EXACT SCIENCES CORP, 10-K filed on 3/1/2013
Annual Report
Document and Entity Information (USD $)
12 Months Ended
Dec. 31, 2012
Feb. 26, 2013
Jun. 29, 2012
Document and Entity Information
 
 
 
Entity Registrant Name
EXACT SCIENCES CORP 
 
 
Entity Central Index Key
0001124140 
 
 
Document Type
10-K 
 
 
Document Period End Date
Dec. 31, 2012 
 
 
Amendment Flag
false 
 
 
Current Fiscal Year End Date
--12-31 
 
 
Entity Well-known Seasoned Issuer
No 
 
 
Entity Voluntary Filers
No 
 
 
Entity Current Reporting Status
Yes 
 
 
Entity Filer Category
Accelerated Filer 
 
 
Entity Public Float
 
 
$ 607,437,716 
Entity Common Stock, Shares Outstanding
 
64,031,106 
 
Document Fiscal Year Focus
2012 
 
 
Document Fiscal Period Focus
FY 
 
 
Balance Sheets (USD $)
In Thousands, unless otherwise specified
Dec. 31, 2012
Dec. 31, 2011
Current Assets:
 
 
Cash and cash equivalents
$ 13,345 
$ 35,781 
Marketable securities
94,776 
57,580 
Prepaid expenses and other current assets
593 
1,034 
Total current assets
108,714 
94,395 
Property and Equipment, at cost:
 
 
Laboratory equipment
4,051 
2,314 
Office and computer equipment
824 
729 
Leasehold improvements
283 
288 
Furniture and fixtures
28 
23 
Property and Equipment, gross
5,186 
3,354 
Less-Accumulated depreciation and amortization
(1,781)
(796)
Property and Equipment, net
3,405 
2,558 
TOTAL ASSETS
112,119 
96,953 
Current Liabilities:
 
 
Accounts payable
3,652 
765 
Accrued expenses
3,327 
3,069 
Capital lease obligation, current portion
333 
 
Deferred license fees, current portion
4,143 
4,143 
Total current liabilities
11,455 
7,977 
Long term debt
1,000 
1,000 
Long term accrued interest
63 
42 
Capital lease obligation, less current portion
711 
 
Deferred license fees, less current portion
295 
4,439 
Commitments and contingencies
   
   
Stockholders' Equity:
 
 
Preferred stock, $0.01 par value Authorized-5,000,000 shares Issued and outstanding-none at December 31, 2012 and 2011
   
   
Common stock, $0.01 par value Authorized-100,000,000 shares Issued and outstanding-63,909,800 and 56,624,763 shares at December 31, 2012 and 2011, respectively
639 
566 
Additional paid-in capital
372,123 
304,767 
Other comprehensive income (loss)
78 
(14)
Accumulated deficit
(274,245)
(221,824)
Total stockholders' equity
98,595 
83,495 
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY
$ 112,119 
$ 96,953 
Balance Sheets (Parenthetical) (USD $)
Dec. 31, 2012
Dec. 31, 2011
Balance Sheets
 
 
Preferred stock, par value (in dollars per share)
$ 0.01 
$ 0.01 
Preferred stock, Authorized shares
5,000,000 
5,000,000 
Preferred stock, Issued shares
Preferred stock, outstanding shares
Common stock, par value (in dollars per share)
$ 0.01 
$ 0.01 
Common stock, Authorized shares
100,000,000 
100,000,000 
Common stock, Issued shares
63,909,800 
56,624,763 
Common stock, outstanding shares
63,909,800 
56,624,763 
Statements of Operations (USD $)
In Thousands, except Per Share data, unless otherwise specified
12 Months Ended
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2010
Revenue:
 
 
 
Product royalty fees
 
$ 20 
$ 26 
License fees
4,144 
4,143 
5,318 
Total revenue
4,144 
4,163 
5,344 
Cost of revenue:
 
 
 
Product royalty fees
 
24 
24 
Gross profit
4,144 
4,139 
5,320 
Operating expenses:
 
 
 
Research and development
42,131 
21,968 
9,023 
General and administrative
9,900 
8,137 
6,330 
Sales and marketing
4,755 
2,857 
1,793 
Total operating expenses
56,786 
32,962 
17,146 
Loss from operations
(52,642)
(28,823)
(11,826)
Investment income
262 
169 
46 
Interest expense
(41)
(21)
(20)
Other income
 
 
244 
Net loss
$ (52,421)
$ (28,675)
$ (11,556)
Net loss per share-basic and diluted (in dollars per share)
$ (0.88)
$ (0.54)
$ (0.29)
Weighted average common shares outstanding-basic and diluted (in shares)
59,481 
52,512 
40,455 
Statements of Comprehensive Loss (USD $)
In Thousands, unless otherwise specified
12 Months Ended
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2010
Statements of Comprehensive Loss
 
 
 
Net loss
$ (52,421)
$ (28,675)
$ (11,556)
Other comprehensive income (loss), net of tax:
 
 
 
Unrealized gain (loss) on available-for-sale investments
92 
(15)
Comprehensive loss
$ (52,329)
$ (28,690)
$ (11,554)
Statements of Stockholders' Equity (USD $)
In Thousands, except Share data, unless otherwise specified
Total
Common Stock
Additional Paid In Capital
Other Comprehensive Income (Loss)
Accumulated Deficit
Balance at Dec. 31, 2009
$ 6,094 
$ 355 
$ 187,333 
$ (1)
$ (181,593)
Balance (in shares) at Dec. 31, 2009
 
35,523,140 
 
 
 
Increase (Decrease) in Stockholders' Equity
 
 
 
 
 
Issuance of common stock, net of issuance costs of $3.9, $1.5 and $5.6 million for 2012, 2011 and 2010, respectively
82,327 
157 
82,170 
 
 
Issuance of common stock, net of issuance costs (in shares)
 
15,700,000 
 
 
 
Exercise of common stock options and warrants
466 
461 
 
 
Exercise of common stock options and warrants (in shares)
 
528,937 
 
 
 
Issuance of common stock to fund the Company's 2011, 2010 and 2009 401(k) match
65 
64 
 
 
Issuance of common stock to fund the Company's 2011, 2010 and 2009 401(k) match (in shares)
 
15,460 
 
 
 
Compensation expense related to issuance of stock options and restricted stock awards
2,121 
2,117 
 
 
Compensation expense related to issuance of stock options and restricted stock awards (in shares)
 
337,383 
 
 
 
Purchase of employee stock purchase plan shares
128 
 
128 
 
 
Purchase of employee stock purchase plan shares (in shares)
 
58,709 
 
 
 
Expense related to warrants (Note 4)
107 
 
107 
 
 
Net loss
(11,556)
 
 
 
(11,556)
Other comprehensive income (loss)
 
 
 
Balance at Dec. 31, 2010
79,754 
522 
272,380 
(193,149)
Balance (in shares) at Dec. 31, 2010
 
52,163,629 
 
 
 
Increase (Decrease) in Stockholders' Equity
 
 
 
 
 
Issuance of common stock, net of issuance costs of $3.9, $1.5 and $5.6 million for 2012, 2011 and 2010, respectively
27,215 
36 
27,179 
 
 
Issuance of common stock, net of issuance costs (in shares)
 
3,593,750 
 
 
 
Exercise of common stock options and warrants
685 
678 
 
 
Exercise of common stock options and warrants (in shares)
 
708,590 
 
 
 
Issuance of common stock to fund the Company's 2011, 2010 and 2009 401(k) match
169 
 
169 
 
 
Issuance of common stock to fund the Company's 2011, 2010 and 2009 401(k) match (in shares)
 
27,872 
 
 
 
Compensation expense related to issuance of stock options and restricted stock awards
3,964 
3,963 
 
 
Compensation expense related to issuance of stock options and restricted stock awards (in shares)
 
79,065 
 
 
 
Purchase of employee stock purchase plan shares
291 
 
291 
 
 
Purchase of employee stock purchase plan shares (in shares)
 
51,857 
 
 
 
Expense related to warrants (Note 4)
107 
 
107 
 
 
Net loss
(28,675)
 
 
 
(28,675)
Other comprehensive income (loss)
(15)
 
 
(15)
 
Balance at Dec. 31, 2011
83,495 
566 
304,767 
(14)
(221,824)
Balance (in shares) at Dec. 31, 2011
56,624,763 
56,624,763 
 
 
 
Increase (Decrease) in Stockholders' Equity
 
 
 
 
 
Issuance of common stock related to the Mayo Transaction (Note 4)
1,000 
999 
 
 
Issuance of common stock related to the Mayo Transaction (Note 4) (in shares)
 
97,466 
 
 
 
Issuance of common stock, net of issuance costs of $3.9, $1.5 and $5.6 million for 2012, 2011 and 2010, respectively
57,755 
63 
57,692 
 
 
Issuance of common stock, net of issuance costs (in shares)
 
6,325,000 
 
 
 
Exercise of common stock options and warrants
2,388 
2,381 
 
 
Exercise of common stock options and warrants (in shares)
 
691,471 
 
 
 
Issuance of common stock to fund the Company's 2011, 2010 and 2009 401(k) match
274 
 
274 
 
 
Issuance of common stock to fund the Company's 2011, 2010 and 2009 401(k) match (in shares)
 
32,872 
 
 
 
Compensation expense related to issuance of stock options and restricted stock awards
5,493 
5,492 
 
 
Compensation expense related to issuance of stock options and restricted stock awards (in shares)
 
74,617 
 
 
 
Purchase of employee stock purchase plan shares
367 
366 
 
 
Purchase of employee stock purchase plan shares (in shares)
 
63,611 
 
 
 
Expense related to warrants (Note 4)
152 
 
152 
 
 
Net loss
(52,421)
 
 
 
(52,421)
Other comprehensive income (loss)
92 
 
 
92 
 
Balance at Dec. 31, 2012
$ 98,595 
$ 639 
$ 372,123 
$ 78 
$ (274,245)
Balance (in shares) at Dec. 31, 2012
63,909,800 
63,909,800 
 
 
 
Statements of Stockholders' Equity (Parenthetical) (USD $)
In Millions, unless otherwise specified
12 Months Ended
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2010
Statements of Stockholders' Equity
 
 
 
Issuance of common stock, issuance costs
$ 3.9 
$ 1.5 
$ 5.6 
Statements of Cash Flows (USD $)
In Thousands, unless otherwise specified
12 Months Ended
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2010
Cash flows from operating activities:
 
 
 
Net loss
$ (52,421)
$ (28,675)
$ (11,556)
Adjustments to reconcile net loss to net cash used in operating activities:
 
 
 
Depreciation and write-offs of fixed assets
985 
411 
230 
Stock-based compensation
5,493 
3,964 
2,121 
Amortization of deferred license fees
(4,144)
(4,143)
(5,318)
Warrant licensing expense
152 
107 
107 
Restricted stock licensing expense
1,000 
 
 
Amortization of premium on short-term investments
532 
360 
37 
Changes in assets and liabilities:
 
 
 
Prepaid expenses and other current assets
441 
(788)
238 
Accounts payable
2,887 
(263)
873 
Accrued expenses
899 
1,542 
795 
Accrued interest
21 
21 
20 
Third party royalty obligation
 
 
(988)
Net cash used in operating activities
(44,155)
(27,464)
(13,441)
Cash flows from investing activities:
 
 
 
Purchases of marketable securities
(96,047)
(87,017)
(24,498)
Maturities of marketable securities
58,411 
45,725 
10,204 
Purchases of property and equipment
(681)
(2,115)
(626)
Net cash used in investing activities
(38,317)
(43,407)
(14,920)
Cash flows from financing activities:
 
 
 
Proceeds from Genzyme Collaboration, License and Purchase Agreement
 
 
1,896 
Proceeds from sale of common stock, net of issuance costs
57,755 
27,215 
82,327 
Proceeds from exercise of common stock options and stock purchase plan
2,388 
685 
466 
Decrease in restricted cash
 
 
500 
Payments on capital lease obligations
(107)
 
 
Net cash provided by financing activities
60,036 
27,900 
85,189 
Net increase (decrease) in cash and cash equivalents
(22,436)
(42,971)
56,828 
Cash and cash equivalents, beginning of period
35,781 
78,752 
21,924 
Cash and cash equivalents, end of period
13,345 
35,781 
78,752 
Supplemental disclosure of non-cash investing and financing activities:
 
 
 
Unrealized gain (loss) on available-for-sale investments
92 
(15)
(2)
Issuance of 32,872, 27,872, and 15,460 shares of common stock to fund the Company's 401(k) matching contribution for 2011, 2010, and 2009, respectively
274 
169 
65 
Conversion of accrued expenses into 63,611, 51,857 and 58,709 shares of common stock in connection with the Company's ESPP for 2012, 2011 and 2010, respectively
367 
291 
128 
Laboratory equipment acquired with a capital lease
$ 1,151 
 
 
Statements of Cash Flows (Parenthetical)
12 Months Ended
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2010
Statements of Cash Flows
 
 
 
Issuance of shares of common stock to fund the Company's 401(k) matching contribution
32,872 
27,872 
15,460 
Conversion of accrued expenses into shares of common stock
63,611 
51,857 
58,709 
ORGANIZATION
ORGANIZATION

(1) ORGANIZATION

        Exact Sciences Corporation ("Exact" or the "Company") was incorporated in February 1995. Exact is a molecular diagnostics company currently focused on the early detection and prevention of colorectal cancer. The Company's non-invasive stool-based DNA (sDNA) screening technology includes proprietary and patented methods that isolate and analyze human DNA present in stool to screen for the presence of colorectal pre-cancer and cancer.

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

(2) SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Use of Estimates

        The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure 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 from those estimates.

Cash and Cash Equivalents

        The Company considers cash on hand, demand deposits in bank, money market funds, and all highly liquid investments with an original maturity of 90 days or less to be cash and cash equivalents. The Company had no restricted cash at December 31, 2012 and 2011.

Marketable Securities

        Management determines the appropriate classification of debt securities at the time of purchase and re-evaluates such designation as of each balance sheet date. Debt securities carried at amortized cost are classified as held-to-maturity when the Company has the positive intent and ability to hold the securities to maturity. Marketable equity securities and debt securities not classified as held-to-maturity are classified as available-for-sale. Available-for-sale securities are carried at fair value, with the unrealized gains and losses, net of tax, reported in other comprehensive income. The amortized cost of debt securities in this category is adjusted for amortization of premiums and accretion of discounts to maturity computed under the straight-line method. Such amortization is included in investment income. Realized gains and losses and declines in value judged to be other-than-temporary on available-for-sale securities are included in investment income. The cost of securities sold is based on the specific identification method. Interest and dividends on securities classified as available-for-sale are included in investment income.

        At December 31, 2012 and December 31, 2011 the Company's investments were comprised of fixed income investments and all were deemed available-for-sale. The objectives of the Company's investment strategy are to provide liquidity and safety of principal while striving to achieve the highest rate of return consistent with these two objectives. The Company's investment policy limits investments to certain types of instruments issued by institutions with investment grade credit ratings and places restrictions on maturities and concentration by type and issuer. Investments in which the Company has the ability and intent, if necessary, to liquidate in order to support its current operations (including those with a contractual term greater than one year from the date of purchase) are classified as current. All of the Company's investments are considered current. Realized gains were $6,231, $419, and $13,149 for the years ended December 31, 2012, 2011, and 2010 respectively. Unrealized gains on investments recorded in other comprehensive income were $77,808 and $721 for the years ended December 31, 2012 and December 31, 2010. Unrealized losses on investments recorded in other comprehensive income were $13,784 for the year ended December 31, 2011.

        Available-for-sale securities at December 31, 2012 consist of the following:

 
  December 31, 2012  
(In thousands)
  Amortized Cost   Gains in Accumulated
Other Comprehensive
Income
  Losses in Accumulated
Other Comprehensive
Income
  Estimated
Fair Value
 

U.S. government agency securities

  $ 44,270   $ 38   $   $ 44,308  

Corporate bonds

    43,303     27         43,330  

Certificates of deposit

    5,926     13         5,939  

Commercial paper

    1,199             1,199  
                   

Total available-for-sale securities

  $ 94,698   $ 78   $   $ 94,776  
                   

        Available-for-sale securities at December 31, 2011 consist of the following:

 
  December 31, 2011  
(In thousands)
  Amortized Cost   Gains in Accumulated
Other Comprehensive
Income
  Losses in Accumulated
Other Comprehensive
Income
  Estimated
Fair Value
 

U.S. government agency securities

  $ 28,004   $   $ (10 ) $ 27,994  

Corporate bonds

    19,124           (2 )   19,122  

Certificates of deposit

    9,467         (2 )   9,465  

Commercial paper

    999             999  
                   

Total available-for-sale securities

  $ 57,594   $   $ (14 ) $ 57,580  
                   

Property and Equipment

        Property and equipment are stated at cost and depreciated using the straight-line method over the assets' estimated useful lives. Maintenance and repairs are expensed when incurred; additions and improvements are capitalized. The estimated useful lives of fixed assets are as follows:

Asset Classification
  Estimated Useful Life

Laboratory equipment

  3 - 5 years

Office and computer equipment

  3 years

Leasehold improvements

  Lesser of the remaining

 

  lease term or useful life

Furniture and fixtures

  3 years

        Depreciation expense for the years ended December 31, 2012, 2011, and 2010 was $1.0 million, $0.4 million, and $0.2 million, respectively.

Patent Costs

        Patent costs, which have historically consisted of related legal fees, are capitalized as incurred only if the Company determines that there is some probable future economic benefit derived from the transaction. The capitalized patents are amortized beginning when patents are approved over an estimated useful life of five years. Capitalized patent costs are expensed upon disapproval, upon a decision by the Company to no longer pursue the patent or when the related intellectual property is either sold or deemed to be no longer of value to the Company. The Company determined that all patent costs incurred during the year ended December 31, 2012, 2011 and 2010 should be expensed and not capitalized as the future economic benefit derived from the transactions cannot be determined.

  • Clinical Trial Accrual

        Accruals are recorded for clinical trial patient site costs when the liability is probable and reasonably estimable. For our pivotal FDA clinical trial and other sample procurement studies we undertake periodically, an accrual is made for a patient site cost once the patient has progressed past certain steps in the patient assessment and sample processing procedure. The accrual is estimated based on historical average patient reimbursement fees. Management has recorded an accrual of $0.4 million at December 31, 2012 and 2011 for clinical trial costs related to site payments. We do not expect that actual amounts paid for these patient costs will materially differ from the amounts accrued.

Net Loss Per Share

        Basic net loss per common share was determined by dividing net loss applicable to common stockholders by the weighted average common shares outstanding during the period. Basic and diluted net loss per share is the same because all outstanding common stock equivalents have been excluded, as they are anti-dilutive as a result of the Company's losses.

        The following potentially issuable common shares were not included in the computation of diluted net loss per share because they would have an anti-dilutive effect due to net losses for each period (amounts are in thousands):

 
  2012   2011   2010  

Shares issuable upon exercise of stock options

    6,182     6,454     6,217  

Shares issuable upon exercise of outstanding warrants(1)

    325     325     825  

Shares issuable upon the release of restricted stock awards

    814     401     264  

Shares issuable upon exercise of restricted stock awards related to licensing agreement

    73          
               

 

    7,394     7,180     7,306  
               

(1)
At December 31, 2012 and December 31, 2011, represents warrants to purchase 250,000 shares of common stock issued under a licensing agreement and warrants to purchase 75,000 shares of common stock issued under a consulting agreement. At December 31, 2010 represents represents warrants to purchase 750,000 shares of common stock issued under a licensing agreement and warrants to purchase 75,000 shares of common stock issued under a consulting agreement.

Accounting for Stock-Based Compensation

        The Company requires all share-based payments to employees, including grants of employee stock options, restricted stock, restricted stock units and shares purchased under an ESPP (if certain parameters are not met), to be recognized in the financial statements based on their fair values.

Revenue Recognition

        License fees.    License fees for the licensing of product rights are recorded as deferred revenue upon receipt of cash and recognized as revenue on a straight-line basis over the license period. On June 27, 2007, the Company entered into an amendment to its exclusive license agreement with LabCorp (the "Second Amendment") that, among other modifications to the terms of the license, extended the exclusive license period from August 2008 to December 2010, subject to carve-outs for certain named organizations. Accordingly, the Company amortized the remaining deferred revenue balance resulting from its license agreement with LabCorp at the time of the Second Amendment ($4.7 million) on a straight-line basis over the remaining exclusive license period, which ended in December 2010.

        As more fully described in Note 3 below, in connection with the Company's transaction with Genzyme Corporation, Genzyme agreed to pay the Company a total of $18.5 million, of which $16.65 million was paid on January 27, 2009 and $1.85 million was subject to a holdback by Genzyme to satisfy certain potential indemnification obligations in exchange for the assignment and licensing of certain intellectual property to Genzyme. The Company's on-going performance obligations to Genzyme under the Collaboration, License and Purchase Agreement (the "CLP Agreement"), as described below, including its obligation to deliver through licenses certain intellectual property improvements to Genzyme, if improvements are made during the initial five-year collaboration period, were deemed to be undelivered elements of the CLP Agreement on the date of closing. Accordingly, the Company deferred the initial $16.65 million in cash received at closing and is amortizing that up-front payment on a straight line basis into revenue over the initial five-year collaboration period ending in January 2014. The Company received the first holdback amount of $962,000, which included accrued interest, due from Genzyme during the first quarter of 2010. The Company received the second holdback amount of $934,250 which included accrued interest due, from Genzyme during the third quarter of 2010. The amounts were deferred and are being amortized on a straight-line basis into revenue over the remaining term of the collaboration at the time of receipt.

        In addition, Genzyme purchased 3,000,000 shares of common stock purchased from the Company on January 27, 2009 for $2.00 per share, representing a premium of $0.51 per share above the closing price of the Company's common stock on that date of $1.49 per share. The aggregate premium paid by Genzyme over the closing price of the Company's common stock on the date of the transaction of $1.53 million is deemed to be a part of the total consideration for the CLP Agreement. Accordingly, the Company deferred the aggregate $1.53 million premium and is amortizing that amount on a straight line basis into revenue over the initial five-year collaboration period ending in January 2014.

        The Company recognized approximately $4.1 million in license fee revenue in connection with the amortization of the up-front payments from Genzyme during the years ended December 31, 2012 and December 31, 2011. The Company recognized $5.3 million in license fee revenue in connection with the amortization of the up-front payments from LabCorp and Genzyme during the year ended December 31, 2010.

        Product royalty fees.    The Company has licensed certain of its technologies, including improvements to such technologies, on an exclusive basis to LabCorp. LabCorp developed and commercially offered a non-invasive stool-based DNA colorectal cancer screening service for the average-risk population based on the Company's technology. The Company is entitled to certain royalties on any sales of this product. Accordingly, the Company records product royalty fees based on the specified contractual percentage of LabCorp's net revenues from its sales of such colorectal cancer screening tests, as reported to the Company each month by LabCorp. The current royalty rate is subject to an increase in the event that LabCorp achieves a specified significant threshold of annual net revenues from the sales of such colorectal cancer screening tests. No sales of this product were reported to the Company during the year ended December 31, 2012 and no product royalty fees were recorded. Product royalty fees were $20,000 and $26,000 for the years ended December 31, 2011 and 2010, respectively.

Other Income

        The Company recognizes other income as earned. Other income consists of income received related to activities not related to the Company's core business operations. The Company had no other income during the years ended December 31, 2012 and 2011. During 2010, the Company received notice that it had been awarded a total cash grant of $244,479 under the Qualifying Therapeutic Discovery Project program administered under Section 48D of the Internal Revenue Code, all of which relates to qualifying expenses that have previously been incurred. The Company recognized the full amount of the grant as other income for the year ended December 31, 2010 as the Company has incurred all of the qualifying expenses and the amount had been received in full.

Advertising Costs

        The Company expenses the costs of media advertising at the time the advertising takes place. The Company expensed approximately $57,400, $110,000 and $68,100 of media advertising during the years ended December 31, 2012, 2011, and 2010, respectively.

Fair Value Measurements

        The FASB has issued authoritative guidance which requires that fair value should be based on the assumptions market participants would use when pricing an asset or liability and establishes a fair value hierarchy that prioritizes the information used to develop those assumptions. This guidance was adopted in 2009 for non-financial assets and liabilities. Under the standard, fair value measurements are separately disclosed by level within the fair value hierarchy. The fair value hierarchy establishes and prioritizes the inputs used to measure fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs. Observable inputs are inputs that reflect the assumptions that market participants would use in pricing the asset or liability developed based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company's assumptions about the assumptions market participants would use in pricing the asset or liability developed based on the best information available in the circumstances.

        The three levels of the fair value hierarchy established are as follows:

Level 1   Quoted prices (unadjusted) in active markets for identical assets or liabilities that the Company has the ability to access as of the reporting date. Active markets are those in which transactions for the asset or liability occur in sufficient frequency and volume to provide pricing information on an ongoing basis.

Level 2

 

Pricing inputs other than quoted prices in active markets included in Level 1, which are either directly or indirectly observable as of the reporting date. These include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active.

Level 3

 

Unobservable inputs that reflect the Company's assumptions about the assumptions that market participants would use in pricing the asset or liability. Unobservable inputs shall be used to measure fair value to the extent that observable inputs are not available.

        Fixed-income securities and mutual funds are valued using a third party pricing agency. The valuation is based on observable inputs including pricing for similar assets and other observable market factors. There has been no material change from period to period.

        The following table presents the Company's fair value measurements as of December 31, 2012 along with the level within the fair value hierarchy in which the fair value measurements in their entirety fall. Amounts in the table are in thousands.

 
   
  Fair Value Measurement at December 31, 2012 Using:  
Description
  Fair Value at
December 31, 2012
  Quoted Prices
in Active
Markets for Identical Assets
(Level 1)
  Significant Other
Observable
Inputs
(Level 2)
  Significant
Unobservable
Inputs
(Level 3)
 

Cash equivalents(1)

  $ 8,405   $ 8,405   $   $  

Available-for-Sale

                         

Marketable securities

                         

U.S. government agency securities

    44,308         44,308      

Certificates of deposit

    5,939         5,939      

Corporate bonds

    43,330         43,330      

Commercial paper

    1,199         1,199      
                   

Total

  $ 103,181   $ 8,405   $ 94,776   $  
                   

(1)
The $8.4 million of cash equivalents above is included in the cash and cash equivalents balance of $13.3 million at December 31, 2012.

        The following table presents the Company's fair value measurements as of December 31, 2011 along with the level within the fair value hierarchy in which the fair value measurements in their entirety fall. Amounts in the table are in thousands.

 
   
  Fair Value Measurement at December 31, 2011 Using:  
Description
  Fair Value at
December 31, 2011
  Quoted Prices
in Active
Markets for Identical Assets
(Level 1)
  Significant Other
Observable
Inputs
(Level 2)
  Significant
Unobservable
Inputs
(Level 3)
 

Cash equivalents(1)

  $ 35,385   $ 35,385   $   $  

Available-for-Sale

                         

Marketable securities

                         

U.S. government agency securities

    27,994         27,994      

Certificates of deposit

    9,465         9,465      

Corporate bonds

    19,122         19,122      

Commercial paper

    999         999      
                   

Total

  $ 92,965   $ 35,385   $ 57,580   $  
                   

(1)
The $35.4 million of cash equivalents above is included in the cash and cash equivalents balance of $35.8 million at December 31, 2011.

        As of December 31, 2012 and 2011 there were available for sale securities in a continuous unrealized loss position for less than twelve months where the total unrealized losses were $4,800 and $28,500 respectively. At December 31, 2012 and 2011 there were no available for sale securities in a continuous unrealized loss position for greater than twelve months.

        The following summarizes contractual underlying maturities of the Company's available-for-sale investments at December 31, 2012 (in thousands):

 
  Cost   Fair Value  

Due in one year or less

  $ 58,882   $ 58,922  

Due after one year through two years

    35,816     35,854  
           

 

  $ 94,698   $ 94,776  
           

Concentration of Credit Risk

        In accordance with GAAP, the Company is required to disclose any significant off-balance-sheet risk and credit risk concentration. The Company has no significant off-balance-sheet risk, such as foreign exchange contracts or other hedging arrangements. Financial instruments that subject the Company to credit risk consist of cash, cash equivalents and marketable securities. As of December 31, 2012, the Company had cash and cash equivalents deposited in financial institutions in which the balances exceed the federal government agency insured limit of $250,000 by approximately $13.1 million. The Company has not experienced any losses in such accounts and management believes it is not exposed to any significant credit risk.

Subsequent Events

        The Company evaluates events that occur through the filing date and discloses those events or transactions that provide additional evidence with respect to conditions that existed at the date of the balance sheet. In addition, the financial statements are adjusted for any changes in estimates resulting from the use of such evidence.

Recent Accounting Pronouncements

        In December 2011, the FASB issued ASU No. 2011-11, Balance Sheet (Topic 210)—Disclosures about Offsetting Assets and Liabilities. ASU 2011-11 requires an entity to disclose information about offsetting and related arrangements to enable users of its financial statements to understand the effect of those arrangements on its financial position. Entities are required to disclose both gross and net information about these instruments. ASU 2011-11 is effective for annual reporting periods beginning on or after January 1, 2013, and interim periods within those annual periods. The adoption of this ASU is not expected to have a material impact on our financial statements.

Reclassifications

        Certain prior year amounts have been reclassified to conform to the current year presentation in the financial statements and accompanying notes to the financial statements.

GENZYME STRATEGIC TRANSACTION
GENZYME STRATEGIC TRANSACTION

(3) GENZYME STRATEGIC TRANSACTION

Transaction summary

        On January 27, 2009, the Company entered into a Collaboration, License and Purchase Agreement (the "CLP Agreement") with Genzyme Corporation ("Genzyme"). Pursuant to the CLP Agreement, the Company (i) assigned to Genzyme all of its intellectual property applicable to the fields of prenatal and reproductive health (the "Transferred Intellectual Property"), (ii) granted Genzyme an irrevocable, perpetual, exclusive, worldwide, fully-paid, royalty-free license to use and sublicense all of the Company's remaining intellectual property (the "Retained Intellectual Property") in the fields of prenatal and reproductive health (the "Genzyme Core Field"), and (iii) granted Genzyme an irrevocable, perpetual, non-exclusive, worldwide, fully-paid, royalty-free license to use and sublicense the Retained Intellectual Property in all fields other than the Genzyme Core Field and other than colorectal cancer detection and stool-based disease detection (the "Company Field"). Following the transaction, the Company retained rights in its intellectual property to pursue only the fields of colorectal cancer detection and stool-based detection of any disease or condition. As part of the transaction on January 27, 2009, the Company entered into an Assignment, Sublicense, Consent and Eighth Amendment to License Agreement (the "JHU Amendment") with Genzyme and Johns Hopkins University ("JHU") (collectively, with the licenses and assignment described herein, the "Genzyme Strategic Transaction"), whereby the Company assigned its rights under the license agreement between the Company and JHU dated March 25, 2003, as amended (the "JHU Agreement") to Genzyme. Pursuant to the JHU Amendment, Genzyme sublicensed to the Company the intellectual property subject to the JHU Agreement for colorectal cancer detection and stool-based disease detection, including the BEAMing technology for the detection of colorectal cancer. Under the JHU Amendment, the Company and Genzyme will share in the royalty and annual payment obligations to JHU.

        Also as part of the Genzyme Strategic Transaction, the Company entered into an Amended and Restated License Agreement (the "Restated License") with Genzyme on January 27, 2009, which amended and restated the License Agreement between the parties dated March 25, 1999, effective as of January 27, 2009. Pursuant to the Restated License, Genzyme granted to the Company a non-exclusive license to use technology related to the use of certain genes, specifically APC and p53, and methodologies related thereto. In exchange for the license, which continues until the expiration of the last to expire licensed patent, the Company agreed to pay Genzyme royalties based on net revenues received from performing tests that incorporate the licensed technology and sales of reagents and diagnostic test kits that incorporate the licensed technology, as well as certain minimum royalties, milestone payments and maintenance fees.

        Pursuant to the Genzyme Strategic Transaction, Genzyme agreed to pay an aggregate of $18.5 million to the Company, of which $16.65 million was paid at closing and $1.85 million (the "Holdback Amount") was subject to a holdback by Genzyme to satisfy certain potential indemnification obligations of the Company. Genzyme also agreed to pay a double-digit royalty to the Company on income received by Genzyme as a result of any licenses or sublicenses to third parties of the Transferred Intellectual Property or the Retained Intellectual Property in any field other than the Genzyme Core Field or the Company Field.

        The Company's on-going performance obligations to Genzyme under the CLP, including the obligation to deliver certain intellectual property improvements to Genzyme, if improvements are made during the initial five year collaboration period, were deemed to be undelivered elements of the CLP Agreement on the date of closing. Accordingly, the Company deferred the initial $16.65 million in cash received at closing and is amortizing that up-front payment on a straight line basis into the License Fee Revenue line item in its statements of operations over the initial five year collaboration period. The Company received the first holdback amount of $962,000, which included accrued interest, due from Genzyme during the first quarter of 2010. The Company received the second holdback amount of $934,250 which included accrued interest due, from Genzyme during the third quarter of 2010. The amounts were deferred and are being amortized on a straight-line basis into revenue over the remaining term of the collaboration through January 2014.

        In addition, the Company entered into a Common Stock Subscription Agreement with Genzyme on January 27, 2009, which provided for the private issuance and sale to Genzyme of 3,000,000 shares (the "Shares") of the Company's common stock, $0.01 par value per share, at a per share price of $2.00, for an aggregate purchase price of $6.0 million. The price paid by Genzyme for the Shares represented a premium of $0.51 per share above the closing price of the Company's common stock on that date of $1.49 per share. The aggregate premium paid by Genzyme over the closing price of the Company's common stock on the date of the transaction of $1.53 million is included as a part of the total consideration for the CLP. Accordingly, the Company deferred the aggregate $1.53 million premium and is amortizing that amount on a straight line basis into the License fees line item in the Company's statements of operations over the initial five-year collaboration period.

        The Company recognized approximately $4.1 million, $4.1 million, and $4.0 million in license fee revenue in connection with the amortization of the up-front payments and holdback amounts from Genzyme during the years ended December 31, 2012, 2011, and 2010, respectively.

MAYO LICENSE AGREEMENT
MAYO LICENSE AGREEMENT

(4) MAYO LICENSE AGREEMENT

Overview

        On June 11, 2009, the Company entered into a license agreement (the "License Agreement") with MAYO Foundation for Medical Education and Research ("MAYO"). Under the License Agreement, MAYO granted the Company an exclusive, worldwide license within the field (the "Field") of stool or blood based cancer diagnostics and screening (excluding a specified proteomic target) with regard to certain MAYO patents, and a non-exclusive worldwide license within the Field with regard to certain MAYO know-how. The licensed patents cover advances in sample processing, analytical testing and data analysis associated with non-invasive, stool-based DNA screening for colorectal cancer. Under the License Agreement, the Company assumes the obligation and expense of prosecuting and maintaining the licensed patents and is obligated to make commercially reasonable efforts to bring products covered by the licenses to market. Pursuant to the License Agreement, the Company granted MAYO two common stock purchase warrants with an exercise price of $1.90 per share covering 1,000,000 and 250,000 shares of common stock, respectively. The Company also is required to make payments to MAYO for up-front fees, fees once certain milestones are reached by the Company, and other payments as outlined in the agreement. In addition to the license to intellectual property owned by MAYO, the Company will receive product development and research and development efforts from MAYO personnel. The Company determined that the payments made for intellectual property should not be capitalized as the future economic benefit derived from the transactions is uncertain. The Company is also liable to make royalty payments to MAYO on potential future net sales of any products developed from the licensed technology.

Warrants

        The warrants granted to MAYO were valued using a Black-Scholes pricing model at the date of the grant. The warrants were granted with an exercise price of $1.90 per share of common stock. The grant to purchase 1,000,000 shares was immediately exercisable and the grant to purchase 250,000 shares vests and becomes exercisable over a four year period. The total value of the warrants was calculated to be $2.1 million and a non-cash charge of $1.7 million was recognized as research and development expense in the second quarter of 2009 and the remaining $0.4 million non-cash charge is being recognized straight-line over the four year vesting period.

        In March of 2010, MAYO partially exercised its warrant covering 1,000,000 shares by utilizing the cashless exercise provision contained in the agreement. As a result of this exercise for a gross amount of 200,000 shares, in lieu of paying a cash exercise price, MAYO forfeited its rights with respects to 86,596 shares leaving it with a net amount of 113,404 shares.

        In September of 2010, MAYO partially exercised its warrant covering the remaining 800,000 shares by utilizing the cashless exercise provision contained in the agreement. As a result of this exercise for a gross amount of 300,000 shares, in lieu of paying a cash exercise price, MAYO forfeited its rights with respect to 97,853 shares leaving it with a net amount of 202,147 shares.

        In June of 2011, MAYO partially exercised its warrant covering the remaining 500,000 shares by utilizing the cashless exercise provision contained in the warrant. As a result of this exercise for a gross amount of 250,000 shares, in lieu of paying a cash exercise price, MAYO forfeited its rights with respect to 60,246 shares leaving it with a net amount of 189,754 shares.

        In September of 2011, MAYO partially exercised its warrant covering the remaining 250,000 shares by utilizing the cashless exercise provision contained in the warrant. As a result of this exercise for a gross amount of 250,000 shares, in lieu or paying a cash exercise price, MAYO forfeited its right with respect to 56,641 shares leaving it with a net amount of 193,359 shares. Following this exercise, the warrant was fully exercised.

        As of December 31, 2012 the warrant grant to purchase 250,000 shares remained outstanding and unexercised.

Royalty Payments

        The Company will make royalty payments to MAYO based on a percentage of net sales of products developed from the licensed technology starting in the third year of the agreement. Minimum royalty payments will be $10,000 in 2012 and $25,000 per year thereafter through 2029, the year the last patent expires.

Other Payments

        Other payments under the License Agreement include an upfront payment of $80,000, a milestone payment of $250,000 on the commencement of patient enrollment in a human cancer screening clinical, and a $500,000 payment upon FDA approval of the Company's Cologuard test. The upfront payment of $80,000 was made in the third quarter of 2009 and expensed to research and development in the second quarter of 2009. The Company began enrollment in its FDA trial in June 2011 and the milestone payment of $250,000 was made and expensed to research and development in June 2011. It is uncertain as to when the FDA will approve the Company's Cologuard test; therefore the $500,000 milestone payment has not been recorded as a liability. The Company evaluates the status of the FDA trial at each reporting date to determine if a liability should be recorded for the milestone payment.

        In addition, the Company is paying MAYO for research and development efforts. As part of the Company's research collaboration with MAYO, the Company has incurred charges of $1.2 million and has made payments of $1.1 million for the year ended December 31, 2012. The Company has recorded an estimated liability in the amount of $127,000 for research and development efforts as of December 31, 2012. The Company incurred charges of $1.4 million and made payments of $1.4 million for the year ended December 31, 2011. The Company recorded an estimated liability in the amount of $53,000 for research and development efforts at December 31, 2011.

  • Amendments—May 2012

        In May 2012 the Company expanded the relationship with MAYO through an amendment to the License Agreement. As part of the amendment, MAYO expanded the Company's license to include all gastrointestinal cancers and diseases, and new cancer screening applications of stool- and blood-based testing. As consideration for the expanded license, the Company granted MAYO 97,466 shares of restricted stock, one quarter of which vested immediately, with the remainder to vest in three equal annual installments. The Company recognized $1.0 million in licensing expense during the twelve months ended December 31, 2012 in connection with the restricted stock grant due to the uncertainty in the license providing a future benefit.

        As part of the amendment, the Company will also be responsible for making additional restricted stock grants to MAYO as certain milestones are met with respect to the commercial launch of the Company's second and third licensed products. Additionally, the Company will make milestone payments once certain sales levels are reached on the second and third licensed products. It is uncertain as to when these milestones will be met; therefore, the milestone payments have not been recorded as a liability. The Company evaluates the status of the milestone payments at each reporting date to determine if a liability should be recorded for the milestone payment.

ISSUANCES OF COMMON STOCK
ISSUANCES OF COMMON STOCK

(5) ISSUANCES OF COMMON STOCK

        On April 19, 2010, the Company completed an underwritten public offering of 4.2 million shares of common stock at a price of $4.50 per share to the public. The Company received approximately $17.6 million of net proceeds from the offering, after deducting $1.3 million for the underwriting discount and other stock issuance costs paid by the Company. The Company expects to use the net proceeds from the offering for general corporate and working capital purposes, including the funding of strategic initiatives that the Company may undertake from time to time, for product development and the furtherance of the Company's efforts to obtain FDA clearance in its sDNA colorectal cancer screening product.

        On November 10, 2010, the Company completed an underwritten public offering of 11.5 million shares of common stock at a price of $6.00 per share to the public. The Company received approximately $64.7 million of net proceeds from the offering, after deducting $4.3 million for the underwriting discount and other stock issuance costs paid by the Company.

        On December 6, 2011, the Company completed an underwritten public offering of 3.6 million shares of common stock at a price of $8.00 per share to the public. The Company received approximately $27.2 million of net proceeds from the offering, after deducting $1.5 million for the underwriting discount and other stock issuance costs paid by the Company.

        On August 13, 2012, the Company completed an underwritten public offering of 6.3 million shares of common stock at a price of $9.75 per share to the public. The Company received approximately $57.8 million of net proceeds from the offering, after deducting $3.9 million for the underwriting discount and other stock issuance costs paid by the Company.

STOCK-BASED COMPENSATION
STOCK-BASED COMPENSATION

(6) STOCK-BASED COMPENSATION

Stock-Based Compensation Plans

        The Company maintains the 2010 Omnibus Long-Term Incentive Plan, the 2010 Employee Stock Purchase Plan, the 2000 Stock Option and Incentive Plan and the 2000 Employee Stock Purchase Plan (collectively, the "Stock Plans").

        2000 Stock Option and Incentive Plan    The Company adopted the 2000 Option and Incentive Plan (the "2000 Option Plan") on October 17, 2000. The 2000 Option Plan expired October 17, 2010 and after such date no further awards could be granted under the plan. Under the terms of the 2000 Option Plan, the Company was authorized to grant incentive stock options, as defined under the Internal Revenue Code, non-qualified options, restricted stock awards and other stock awards to employees, officers, directors, consultants and advisors. Options granted under the 2000 Option Plan expire ten years from the date of grant. Grants made from the 2000 Option Plan generally vest over a period of three to four years.

        The 2000 Option Plan was administered by the compensation committee of the Company's board of directors, which selected the individuals to whom equity-based awards would be granted and determined the option exercise price and other terms of each award, subject to the provisions of the 2000 Option Plan. The 2000 Option Plan provides that upon an acquisition of the Company, the vesting of all options to purchase common stock will accelerate by a period of one year. In addition, upon the termination of an employee without cause or for good reason prior to the first anniversary of the completion of the acquisition, all options then outstanding under the 2000 Option Plan held by that employee will immediately become exercisable. At December 31, 2012, options to purchase 4,889,933 shares and 54,000 shares of restricted stock were outstanding under the 2000 Option Plan.

        2010 Omnibus Long-Term Incentive Plan    The Company adopted the 2010 Omnibus Long-Term Incentive Plan (the "2010 Stock Plan") on July 16, 2010. The 2010 Stock Plan will expire on July 16, 2020 and after such date no further awards may be granted under the plan. Under the terms of the 2010 Stock Plan, the Company is authorized to grant incentive stock options, as defined under the Internal Revenue Code, non-qualified options, restricted stock awards and other stock awards to employees, officers, directors, consultants and advisors. Options granted under the 2010 Stock Plan expire ten years from the date of grant. Grants made from the 2010 Stock Plan generally vest over a period of three to four years.

        The 2010 Stock Plan is administered by the compensation committee of the Company's board of directors, which selects the individuals to whom equity-based awards will be granted and determines the option exercise price and other terms of each award, subject to the provisions of the 2010 Stock Plan. The 2010 Stock Plan provides that upon an acquisition of the Company, all equity will accelerate by a period of one year. In addition, upon the termination of an employee without cause or for good reason prior to the first anniversary of the completion of the acquisition, all equity awards then outstanding under the 2010 Stock Plan held by that employee will immediately vest. At December 31, 2012, options to purchase 1,292,063 shares were outstanding under the 2010 Stock Plan, and 759,955 shares of restricted stock and restricted stock units were outstanding. At December 31, 2012, there were 1,489,918 shares available for future grant under the 2010 Stock Plan.

        2010 Employee Stock Purchase Plan    The 2010 Employee Stock Purchase Plan (the "2010 Purchase Plan") was adopted by the Company on July 16, 2010. The 2010 Purchase Plan provides participating employees the right to purchase common stock at a discount through a series of offering periods. The 2010 Purchase Plan will expire on October 31, 2020. At December 31, 2012, there were 184,532 shares of common stock available for purchase by participating employees under the 2010 Purchase Plan.

        The compensation committee of the Company's board of directors administers the 2010 Purchase Plan. Generally, all employees whose customary employment is more than 20 hours per week and more than five months in any calendar year are eligible to participate in the 2010 Purchase Plan. Participating employees authorize an amount, between 1% and 15% of the employee's compensation, to be deducted from the employee's pay during the offering period. On the last day of the offering period, the employee is deemed to have exercised the employee's option to purchase shares of Company common stock, at the option exercise price, to the extent of accumulated payroll deductions. Under the terms of the 2010 Purchase Plan, the option exercise price is an amount equal to 85% of the fair market value, as defined under the 2010 Purchase Plan and no employee can purchase more than $25,000 of Company common stock under the 2010 Purchase Plan in any calendar year. Rights granted under the 2010 Purchase Plan terminate upon an employee's voluntary withdrawal from the 2010 Purchase Plan at any time or upon termination of employment. At December 31, 2012, there were 115,468 cumulative shares issued under the 2010 Purchase Plan, and 63,611 shares were issued in the year ended December 31, 2012, as follows:

Offering period ended
  Number of
Shares
  Weighted Average
Price per Share
 

April 30, 2012

    34,336   $ 5.67  

October 31, 2012

    29,275   $ 5.89  

Stock-Based Compensation Expense

        The Company recorded approximately $5.5 million in stock-based compensation expense during the year ended December 31, 2012, in connection with the amortization of restricted stock and restricted stock unit awards, stock purchase rights granted under the Company's employee stock purchase plans and stock options granted to employees and non-employee directors. The Company recorded $4.0 million in stock-based compensation expense during the year ended December 31, 2011 in connection with the amortization of restricted stock and restricted stock unit awards, stock purchase rights granted under the Company's employee stock purchase plans and stock options granted to employees and non-employee directors. The Company recorded approximately $2.1 million in stock-based compensation expense during the year ended December 31, 2010 in connection with the amortization of awards of common stock, restricted common stock and stock options granted to employees, non-employee directors and non-employee consultants. Non-cash stock-based compensation expense by department for the years ended December 31, 2012, 2011, and 2010 are as follows, and amounts included in the table are in thousands:

 
  December 31,  
 
  2012   2011   2010  

Research and development

  $ 2,396   $ 1,685   $ 1,087  

General and administrative

    2,579     1,622     993  

Sales and marketing

    518     657     41  

        In connection with the December 31, 2011 resignation of the Company's Senior Vice President of Sales and Marketing, the Company accelerated the vesting of 131,250 shares under his previously unvested stock options. This acceleration was done in accordance with his employment agreement. He will have a two year period from December 31, 2011 to exercise these options. The remaining 168,750 stock options from his initial grant were forfeited. As a result of this accelerated vesting, the Company recorded additional stock compensation expense in 2011 to ensure that the total grant date fair value of the actual vested awards was amortized to expense.

Determining Fair Value

        Valuation and Recognition—The fair value of each option award is estimated on the date of grant using the Black-Scholes option-pricing model based on the assumptions in the table below. The estimated fair value of employee stock options is recognized to expense using the straight-line method over the vesting period.

        Expected Term—The Company uses the simplified calculation of expected life, described in the SEC's Staff Accounting Bulletins 107 and 110, as the Company does not currently have sufficient historical exercise data on which to base an estimate of expected life. Using this method, the expected term is determined using the average of the vesting period and the contractual life of the stock options granted.

        Expected Volatility—Expected volatility is based on the Company's historical stock volatility data over the expected term of the awards.

        Risk-Free Interest Rate—The Company bases the risk-free interest rate used in the Black-Scholes valuation method on the implied yield currently available on U.S. Treasury zero-coupon issues with an equivalent expected term.

        Forfeitures—The Company records stock-based compensation expense only for those awards that are expected to vest. A forfeiture rate is estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from initial estimates. The Company's forfeiture rate used in 2012 is 1.4%.

        The fair value of each restricted stock and restricted stock unit award is determined on the date of grant using the closing stock price on that day. The fair value of each option award is estimated on the date of grant using the Black-Scholes option pricing model based on the assumptions in the following table.

 
  December 31,
 
  2012   2011   2010

Option Plan Shares

           

Risk-free interest rates

  0.81% - 1.00%   0.88% - 2.3%   1.17% - 2.69%

Expected term (in years)

  6   6   6

Expected volatility

  85% - 92%   92%   91% - 92%

Dividend yield

  0%   0%   0%

Weighted average fair value per share of options granted during the period

  $6.90   $4.78   $3.07

ESPP Shares

           

Risk-free interest rates

  0.18% - 0.30%   0.13% - 0.61%   0.16% - 0.38%

Expected term (in years)

  0.5 - 2   0.5 - 2   0.5 - 2

Expected volatility

  34.0% - 54.9%   48% - 63%   53% - 127%

Dividend yield

  0%   0%   0%

Weighted average fair value per share of stock purchase rights granted during the period

  $2.84   $2.83   $2.03

Stock Option, Restricted Stock, and Restricted Stock Unit Activity

        A summary of stock option activity under the Stock Plans during the years ended 2012, 2011 and 2010 is as follows:

Options
  Shares   Weighted
Average
Exercise
Price
  Weighted
Average
Remaining
Contractual
Term (Years)
  Aggregate
Intrinsic
Value(1)
 

(Aggregate intrinsic value in thousands)

                         

Outstanding, January 1, 2010

   
5,912,019
 
$

1.76
             

Granted

    518,566     4.09              

Exercised

    (213,386 )   2.19              
                       

Outstanding, December 31, 2010

    6,217,199     1.93              

Granted

   
814,424
   
6.26
             

Exercised

    (325,477 )   2.11              

Forfeited

    (252,502 )   7.15              
                       

Outstanding, December 31, 2011

    6,453,644     2.27              

Granted

   
499,198
   
9.18
             

Exercised

    (691,471 )   3.45              

Forfeited

    (79,375 )   7.60              
                       

Outstanding, December 31, 2012

    6,181,996   $ 2.62     6.6   $ 49,439  
                   

Exercisable, December 31, 2012

    4,730,475   $ 1.72     6.2   $ 42,154  
                   

Vested and expected to vest, December 31, 2012

    6,175,107   $ 2.66     6.6   $ 49,430  
                   

(1)
The aggregate intrinsic value of options outstanding at December 31, 2012 is calculated as the difference between the exercise price of the underlying options and the market price of the Company's common stock for the 6,100,211 options that had exercise prices that were lower than the $10.59 market price of our common stock at December 31, 2012. The aggregate intrinsic value of options exercisable at December 31, 2012 is calculated as the difference between the exercise price of the underlying options and the market price of the Company's common stock for the 4,655,475 options that had exercise prices that were lower than the $10.59 market price of our common stock at December 31, 2012. The total intrinsic value of options exercised during the years ended December 31, 2012, 2011 and 2010 was $4.5 million, $1.9 million, $0.4 million, respectively, determined as of the date of exercise.

        Warrants to purchase 75,000 shares of common stock were issued in connection with a consulting agreement in 2009. The warrants contain a performance condition and vest if the Company successfully receives FDA approval for Cologuard. The Company is uncertain if the performance condition will be attained, and therefore no expense has been recorded on this warrant as of December 31, 2012. The exercise price of the warrant is $0.01.

        A summary of restricted stock and restricted stock unit activity under the Stock Plans during the years ended December 31, 2012, 2011 and 2010 is as follows:

 
  Restricted
Shares
  Weighted
Average
Grant Date
Fair Value
 

Outstanding, January 1, 2010

    40,000   $ 1.72  

Granted

    326,197     5.73  

Released

    (102,567 )   2.94  
           

Outstanding, December 31, 2010

    263,630     6.20  

Granted

   
335,716
   
6.06
 

Released

    (192,856 )   5.89  

Forfeited

    (5,000 )   5.61  
           

Outstanding, December 31, 2011

    401,490     6.24  

Granted

   
602,268
   
9.47
 

Released

    (185,116 )   5.67  

Forfeited

    (4,687 )   7.69  
           

Outstanding, December 31, 2012

    813,955   $ 8.51  
           

        As of December 31, 2012, there was approximately $9.8 million of total unrecognized compensation cost related to non-vested share-based compensation arrangements granted under all equity compensation plans. Total unrecognized compensation cost will be adjusted for future changes in forfeitures. The Company expects to recognize that cost over a weighted average period of 2.4 years.

        The Company received approximately $2.4 million, $0.7 million and $0.5 million from stock option exercises during the years ended December 31, 2012, 2011 and 2010, respectively. During the years ended December 31, 2012 and 2011, 63,611 and 51,857 shares of common stock, respectively, were issued under the Company's 2010 Purchase Plan resulting in proceeds to the company of $0.4 million and $0.3 million, respectively. During the year ended December 31, 2010, 58,709 shares of common stock were issued under the Company's 2000 Purchase Plan resulting in proceeds to the Company of $0.1 million.

        The following table summarizes information relating to currently outstanding and exercisable stock options as of December 31, 2012:

 
  Outstanding   Exercisable  
Exercise Price
  Number of
Options
  Weighted
Average
Remaining
Contractual
Life (Years)
  Weighted
Average
Exercise
Price
  Number of
Options
  Weighted
Average
Exercise
Price
 

$—    - $1.00

    3,780,000     6.2   $ 0.83     3,545,625   $ 0.83  

$1.01 - $2.00

    98,500     6.3   $ 1.41     27,250   $ 1.39  

$2.01 - $3.00

    786,250     6.3   $ 2.80     629,999   $ 2.79  

$3.01 - $4.00

    124,566     7.5   $ 3.51     94,896   $ 3.48  

$4.01 - $5.00

    341,183     6.7   $ 4.27     193,433   $ 4.36  

$5.01 - $7.00

    269,625     8.2   $ 5.85     56,438   $ 5.98  

$7.01 - $9.00

    205,174     7.8   $ 8.15     97,834   $ 8.21  

$9.01 - $14.00

    576,698     7.9   $ 9.72     85,000   $ 12.79  
                       

 

    6,181,996     6.6   $ 2.62     4,730,475   $ 1.72  
                       

        During the first quarter of 2012, the Company granted a total of 262,500 restricted stock units to certain executives that will vest based upon the satisfaction of certain service and performance conditions. The Company performed an evaluation of internal and external factors, and determined the number of shares that are most likely to vest based on the probability of what performance conditions will be met. The expense for the fair value of the awards that are expected to vest, is being recognized ratably over the vesting period.

Shares Reserved for Issuance

        The Company has reserved shares of its authorized common stock for issuance pursuant to its employee stock purchase and stock option plans, including all outstanding stock option grants noted above at December 31, 2012, as follows:

Shares reserved for issuance
   
 

2010 Option Plan

    1,489,918  

2010 Purchase Plan

    184,532  
       

 

    1,674,450  
       
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES

(7) COMMITMENTS AND CONTINGENCIES

Operating Leases

        During November 2009, the Company entered into a five year lease for a 17,500 square feet laboratory office facility in Madison, Wisconsin. This lease contains periodic rent escalation adjustments. During November 2010, the Company entered into an amended lease agreement to lease an additional 7,072 square feet of laboratory and office space for a total of 24,572 square feet. The amended agreement covers the same term as the original term and is also subject to periodic rent escalation adjustments. During March 2012, the Company entered into an amended lease agreement to lease an additional 10,428 square feet of laboratory and office space for a total of 35,000 square feet. The amended agreement covers the same term as the original term and is also subject to periodic rent escalation adjustments.

        Future minimum payments under operating leases as of December 31, 2012 are as follows. Amounts included in the table are in thousands.

Year Ending December 31,

       

2013

  $ 527  

2014

    449  

2015

     

2016

     

2017

     

Thereafter

     
       

Total lease obligations

  $ 976  
       

        Rent expense included in the accompanying statements of operations was approximately $0.4 million, $0.3 million, and $0.2 million for the years ended December 31, 2012, 2011 and 2010, respectively.

        During the fourth quarter of 2009, the Company entered into a sublease agreement (the "2009 Sublease Agreement") with an unrelated party (Sublessee) to sublease approximately 5,086 square feet of rentable area in the Company's Madison facility. The term of the 2009 Sublease Agreement, which commenced on November 1, 2009, was 36 months. The Company has received approximately $0.2 million in sublease payments over the life of the 2009 Sublease Agreement. Pursuant to the Sublease Agreement, Sublessee has no rights to renew or extend the 2009 Sublease Agreement. The Company received $66,800, $78,500 and $76,600 in sublease payments in 2012, 2011, and 2010, respectively. The 2009 Sublease Agreement expired on November 1, 2012.

Licensing and Research Agreements

        The Company licenses, on a non-exclusive basis, certain technologies that are, or may be, incorporated into its technology under several license agreements. Generally, the license agreements require the Company to pay royalties based on net revenues received using the technologies, and may require minimum royalty amounts or maintenance fees.

JHU

        On March 24, 2003, the Company entered into a license agreement, subsequently amended on November 17, 2004, May 11, 2006, March 19, 2007, October 17, 2008, October 30, 2008, and again on January 27, 2009 with JHU for an exclusive long-term license to certain patents for use in colorectal cancer detection in stool relating to the digital-PCR technology developed by Dr. Bert Vogelstein's laboratory at the Johns Hopkins Kimmel Cancer Center. Pursuant to the terms of this license agreement, and subsequent to the closing of the Genzyme strategic transaction (See Note 3), the Company has agreed to pay JHU a license fee based on a percentage of the Company's net revenues, including an annual minimum license fee of approximately $0.1 million, over the life of the licensed patents, or 2023.

Mayo

        On June 11, 2009 the Company entered into a patent licensing agreement with MAYO primarily for the rights to certain patented intellectual property owned by Mayo. The Company has agreed to pay Mayo a royalty fee based on a percentage of the Company's net sales of licensed products. The Company is also required to pay minimum annual royalty fees of $10,000 on June 12, 2012 and $25,000 on June 12, 2013 and each year thereafter through 2029. The Company is required to make a $500,000 payment to MAYO upon FDA approval of the Company's Cologuard test. It is uncertain as to when the FDA will approve the Company's Cologuard test. Therefore, the $500,000 milestone payment has not been recorded as a liability. The Company evaluates the status of the FDA trial at each reporting date to determine if a liability should be recorded for the milestone payment.

Hologic

        On October 14, 2009, the Company entered into a technology license agreement with Hologic, Inc. (Hologic). Under the license agreement, Hologic granted the Company an exclusive, worldwide license within the field of human stool based colorectal cancer and pre-cancer detection or identification with regard to certain Hologic patents and improvements. On December 14, 2012 the Company and Hologic entered into an amendment to this license agreement pursuant to which Hologic granted the Company a non-exclusive worldwide license within the field of any disease or condition within, related to or affecting the gastrointestinal tract and/or appended mucosal surfaces with regard to certain Hologic patents and improvements. The Company paid Hologic $50,000 upon executing the license agreement in 2009 and $100,000 when the Company began enrollment in its FDA trial in June 2011. The Company is required to pay Hologic a royalty fee based on a percentage of the Company's net sales of the licensed products, and required to make a $100,000 milestone payment upon FDA approval of the Company's Cologuard test. It is uncertain as to when the FDA will approve the Company's Cologuard test. Therefore, the $100,000 milestone payment has not been recorded as a liability. The Company evaluates the status of the FDA trial at each reporting date to determine if a liability should be recorded for the milestone payment.

MDx Health

        On July 26, 2010, the Company entered into a technology license and royalty agreement with MDx Health (formerly Oncomethylome Sciences, S.A.). Under the license agreement, MDx Health granted the Company a royalty bearing exclusive, worldwide license to certain patents. Under the licensing agreement, the Company is obligated to make commercially reasonable efforts to bring products covered by the license agreement to market. The Company is required to pay MDx Health a minimum royalty fee of $100,000 on each anniversary of the agreement for the life of the contract. The Company also agreed to pay $100,000 upon the first commercial sale of a licensed product after the receipt of FDA approval and $150,000 after the Company has reached net sales of $10 million of a licensed product after receipt of FDA approval, $750,000 after the Company has reached net sales of $50 million, and $1 million after the Company has reached net sales of $50 million in a single calendar year. The Company is also required to pay MDx Health a royalty fee based on a certain percentage of the Company's net sales of the licensed products.

        The Company has recorded research and development expense associated with license agreements of $1.4 million, $0.8 million, and $0.4 million, respectively, for the years ended December 31, 2012, 2011 and 2010. Future minimum payments due under the Company's technology licenses as of December 31, 2012 are as follows. Amounts included in the table are in thousands.

Year ending December 31,

       

2013

  $ 496  

2014

    296  

2015

    296  

2016

    256  

2017

    256  

Thereafter

    2,288  
       

 

  $ 3,888  
       

Research collaborations

        The Company has also entered into several clinical research agreements, under which it is obligated to fund certain research activities for purposes of technology development. The Company has recorded research and development expense associated with clinical research agreements of approximately $1.2 million, $1.0 million, and $1.3 million, respectively, for the years ended December 31, 2012, 2011 and 2010. As of December 31, 2012, the Company did not have any remaining obligation under these agreements.

Capital Lease

        In 2012 the Company entered into a lease agreement which is accounted for as a capital lease. The leased equipment is recorded at $1,151,000 and is included in the balance sheet as laboratory equipment at December 31, 2012. The cost of the leased equipment is depreciated over the three year lease term, and the expense is recorded as depreciation expense. Accumulated depreciation of the leased equipment at December 31, 2012 was approximately $128,000. The Company is required to make principal and interest payments of approximately $32,000 per month over the three year term of the lease agreement.

        The future minimum lease payments required under the capital lease and the present value of the net minimum lease payments as of December 31, 2012 are as follows (in thousands):

Year Ending December 31,

       

2013

  $ 381  

2014

    381  

2015

    368  
       

Total lease obligations

  $ 1,130  

Less imputed interest

    (86 )

Present value of minimum lease payments

    1,044  
       

Less current maturities of capital lease obligations

    (333 )
       

Long term capital lease obligations

  $ 711  
       
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS

(8) RELATED PARTY TRANSACTIONS

        In 2012, the Company entered into a one year consulting agreement with a non-employee director under which the director will provide advisory services in support of the Company's commercialization activities. In accordance with the agreement, the Company granted a restricted stock award for 4,873 shares of common stock that vests over one year, and will make cash payments totaling $60,000 over the one year term of the agreement.

ACCRUED EXPENSES
ACCRUED EXPENSES

(9) ACCRUED EXPENSES

        Accrued expenses at December 31, 2012 and 2011 consisted of the following. Amounts included in the table are in thousands.

 
  December 31,  
 
  2012   2011  

Compensation

  $ 1,985   $ 2,041  

Research and trial related expenses

    576     440  

Licenses

    373     338  

Professional fees

    351     182  

Occupancy costs

    23     31  

Other

    19     37  
           

 

  $ 3,327   $ 3,069  
           
LONG TERM DEBT
LONG TERM DEBT

(10) LONG TERM DEBT

        During November 2009, the Company entered into a loan agreement with the Wisconsin Department of Commerce pursuant to which the Wisconsin Department of Commerce agreed to lend up to $1 million to the Company subject to the Company's satisfaction of certain conditions. The Company received the $1 million in December 2009. The terms of the loan are such that portions of the loan become forgivable if the Company meets certain job creation requirements. After the Company creates 100 full time positions, the principal shall be reduced at the rate of $5,405 for each new position created thereafter during the measurement period. If the Company has created 185 new full-time positions as of June 30, 2015, the full amount of principal shall be forgiven. The loan bears an interest rate of 2%, which is subject to an increase to 4% if the Company does not meet certain job creation requirements. Both principal and interest payments under the loan agreement are deferred for five years. The difference between the fair value of this loan at December 31, 2012 and the carrying value at this date is not significant. That determination is a Level 3 fair value measurement and the Company considered the expected repayment terms and current interest rates. Based on the Company's estimation of the loan obligation, the table below represents the future principal obligations as of December 31, 2012:

Year ending December 31,

       

2013

  $  

2014

     

2015

    145  

2016

    217  

2017

    221  

Thereafter

    417  
       

 

  $ 1,000  
       
EMPLOYEE BENEFIT PLAN
EMPLOYEE BENEFIT PLAN

(11) EMPLOYEE BENEFIT PLAN

        The Company maintains a qualified 401(k) retirement savings plan (the "401(k) Plan") covering all employees. Under the terms of the 401(k) Plan, participants may elect to defer a portion of their compensation into the 401(k) Plan, subject to certain limitations. Company matching contributions may be made at the discretion of the Board of Directors.

        The Company's Board of Directors approved 401(k) Plan matching contributions for the years ended December 31, 2012, 2011 and 2010 in the form of Company common stock equal to 100% up to 6% of the participant's salary for that year. The Company recorded compensation expense of approximately $0.4 million, $0.3 million, and $0.2 million, respectively, in the statements of operations for the years ended December 31, 2012, 2011 and 2010 in connection with 401(k) Plan matching contributions.

INCOME TAXES
INCOME TAXES

(12) INCOME TAXES

        The Company is subject to taxation in the U.S. and various state jurisdictions. All of the Company's tax years are subject to examination by the U.S. and state tax authorities due to the carryforward of unutilized net operating losses.

        Under financial accounting standards, deferred tax assets or liabilities are computed based on the differences between the financial statement and income tax bases of assets and liabilities using the enacted tax rates. Deferred income tax expense or benefit represents the change in the deferred tax assets or liabilities from period to period. At December 31, 2012, the Company had federal net operating loss and state net operating loss carryforward of approximately $250.7 million and $158.7 million, respectively for financial reporting purposes, which may be used to offset future taxable income. The Company also had federal and state research tax credit carryforwards of $4.2 million and $9.0 million, respectively which may be used to offset future income tax liability. The federal and state carryforwards expire beginning 2013 through 2032 and are subject to review and possible adjustment by the Internal Revenue Service. In the event of a change of ownership, the federal and state net operating loss and research and development tax credit carryforwards may be subject to annual limitations provided by the Internal Revenue Code and similar state provisions.

        As of December 31, 2012 and 2011, the Company had $14.2 million and $10.6 million respectively in excess tax benefit stock option deductions. The excess tax benefit arising from these deductions is credited to additional paid in capital as the benefit is realized.

        The components of the net deferred tax asset with the approximate income tax effect of each type of carryforward, credit and temporary differences are as follows. Amounts included in the table are in thousands.

 
  December 31,  
 
  2012   2011  

Deferred tax assets:

             

Operating loss carryforwards

  $ 88,532   $ 71,471  

Tax credit carryforwards

    10,184     7,511  

Deferred revenue

    1,758     3,399  

Other temporary differences

    3,445     2,257  
           

Tax assets before valuation allowance

    103,919     84,638  

Less—Valuation allowance

    (103,919 )   (84,638 )
           

Net deferred taxes

  $   $  
           

        A valuation allowance to reduce the deferred tax assets is reported if, based on the weight of the evidence, it is more likely than not that some portion or all of the deferred tax assets will not be realized. The Company has incurred significant losses since its inception and due to the uncertainty of the amount and timing of future taxable income, management has determined that a $103.9 million and $84.6 million valuation allowance at December 31, 2012 and 2011 is necessary to reduce the tax assets to the amount that is more likely than not to be realized. The change in valuation allowance for the current year is $19.3 million. Due to the existence of the valuation allowance, future changes in our unrecognized tax benefits will not impact the Company's effective tax rate.

        The effective tax rate differs from the statutory tax rate due to the following:

 
  December 31,  
 
  2012   2011   2010  

U.S. Federal statutory rate

    34.0 %   34.0 %   34.0 %

State taxes

    1.7     5.6     5.6  

Research and development tax credit

    5.1     1.7     2.6  

Stock-based compensation expense

    (0.6 )   (2.4 )   (1.9 )

Other adjustments

    (0.1 )   0.1     (0.1 )

Valuation allowance

    (40.1 )   (39.0 )   (40.1 )
               

Effective tax rate

    0.0 %   0.0 %   0.1 %
               

        The Company recognizes the financial statement benefit of a tax position only after determining that the relevant tax authority would more likely than not sustain the position following an audit. For tax positions meeting the more-likely-than-not threshold, the amount recognized in the financial statements is the largest benefit that has a greater than 50 percent likelihood of being realized upon ultimate settlement with the relevant tax authority. The amount of unrecognized tax benefits as of January 1, 2010 was none. There have been no changes in unrecognized tax benefits since January 1, 2010, nor are there any tax positions where it is reasonably possible that the total amounts of unrecognized tax benefits will significantly increase or decrease within the 12 months following December 31, 2012.

        As of December 31, 2012, due to the carryforward of unutilized net operating losses and research and development credits, the Company is subject to U.S. Federal income tax examinations for the tax years 1995 through 2012, and to state income tax examinations for the tax years 1995 through 2012. Interest and penalties are recorded as income tax expense in the period incurred. There were no interest or penalties related to income taxes that have been accrued or recognized as of and for the years ended December 31, 2012, 2011 and 2010.

QUARTERLY RESULTS OF OPERATIONS (UNAUDITED)
QUARTERLY RESULTS OF OPERATIONS (UNAUDITED)

(13) QUARTERLY RESULTS OF OPERATIONS (UNAUDITED)

        The following table sets forth unaudited quarterly statement of operations data for each of the eight quarters ended December 31, 2012. In the opinion of management, this information has been prepared on the same basis as the audited financial statements and all necessary adjustments, consisting only of normal recurring adjustments, have been included in the amounts stated below to present fairly the unaudited quarterly results of operations. The quarterly data should be read in conjunction with our financial statements.

 
  Quarter Ended  
 
  March 31,   June 30,   September 30,   December 31,  
 
  (Amounts in thousands, except per share data)
 

2012

                         

Revenue

  $ 1,036   $ 1,036   $ 1,036   $ 1,036  

Cost of revenue

                 
                   

Gross profit

    1,036     1,036     1,036     1,036  

Research and development

    8,999     12,202     10,491     10,439  

General and administrative

    2,145     2,393     2,547     2,815  

Sales and marketing

    594     1,331     1,006     1,824  
                   

Loss from operations

    (10,702 )   (14,890 )   (13,008 )   (14,042 )

Investment income

    62     59     67     74  

Interest expense

    (5 )   (5 )   (11 )   (20 )
                   

Net loss

  $ (10,645 ) $ (14,836 ) $ (12,952 ) $ (13,988 )
                   

Net loss per share—basic and diluted

  $ (0.19 ) $ (0.26 ) $ (0.21 ) $ (0.22 )
                   

Weighted average common shares outstanding—basic and diluted

    56,718     57,037     60,531     63,582  
                   

2011

                         

Revenue

  $ 1,040   $ 1,042   $ 1,039   $ 1,042  

Cost of revenue

    6     6     6     6  
                   

Gross profit

    1,034     1,036     1,033     1,036  

Research and development

    2,989     5,197     6,110     7,672  

General and administrative

    2,150     1,830     1,951     2,206  

Sales and marketing

    297     651     815     1,094  
                   

Loss from operations

    (4,402 )   (6,642 )   (7,843 )   (9,936 )

Investment income

    34     22     75     38  

Interest expense

    (5 )   (5 )   (5 )   (6 )
                   

Net loss

  $ (4,373 ) $ (6,625 ) $ (7,773 ) $ (9,904 )
                   

Net loss per share—basic and diluted

  $ (0.08 ) $ (0.13 ) $ (0.15 ) $ (0.18 )
                   

Weighted average common shares outstanding—basic and diluted

    51,930     52,010     52,443     53,647  
                   
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)

Use of Estimates

        The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure 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 from those estimates.

Cash and Cash Equivalents

        The Company considers cash on hand, demand deposits in bank, money market funds, and all highly liquid investments with an original maturity of 90 days or less to be cash and cash equivalents. The Company had no restricted cash at December 31, 2012 and 2011.

Marketable Securities

        Management determines the appropriate classification of debt securities at the time of purchase and re-evaluates such designation as of each balance sheet date. Debt securities carried at amortized cost are classified as held-to-maturity when the Company has the positive intent and ability to hold the securities to maturity. Marketable equity securities and debt securities not classified as held-to-maturity are classified as available-for-sale. Available-for-sale securities are carried at fair value, with the unrealized gains and losses, net of tax, reported in other comprehensive income. The amortized cost of debt securities in this category is adjusted for amortization of premiums and accretion of discounts to maturity computed under the straight-line method. Such amortization is included in investment income. Realized gains and losses and declines in value judged to be other-than-temporary on available-for-sale securities are included in investment income. The cost of securities sold is based on the specific identification method. Interest and dividends on securities classified as available-for-sale are included in investment income.

        At December 31, 2012 and December 31, 2011 the Company's investments were comprised of fixed income investments and all were deemed available-for-sale. The objectives of the Company's investment strategy are to provide liquidity and safety of principal while striving to achieve the highest rate of return consistent with these two objectives. The Company's investment policy limits investments to certain types of instruments issued by institutions with investment grade credit ratings and places restrictions on maturities and concentration by type and issuer. Investments in which the Company has the ability and intent, if necessary, to liquidate in order to support its current operations (including those with a contractual term greater than one year from the date of purchase) are classified as current. All of the Company's investments are considered current. Realized gains were $6,231, $419, and $13,149 for the years ended December 31, 2012, 2011, and 2010 respectively. Unrealized gains on investments recorded in other comprehensive income were $77,808 and $721 for the years ended December 31, 2012 and December 31, 2010. Unrealized losses on investments recorded in other comprehensive income were $13,784 for the year ended December 31, 2011.

        Available-for-sale securities at December 31, 2012 consist of the following:

 
  December 31, 2012  
(In thousands)
  Amortized Cost   Gains in Accumulated
Other Comprehensive
Income
  Losses in Accumulated
Other Comprehensive
Income
  Estimated
Fair Value
 

U.S. government agency securities

  $ 44,270   $ 38   $   $ 44,308  

Corporate bonds

    43,303     27         43,330  

Certificates of deposit

    5,926     13         5,939  

Commercial paper

    1,199             1,199  
                   

Total available-for-sale securities

  $ 94,698   $ 78   $   $ 94,776  
                   

        Available-for-sale securities at December 31, 2011 consist of the following:

 
  December 31, 2011  
(In thousands)
  Amortized Cost   Gains in Accumulated
Other Comprehensive
Income
  Losses in Accumulated
Other Comprehensive
Income
  Estimated
Fair Value
 

U.S. government agency securities

  $ 28,004   $   $ (10 ) $ 27,994  

Corporate bonds

    19,124           (2 )   19,122  

Certificates of deposit

    9,467         (2 )   9,465  

Commercial paper

    999             999  
                   

Total available-for-sale securities

  $ 57,594   $   $ (14 ) $ 57,580  
                   

Property and Equipment

        Property and equipment are stated at cost and depreciated using the straight-line method over the assets' estimated useful lives. Maintenance and repairs are expensed when incurred; additions and improvements are capitalized. The estimated useful lives of fixed assets are as follows:

Asset Classification
  Estimated Useful Life

Laboratory equipment

  3 - 5 years

Office and computer equipment

  3 years

Leasehold improvements

  Lesser of the remaining

 

  lease term or useful life

Furniture and fixtures

  3 years

        Depreciation expense for the years ended December 31, 2012, 2011, and 2010 was $1.0 million, $0.4 million, and $0.2 million, respectively.

Patent Costs

        Patent costs, which have historically consisted of related legal fees, are capitalized as incurred only if the Company determines that there is some probable future economic benefit derived from the transaction. The capitalized patents are amortized beginning when patents are approved over an estimated useful life of five years. Capitalized patent costs are expensed upon disapproval, upon a decision by the Company to no longer pursue the patent or when the related intellectual property is either sold or deemed to be no longer of value to the Company. The Company determined that all patent costs incurred during the year ended December 31, 2012, 2011 and 2010 should be expensed and not capitalized as the future economic benefit derived from the transactions cannot be determined.

  • Clinical Trial Accrual

        Accruals are recorded for clinical trial patient site costs when the liability is probable and reasonably estimable. For our pivotal FDA clinical trial and other sample procurement studies we undertake periodically, an accrual is made for a patient site cost once the patient has progressed past certain steps in the patient assessment and sample processing procedure. The accrual is estimated based on historical average patient reimbursement fees. Management has recorded an accrual of $0.4 million at December 31, 2012 and 2011 for clinical trial costs related to site payments. We do not expect that actual amounts paid for these patient costs will materially differ from the amounts accrued.

Net Loss Per Share

        Basic net loss per common share was determined by dividing net loss applicable to common stockholders by the weighted average common shares outstanding during the period. Basic and diluted net loss per share is the same because all outstanding common stock equivalents have been excluded, as they are anti-dilutive as a result of the Company's losses.

        The following potentially issuable common shares were not included in the computation of diluted net loss per share because they would have an anti-dilutive effect due to net losses for each period (amounts are in thousands):

 
  2012   2011   2010  

Shares issuable upon exercise of stock options

    6,182     6,454     6,217  

Shares issuable upon exercise of outstanding warrants(1)

    325     325     825  

Shares issuable upon the release of restricted stock awards

    814     401     264  

Shares issuable upon exercise of restricted stock awards related to licensing agreement

    73          
               

 

    7,394     7,180     7,306  
               

(1)
At December 31, 2012 and December 31, 2011, represents warrants to purchase 250,000 shares of common stock issued under a licensing agreement and warrants to purchase 75,000 shares of common stock issued under a consulting agreement. At December 31, 2010 represents represents warrants to purchase 750,000 shares of common stock issued under a licensing agreement and warrants to purchase 75,000 shares of common stock issued under a consulting agreement.

Accounting for Stock-Based Compensation

        The Company requires all share-based payments to employees, including grants of employee stock options, restricted stock, restricted stock units and shares purchased under an ESPP (if certain parameters are not met), to be recognized in the financial statements based on their fair values.

Revenue Recognition

        License fees.    License fees for the licensing of product rights are recorded as deferred revenue upon receipt of cash and recognized as revenue on a straight-line basis over the license period. On June 27, 2007, the Company entered into an amendment to its exclusive license agreement with LabCorp (the "Second Amendment") that, among other modifications to the terms of the license, extended the exclusive license period from August 2008 to December 2010, subject to carve-outs for certain named organizations. Accordingly, the Company amortized the remaining deferred revenue balance resulting from its license agreement with LabCorp at the time of the Second Amendment ($4.7 million) on a straight-line basis over the remaining exclusive license period, which ended in December 2010.

        As more fully described in Note 3 below, in connection with the Company's transaction with Genzyme Corporation, Genzyme agreed to pay the Company a total of $18.5 million, of which $16.65 million was paid on January 27, 2009 and $1.85 million was subject to a holdback by Genzyme to satisfy certain potential indemnification obligations in exchange for the assignment and licensing of certain intellectual property to Genzyme. The Company's on-going performance obligations to Genzyme under the Collaboration, License and Purchase Agreement (the "CLP Agreement"), as described below, including its obligation to deliver through licenses certain intellectual property improvements to Genzyme, if improvements are made during the initial five-year collaboration period, were deemed to be undelivered elements of the CLP Agreement on the date of closing. Accordingly, the Company deferred the initial $16.65 million in cash received at closing and is amortizing that up-front payment on a straight line basis into revenue over the initial five-year collaboration period ending in January 2014. The Company received the first holdback amount of $962,000, which included accrued interest, due from Genzyme during the first quarter of 2010. The Company received the second holdback amount of $934,250 which included accrued interest due, from Genzyme during the third quarter of 2010. The amounts were deferred and are being amortized on a straight-line basis into revenue over the remaining term of the collaboration at the time of receipt.

        In addition, Genzyme purchased 3,000,000 shares of common stock purchased from the Company on January 27, 2009 for $2.00 per share, representing a premium of $0.51 per share above the closing price of the Company's common stock on that date of $1.49 per share. The aggregate premium paid by Genzyme over the closing price of the Company's common stock on the date of the transaction of $1.53 million is deemed to be a part of the total consideration for the CLP Agreement. Accordingly, the Company deferred the aggregate $1.53 million premium and is amortizing that amount on a straight line basis into revenue over the initial five-year collaboration period ending in January 2014.

        The Company recognized approximately $4.1 million in license fee revenue in connection with the amortization of the up-front payments from Genzyme during the years ended December 31, 2012 and December 31, 2011. The Company recognized $5.3 million in license fee revenue in connection with the amortization of the up-front payments from LabCorp and Genzyme during the year ended December 31, 2010.

        Product royalty fees.    The Company has licensed certain of its technologies, including improvements to such technologies, on an exclusive basis to LabCorp. LabCorp developed and commercially offered a non-invasive stool-based DNA colorectal cancer screening service for the average-risk population based on the Company's technology. The Company is entitled to certain royalties on any sales of this product. Accordingly, the Company records product royalty fees based on the specified contractual percentage of LabCorp's net revenues from its sales of such colorectal cancer screening tests, as reported to the Company each month by LabCorp. The current royalty rate is subject to an increase in the event that LabCorp achieves a specified significant threshold of annual net revenues from the sales of such colorectal cancer screening tests. No sales of this product were reported to the Company during the year ended December 31, 2012 and no product royalty fees were recorded. Product royalty fees were $20,000 and $26,000 for the years ended December 31, 2011 and 2010, respectively.

Other Income

        The Company recognizes other income as earned. Other income consists of income received related to activities not related to the Company's core business operations. The Company had no other income during the years ended December 31, 2012 and 2011. During 2010, the Company received notice that it had been awarded a total cash grant of $244,479 under the Qualifying Therapeutic Discovery Project program administered under Section 48D of the Internal Revenue Code, all of which relates to qualifying expenses that have previously been incurred. The Company recognized the full amount of the grant as other income for the year ended December 31, 2010 as the Company has incurred all of the qualifying expenses and the amount had been received in full.

Advertising Costs

        The Company expenses the costs of media advertising at the time the advertising takes place. The Company expensed approximately $57,400, $110,000 and $68,100 of media advertising during the years ended December 31, 2012, 2011, and 2010, respectively.

Fair Value Measurements

        The FASB has issued authoritative guidance which requires that fair value should be based on the assumptions market participants would use when pricing an asset or liability and establishes a fair value hierarchy that prioritizes the information used to develop those assumptions. This guidance was adopted in 2009 for non-financial assets and liabilities. Under the standard, fair value measurements are separately disclosed by level within the fair value hierarchy. The fair value hierarchy establishes and prioritizes the inputs used to measure fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs. Observable inputs are inputs that reflect the assumptions that market participants would use in pricing the asset or liability developed based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company's assumptions about the assumptions market participants would use in pricing the asset or liability developed based on the best information available in the circumstances.

        The three levels of the fair value hierarchy established are as follows:

Level 1   Quoted prices (unadjusted) in active markets for identical assets or liabilities that the Company has the ability to access as of the reporting date. Active markets are those in which transactions for the asset or liability occur in sufficient frequency and volume to provide pricing information on an ongoing basis.

Level 2

 

Pricing inputs other than quoted prices in active markets included in Level 1, which are either directly or indirectly observable as of the reporting date. These include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active.

Level 3

 

Unobservable inputs that reflect the Company's assumptions about the assumptions that market participants would use in pricing the asset or liability. Unobservable inputs shall be used to measure fair value to the extent that observable inputs are not available.

        Fixed-income securities and mutual funds are valued using a third party pricing agency. The valuation is based on observable inputs including pricing for similar assets and other observable market factors. There has been no material change from period to period.

        The following table presents the Company's fair value measurements as of December 31, 2012 along with the level within the fair value hierarchy in which the fair value measurements in their entirety fall. Amounts in the table are in thousands.

 
   
  Fair Value Measurement at December 31, 2012 Using:  
Description
  Fair Value at
December 31, 2012
  Quoted Prices
in Active
Markets for Identical Assets
(Level 1)
  Significant Other
Observable
Inputs
(Level 2)
  Significant
Unobservable
Inputs
(Level 3)
 

Cash equivalents(1)

  $ 8,405   $ 8,405   $   $  

Available-for-Sale

                         

Marketable securities

                         

U.S. government agency securities

    44,308         44,308      

Certificates of deposit

    5,939         5,939      

Corporate bonds

    43,330         43,330      

Commercial paper

    1,199         1,199      
                   

Total

  $ 103,181   $ 8,405   $ 94,776   $  
                   

(1)
The $8.4 million of cash equivalents above is included in the cash and cash equivalents balance of $13.3 million at December 31, 2012.

        The following table presents the Company's fair value measurements as of December 31, 2011 along with the level within the fair value hierarchy in which the fair value measurements in their entirety fall. Amounts in the table are in thousands.

 
   
  Fair Value Measurement at December 31, 2011 Using:  
Description
  Fair Value at
December 31, 2011
  Quoted Prices
in Active
Markets for Identical Assets
(Level 1)
  Significant Other
Observable
Inputs
(Level 2)
  Significant
Unobservable
Inputs
(Level 3)
 

Cash equivalents(1)

  $ 35,385   $ 35,385   $   $  

Available-for-Sale

                         

Marketable securities

                         

U.S. government agency securities

    27,994         27,994      

Certificates of deposit

    9,465         9,465      

Corporate bonds

    19,122         19,122      

Commercial paper

    999         999      
                   

Total

  $ 92,965   $ 35,385   $ 57,580   $  
                   

(1)
The $35.4 million of cash equivalents above is included in the cash and cash equivalents balance of $35.8 million at December 31, 2011.

        As of December 31, 2012 and 2011 there were available for sale securities in a continuous unrealized loss position for less than twelve months where the total unrealized losses were $4,800 and $28,500 respectively. At December 31, 2012 and 2011 there were no available for sale securities in a continuous unrealized loss position for greater than twelve months.

        The following summarizes contractual underlying maturities of the Company's available-for-sale investments at December 31, 2012 (in thousands):

 
  Cost   Fair Value  

Due in one year or less

  $ 58,882   $ 58,922  

Due after one year through two years

    35,816     35,854  
           

 

  $ 94,698   $ 94,776  
           

Concentration of Credit Risk

        In accordance with GAAP, the Company is required to disclose any significant off-balance-sheet risk and credit risk concentration. The Company has no significant off-balance-sheet risk, such as foreign exchange contracts or other hedging arrangements. Financial instruments that subject the Company to credit risk consist of cash, cash equivalents and marketable securities. As of December 31, 2012, the Company had cash and cash equivalents deposited in financial institutions in which the balances exceed the federal government agency insured limit of $250,000 by approximately $13.1 million. The Company has not experienced any losses in such accounts and management believes it is not exposed to any significant credit risk.

Subsequent Events

        The Company evaluates events that occur through the filing date and discloses those events or transactions that provide additional evidence with respect to conditions that existed at the date of the balance sheet. In addition, the financial statements are adjusted for any changes in estimates resulting from the use of such evidence.

Recent Accounting Pronouncements

        In December 2011, the FASB issued ASU No. 2011-11, Balance Sheet (Topic 210)—Disclosures about Offsetting Assets and Liabilities. ASU 2011-11 requires an entity to disclose information about offsetting and related arrangements to enable users of its financial statements to understand the effect of those arrangements on its financial position. Entities are required to disclose both gross and net information about these instruments. ASU 2011-11 is effective for annual reporting periods beginning on or after January 1, 2013, and interim periods within those annual periods. The adoption of this ASU is not expected to have a material impact on our financial statements.

Reclassifications

        Certain prior year amounts have been reclassified to conform to the current year presentation in the financial statements and accompanying notes to the financial statements.

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables)

 

        Available-for-sale securities at December 31, 2012 consist of the following:

 
  December 31, 2012  
(In thousands)
  Amortized Cost   Gains in Accumulated
Other Comprehensive
Income
  Losses in Accumulated
Other Comprehensive
Income
  Estimated
Fair Value
 

U.S. government agency securities

  $ 44,270   $ 38   $   $ 44,308  

Corporate bonds

    43,303     27         43,330  

Certificates of deposit

    5,926     13         5,939  

Commercial paper

    1,199             1,199  
                   

Total available-for-sale securities

  $ 94,698   $ 78   $   $ 94,776  
                   

        Available-for-sale securities at December 31, 2011 consist of the following:

 
  December 31, 2011  
(In thousands)
  Amortized Cost   Gains in Accumulated
Other Comprehensive
Income
  Losses in Accumulated
Other Comprehensive
Income
  Estimated
Fair Value
 

U.S. government agency securities

  $ 28,004   $   $ (10 ) $ 27,994  

Corporate bonds

    19,124           (2 )   19,122  

Certificates of deposit

    9,467         (2 )   9,465  

Commercial paper

    999             999  
                   

Total available-for-sale securities

  $ 57,594   $   $ (14 ) $ 57,580  
                   

 

 

Asset Classification
  Estimated Useful Life

Laboratory equipment

  3 - 5 years

Office and computer equipment

  3 years

Leasehold improvements

  Lesser of the remaining

 

  lease term or useful life

Furniture and fixtures

  3 years

The following potentially issuable common shares were not included in the computation of diluted net loss per share because they would have an anti-dilutive effect due to net losses for each period (amounts are in thousands):

 
  2012   2011   2010  

Shares issuable upon exercise of stock options

    6,182     6,454     6,217  

Shares issuable upon exercise of outstanding warrants(1)

    325     325     825  

Shares issuable upon the release of restricted stock awards

    814     401     264  

Shares issuable upon exercise of restricted stock awards related to licensing agreement

    73          
               

 

    7,394     7,180     7,306  
               

(1)
At December 31, 2012 and December 31, 2011, represents warrants to purchase 250,000 shares of common stock issued under a licensing agreement and warrants to purchase 75,000 shares of common stock issued under a consulting agreement. At December 31, 2010 represents represents warrants to purchase 750,000 shares of common stock issued under a licensing agreement and warrants to purchase 75,000 shares of common stock issued under a consulting agreement.

Amounts in the table are in thousands.

 
   
  Fair Value Measurement at December 31, 2012 Using:  
Description
  Fair Value at
December 31, 2012
  Quoted Prices
in Active
Markets for Identical Assets
(Level 1)
  Significant Other
Observable
Inputs
(Level 2)
  Significant
Unobservable
Inputs
(Level 3)
 

Cash equivalents(1)

  $ 8,405   $ 8,405   $   $  

Available-for-Sale

                         

Marketable securities

                         

U.S. government agency securities

    44,308         44,308      

Certificates of deposit

    5,939         5,939      

Corporate bonds

    43,330         43,330      

Commercial paper

    1,199         1,199      
                   

Total

  $ 103,181   $ 8,405   $ 94,776   $  
                   

(1)
The $8.4 million of cash equivalents above is included in the cash and cash equivalents balance of $13.3 million at December 31, 2012.

 
   
  Fair Value Measurement at December 31, 2011 Using:  
Description
  Fair Value at
December 31, 2011
  Quoted Prices
in Active
Markets for Identical Assets
(Level 1)
  Significant Other
Observable
Inputs
(Level 2)
  Significant
Unobservable
Inputs
(Level 3)
 

Cash equivalents(1)

  $ 35,385   $ 35,385   $   $  

Available-for-Sale

                         

Marketable securities

                         

U.S. government agency securities

    27,994         27,994      

Certificates of deposit

    9,465         9,465      

Corporate bonds

    19,122         19,122      

Commercial paper

    999         999      
                   

Total

  $ 92,965   $ 35,385   $ 57,580   $  
                   

(1)
The $35.4 million of cash equivalents above is included in the cash and cash equivalents balance of $35.8 million at December 31, 2011.

The following summarizes contractual underlying maturities of the Company's available-for-sale investments at December 31, 2012 (in thousands):

 
  Cost   Fair Value  

Due in one year or less

  $ 58,882   $ 58,922  

Due after one year through two years

    35,816     35,854  
           

 

  $ 94,698   $ 94,776  
           
STOCK-BASED COMPENSATION (Tables)

Amounts included in the table are in thousands:

 
  December 31,  
 
  2012   2011   2010  

Research and development

  $ 2,396   $ 1,685   $ 1,087  

General and administrative

    2,579     1,622     993  

Sales and marketing

    518     657     41  

 

 

 
  December 31,
 
  2012   2011   2010

Option Plan Shares

           

Risk-free interest rates

  0.81% - 1.00%   0.88% - 2.3%   1.17% - 2.69%

Expected term (in years)

  6   6   6

Expected volatility

  85% - 92%   92%   91% - 92%

Dividend yield

  0%   0%   0%

Weighted average fair value per share of options granted during the period

  $6.90   $4.78   $3.07

ESPP Shares

           

Risk-free interest rates

  0.18% - 0.30%   0.13% - 0.61%   0.16% - 0.38%

Expected term (in years)

  0.5 - 2   0.5 - 2   0.5 - 2

Expected volatility

  34.0% - 54.9%   48% - 63%   53% - 127%

Dividend yield

  0%   0%   0%

Weighted average fair value per share of stock purchase rights granted during the period

  $2.84   $2.83   $2.03

 

 

Options
  Shares   Weighted
Average
Exercise
Price
  Weighted
Average
Remaining
Contractual
Term (Years)
  Aggregate
Intrinsic
Value(1)
 

(Aggregate intrinsic value in thousands)

                         

Outstanding, January 1, 2010

   
5,912,019
 
$

1.76
             

Granted

    518,566     4.09              

Exercised

    (213,386 )   2.19              
                       

Outstanding, December 31, 2010

    6,217,199     1.93              

Granted

   
814,424
   
6.26
             

Exercised

    (325,477 )   2.11              

Forfeited

    (252,502 )   7.15              
                       

Outstanding, December 31, 2011

    6,453,644     2.27              

Granted

   
499,198
   
9.18
             

Exercised

    (691,471 )   3.45              

Forfeited

    (79,375 )   7.60              
                       

Outstanding, December 31, 2012

    6,181,996   $ 2.62     6.6   $ 49,439  
                   

Exercisable, December 31, 2012

    4,730,475   $ 1.72     6.2   $ 42,154  
                   

Vested and expected to vest, December 31, 2012

    6,175,107   $ 2.66     6.6   $ 49,430  
                   

(1)
The aggregate intrinsic value of options outstanding at December 31, 2012 is calculated as the difference between the exercise price of the underlying options and the market price of the Company's common stock for the 6,100,211 options that had exercise prices that were lower than the $10.59 market price of our common stock at December 31, 2012. The aggregate intrinsic value of options exercisable at December 31, 2012 is calculated as the difference between the exercise price of the underlying options and the market price of the Company's common stock for the 4,655,475 options that had exercise prices that were lower than the $10.59 market price of our common stock at December 31, 2012. The total intrinsic value of options exercised during the years ended December 31, 2012, 2011 and 2010 was $4.5 million, $1.9 million, $0.4 million, respectively, determined as of the date of exercise.

 

 

 
  Restricted
Shares
  Weighted
Average
Grant Date
Fair Value
 

Outstanding, January 1, 2010

    40,000   $ 1.72  

Granted

    326,197     5.73  

Released

    (102,567 )   2.94  
           

Outstanding, December 31, 2010

    263,630     6.20  

Granted

   
335,716
   
6.06
 

Released

    (192,856 )   5.89  

Forfeited

    (5,000 )   5.61  
           

Outstanding, December 31, 2011

    401,490     6.24  

Granted

   
602,268
   
9.47
 

Released

    (185,116 )   5.67  

Forfeited

    (4,687 )   7.69  
           

Outstanding, December 31, 2012

    813,955   $ 8.51  
           

 

 

 
  Outstanding   Exercisable  
Exercise Price
  Number of
Options
  Weighted
Average
Remaining
Contractual
Life (Years)
  Weighted
Average
Exercise
Price
  Number of
Options
  Weighted
Average
Exercise
Price
 

$—    - $1.00

    3,780,000     6.2   $ 0.83     3,545,625   $ 0.83  

$1.01 - $2.00

    98,500     6.3   $ 1.41     27,250   $ 1.39  

$2.01 - $3.00

    786,250     6.3   $ 2.80     629,999   $ 2.79  

$3.01 - $4.00

    124,566     7.5   $ 3.51     94,896   $ 3.48  

$4.01 - $5.00

    341,183     6.7   $ 4.27     193,433   $ 4.36  

$5.01 - $7.00

    269,625     8.2   $ 5.85     56,438   $ 5.98  

$7.01 - $9.00

    205,174     7.8   $ 8.15     97,834   $ 8.21  

$9.01 - $14.00

    576,698     7.9   $ 9.72     85,000   $ 12.79  
                       

 

    6,181,996     6.6   $ 2.62     4,730,475   $ 1.72  
                       

 

Shares reserved for issuance
   
 

2010 Option Plan

    1,489,918  

2010 Purchase Plan

    184,532  
       

 

    1,674,450  
       

 

Offering period ended
  Number of
Shares
  Weighted Average
Price per Share
 

April 30, 2012

    34,336   $ 5.67  

October 31, 2012

    29,275   $ 5.89  
COMMITMENTS AND CONTINGENCIES (Tables)

Amounts included in the table are in thousands.

Year Ending December 31,

       

2013

  $ 527  

2014

    449  

2015

     

2016

     

2017

     

Thereafter

     
       

Total lease obligations

  $ 976  
       

Amounts included in the table are in thousands.

Year ending December 31,

       

2013

  $ 496  

2014

    296  

2015

    296  

2016

    256  

2017

    256  

Thereafter

    2,288  
       

 

  $ 3,888  
       

 The future minimum lease payments required under the capital lease and the present value of the net minimum lease payments as of December 31, 2012 are as follows (in thousands):

Year Ending December 31,

       

2013

  $ 381  

2014

    381  

2015

    368  
       

Total lease obligations

  $ 1,130  

Less imputed interest

    (86 )

Present value of minimum lease payments

    1,044  
       

Less current maturities of capital lease obligations

    (333 )
       

Long term capital lease obligations

  $ 711  
       
ACCRUED EXPENSES (Tables)
Schedule of accrued expenses

Amounts included in the table are in thousands.

 
  December 31,  
 
  2012   2011  

Compensation

  $ 1,985   $ 2,041  

Research and trial related expenses

    576     440  

Licenses

    373     338  

Professional fees

    351     182  

Occupancy costs

    23     31  

Other

    19     37  
           

 

  $ 3,327   $ 3,069  
           
LONG TERM DEBT (Tables)
Schedule of future principal obligations

Year ending December 31,

       

2013

  $  

2014

     

2015

    145  

2016

    217  

2017

    221  

Thereafter

    417  
       

 

  $ 1,000  
       
INCOME TAXES (Tables)

Amounts included in the table are in thousands.

 
  December 31,  
 
  2012   2011  

Deferred tax assets:

             

Operating loss carryforwards

  $ 88,532   $ 71,471  

Tax credit carryforwards

    10,184     7,511  

Deferred revenue

    1,758     3,399  

Other temporary differences

    3,445     2,257  
           

Tax assets before valuation allowance

    103,919     84,638  

Less—Valuation allowance

    (103,919 )   (84,638 )
           

Net deferred taxes

  $   $  
           
 
  December 31,  
 
  2012   2011   2010  

U.S. Federal statutory rate

    34.0 %   34.0 %   34.0 %

State taxes

    1.7     5.6     5.6  

Research and development tax credit

    5.1     1.7     2.6  

Stock-based compensation expense

    (0.6 )   (2.4 )   (1.9 )

Other adjustments

    (0.1 )   0.1     (0.1 )

Valuation allowance

    (40.1 )   (39.0 )   (40.1 )
               

Effective tax rate

    0.0 %   0.0 %   0.1 %
               
QUARTERLY RESULTS OF OPERATIONS (UNAUDITED) (Tables)
Schedule of quarterly statement of operations

 

 

 
  Quarter Ended  
 
  March 31,   June 30,   September 30,   December 31,  
 
  (Amounts in thousands, except per share data)
 

2012

                         

Revenue

  $ 1,036   $ 1,036   $ 1,036   $ 1,036  

Cost of revenue

                 
                   

Gross profit

    1,036     1,036     1,036     1,036  

Research and development

    8,999     12,202     10,491     10,439  

General and administrative

    2,145     2,393     2,547     2,815  

Sales and marketing

    594     1,331     1,006     1,824  
                   

Loss from operations

    (10,702 )   (14,890 )   (13,008 )   (14,042 )

Investment income

    62     59     67     74  

Interest expense

    (5 )   (5 )   (11 )   (20 )
                   

Net loss

  $ (10,645 ) $ (14,836 ) $ (12,952 ) $ (13,988 )
                   

Net loss per share—basic and diluted

  $ (0.19 ) $ (0.26 ) $ (0.21 ) $ (0.22 )
                   

Weighted average common shares outstanding—basic and diluted

    56,718     57,037     60,531     63,582  
                   

2011

                         

Revenue

  $ 1,040   $ 1,042   $ 1,039   $ 1,042  

Cost of revenue

    6     6     6     6  
                   

Gross profit

    1,034     1,036     1,033     1,036  

Research and development

    2,989     5,197     6,110     7,672  

General and administrative

    2,150     1,830     1,951     2,206  

Sales and marketing

    297     651     815     1,094  
                   

Loss from operations

    (4,402 )   (6,642 )   (7,843 )   (9,936 )

Investment income

    34     22     75     38  

Interest expense

    (5 )   (5 )   (5 )   (6 )
                   

Net loss

  $ (4,373 ) $ (6,625 ) $ (7,773 ) $ (9,904 )
                   

Net loss per share—basic and diluted

  $ (0.08 ) $ (0.13 ) $ (0.15 ) $ (0.18 )
                   

Weighted average common shares outstanding—basic and diluted

    51,930     52,010     52,443     53,647  
                   
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) (USD $)
In Thousands, unless otherwise specified
12 Months Ended
Dec. 31, 2012
objective
Dec. 31, 2011
Dec. 31, 2010
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
 
 
 
Number of objectives of the entity's investment strategy
 
 
Realized gains
$ 6,231 
$ 419 
$ 13,149 
Unrealized Gain (Loss) on Investments
77,808 
(13,784)
721 
Available-for-sale securities
 
 
 
Amortized Cost
94,698 
57,594 
 
Gains in Accumulated Other Comprehensive Income
78 
 
 
Losses in Accumulated Other Comprehensive Income
 
(14)
 
Estimated Fair Value
94,776 
57,580 
 
U.S. government agency securities
 
 
 
Available-for-sale securities
 
 
 
Amortized Cost
44,270 
28,004 
 
Gains in Accumulated Other Comprehensive Income
38 
 
 
Losses in Accumulated Other Comprehensive Income
 
(10)
 
Estimated Fair Value
44,308 
27,994 
 
Corporate bonds
 
 
 
Available-for-sale securities
 
 
 
Amortized Cost
43,303 
19,124 
 
Gains in Accumulated Other Comprehensive Income
27 
 
 
Losses in Accumulated Other Comprehensive Income
 
(2)
 
Estimated Fair Value
43,330 
19,122 
 
Certificates of deposit
 
 
 
Available-for-sale securities
 
 
 
Amortized Cost
5,926 
9,467 
 
Gains in Accumulated Other Comprehensive Income
13 
 
 
Losses in Accumulated Other Comprehensive Income
 
(2)
 
Estimated Fair Value
5,939 
9,465 
 
Commercial paper
 
 
 
Available-for-sale securities
 
 
 
Amortized Cost
1,199 
999 
 
Estimated Fair Value
$ 1,199 
$ 999 
 
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details 2) (USD $)
In Thousands, unless otherwise specified
12 Months Ended
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2010
Property and equipment
 
 
 
Depreciation expense
$ 985 
$ 411 
$ 230 
Patent Costs
 
 
 
Estimated useful life of patents
5 years 
 
 
Accrued clinical trial costs related to site payments
$ 400 
$ 400 
 
Laboratory equipment |
Minimum
 
 
 
Property and equipment
 
 
 
Estimated Useful Life
3 years 
 
 
Laboratory equipment |
Maximum
 
 
 
Property and equipment
 
 
 
Estimated Useful Life
5 years 
 
 
Office and computer equipment
 
 
 
Property and equipment
 
 
 
Estimated Useful Life
3 years 
 
 
Furniture and fixtures
 
 
 
Property and equipment
 
 
 
Estimated Useful Life
3 years 
 
 
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details 3)
12 Months Ended
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2010
Common shares not included in the computation of diluted net loss per share
 
 
 
Potentially issuable common shares not included in the computation of diluted net loss per share because they would have an anti-dilutive effect
7,394,000 
7,180,000 
7,306,000 
Additional disclosure
 
 
 
Number of shares of common stock that can be purchased through issuance of warrants under a licensing agreement
250,000 
250,000 
750,000 
Number of shares of common stock that can be purchased through issuance of warrants under a consulting agreement
75,000 
75,000 
75,000 
Shares issuable upon exercise of stock options
 
 
 
Common shares not included in the computation of diluted net loss per share
 
 
 
Potentially issuable common shares not included in the computation of diluted net loss per share because they would have an anti-dilutive effect
6,182,000 
6,454,000 
6,217,000 
Shares issuable upon exercise of outstanding warrants
 
 
 
Common shares not included in the computation of diluted net loss per share
 
 
 
Potentially issuable common shares not included in the computation of diluted net loss per share because they would have an anti-dilutive effect
325,000 
325,000 
825,000 
Shares issuable upon the release of restricted stock awards
 
 
 
Common shares not included in the computation of diluted net loss per share
 
 
 
Potentially issuable common shares not included in the computation of diluted net loss per share because they would have an anti-dilutive effect
814,000 
401,000 
264,000 
Shares issuable upon exercise of restricted stock awards related to licensing agreement
 
 
 
Common shares not included in the computation of diluted net loss per share
 
 
 
Potentially issuable common shares not included in the computation of diluted net loss per share because they would have an anti-dilutive effect
73,000 
 
 
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details 4) (USD $)
12 Months Ended 1 Months Ended 3 Months Ended 12 Months Ended 12 Months Ended
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2010
Aug. 13, 2012
Dec. 6, 2011
Nov. 10, 2010
Apr. 19, 2010
Jan. 31, 2009
CLP Agreement
Genzyme Corporation
Sep. 30, 2010
CLP Agreement
Genzyme Corporation
Mar. 31, 2010
CLP Agreement
Genzyme Corporation
Dec. 31, 2012
CLP Agreement
Genzyme Corporation
Dec. 31, 2011
CLP Agreement
Genzyme Corporation
Dec. 31, 2010
CLP Agreement
Genzyme Corporation
Jan. 27, 2009
CLP Agreement
Genzyme Corporation
Dec. 31, 2010
License Agreement
LabCorp
License fees
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Amount received
 
 
$ 1,896,000 
 
 
 
 
$ 16,650,000 
$ 934,250 
$ 962,000 
 
 
 
 
$ 4,700,000 
Total agreed consideration amount
 
 
 
 
 
 
 
18,500,000 
 
 
 
 
 
 
 
Amount subject to holdback
 
 
 
 
 
 
 
1,850,000 
 
 
 
 
 
 
 
Initial collaboration period (in years)
 
 
 
 
 
 
 
5 years 
 
 
 
 
 
 
 
Sale of common stock (in shares)
63,909,800 
56,624,763 
 
 
 
 
 
 
 
 
 
 
 
3,000,000 
 
Price at which share of common stock are sold (in dollars per share)
 
 
 
 
 
 
 
 
 
 
 
 
 
$ 2.00 
 
Premium above closing price of common stock at which shares are sold (in dollars per share)
 
 
 
 
 
 
 
 
 
 
 
 
 
$ 0.51 
 
Closing price of common stock (in dollars per share)
$ 10.59 
 
 
$ 9.75 
$ 8.00 
$ 6.00 
$ 4.50 
 
 
 
 
 
 
$ 1.49 
 
Aggregate premium received over the closing price of common stock
 
 
 
 
 
 
 
 
 
 
 
 
 
1,530,000 
 
License fee revenue
4,144,000 
4,143,000 
5,318,000 
 
 
 
 
 
 
 
4,100,000 
4,100,000 
4,000,000 
 
 
Product royalty fees
 
20,000 
26,000 
 
 
 
 
 
 
 
 
 
 
 
 
Other Income
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Cash grant under the Qualifying Therapeutic Discovery Project program administered under Section 48D of the Internal Revenue Code
 
 
244,000 
 
 
 
 
 
 
 
 
 
 
 
 
Advertising Costs
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Advertising expense
$ 57,400 
$ 110,000 
$ 68,100 
 
 
 
 
 
 
 
 
 
 
 
 
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details 5) (USD $)
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2010
Dec. 31, 2009
Fair Value Measurements
 
 
 
 
Cash and cash equivalents
$ 13,345,000 
$ 35,781,000 
$ 78,752,000 
$ 21,924,000 
Marketable securities
 
 
 
 
Available-for-sale securities
94,776,000 
57,580,000 
 
 
Available-for-sale securities in a countinuous unrealized loss position
 
 
 
 
Total unrealized losses of available for sale securities in a continuous unrealized loss position for less than twelve months
4,800 
285,000 
 
 
Contractual maturities of the available-for-sale investments, Fair Value
 
 
 
 
Due in one year or less
58,922,000 
 
 
 
Due after one year through two years
35,854,000 
 
 
 
Estimated Fair Value
94,776,000 
57,580,000 
 
 
Contractual maturities of the available-for-sale investments, Cost
 
 
 
 
Due in one year or less
58,882,000 
 
 
 
Due after one year through two years
35,816,000 
 
 
 
Cost
94,698,000 
 
 
 
Concentration of Credit Risk
 
 
 
 
Cash and cash equivalents, federal government agency insured limit
250,000 
 
 
 
Cash and cash equivalents in excess of federal government agency insured limit
13,100,000 
 
 
 
Fair Value
 
 
 
 
Marketable securities
 
 
 
 
Available-for-sale securities
103,181,000 
92,965,000 
 
 
Contractual maturities of the available-for-sale investments, Fair Value
 
 
 
 
Estimated Fair Value
103,181,000 
92,965,000 
 
 
Fair Value |
Cash equivalents
 
 
 
 
Marketable securities
 
 
 
 
Available-for-sale securities
8,405,000 
35,385,000 
 
 
Contractual maturities of the available-for-sale investments, Fair Value
 
 
 
 
Estimated Fair Value
8,405,000 
35,385,000 
 
 
Fair Value |
U.S. government agency securities
 
 
 
 
Marketable securities
 
 
 
 
Available-for-sale securities
44,308,000 
27,994,000 
 
 
Contractual maturities of the available-for-sale investments, Fair Value
 
 
 
 
Estimated Fair Value
44,308,000 
27,994,000 
 
 
Fair Value |
Certificates of deposit
 
 
 
 
Marketable securities
 
 
 
 
Available-for-sale securities
5,939,000 
9,465,000 
 
 
Contractual maturities of the available-for-sale investments, Fair Value
 
 
 
 
Estimated Fair Value
5,939,000 
9,465,000 
 
 
Fair Value |
Corporate bonds
 
 
 
 
Marketable securities
 
 
 
 
Available-for-sale securities
43,330,000 
19,122,000 
 
 
Contractual maturities of the available-for-sale investments, Fair Value
 
 
 
 
Estimated Fair Value
43,330,000 
19,122,000 
 
 
Fair Value |
Commercial paper
 
 
 
 
Marketable securities
 
 
 
 
Available-for-sale securities
1,199,000 
999,000 
 
 
Contractual maturities of the available-for-sale investments, Fair Value
 
 
 
 
Estimated Fair Value
1,199,000 
999,000 
 
 
Quoted Prices in Active Markets for Identical Assets (Level1)
 
 
 
 
Marketable securities
 
 
 
 
Available-for-sale securities
8,405,000 
35,385,000 
 
 
Contractual maturities of the available-for-sale investments, Fair Value
 
 
 
 
Estimated Fair Value
8,405,000 
35,385,000 
 
 
Quoted Prices in Active Markets for Identical Assets (Level1) |
Cash equivalents
 
 
 
 
Marketable securities
 
 
 
 
Available-for-sale securities
8,405,000 
35,385,000 
 
 
Contractual maturities of the available-for-sale investments, Fair Value
 
 
 
 
Estimated Fair Value
8,405,000 
35,385,000 
 
 
Significant Other Observable Inputs (Level 2)
 
 
 
 
Marketable securities
 
 
 
 
Available-for-sale securities
94,776,000 
57,580,000 
 
 
Contractual maturities of the available-for-sale investments, Fair Value
 
 
 
 
Estimated Fair Value
94,776,000 
57,580,000 
 
 
Significant Other Observable Inputs (Level 2) |
U.S. government agency securities
 
 
 
 
Marketable securities
 
 
 
 
Available-for-sale securities
44,308,000 
27,994,000 
 
 
Contractual maturities of the available-for-sale investments, Fair Value
 
 
 
 
Estimated Fair Value
44,308,000 
27,994,000 
 
 
Significant Other Observable Inputs (Level 2) |
Certificates of deposit
 
 
 
 
Marketable securities
 
 
 
 
Available-for-sale securities
5,939,000 
9,465,000 
 
 
Contractual maturities of the available-for-sale investments, Fair Value
 
 
 
 
Estimated Fair Value
5,939,000 
9,465,000 
 
 
Significant Other Observable Inputs (Level 2) |
Corporate bonds
 
 
 
 
Marketable securities
 
 
 
 
Available-for-sale securities
43,330,000 
19,122,000 
 
 
Contractual maturities of the available-for-sale investments, Fair Value
 
 
 
 
Estimated Fair Value
43,330,000 
19,122,000 
 
 
Significant Other Observable Inputs (Level 2) |
Commercial paper
 
 
 
 
Marketable securities
 
 
 
 
Available-for-sale securities
1,199,000 
999,000 
 
 
Contractual maturities of the available-for-sale investments, Fair Value
 
 
 
 
Estimated Fair Value
$ 1,199,000 
$ 999,000 
 
 
GENZYME STRATEGIC TRANSACTION (Details) (USD $)
12 Months Ended 0 Months Ended 1 Months Ended 3 Months Ended 12 Months Ended
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2010
Aug. 13, 2012
Dec. 6, 2011
Nov. 10, 2010
Apr. 19, 2010
Jan. 27, 2009
CLP Agreement
Genzyme Corporation
Jan. 31, 2009
CLP Agreement
Genzyme Corporation
Sep. 30, 2010
CLP Agreement
Genzyme Corporation
Mar. 31, 2010
CLP Agreement
Genzyme Corporation
Dec. 31, 2012
CLP Agreement
Genzyme Corporation
Dec. 31, 2011
CLP Agreement
Genzyme Corporation
Dec. 31, 2010
CLP Agreement
Genzyme Corporation
License fees
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Total agreed consideration amount
 
 
 
 
 
 
 
 
$ 18,500,000 
 
 
 
 
 
Proceeds from Genzyme Collaboration, License and Purchase Agreement
 
 
1,896,000 
 
 
 
 
 
16,650,000 
934,250 
962,000 
 
 
 
Amount subject to holdback
 
 
 
 
 
 
 
 
1,850,000 
 
 
 
 
 
Initial collaboration period (in years)
 
 
 
 
 
 
 
 
5 years 
 
 
 
 
 
Sale of common stock (in shares)
63,909,800 
56,624,763 
 
 
 
 
 
3,000,000 
 
 
 
 
 
 
Common stock, par value (in dollars per share)
$ 0.01 
$ 0.01 
 
 
 
 
 
 
 
 
 
 
 
 
Price at which share of common stock are sold (in dollars per share)
 
 
 
 
 
 
 
$ 2.00 
 
 
 
 
 
 
Aggregate purchase price
 
 
 
 
 
 
 
6,000,000 
 
 
 
 
 
 
Premium above closing price of common stock at which shares are sold (in dollars per share)
 
 
 
 
 
 
 
$ 0.51 
 
 
 
 
 
 
Closing price of common stock (in dollars per share)
$ 10.59 
 
 
$ 9.75 
$ 8.00 
$ 6.00 
$ 4.50 
$ 1.49 
 
 
 
 
 
 
Aggregate premium received over the closing price of common stock
 
 
 
 
 
 
 
1,530,000 
 
 
 
 
 
 
License fee revenue
$ 4,144,000 
$ 4,143,000 
$ 5,318,000 
 
 
 
 
 
 
 
 
$ 4,100,000 
$ 4,100,000 
$ 4,000,000 
MAYO LICENSE AGREEMENT (Details) (USD $)
0 Months Ended 3 Months Ended 12 Months Ended 0 Months Ended 1 Months Ended 12 Months Ended 0 Months Ended 0 Months Ended 12 Months Ended
Aug. 13, 2012
Dec. 6, 2011
Nov. 10, 2010
Apr. 19, 2010
Dec. 31, 2012
Sep. 30, 2012
Jun. 30, 2012
Mar. 31, 2012
Dec. 31, 2011
Sep. 30, 2011
Jun. 30, 2011
Mar. 31, 2011
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2010
Dec. 31, 2012
License Agreement
Dec. 31, 2011
License Agreement
Dec. 31, 2010
License Agreement
Jun. 11, 2009
License Agreement
MAYO
May 31, 2012
License Agreement
MAYO
item
Jun. 30, 2009
License Agreement
MAYO
warrant
Dec. 31, 2012
License Agreement
MAYO
Dec. 31, 2011
License Agreement
MAYO
Jun. 12, 2013
License Agreement
MAYO
Jun. 12, 2012
License Agreement
MAYO
Sep. 30, 2011
License Agreement
MAYO
Warrant covering 1,000,000 shares of common stock
Jun. 30, 2011
License Agreement
MAYO
Warrant covering 1,000,000 shares of common stock
Sep. 30, 2010
License Agreement
MAYO
Warrant covering 1,000,000 shares of common stock
Mar. 31, 2010
License Agreement
MAYO
Warrant covering 1,000,000 shares of common stock
Jun. 11, 2009
License Agreement
MAYO
Warrant covering 1,000,000 shares of common stock
Jun. 11, 2009
License Agreement
MAYO
Warrant covering 250,000 shares of common stock
Dec. 31, 2012
License Agreement
MAYO
Warrant covering 250,000 shares of common stock
Warrants
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Number of common stock purchase warrants granted
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Exercise price (in dollars per share)
 
 
 
 
$ 0.01 
 
 
 
 
 
 
 
$ 0.01 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
$ 1.90 
$ 1.90 
 
Number of shares of common stock covered by warrants
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
250,000 
500,000 
800,000 
 
1,000,000 
250,000 
 
Vesting period of warrant (in years)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
4 years 
4 years 
Total value of warrants
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
$ 2,100,000 
 
 
 
 
 
 
 
 
 
 
 
 
 
Non-cash charge recognized as research and development expense
 
 
 
 
 
 
 
 
 
 
 
 
152,000 
107,000 
107,000 
 
 
 
1,700,000 
 
 
 
 
 
 
 
 
 
 
 
 
 
Remaining non-cash charge recognized on straight-line basis
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
400,000 
 
 
 
 
 
 
 
 
 
 
 
 
 
Warrants exercised, gross (in shares)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
250,000 
250,000 
300,000 
200,000 
 
 
 
Warrants forfeited (in shares)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
56,641 
60,246 
97,853 
86,596 
 
 
 
Warrants exercised, net of forfeiture (in shares)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
193,359 
189,754 
202,147 
113,404 
 
 
 
Number of warrants outstanding and unexercised
 
 
 
 
250,000 
 
 
 
 
 
 
 
250,000 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Royalty Payments
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Minimum royalty payments
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
25,000 
10,000 
 
 
 
 
 
 
 
Other Payments
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Milestone payment contingent upon FDA approval
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
500,000 
 
 
 
 
 
 
 
 
 
 
Charges incurred as part of the research collaboration
 
 
 
 
10,439,000 
10,491,000 
12,202,000 
8,999,000 
7,672,000 
6,110,000 
5,197,000 
2,989,000 
42,131,000 
21,968,000 
9,023,000 
1,400,000 
800,000 
400,000 
 
 
 
1,200,000 
1,400,000 
 
 
 
 
 
 
 
 
 
Payments for research and development efforts
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1,100,000 
1,400,000 
 
 
 
 
 
 
 
 
 
Estimated liability for research and development efforts
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
127,000 
53,000 
 
 
 
 
 
 
 
 
 
Amendments - May 2012
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Number of shares of restricted stock granted as a consideration for the expanded license
6,300,000 
3,600,000 
11,500,000 
4,200,000 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
97,466 
 
 
 
 
 
 
 
 
 
 
 
 
Vesting right percentage of restricted stock
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
25.00% 
 
 
 
 
 
 
 
 
 
 
 
 
Number of equal annual installments in which restricted stock are to be vested
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Licensing expense recognized in connection with the restricted stock grant
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
$ 1,000,000 
 
 
 
 
 
 
 
 
 
 
ISSUANCES OF COMMON STOCK (Details) (USD $)
Share data in Millions, except Per Share data, unless otherwise specified
0 Months Ended 12 Months Ended
Aug. 13, 2012
Dec. 6, 2011
Nov. 10, 2010
Apr. 19, 2010
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2010
ISSUANCES OF COMMON STOCK
 
 
 
 
 
 
 
Issuance of stock on underwritten public offering (in shares)
6.3 
3.6 
11.5 
4.2 
 
 
 
Price of common stock (in dollars per share)
$ 9.75 
$ 8.00 
$ 6.00 
$ 4.50 
$ 10.59 
 
 
Net proceeds received from the offerings
$ 57,800,000 
$ 27,200,000 
$ 64,700,000 
$ 17,600,000 
$ 57,755,000 
$ 27,215,000 
$ 82,327,000 
Underwriting discount and other stock issuance costs
$ 3,900,000 
$ 1,500,000 
$ 4,300,000 
$ 1,300,000 
 
 
 
STOCK-BASED COMPENSATION (Details) (USD $)
12 Months Ended 12 Months Ended 12 Months Ended 12 Months Ended
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2010
Dec. 31, 2012
Options
Dec. 31, 2011
Options
Dec. 31, 2010
Options
Dec. 31, 2009
Options
Dec. 31, 2012
Restricted stock and restricted stock unit
Dec. 31, 2011
Restricted stock and restricted stock unit
Dec. 31, 2010
Restricted stock and restricted stock unit
Dec. 31, 2009
Restricted stock and restricted stock unit
Dec. 31, 2012
2000 Option Plan
Dec. 31, 2012
2000 Option Plan
Maximum
Dec. 31, 2012
2000 Option Plan
Minimum
Dec. 31, 2012
2000 Option Plan
Options
Dec. 31, 2012
2000 Option Plan
Restricted stock
Dec. 31, 2010
2000 Purchase Plan
Dec. 31, 2012
2010 Stock Plan
Dec. 31, 2012
2010 Stock Plan
Maximum
Dec. 31, 2012
2010 Stock Plan
Minimum
Dec. 31, 2012
2010 Stock Plan
Options
Dec. 31, 2012
2010 Stock Plan
Restricted stock
Dec. 31, 2012
2010 Purchase Plan
Dec. 31, 2011
2010 Purchase Plan
Dec. 31, 2010
2010 Purchase Plan
Dec. 31, 2012
2010 Purchase Plan
April 30, 2012
Dec. 31, 2012
2010 Purchase Plan
October 31, 2012
Dec. 31, 2012
2010 Purchase Plan
Maximum
Dec. 31, 2012
2010 Purchase Plan
Minimum
item
Stock-based compensation
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Expiration period from the date of grant
 
 
 
 
 
 
 
 
 
 
 
 
 
 
10 years 
 
 
 
 
 
10 years 
 
 
 
 
 
 
 
 
Vesting period
1 year 
 
 
 
 
 
 
 
 
 
 
 
4 years 
3 years 
 
 
 
 
4 years 
3 years 
 
 
 
 
 
 
 
 
 
Period by which all options to purchase common stock will accelerate upon an acquisition of the company
 
 
 
 
 
 
 
 
 
 
 
1 year 
 
 
 
 
 
1 year 
 
 
 
 
 
 
 
 
 
 
 
Period from the completion of acquisition, during which if an employee is terminated without cause or for good reason, all awards then outstanding held by that employee will immediately become exercisable
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 year 
 
 
 
 
 
 
 
 
 
 
 
Shares outstanding
 
 
 
6,181,996 
6,453,644 
6,217,199 
5,912,019 
 
 
 
 
 
 
 
4,889,933 
54,000 
 
 
 
 
1,292,063 
759,955 
 
 
 
 
 
 
 
Shares unreleased
 
 
 
 
 
 
 
813,955 
401,490 
263,630 
40,000 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Number of hours per week of customary employment required to participate in the plan
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
20 
Number of months of customary employment required to participate in the plan
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
5 months 
Percentage of employee's compensation to be deducted from the employee's pay
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
15.00% 
1.00% 
Option exercise price, expressed as a percentage of fair market value
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
85.00% 
 
 
 
 
 
 
Maximum value of shares that an employee is permitted to purchase
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
$ 25,000 
 
 
 
 
 
 
Number of Shares
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
58,709 
 
 
 
 
 
63,611 
51,857 
115,468 
34,336 
29,275 
 
 
Weighted Average Price per Share (in dollars per share)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
$ 5.67 
$ 5.89 
 
 
Shares available for future grant
1,674,450 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1,489,918 
 
 
 
 
184,532 
 
 
 
 
 
 
Proceeds from stock option exercise
$ 2,400,000 
$ 700,000 
$ 500,000 
 
 
 
 
 
 
 
 
 
 
 
 
 
$ 100,000 
 
 
 
 
 
$ 400,000 
$ 300,000 
 
 
 
 
 
STOCK-BASED COMPENSATION (Details 2) (USD $)
In Thousands, unless otherwise specified
12 Months Ended
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2010
Stock-based compensation expense
 
 
 
Stock-based compensation
$ 5,493 
$ 3,964 
$ 2,121 
Non-cash stock-based compensation expense
5,500 
4,000 
2,100 
Research and development
 
 
 
Stock-based compensation expense
 
 
 
Non-cash stock-based compensation expense
2,396 
1,685 
1,087 
General and administrative
 
 
 
Stock-based compensation expense
 
 
 
Non-cash stock-based compensation expense
2,579 
1,622 
993 
Sales and marketing
 
 
 
Stock-based compensation expense
 
 
 
Non-cash stock-based compensation expense
$ 518 
$ 657 
$ 41 
STOCK-BASED COMPENSATION (Details 3) (USD $)
12 Months Ended 12 Months Ended 3 Months Ended 12 Months Ended
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2010
Aug. 13, 2012
Dec. 6, 2011
Nov. 10, 2010
Apr. 19, 2010
Dec. 31, 2012
Option Plan Shares
Dec. 31, 2011
Option Plan Shares
Dec. 31, 2010
Option Plan Shares
Dec. 31, 2012
ESPP Shares
Dec. 31, 2011
ESPP Shares
Dec. 31, 2010
ESPP Shares
Dec. 31, 2012
ESPP Shares
Maximum
Dec. 31, 2011
ESPP Shares
Maximum
Dec. 31, 2010
ESPP Shares
Maximum
Dec. 31, 2012
ESPP Shares
Minimum
Dec. 31, 2011
ESPP Shares
Minimum
Dec. 31, 2010
ESPP Shares
Minimum
Mar. 30, 2012
Restricted stock and restricted stock unit
Dec. 31, 2012
Restricted stock and restricted stock unit
Dec. 31, 2011
Restricted stock and restricted stock unit
Dec. 31, 2010
Restricted stock and restricted stock unit
Valuation assumptions
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Forfeiture rate (as a percent)
 
 
 
 
 
 
 
1.40% 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Risk-free interest rates, minimum (as a percent)
 
 
 
 
 
 
 
0.81% 
0.88% 
1.17% 
0.18% 
0.13% 
0.16% 
 
 
 
 
 
 
 
 
 
 
Risk-free interest rates, maximum (as a percent)
 
 
 
 
 
 
 
1.00% 
2.30% 
2.69% 
0.30% 
0.61% 
0.38% 
 
 
 
 
 
 
 
 
 
 
Expected term (in years)
 
 
 
 
 
 
 
6 years 
6 years 
6 years 
 
 
 
2 years 
2 years 
2 years 
6 months 
6 months 
6 months 
 
 
 
 
Expected volatility (as a percent)
 
 
 
 
 
 
 
 
92.00% 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Expected volatility, minimum (as a percent)
 
 
 
 
 
 
 
85.00% 
 
91.00% 
34.00% 
48.00% 
53.00% 
 
 
 
 
 
 
 
 
 
 
Expected volatility, maximum (as a percent)
 
 
 
 
 
 
 
92.00% 
 
92.00% 
54.90% 
63.00% 
127.00% 
 
 
 
 
 
 
 
 
 
 
Dividend yield (as a percent)
 
 
 
 
 
 
 
0.00% 
0.00% 
0.00% 
0.00% 
0.00% 
0.00% 
 
 
 
 
 
 
 
 
 
 
Weighted average fair value per share of options granted during the period (in dollars per share)
 
 
 
 
 
 
 
$ 6.90 
$ 4.78 
$ 3.07 
$ 2.84 
$ 2.83 
$ 2.03 
 
 
 
 
 
 
 
 
 
 
Shares
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Outstanding at the beginning of the period (in shares)
 
 
 
 
 
 
 
6,453,644 
6,217,199 
5,912,019 
 
 
 
 
 
 
 
 
 
 
 
 
 
Granted (in shares)
 
 
 
 
 
 
 
499,198 
814,424 
518,566 
 
 
 
 
 
 
 
 
 
262,500 
 
 
 
Exercised (in shares)
 
 
 
 
 
 
 
(691,471)
(325,477)
(213,386)
 
 
 
 
 
 
 
 
 
 
 
 
 
Cancelled/Forfeited (in shares)
 
 
 
 
 
 
 
(79,375)
(252,502)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Outstanding at the end of the period (in shares)
 
 
 
 
 
 
 
6,181,996 
6,453,644 
6,217,199 
 
 
 
 
 
 
 
 
 
 
 
 
 
Exercisable at the end of the period (in shares)
 
 
 
 
 
 
 
4,730,475 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Vested and expected to vest at the end of the period (in shares)
 
 
 
 
 
 
 
6,175,107 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Weighted Average Exercise Price
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Outstanding at the beginning of the period (in dollars per share)
 
 
 
 
 
 
 
$ 2.27 
$ 1.93 
$ 1.76 
 
 
 
 
 
 
 
 
 
 
 
 
 
Granted (in dollars per share)
 
 
 
 
 
 
 
$ 9.18 
$ 6.26 
$ 4.09 
 
 
 
 
 
 
 
 
 
 
 
 
 
Exercised (in dollars per share)
 
 
 
 
 
 
 
$ 3.45 
$ 2.11 
$ 2.19 
 
 
 
 
 
 
 
 
 
 
 
 
 
Cancelled/Forfeited (in dollars per share)
 
 
 
 
 
 
 
$ 7.60 
$ 7.15 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Outstanding at the end of the period (in dollars per share)
 
 
 
 
 
 
 
$ 2.62 
$ 2.27 
$ 1.93 
 
 
 
 
 
 
 
 
 
 
 
 
 
Exercisable at the end of the period (in dollars per share)
 
 
 
 
 
 
 
$ 1.72 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Vested and expected to vest at the end of the period (in dollars per share)
 
 
 
 
 
 
 
$ 2.66 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Weighted Average Remaining Contractual Term (in years)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Outstanding at the end of the period (in years)
 
 
 
 
 
 
 
6 years 7 months 6 days 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Exercisable at the end of the period (in years)
 
 
 
 
 
 
 
6 years 2 months 12 days 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Vested and expected to vest at the end of the period (in years)
 
 
 
 
 
 
 
6 years 7 months 6 days 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Aggregate Intrinsic Value
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Outstanding at the end of the period
 
 
 
 
 
 
 
$ 49,439,000 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Exercisable at the end of the period
 
 
 
 
 
 
 
42,154,000 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Vested and expected to vest at the end of the period
 
 
 
 
 
 
 
49,430,000 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Additional disclosures
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Options outstanding that had exercise prices that were lower than the market price of common stock (in shares)
6,100,211 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Options exercisable that had exercise prices that were lower than the market price of common stock (in shares)
4,655,475 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Market price (in dollars per share)
$ 10.59 
 
 
$ 9.75 
$ 8.00 
$ 6.00 
$ 4.50 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Total intrinsic value of options exercised
4,500,000 
1,900,000 
400,000 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Number of shares of common stock that can be purchased through issuance of warrants under a consulting agreement
75,000 
75,000 
75,000 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Exercise price of warrants issued
$ 0.01 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Restricted Shares
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Outstanding at the beginning of the period (in shares)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
401,490 
401,490 
263,630 
40,000 
Granted (in shares)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
602,268 
335,716 
326,197 
Released (in shares)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(185,116)
(192,856)
(102,567)
Forfeited (in shares)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(4,687)
(5,000)
 
Outstanding at the end of the period (in shares)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
813,955 
401,490 
263,630 
Weighted Average Grant Date Fair Value
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Outstanding at the beginning of the period (in dollars per share)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
$ 6.24 
$ 6.24 
$ 6.20 
$ 1.72 
Granted (in dollars per share)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
$ 9.47 
$ 6.06 
$ 5.73 
Released (in dollars per share)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
$ 5.67 
$ 5.89 
$ 2.94 
Forfeited (in dollars per share)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
$ 7.69 
$ 5.61 
 
Outstanding at the end of the period (in dollars per share)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
$ 8.51 
$ 6.24 
$ 6.20 
Unrecognized compensation cost
$ 9,800,000 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Weighted average period for recognition of unrecognized compensation cost
2 years 4 months 24 days 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
STOCK-BASED COMPENSATION (Details 4) (USD $)
12 Months Ended
Dec. 31, 2012
Outstanding
 
Number of Options
6,181,996 
Weighted Average Remaining Contractual Life
6 years 7 months 6 days 
Weighted Average Exercise Price (in dollars per share)
$ 2.62 
Exercisable
 
Number of Options
4,730,475 
Weighted Average Exercise Price (in dollars per share)
$ 1.72 
$ 0.00 - $ 1.00
 
Information relating to outstanding and exercisable stock options
 
Exercise price, low end of range (in dollars per share)
$ 0.00 
Exercise price, high end of range (in dollars per share)
$ 1.00 
Outstanding
 
Number of Options
3,780,000 
Weighted Average Remaining Contractual Life
6 years 2 months 12 days 
Weighted Average Exercise Price (in dollars per share)
$ 0.83 
Exercisable
 
Number of Options
3,545,625 
Weighted Average Exercise Price (in dollars per share)
$ 0.83 
$ 1.01 - $ 2.00
 
Information relating to outstanding and exercisable stock options
 
Exercise price, low end of range (in dollars per share)
$ 1.01 
Exercise price, high end of range (in dollars per share)
$ 2.00 
Outstanding
 
Number of Options
98,500 
Weighted Average Remaining Contractual Life
6 years 3 months 18 days 
Weighted Average Exercise Price (in dollars per share)
$ 1.41 
Exercisable
 
Number of Options
27,250 
Weighted Average Exercise Price (in dollars per share)
$ 1.39 
$ 2.01 - $ 3.00
 
Information relating to outstanding and exercisable stock options
 
Exercise price, low end of range (in dollars per share)
$ 2.01 
Exercise price, high end of range (in dollars per share)
$ 3.00 
Outstanding
 
Number of Options
786,250 
Weighted Average Remaining Contractual Life
6 years 3 months 18 days 
Weighted Average Exercise Price (in dollars per share)
$ 2.80 
Exercisable
 
Number of Options
629,999 
Weighted Average Exercise Price (in dollars per share)
$ 2.79 
$ 3.01 - $ 4.00
 
Information relating to outstanding and exercisable stock options
 
Exercise price, low end of range (in dollars per share)
$ 3.01 
Exercise price, high end of range (in dollars per share)
$ 4.00 
Outstanding
 
Number of Options
124,566 
Weighted Average Remaining Contractual Life
7 years 6 months 
Weighted Average Exercise Price (in dollars per share)
$ 3.51 
Exercisable
 
Number of Options
94,896 
Weighted Average Exercise Price (in dollars per share)
$ 3.48 
$ 4.01 - $ 5.00
 
Information relating to outstanding and exercisable stock options
 
Exercise price, low end of range (in dollars per share)
$ 4.01 
Exercise price, high end of range (in dollars per share)
$ 5.00 
Outstanding
 
Number of Options
341,183 
Weighted Average Remaining Contractual Life
6 years 8 months 12 days 
Weighted Average Exercise Price (in dollars per share)
$ 4.27 
Exercisable
 
Number of Options
193,433 
Weighted Average Exercise Price (in dollars per share)
$ 4.36 
$ 5.01 - $ 7.00
 
Information relating to outstanding and exercisable stock options
 
Exercise price, low end of range (in dollars per share)
$ 5.01 
Exercise price, high end of range (in dollars per share)
$ 7.00 
Outstanding
 
Number of Options
269,625 
Weighted Average Remaining Contractual Life
8 years 2 months 12 days 
Weighted Average Exercise Price (in dollars per share)
$ 5.85 
Exercisable
 
Number of Options
56,438 
Weighted Average Exercise Price (in dollars per share)
$ 5.98 
$ 7.01 - $ 9.00
 
Information relating to outstanding and exercisable stock options
 
Exercise price, low end of range (in dollars per share)
$ 7.01 
Exercise price, high end of range (in dollars per share)
$ 9.00 
Outstanding
 
Number of Options
205,174 
Weighted Average Remaining Contractual Life
7 years 9 months 18 days 
Weighted Average Exercise Price (in dollars per share)
$ 8.15 
Exercisable
 
Number of Options
97,834 
Weighted Average Exercise Price (in dollars per share)
$ 8.21 
$ 9.01 - $ 14.00
 
Information relating to outstanding and exercisable stock options
 
Exercise price, low end of range (in dollars per share)
$ 9.01 
Exercise price, high end of range (in dollars per share)
$ 14.00 
Outstanding
 
Number of Options
576,698 
Weighted Average Remaining Contractual Life
7 years 10 months 24 days 
Weighted Average Exercise Price (in dollars per share)
$ 9.72 
Exercisable
 
Number of Options
85,000 
Weighted Average Exercise Price (in dollars per share)
$ 12.79 
STOCK-BASED COMPENSATION (Details 5)
12 Months Ended
Dec. 31, 2012
Dec. 31, 2012
2010 Option Plan
Dec. 31, 2012
2010 Stock Purchase Plan
Dec. 31, 2011
Senior Vice President of Sales and Marketing
Option Modifications
 
 
 
 
Remaining number of options that will be forfeited
 
 
 
131,250 
Vesting period of shares accelerated
 
 
 
2 years 
Number of shares affected by acceleration of options held by Mr. Krayacich
 
 
 
168,750 
Shares reserved for issuance
1,674,450 
1,489,918 
184,532 
 
COMMITMENTS AND CONTINGENCIES (Details) (USD $)
1 Months Ended 12 Months Ended 3 Months Ended 12 Months Ended
Mar. 31, 2012
sqft
Nov. 30, 2010
sqft
Nov. 30, 2009
sqft
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2010
Dec. 31, 2009
Aldevron Madison
sqft
Dec. 31, 2012
Aldevron Madison
Dec. 31, 2011
Aldevron Madison
Dec. 31, 2010
Aldevron Madison
COMMITMENTS AND CONTINGENCIES
 
 
 
 
 
 
 
 
 
 
Initial term of the lease
 
 
5 years 
 
 
 
 
 
 
 
Area of laboratory office facility under operating lease (in square feet)
35,000 
24,572 
17,500 
 
 
 
 
 
 
 
Additional area of laboratory and office under the amended lease agreement (in square feet)
10,428 
7,072 
 
 
 
 
 
 
 
 
Future minimum payments under operating leases
 
 
 
 
 
 
 
 
 
 
2013
 
 
 
$ 527,000 
 
 
 
 
 
 
2014
 
 
 
449,000 
 
 
 
 
 
 
Total lease obligations
 
 
 
976,000 
 
 
 
 
 
 
Additional disclosure
 
 
 
 
 
 
 
 
 
 
Rent expense
 
 
 
400,000 
300,000 
200,000 
 
 
 
 
Commitments and contingencies
 
 
 
 
 
 
 
 
 
 
Rentable area under the sublease agreement (in square feet)
 
 
 
 
 
 
5,086 
 
 
 
Proceeds from the sublease agreement
 
 
 
 
 
 
 
66,800 
78,500 
76,600 
Term of the sublease agreement
 
 
 
 
 
 
36 months 
 
 
 
Amount expected to be received in sublease payments over the life of the sublease agreement
 
 
 
 
 
 
$ 200,000 
 
 
 
COMMITMENTS AND CONTINGENCIES (Details 2) (USD $)
3 Months Ended 12 Months Ended 12 Months Ended 0 Months Ended 12 Months Ended 0 Months Ended 3 Months Ended 12 Months Ended 0 Months Ended 12 Months Ended
Dec. 31, 2012
Sep. 30, 2012
Jun. 30, 2012
Mar. 31, 2012
Dec. 31, 2011
Sep. 30, 2011
Jun. 30, 2011
Mar. 31, 2011
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2010
Dec. 31, 2012
License agreement
Dec. 31, 2011
License agreement
Dec. 31, 2010
License agreement
Dec. 31, 2012
License agreement
JHU
Dec. 31, 2012
License agreement
MAYO
Dec. 31, 2011
License agreement
MAYO
Jun. 12, 2013
License agreement
MAYO
Jun. 12, 2012
License agreement
MAYO
Sep. 30, 2011
License agreement
MAYO
Warrant covering 1,000,000 shares of common stock
Jun. 30, 2011
License agreement
MAYO
Warrant covering 1,000,000 shares of common stock
Sep. 30, 2010
License agreement
MAYO
Warrant covering 1,000,000 shares of common stock
Jun. 11, 2009
License agreement
MAYO
Warrant covering 1,000,000 shares of common stock
Jun. 11, 2009
License agreement
MAYO
Warrant covering 250,000 shares of common stock
Dec. 31, 2012
License agreement
MAYO
Warrant covering 250,000 shares of common stock
Oct. 14, 2009
License agreement
Hologic
Jun. 30, 2011
License agreement
Hologic
Dec. 31, 2012
License agreement
Hologic
Jul. 26, 2010
License agreement
MDx Health
Dec. 31, 2012
License agreement
MDx Health
Dec. 31, 2012
License agreement
MDx Health
Net sales of $ 10 million
Dec. 31, 2012
License agreement
MDx Health
Net sales of $ 50 million
Dec. 31, 2012
License agreement
MDx Health
Net sales of $ 50 million
Dec. 31, 2012
Clinical research agreements
Dec. 31, 2011
Clinical research agreements
Dec. 31, 2010
Clinical research agreements
Commitments and contingencies
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Annual minimum license fee agreed to be paid by the entity
 
 
 
 
 
 
 
 
 
 
 
 
 
 
$ 100,000 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Upfront payment
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
50,000 
 
 
 
 
 
 
 
 
 
 
Amount paid upon enrollment in FDA trial
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
100,000 
 
 
 
 
 
 
 
 
 
Minimum royalty payments
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
25,000 
10,000 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Number of shares of common stock covered by warrants
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
250,000 
500,000 
800,000 
1,000,000 
250,000 
 
 
 
 
 
 
 
 
 
 
 
 
Vesting period of warrant (in years)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
4 years 
4 years 
 
 
 
 
 
 
 
 
 
 
 
Period for recognition of related expenses
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
4 years 
4 years 
 
 
 
 
 
 
 
 
 
 
 
Milestone payment contingent upon FDA approval
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
500,000 
 
 
 
 
 
 
 
 
 
 
 
100,000 
100,000 
 
 
 
 
 
 
 
Minimum royalty fee that the entity is required to pay on each anniversary
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
100,000 
 
 
 
 
 
 
Amount agreed to be paid upon the first commercial sale of a licensed product
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
100,000 
 
 
 
 
 
 
Amount agreed to be paid upon reaching the specified amount of net sales
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
150,000 
750,000 
1,000,000 
 
 
 
Net sales of a licensed product
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
10,000,000 
50,000,000 
50,000,000 
 
 
 
Research and development expense
10,439,000 
10,491,000 
12,202,000 
8,999,000 
7,672,000 
6,110,000 
5,197,000 
2,989,000 
42,131,000 
21,968,000 
9,023,000 
1,400,000 
800,000 
400,000 
 
1,200,000 
1,400,000 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1,200,000 
1,000,000 
1,300,000 
Future minimum payments due under the entity's technology licenses
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2013
496,000 
 
 
 
 
 
 
 
496,000 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2014
296,000 
 
 
 
 
 
 
 
296,000 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2015
296,000 
 
 
 
 
 
 
 
296,000 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2016
256,000 
 
 
 
 
 
 
 
256,000 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2017
256,000 
 
 
 
 
 
 
 
256,000 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Thereafter
2,288,000 
 
 
 
 
 
 
 
2,288,000 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Total
$ 3,888,000 
 
 
 
 
 
 
 
$ 3,888,000 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
COMMITMENTS AND CONTINGENCIES (Details 3) (USD $)
12 Months Ended
Dec. 31, 2012
COMMITMENTS AND CONTINGENCIES
 
Laboratory equipment
$ 1,151,000 
Lease term of leased equipment
3 years 
Accumulated depreciation of the leased equipment
128,000 
Rental payment per month
32,000 
Future minimum lease payments required under the capital lease
 
2013
381,000 
2014
381,000 
2015
368,000 
Total lease obligations
1,130,000 
Less imputed interest
(86,000)
Present value of minimum lease payments
1,044,000 
Less current maturities of capital lease obligations
333,000 
Long term capital lease obligations
$ 711,000 
RELATED PARTY TRANSACTIONS (Details) (USD $)
12 Months Ended
Dec. 31, 2012
RELATED PARTY TRANSACTIONS
 
Consulting agreement term
1 year 
Vesting period of awards granted
1 year 
Cash payable over term of agreement
$ 60,000 
Non-employee director |
Restricted stock award
 
RELATED PARTY TRANSACTIONS
 
Shares of common stock granted
4,873 
ACCRUED EXPENSES (Details) (USD $)
In Thousands, unless otherwise specified
Dec. 31, 2012
Dec. 31, 2011
ACCRUED EXPENSES
 
 
Compensation
$ 1,985 
$ 2,041 
Research and trial related expenses
576 
440 
Licenses
373 
338 
Professional fees
351 
182 
Occupancy costs
23 
31 
Other
19 
37 
Accrued expenses
$ 3,327 
$ 3,069 
LONG TERM DEBT (Details) (Loan agreement with Wisconsin Department of Commerce, USD $)
1 Months Ended 12 Months Ended
Dec. 31, 2009
Dec. 31, 2012
item
Nov. 30, 2009
Maximum
Long term debt
 
 
 
Loan amount
 
 
$ 1,000,000 
Proceeds from long term debt
1,000,000 
 
 
Number of new full time positions required to be created for reduction in principal amount by specified amount
 
100 
 
Reduction in the principal amount for each new position created
 
5,405 
 
Full time positions required to be created for forgiveness of full amount of principal
 
185 
 
Interest rate (as a percent)
 
2.00% 
 
Interest rate if job creation requirements are not met (as a percent)
 
4.00% 
 
Period for which both principal and interest payments are deferred
 
5 years 
 
Future principal obligations
 
 
 
2015
 
145 
 
2016
 
217 
 
2017
 
221 
 
Thereafter
 
417 
 
Total
 
$ 1,000 
 
EMPLOYEE BENEFIT PLAN (Details) (USD $)
In Millions, unless otherwise specified
12 Months Ended
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2010
EMPLOYEE BENEFIT PLAN
 
 
 
Matching contribution by employer (as a percent)
100.00% 
100.00% 
100.00% 
Percentage of participant's salary matched by employer
6.00% 
6.00% 
6.00% 
Compensation expense in connection with the 401 (k) Plan
$ 0.4 
$ 0.3 
$ 0.2 
INCOME TAXES (Details) (USD $)
12 Months Ended
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2010
Other information
 
 
 
Excess tax benefit arising from stock option deductions credited to additional paid in capital
$ 14,200,000 
$ 10,600,000 
 
Deferred tax assets:
 
 
 
Operating loss carryforwards
88,532,000 
71,471,000 
 
Tax credit carryforwards
10,184,000 
7,511,000 
 
Deferred revenue
1,758,000 
3,399,000 
 
Other temporary differences
3,445,000 
2,257,000 
 
Tax assets before valuation allowance
103,919,000 
84,638,000 
 
Less-Valuation allowance
(103,919,000)
(84,638,000)
 
Net deferred taxes
 
Valuation allowance
 
 
 
Change in valuation allowance
19,300,000 
 
 
Differences between the effective income tax rate and the statutory tax rate
 
 
 
U.S. Federal statutory rate (as a percent)
34.00% 
34.00% 
34.00% 
State taxes (as a percent)
1.70% 
5.60% 
5.60% 
Research and development tax credit (as a percent)
5.10% 
1.70% 
2.60% 
Stock-based compensation expense (as a percent)
(0.60%)
(2.40%)
(1.90%)
Other adjustments (as a percent)
(0.10%)
0.10% 
(0.10%)
Valuation allowance (as a percent)
(40.10%)
(39.00%)
(40.10%)
Effective tax rate (as a percent)
0.00% 
0.00% 
0.10% 
Federal
 
 
 
Operating loss carryforwards and tax credit carryforwards
 
 
 
Operating loss carryforwards
250,700,000 
 
 
Federal |
Research tax credit
 
 
 
Operating loss carryforwards and tax credit carryforwards
 
 
 
Tax credit carryforwards
4,200,000 
 
 
State
 
 
 
Operating loss carryforwards and tax credit carryforwards
 
 
 
Operating loss carryforwards
158,700,000 
 
 
State |
Research tax credit
 
 
 
Operating loss carryforwards and tax credit carryforwards
 
 
 
Tax credit carryforwards
$ 9,000,000 
 
 
QUARTERLY RESULTS OF OPERATIONS (UNAUDITED) (Details) (USD $)
In Thousands, except Per Share data, unless otherwise specified
3 Months Ended 12 Months Ended
Dec. 31, 2012
Sep. 30, 2012
Jun. 30, 2012
Mar. 31, 2012
Dec. 31, 2011
Sep. 30, 2011
Jun. 30, 2011
Mar. 31, 2011
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2010
QUARTERLY RESULTS OF OPERATIONS (UNAUDITED)
 
 
 
 
 
 
 
 
 
 
 
Revenue
$ 1,036 
$ 1,036 
$ 1,036 
$ 1,036 
$ 1,042 
$ 1,039 
$ 1,042 
$ 1,040 
$ 4,144 
$ 4,163 
$ 5,344 
Cost of revenue
 
 
 
 
 
24 
24 
Gross profit
1,036 
1,036 
1,036 
1,036 
1,036 
1,033 
1,036 
1,034 
4,144 
4,139 
5,320 
Research and development
10,439 
10,491 
12,202 
8,999 
7,672 
6,110 
5,197 
2,989 
42,131 
21,968 
9,023 
General and administrative
2,815 
2,547 
2,393 
2,145 
2,206 
1,951 
1,830 
2,150 
9,900 
8,137 
6,330 
Sales and marketing
1,824 
1,006 
1,331 
594 
1,094 
815 
651 
297 
4,755 
2,857 
1,793 
Loss from operations
(14,042)
(13,008)
(14,890)
(10,702)
(9,936)
(7,843)
(6,642)
(4,402)
(52,642)
(28,823)
(11,826)
Investment income
74 
67 
59 
62 
38 
75 
22 
34 
262 
169 
46 
Interest expense
(20)
(11)
(5)
(5)
(6)
(5)
(5)
(5)
(41)
(21)
(20)
Other income
 
 
 
 
 
 
 
 
 
 
244 
Net loss
$ (13,988)
$ (12,952)
$ (14,836)
$ (10,645)
$ (9,904)
$ (7,773)
$ (6,625)
$ (4,373)
$ (52,421)
$ (28,675)
$ (11,556)
Net loss per share-basic and diluted (in dollars per share)
$ 0.22 
$ (0.21)
$ (0.26)
$ (0.19)
$ (0.18)
$ (0.15)
$ (0.13)
$ (0.08)
$ (0.88)
$ (0.54)
$ (0.29)
Weighted average common shares outstanding-basic and diluted (in shares)
63,582 
60,531 
57,037 
56,718 
53,647 
52,443 
52,010 
51,930 
59,481 
52,512 
40,455