Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Feb. 22, 2016 | Jun. 30, 2015 | |
Document and Entity Information | |||
Entity Registrant Name | EXACT SCIENCES CORP | ||
Entity Central Index Key | 1,124,140 | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2015 | ||
Amendment Flag | false | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Public Float | $ 2,610,196,915 | ||
Entity Common Stock, Shares Outstanding | 97,449,890 | ||
Document Fiscal Year Focus | 2,015 | ||
Document Fiscal Period Focus | FY |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Current Assets: | ||
Cash and cash equivalents | $ 41,135 | $ 58,131 |
Marketable securities | 265,744 | 224,625 |
Accounts receivable, net of reserves of $275 and $86 at December 31, 2015 and December 31, 2014 | 4,933 | 1,376 |
Inventory, net | 6,677 | 4,017 |
Prepaid expenses and other current assets | 7,641 | 3,528 |
Total current assets | 326,130 | 291,677 |
Property and Equipment, at cost: | ||
Laboratory equipment | 12,786 | 10,381 |
Computer equipment and computer software | 14,025 | 7,577 |
Assets under construction | 8,038 | 1,552 |
Leasehold improvements | 7,118 | 5,937 |
Buildings | 4,777 | |
Furniture and fixtures | 1,265 | 939 |
Property and Equipment, gross | 48,009 | 26,386 |
Less-Accumulated depreciation | (13,913) | (6,439) |
Net property and equipment | 34,096 | 19,947 |
Other long-term assets | 4,070 | 1,200 |
Total assets | 364,296 | 312,824 |
Current Liabilities: | ||
Accounts payable | 3,308 | 2,647 |
Accrued liabilities | 22,253 | 13,960 |
Debt and capital lease obligation, current portion | 166 | 360 |
Other short-term liabilities | 996 | 554 |
Total current liabilities | 26,723 | 17,521 |
Long-term debt | 4,852 | 1,000 |
Long-term accrued interest | 106 | |
Other long-term liabilities | 4,804 | 3,599 |
Lease incentive obligation, less current portion | 1,061 | 1,614 |
Total liabilities | $ 37,440 | $ 23,840 |
Commitments and contingencies (Note 8) | ||
Stockholders' Equity: | ||
Preferred stock, $0.01 par value Authorized—5,000,000 shares Issued and outstanding—no shares at December 31, 2015 and December 31, 2014 | ||
Common stock, $0.01 par value Authorized—200,000,000 shares Issued and outstanding—96,674,786 and 88,626,042 shares at December 31, 2015 and December 31, 2014 | $ 968 | $ 887 |
Additional paid-in capital | 904,931 | 709,019 |
Accumulated other comprehensive loss | (433) | (115) |
Accumulated deficit | (578,610) | (420,807) |
Total stockholders' equity | 326,856 | 288,984 |
Total liabilities and stockholders’ equity | $ 364,296 | $ 312,824 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Consolidated Balance Sheets | ||
Accounts receivable, reserves | $ 275 | $ 86 |
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 | 0 | 0 |
Preferred stock, outstanding shares | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, Authorized shares | 200,000,000 | 200,000,000 |
Common stock, Issued shares | 96,674,786 | 88,626,042 |
Common stock, outstanding shares | 96,674,786 | 88,626,042 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Revenue | |||
Laboratory service revenue | $ 39,437 | $ 1,504 | |
License fees | 294 | $ 4,144 | |
Total revenue | 39,437 | 1,798 | 4,144 |
Cost of sales | 24,501 | 4,325 | |
Gross margin | 14,936 | (2,527) | 4,144 |
Operating expenses: | |||
Research and development | 33,914 | 28,669 | 27,678 |
General and administrative | 57,950 | 30,435 | 13,649 |
Sales and marketing | 82,140 | 38,908 | 9,578 |
Total operating expenses | 174,004 | 98,012 | 50,905 |
Loss from operations | (159,068) | (100,539) | (46,761) |
Other income (expense) | |||
Investment income | 1,271 | 542 | 316 |
Interest (expense) | (6) | (51) | (69) |
Total other income | 1,265 | 491 | 247 |
Net loss | $ (157,803) | $ (100,048) | $ (46,514) |
Net loss per share-basic and diluted (in dollars per share) | $ (1.71) | $ (1.25) | $ (0.69) |
Weighted average common shares outstanding-basic and diluted (in shares) | 92,135 | 80,232 | 67,493 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Consolidated Statements of Comprehensive Loss | |||
Net loss | $ (157,803) | $ (100,048) | $ (46,514) |
Other comprehensive loss, net of tax: | |||
Unrealized gain (loss) on available-for-sale investments | (329) | (240) | 47 |
Foreign currency translation gain | 11 | ||
Comprehensive loss | $ (158,121) | $ (100,288) | $ (46,467) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Common Stock | Additional Paid In Capital | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit | Total |
Balance at Dec. 31, 2012 | $ 639 | $ 372,123 | $ 78 | $ (274,245) | $ 98,595 |
Balance (in shares) at Dec. 31, 2012 | 63,909,800 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Issuance of common stock, net of issuance costs of $4.4, $11.0 and $4.8 million for 2015, 2014 and 2013, respectively | $ 63 | 73,232 | 73,296 | ||
Issuance of common stock, net of issuance costs (in shares) | 6,325,000 | ||||
Exercise of common stock options and warrants | $ 4 | 1,337 | 1,341 | ||
Exercise of common stock options and warrants (in shares) | 418,146 | ||||
Issuance of common stock to fund the Company's 401(k) match | $ 1 | 354 | 354 | ||
Issuance of common stock to fund the Company's 401(k) match (in shares) | 30,538 | ||||
Compensation expense related to issuance of stock options and restricted stock awards | $ 3 | 7,741 | 7,744 | ||
Compensation expense related to issuance of stock options and restricted stock awards (in shares) | 328,422 | ||||
Purchase of employee stock purchase plan shares | $ 1 | 452 | 453 | ||
Purchase of employee stock purchase plan shares (in shares) | 59,932 | ||||
Net loss | (46,514) | (46,514) | |||
Accumulated other comprehensive income | 47 | 47 | |||
Balance at Dec. 31, 2013 | $ 711 | 455,239 | 125 | (320,759) | 135,316 |
Balance (in shares) at Dec. 31, 2013 | 71,071,838 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Issuance of common stock, net of issuance costs of $4.4, $11.0 and $4.8 million for 2015, 2014 and 2013, respectively | $ 155 | 238,425 | 238,580 | ||
Issuance of common stock, net of issuance costs (in shares) | 15,500,000 | ||||
Exercise of common stock options and warrants | $ 15 | 2,625 | 2,640 | ||
Exercise of common stock options and warrants (in shares) | 1,522,753 | ||||
Issuance of common stock to fund the Company's 401(k) match | $ 1 | 455 | 456 | ||
Issuance of common stock to fund the Company's 401(k) match (in shares) | 32,666 | ||||
Compensation expense related to issuance of stock options and restricted stock awards | $ 4 | 11,516 | 11,520 | ||
Compensation expense related to issuance of stock options and restricted stock awards (in shares) | 410,619 | ||||
Purchase of employee stock purchase plan shares | $ 1 | 759 | 760 | ||
Purchase of employee stock purchase plan shares (in shares) | 88,166 | ||||
Net loss | (100,048) | (100,048) | |||
Accumulated other comprehensive income | (240) | (240) | |||
Balance at Dec. 31, 2014 | $ 887 | 709,019 | (115) | (420,807) | $ 288,984 |
Balance (in shares) at Dec. 31, 2014 | 88,626,042 | 88,626,042 | |||
Increase (Decrease) in Stockholders' Equity | |||||
Issuance of common stock, net of issuance costs of $4.4, $11.0 and $4.8 million for 2015, 2014 and 2013, respectively | $ 70 | 174,070 | $ 174,140 | ||
Issuance of common stock, net of issuance costs (in shares) | 7,000,000 | ||||
Exercise of common stock options and warrants | $ 3 | 1,245 | 1,248 | ||
Exercise of common stock options and warrants (in shares) | 281,315 | ||||
Issuance of common stock to fund the Company's 401(k) match | 836 | 836 | |||
Issuance of common stock to fund the Company's 401(k) match (in shares) | 21,826 | ||||
Compensation expense related to issuance of stock options and restricted stock awards | $ 6 | 18,044 | 18,050 | ||
Compensation expense related to issuance of stock options and restricted stock awards (in shares) | 568,818 | ||||
Purchase of employee stock purchase plan shares | $ 2 | 1,717 | 1,719 | ||
Purchase of employee stock purchase plan shares (in shares) | 176,785 | ||||
Net loss | (157,803) | (157,803) | |||
Accumulated other comprehensive income | (318) | (318) | |||
Balance at Dec. 31, 2015 | $ 968 | $ 904,931 | $ (433) | $ (578,610) | $ 326,856 |
Balance (in shares) at Dec. 31, 2015 | 96,674,786 | 96,674,786 |
Consolidated Statements of Sto7
Consolidated Statements of Stockholders' Equity (Parenthetical) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Consolidated Statements of Stockholders' Equity | |||
Issuance of common stock, issuance costs | $ 4.4 | $ 11 | $ 4.8 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Cash flows from operating activities: | |||
Net loss | $ (157,803) | $ (100,048) | $ (46,514) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization of fixed assets | 7,600 | 3,710 | 1,418 |
Loss on disposal of property and equipment | 40 | 49 | 100 |
Stock-based compensation | 18,050 | 11,520 | 7,744 |
Amortization of deferred license fees | (294) | (4,144) | |
Amortization of other liabilities | (573) | ||
Amortization of deferred financing costs | 44 | ||
Forgiveness of long-term debt | (1,000) | ||
Amortization of premium on short-term investments | 1,323 | 842 | 636 |
Amortization of intangible assets | 150 | ||
Changes in assets and liabilities: | |||
Accounts receivable | (3,557) | (1,376) | |
Inventory, net | (2,660) | (4,017) | |
Prepaid expenses and other current assets | (3,057) | (1,329) | (1,606) |
Accounts payable | 661 | 1,886 | (2,891) |
Accrued liabilities | 7,424 | 8,064 | 2,299 |
Lease incentive obligation | (553) | (487) | 2,655 |
Accrued interest | (106) | 22 | 21 |
Net cash used in operating activities | (134,017) | (81,458) | (40,282) |
Cash flows from investing activities: | |||
Purchases of marketable securities | (205,054) | (209,471) | (98,510) |
Maturities of marketable securities | 162,283 | 104,172 | 72,289 |
Purchases of property and equipment | (20,084) | (11,991) | (8,748) |
Purchases of intangible assets | (1,900) | ||
Net cash used in investing activities | (64,755) | (117,290) | (34,969) |
Cash flows from financing activities: | |||
Proceeds from exercise of common stock options | 1,248 | 2,640 | 1,341 |
Proceeds from sale of common stock, net of issuance costs | 174,140 | 238,580 | 73,296 |
Payments on capital lease obligations | (360) | (351) | (333) |
Payments on mortgage payable | (44) | ||
Proceeds from mortgage payable | 5,062 | ||
Proceeds from New Market Tax Credit financing agreements | 2,399 | ||
Proceeds in connection with the Company's employee stock purchase plan | 1,719 | 760 | 453 |
Net cash provided by financing activities | 181,765 | 244,028 | 74,757 |
Effects of exchange rate on cash and cash equivalents | 11 | ||
Net (decrease) increase in cash and cash equivalents | (16,996) | 45,280 | (494) |
Cash and cash equivalents, beginning of period | 58,131 | 12,851 | 13,345 |
Cash and cash equivalents, end of period | 41,135 | 58,131 | 12,851 |
Supplemental disclosure of non-cash investing and financing activities: | |||
Property and equipment acquired but not paid | 1,705 | 546 | 534 |
Unrealized gain on available-for-sale investments | (329) | (240) | 47 |
Issuance of 21,826 and 32,669 shares of common stock to fund the Company’s 401(k) matching contribution for 2015 and 2014, respectively | 836 | 456 | 354 |
Interest paid | $ 95 | $ 29 | $ 48 |
Consolidated Statements of Cas9
Consolidated Statements of Cash Flows (Parenthetical) - shares | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Consolidated Statements of Cash Flows | |||
Issuance of shares of common stock to fund the Company's 401(k) matching contribution | 21,826 | 32,666 | 30,538 |
ORGANIZATION
ORGANIZATION | 12 Months Ended |
Dec. 31, 2015 | |
ORGANIZATION | |
ORGANIZATION | (1) ORGANIZATIO N 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 some of the deadliest forms of cancer . The Company has developed an accurate, non-invasive, patient friendly screening test called Cologuard for the early detection of colorectal cancer and pre-cancer, and is currently working on the development of tests for lung cancer, pancreatic cancer and esophageal cancer. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2015 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | (2) SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Principles of Consolidation The accompanying consolidated financial statements include the accounts of the Company’s wholly ‑owned subsidiaries, Exact Sciences Laboratories, LLC, Exact Sciences Finance Corporation, Exact Sciences Europe LTD, Beijing Exact Sciences Medical Technology Company Limited, and variable interest e ntities. See Note 1 3 for the discussion of financing arrangements involving certain entities that are variable interest entities that are included in our consolidated financial statements. All significant intercompany transactions and balances have been eliminated in consolidation. References to “ Exact ” , “ we ” , “ us ” , “ our ” , or the “ Company ” refer to Exact Sciences Corporation and its wholly owned subsidiar ies . Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States (“GAAP”) 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, 201 5 and 201 4 . 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, 201 5 and December 31, 201 4 the Company ’ s investments consisted 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 $14,205 , $ 11,000 , a nd $9,639 , net of insignificant realized losses, for the years ended December 31, 2015, 2014, and 2013, respectively. The Company periodically reviews investments in unrealized loss positions for other-than-temporary impairments. This evaluation includes, but is not limited to, significant quantitative and qualitative assessments and estimates regarding credit ratings, collateralized support, the length of time and significance of a security’s loss position, the Company’s intent not to sell the security, and whether it is more likely than not that the Company will have to sell the security before recovery of its cost basis. For the year ended December 31, 2015, no investments were identified with other-than-temporary declines in value. Available ‑for ‑sale securities at December 31, 2015 consist of the following: December 31, 2015 Gains in Accumulated Losses in Accumulated Other Comprehensive Other Comprehensive Estimated Fair (In thousands) Amortized Cost Income Income Value Corporate bonds $ $ $ $ U.S. government agency securities — Asset backed securities — Certificates of deposit — — Total available-for-sale securities $ $ $ $ Available ‑for ‑sale securities at December 31, 2014 consist of the following: December 31, 2014 Gains in Accumulated Losses in Accumulated Other Comprehensive Other Comprehensive Estimated Fair (In thousands) Amortized Cost Income Income Value Corporate bonds $ $ $ $ U.S. government agency securities Asset backed securities Commercial paper — — Total available-for-sale securities $ $ $ $ Changes in Accumulated Other Comprehensive Income (Loss) The amount recognized in accumulated other comprehensive income (loss) ( “ AOCI ” ) for the years ended Dece mber 31, 2015 and 201 4 were as follows (in thousands): Accumulated Cumulative Unrealized Other Translation Gain (Loss) Comprehensive Adjustment on Securities Income (Loss) Balance at January 1, 2013 $ — $ $ Other comprehensive (loss) income before reclassifications — Amounts reclassified from accumulated other comprehensive loss — Net current period change in accumulated other comprehensive income (loss) — Balance at December 31, 2013 $ — $ $ Other comprehensive (loss) income before reclassifications — Amounts reclassified from accumulated other comprehensive loss — Net current period change in accumulated other comprehensive income (loss) — Balance at December 31, 2014 $ — $ $ Other comprehensive (loss) income before reclassifications Amounts reclassified from accumulated other comprehensive loss — Net current period change in accumulated other comprehensive income (loss) Balance at December 31, 2015 $ $ $ Amounts reclassified from accumulated other comprehensive income (loss) for the years ended December 31, 2015, 2014 and 2013 were as follows (in thousands): Affected Line Item in the Year Ended December 31, Details about AOCI Components Statement of Operations 2015 2014 2013 Change in value of available-for-sale investments Sales and maturities of available-for-sale investments Investment income $ $ $ Total reclassifications $ $ $ Allowance for Doubtful Accounts The Company estimates an allowance for doubtful accounts against individual patient accounts receivable based on estimates of expected payment consistent with historical payment experience. The allowance for doubtful accounts is evaluated on a regular basis and adjusted when trends or significant events indicate that a change in the estimate is appropriate. Accounts receivable are written off against the allowance when the appeals process is exhausted or when there is other substantive evidence that the account will not be paid. As of December 31, 2015 and 2014 the Company’s allowance for doubtful accounts was $275,000 and $86,000 , respectively. The Company did not have an allowance for doubtful accounts in 2013. For the years ended December 31, 2015 and 2014 net additions charged to revenue were $189,000 and $86,000 , respectively. There were no charges to revenue during the year ended December 31, 2013. Property and Equipment Pro perty 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: Estimated Asset Classification Useful Life Laboratory equipment 3 - 5 years Computer equipment and computer software 3 years Leasehold improvements Lesser of the remaining lease term or useful life Furniture and fixtures 3 years Buildings 30 years Depreciation expense for the years ended December 31, 2015, 2014, and 2013 was $7.6 million, $ 3.7 million, and $1.4 million, respectively. At December 31, 2015, the Company had $8.0 million of assets under construction which consisted of $5.1 million related to building and leasehold improvements, $1.7 m illion of capitalized costs related to software projects and $1.2 million of costs related to machinery and equipment. Depreciation will begin on these assets once they are placed into service. The Company expects that it will cost $1.2 million to complete the building and leasehold improvements. The Company expects to incur minimal costs to complete the machinery and equipment and the software projects, and these projects are expected to be completed in 2016. The Company assesses its long-lived assets, consisting primarily of property and equipment, for impairment when material events and changes in circumstances indicate that the carrying value may not be recoverable. There were no impairment losses for the years ended December 31, 2015, 2014 or 2013. Software Capitalization Policy Software development costs related to internal use software are incurred in three stages of development : the preliminary project stage, the application development stage, and the post ‑implementation stage. Costs incurred during the preliminary project and post ‑implementation stages are expensed as incurred. Costs in the application development stage that meet the criteria for capitalization are capitalized and amortized using the straight ‑line basis over the estimated economic useful life of the software. Patent Costs and Intangible Assets 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. 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, 2015, 2014 and 2013 should be expensed and not capitalized as the future economic benefit derived from the transactions cannot be determined. Under a technology license and royalty agreement en tered into with MDx Health , the Company is required to pay MDx Health milestone-based royalties on sales of products or services covered by the licensed intellectual property. Once the achievement of a milestone has occurred or is considered probable, an intangible asset and corresponding liability is reported in other long-term assets and accrued expenses, respectively. The intangible asset is amortized over the estimated ten -year useful life of the licensed intellectual property, and such amortization is reported in cost of sales. As of December 31, 2015, an intangible asset of $1.8 million and a liability of $2.0 million are reported in other long-term assets and accrued expenses, respectively. Amortization expense for the year ended December 31, 2015 was $0.2 million. 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): 2015 2014 2013 Shares issuable upon exercise of stock options Shares issuable upon exercise of outstanding warrants(1) — — Shares issuable upon the release of restricted stock awards Shares issuable upon the vesting of restricted stock awards related to licensing agreement — (1) At December 31, 2013, represents warrants to purchase 80,000 shares of common stock issued under a license 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 Laboratory service revenue. The Company’s laboratory service revenue are generated by performing diagnostic services using its Cologuard test, and the service is completed upon delivery of a test result to an ordering physician. The Company recognizes revenue in accordance with the provision of ASC 954-605, Health Care Entities - Revenue Recognition. The Company recognizes revenue related to billings for Medicare and other third-party payors on an accrual basis, net of contractual and other adjustments, when amounts that will ultimately be realized can be estimated. Contractual and other adjustments represent the difference between the list price (the billing rate) and the estimated reimbursement rate for each payor. Upon ultimate collection, the amount received from Medicare and other third-party payors where reimbursement was estimated is compared to previous estimates and, if necessary, the contractual allowance is adjusted accordingly. The estimates of amounts that will ultimately be realized requires significant judgment by management. Some patients have out-of-pocket costs for amounts not covered by their insurance carrier, and the Company may bill the patient directly for these amounts in the form of co-payments and co-insurance in accordance with their insurance carrier and health plans. Some payors may not cover Cologuard as ordered by the prescribing physician under their reimbursement policies. The Company pursues reimbursement from such patients on a case-by-case basis. In the absence of contracted reimbursement coverage or the ability to estimate the amount that will ultimately be realized for the Company’s services, revenue is recognized upon cash receipt. The Company uses judgment in determining if it is able to make an estimate of what will ultimately be realized. The Company also uses judgment in estimating the amounts it expects to collect by payor. The Company’s judgments will continue to evolve in the future as it continues to gain payment experience with third-party payors and patients. The Company recognized approximately $ 39.4 million and $1.5 million in laboratory service revenue for the years ended December 31, 2015 and 2014, respectively. 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. 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 $934,000 which included accrued interest due, from Genzyme during the third quarter of 2010. The amounts were deferred and were 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 amortized that amount on a straight line basis into revenue over the initial five ‑year collaboration period ending in January 2014. The Company did not recognize license fee revenue for the year ended December 31, 2015. The Company recognized approximately $0.3 million and $4.1 million in license fee revenue for the years ended December 31, 2014 and 2013, respectively, in connection with the amortization of the up-front payments from Genzyme. Inventor y Inventory is stated at the lower of cost or market value (net realizable value). The Company determines the cost of inventory using the first-in, first out method ( “ FIFO ” ). The Company estimates the recoverability of inventory by reference to internal estimates of future demands and product life cycles, including expiration. The Company periodically analyzes its inventory levels to identify inventory that may expire prior to expected sale or has a cost basis in excess of its estimated realizable value, and records a charge to cost of sales for such inventory as appropriate. In addition, the Company’s products are subject to strict quality control and monitoring which the Company performs throughout the production process . If certain batches or units of product no longer meet quality specifications or become obsolete due to expiration, the Company records a charge to cost of sales to write down such unmarketable inventory to its estimated realizable value. Direct and indirect manufacturing costs incurred during process validation and for other research and development activities, which are not permitted to be sold, have been expensed to research and development. Inventory consists of the following (amount in thousands): December 31, 2015 2014 Raw materials $ $ Semi-finished and finished goods Total inventory $ $ Advertising Costs The Company expenses the costs of media advertising at the time the advertising takes place. The Company expensed approximately $10.8 million, $5.3 million and $0.1 million of media advertising during the years ended December 31, 2015, 2014, and 2013, 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. 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, 2015 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, 2015 Using: Quoted Prices Significant in Active Other Significant Markets for Observable Unobservable Fair Value at Identical Assets Inputs Inputs Description December 31, 2015 (Level 1) (Level 2) (Level 3) Cash and cash equivalents Cash and money market $ $ $ — $ — Commercial paper — — Available-for-Sale Marketable securities Corporate bonds — — Asset backed securities — — U.S. government agency securities — — Certificates of deposit — — Total $ $ $ $ — The following table presents the Company’s fair value measurements as of December 31, 2014 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, 2014 Using: Quoted Prices Significant in Active Other Significant Markets for Observable Unobservable Fair Value at Identical Assets Inputs Inputs Description December 31, 2014 (Level 1) (Level 2) (Level 3) Cash and cash equivalents Cash and money market $ $ $ — $ — Corporate bonds — — Available-for-Sale Marketable securities Corporate bonds — — U.S. government agency securities — — Asset backed securities — — Commercial paper — — Total $ $ $ $ — The Company monitors investments for other-than-temporary impairment. It was determined that unrealized gains and losses at December 31, 2015 and 2014, are temporary in nature, because the change in market value for those securities has resulted from fluctuating interest rates, rather than a deterioration of the credit worthiness of the issuers. So long as the Company holds these securities to maturity, it is unlikely to experience gains or losses. In the event that the Company disposes of these securities before maturity, it is expected that realized gains or losses, if any, will be immaterial. The following table summarizes the gross unrealized losses and fair values of investments in an unrealized loss position as of December 31, 2015 , aggregated by investment category and length of time that individual securities have been in a continuous unrealized loss position: December 31, 2015 Less than 12 months 12 months or greater Total (In thousands) Fair Value Gross Unrealized Loss Fair Value Gross Unrealized Loss Fair Value Gross Unrealized Loss Marketable Securities Corporate bonds $ $ $ — $ — $ $ U.S. government agency securities — — Asset backed securities Total $ $ $ $ $ $ The following table summarizes the gross unrealized losses and fair value of investments in an unrealized loss position as of December 31, 2014, aggregated by investment category and length of time that individual securities have been in a continuous unrealized loss position: December 31, 2014 Less than 12 months 12 months or greater Total (In thousands) Fair Value Gross Unrealized Loss Fair Value Gross Unrealized Loss Fair Value Gross Unrealized Loss Marketable Securities Corporate bonds $ $ $ — $ — $ $ Asset backed securities — — U.S. government agency securities — — Total $ $ $ — $ — $ $ The following table summarizes contractual underlying maturities of the Company’s available ‑for ‑sale investments at December 31, 2015 (in thousands): Due one year or less Due after one year through four years Description Cost Fair Value Cost Fair Value Marketable Securities U.S. government agency securities $ $ $ $ Corporate bonds Certificates of deposit — — Asset backed securities Total $ $ $ $ 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, 2015, 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 $ 40.1 million. The Company has not experienced any losses in such accounts and management believes it is not exposed to any significant credit risk. Through December 31, 2015, all of the Company’s laboratory service revenues have been derived from the sale of Cologuard, and one pa yor, Centers for Medicare and Medicaid Services , has provided greater than 10% of revenue during the years ended December 31, 2015 and 2014. Medicare revenue as a percentage of total laboratory service revenue was 71% and 80% for the years ended December 31, 2015 and 2014 , respectively. Medicare accounts receivable as a percentage of total accounts receivable were 64% and 88% at December 31 , 2015 and 2014, respectively. As the number of payors reimbursing for Cologuard increases, the percentage of laboratory service revenue derived from Medicare will continue to change as a percentage of revenue and accounts receivable. 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. Tax Positions 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, the Company has determined that a $215.1 million and $161.9 million valuation allowance at December 31, 2015 and 2014 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 December 31, 2015 and 2014 was $53.2 million and $37.4 million, respectively. Due to the existence of the valuation allowance, future changes in the Company’s unrecognized tax benefits will not impact the Company’s effective tax rate. Recent Accounting Pronouncements In February 2015, the FASB Issued ASU No. 2015-02, “Amendments to the Consolidation Analysis (Topic 8 10 ) . ” The amendments in this Update affect reporting entities that are required to evaluate whether they should consolidate certain legal entities. All legal entities are subject to reevaluation under the revised consolidation model. Specifically, the amendments (1) modify the evaluation of whether limited partnerships and similar legal entities are variable interest entities (“VIEs”) or voting interest entities, (2) eliminate the presumption that a general partner should consolidate a limited partnership, (3) affect the consolidation analysis of reporting entities that are involved with VIEs, particularly those that have fee arrangements and related party relationships and (4) provide a scope exception from consolidation guidance for reporting entities with interests in legal entities that are required to comply with or operate in accordance with requirements that are similar to those in Rule 2a-7 of the Investment Company Act of 1940. The amendments in this Update are effective for public business entities for fiscal years, and for interim periods within those fiscal years, beginning after December 15, 2015. Early adoption is permitted. The Company has not early adopted this Update, and the adoption of this Update is not expected to have a material impact on the Company’s consolidated financial statements. In July 2015, the Financial Accounting Standards Board issued Accounting Standards Update No. 2015-11, “Simplifying the Measurement of Inventory (Topic 330).” The new guidance requires most inventory to be measured at the lower of cost and net realizable value, thereby simplifying the previous guidance under which an entity must measure inventory at the lower of cost or market. Market is defined as replacement cost, net realizable value (“NRV”), less a normal profit margin. The Accounting Standards Update will not apply to inventory that is measured using either the last-in, first-out method or the retail inventory method. The standard will be effective prospectively for the first interim period within annual reporting periods beginning after December 15, 2016. Early adoption is permitted. We do not expect to early adopt this guidance and are currently assessing the provisions of the guidance and have not determined the impact of the adoption of this guidance on our consolidated financial statements. In April 2015, the Financial Accounting Standards Board issued Accounting Standards Update No. 2015-05, “ Customer’s Accounting for Fees Paid in a Cloud Computing Arrangement”, which provides guidance that requires management to evaluate each cloud computing arrangement in order to determine whether it includes a software license that must be accounted for separately from hosted services. The new guidance clarifies that if a cloud computing arrangement includes a software license, we should account for the software license consistent with our accounting for other software licenses. If the arrangement does not include a software license, we should account for the arrangement as a service contract. The standard will be effective for our financial statements that we issue for fiscal periods beginning on or after January 1, 2016. Early adoption is permitted for financial statements that have not previously been issued. The adoption of this standard is not expected to have a material impact on our consolidated financial statements. In April 2015, the Financial Accounting Standards Board issued Accounting Standards Update No. 2015-03, “ Simplifying the Presentation of Debt Issuance Costs”, which requires debt issuance costs to be presented in the balance sheet as a direct deduction from the associated debt liability. This guidance simplifies presentation of debt issuance costs but does not address presentation or subsequent measurement of debt issue costs related to line of credit arrangements. In August 2015, the Financial Accounting Standards Board issued Accounting Standards Update No. 2015-15 “Interest-Imputation of Interest (Subtopic 835-30) Presentation and Subsequent Measurement of Debt Issuance Costs Associated with Line-of-Credit Arrangements” which indicates the SEC staff would not object to an entity deferring and presenting debt issuance costs related to line-of-credit arrangements as an asset and subsequently amortizing the deferred debt issuance costs ratably over the term of the line-of-credit arra |
GENZYME STRATEGIC TRANSACTION
GENZYME STRATEGIC TRANSACTION | 12 Months Ended |
Dec. 31, 2015 | |
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 . The Company agreed to deliver to Genzyme certain intellectual property improvements, if improvements were made during the initial five year collaboration period . 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 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 amortized 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 $934,000 which included accrued interest due, from Genzyme during the third quarter of 2010. The amounts were deferred and were 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 amortized 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 did not recognize license fee revenue from the CLP Agreement during the year ended December 31, 2015. The Company recognized approximately $0.3 million and $4.1 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, 2014 and 2013, respectively. |
MAYO LICENSE AGREEMENT
MAYO LICENSE AGREEMENT | 12 Months Ended |
Dec. 31, 2015 | |
MAYO LICENSE AGREEMENT | |
MAYO LICENSE AGREEMENT | (4) MAYO LICENSE AGREEMENT On June 11, 2009, the Company entered into a patent licensing agreement with MAYO Foundation for Medical Education and Research (“MAYO”). The Company’s license agreement with MAYO was most recently amended and restated in February 2015 and further amended in January 2016. Under the license agreement, MAYO granted the Company an exclusive, worldwide license to certain MAYO patents and patent applications, as well as a non ‑exclusive, worldwide license with regard to certain MAYO know ‑how. The scope of the license initially covered diagnostics and screenings for stool or blood based cancer, but was later amended to cover gastrointestinal cancers, pre-cancers, diseases and conditions. Under the January 2016 amendment to the license agreement, the scope has been expanded to cover any screening, surveillance or diagnostic tests or tools for use in connection with any type of cancers, pre-cancers, diseases or conditions. The licensed MAYO patents and patent applications contain both method and composition ‑of ‑matter claims that relate to sample processing, analytical testing and data analysis associated with nucleic screening for cancers and other diseases. The jurisdictions covered by these patents and patent applications include the U.S., Canada, the European Union and Japan. In addition to granting the Company a license to the covered MAYO intellectual property, MAYO agreed to make available personnel to provide the Company product development and research and development assistance. Under the license agreement, the Company assumed the obligation and expense of prosecuting and maintaining the licensed MAYO patents and are obligated to make commercially reasonable efforts to bring to market products using the licensed MAYO intellectual property. MAYO has agreed to make available personnel through January 2020 to provide us product development and research and development assistance. Pursuant to the Company’s agreement with MAYO, the Company is required to pay MAYO a low single digit royalty on the Company’s net sales of products using the licensed MAYO intellectual property, w ith minimum annual royalty fees of $25,000 each year through 2033, the year the last patent expires. The January 2016 amendment to the MAYO license agreement established various low single digit royalty rates on net sales of current and future products and clarified how net sales will be calculated. As part of the amendment, the royalty rate on the Company’s net sales of Cologuard increased and, if in the future, improvements are made to the Cologuard product, the royalty rate may further increase. However, the amendment provides that the Cologuard royalty will remain a low single digit percentage of net sales. The Company is also required to issue MAYO shares of the Company’s common stock with a value of $200,000 upon commercial launch of our second and third products that use the licensed MAYO intellectual property, as well as to pay MAYO, for each of the Company’s products that use licensed MAYO intellectual property, $200,000 cash upon such product reaching $5 million in cumulative net sales, $750,000 cash upon such product reaching $20 million in cumulative net sales, and $2 million cash upon such product reaching $50 million in cumulative net sales. As part of the February 2015 amendment and restatement of the license agreement, the Company agreed to pay MAYO an additional $5,000,000 , payable in five annual installments, through 2019. 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 $2.6 million and has made payments of $2.6 million for the year ended December 31, 2015. The Company has recorded an estimated liability in the amount of $1.3 million for research and development efforts as of December 31, 2015. The Company incurred charges of $2.3 million and made payments of $0.7 million for the year ended December 31, 2014. The Company recorded an estimated liability in the amount of $1.5 million for research and development efforts at December 31, 2014. The Company incurred charges of $1.7 million and made payments of $1.0 million for the year ended December 31, 201 3 . The MAYO license agreement required, among other things, a $0.5 million milestone payment upon FDA approval of the Company’s Cologuard test. The Company received this FDA approval , and paid the milestone payment in August 2014 . 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 warrant covering 1,000,000 shares was fully exercised as of September 2011. The warrant covering 250,000 shares was exercised at various dates in 2013 and 2014 and became fully exercised as of June 2014. The license agreement will remain in effect, unless earlier terminated by the parties in accordance with the agreement, until the last of the licensed patents expires in 2033 (or later, if certain licensed patent applications are issued). However, if we are still using the licensed MAYO know ‑how or certain MAYO ‑provided biological specimens or their derivatives on such expiration date, the term shall continue until the earlier of the date we stop using such know ‑how and materials and the date that is five years after the last licensed patents expires. The license agreement contains customary termination provisions and permits MAYO to terminate the license agreement if the Company sues MAYO or its affiliates, other than any such suit claiming an uncured material breach by MAYO of the license agreement. |
MD ANDERSON LICENSE AGREEMENT
MD ANDERSON LICENSE AGREEMENT | 12 Months Ended |
Dec. 31, 2015 | |
MD ANDERSON LICENSE AGREEMENT | |
MD ANDERSON LICENSE AGREEMENT | (5) MD ANDERSON LICENSE AGREEMENT Overview On April 10, 2015, the Company entered into a Joint Development and License Agreement (“MD Anderson Agreement”) with the University of Texas M.D. Anderson Cancer Center (“MD Anderson”) to jointly develop, clinically validate and obtain FDA approval and CMS coverage and reimbursement for in-vitro diagnostic and screening tools for the early detection of lung cancer (the “IVD Assays”). Under the MD Anderson Agreement, MD Anderson assigned certain patent rights to the Company and granted the Company an exclusive license to certain intellectual property rights for the purpose of developing, manufacturing and marketing IVD Assays. In addition, MD Anderson agreed to make personnel available to provide the Company product development and research and development assistance. Pursuant to the MD Anderson Agreement, the Company is obligated to reimburse IVD Assay development expenses incurred by the staff at MD Anderson, up to a maximum of $1.0 million per year for the first two years of the MD Anderson Agreement. The Company’s current focus for lung cancer is to develop a test to detect cancer in lung nodules which is a shift from the product development efforts that were underway with MD Anderson. Therefore, the Company and MD Anderson have mutually agreed to terminate their collaboration effective February 2016. At December 31, 2015 the Company recorded an estimated liability in the amount of $15,000 for IVD Assay development efforts. During the year ended December 31, 2015, the Company made payments for IVD Assay development costs to MD Anderson of $0.5 million. |
ISSUANCES OF EQUITY
ISSUANCES OF EQUITY | 12 Months Ended |
Dec. 31, 2015 | |
ISSUANCES OF EQUITY | |
ISSUANCES OF EQUITY | (6 ) ISSUANCES OF EQUITY Underwritten Public Offerings On June 21, 2013, the Company completed an underwritten public offering of 6.3 million shares of common stock at a price of $12.35 per share to the public. The Company received approximately $73.3 million of net proceeds from the offering, after deducting $4.8 million for the underwriting discount and other stock issuance costs paid by the Company. On April 2, 2014, the Company completed an underwritten public offering of 11.5 million shares of common stock at a price of $12.75 per share to the public. The Company received approximately $137.7 million of net proceeds from the offering, after deducting the $8.9 million for the underwriting discount and other stock issuance costs paid by the Company. On December 16, 2014, the Company completed an underwritten public offering of 4.0 million shares of common stock at a price of $25.75 per share to the public. The Company received approximately $100.9 million of net proceeds from the offering, after deducting $2.1 million for the underwriting discount and other stock issuance costs paid by the Company. On July 24, 2015 the Company completed an underwritten public offering of 7.0 million shares of common stock at a price of $25.50 per share to the public. The Company received approximately $174.1 million of net proceeds from the offering, after deducting $4.4 million for the underwriting discount and commissions and other stock issuance costs paid by the Company. Rights Agreement In February 2011, the Company adopted a rights agreement and subsequently distributed to the Company ’ s stockholders preferred stock purchase rights. Under certain circumstances, each right can be exercised for one one ‑thousandth of a share of Series A Junior Participating Preferred Stock. In general, the rights will become exercisable in the event of an announcement of an acquisition of 15% or more of the Company ’ s outstanding common stock or the commencement or announcement of an intention to make a tender offer or exchange offer for 15% or more of the Company ’ s outstanding common stock. If any person or group acquires 15% or more of the Company ’ s common stock, the Company ’ s stockholders, other than the acquiror, will have the right to purchase additional shares of the Company ’ s common stock (in lieu of the Series A Junior Participating Preferred Stock) at a substantial discount to the then prevailing market price. The rights agreement could significantly dilute such acquiror ’ s ownership position in the Company ’ s shares, thereby making a takeover prohibitively expensive and encouraging such acquiror to negotiate with the Company ’ s board of directors. The ability to exercise these rights is contingent on events that the Company has determined to be unlikely at this time, and therefore this provision has not been considered in the computation of equity or earnings per share. |
STOCK-BASED COMPENSATION
STOCK-BASED COMPENSATION | 12 Months Ended |
Dec. 31, 2015 | |
STOCK-BASED COMPENSATION | |
STOCK-BASED COMPENSATION | (7) STOCK ‑BASED COMPENSATION Stock ‑Based Compensation Plans The Company maintains the 2010 Omnibus Long ‑Term Incentive Plan, the 2010 Employee Stock Purchase Plan , the 2015 Inducement Award Plan and the 2000 Stock Option and Incentive 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, 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, 2015, options to purchase 3,345,800 shares were outstanding under the 2000 Option Plan. There were no shares of restricted stock 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, 2015, options to purchase 1,590,794 shares were outstanding under the 2010 Stock Plan and 3,200,845 shares of restricted stock and restricted stock units were outstanding. On July 23 , 201 5 the Company’s stockholders approve d an amendment to the 2010 Stock Plan to increase the number of shares available for issuance thereunder by 8,360,000 shares . At December 31, 2015, there were 6,159,082 shares available for future grant under the 2010 Stock Plan. 2015 Inducement Award Plan The Company adopted the 2015 Inducement Award Plan (“the 2015 Inducement Plan”) on February 9, 2015. The 2015 Inducement Plan expired on July 27, 2015 and after such date no further awards may be granted under the plan. Under the terms of the 2015 Inducement 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 who were not previously an employee of the Company or any of its Subsidiaries. Options granted under the 2015 Inducement Plan expire ten years from the date of grant. Grants made from the 2015 Inducement Plan generally vest over a period of three to four years. The 2015 Inducement 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 2015 Inducement Plan. The 2015 Inducement Plan provides that upon an acquisition of the Company, all equity will accelerate by a period of one year. In addition, upon 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 2015 Inducement Plan held by that employee will immediately vest. At December 31, 2015, there were 243,849 shares of restricted stock and restricted stock units outstanding. At December 31, 2015, there were no shares available for future grant under the 2015 Inducement 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. On July 24, 2014 the stockholders of Exact Sciences Corporation approved an amendment to the 2010 Employee Stock Purchase Plan to increase the number of shares available for purchase thereunder by 500,000 shares. At December 31, 2015, there were 363,392 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 $25,00 0 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, 2015, there were 436,608 cumulative shares issued under the 2010 Purchase Plan, and 176,785 shares were issued in the year ended December 31, 2015, as follows: Weighted Average Offering period ended Number of Shares price per Share April 30, 2015 $ October 31, 2015 $ Stock ‑Based Compensation Expense The Company recorded approximately $ 18.1 million, $11.5 million and $7.7 million in stock ‑based compensation expense during the years ended December 31, 2015, 2014 and 2013, respectively, in connection with the amortization of restricted stock and restricted stock unit awards, stock purchase rights granted under the Company’s employee stock purchase plan and stock options granted to employees, non ‑employee consultants and non ‑employee directors. Non ‑cash stock ‑based compensation expense by expense category for the years ended December 31, 2015, 2014, and 2013 are as follows, and amounts included in the table are in thousands: December 31, 2015 2014 2013 Cost of sales $ $ $ — Research and development General and administrative Sales and marketing Total stock-based compensation $ $ $ In connection with the June 7, 2013 resignation of the Company’s former Chief Commercial Officer, the Company modified the vesting of 100,000 shares of her previously unvested restricted stock units whereby 41,250 of the restricted stock units vested upon the execution of the separation agreement, 10,000 vested in March 2014, and the remaining 48,750 ve st in twenty ‑ four equal monthly installments beginning in April 2014, subject to her continuing compliance with the terms of the separation agreement. She forfeited all other unvested restricted stock units and stock option awards. It was determined that the continuing compliance and service to be provided to the Company under the separation agreement was not substantive and, as a result, the Company recorded the full value of the modified restricted stock units as additional stock ‑based compensation expense in the second quarter of 2013. 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 model 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 used in the twelve months ended December 31, 2015, 2014 and 2013 was 4.99% , 4.99% , and 2.76% , respectively . The fair value of service-based awards for 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 market measure-based share-based compensation plans are calculated using a Monte Carlo simulation pricing model. 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: Year Ended December 31, 2015 2014 2013 Option Plan Shares Risk-free interest rates 1.5% - 1.92% 1.96% - 2.01% 0.94% - 1.73% Expected term (in years) 6.25 - 6.6 6 6 Expected volatility 67.1% - 73.2% 77.6% - 80.8% 82.9% - 84% Dividend yield 0% 0% 0 % Weighted average fair value per share of options granted during the period $15.81 $ 10.05 $ 8.12 ESPP Shares Risk-free interest rates 0.25% - 0.75% 0.1% - 0.5% 0.1% - 0.33% Expected term (in years) 0.5 - 2 0.5 - 2 0.5 - 2 Expected volatility 51.2% - 110% 42.5% - 62.7% 39.1% - 45.6% Dividend yield 0% 0% 0 % Weighted average fair value per share of stock purchase rights granted during the period $ 4.67 $ 6.3 $ 3.13 Stock Option, Restricted Stock, and Restricted Stock Unit Activity A summary of stock option activity under the Stock Plans during the years ended 2015, 2014 and 2013 is as follows: Weighted Weighted Average Average Remaining Aggregate Exercise Contractual Intrinsic Options Shares Price Term (Years) Value(1) (Aggregate intrinsic value in thousands) Outstanding, January 1, 2013 $ Granted Exercised Forfeited Outstanding, December 31, 2013 $ Granted Exercised Forfeited Outstanding, December 31, 2014 $ Granted Exercised Forfeited Outstanding, December 31, 2015 $ $ Exercisable, December 31, 2015 $ $ Vested and expected to vest, December 31, 2015 $ $ (1) The aggregate intrinsic value of options outstanding at December 31, 2015 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 4,936,594 options that had exercise prices that were lower than the $9.23 market price of our common stock at December 31, 2015. The aggregate intrinsic value of options exercisable at December 31, 2015 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 4,219,865 options that had exercise prices that were lower than the $9.23 market price of our common stock at December 31, 2015. The total intrinsic value of options exercised during the years ended December 31, 2015, 2014 and 2013 was $3.6 million, $29.2 million, $1.9 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 to provide specific assistance to the Company in attaining FDA approval of Cologuard. The 75,000 warrants vested in the third quarter of 2014 upon successful approval for Cologuard. The Company recorded $1.3 million, the fair value of the warrant on the vesting date as stock-based compensation expense during the third quarter of 2014 in connection with the vesting of this warrant. A summary of restricted stock and restricted stock unit activity under the Stock Plans during the years ended December 31, 2015, 2014 and 2013 is as follows: Weighted Restricted Average Grant Shares Date Fair Value Outstanding, January 1, 2013 $ Granted Released Forfeited Outstanding, December 31, 2013 $ Granted Released Forfeited Outstanding, December 31, 2014 $ Granted Released Forfeited Outstanding, December 31, 2015 $ As of December 31, 2015, there was approximately $41.1 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 2.8 years. The Company received approximately $1.2 million, $2.6 million and $1.3 million from stock option exercises during the years ended December 31, 2015, 2014 and 2013, respectively. During the years ended December 31, 2015, 2014 and 2013, 176,785 , 88,166 and 59,932 shares of common stock, respectively, were issued under the Company’s 2010 Purchase Plan resulting in proceeds to the company of $1.7 million, $0.8 million and $0.5 million, respectively. The following table summarizes information relating to currently outstanding and exercisable stock options as of December 31, 2015: Outstanding Exercisable Weighted Average Weighted Weighted Remaining Average Average Number of Contractual Exercise Number of Exercise Exercise Price Options Life (Years) Price Options Price $0.00 - $3.00 $ $ $3.01 - $6.00 $6.01 - $9.00 $9.01 - $12.00 $12.01 - $15.00 $15.01 - $18.00 $18.01 - $24.00 — — $24.01 - $26.98 — — $ $ During the first quarter of 2013, the Company granted a total of 180,750 restricted stock units to certain executives that vest based upon the satisfaction of certain 2013 performance conditions. Based on the conditions that were met 100,800 shares were earned. The shares vest equally over three years with the first vesting date at December 31, 2013. The company recognized $0.4 million during the year ended December 31, 2013 related to this restricted stock unit grant. During the first quarter of 2015, the Company granted a total of 203,100 restricted stock units to certain executives that would have vested 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 were most likely to vest based on the probability of what performance conditions were met. The expense for the fair value of the awards that were expected to vest of $0.4 million was recognized during the year ended December 31, 201 5 . The service and performance conditions were not met and the expense of $0.4 million was reversed in the fourth quarter of the year ended December 31, 2015. 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, 2015, as follows: Shares reserved for issuance 2010 Option Plan 2010 Purchase Plan |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2015 | |
COMMITMENTS AND CONTINGENCIES | |
COMMITMENTS AND CONTINGENCIES | (8 ) COMMITMENTS AND CONTINGENCIES Operating Leases The Company leases a 35,000 square foo t laboratory and office facility in Madison, Wisconsin. This lease has been in effect since 2010 and expires in October 2016. The Company has one option to extend the term of the lease for five years. The lease is not subject to periodic rent escalation adjustments. During the second quarter of 2013, the Company entered into a five year lease for a 28,994 square foot facility in Madison, Wisconsin to house its commercial lab operations. This lease contains periodic rent escalation adjustments and includes provisions for tenant improvements. During August 2014, the Company entered into an amended lease agreement to lease an additional 3,189 square feet of office. The amended agreement covers the same term as the original term and is also subject to periodic rent escalation adjustments. During November 2014, the Company entered into an amended lease agreement to lease adjacent land for the construction of a parking lot. The amended agreement covers the same term as the original term and is also subject to periodic rent escalation adjustments. During May 2015, the Company entered into an amended lease agreement to lease an additional 7,853 square feet effective immediately, and another 5,810 square feet effective in June 2015. The lease now covers a total of 50,000 square feet. The amended agreement extended the initial term of the lease and is subject to periodic rent escalation adjustments. The Company has two options to extend the term of the lease for five years. The Company has two options to extend the term of the lease for five years each. As part of the lease agreement, the landlord agreed to pay for a portion of leasehold improvements constructed. These payments are recorded as a lease incentive obligation and will be amortized over the five year term of the lease as a reduction of rent expense. As of December 31, 2015 and 2014, the lease incentive obligation was $1.6 million and $2.7 million , respectively . Construction of the laboratory facility was substantially complete at December 31, 2013 and the leasehold improvements related to the laboratory were placed into service. The amortization of the lease incentive obligation began in December of 2013. During April 2014, the Company entered into a one year lease for a 10,137 square foot facility in Madison, Wisconsin for administration purposes. The lease is subject to an annual rent escalation adjustment and includes an option for a one -year extension. During September 2014, the Company entered into an amended lease agreement to lease an additional 12,338 square feet of space for a total of 22,475 square feet. The amended agreement covers the same term as the original lease with an annual rent escalation adjustment and an option for a one -year extension. During November 2015, the Company entered into an amended lease agreement to lease an additional 11,238 square feet. The amended agreement extended the initial term of the lease and is subject to periodic rent escalation adjustments. The Company has two options to extend the lease. During July 2015, the Company entered into a lease for a 21,000 square foot warehouse facility in Madison, Wisconsin. The lease commenced in October 2015 and is effective until May 2025 and includes an option for a five -year extension. The lease contains periodic rent escalation adjustments. During November 2014, the Company entered into a two -y ear lease agreement for a 620 square foot office facility in London, United Kingdom that is to house European operations. This lease contains periodic rent escalation adjustments. Future minimum payments under operating leases as of December 31, 201 5 are as follows. Amounts included in the table are in thousands. Year Ending December 31, 2016 $ 2017 2018 2019 2020 Thereafter Total lease obligations $ Rent expense included in the accompanying consolidated statements of operations was approximately $1.5 million, $1.0 million, and $0.7 million for the years ended December 31, 201 5 , 201 4 and 2013 , respectively. License 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. MAYO See Note 4 for information related to the MAYO license agreement. 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, patent applications and improvements, including Hologic’s Invader detection chemistry (the “Covered Hologic IP”). The licensed patents and patent applications contain both method and composition ‑of ‑matter claims. The jurisdictions covered by these patents and patent applications include the U.S., Canada, the European Union, Australia and Japan. The license agreement also provided the Company with non ‑exclusive, worldwide licenses to the Covered Hologic IP within the field of clinical diagnostic purposes relating to colorectal cancer (including cancer diagnosis, treatment, monitoring or staging) and the field of detection or identification of colorectal cancer and pre ‑cancers through means other than human stool samples. In December 2012 the Company entered into an amendment to this license agreement with Hologic pursuant to which Hologic granted the Company a non ‑exclusive worldwide license to the Covered Hologic IP within the field of any disease or condition within, related to or affecting the gastrointestinal tract and/or appended mucosal surfaces. The Company received FDA approval for its Cologuard test in August 2014, and was required to make a milestone payment of $100,000 to Hologic, which was expensed to research and development in August 2014. The Company is required to pay Hologic a low single digit royalty on the Company’s net sales of products using the Covered Hologic IP. 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 cumulative net sales o f $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. Capital Lease In 2012 the Company entered into a lease agreement which is accounted for as a capital lease and the final lease payment was made in September 2015 . The leased equipment is recorded at $1.2 million and is included in the balance sheet as laboratory equipment. The cost of the leased equipment was depreciated over the three year lease term, and the expense was recorded as depreciation expense. T he leased equipment was fully depreciated at December 31, 201 5. The Company was required to make principal and interest payments of approximately $32,000 per month over the three year term of the lease agreement. |
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS | 12 Months Ended |
Dec. 31, 2015 | |
RELATED PARTY TRANSACTIONS | |
RELATED PARTY TRANSACTIONS | (9 ) RELATED PARTY TRANSACTIONS In August 2013, the Company renewed a one year consulting agreement with a non ‑employee director for an additional year. In accordance with the agreement, the Company granted a restricted stock award for 4,277 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. The Company recorded expense related to this consulting agreement of $25,000 in 2013. |
ACCRUED LIABILITIES
ACCRUED LIABILITIES | 12 Months Ended |
Dec. 31, 2015 | |
ACCRUED LIABILITIES | |
ACCRUED LIABILITIES | (10 ) ACCRUED LIABILITIES Accrued liabilities at December 31, 201 5 and 201 4 consisted of the following. Amounts included in the table are in thousands. December 31, 2015 2014 Compensation $ $ Professional fees Licenses Research and trial related expenses Other Miscellaneous taxes Occupancy costs $ $ |
LONG-TERM DEBT
LONG-TERM DEBT | 12 Months Ended |
Dec. 31, 2015 | |
LONG TERM DEBT | |
LONG-TERM DEBT | (11 ) LONG TERM DEBT Building Purchase Mortgage During June 2015, the Company entered into a $5.1 million credit agreement with an unrelated third-party financial institution to finance the purchase of a facility located in Madison, WI. The credit agreement is collateralized by the acquired building. Borrowings under the credit agreement bear interest at 4.15% . The Company made interest only payments on the outstanding principal balance for the period between July 12, 2015 and September 12, 2015. Beginning on October 12, 2015 and continuing through the maturity date, May 12, 2019, the Company is required to make monthly principal and interest payments of $31,000 . The final principal and interest payment due on June 12, 2019 is $4.4 million. Additionally, the Company has recorded $73,000 in deferred financing costs which are being amortized through June 12, 2019. For the year ended December 31, 2015, the Company has recorded $10,000 in amortization of deferred financing costs. The table below represents the future principal obl igations as of December 31, 2015 : Year ending December 31, 2016 $ 2017 2018 2019 2020 — Thereafter — $ Wisconsin Department of Commerce Loan 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 $1.0 million to the Company subject to the Company’s satisfaction of certain conditions. The Company received the $1.0 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 at a specified wage rate. 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. 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 loan’s terms also contain a milestone that if the Company has created 185 new full-time positions as of June 30, 2015, the full amount of principal shall be forgiven. The Company met this job creation milestone and the $1.0 million benefit associated with the loan forgiveness has been recorded as an offset to the operating expenses during the year ended December 31, 2015. |
EMPLOYEE BENEFIT PLAN
EMPLOYEE BENEFIT PLAN | 12 Months Ended |
Dec. 31, 2015 | |
EMPLOYEE BENEFIT PLAN | |
EMPLOYEE BENEFIT PLAN | (12 ) 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, 201 5 , 201 4 and 201 3 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 $2.1 million, $0.8 million, and $0.5 million, respectively, in the statements of operations for the years ended December 31, 201 5 , 201 4 and 201 3 in connection with 401(k) Plan matching contributions. |
NEW MARKET TAX CREDIT
NEW MARKET TAX CREDIT | 12 Months Ended |
Dec. 31, 2015 | |
NEW MARKET TAX CREDIT | |
NEW MARKET TAX CREDIT | (13) NEW MARKET TAX CREDIT During the fourth quarter of 2014, the Company received approximately $2.4 million in net proceeds from financing agreements related to working capital and capital improvements at one of its Madison, Wisconsin facilities. This financing arrangement was str uctured with an unrelated third- party financial institution (the “Investor” ), an investment fund, and its majority owned community development entity in connection with the Company’s participation in transactions qualified under the federal New Markets Tax Credit (“NMTC”) program, pursuant to Section 45D of the Internal Revenue Code of 1986, as amended. Through its participation in this program, the Company has secured low interest financing and the potential for future debt forgiveness related to the Madison, Wisconsin facility. Upon closing of this transaction, the Company provided an aggregate of approximately $5.1 million to the Investor, in the form of a loan receivable, with a term of seven years, bearing an interest rate of 2.74% per annum. This $5.1 million in proceeds plus $2.4 million of capital from the Investor was used to make an aggregate $7.5 million loan to a subsidiary of the Company. This financing arrangement is not secured by any assets of the Company. On December 1, 2021, the Company would receive a repayment of its approximately $5.1 million loan. The $5.1 million is eliminated in the consolidation of the financial statements. This transaction also includes a put/call feature that becomes enforceable at the end of the seven -year compliance period. The Investor may exercise its put option or the Company can exercise the call, both of which will serve to trigger forgiveness of the debt. The value attributable to the put/call is nominal. The $2.4 million was recorded in other long-term liabilities on the balance sheets. The benefit of this net $2.4 million contribution will be recognized as a decrease in expenses, included in cost of sales, as the Company amortizes the contribution liability over the seven -year compliance period as it is being earned through the Company’s on-going compliance with the conditions of the NMTC program. The Company has recorded $0.4 million as a decrease of expenses for the year ended December 31, 2015. At December 31, 2015, the remaining balance of $2.0 million is included in Other Long Term Liabilities. The Company incurred approximately $0.2 million of debt issuance costs related to the above transactions, which are being amortized over the life of the agreements. The Investor is subject to 100% recapture of the NMTC it receives for a period of seven years as provided in the Internal Revenue Code and applicable U.S. Treasury regulations. The Company is required to be in compliance with various regulations and contractual provisions that apply to the NMTC arrangement. Noncompliance with applicable requirements could result in the Investor’s projected tax benefits not being realized and, therefore, require the Company to indemnify the Investor for any loss or recapture of NMTC related to the financing until such time as the recapture provisions have expired under the applicable statute of limitations. The Company does not anticipate any credit recapture will be required in connection with this financing arrangement. The Investor and its majority owned community development entity are considered Variable Interest Entities ( “ VIEs ” ) and the Company is the primary beneficiary of the VIEs. This conclusion was reached based on the following: · The ongoing activities of the VIEs—collecting and remitting interest and fees and NMTC compliance—were all considered in the initial design and are not expected to significantly affect performance throughout the life of the VIE; · Contractual arrangements obligate the Company to comply with NMTC rules and regulations and provide various other guarantees to the Investor and community development entity; · The Investor lacks a material interest in the underling economics of the project; and · The Company is obligated to absorb losses of the VIEs. Because the Company is the primary beneficiary of the VIEs, they have been included in the consolidated financial statements. There are no other assets, liabilities or transactions in these VIEs outside of the financing transactions executed as part of the NMTC arrangement. Also in December 2014, in connection with the NMTC transaction, the Company entered into a land purchase option agreement with the owner of certain real property (land) adjacent to certain of the Company’s current Madison, Wisconsin facilities. The option is renewable annually in exchange for a fee. If the Company exercises its land purchase option, it will pay a fixed amount for the land. That fixed amount approximates the then-current fair value of the land. If the Company decides not to exercise its option, then on December 31, 2021 (which is after the seven year compliance period of the NMTC program) the Company must pay $1.2 million to the community development entity. As discussed below, the community development entity is a variable interest entity consolidated into the Company. The community development entity would then distribute this money to its members. The majority member of the community development entity is also the owner of the land subject to the land purchase option. The Company has recorded the obligation and the land purchase option asset for $1.2 million to reflect the Company’s assessment that it is probable that at least $1.2 million will be paid in the future based on resolution of the land purchase option. The asset is included in Other Long-Term Assets and the liability is included in Other Long-Term Liabilities on the consolidated balance sheet. |
WISCONSIN ECONOMIC DEVELOPMENT
WISCONSIN ECONOMIC DEVELOPMENT TAX CREDIT | 12 Months Ended |
Dec. 31, 2015 | |
WISCONSIN ECONOMIC DEVELOPMENT TAX CREDIT. | |
WISCONSIN ECONOMIC DEVELOPMENT TAX CREDIT | (14) WISCONSIN ECONOMIC DEVELOPMENT TAX CREDITS During the first quarter of 2015, the Company entered into an agreement with the Wisconsin Economic Development Corporation (“WEDC”) to earn $9.0 million in refundable tax credits if the Company expends $26.3 million in capital investments and establishes and maintains 758 full-time positions in the state of Wisconsin over a seven year period. The tax credits earned should first be applied against the tax liability otherwise due and if there is no such liability present, the claim for tax credits will be reimbursed in cash to the Company. The maximum amount of the refundable tax credit to be earned for each year is fixed, and the Company earns the credits by meeting certain capital investment and job creation thresholds over the seven year period. Should the Company earn and receive the job creation tax credits but not maintain those full-time positions through the end of the agreement, the Company may be required to pay those credits back to the WEDC. The Company will record the earned tax credits as job creation and capital investments occur. The amount of tax credits earned will be recorded as a liability and amortized as a reduction of operating expenses over the expected period of benefit. The tax credits earned from capital investment will be recognized as an offset to depreciation expense over the expected life of the acquired capital assets. The tax credits earned related to job creation will be recognized as an offset to operational expenses over the life of the agreement as the Company is required to maintain the minimum level of full-time positions through the seven year period. As of December 31, 2015 the Company has earned $2.2 million of tax credits. $1.1 million is reported in prepaid expenses and other current assets and $1.1 million is reported in other long-term assets, reflecting when collection of the refundable tax credits is expected to occur. During the year ended December 31, 2015, the Company has amortized $0.2 million of the credits earned as a reduction of operating expenses. As of December 31, 2015, the Company also has recorded a $0.4 million liability in other short-term liablities and a $1.6 million liability in other long-term liabilities, reflecting when the expected benefit of the tax credit amortization will reduce future operating expenses. |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2015 | |
INCOME TAXES | |
INCOME TAXES | (15 ) 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, 2015, the Company had federal net operating loss and state net operating loss carryforward s of approximately $565.9 million and $208.9 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 $7.5 million and $16.0 million, respectively which may be used to offset future income tax liability. The federal and state carryforwards expire beginning 2016 through 2035 and are subject to review and possible adjustment by the Internal Revenue Service and state tax jurisdictions . 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, 201 5 and 201 4 , the Company had $45.5 million and $39.8 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, 2015 2014 Deferred tax assets: Operating loss carryforwards $ $ Tax credit carryforwards Deferred revenue — Other temporary differences Tax assets before valuation allowance Less—Valuation allowance 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 valuation allowance of $215.1 million and $161.9 million at December 31, 2015 and 2014 , respectively, 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 December 31, 201 5 and 201 4 was $53.2 million and $37.4 million, respectively . 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, 2015 2014 2013 U.S. Federal statutory rate % % % State taxes Federal and state tax rate changes — — Research and development tax credits Stock-based compensation expense Other adjustments Valuation allowance Effective tax rate % % % There are no unrecognized tax benefits as of December 2015 , 201 4 and 201 3 , 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, 201 5 . As of December 31, 201 5 , due to the carryforward of unutilized net operating losses and research and development credits, the Company is subject to U.S. Federal and state income tax examinations for the tax years 1995 through 201 5 , and to state income tax examinations for the tax years 1995 through 201 5 . 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, 2015 , 201 4 and 201 3 . |
QUARTERLY RESULTS OF OPERATIONS
QUARTERLY RESULTS OF OPERATIONS (UNAUDITED) | 12 Months Ended |
Dec. 31, 2015 | |
QUARTERLY RESULTS OF OPERATIONS (UNAUDITED) | |
QUARTERLY RESULTS OF OPERATIONS (UNAUDITED) | (16 ) 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, 2015 and 2014 . In the opinion of management, this information has been prepared on the same basis as the audited consolidated financial statements appearing elsewhere in this Form 10 ‑K, 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 audited consolidated financial statements and the notes to the consolidated financial statements appearing elsewhere in this Form 10 ‑K. Quarter Ended March 31, June 30, September 30, December 31, (Amounts in thousands, except per share data) 2015 Laboratory service revenue $ $ $ $ Cost of revenue Gross profit Research and development General and administrative Sales and marketing Loss from operations Investment income Interest income (expense) Net loss $ $ $ $ Net loss per share—basic and diluted $ $ $ $ Weighted average common shares outstanding—basic and diluted 2014 Laboratory service revenue $ — $ — $ — $ License fee revenue $ $ — $ — $ — Cost of revenue — — Gross profit — Research and development General and administrative Sales and marketing Loss from operations Investment income Interest expense Net loss $ $ $ $ Net loss per share—basic and diluted $ $ $ $ Weighted average common shares outstanding—basic and diluted |
SUMMARY OF SIGNIFICANT ACCOUN26
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2015 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Principles of Consolidation | Principles of Consolidation The accompanying consolidated financial statements include the accounts of the Company’s wholly ‑owned subsidiaries, Exact Sciences Laboratories, LLC, Exact Sciences Finance Corporation, Exact Sciences Europe LTD, Beijing Exact Sciences Medical Technology Company Limited, and variable interest e ntities. See Note 1 3 for the discussion of financing arrangements involving certain entities that are variable interest entities that are included in our consolidated financial statements. All significant intercompany transactions and balances have been eliminated in consolidation. References to “ Exact ” , “ we ” , “ us ” , “ our ” , or the “ Company ” refer to Exact Sciences Corporation and its wholly owned subsidiar ies . |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States (“GAAP”) 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 | 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, 201 5 and 201 4 . |
Marketable Securities | 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, 201 5 and December 31, 201 4 the Company ’ s investments consisted 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 $14,205 , $ 11,000 , a nd $9,639 , net of insignificant realized losses, for the years ended December 31, 2015, 2014, and 2013, respectively. The Company periodically reviews investments in unrealized loss positions for other-than-temporary impairments. This evaluation includes, but is not limited to, significant quantitative and qualitative assessments and estimates regarding credit ratings, collateralized support, the length of time and significance of a security’s loss position, the Company’s intent not to sell the security, and whether it is more likely than not that the Company will have to sell the security before recovery of its cost basis. For the year ended December 31, 2015, no investments were identified with other-than-temporary declines in value. Available ‑for ‑sale securities at December 31, 2015 consist of the following: December 31, 2015 Gains in Accumulated Losses in Accumulated Other Comprehensive Other Comprehensive Estimated Fair (In thousands) Amortized Cost Income Income Value Corporate bonds $ $ $ $ U.S. government agency securities — Asset backed securities — Certificates of deposit — — Total available-for-sale securities $ $ $ $ Available ‑for ‑sale securities at December 31, 2014 consist of the following: December 31, 2014 Gains in Accumulated Losses in Accumulated Other Comprehensive Other Comprehensive Estimated Fair (In thousands) Amortized Cost Income Income Value Corporate bonds $ $ $ $ U.S. government agency securities Asset backed securities Commercial paper — — Total available-for-sale securities $ $ $ $ |
Changes in Accumulated Other Comprehensive Income (Loss) | Changes in Accumulated Other Comprehensive Income (Loss) The amount recognized in accumulated other comprehensive income (loss) ( “ AOCI ” ) for the years ended Dece mber 31, 2015 and 201 4 were as follows (in thousands): Accumulated Cumulative Unrealized Other Translation Gain (Loss) Comprehensive Adjustment on Securities Income (Loss) Balance at January 1, 2013 $ — $ $ Other comprehensive (loss) income before reclassifications — Amounts reclassified from accumulated other comprehensive loss — Net current period change in accumulated other comprehensive income (loss) — Balance at December 31, 2013 $ — $ $ Other comprehensive (loss) income before reclassifications — Amounts reclassified from accumulated other comprehensive loss — Net current period change in accumulated other comprehensive income (loss) — Balance at December 31, 2014 $ — $ $ Other comprehensive (loss) income before reclassifications Amounts reclassified from accumulated other comprehensive loss — Net current period change in accumulated other comprehensive income (loss) Balance at December 31, 2015 $ $ $ Amounts reclassified from accumulated other comprehensive income (loss) for the years ended December 31, 2015, 2014 and 2013 were as follows (in thousands): Affected Line Item in the Year Ended December 31, Details about AOCI Components Statement of Operations 2015 2014 2013 Change in value of available-for-sale investments Sales and maturities of available-for-sale investments Investment income $ $ $ Total reclassifications $ $ $ Allowance for Doubtful Accounts The Company estimates an allowance for doubtful accounts against individual patient accounts receivable based on estimates of expected payment consistent with historical payment experience. The allowance for doubtful accounts is evaluated on a regular basis and adjusted when trends or significant events indicate that a change in the estimate is appropriate. Accounts receivable are written off against the allowance when the appeals process is exhausted or when there is other substantive evidence that the account will not be paid. As of December 31, 2015 and 2014 the Company’s allowance for doubtful accounts was $275,000 and $86,000 , respectively. The Company did not have an allowance for doubtful accounts in 2013. For the years ended December 31, 2015 and 2014 net additions charged to revenue were $189,000 and $86,000 , respectively. There were no charges to revenue during the year ended December 31, 2013. |
Property and Equipment | Allowance for Doubtful Accounts The Company estimates an allowance for doubtful accounts against individual patient accounts receivable based on estimates of expected payment consistent with historical payment experience. The allowance for doubtful accounts is evaluated on a regular basis and adjusted when trends or significant events indicate that a change in the estimate is appropriate. Accounts receivable are written off against the allowance when the appeals process is exhausted or when there is other substantive evidence that the account will not be paid. As of December 31, 2015 and 2014 the Company’s allowance for doubtful accounts was $275,000 and $86,000 , respectively. The Company did not have an allowance for doubtful accounts in 2013. For the years ended December 31, 2015 and 2014 net additions charged to revenue were $189,000 and $86,000 , respectively. There were no charges to revenue during the year ended December 31, 2013. Property and Equipment Pro perty 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: Estimated Asset Classification Useful Life Laboratory equipment 3 - 5 years Computer equipment and computer software 3 years Leasehold improvements Lesser of the remaining lease term or useful life Furniture and fixtures 3 years Buildings 30 years Depreciation expense for the years ended December 31, 2015, 2014, and 2013 was $7.6 million, $ 3.7 million, and $1.4 million, respectively. At December 31, 2015, the Company had $8.0 million of assets under construction which consisted of $5.1 million related to building and leasehold improvements, $1.7 m illion of capitalized costs related to software projects and $1.2 million of costs related to machinery and equipment. Depreciation will begin on these assets once they are placed into service. The Company expects that it will cost $1.2 million to complete the building and leasehold improvements. The Company expects to incur minimal costs to complete the machinery and equipment and the software projects, and these projects are expected to be completed in 2016. The Company assesses its long-lived assets, consisting primarily of property and equipment, for impairment when material events and changes in circumstances indicate that the carrying value may not be recoverable. There were no impairment losses for the years ended December 31, 2015, 2014 or 2013. |
Software Capitalization Policy | Software Capitalization Policy Software development costs related to internal use software are incurred in three stages of development : the preliminary project stage, the application development stage, and the post ‑implementation stage. Costs incurred during the preliminary project and post ‑implementation stages are expensed as incurred. Costs in the application development stage that meet the criteria for capitalization are capitalized and amortized using the straight ‑line basis over the estimated economic useful life of the software. |
Patent Costs and Intangible Asset | Patent Costs and Intangible Assets 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. 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, 2015, 2014 and 2013 should be expensed and not capitalized as the future economic benefit derived from the transactions cannot be determined. Under a technology license and royalty agreement en tered into with MDx Health , the Company is required to pay MDx Health milestone-based royalties on sales of products or services covered by the licensed intellectual property. Once the achievement of a milestone has occurred or is considered probable, an intangible asset and corresponding liability is reported in other long-term assets and accrued expenses, respectively. The intangible asset is amortized over the estimated ten -year useful life of the licensed intellectual property, and such amortization is reported in cost of sales. As of December 31, 2015, an intangible asset of $1.8 million and a liability of $2.0 million are reported in other long-term assets and accrued expenses, respectively. Amortization expense for the year ended December 31, 2015 was $0.2 million. |
Net Loss Per Share | 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): 2015 2014 2013 Shares issuable upon exercise of stock options Shares issuable upon exercise of outstanding warrants(1) — — Shares issuable upon the release of restricted stock awards Shares issuable upon the vesting of restricted stock awards related to licensing agreement — (1) At December 31, 2013, represents warrants to purchase 80,000 shares of common stock issued under a license agreement and warrants to purchase 75,000 shares of common stock issued under a consulting agreement. |
Accounting for Stock-Based Compensation | 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 | Revenue Recognition Laboratory service revenue. The Company’s laboratory service revenue are generated by performing diagnostic services using its Cologuard test, and the service is completed upon delivery of a test result to an ordering physician. The Company recognizes revenue in accordance with the provision of ASC 954-605, Health Care Entities - Revenue Recognition. The Company recognizes revenue related to billings for Medicare and other third-party payors on an accrual basis, net of contractual and other adjustments, when amounts that will ultimately be realized can be estimated. Contractual and other adjustments represent the difference between the list price (the billing rate) and the estimated reimbursement rate for each payor. Upon ultimate collection, the amount received from Medicare and other third-party payors where reimbursement was estimated is compared to previous estimates and, if necessary, the contractual allowance is adjusted accordingly. The estimates of amounts that will ultimately be realized requires significant judgment by management. Some patients have out-of-pocket costs for amounts not covered by their insurance carrier, and the Company may bill the patient directly for these amounts in the form of co-payments and co-insurance in accordance with their insurance carrier and health plans. Some payors may not cover Cologuard as ordered by the prescribing physician under their reimbursement policies. The Company pursues reimbursement from such patients on a case-by-case basis. In the absence of contracted reimbursement coverage or the ability to estimate the amount that will ultimately be realized for the Company’s services, revenue is recognized upon cash receipt. The Company uses judgment in determining if it is able to make an estimate of what will ultimately be realized. The Company also uses judgment in estimating the amounts it expects to collect by payor. The Company’s judgments will continue to evolve in the future as it continues to gain payment experience with third-party payors and patients. The Company recognized approximately $ 39.4 million and $1.5 million in laboratory service revenue for the years ended December 31, 2015 and 2014, respectively. 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. 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 $934,000 which included accrued interest due, from Genzyme during the third quarter of 2010. The amounts were deferred and were 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 amortized that amount on a straight line basis into revenue over the initial five ‑year collaboration period ending in January 2014. The Company did not recognize license fee revenue for the year ended December 31, 2015. The Company recognized approximately $0.3 million and $4.1 million in license fee revenue for the years ended December 31, 2014 and 2013, respectively, in connection with the amortization of the up-front payments from Genzyme. |
Inventory | Inventor y Inventory is stated at the lower of cost or market value (net realizable value). The Company determines the cost of inventory using the first-in, first out method ( “ FIFO ” ). The Company estimates the recoverability of inventory by reference to internal estimates of future demands and product life cycles, including expiration. The Company periodically analyzes its inventory levels to identify inventory that may expire prior to expected sale or has a cost basis in excess of its estimated realizable value, and records a charge to cost of sales for such inventory as appropriate. In addition, the Company’s products are subject to strict quality control and monitoring which the Company performs throughout the production process . If certain batches or units of product no longer meet quality specifications or become obsolete due to expiration, the Company records a charge to cost of sales to write down such unmarketable inventory to its estimated realizable value. Direct and indirect manufacturing costs incurred during process validation and for other research and development activities, which are not permitted to be sold, have been expensed to research and development. Inventory consists of the following (amount in thousands): December 31, 2015 2014 Raw materials $ $ Semi-finished and finished goods Total inventory $ $ |
Advertising Costs | Advertising Costs The Company expenses the costs of media advertising at the time the advertising takes place. The Company expensed approximately $10.8 million, $5.3 million and $0.1 million of media advertising during the years ended December 31, 2015, 2014, and 2013, respectively. |
Fair Value Measurements | 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. 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, 2015 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, 2015 Using: Quoted Prices Significant in Active Other Significant Markets for Observable Unobservable Fair Value at Identical Assets Inputs Inputs Description December 31, 2015 (Level 1) (Level 2) (Level 3) Cash and cash equivalents Cash and money market $ $ $ — $ — Commercial paper — — Available-for-Sale Marketable securities Corporate bonds — — Asset backed securities — — U.S. government agency securities — — Certificates of deposit — — Total $ $ $ $ — The following table presents the Company’s fair value measurements as of December 31, 2014 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, 2014 Using: Quoted Prices Significant in Active Other Significant Markets for Observable Unobservable Fair Value at Identical Assets Inputs Inputs Description December 31, 2014 (Level 1) (Level 2) (Level 3) Cash and cash equivalents Cash and money market $ $ $ — $ — Corporate bonds — — Available-for-Sale Marketable securities Corporate bonds — — U.S. government agency securities — — Asset backed securities — — Commercial paper — — Total $ $ $ $ — The Company monitors investments for other-than-temporary impairment. It was determined that unrealized gains and losses at December 31, 2015 and 2014, are temporary in nature, because the change in market value for those securities has resulted from fluctuating interest rates, rather than a deterioration of the credit worthiness of the issuers. So long as the Company holds these securities to maturity, it is unlikely to experience gains or losses. In the event that the Company disposes of these securities before maturity, it is expected that realized gains or losses, if any, will be immaterial. The following table summarizes the gross unrealized losses and fair values of investments in an unrealized loss position as of December 31, 2015 , aggregated by investment category and length of time that individual securities have been in a continuous unrealized loss position: December 31, 2015 Less than 12 months 12 months or greater Total (In thousands) Fair Value Gross Unrealized Loss Fair Value Gross Unrealized Loss Fair Value Gross Unrealized Loss Marketable Securities Corporate bonds $ $ $ — $ — $ $ U.S. government agency securities — — Asset backed securities Total $ $ $ $ $ $ The following table summarizes the gross unrealized losses and fair value of investments in an unrealized loss position as of December 31, 2014, aggregated by investment category and length of time that individual securities have been in a continuous unrealized loss position: December 31, 2014 Less than 12 months 12 months or greater Total (In thousands) Fair Value Gross Unrealized Loss Fair Value Gross Unrealized Loss Fair Value Gross Unrealized Loss Marketable Securities Corporate bonds $ $ $ — $ — $ $ Asset backed securities — — U.S. government agency securities — — Total $ $ $ — $ — $ $ The following table summarizes contractual underlying maturities of the Company’s available ‑for ‑sale investments at December 31, 2015 (in thousands): Due one year or less Due after one year through four years Description Cost Fair Value Cost Fair Value Marketable Securities U.S. government agency securities $ $ $ $ Corporate bonds Certificates of deposit — — Asset backed securities Total $ $ $ $ |
Concentration of Credit Risk | 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, 2015, 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 $ 40.1 million. The Company has not experienced any losses in such accounts and management believes it is not exposed to any significant credit risk. Through December 31, 2015, all of the Company’s laboratory service revenues have been derived from the sale of Cologuard, and one pa yor, Centers for Medicare and Medicaid Services , has provided greater than 10% of revenue during the years ended December 31, 2015 and 2014. Medicare revenue as a percentage of total laboratory service revenue was 71% and 80% for the years ended December 31, 2015 and 2014 , respectively. Medicare accounts receivable as a percentage of total accounts receivable were 64% and 88% at December 31 , 2015 and 2014, respectively. As the number of payors reimbursing for Cologuard increases, the percentage of laboratory service revenue derived from Medicare will continue to change as a percentage of revenue and accounts receivable. |
Subsequent Events | 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. |
Tax Positions | Tax Positions 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, the Company has determined that a $215.1 million and $161.9 million valuation allowance at December 31, 2015 and 2014 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 December 31, 2015 and 2014 was $53.2 million and $37.4 million, respectively. Due to the existence of the valuation allowance, future changes in the Company’s unrecognized tax benefits will not impact the Company’s effective tax rate. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In February 2015, the FASB Issued ASU No. 2015-02, “Amendments to the Consolidation Analysis (Topic 8 10 ) . ” The amendments in this Update affect reporting entities that are required to evaluate whether they should consolidate certain legal entities. All legal entities are subject to reevaluation under the revised consolidation model. Specifically, the amendments (1) modify the evaluation of whether limited partnerships and similar legal entities are variable interest entities (“VIEs”) or voting interest entities, (2) eliminate the presumption that a general partner should consolidate a limited partnership, (3) affect the consolidation analysis of reporting entities that are involved with VIEs, particularly those that have fee arrangements and related party relationships and (4) provide a scope exception from consolidation guidance for reporting entities with interests in legal entities that are required to comply with or operate in accordance with requirements that are similar to those in Rule 2a-7 of the Investment Company Act of 1940. The amendments in this Update are effective for public business entities for fiscal years, and for interim periods within those fiscal years, beginning after December 15, 2015. Early adoption is permitted. The Company has not early adopted this Update, and the adoption of this Update is not expected to have a material impact on the Company’s consolidated financial statements. In July 2015, the Financial Accounting Standards Board issued Accounting Standards Update No. 2015-11, “Simplifying the Measurement of Inventory (Topic 330).” The new guidance requires most inventory to be measured at the lower of cost and net realizable value, thereby simplifying the previous guidance under which an entity must measure inventory at the lower of cost or market. Market is defined as replacement cost, net realizable value (“NRV”), less a normal profit margin. The Accounting Standards Update will not apply to inventory that is measured using either the last-in, first-out method or the retail inventory method. The standard will be effective prospectively for the first interim period within annual reporting periods beginning after December 15, 2016. Early adoption is permitted. We do not expect to early adopt this guidance and are currently assessing the provisions of the guidance and have not determined the impact of the adoption of this guidance on our consolidated financial statements. In April 2015, the Financial Accounting Standards Board issued Accounting Standards Update No. 2015-05, “ Customer’s Accounting for Fees Paid in a Cloud Computing Arrangement”, which provides guidance that requires management to evaluate each cloud computing arrangement in order to determine whether it includes a software license that must be accounted for separately from hosted services. The new guidance clarifies that if a cloud computing arrangement includes a software license, we should account for the software license consistent with our accounting for other software licenses. If the arrangement does not include a software license, we should account for the arrangement as a service contract. The standard will be effective for our financial statements that we issue for fiscal periods beginning on or after January 1, 2016. Early adoption is permitted for financial statements that have not previously been issued. The adoption of this standard is not expected to have a material impact on our consolidated financial statements. In April 2015, the Financial Accounting Standards Board issued Accounting Standards Update No. 2015-03, “ Simplifying the Presentation of Debt Issuance Costs”, which requires debt issuance costs to be presented in the balance sheet as a direct deduction from the associated debt liability. This guidance simplifies presentation of debt issuance costs but does not address presentation or subsequent measurement of debt issue costs related to line of credit arrangements. In August 2015, the Financial Accounting Standards Board issued Accounting Standards Update No. 2015-15 “Interest-Imputation of Interest (Subtopic 835-30) Presentation and Subsequent Measurement of Debt Issuance Costs Associated with Line-of-Credit Arrangements” which indicates the SEC staff would not object to an entity deferring and presenting debt issuance costs related to line-of-credit arrangements as an asset and subsequently amortizing the deferred debt issuance costs ratably over the term of the line-of-credit arrangement, regardless of whether there are any outstanding borrowings on the line-of-credit arrangement. Accounting Standards Update No. 2015-03 will be effective for the first interim period within annual reporting periods beginning after December 15, 2015. Early adoption is permitted. The adoption of this standard is not expected to have a material impact on our financial statements. In August 2015, the Financial Accounting Standards Board issued Accounting Standards Update No. 2015-14, “Revenue from Contracts with Customers: Deferral of the Effective Date” to defer for one year the effective date of the new revenue standard and allow early adoption as of the original effective date which is for annual reports beginning after December 15, 2016. We are currently evaluating the impact of this amendment on our financial position and results of operations. In November 2015, the FASB Issued ASU No. 2015-17, “Balance Sheet Classification of Deferred Taxes (Topic 740)” . The amendments in this Update simplify the presentation of deferred income taxes, by requiring that deferred tax liabilities and assets be classified as noncurrent in a classified statement of financial position. The amendments in this Update apply to all entities that present a classified statement of financial position. The amendments in this Update are effective for public business entities for fiscal years, and for interim periods within those fiscal years, beginning after December 15, 2016. Early adoption is permitted. The Company does not expect to early adopt this Update, and the adoption of this Update is not expected to have a material impact on the Company’s consolidated financial statements. In January 2016, the FASB Issued ASU No. 2016-01, “Recognition and Measurement of Financial Assets and Financial Liabilities (Subtopic 825-10)” . The amendments in this Update supersede the guidance to classify equity securities with readily determinable fair values into different categories (that is, trading or available-for-sale) and require equity securities (including other ownership interests, such as partnerships, unincorporated joint ventures, and limited liability companies) to be measured at fair value with changes in the fair value recognized through net income. An entity’s equity investments that are accounted for under the equity method of accounting or result in consolidation of an investee are not included within the scope of this Update. The amendments allow equity investments that do not have readily determinable fair values to be remeasured at fair value either upon the occurrence of an observable price change or upon identification of an impairment. The amendments also require enhanced disclosures about those investments. The amendments improve financial reporting by providing relevant information about an entity’s equity investments and reducing the number of items that are recognized in other comprehensive income. The amendments in this Update are effective for public business entities for fiscal years, and for interim periods within those fiscal years, beginning after December 15, 2017. Early adoption is permitted. The Company does not expect to early adopt this Update, and the adoption of this Update is not expected to have a material impact on the Company’s consolidated financial statements. |
Foreign Currency Translation | Foreign Currency Translation For the Company’s international subsidiaries, the local currency is the functional currency. Assets and liabilities of these subsidiaries are translated into United States dollars at the period-end exchange rate or historical rates as appropriate. Consolidated statements of operations amounts are translated at average exchange rates for the period. The cumulative translation adjustments resulting from changes in exchange rates are included in the consolidated balance sheet as a component of accumulated other comprehensive income in total Exact Sciences Corporation’s shareholders’ equity. Transaction gains and losses are included in the consolidated statement of operations in 2015. |
Reclassifications | Reclassifications Certain prior year amounts have been reclassified to conform to the current year presentation in the consolidated financial statements and accompanying notes to the consolidated financial statements. |
SUMMARY OF SIGNIFICANT ACCOUN27
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Schedule of available-for-sale securities | Available ‑for ‑sale securities at December 31, 2015 consist of the following: December 31, 2015 Gains in Accumulated Losses in Accumulated Other Comprehensive Other Comprehensive Estimated Fair (In thousands) Amortized Cost Income Income Value Corporate bonds $ $ $ $ U.S. government agency securities — Asset backed securities — Certificates of deposit — — Total available-for-sale securities $ $ $ $ Available ‑for ‑sale securities at December 31, 2014 consist of the following: December 31, 2014 Gains in Accumulated Losses in Accumulated Other Comprehensive Other Comprehensive Estimated Fair (In thousands) Amortized Cost Income Income Value Corporate bonds $ $ $ $ U.S. government agency securities Asset backed securities Commercial paper — — Total available-for-sale securities $ $ $ $ |
Schedule of amounts recognized in accumulated other comprehensive income (loss) (AOCI) | The amount recognized in accumulated other comprehensive income (loss) ( “ AOCI ” ) for the years ended Dece mber 31, 2015 and 201 4 were as follows (in thousands): Accumulated Cumulative Unrealized Other Translation Gain (Loss) Comprehensive Adjustment on Securities Income (Loss) Balance at January 1, 2013 $ — $ $ Other comprehensive (loss) income before reclassifications — Amounts reclassified from accumulated other comprehensive loss — Net current period change in accumulated other comprehensive income (loss) — Balance at December 31, 2013 $ — $ $ Other comprehensive (loss) income before reclassifications — Amounts reclassified from accumulated other comprehensive loss — Net current period change in accumulated other comprehensive income (loss) — Balance at December 31, 2014 $ — $ $ Other comprehensive (loss) income before reclassifications Amounts reclassified from accumulated other comprehensive loss — Net current period change in accumulated other comprehensive income (loss) Balance at December 31, 2015 $ $ $ |
Schedule of amounts reclassified from accumulated other comprehensive income (loss) | Amounts reclassified from accumulated other comprehensive income (loss) for the years ended December 31, 2015, 2014 and 2013 were as follows (in thousands): Affected Line Item in the Year Ended December 31, Details about AOCI Components Statement of Operations 2015 2014 2013 Change in value of available-for-sale investments Sales and maturities of available-for-sale investments Investment income $ $ $ Total reclassifications $ $ $ |
Schedule of estimated useful lives of fixed assets | Estimated Asset Classification Useful Life Laboratory equipment 3 - 5 years Computer equipment and computer software 3 years Leasehold improvements Lesser of the remaining lease term or useful life Furniture and fixtures 3 years Buildings 30 years |
Schedule of potentially issuable common shares not included in the computation of diluted net loss per share because they would have an anti-dilutive effect | 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): 2015 2014 2013 Shares issuable upon exercise of stock options Shares issuable upon exercise of outstanding warrants(1) — — Shares issuable upon the release of restricted stock awards Shares issuable upon the vesting of restricted stock awards related to licensing agreement — (1) At December 31, 2013, represents warrants to purchase 80,000 shares of common stock issued under a license agreement and warrants to purchase 75,000 shares of common stock issued under a consulting agreement. |
Schedule of inventory | Inventory consists of the following (amount in thousands): December 31, 2015 2014 Raw materials $ $ Semi-finished and finished goods Total inventory $ $ |
Schedule of fair value measurements along with the level within the fair value hierarchy in which the fair value measurements fall | The following table presents the Company’s fair value measurements as of December 31, 2015 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, 2015 Using: Quoted Prices Significant in Active Other Significant Markets for Observable Unobservable Fair Value at Identical Assets Inputs Inputs Description December 31, 2015 (Level 1) (Level 2) (Level 3) Cash and cash equivalents Cash and money market $ $ $ — $ — Commercial paper — — Available-for-Sale Marketable securities Corporate bonds — — Asset backed securities — — U.S. government agency securities — — Certificates of deposit — — Total $ $ $ $ — The following table presents the Company’s fair value measurements as of December 31, 2014 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, 2014 Using: Quoted Prices Significant in Active Other Significant Markets for Observable Unobservable Fair Value at Identical Assets Inputs Inputs Description December 31, 2014 (Level 1) (Level 2) (Level 3) Cash and cash equivalents Cash and money market $ $ $ — $ — Corporate bonds — — Available-for-Sale Marketable securities Corporate bonds — — U.S. government agency securities — — Asset backed securities — — Commercial paper — — Total $ $ $ $ — |
Schedule of gross unrealized losses and fair values of investments in an unrealized loss position | The following table summarizes the gross unrealized losses and fair values of investments in an unrealized loss position as of December 31, 2015 , aggregated by investment category and length of time that individual securities have been in a continuous unrealized loss position: December 31, 2015 Less than 12 months 12 months or greater Total (In thousands) Fair Value Gross Unrealized Loss Fair Value Gross Unrealized Loss Fair Value Gross Unrealized Loss Marketable Securities Corporate bonds $ $ $ — $ — $ $ U.S. government agency securities — — Asset backed securities Total $ $ $ $ $ $ The following table summarizes the gross unrealized losses and fair value of investments in an unrealized loss position as of December 31, 2014, aggregated by investment category and length of time that individual securities have been in a continuous unrealized loss position: December 31, 2014 Less than 12 months 12 months or greater Total (In thousands) Fair Value Gross Unrealized Loss Fair Value Gross Unrealized Loss Fair Value Gross Unrealized Loss Marketable Securities Corporate bonds $ $ $ — $ — $ $ Asset backed securities — — U.S. government agency securities — — Total $ $ $ — $ — $ $ |
Schedule of contractual maturities of available-for-sale investments | The following table summarizes contractual underlying maturities of the Company’s available ‑for ‑sale investments at December 31, 2015 (in thousands): Due one year or less Due after one year through four years Description Cost Fair Value Cost Fair Value Marketable Securities U.S. government agency securities $ $ $ $ Corporate bonds Certificates of deposit — — Asset backed securities Total $ $ $ $ |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Stock-based compensation | |
Schedule of non-cash stock-based compensation expense by department | December 31, 2015 2014 2013 Cost of sales $ $ $ — Research and development General and administrative Sales and marketing Total stock-based compensation $ $ $ |
Schedule of valuation assumptions | Year Ended December 31, 2015 2014 2013 Option Plan Shares Risk-free interest rates 1.5% - 1.92% 1.96% - 2.01% 0.94% - 1.73% Expected term (in years) 6.25 - 6.6 6 6 Expected volatility 67.1% - 73.2% 77.6% - 80.8% 82.9% - 84% Dividend yield 0% 0% 0 % Weighted average fair value per share of options granted during the period $15.81 $ 10.05 $ 8.12 ESPP Shares Risk-free interest rates 0.25% - 0.75% 0.1% - 0.5% 0.1% - 0.33% Expected term (in years) 0.5 - 2 0.5 - 2 0.5 - 2 Expected volatility 51.2% - 110% 42.5% - 62.7% 39.1% - 45.6% Dividend yield 0% 0% 0 % Weighted average fair value per share of stock purchase rights granted during the period $ 4.67 $ 6.3 $ 3.13 |
Summary of stock option activity under the Stock Plans | Weighted Weighted Average Average Remaining Aggregate Exercise Contractual Intrinsic Options Shares Price Term (Years) Value(1) (Aggregate intrinsic value in thousands) Outstanding, January 1, 2013 $ Granted Exercised Forfeited Outstanding, December 31, 2013 $ Granted Exercised Forfeited Outstanding, December 31, 2014 $ Granted Exercised Forfeited Outstanding, December 31, 2015 $ $ Exercisable, December 31, 2015 $ $ Vested and expected to vest, December 31, 2015 $ $ (1) The aggregate intrinsic value of options outstanding at December 31, 2015 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 4,936,594 options that had exercise prices that were lower than the $9.23 market price of our common stock at December 31, 2015. The aggregate intrinsic value of options exercisable at December 31, 2015 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 4,219,865 options that had exercise prices that were lower than the $9.23 market price of our common stock at December 31, 2015. The total intrinsic value of options exercised during the years ended December 31, 2015, 2014 and 2013 was $3.6 million, $29.2 million, $1.9 million, respectively, determined as of the date of exercise. |
Summary of restricted stock and restricted stock unit activity under the Stock Plans | Weighted Restricted Average Grant Shares Date Fair Value Outstanding, January 1, 2013 $ Granted Released Forfeited Outstanding, December 31, 2013 $ Granted Released Forfeited Outstanding, December 31, 2014 $ Granted Released Forfeited Outstanding, December 31, 2015 $ |
Summary of information relating to outstanding and exercisable stock options | The following table summarizes information relating to currently outstanding and exercisable stock options as of December 31, 2015: Outstanding Exercisable Weighted Average Weighted Weighted Remaining Average Average Number of Contractual Exercise Number of Exercise Exercise Price Options Life (Years) Price Options Price $0.00 - $3.00 $ $ $3.01 - $6.00 $6.01 - $9.00 $9.01 - $12.00 $12.01 - $15.00 $15.01 - $18.00 $18.01 - $24.00 — — $24.01 - $26.98 — — $ $ |
Summary of shares of authorized common stock reserved for issuance | Shares reserved for issuance 2010 Option Plan 2010 Purchase Plan |
2010 Employee Stock Purchase Plan | |
Stock-based compensation | |
Schedule of shares of common stock issued | Weighted Average Offering period ended Number of Shares price per Share April 30, 2015 $ October 31, 2015 $ |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
COMMITMENTS AND CONTINGENCIES | |
Schedule of future minimum payments under the operating lease | Future minimum payments under operating leases as of December 31, 201 5 are as follows. Amounts included in the table are in thousands. Year Ending December 31, 2016 $ 2017 2018 2019 2020 Thereafter Total lease obligations $ |
ACCRUED LIABILITIES (Tables)
ACCRUED LIABILITIES (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
ACCRUED LIABILITIES | |
Schedule of accrued expenses | Accrued liabilities at December 31, 201 5 and 201 4 consisted of the following. Amounts included in the table are in thousands. December 31, 2015 2014 Compensation $ $ Professional fees Licenses Research and trial related expenses Other Miscellaneous taxes Occupancy costs $ $ |
LONG TERM DEBT (Tables)
LONG TERM DEBT (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
LONG TERM DEBT | |
Schedule of future principal obligations | Year ending December 31, 2016 $ 2017 2018 2019 2020 — Thereafter — $ |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
INCOME TAXES | |
Schedule of components of the net deferred tax asset | 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, 2015 2014 Deferred tax assets: Operating loss carryforwards $ $ Tax credit carryforwards Deferred revenue — Other temporary differences Tax assets before valuation allowance Less—Valuation allowance Net deferred taxes $ — $ — |
Schedule of differences between the effective income tax rate and the statutory tax rate | December 31, 2015 2014 2013 U.S. Federal statutory rate % % % State taxes Federal and state tax rate changes — — Research and development tax credits Stock-based compensation expense Other adjustments Valuation allowance Effective tax rate % % % |
QUARTERLY RESULTS OF OPERATIO33
QUARTERLY RESULTS OF OPERATIONS (UNAUDITED) (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
QUARTERLY RESULTS OF OPERATIONS (UNAUDITED) | |
Schedule of quarterly statement of operations | Quarter Ended March 31, June 30, September 30, December 31, (Amounts in thousands, except per share data) 2015 Laboratory service revenue $ $ $ $ Cost of revenue Gross profit Research and development General and administrative Sales and marketing Loss from operations Investment income Interest income (expense) Net loss $ $ $ $ Net loss per share—basic and diluted $ $ $ $ Weighted average common shares outstanding—basic and diluted 2014 Laboratory service revenue $ — $ — $ — $ License fee revenue $ $ — $ — $ — Cost of revenue — — Gross profit — Research and development General and administrative Sales and marketing Loss from operations Investment income Interest expense Net loss $ $ $ $ Net loss per share—basic and diluted $ $ $ $ Weighted average common shares outstanding—basic and diluted |
SUMMARY OF SIGNIFICANT ACCOUN34
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Available-for-sale Securities (Details) | 12 Months Ended | ||
Dec. 31, 2015USD ($)item | Dec. 31, 2014USD ($) | Dec. 31, 2013USD ($) | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |||
Restricted cash | $ 0 | $ 0 | |
Number of objectives of the entity's investment strategy | item | 2 | ||
Minimum contractual term of certain current investments which can be liquidated | 1 year | ||
Realized gains | $ 14,205 | 11,000 | $ 9,639 |
Available-for-sale securities | |||
Amortized Cost | 266,188,000 | 224,740,000 | |
Gains in Accumulated Other Comprehensive Income | 2,000 | 45,000 | |
Losses in Accumulated Other Comprehensive Income | (446,000) | (160,000) | |
Estimated Fair Value | 265,744,000 | 224,625,000 | |
Corporate bonds | |||
Available-for-sale securities | |||
Amortized Cost | 179,471,000 | 141,239,000 | |
Gains in Accumulated Other Comprehensive Income | 2,000 | 20,000 | |
Losses in Accumulated Other Comprehensive Income | (262,000) | (135,000) | |
Estimated Fair Value | 179,211,000 | 141,124,000 | |
U.S. government agency securities | |||
Available-for-sale securities | |||
Amortized Cost | 7,057,000 | 18,687,000 | |
Gains in Accumulated Other Comprehensive Income | 8,000 | ||
Losses in Accumulated Other Comprehensive Income | (18,000) | (7,000) | |
Estimated Fair Value | 7,039,000 | 18,688,000 | |
Asset backed securities | |||
Available-for-sale securities | |||
Amortized Cost | 77,661,000 | 60,821,000 | |
Gains in Accumulated Other Comprehensive Income | 17,000 | ||
Losses in Accumulated Other Comprehensive Income | (166,000) | (18,000) | |
Estimated Fair Value | 77,495,000 | 60,820,000 | |
Certificates of deposit | |||
Available-for-sale securities | |||
Amortized Cost | 1,999,000 | ||
Estimated Fair Value | $ 1,999,000 | ||
Commercial paper | |||
Available-for-sale securities | |||
Amortized Cost | 3,993,000 | ||
Estimated Fair Value | $ 3,993,000 |
SUMMARY OF SIGNIFICANT ACCOUN35
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Changes in AOCI (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Changes in Accumulated Other Comprehensive Income (Loss) | |||
Beginning Balance | $ (115) | $ 125 | $ 78 |
Other comprehensive (loss) income before reclassifications | (350) | (200) | 90 |
Amounts reclassified from accumulated other comprehensive loss | 32 | (40) | (43) |
Net current period change in accumulated other comprehensive income (loss) | (318) | (240) | 47 |
Ending Balance | (433) | (115) | 125 |
Accumulated Net Unrealized Investment Gain Loss | |||
Changes in Accumulated Other Comprehensive Income (Loss) | |||
Beginning Balance | (115) | 125 | 78 |
Other comprehensive (loss) income before reclassifications | (361) | (200) | 90 |
Amounts reclassified from accumulated other comprehensive loss | 32 | (40) | (43) |
Net current period change in accumulated other comprehensive income (loss) | (329) | (240) | 47 |
Ending Balance | (444) | $ (115) | $ 125 |
Cumulative Translation Adjustment | |||
Changes in Accumulated Other Comprehensive Income (Loss) | |||
Other comprehensive (loss) income before reclassifications | 11 | ||
Net current period change in accumulated other comprehensive income (loss) | 11 | ||
Ending Balance | $ 11 |
SUMMARY OF SIGNIFICANT ACCOUN36
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Details About AOCI (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Details about AOCI Components | |||||||||||
Investment income | $ 491 | $ 365 | $ 193 | $ 222 | $ 150 | $ 160 | $ 146 | $ 86 | $ 1,271 | $ 542 | $ 316 |
Reclassification Out Of Accumulated Other Comprehensive Income (Loss) | |||||||||||
Details about AOCI Components | |||||||||||
Investment income | 32 | (40) | (43) | ||||||||
Accumulated Net Unrealized Investment Gain Loss | Reclassification Out Of Accumulated Other Comprehensive Income (Loss) | |||||||||||
Details about AOCI Components | |||||||||||
Investment income | $ 32 | $ (40) | $ (43) |
SUMMARY OF SIGNIFICANT ACCOUN37
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Property & Equipment and Patent Costs (Details) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015USD ($)item | Dec. 31, 2014USD ($) | Dec. 31, 2013USD ($) | |
Property and equipment | |||
Depreciation expense | $ 7,600 | $ 3,700 | $ 1,400 |
Assets under construction | 8,038 | 1,552 | |
Impairment of long-lived assets | 0 | 0 | 0 |
Allowance for Doubtful Accounts | |||
Allowance for doubtful accounts | 275 | 86 | 0 |
Net additions charged to revenue | $ 189 | 86 | $ 0 |
Software Capitalization Policy | |||
Software development stages | item | 3 | ||
Patent Costs and Intangible Assets | |||
Accrued liabilities | $ 22,253 | $ 13,960 | |
Amortization of intangible assets | $ 150 | ||
MDx Health | Licensed Intellectual Property | |||
Patent Costs and Intangible Assets | |||
Estimated useful life | 10 years | ||
Intangible asset, net | $ 1,800 | ||
Accrued liabilities | 2,000 | ||
Amortization of intangible assets | $ 200 | ||
Laboratory equipment | Minimum | |||
Property and equipment | |||
Estimated Useful Life | 3 years | ||
Laboratory equipment | Maximum | |||
Property and equipment | |||
Estimated Useful Life | 5 years | ||
Furniture and fixtures | |||
Property and equipment | |||
Estimated Useful Life | 3 years | ||
Computer equipment and computer software | |||
Property and equipment | |||
Estimated Useful Life | 3 years | ||
Buildings | |||
Property and equipment | |||
Estimated Useful Life | 30 years | ||
Leasehold Improvements | |||
Property and equipment | |||
Assets under construction | $ 1,700 | ||
Building and leasehold improvements | |||
Property and equipment | |||
Assets under construction | 5,100 | ||
Expected cost to complete construction of project | $ 1,200 |
SUMMARY OF SIGNIFICANT ACCOUN38
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Anti-Dilutive Effect (Details) - shares | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
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 | 8,382,000 | 6,499,000 | 7,418,000 |
Additional disclosure | |||
Number of shares of common stock that can be purchased through issuance of warrants under a license agreement | 80,000 | ||
Number of shares of common stock that can be purchased through issuance of warrants under a consulting agreement | 75,000 | ||
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 | 4,937,000 | 4,934,000 | 6,063,000 |
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 | 155,000 | ||
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 | 3,445,000 | 1,541,000 | 1,151,000 |
Restricted Stock 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 | 24,000 | 49,000 |
SUMMARY OF SIGNIFICANT ACCOUN39
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Revenue Recognition, Inventory and Advertising Costs (Details) - USD ($) | Jan. 27, 2009 | Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Mar. 31, 2014 | Sep. 30, 2010 | Mar. 31, 2010 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Jul. 24, 2015 | Dec. 16, 2014 | Apr. 02, 2014 | Jun. 21, 2013 |
Revenue Recognition | ||||||||||||||||
Laboratory service revenue | $ 14,420,000 | $ 12,632,000 | $ 8,119,000 | $ 4,266,000 | $ 1,504,000 | $ 39,437,000 | $ 1,504,000 | |||||||||
Sale of common stock (in shares) | 96,674,786 | 88,626,042 | 96,674,786 | 88,626,042 | ||||||||||||
Price of common stock (in dollars per share) | $ 9.23 | $ 9.23 | $ 25.50 | $ 25.75 | $ 12.75 | $ 12.35 | ||||||||||
License fee revenue | $ 294,000 | $ 294,000 | $ 4,144,000 | |||||||||||||
Inventory | ||||||||||||||||
Raw materials | $ 1,772,000 | $ 1,019,000 | $ 1,772,000 | 1,019,000 | ||||||||||||
Semi-finished and finished goods | 4,905,000 | 2,998,000 | 4,905,000 | 2,998,000 | ||||||||||||
Total inventory | $ 6,677,000 | $ 4,017,000 | 6,677,000 | 4,017,000 | ||||||||||||
Advertising Costs | ||||||||||||||||
Advertising expense | $ 10,800,000 | 5,300,000 | 100,000 | |||||||||||||
Collaboration License And Purchase Agreement | Genzyme Corporation | ||||||||||||||||
Revenue Recognition | ||||||||||||||||
Total agreed consideration amount | $ 18,500,000 | |||||||||||||||
Amount of Deferred Revenue | 16,650,000 | |||||||||||||||
Amount subject to holdback | $ 1,850,000 | |||||||||||||||
Initial collaboration period | 5 years | |||||||||||||||
Amount received | $ 16,650,000 | $ 934,000 | $ 962,000 | |||||||||||||
Sale of common stock (in shares) | 3,000,000 | |||||||||||||||
Price at which share of common stock are sold (in dollars per share) | $ 2 | |||||||||||||||
Premium above closing price of common stock at which shares are sold (in dollars per share) | 0.51 | |||||||||||||||
Price of common stock (in dollars per share) | $ 1.49 | |||||||||||||||
Aggregate premium received over the closing price of common stock | $ 1,530,000 | |||||||||||||||
Amount of premium being amortized | $ 1,530,000 | |||||||||||||||
License fee revenue | $ 300,000 | $ 4,100,000 |
SUMMARY OF SIGNIFICANT ACCOUN40
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Fair Value (Details) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Fair value measurements | ||||
Cash and cash equivalents | $ 41,135 | $ 58,131 | $ 12,851 | $ 13,345 |
Marketable securities | 265,744 | 224,625 | ||
Fair Value Inputs Level 1 | ||||
Fair value measurements | ||||
Total | 37,435 | 53,569 | ||
Fair Value Inputs Level 1 | Cash and Money Market | ||||
Fair value measurements | ||||
Cash and cash equivalents | 37,435 | 53,569 | ||
Fair Value Inputs Level 2 | ||||
Fair value measurements | ||||
Total | 269,444 | 229,187 | ||
Fair Value Inputs Level 2 | Corporate bonds | ||||
Fair value measurements | ||||
Cash and cash equivalents | 4,562 | |||
Marketable securities | 179,211 | 141,124 | ||
Fair Value Inputs Level 2 | U.S. government agency securities | ||||
Fair value measurements | ||||
Marketable securities | 7,039 | 18,688 | ||
Fair Value Inputs Level 2 | Certificates of deposit | ||||
Fair value measurements | ||||
Marketable securities | 1,999 | |||
Fair Value Inputs Level 2 | Commercial Paper. | ||||
Fair value measurements | ||||
Cash and cash equivalents | 3,700 | |||
Marketable securities | 3,993 | |||
Fair Value Inputs Level 2 | Asset backed securities | ||||
Fair value measurements | ||||
Marketable securities | 77,495 | 60,820 | ||
Estimate Of Fair Value Fair Value Disclosure | ||||
Fair value measurements | ||||
Total | 306,879 | 282,756 | ||
Estimate Of Fair Value Fair Value Disclosure | Cash and Money Market | ||||
Fair value measurements | ||||
Cash and cash equivalents | 37,435 | 53,569 | ||
Estimate Of Fair Value Fair Value Disclosure | Corporate bonds | ||||
Fair value measurements | ||||
Cash and cash equivalents | 4,562 | |||
Marketable securities | 179,211 | 141,124 | ||
Estimate Of Fair Value Fair Value Disclosure | U.S. government agency securities | ||||
Fair value measurements | ||||
Marketable securities | 7,039 | 18,688 | ||
Estimate Of Fair Value Fair Value Disclosure | Certificates of deposit | ||||
Fair value measurements | ||||
Marketable securities | 1,999 | |||
Estimate Of Fair Value Fair Value Disclosure | Commercial Paper. | ||||
Fair value measurements | ||||
Cash and cash equivalents | 3,700 | |||
Marketable securities | 3,993 | |||
Estimate Of Fair Value Fair Value Disclosure | Asset backed securities | ||||
Fair value measurements | ||||
Marketable securities | $ 77,495 | $ 60,820 |
SUMMARY OF SIGNIFICANT ACCOUN41
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Investments in an Unrealized Loss Position (Details) - USD ($) | Dec. 31, 2015 | Dec. 31, 2014 |
Fair value of investments in unrealized loss positions | ||
Total fair value of available-for-sale securities in a continuous unrealized loss position for less than twelve months | $ 246,069,000 | $ 152,674,000 |
Total fair value of available for sale securities in a continuous unrealized loss position for greater than twelve months | 3,887,000 | |
Total fair value of available-for-sale securities in a continuous unrealized loss position | 249,956,000 | 152,674,000 |
Gross unrealized loss of investments in unrealized loss positions | ||
Total gross unrealized losses of available-for-sale securities in a continuous unrealized loss position for less than twelve months | (444,000) | (160,000) |
Total gross unrealized losses of available-for-sale securities in a continuous unrealized loss position for greater than twelve months | (2,000) | |
Total gross unrealized losses of available-for-sale securities in a continuous unrealized loss position | (446,000) | (160,000) |
Contractual maturities of the available-for-sale investments in debt securities, Cost | ||
Due in one year or less | 120,519,000 | |
Due after one year through two years | 145,669,000 | |
Contractual maturities of the available-for-sale investments in debt securities, Fair Value | ||
Due in one year or less | 120,421,000 | |
Due after one year through two years | 145,323,000 | |
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 | 40,100,000 | |
Corporate bonds | ||
Fair value of investments in unrealized loss positions | ||
Total fair value of available-for-sale securities in a continuous unrealized loss position for less than twelve months | 166,238,000 | 113,960,000 |
Total fair value of available-for-sale securities in a continuous unrealized loss position | 166,238,000 | 113,960,000 |
Gross unrealized loss of investments in unrealized loss positions | ||
Total gross unrealized losses of available-for-sale securities in a continuous unrealized loss position for less than twelve months | (262,000) | (135,000) |
Total gross unrealized losses of available-for-sale securities in a continuous unrealized loss position | (262,000) | (135,000) |
Contractual maturities of the available-for-sale investments in debt securities, Cost | ||
Due in one year or less | 115,647,000 | |
Due after one year through two years | 63,824,000 | |
Contractual maturities of the available-for-sale investments in debt securities, Fair Value | ||
Due in one year or less | 115,555,000 | |
Due after one year through two years | 63,656,000 | |
Asset backed securities | ||
Fair value of investments in unrealized loss positions | ||
Total fair value of available-for-sale securities in a continuous unrealized loss position for less than twelve months | 72,792,000 | 33,073,000 |
Total fair value of available for sale securities in a continuous unrealized loss position for greater than twelve months | 3,887,000 | |
Total fair value of available-for-sale securities in a continuous unrealized loss position | 76,679,000 | 33,073,000 |
Gross unrealized loss of investments in unrealized loss positions | ||
Total gross unrealized losses of available-for-sale securities in a continuous unrealized loss position for less than twelve months | (164,000) | (18,000) |
Total gross unrealized losses of available-for-sale securities in a continuous unrealized loss position for greater than twelve months | (2,000) | |
Total gross unrealized losses of available-for-sale securities in a continuous unrealized loss position | (166,000) | (18,000) |
Contractual maturities of the available-for-sale investments in debt securities, Cost | ||
Due in one year or less | 373,000 | |
Due after one year through two years | 77,288,000 | |
Contractual maturities of the available-for-sale investments in debt securities, Fair Value | ||
Due in one year or less | 373,000 | |
Due after one year through two years | 77,122,000 | |
U.S. government agency securities | ||
Fair value of investments in unrealized loss positions | ||
Total fair value of available-for-sale securities in a continuous unrealized loss position for less than twelve months | 7,039,000 | |
Total fair value of available-for-sale securities in a continuous unrealized loss position | 7,039,000 | |
Gross unrealized loss of investments in unrealized loss positions | ||
Total gross unrealized losses of available-for-sale securities in a continuous unrealized loss position for less than twelve months | (18,000) | |
Total gross unrealized losses of available-for-sale securities in a continuous unrealized loss position | (18,000) | |
Contractual maturities of the available-for-sale investments in debt securities, Cost | ||
Due in one year or less | 2,500,000 | |
Due after one year through two years | 4,557,000 | |
Contractual maturities of the available-for-sale investments in debt securities, Fair Value | ||
Due in one year or less | 2,494,000 | |
Due after one year through two years | 4,545,000 | |
Commercial Paper. | ||
Fair value of investments in unrealized loss positions | ||
Total fair value of available-for-sale securities in a continuous unrealized loss position for less than twelve months | 5,641,000 | |
Total fair value of available-for-sale securities in a continuous unrealized loss position | 5,641,000 | |
Gross unrealized loss of investments in unrealized loss positions | ||
Total gross unrealized losses of available-for-sale securities in a continuous unrealized loss position for less than twelve months | (7,000) | |
Total gross unrealized losses of available-for-sale securities in a continuous unrealized loss position | $ (7,000) | |
Certificates of deposit | ||
Contractual maturities of the available-for-sale investments in debt securities, Cost | ||
Due in one year or less | 1,999,000 | |
Contractual maturities of the available-for-sale investments in debt securities, Fair Value | ||
Due in one year or less | $ 1,999,000 |
SUMMARY OF SIGNIFICANT ACCOUN42
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Concentration of Risk and Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Valuation allowance | ||
Deferred tax asset valuation allowance | $ 215,100 | $ 161,940 |
Change in valuation allowance | $ 53,200 | $ 37,400 |
Revenue | Customer Concentration Risk | Medicare | ||
Concentration of Credit Risk | ||
Concentration risk (as a percent) | 71.00% | 80.00% |
Accounts Receivable | Customer Concentration Risk | Medicare | ||
Concentration of Credit Risk | ||
Concentration risk (as a percent) | 64.00% | 88.00% |
GENZYME STRATEGIC TRANSACTION (
GENZYME STRATEGIC TRANSACTION (Details) - USD ($) | Jan. 27, 2009 | Mar. 31, 2014 | Sep. 30, 2010 | Mar. 31, 2010 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2015 | Jul. 24, 2015 | Dec. 16, 2014 | Apr. 02, 2014 | Jun. 21, 2013 |
Revenue Recognition | |||||||||||
Sale of common stock (in shares) | 88,626,042 | 96,674,786 | |||||||||
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 | $ 0.01 | ||||||||
Price of common stock (in dollars per share) | $ 9.23 | $ 25.50 | $ 25.75 | $ 12.75 | $ 12.35 | ||||||
License fee revenue | $ 294,000 | $ 294,000 | $ 4,144,000 | ||||||||
Collaboration License And Purchase Agreement | Genzyme Corporation | |||||||||||
Revenue Recognition | |||||||||||
Total agreed consideration amount | $ 18,500,000 | ||||||||||
Proceeds from Genzyme Collaboration, License and Purchase Agreement | 16,650,000 | $ 934,000 | $ 962,000 | ||||||||
Amount subject to holdback | $ 1,850,000 | ||||||||||
Initial collaboration period | 5 years | ||||||||||
Sale of common stock (in shares) | 3,000,000 | ||||||||||
Price at which share of common stock are sold (in dollars per share) | $ 2 | ||||||||||
Aggregate purchase price | $ 6,000,000 | ||||||||||
Premium above closing price of common stock at which shares are sold (in dollars per share) | $ 0.51 | ||||||||||
Price of common stock (in dollars per share) | $ 1.49 | ||||||||||
Aggregate premium received over the closing price of common stock | $ 1,530,000 | ||||||||||
License fee revenue | $ 300,000 | $ 4,100,000 |
MAYO LICENSE AGREEMENT (Details
MAYO LICENSE AGREEMENT (Details) | Jul. 24, 2015shares | Dec. 16, 2014shares | Apr. 02, 2014shares | Jun. 21, 2013shares | Jun. 30, 2009item$ / sharesshares | Jan. 31, 2016USD ($) | Aug. 31, 2014USD ($) | Sep. 30, 2011shares | Dec. 31, 2015USD ($) | Sep. 30, 2015USD ($) | Jun. 30, 2015USD ($) | Mar. 31, 2015USD ($) | Dec. 31, 2014USD ($) | Sep. 30, 2014USD ($) | Jun. 30, 2014USD ($) | Mar. 31, 2014USD ($) | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | Dec. 31, 2013USD ($) | Jun. 30, 2014shares | Feb. 28, 2015USD ($)installment | Dec. 31, 2009shares |
Warrants | ||||||||||||||||||||||
Number of shares of common stock covered by warrants | shares | 75,000 | |||||||||||||||||||||
Other Payments | ||||||||||||||||||||||
Charges incurred as part of the research collaboration | $ 9,365,000 | $ 9,863,000 | $ 8,115,000 | $ 6,571,000 | $ 4,992,000 | $ 9,073,000 | $ 7,174,000 | $ 7,430,000 | $ 33,914,000 | $ 28,669,000 | $ 27,678,000 | |||||||||||
Amendments | ||||||||||||||||||||||
Number of shares of restricted stock granted as a consideration for the expanded license | shares | 7,000,000 | 4,000,000 | 11,500,000 | 6,300,000 | ||||||||||||||||||
Licensing Agreements | MAYO | ||||||||||||||||||||||
Warrants | ||||||||||||||||||||||
Number of common stock purchase warrants granted | item | 2 | |||||||||||||||||||||
Exercise price (in dollars per share) | $ / shares | $ 1.90 | |||||||||||||||||||||
Value of common stock required to be issued upon commercial launch of second and third products | $ 200,000 | |||||||||||||||||||||
Other Payments | ||||||||||||||||||||||
Milestone payment contingent upon FDA approval | $ 500,000 | |||||||||||||||||||||
Charges incurred as part of the research collaboration | 2,600,000 | 2,300,000 | 1,700,000 | |||||||||||||||||||
Payments for research and development efforts | 2,600,000 | 700,000 | $ 1,000,000 | |||||||||||||||||||
Estimated liability for research and development efforts | $ 1,300,000 | $ 1,500,000 | $ 1,300,000 | $ 1,500,000 | ||||||||||||||||||
Amendments | ||||||||||||||||||||||
Time period after the last licensed patent expires that the license agreement will remain in effect | 5 years | |||||||||||||||||||||
License fees payable in five annual installments | $ 5,000,000 | |||||||||||||||||||||
Number of annual installments in which license fees are payable | installment | 5 | |||||||||||||||||||||
Licensing Agreements | Minimum | MAYO | ||||||||||||||||||||||
Warrants | ||||||||||||||||||||||
Royalty payments | $ 25,000 | |||||||||||||||||||||
Licensing Agreements | Warrant Covering One Million Shares | MAYO | ||||||||||||||||||||||
Warrants | ||||||||||||||||||||||
Number of shares of common stock covered by warrants | shares | 1,000,000 | |||||||||||||||||||||
Warrants exercised, gross (in shares) | shares | 1,000,000 | |||||||||||||||||||||
Licensing Agreements | Warrant Covering Two Hundred Fifty Thousand Shares | MAYO | ||||||||||||||||||||||
Warrants | ||||||||||||||||||||||
Number of shares of common stock covered by warrants | shares | 250,000 | |||||||||||||||||||||
Warrants exercised, gross (in shares) | shares | 250,000 | |||||||||||||||||||||
Sales Milestone Range One | Licensing Agreements | MAYO | ||||||||||||||||||||||
Warrants | ||||||||||||||||||||||
Amount agreed to be paid upon reaching the specified amount of net sales | 200,000 | |||||||||||||||||||||
Net sales of a licensed product | 5,000,000 | |||||||||||||||||||||
Sales Milestone Range Two | Licensing Agreements | MAYO | ||||||||||||||||||||||
Warrants | ||||||||||||||||||||||
Amount agreed to be paid upon reaching the specified amount of net sales | 750,000 | |||||||||||||||||||||
Net sales of a licensed product | 20,000,000 | |||||||||||||||||||||
Sales Milestone Range Three | Licensing Agreements | MAYO | ||||||||||||||||||||||
Warrants | ||||||||||||||||||||||
Amount agreed to be paid upon reaching the specified amount of net sales | 2,000,000 | |||||||||||||||||||||
Net sales of a licensed product | $ 50,000,000 |
MD ANDERSON LICENSE AGREEMENT (
MD ANDERSON LICENSE AGREEMENT (Details) - MD Anderson License Agreement - USD ($) $ in Thousands | Apr. 10, 2015 | Dec. 31, 2015 |
Agreements | ||
Maximum annual expense incurred by licensee in which the Company is obligated to reimburse | $ 1,000 | |
Time period the maximum amount to be reimbursed for IVD Assay development costs (in years) | 2 years | |
Estimated liability for IVD Assay development efforts | $ 15 | |
Payments for IVD Assay development costs | $ 500 |
ISSUANCES OF EQUITY - Underwrit
ISSUANCES OF EQUITY - Underwritten Public Offerings (Details) - USD ($) $ / shares in Units, $ in Thousands, shares in Millions | Jul. 24, 2015 | Dec. 16, 2014 | Apr. 02, 2014 | Jun. 21, 2013 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 |
ISSUANCES OF EQUITY | |||||||
Issuance of stock on underwritten public offering (in shares) | 7 | 4 | 11.5 | 6.3 | |||
Price of common stock (in dollars per share) | $ 25.50 | $ 25.75 | $ 12.75 | $ 12.35 | $ 9.23 | ||
Net proceeds received from the offerings | $ 174,100 | $ 100,900 | $ 137,700 | $ 73,300 | $ 174,140 | $ 238,580 | $ 73,296 |
Underwriting discount and other stock issuance costs | $ 4,400 | $ 2,100 | $ 8,900 | $ 4,800 |
ISSUANCES OF EQUITY - Rights Ag
ISSUANCES OF EQUITY - Rights Agreement (Details) - Right Agreement [Member] | 1 Months Ended |
Feb. 28, 2011shares | |
ISSUANCES OF EQUITY | |
Number of shares of series A junior participating preferred stock which a holder is entitled to purchase upon exercise of the rights | 0.001 |
Minimum | |
ISSUANCES OF EQUITY | |
Percentage of outstanding common stock to be acquired by potential acquirer | 15.00% |
Percentage of outstanding common stock that is tendered in an offer or exchanged under offer | 15.00% |
STOCK-BASED COMPENSATION - Stoc
STOCK-BASED COMPENSATION - Stock-Based Compensation Plans (Details) | Jul. 27, 2015shares | Jul. 24, 2014shares | Dec. 31, 2015USD ($)item$ / sharesshares | Dec. 31, 2014USD ($)shares | Dec. 31, 2013USD ($)shares | Dec. 31, 2015shares |
Stock-based compensation | ||||||
Shares available for future grant | 6,522,474 | 6,522,474 | ||||
Proceeds from stock option exercise | $ | $ 1,200,000 | $ 2,600,000 | $ 1,300,000 | |||
2000 Stock Option And Incentive Plan | ||||||
Stock-based compensation | ||||||
Further grants or awards after termination of plan (in shares) | 0 | |||||
Period by which all options to purchase common stock will accelerate upon an acquisition of the company | 1 year | |||||
2000 Stock Option And Incentive Plan | Minimum | ||||||
Stock-based compensation | ||||||
Vesting period | 3 years | |||||
2000 Stock Option And Incentive Plan | Maximum | ||||||
Stock-based compensation | ||||||
Vesting period | 4 years | |||||
2000 Stock Option And Incentive Plan | Stock Options | ||||||
Stock-based compensation | ||||||
Expiration period from the date of grant | 10 years | |||||
Shares outstanding | 3,345,800 | 3,345,800 | ||||
2010 Omnibus Long Term Incentive Plan | ||||||
Stock-based compensation | ||||||
Further grants or awards after termination of plan (in shares) | 0 | |||||
Period by which all options to purchase common stock will accelerate upon an acquisition of the company | 1 year | |||||
Shares available for future grant | 6,159,082 | 6,159,082 | ||||
2010 Omnibus Long Term Incentive Plan | Minimum | ||||||
Stock-based compensation | ||||||
Vesting period | 3 years | |||||
2010 Omnibus Long Term Incentive Plan | Maximum | ||||||
Stock-based compensation | ||||||
Vesting period | 4 years | |||||
2010 Omnibus Long Term Incentive Plan | Stock Options | ||||||
Stock-based compensation | ||||||
Expiration period from the date of grant | 10 years | |||||
Shares outstanding | 1,590,794 | 1,590,794 | ||||
2010 Omnibus Long Term Incentive Plan | Restricted Stock Awards | ||||||
Stock-based compensation | ||||||
Shares outstanding | 3,200,845 | 3,200,845 | ||||
2015 Inducement Award Plan | ||||||
Stock-based compensation | ||||||
Further grants or awards after termination of plan (in shares) | 0 | |||||
Shares outstanding | 243,849 | 243,849 | ||||
Shares available for future grant | 0 | 0 | ||||
2010 Employee Stock Purchase Plan | ||||||
Stock-based compensation | ||||||
Expiration period from the date of grant | 10 years | |||||
Increase in number of shares reserved for issuance | 500,000 | |||||
Shares available for future grant | 363,392 | 363,392 | ||||
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 | 176,785 | 88,166 | 59,932 | 436,608 | ||
Proceeds from stock option exercise | $ | $ 1,700,000 | $ 800,000 | $ 500,000 | |||
2010 Employee Stock Purchase Plan | Offering Period End Date One | ||||||
Stock-based compensation | ||||||
Number of Shares | 56,635 | |||||
Weighted Average Price per Share (in dollars per share) | $ / shares | $ 13.02 | |||||
2010 Employee Stock Purchase Plan | Offering Period End Date Two | ||||||
Stock-based compensation | ||||||
Number of Shares | 120,150 | |||||
Weighted Average Price per Share (in dollars per share) | $ / shares | $ 7.72 | |||||
2010 Employee Stock Purchase Plan | Minimum | ||||||
Stock-based compensation | ||||||
Vesting period | 3 years | |||||
Number of hours per week of customary employment required to participate in the plan | item | 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 | 1.00% | |||||
2010 Employee Stock Purchase Plan | Maximum | ||||||
Stock-based compensation | ||||||
Vesting period | 4 years | |||||
Percentage of employee's compensation to be deducted from the employee's pay | 15.00% |
STOCK-BASED COMPENSATION - St49
STOCK-BASED COMPENSATION - Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Stock-based compensation expense | |||
Stock-based compensation expense | $ 18,050 | $ 11,520 | $ 7,744 |
Cost of sales | |||
Stock-based compensation expense | |||
Stock-based compensation expense | 876 | 279 | |
Research and development | |||
Stock-based compensation expense | |||
Stock-based compensation expense | 3,744 | 4,149 | 2,817 |
General and administrative | |||
Stock-based compensation expense | |||
Stock-based compensation expense | 9,358 | 5,575 | 3,054 |
Selling and marketing | |||
Stock-based compensation expense | |||
Stock-based compensation expense | $ 4,072 | $ 1,517 | $ 1,873 |
STOCK-BASED COMPENSATION - Modi
STOCK-BASED COMPENSATION - Modified Vesting of Shares (Details) - Chief Commercial Officer | 1 Months Ended | ||
Apr. 30, 2014itemshares | Mar. 31, 2014shares | Jun. 07, 2013shares | |
Stock-based compensation | |||
Number of shares affected by modification of options held by former employee | 100,000 | ||
Number of shares that will vest | 41,250 | ||
March 2,014 | |||
Stock-based compensation | |||
Number of shares that will vest | 10,000 | ||
April 2,014 | |||
Stock-based compensation | |||
Number of shares that will vest | 48,750 | ||
Number of installments for vesting of shares | item | 24 |
STOCK-BASED COMPENSATION - Fair
STOCK-BASED COMPENSATION - Fair Value and Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | 66 Months Ended | |||||||
Sep. 30, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2015 | Jul. 24, 2015 | Dec. 16, 2014 | Apr. 02, 2014 | Jun. 21, 2013 | Dec. 31, 2009 | |
STOCK-BASED COMPENSATION | ||||||||||
Forfeiture rate (as a percent) | 4.99% | 4.99% | 2.76% | |||||||
Additional disclosures | ||||||||||
Options outstanding that had exercise prices that were lower than the market price of common stock (in shares) | 4,936,594 | |||||||||
Options exercisable that had exercise prices that were lower than the market price of common stock (in shares) | 4,219,865 | |||||||||
Market price (in dollars per share) | $ 9.23 | $ 9.23 | $ 25.50 | $ 25.75 | $ 12.75 | $ 12.35 | ||||
Total intrinsic value of options exercised | $ 3,600 | $ 29,200 | $ 1,900 | |||||||
Number of shares of common stock covered by warrants issued in connection with a consulting agreement | 75,000 | |||||||||
Number of shares that vested during the period | 75,000 | |||||||||
Expense related to stock warrants | $ 1,300 | |||||||||
Weighted Average Grant Date Fair Value | ||||||||||
Unrecognized compensation cost | $ 41,100 | $ 41,100 | ||||||||
Weighted average period for recognition of unrecognized compensation cost | 2 years 9 months 18 days | |||||||||
Proceeds from stock option exercise | $ 1,200 | $ 2,600 | $ 1,300 | |||||||
Stock Options | ||||||||||
Valuation assumptions | ||||||||||
Risk-free interest rates, minimum (as a percent) | 1.50% | 1.96% | 0.94% | |||||||
Risk-free interest rates, maximum (as a percent) | 1.92% | 2.01% | 1.73% | |||||||
Expected term | 6 years | 6 years | ||||||||
Expected volatility, minimum (as a percent) | 67.10% | 77.60% | 82.90% | |||||||
Expected volatility, maximum (as a percent) | 73.20% | 80.80% | 84.00% | |||||||
Dividend yield (as a percent) | 0.00% | 0.00% | 0.00% | |||||||
Weighted average fair value per share of options granted during the period (in dollars per share) | $ 15.81 | $ 10.05 | $ 8.12 | |||||||
Stock Options | Minimum | ||||||||||
Valuation assumptions | ||||||||||
Expected term | 6 years 3 months | |||||||||
Stock Options | Maximum | ||||||||||
Valuation assumptions | ||||||||||
Expected term | 6 years 7 months 6 days | |||||||||
Employee Stock | ||||||||||
Valuation assumptions | ||||||||||
Risk-free interest rates, minimum (as a percent) | 0.25% | 0.10% | 0.10% | |||||||
Risk-free interest rates, maximum (as a percent) | 0.75% | 0.50% | 0.33% | |||||||
Expected volatility, minimum (as a percent) | 51.20% | 42.50% | 39.10% | |||||||
Expected volatility, maximum (as a percent) | 110.00% | 62.70% | 45.60% | |||||||
Dividend yield (as a percent) | 0.00% | 0.00% | 0.00% | |||||||
Weighted average fair value per share of options granted during the period (in dollars per share) | $ 4.67 | $ 6.30 | $ 3.13 | |||||||
Shares | ||||||||||
Outstanding at the beginning of the period (in shares) | 4,934,317 | 6,062,587 | 6,181,936 | |||||||
Granted (in shares) | 340,978 | 266,477 | 290,570 | |||||||
Exercised (in shares) | (281,315) | (1,378,372) | (274,919) | |||||||
Forfeited (in shares) | (57,386) | (16,375) | (135,000) | |||||||
Outstanding at the end of the period (in shares) | 4,936,594 | 4,934,317 | 6,062,587 | 4,936,594 | ||||||
Exercisable at the end of the period (in shares) | 4,219,865 | 4,219,865 | ||||||||
Vested and expected to vest at the end of the period (in shares) | 4,900,829 | 4,900,829 | ||||||||
Weighted Average Exercise Price | ||||||||||
Outstanding at the beginning of the period (in dollars per share) | $ 3.63 | $ 2.78 | $ 2.62 | |||||||
Granted (in dollars per share) | 23.51 | 14.28 | 11.36 | |||||||
Exercised (in dollars per share) | 4.44 | 1.91 | 5.17 | |||||||
Forfeited (in dollars per share) | 16.99 | 6.37 | 10.08 | |||||||
Outstanding at the end of the period (in dollars per share) | 4.80 | $ 3.63 | $ 2.78 | $ 4.80 | ||||||
Exercisable at the end of the period (in dollars per share) | 2.69 | 2.69 | ||||||||
Vested and expected to vest at the end of the period (in dollars per share) | $ 4.71 | $ 4.71 | ||||||||
Weighted Average Remaining Contractual Term | ||||||||||
Outstanding at the end of the period | 4 years 6 months | 5 years 2 months 12 days | 6 years 7 months 6 days | |||||||
Exercisable at the end of the period | 3 years 10 months 24 days | |||||||||
Vested and expected to vest at the end of the period | 5 years 2 months 12 days | |||||||||
Aggregate Intrinsic Value | ||||||||||
Outstanding at the end of the period | $ 28,126 | $ 28,126 | ||||||||
Exercisable at the end of the period | 27,585 | 27,585 | ||||||||
Vested and expected to vest at the end of the period | $ 27,601 | $ 27,601 | ||||||||
Employee Stock | Minimum | ||||||||||
Valuation assumptions | ||||||||||
Expected term | 6 months | 6 months | 6 months | |||||||
Employee Stock | Maximum | ||||||||||
Valuation assumptions | ||||||||||
Expected term | 2 years | 2 years | 2 years | |||||||
Restricted Stock Awards And Restricted Stock Units RSU | ||||||||||
Restricted Shares | ||||||||||
Outstanding at the beginning of the period (in shares) | 1,541,114 | 1,150,694 | 813,955 | |||||||
Granted (in shares) | 2,895,818 | 926,171 | 1,147,553 | |||||||
Released (in shares) | (578,033) | (491,370) | (344,611) | |||||||
Forfeited (in shares) | (414,205) | (44,381) | (466,203) | |||||||
Outstanding at the end of the period (in shares) | 3,444,694 | 1,541,114 | 1,150,694 | 3,444,694 | ||||||
Weighted Average Grant Date Fair Value | ||||||||||
Outstanding at the beginning of the period (in dollars per share) | $ 13.86 | $ 11.23 | $ 8.51 | |||||||
Granted (in dollars per share) | 15.23 | 15.61 | 11.76 | |||||||
Released (in dollars per share) | 13.77 | 11.17 | 8.56 | |||||||
Forfeited (in dollars per share) | 20.84 | 12.44 | 9.73 | |||||||
Outstanding at the end of the period (in dollars per share) | $ 14.19 | $ 13.86 | $ 11.23 | $ 14.19 | ||||||
2010 Employee Stock Purchase Plan | ||||||||||
Weighted Average Grant Date Fair Value | ||||||||||
Proceeds from stock option exercise | $ 1,700 | $ 800 | $ 500 | |||||||
Stock issued under the Company's stock purchase plan | 176,785 | 88,166 | 59,932 | 436,608 |
STOCK-BASED COMPENSATION - Outs
STOCK-BASED COMPENSATION - Outstanding and Exercisable Options (Details) | 12 Months Ended |
Dec. 31, 2015$ / sharesshares | |
Outstanding | |
Number of Options | shares | 4,936,594 |
Weighted Average Remaining Contractual Life | 4 years 6 months |
Weighted Average Exercise Price (in dollars per share) | $ 4.80 |
Exercisable | |
Number of Options | shares | 4,219,865 |
Weighted Average Exercise Price (in dollars per share) | $ 2.69 |
Exercise Price Range One | |
Information relating to outstanding and exercisable stock options | |
Exercise price, low end of range (in dollars per share) | 0 |
Exercise price, high end of range (in dollars per share) | $ 3 |
Outstanding | |
Number of Options | shares | 3,186,500 |
Weighted Average Remaining Contractual Life | 3 years 3 months 18 days |
Weighted Average Exercise Price (in dollars per share) | $ 1.10 |
Exercisable | |
Number of Options | shares | 3,186,500 |
Weighted Average Exercise Price (in dollars per share) | $ 1.10 |
Exercise Price Range Two | |
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) | $ 6 |
Outstanding | |
Number of Options | shares | 402,822 |
Weighted Average Remaining Contractual Life | 4 years 8 months 12 days |
Weighted Average Exercise Price (in dollars per share) | $ 4.40 |
Exercisable | |
Number of Options | shares | 402,822 |
Weighted Average Exercise Price (in dollars per share) | $ 4.40 |
Exercise Price Range Three | |
Information relating to outstanding and exercisable stock options | |
Exercise price, low end of range (in dollars per share) | 6.01 |
Exercise price, high end of range (in dollars per share) | $ 9 |
Outstanding | |
Number of Options | shares | 146,991 |
Weighted Average Remaining Contractual Life | 5 years 6 months |
Weighted Average Exercise Price (in dollars per share) | $ 7.89 |
Exercisable | |
Number of Options | shares | 146,991 |
Weighted Average Exercise Price (in dollars per share) | $ 7.89 |
Exercise Price Range Four | |
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) | $ 12 |
Outstanding | |
Number of Options | shares | 619,087 |
Weighted Average Remaining Contractual Life | 6 years 6 months |
Weighted Average Exercise Price (in dollars per share) | $ 9.66 |
Exercisable | |
Number of Options | shares | 415,393 |
Weighted Average Exercise Price (in dollars per share) | $ 9.55 |
Exercise Price Range Five | |
Information relating to outstanding and exercisable stock options | |
Exercise price, low end of range (in dollars per share) | 12.01 |
Exercise price, high end of range (in dollars per share) | $ 15 |
Outstanding | |
Number of Options | shares | 233,000 |
Weighted Average Remaining Contractual Life | 8 years 2 months 12 days |
Weighted Average Exercise Price (in dollars per share) | $ 13.96 |
Exercisable | |
Number of Options | shares | 58,250 |
Weighted Average Exercise Price (in dollars per share) | $ 13.96 |
Exercise Price Range Six | |
Information relating to outstanding and exercisable stock options | |
Exercise price, low end of range (in dollars per share) | 15.01 |
Exercise price, high end of range (in dollars per share) | $ 18 |
Outstanding | |
Number of Options | shares | 22,227 |
Weighted Average Remaining Contractual Life | 8 years 7 months 6 days |
Weighted Average Exercise Price (in dollars per share) | $ 16.52 |
Exercisable | |
Number of Options | shares | 9,909 |
Weighted Average Exercise Price (in dollars per share) | $ 16.52 |
Exercise Price Range Seven | |
Information relating to outstanding and exercisable stock options | |
Exercise price, low end of range (in dollars per share) | 18.01 |
Exercise price, high end of range (in dollars per share) | $ 24 |
Outstanding | |
Number of Options | shares | 313,359 |
Weighted Average Remaining Contractual Life | 9 years 2 months 12 days |
Weighted Average Exercise Price (in dollars per share) | $ 23.38 |
Exercise Price Range Eight | |
Information relating to outstanding and exercisable stock options | |
Exercise price, low end of range (in dollars per share) | 24.01 |
Exercise price, high end of range (in dollars per share) | $ 26.98 |
Outstanding | |
Number of Options | shares | 12,608 |
Weighted Average Remaining Contractual Life | 9 years 1 month 6 days |
Weighted Average Exercise Price (in dollars per share) | $ 26.98 |
STOCK-BASED COMPENSATION - Shar
STOCK-BASED COMPENSATION - Shares Reserved for Issuance (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||
Dec. 31, 2015 | Mar. 31, 2015 | Mar. 31, 2013 | Sep. 30, 2015 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Stock-based compensation | |||||||
Share based compensation expense | $ 18,050 | $ 11,520 | $ 7,744 | ||||
Shares reserved for issuance | |||||||
Shares reserved for issuance | 6,522,474 | 6,522,474 | |||||
Restricted Stock Awards And Restricted Stock Units RSU | |||||||
Stock-based compensation | |||||||
Granted (in shares) | 2,895,818 | 926,171 | 1,147,553 | ||||
Number of shares earned | 578,033 | 491,370 | 344,611 | ||||
2010 Omnibus Long Term Incentive Plan | |||||||
Shares reserved for issuance | |||||||
Shares reserved for issuance | 6,159,082 | 6,159,082 | |||||
2010 Employee Stock Purchase Plan | |||||||
Shares reserved for issuance | |||||||
Shares reserved for issuance | 363,392 | 363,392 | |||||
Certain Executives | |||||||
Stock-based compensation | |||||||
Granted (in shares) | 203,100 | ||||||
Share based compensation expense | $ 400 | $ 400 | |||||
Certain Executives | Restricted Stock Units RSU | |||||||
Stock-based compensation | |||||||
Granted (in shares) | 180,750 | ||||||
Share based compensation expense | $ 400 | ||||||
Number of shares earned | 100,800 | ||||||
Vesting period of awards granted | 3 years |
COMMITMENTS AND CONTINGENCIES -
COMMITMENTS AND CONTINGENCIES - Operating Leases (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||||
Nov. 30, 2015ft²item | Jun. 30, 2015ft² | May. 31, 2015ft² | Nov. 30, 2014ft² | Sep. 30, 2014ft² | Aug. 31, 2014ft² | Apr. 30, 2014 | Jun. 30, 2013ft² | Dec. 31, 2015USD ($)ft²item | Dec. 31, 2014USD ($) | Dec. 31, 2013USD ($) | |
Future minimum payments under operating leases | |||||||||||
2016 | $ | $ 2,073 | ||||||||||
2017 | $ | 1,664 | ||||||||||
2018 | $ | 1,118 | ||||||||||
2019 | $ | 548 | ||||||||||
2020 | $ | 277 | ||||||||||
Thereafter | $ | 358 | ||||||||||
Total lease obligations | $ | 6,038 | ||||||||||
Additional disclosure | |||||||||||
Rent expense | $ | $ 1,500 | $ 1,000 | $ 700 | ||||||||
Lease One Madison WI - Lab & Office | |||||||||||
Operating Leases | |||||||||||
Area of space under operating lease (in square feet) | ft² | 35,000 | ||||||||||
Lease Two Madison WI -Commercial Lab Operations | |||||||||||
Operating Leases | |||||||||||
Initial term of the lease | 5 years | ||||||||||
Area of space under operating lease (in square feet) | ft² | 50,000 | 28,994 | |||||||||
Number of extensions of lease term | item | 2 | ||||||||||
Extension term | 5 years | ||||||||||
Additional disclosure | |||||||||||
Lease incentive obligation | $ | $ 1,600 | $ 2,700 | |||||||||
Lease Two 2014 Amendment Madison WI | |||||||||||
Operating Leases | |||||||||||
Additional area of space under operating lease (in square feet) | ft² | 3,189 | ||||||||||
Lease Two 2015 Amendment Madison WI | |||||||||||
Operating Leases | |||||||||||
Additional area of space under operating lease (in square feet) | ft² | 5,810 | 7,853 | |||||||||
Lease Three Madison WI - Administration | |||||||||||
Operating Leases | |||||||||||
Extension term | 1 year | ||||||||||
Lease Three 2014 Amendment Madison WI | |||||||||||
Operating Leases | |||||||||||
Area of space under operating lease (in square feet) | ft² | 22,475 | ||||||||||
Additional area of space under operating lease (in square feet) | ft² | 12,338 | ||||||||||
Extension term | 1 year | ||||||||||
Lease Three 2015 Amendment Madison WI | |||||||||||
Operating Leases | |||||||||||
Additional area of space under operating lease (in square feet) | ft² | 11,238 | ||||||||||
Number of extensions of lease term | item | 2 | ||||||||||
Lease Four Madison WI - Warehouse | |||||||||||
Operating Leases | |||||||||||
Area of space under operating lease (in square feet) | ft² | 21,000 | ||||||||||
Extension term | 5 years | ||||||||||
Office Lease London United Kingdom | |||||||||||
Operating Leases | |||||||||||
Initial term of the lease | 2 years | ||||||||||
Area of space under operating lease (in square feet) | ft² | 620 |
COMMITMENTS AND CONTINGENCIES55
COMMITMENTS AND CONTINGENCIES - Licensing Agreements (Details) - USD ($) | Jul. 24, 2015 | Dec. 16, 2014 | Apr. 02, 2014 | Jun. 21, 2013 | Jul. 26, 2010 | Aug. 31, 2014 | Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2009 |
Commitments and contingencies | ||||||||||||||||||
Number of shares of common stock covered by warrants | 75,000 | |||||||||||||||||
Number of shares of restricted stock granted as a consideration for the expanded license | 7,000,000 | 4,000,000 | 11,500,000 | 6,300,000 | ||||||||||||||
Research and development expense | $ 9,365,000 | $ 9,863,000 | $ 8,115,000 | $ 6,571,000 | $ 4,992,000 | $ 9,073,000 | $ 7,174,000 | $ 7,430,000 | $ 33,914,000 | $ 28,669,000 | $ 27,678,000 | |||||||
Licensing Agreements | Hologic | ||||||||||||||||||
Commitments and contingencies | ||||||||||||||||||
Milestone payment contingent upon FDA approval | $ 100,000 | |||||||||||||||||
Licensing Agreements | MDx Health | ||||||||||||||||||
Commitments and contingencies | ||||||||||||||||||
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 | |||||||||||||||||
Licensing Agreements | MDx Health | Sales Milestone Range One | ||||||||||||||||||
Commitments and contingencies | ||||||||||||||||||
Amount agreed to be paid upon reaching the specified amount of net sales | 150,000 | |||||||||||||||||
Net sales of a licensed product | 10,000,000 | |||||||||||||||||
Licensing Agreements | MDx Health | Sales Milestone Range Two | ||||||||||||||||||
Commitments and contingencies | ||||||||||||||||||
Amount agreed to be paid upon reaching the specified amount of net sales | 750,000 | |||||||||||||||||
Net sales of a licensed product | 50,000,000 | |||||||||||||||||
Licensing Agreements | MDx Health | Sales Milestone Range Three | ||||||||||||||||||
Commitments and contingencies | ||||||||||||||||||
Amount agreed to be paid upon reaching the specified amount of net sales | 1,000,000 | |||||||||||||||||
Net sales of a licensed product | $ 50,000,000 |
COMMITMENTS AND CONTINGENCIES56
COMMITMENTS AND CONTINGENCIES - Capital Lease (Details) | 12 Months Ended |
Dec. 31, 2012USD ($) | |
COMMITMENTS AND CONTINGENCIES | |
Laboratory equipment | $ 1,200,000 |
Lease term of leased equipment | 3 years |
Rental payment per month | $ 32,000 |
RELATED PARTY TRANSACTIONS (Det
RELATED PARTY TRANSACTIONS (Details) - Director - Consulting Agreement With Related Party Two - Restricted Stock Awards - USD ($) | 1 Months Ended | 12 Months Ended |
Aug. 31, 2013 | Dec. 31, 2013 | |
RELATED PARTY TRANSACTIONS | ||
Consulting agreement term | 1 year | |
Shares of common stock granted | 4,277 | |
Vesting period of awards granted | 1 year | |
Cash payable over term of agreement | $ 60,000 | |
Consulting agreement expenses | $ 25,000 |
ACCRUED LIABILITIES (Details)
ACCRUED LIABILITIES (Details) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
ACCRUED LIABILITIES | ||
Compensation | $ 8,460 | $ 5,668 |
Professional fees | 7,502 | 5,764 |
Research and trial related expenses | 3,761 | 646 |
Licenses | 1,528 | 1,447 |
Miscellaneous taxes | 646 | 122 |
Other | 309 | 261 |
Occupancy costs | 47 | 52 |
Accrued liabilities | $ 22,253 | $ 13,960 |
LONG-TERM DEBT (Details)
LONG-TERM DEBT (Details) | 1 Months Ended | 12 Months Ended | |||
Dec. 31, 2009USD ($) | Nov. 30, 2009USD ($)item | Dec. 31, 2015USD ($) | Jun. 30, 2015USD ($) | Dec. 31, 2014USD ($) | |
Long-term debt | |||||
Total debt outstanding | $ 5,018,000 | ||||
Long-term debt | 4,852,000 | $ 1,000,000 | |||
Amortization of deferred financing costs | 44,000 | ||||
Future principal obligations | |||||
2,016 | 166,000 | ||||
2,017 | 174,000 | ||||
2,018 | 182,000 | ||||
2,019 | 4,496,000 | ||||
Total | 5,018,000 | ||||
Debt Agreement to Finance Building Purchase and Improvements | |||||
Long-term debt | |||||
Maximum funds available under debt agreement | $ 5,100,000 | ||||
Interest rate (as a percent) | 4.15% | ||||
Total amount of principal and interest payments to be paid through the maturity date of the debt agreement | $ 31,000 | ||||
Final principal and interest payment due under the debt agreement | 4,400,000 | ||||
Deferred financing costs | $ 73,000 | ||||
Amortization of deferred financing costs | 10,000 | ||||
Wisconsin Department of Commerce Loan | |||||
Long-term debt | |||||
Maximum funds available under debt agreement | $ 1,000,000 | ||||
Interest rate (as a percent) | 2.00% | ||||
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 | item | 100 | ||||
Reduction in the principal amount for each new position created | $ 5,405 | ||||
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 | ||||
Number of new full-time positions created | item | 185 | ||||
Benefit associated with the expected loan forgiveness that has been recorded as an offset to operating expenses | $ 1,000,000 |
EMPLOYEE BENEFIT PLAN (Details)
EMPLOYEE BENEFIT PLAN (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
EMPLOYEE BENEFIT PLAN | |||
Matching contribution by employer | 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 (in dollars) | $ 2.1 | $ 0.8 | $ 0.5 |
NEW MARKET TAX CREDIT (Details)
NEW MARKET TAX CREDIT (Details) - USD ($) $ in Millions | 3 Months Ended | 12 Months Ended |
Dec. 31, 2014 | Dec. 31, 2015 | |
Disclosures related to New Market Tax Credit | ||
Fee related to not exercising the option to purchase certain real property under a specified agreement | $ 1.2 | |
Amortization of contribution liability recognized as a decrease in expenses | $ 0.4 | |
Other long-term liabilities | ||
Disclosures related to New Market Tax Credit | ||
Financing arrangement, amount outstanding | 2.4 | |
New Market Tax Credit Program | ||
Disclosures related to New Market Tax Credit | ||
Net proceeds received from financing arrangements | 2.4 | |
Loan issued to a subsidiary of the Company by the Investor | 7.5 | |
Loan transaction eliminated in Company's consolidated financial statements | 5.1 | |
Variable Interest Entity, Primary Beneficiary | ||
Disclosures related to New Market Tax Credit | ||
Debt issuance costs | 0.2 | |
Investor | New Market Tax Credit Program | ||
Disclosures related to New Market Tax Credit | ||
Loan receivable issued to Investor | $ 5.1 | |
Term of the loan receivable | 7 years | |
Loan receivable interest rate (as a percent) | 2.74% | |
Recapture (as a percentage) | 100.00% | |
Recapture period | 7 years | |
Investor | Variable Interest Entity, Primary Beneficiary | Cash and cash equivalents | ||
Disclosures related to New Market Tax Credit | ||
Financing arrangement, investor contribution | $ 2.4 | |
Investor | Variable Interest Entity, Primary Beneficiary | Other long-term liabilities | ||
Disclosures related to New Market Tax Credit | ||
Financing arrangement, amount outstanding | $ 2 |
WISCONSIN ECONOMIC DEVELOPMEN62
WISCONSIN ECONOMIC DEVELOPMENT TAX CREDIT (Details) - Wisconsin Economic Development Tax Credit Agreement $ in Millions | 3 Months Ended | 12 Months Ended |
Mar. 31, 2015USD ($)item | Dec. 31, 2015USD ($) | |
Agreements | ||
Refundable tax credits available, contingent on the Company expending $26.3 million in capital investments and establishing 758 full-time positions | $ 9 | |
Capital investment expenditures over specified period, requirement to earn the refundable tax credits | $ 26.3 | |
Full-time positions that must be created over a specified time period to earn the refundable tax credits | item | 758 | |
Period over which the capital investment expenditures must be incurred and the creation of full-time positions must be completed | 7 years | |
Refundable tax credits earned | $ 2.2 | |
Amortization of tax credits | 0.2 | |
Prepaid expenses and other current assets | ||
Agreements | ||
Refundable tax credit receivable | 1.1 | |
Other long-term assets | ||
Agreements | ||
Refundable tax credit receivable | 1.1 | |
Short-term other liabilities | ||
Agreements | ||
Refundable tax credit, offsetting liability | 0.4 | |
Other long-term liabilities | ||
Agreements | ||
Refundable tax credit, offsetting liability | $ 1.6 |
INCOME TAXES (Details)
INCOME TAXES (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Other information | |||
Excess tax benefit arising from stock option deductions credited to additional paid in capital | $ 45,500 | $ 39,800 | |
Deferred tax assets: | |||
Operating loss carryforwards | 189,007 | 140,471 | |
Tax credit carryforwards | 17,947 | 16,915 | |
Deferred revenue | 11 | ||
Other temporary differences | 8,146 | 4,543 | |
Tax assets before valuation allowance | 215,100 | 161,940 | |
Less-Valuation allowance | (215,100) | (161,940) | |
Valuation allowance | |||
Change in valuation allowance | $ 53,200 | $ 37,400 | |
Differences between the effective income tax rate and the statutory tax rate | |||
U.S. Federal statutory rate (as a percent) | 35.00% | 34.00% | 34.00% |
State taxes (as a percent) | 2.10% | 5.50% | 4.80% |
Federal and state tax rate changes (as a percent) | (1.70%) | ||
Research and development tax credit (as a percent) | 0.90% | (1.10%) | 16.90% |
Stock-based compensation expense (as a percent) | (0.60%) | (0.50%) | (1.10%) |
Other adjustments (as a percent) | (0.90%) | (0.80%) | (0.30%) |
Valuation allowance (as a percent) | (34.80%) | (37.10%) | (54.30%) |
Effective tax rate (as a percent) | 0.00% | 0.00% | 0.00% |
Unrecognized tax benefits | $ 0 | $ 0 | $ 0 |
Accrued interest or penalties | 0 | 0 | 0 |
Recognized interest or penalties | 0 | $ 0 | $ 0 |
Internal Revenue Service | |||
Operating loss carryforwards and tax credit carryforwards | |||
Operating loss carryforwards | 565,900 | ||
Internal Revenue Service | Research | |||
Operating loss carryforwards and tax credit carryforwards | |||
Tax credit carryforwards | 7,500 | ||
State And Local Jurisdiction | |||
Operating loss carryforwards and tax credit carryforwards | |||
Operating loss carryforwards | 208,900 | ||
State And Local Jurisdiction | Research | |||
Operating loss carryforwards and tax credit carryforwards | |||
Tax credit carryforwards | $ 16,000 |
QUARTERLY RESULTS OF OPERATIO64
QUARTERLY RESULTS OF OPERATIONS (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
QUARTERLY RESULTS OF OPERATIONS (UNAUDITED) | |||||||||||
Laboratory service revenue | $ 14,420 | $ 12,632 | $ 8,119 | $ 4,266 | $ 1,504 | $ 39,437 | $ 1,504 | ||||
License fee revenue | $ 294 | 294 | $ 4,144 | ||||||||
Cost of revenue | 7,667 | 7,528 | 5,094 | 4,212 | 3,401 | $ 924 | 24,501 | 4,325 | |||
Gross margin | 6,753 | 5,104 | 3,025 | 54 | (1,897) | (924) | 294 | 14,936 | (2,527) | 4,144 | |
Research and development | 9,365 | 9,863 | 8,115 | 6,571 | 4,992 | 9,073 | $ 7,174 | 7,430 | 33,914 | 28,669 | 27,678 |
General and administrative | 15,864 | 15,432 | 13,683 | 12,971 | 10,625 | 8,994 | 6,230 | 4,586 | 57,950 | 30,435 | 13,649 |
Sales and marketing | 21,944 | 23,079 | 20,593 | 16,524 | 15,069 | 13,217 | 6,166 | 4,456 | 82,140 | 38,908 | 9,578 |
Loss from operations | (40,420) | (43,270) | (39,366) | (36,012) | (32,583) | (32,208) | (19,570) | (16,178) | (159,068) | (100,539) | (46,761) |
Investment income | 491 | 365 | 193 | 222 | 150 | 160 | 146 | 86 | 1,271 | 542 | 316 |
Interest income (expense) | (62) | (40) | 107 | (11) | |||||||
Interest expense | (11) | (12) | (13) | (15) | (6) | (51) | (69) | ||||
Net loss | $ (39,991) | $ (42,945) | $ (39,066) | $ (35,801) | $ (32,444) | $ (32,060) | $ (19,437) | $ (16,107) | $ (157,803) | $ (100,048) | $ (46,514) |
Net loss per share-basic and diluted (in dollars per share) | $ (0.41) | $ (0.45) | $ (0.44) | $ (0.40) | $ (0.38) | $ (0.39) | $ (0.24) | $ (0.23) | $ (1.71) | $ (1.25) | $ (0.69) |
Weighted average common shares outstanding-basic and diluted (in shares) | 96,404 | 94,444 | 88,919 | 88,662 | 84,734 | 82,941 | 82,048 | 70,987 | 92,135 | 80,232 | 67,493 |