU No. 2013-02 in the Statements of Comprehensive Loss.

Stock-Based Compensation (Tables)
Summary of total stock-based compensation expense
                 
    Three Months Ended
March 31,
 
        2013             2012      

Research and development

  $ 312     $ 287  

Manufacturing and production

    68       49  

General and administrative

    758       584  
   

 

 

   

 

 

 

Total stock-based compensation expense

  $ 1,138     $ 920  
   

 

 

   

 

 

 
Other Balance Sheet Accounts (Tables)
Summary of accounts payable and accrued expenses
                 
    March 31,
2013
    December 31,
2012
 

Employee compensation

  $ 2,392     $ 3,858  

Post-termination benefit accrual

    463       —    

Clinical trial accrual

    708       660  

Accounts payable

    645       377  

Deferred rent

    322       307  

Other accrued liabilities

    579       427  
   

 

 

   

 

 

 

Total accounts payable and accrued expenses

  $ 5,109     $ 5,629  
   

 

 

   

 

 

 
Marketable Securities, Available For Sale (Tables)
Summary of available for sale marketable securities
                                 

March 31, 2013

  Amortized
Cost
    Unrealized
Gain
    Unrealized
Loss
    Market
Value
 

U.S. treasuries

  $ 7,574     $ 2     $ —       $ 7,576  

Government-sponsored enterprise securities

    7,751       —         —         7,751  

Corporate bonds

    9,246       —         6       9,240  

Certificates of deposit

    785       —         —         785  
   

 

 

   

 

 

   

 

 

   

 

 

 
    $ 25,356     $ 2     $ 6     $ 25,352  
   

 

 

   

 

 

   

 

 

   

 

 

 

 

                                 

December 31, 2012

  Amortized
Cost
    Unrealized
Gain
    Unrealized
Loss
    Market
Value
 

U.S. treasuries

  $ 10,135     $ 1     $ —       $ 10,136  

Government-sponsored enterprise securities

    15,507       —         1       15,506  

Corporate bonds

    11,509       —         8       11,501  

Certificates of deposit

    496       —         —          496  
   

 

 

   

 

 

   

 

 

   

 

 

 
    $ 37,647     $ 1     $ 9     $ 37,639  
   

 

 

   

 

 

   

 

 

   

 

 

 
Fair Value Measurements (Tables)
                                 
    Fair Value Measurements  

March 31, 2013

  Level 1     Level 2     Level 3     Total  

Certificates of deposit

  $ 785     $ —       $ —       $ 785  

Money market funds

    19,816       —         —         19,816  

U.S. treasuries

    7,576       —         —         7,576  

Corporate bonds

    —         9,240       —         9,240  

Government-sponsored enterprise securities

    —         7,751       —         7,751  

Auction rate securities

    —         —         2,197       2,197  
   

 

 

   

 

 

   

 

 

   

 

 

 
    $ 28,177     $ 16,991     $ 2,197     $ 47,365  
   

 

 

   

 

 

   

 

 

   

 

 

 

 

                                 
    Fair Value Measurements  

December 31, 2012

  Level 1     Level 2     Level 3     Total  

Certificates of deposit

  $ 496     $ —       $ —       $ 496  

Money market funds

    18,500       —         —         18,500  

U.S. treasuries

    10,136       —         —         10,136  

Corporate bonds

    —         11,501       —         11,501  

Government-sponsored enterprise securities

    —         15,506       —         15,506  

Auction rate securities

    —         —         2,225       2,225  
   

 

 

   

 

 

   

 

 

   

 

 

 
    $ 29,132     $ 27,007     $ 2,225     $ 58,364  
   

 

 

   

 

 

   

 

 

   

 

 

 
         
    Three Months
Ended

March  31, 2013
 

Balance at December 31, 2012

  $ 2,225  

Total net unrealized losses included in other comprehensive income

    (28
   

 

 

 

Balance at March 31, 2013

  $ 2,197  
   

 

 

 

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

  $ —    
   

 

 

 
General (Details) (USD $)
In Thousands, except Share data in Millions, unless otherwise specified
3 Months Ended
Mar. 31, 2013
Mar. 31, 2012
Dec. 31, 2012
General (Textual) [Abstract]
 
 
 
Maximum period for cash and highly liquid securities with original maturities
ninety days or less 
 
 
Minimum period for marketable securities classified as available-for-sale with original maturities
more than ninety days 
 
 
Restricted cash
$ 3,059 
 
$ 3,059 
Common stock equivalents included in the calculation of diluted net income per share
 
1.6 
 
Common stock equivalents excluded from the calculation of diluted net income per share
1.6 
 
 
Letter of Credit [Member]
 
 
 
Amount of letter of credit, description
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. 
 
 
Stock-Based Compensation (Details) (USD $)
In Thousands, unless otherwise specified
3 Months Ended
Mar. 31, 2013
Mar. 31, 2012
Summary of total stock-based compensation expense
 
 
Total stock-based compensation expense
$ 1,138 
$ 920 
Research and development [Member]
 
 
Summary of total stock-based compensation expense
 
 
Total stock-based compensation expense
312 
287 
Manufacturing and production [Member]
 
 
Summary of total stock-based compensation expense
 
 
Total stock-based compensation expense
68 
49 
General and administrative [Member]
 
 
Summary of total stock-based compensation expense
 
 
Total stock-based compensation expense
$ 758 
$ 584 
Stock-Based Compensation (Details Textual) (USD $)
In Millions, unless otherwise specified
3 Months Ended
Mar. 31, 2013
Mar. 31, 2012
Stock-Based Compensation (Textual) [Abstract]
 
 
Estimated value of stock-based awards, granted
3.1 
3.6 
Unrecognized compensation cost related to unvested options
$ 4.3 
 
Unvested stock-based awards expected to be recognized, weighted-average period
1 year 6 months 
 
Portion of stock-based awards granted from outstanding common shares
1.80% 
1.90% 
Other Balance Sheet Accounts (Details) (USD $)
In Thousands, unless otherwise specified
Mar. 31, 2013
Dec. 31, 2012
Summary of accounts payable and accrued expenses
 
 
Employee compensation
$ 2,392 
$ 3,858 
Post-termination benefit accrual
463 
 
Clinical trial accrual
708 
660 
Accounts payable
645 
377 
Deferred rent
322 
307 
Other accrued liabilities
579 
427 
Total accounts payable and accrued expenses
$ 5,109 
$ 5,629 
Marketable Securities, Available For Sale (Details) (USD $)
In Thousands, unless otherwise specified
Mar. 31, 2013
Dec. 31, 2012
Summary of available-for-sale marketable securities
 
 
Amortized Cost
$ 25,356 
$ 37,647 
Unrealized Gain
Unrealized Loss
Market Value
25,352 
37,639 
U.S. treasuries [Member]
 
 
Summary of available-for-sale marketable securities
 
 
Amortized Cost
7,574 
10,135 
Unrealized Gain
Unrealized Loss
   
 
Market Value
7,576 
10,136 
Government-sponsored enterprise securities [Member]
 
 
Summary of available-for-sale marketable securities
 
 
Amortized Cost
7,751 
15,507 
Unrealized Gain
   
 
Unrealized Loss
   
Market Value
7,751 
15,506 
Corporate bonds [Member]
 
 
Summary of available-for-sale marketable securities
 
 
Amortized Cost
9,246 
11,509 
Unrealized Gain
   
 
Unrealized Loss
Market Value
9,240 
11,501 
Certificates of deposit [Member]
 
 
Summary of available-for-sale marketable securities
 
 
Amortized Cost
785 
496 
Unrealized Gain
   
 
Unrealized Loss
   
 
Market Value
$ 785 
$ 496 
Marketable Securities, Available For Sale (Details Textual) (USD $)
3 Months Ended
Mar. 31, 2013
Marketable Securities, Available For Sale (Textual) [Abstract]
 
Available-for-sale securities maturing outside of one year
$ 7,800,000 
Realized gains or losses on sales of available-for-sale securities
Available-for-sale securities in a continuous loss position longer than one year
$ 0 
Long-Term Investments (Details) (USD $)
1 Months Ended 3 Months Ended
Mar. 31, 2012
Investments
Mar. 31, 2013
Mar. 31, 2012
Long-Term Investments (Textual) [Abstract]
 
 
 
Number of long-term investments sold during the period
 
 
Auction rate securities sold, at par value
$ 4,000,000 
 
 
Auction rate securities held, at par value
 
2,500,000 
 
Gain related to auction rate securities
 
 
300,000 
Maturity of long-term investment
 
2038 
 
Recognized cumulative losses
 
500,000 
 
Unrealized losses on auction rate securities
 
17,000 
6,000 
Cumulative unrealized gains
 
400,000 
 
Carrying value of auction rate security
 
$ 2,200,000 
 
Fair Value Measurements (Details) (USD $)
In Thousands, unless otherwise specified
Mar. 31, 2013
Dec. 31, 2012
Summary of cash equivalents, marketable securities and long-term investments measured at fair value
 
 
Fair Value
$ 47,365 
$ 58,364 
Certificates of deposit [Member]
 
 
Summary of cash equivalents, marketable securities and long-term investments measured at fair value
 
 
Fair Value
785 
496 
Money market funds [Member]
 
 
Summary of cash equivalents, marketable securities and long-term investments measured at fair value
 
 
Fair Value
19,816 
18,500 
U.S. treasuries [Member]
 
 
Summary of cash equivalents, marketable securities and long-term investments measured at fair value
 
 
Fair Value
7,576 
10,136 
Corporate bonds [Member]
 
 
Summary of cash equivalents, marketable securities and long-term investments measured at fair value
 
 
Fair Value
9,240 
11,501 
Government-sponsored enterprise securities [Member]
 
 
Summary of cash equivalents, marketable securities and long-term investments measured at fair value
 
 
Fair Value
7,751 
15,506 
Auction rate securities [Member]
 
 
Summary of cash equivalents, marketable securities and long-term investments measured at fair value
 
 
Fair Value
2,197 
2,225 
Level 1 [Member]
 
 
Summary of cash equivalents, marketable securities and long-term investments measured at fair value
 
 
Fair Value
28,177 
29,132 
Level 1 [Member] |
Certificates of deposit [Member]
 
 
Summary of cash equivalents, marketable securities and long-term investments measured at fair value
 
 
Fair Value
785 
496 
Level 1 [Member] |
Money market funds [Member]
 
 
Summary of cash equivalents, marketable securities and long-term investments measured at fair value
 
 
Fair Value
19,816 
18,500 
Level 1 [Member] |
U.S. treasuries [Member]
 
 
Summary of cash equivalents, marketable securities and long-term investments measured at fair value
 
 
Fair Value
7,576 
10,136 
Level 1 [Member] |
Corporate bonds [Member]
 
 
Summary of cash equivalents, marketable securities and long-term investments measured at fair value
 
 
Fair Value
   
   
Level 1 [Member] |
Government-sponsored enterprise securities [Member]
 
 
Summary of cash equivalents, marketable securities and long-term investments measured at fair value
 
 
Fair Value
   
   
Level 1 [Member] |
Auction rate securities [Member]
 
 
Summary of cash equivalents, marketable securities and long-term investments measured at fair value
 
 
Fair Value
   
   
Level 2 [Member]
 
 
Summary of cash equivalents, marketable securities and long-term investments measured at fair value
 
 
Fair Value
16,991 
27,007 
Level 2 [Member] |
Certificates of deposit [Member]
 
 
Summary of cash equivalents, marketable securities and long-term investments measured at fair value
 
 
Fair Value
   
   
Level 2 [Member] |
Money market funds [Member]
 
 
Summary of cash equivalents, marketable securities and long-term investments measured at fair value
 
 
Fair Value
   
   
Level 2 [Member] |
U.S. treasuries [Member]
 
 
Summary of cash equivalents, marketable securities and long-term investments measured at fair value
 
 
Fair Value
   
   
Level 2 [Member] |
Corporate bonds [Member]
 
 
Summary of cash equivalents, marketable securities and long-term investments measured at fair value
 
 
Fair Value
9,240 
11,501 
Level 2 [Member] |
Government-sponsored enterprise securities [Member]
 
 
Summary of cash equivalents, marketable securities and long-term investments measured at fair value
 
 
Fair Value
7,751 
15,506 
Level 2 [Member] |
Auction rate securities [Member]
 
 
Summary of cash equivalents, marketable securities and long-term investments measured at fair value
 
 
Fair Value
   
   
Level 3 [Member]
 
 
Summary of cash equivalents, marketable securities and long-term investments measured at fair value
 
 
Fair Value
2,197 
2,225 
Level 3 [Member] |
Certificates of deposit [Member]
 
 
Summary of cash equivalents, marketable securities and long-term investments measured at fair value
 
 
Fair Value
   
   
Level 3 [Member] |
Money market funds [Member]
 
 
Summary of cash equivalents, marketable securities and long-term investments measured at fair value
 
 
Fair Value
   
   
Level 3 [Member] |
U.S. treasuries [Member]
 
 
Summary of cash equivalents, marketable securities and long-term investments measured at fair value
 
 
Fair Value
   
   
Level 3 [Member] |
Corporate bonds [Member]
 
 
Summary of cash equivalents, marketable securities and long-term investments measured at fair value
 
 
Fair Value
   
   
Level 3 [Member] |
Government-sponsored enterprise securities [Member]
 
 
Summary of cash equivalents, marketable securities and long-term investments measured at fair value
 
 
Fair Value
   
   
Level 3 [Member] |
Auction rate securities [Member]
 
 
Summary of cash equivalents, marketable securities and long-term investments measured at fair value
 
 
Fair Value
$ 2,197 
$ 2,225 
Fair Value Measurements (Details 1) (USD $)
In Thousands, unless otherwise specified
3 Months Ended
Mar. 31, 2013
Summary of activity for assets measured at fair value using significant unobservable inputs
 
Balance at December 31, 2012
$ 2,225 
Total net unrealized losses included in other comprehensive income
(28)
Balance at March 31, 2013
2,197 
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
   
Stockholders' Equity (Details) (USD $)
1 Months Ended
Feb. 29, 2012
Jan. 31, 2012
Nov. 30, 2012
Stockholders' Equity (Textual) [Abstract]
 
 
 
Number of shares of common stock sold in public offering
 
13,333,334 
 
Common stock, public offering price
$ 3.75 
$ 3.75 
 
Net proceeds from offering
 
$ 48,700,000 
 
No of common stock issued on partial exercise of underwriters' overallotment option
576,358 
 
 
Maximum value of common stock issuable under agreement
 
 
$ 50,000,000 
Astellas Agreements (Details) (USD $)
In Millions, unless otherwise specified
1 Months Ended 3 Months Ended
Aug. 31, 2012
Mar. 31, 2013
Mar. 31, 2012
Mar. 31, 2011
Astellas Agreements (Textual) [Abstract]
 
 
 
 
Recognized license revenue
 
$ 0.1 
$ 10.1 
$ 25.0 
Additional amount received upon finalization of the general trial design
 
 
10.0 
 
Amount payable under license agreement on achievement of milestone
$ 95.0 
 
 
 
Recognized revenue related to contract services
 
1.1 
1.0