CERUS CORP, 10-K filed on 3/12/2013
Annual Report
Document and Entity Information (USD $)
12 Months Ended
Dec. 31, 2012
Mar. 1, 2013
Jun. 29, 2012
Document Information [Line Items]
 
 
 
Document Type
10-K 
 
 
Amendment Flag
false 
 
 
Document Period End Date
Dec. 31, 2012 
 
 
Document Fiscal Year Focus
2012 
 
 
Document Fiscal Period Focus
FY 
 
 
Trading Symbol
CERS 
 
 
Entity Registrant Name
CERUS CORP 
 
 
Entity Central Index Key
0001020214 
 
 
Current Fiscal Year End Date
--12-31 
 
 
Entity Well-known Seasoned Issuer
No 
 
 
Entity Current Reporting Status
Yes 
 
 
Entity Voluntary Filers
No 
 
 
Entity Filer Category
Accelerated Filer 
 
 
Entity Common Stock, Shares Outstanding
 
60,103,000 
 
Entity Public Float
 
 
$ 135,400,000 
CONSOLIDATED BALANCE SHEETS (USD $)
In Thousands, unless otherwise specified
Dec. 31, 2012
Dec. 31, 2011
Current assets:
 
 
Cash and cash equivalents
$ 26,696 
$ 25,497 
Short-term investments
287 
Accounts receivable, net of allowance of $0 and $5 at December 31, 2012 and 2011, respectively
4,444 
6,096 
Inventories
10,180 
6,444 
Prepaid expenses
638 
810 
Other current assets
2,038 
605 
Total current assets
43,996 
39,739 
Non-current assets:
 
 
Property and equipment, net
1,698 
2,032 
Goodwill
1,316 
1,316 
Intangible assets, net
1,546 
1,748 
Restricted cash
304 
303 
Other assets
59 
229 
Total assets
48,919 
45,367 
Current liabilities:
 
 
Accounts payable
7,186 
4,680 
Accrued liabilities
7,619 
5,825 
Deferred revenue
77 
111 
Debt-current
4,828 
2,519 
Warrant liability
5,903 
7,979 
Total current liabilities
25,613 
21,114 
Non-current liabilities:
 
 
Debt-non-current
2,896 
4,697 
Deferred income taxes
62 
Other non-current liabilities
1,241 
1,243 
Total liabilities
29,812 
27,054 
Commitments and contingencies
   
   
Stockholders' equity:
 
 
Preferred stock, $0.001 par value 5,000 shares authorized, issuable in series; 0 and 3 shares issued and outstanding at December 31, 2012 and 2011; respectively, aggregate liquidation preference of $0 and $9,496 at December 31, 2012 and 2011, respectively
9,496 
Common stock, $0.001 par value 112,500 shares authorized; 56,252 and 51,211 shares issued and outstanding at December 31, 2012 and 2011, respectively
56 
51 
Additional paid-in capital
478,903 
452,701 
Accumulated deficit
(459,852)
(443,935)
Total stockholders' equity
19,107 
18,313 
Total liabilities and stockholders' equity
$ 48,919 
$ 45,367 
CONSOLIDATED BALANCE SHEETS (Parenthetical) (USD $)
In Thousands, except Per Share data, unless otherwise specified
Dec. 31, 2012
Dec. 31, 2011
Accounts receivable, allowance
$ 0 
$ 5 
Preferred stock, par value
$ 0.001 
$ 0.001 
Preferred stock, shares authorized
5,000 
5,000 
Preferred stock, shares issued
Preferred stock, shares outstanding
Preferred stock, liquidation preference
$ 0 
$ 9,496 
Common stock, par value
$ 0.001 
$ 0.001 
Common stock, shares authorized
112,500 
112,500 
Common stock, shares issued
56,252 
51,211 
Common stock, shares outstanding
56,252 
51,211 
CONSOLIDATED STATEMENTS OF OPERATIONS (USD $)
In Thousands, except Per Share data, unless otherwise specified
12 Months Ended
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2010
Product related:
 
 
 
Product revenue
$ 36,695 
$ 30,602 
$ 21,677 
Cost of product revenue
20,616 
18,535 
12,046 
Gross profit on product revenue
16,079 
12,067 
9,631 
Government grants and cooperative agreements revenue
91 
2,442 
1,432 
Operating expenses:
 
 
 
Research and development
7,603 
7,178 
5,195 
Selling, general and administrative
25,665 
23,053 
21,577 
Amortization of intangible assets
202 
202 
67 
Acquisition related costs net of gain on non-controlling equity interest
182 
Total operating expenses
33,470 
30,433 
27,021 
Loss from operations
(17,300)
(15,924)
(15,958)
Non-operating income (expense), net:
 
 
 
Revaluation of warrant liability
2,059 
486 
39 
Foreign exchange gain (loss)
86 
(529)
(816)
Interest expense
(551)
(964)
(689)
Other income, net
31 
92 
607 
Total non-operating income (expense), net
1,625 
(915)
(859)
Loss before income taxes
(15,675)
(16,839)
(16,817)
Provision for income taxes
242 
143 
94 
Net loss
$ (15,917)
$ (16,982)
$ (16,911)
Net loss per common share:
 
 
 
Basic
$ (0.29)
$ (0.35)
$ (0.42)
Diluted
$ (0.33)
$ (0.35)
$ (0.42)
Weighted average common shares outstanding used for calculating net loss per common share:
 
 
 
Basic
54,515 
48,050 
40,300 
Diluted
55,061 
48,050 
40,300 
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (USD $)
In Thousands, unless otherwise specified
12 Months Ended
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2010
Net loss
$ (15,917)
$ (16,982)
$ (16,911)
Other comprehensive income (loss):
 
 
 
Net unrealized gains (losses) on available-for-sale securities, net of taxes
(108)
50 
Comprehensive loss
$ (15,917)
$ (17,090)
$ (16,861)
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (USD $)
In Thousands
Total
Preferred Stock
Common Stock
Additional Paid-in Capital
Accumulated Other Comprehensive Income
Accumulated Deficit
Beginning Balance at Dec. 31, 2009
$ 21,448 
$ 9,496 
$ 39 
$ 421,897 
$ 58 
$ (410,042)
Beginning Balance (in shares) at Dec. 31, 2009
 
38,678 
 
 
 
Net loss
(16,911)
(16,911)
Other comprehensive income (loss)
50 
50 
Issuance of common stock from public offering, net of expenses of $550 for 2012 ,$420 for 2011 and $1,710,for 2010 (in shares)
 
8,306 
 
 
 
Issuance of common stock from public offering, net of expenses of $550 for 2012 ,$420 for 2011 and $1,710,for 2010
16,948 
16,940 
Issuance of common stock from exercise of stock options and/or warrants, and purchases from ESPP(In Shares)
 
345 
 
 
 
Issuance of common stock from exercise of stock options and/or warrants, and purchases from ESPP
369 
369 
Stock-based compensation
1,828 
1,828 
Ending Balance at Dec. 31, 2010
23,732 
9,496 
47 
441,034 
108 
(426,953)
Ending Balance (in shares) at Dec. 31, 2010
 
47,329 
 
 
 
Net loss
(16,982)
(16,982)
Other comprehensive income (loss)
(108)
(108)
Issuance of common stock from public offering, net of expenses of $550 for 2012 ,$420 for 2011 and $1,710,for 2010 (in shares)
 
3,701 
 
 
 
Issuance of common stock from public offering, net of expenses of $550 for 2012 ,$420 for 2011 and $1,710,for 2010
9,678 
9,674 
Issuance of common stock from exercise of stock options and/or warrants, and purchases from ESPP(In Shares)
 
181 
 
 
 
Issuance of common stock from exercise of stock options and/or warrants, and purchases from ESPP
143 
143 
Stock-based compensation
1,850 
1,850 
Ending Balance at Dec. 31, 2011
18,313 
9,496 
51 
452,701 
(443,935)
Ending Balance (in shares) at Dec. 31, 2011
 
51,211 
 
 
 
Net loss
(15,917)
(15,917)
Issuance of common stock from public offering, net of expenses of $550 for 2012 ,$420 for 2011 and $1,710,for 2010 (in shares)
 
4,487 
 
 
 
Issuance of common stock from public offering, net of expenses of $550 for 2012 ,$420 for 2011 and $1,710,for 2010
13,821 
13,816 
Issuance of common stock from exercise of stock options and/or warrants, and purchases from ESPP(In Shares)
 
221 
 
 
 
Issuance of common stock from exercise of stock options and/or warrants, and purchases from ESPP
349 
349 
Preferred stock conversion (in shares)
 
(3)
333 
 
 
 
Preferred stock conversion
(9,496)
9,496 
Stock-based compensation
2,541 
2,541 
Ending Balance at Dec. 31, 2012
$ 19,107 
$ 0 
$ 56 
$ 478,903 
$ 0 
$ (459,852)
Ending Balance (in shares) at Dec. 31, 2012
 
56,252 
 
 
 
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Parenthetical) (USD $)
In Thousands, unless otherwise specified
12 Months Ended
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2010
Issuance of common stock from public offering, expenses
$ 550 
$ 420 
$ 1,710 
CONSOLIDATED STATEMENTS OF CASH FLOWS (USD $)
In Thousands, unless otherwise specified
12 Months Ended
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2010
Operating activities
 
 
 
Net loss
$ (15,917)
$ (16,982)
$ (16,911)
Adjustments to reconcile net loss to net cash used in operating activities:
 
 
 
Depreciation and amortization
744 
922 
853 
Stock-based compensation
2,541 
1,850 
1,828 
Changes in revaluation of warrant liability
(2,059)
(486)
(39)
Gain on non-controlling equity interest
(315)
Non-cash interest expense
20 
152 
Deferred income taxes
62 
Changes in operating assets and liabilities, net of effects of acquired business:
 
 
 
Accounts receivable
1,652 
(1,304)
(1,167)
Inventories
(3,740)
(601)
2,066 
Other assets
(1,663)
(13)
99 
Accounts payable
2,506 
1,450 
(1,193)
Accrued restructuring
(113)
Accrued liabilities
1,971 
(336)
569 
Deferred revenue
(34)
(137)
(97)
Net cash used in operating activities
(13,917)
(15,632)
(14,268)
Investing activities
 
 
 
Purchases of furniture, equipment and leasehold improvements
(81)
(158)
(1,692)
Sales (purchases) of certain other assets
(1)
55 
(11)
Sales of investments
88 
Maturities of investments
287 
666 
1,545 
Net cash provided by (used in) investing activities
205 
563 
(70)
Financing activities
 
 
 
Net proceeds from equity incentives and the exercise of warrants
332 
143 
370 
Net proceeds from public offering
14,226 
9,273 
19,291 
Proceeds from landlord provided leasehold incentives
1,561 
Proceeds from revolving line of credit
1,810 
2,300 
Proceeds from debt, net of discount
4,910 
4,811 
Payments on revolving line of credit
(920)
Payments on debt and landlord provided leasehold incentives
(537)
(5,008)
(34)
Net cash provided by financing activities
14,911 
11,618 
25,999 
Net increase (decrease) in cash and cash equivalents
1,199 
(3,451)
11,661 
Cash and cash equivalents, beginning of period
25,497 
28,948 
17,287 
Cash and cash equivalents, end of period
26,696 
25,497 
28,948 
Supplemental disclosures:
 
 
 
Non-cash conversion of preferred stock to common stock
9,496 
Common stock issued in connection with the acquisition of certain assets of BioOne
3,423 
Cash paid for interest
460 
1,024 
600 
Cash paid for income taxes
$ 162 
$ 125 
$ 114 
Nature of Operations and Basis of Presentation
Nature of Operations and Basis of Presentation

Note 1. Nature of Operations and Basis of Presentation

Cerus Corporation (the “Company”) was incorporated in September 1991, and is developing and commercializing the INTERCEPT Blood System, which is designed to enhance the safety of blood components through pathogen inactivation. The Company has worldwide commercialization rights for the INTERCEPT Blood System for platelets, plasma and red blood cells.

The Company sells its INTERCEPT platelet and plasma systems in Europe, the Commonwealth of Independent States (“CIS”) countries, the Middle East and selected countries in other regions around the world. The Company conducts significant research, development, testing and regulatory compliance activities on its product candidates that, together with anticipated selling, general, and administrative expenses, are expected to result in substantial additional losses, and the Company may need to adjust its operating plans and programs based on the availability of cash resources. The Company’s ability to achieve a profitable level of operations will depend on successfully completing development, obtaining additional regulatory approvals and achieving widespread market acceptance of its products. There can be no assurance that the Company will ever achieve a profitable level of operations.

Summary of Significant Accounting Policies
Summary of Significant Accounting Policies

Note 2. Summary of Significant Accounting Policies

Principles of Consolidation

The accompanying consolidated financial statements include those of Cerus Corporation and its subsidiary, Cerus Europe B.V. (collectively hereinafter “Cerus” or the “Company”) after elimination of all intercompany accounts and transactions. These consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”).

Use of Estimates

The preparation of financial statements requires management to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosures of contingent assets and liabilities. On an ongoing basis, the Company evaluates its estimates, including those related to revenue recognition, inventory valuation, certain accrued liabilities, valuation and impairment of purchased intangibles and goodwill, valuation of warrants, valuation of stock options under share-based payments, valuation allowance of its deferred tax assets and uncertain income tax positions. The Company basis its estimates on historical experience and on various other assumptions that the Company believes to be reasonable under the circumstances, the results of which form its basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from those estimates under different assumptions or conditions.

Reclassifications

Certain reclassifications have been made to prior period reported amounts to conform to the current period presentations. Previously the Company had presented its provision for income taxes as a component of other income (expense) , net on the Consolidated Statements of Operations. The Company has reclassified the provision for income taxes to a separate line item in the Consolidated Statements of Operations, and as presented in Note 17 and 19 to the Consolidated Financial Statements. This reclassification had no impact on net loss, total assets or total stockholders’ equity.

 

Revenue

The Company recognizes revenue in accordance with ASC Topic 605-25, “Revenue Recognition—Arrangements with Multiple Deliverables,” as applicable. Revenue is recognized when (i) persuasive evidence of an agreement exists; (ii) services have been rendered or product has been delivered; (iii) pricing is fixed or determinable; and (iv) collection is reasonably assured. The Company’s main sources of revenues for the years ended December 31, 2012, 2011 and 2010 were product revenue from sales of the INTERCEPT Blood System for platelets and plasma (“platelet and plasma systems”) and United States government grants and awards.

Revenue related to product sales is generally recognized when the Company fulfills its obligations for each element of an agreement. For all sales of the Company’s INTERCEPT Blood System products, the Company uses a binding purchase order and signed sales contract as evidence of a written agreement. The Company sells its platelet and plasma systems directly to blood banks, hospitals, universities, government agencies, as well as to distributors in certain regions. Generally, the Company’s contracts with its customers do not provide for open return rights, except within a reasonable time after receipt of goods in the case of defective or non-conforming product. Deliverables and the units of accounting vary according to the provisions of each purchase order or sales contract. For revenue arrangements with multiple elements, the Company determines whether the delivered elements meet the criteria as separate units of accounting. Such criteria require that the deliverable have stand-alone value to the customer and that if a general right of return exists relative to the delivered item, delivery or performance of the undelivered item(s) is considered probable and substantially in the control of the Company. Once the Company determines if the deliverable meets the criteria for a separate unit of accounting, the Company must determine how the consideration should be allocated between the deliverables and how the separate units of accounting should be recognized as revenue. Consideration received is allocated to elements that are identified as discrete units of accounting based on the best estimated selling price. The Company has determined that vendor specific objective evidence is not discernible due to the Company’s limited history of selling its products and variability in its pricing across the regions into which it sells its products. Since the Company’s products are novel and unique and are not sold by others, third-party evidence of selling price is unavailable.

At both December 31, 2012 and 2011, the Company had $0.1 million of short-term deferred revenue on its consolidated balance sheets related to future performance obligations. Freight costs charged to customers are recorded as a component of revenue under ASC Topic 605, “Accounting for Shipping and Handling Fees and Costs.” Value-added-taxes (“VAT”) that the Company invoices to its customers and remits to governments are recorded on a net basis, which excludes such VAT from product revenue.

Revenue related to the cost reimbursement provisions under development contracts or United States government grants was recognized as the costs on the projects are incurred. The Company has received certain United States government grants and contracts that support research in defined research projects. These grants generally have provided for reimbursement of approved costs incurred as defined in the various grants.

Research and Development Expenses

In accordance with ASC Topic 730, “Accounting for Research and Development Expenses,” research and development expenses are charged to expense when incurred, including cost incurred under each grant that has been awarded to the Company by the United States government or development contracts. Research and development expenses include salaries and related expenses for scientific personnel, payments to consultants, supplies and chemicals used in in-house laboratories, costs of research and development facilities, depreciation of equipment and external contract research expenses, including clinical trials, preclinical safety studies, other laboratory studies, process development and product manufacturing for research use.

The Company’s use of estimates in recording accrued liabilities for research and development activities (see “Use of Estimates” above) affects the amounts of research and development expenses recorded and revenue recorded from development funding and government grants and collaborative agreements. Actual results may differ from those estimates under different assumptions or conditions.

Cash Equivalents

The Company considers all highly liquid investments with original maturities of three months or less from the date of purchase to be classified as cash equivalents. These investments primarily consist of money market instruments, and are classified as available-for-sale.

Short-Term Investments

Investments with original maturities of greater than three months but less than one year from the date of purchase as well as available-for-sale investments with original maturities of greater than one year from the date of purchase, which included United States government agency securities, were classified as short-term investments. In accordance with ASC Topic 320, “Accounting for Certain Investments in Debt and Equity Securities,” the Company classified all debt securities as available-for-sale at the time of purchase and reevaluates such designation as of each balance sheet date. Available-for-sale securities are carried at estimated fair value. Unrealized gains and losses derived by changes in the estimated fair value of available-for-sale securities were recorded in “Net unrealized gains (losses) on available-for-sale securities, net of taxes” on the Company’s consolidated statements of comprehensive loss. Realized gains and losses from the sale or maturity of available-for-sale investments were recorded in “Other income, net” on the Company’s consolidated statements of operations. The cost of securities sold was based on the specific identification method. The Company reported the amortization of any premium and accretion of any discount resulting from the purchase of debt securities as a component of interest income.

The Company also reviewed all of its marketable securities on a regular basis to evaluate whether any security has experienced an other-than-temporary decline in fair value.

Restricted Cash

The Company holds a certificate of deposit with a domestic bank for any potential decommissioning resulting from the Company’s possession of radioactive material. The certificate of deposit is held to satisfy the financial surety requirements of the California Department of Health Services and is recorded in “Restricted cash” on the Company’s consolidated balance sheets.

Concentration of Credit Risk

Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash, cash equivalents and accounts receivable.

Pursuant to the Company’s investment policy, substantially all of the Company’s cash and cash equivalents are maintained at a major financial institution in the United States of high credit standing, which at times, may exceed federally insured limits. The Company has not experienced any losses in its cash accounts and believes it not exposed to any significant risk.

Concentrations of credit risk with respect to trade receivables exist. However, in connection with the Company’s revolving line of credit, as discussed in Note 11 in the Notes to Consolidated Financial Statements, the Company purchased a credit insurance policy that mitigates some of its credit risk, as the policy will pay either the Company or its lender on eligible claims filed on its outstanding receivables. On a regular basis, including at the time of sale, the Company performs credit evaluations of its customers. Generally, the Company does not require collateral from its customers to secure accounts receivable. To the extent that the Company determines specific invoices or customer accounts may be uncollectible, the Company reserves against the accounts receivable on its consolidated balance sheets and records a charge on its consolidated statements of operations.

The Company had three customers and two customers that accounted for more than 10% of the Company’s outstanding trade receivables at December 31, 2012 and 2011, respectively. These customers cumulatively represented approximately 59% and 58% of the Company’s outstanding trade receivables at December 31, 2012 and 2011, respectively. To date, the Company has not experienced collection difficulties from these customers.

Inventories

At December 31, 2012 and 2011, inventory consisted of work-in-process and finished goods only. Finished goods include INTERCEPT disposable kits, UVA illumination devices (“illuminators”), and certain replacement parts for the illuminators. Platelet and plasma systems’ disposable kits generally have a two-year life from the date of manufacture. Illuminators and replacement parts do not have regulated expiration dates. Work-in-process includes certain components that are manufactured over a protracted length of time, which can exceed one year, before being incorporated and assembled by Fresenius Kabi AG (“Fresenius”) into the finished INTERCEPT disposable kits. Fresenius is the successor-in-interest to Fenwal, Inc., or Fenwal, and Baxter International, Inc., or Baxter, under certain agreements which arose from the sale of the transfusion therapies division of Baxter in 2007 to Fenwal. Fenwal was recently acquired by Fresenius, which assumed Fenwal’s rights and obligations under these certain agreements, including the Company’s manufacturing and supply agreement with Fenwal. In these footnotes references to Fresenius include references to its predecessors-in-interest. The Company maintains an inventory balance based on its current sales projections, and at each reporting period, the Company evaluates whether its work-in-process inventory would be consumed for production of finished units in order to sell to existing and prospective customers within the next twelve-month period. It is not customary for the Company’s production cycle for inventory to exceed twelve months. Instead, the Company uses its best judgment to factor in lead times for the production of its finished units to meet the Company’s current demands. If actual results differ from those estimates, work-in-process inventory could potentially accumulate for periods exceeding one year. At December 31, 2012 and 2011, the Company classified its work-in-process inventory as a current asset on its consolidated balance sheets based on its evaluation that the work-in-process inventory would be consumed for production and subsequently sold within each respective subsequent twelve-month period.

Inventory is recorded at the lower of cost, determined on a first-in, first-out basis, or market value. The Company uses significant judgment to analyze and determine if the composition of its inventory is obsolete, slow-moving or unsalable and frequently reviews such determinations. Generally, the Company writes-down specifically identified unusable, obsolete, slow-moving, or known unsalable inventory that has no alternative use to net realizable value in the period that it is first recognized by using a number of factors including product expiration dates, open and unfulfilled orders, and sales forecasts. Any write-down of its inventory to net realizable value establishes a new cost basis and will be maintained even if certain circumstances suggest that the inventory is recoverable in subsequent periods. Costs associated with the write-down of inventory are recorded in “Cost of product revenue” on the Company’s consolidated statements of operations. At December 31, 2012 and 2011, the Company had $0.3 million and $0.6 million, respectively, reserved for potential obsolete, expiring or unsalable product. At December 31, 2012, the Company also wrote-down the value of certain unsalable inventory of $1.7 million for which the Company has an offsetting warranty claim against Fresenius. See below in Note 2 in the Notes to Consolidated Financial Statements under “Guarantee and Indemnification Arrangements” and Note 16 in the Notes to Consolidated Financial Statements for further information regarding the Company’s warranty claim against Fresenius.

Property and Equipment, net

Property and equipment is comprised of furniture, equipment, information technology hardware and software and is recorded at cost. At the time the property and equipment is ready for its intended use, it is depreciated on a straight-line basis over the estimated useful lives of the assets (generally three to five years). Leasehold improvements are amortized on a straight-line basis over the shorter of the lease term or the estimated useful lives of the improvements.

Goodwill and Intangible Assets, net

Additions to goodwill and intangible assets, net are derived at the time of a business acquisition, in which the Company assigns the total consideration transferred to the acquired assets based on each asset’s fair value and any residual amount becomes goodwill, an indefinite life intangible asset. Intangible assets, net, which include a license for the right to commercialize the INTERCEPT Blood System in Asia, are subject to ratable amortization over the estimated useful life of ten years. The amortization of the Company’s intangible assets, net, is recorded in “Amortization of intangible assets” on the Company’s consolidated statements of operations.

Goodwill is not amortized but instead is subject to an impairment test performed on an annual basis, or more frequently if events or changes in circumstances indicate that goodwill may be impaired. Such impairment analysis is performed on August 31 of each fiscal year, or more frequently if indicators of impairment exist. Effective January 1, 2012, the test for goodwill impairment may be assessed using qualitative factors to determine whether it is more likely than not that the fair value of a reporting unit is less than the carrying amount. If the Company determines that it is more likely than not that the fair value of a reporting unit is less than the carrying amount, the Company must then proceed with performing the quantitative two-step process to test goodwill for impairment; otherwise, goodwill is not considered impaired and no further testing is warranted. The Company may choose not to perform the qualitative assessment to test goodwill for impairment and proceed directly to the quantitative two-step process; however, the Company may revert to the qualitative assessment to test goodwill for impairment in any subsequent period. The first step of the two-step process compares the fair value of each reporting unit with its respective carrying amount, including goodwill. The Company has determined that it operates in one reporting unit and estimates the fair value of its one reporting unit using the enterprise approach under which it considers the quoted market capitalization of the Company as reported on the Nasdaq Global Market. The Company considers quoted market prices that are available in active markets to be the best evidence of fair value. The Company also considers other factors, which include future forecasted results, the economic environment and overall market conditions. If the fair value of the reporting unit exceeds its carrying amount, goodwill of the reporting unit is not considered impaired and, therefore, the second step of the impairment test is unnecessary. The second step of the two-step process, which is used to measure the amount of impairment loss, compares the implied fair value of each reporting unit’s goodwill with the respective carrying amount of that goodwill. If the carrying amount of the reporting unit’s goodwill exceeds the implied fair value of that goodwill, an impairment loss is recognized in an amount equal to that excess.

The Company performs an impairment test on its intangible assets, in accordance ASC Topic 360-10, “Property, Plant and Equipment,” if certain events or changes in circumstances occur which indicate that the carrying amounts of its intangible assets may not be recoverable. If the intangible assets are not recoverable, an impairment loss would be recognized by the Company based on the excess amount of the carrying value of the intangible assets over its fair value. For further details regarding the impairment analysis, reference is made to the section below under “Long-lived Assets.” Also, see Note 8 in the Notes to Consolidated Financial Statements for further information regarding the Company’s impairment analysis and the valuation of goodwill and intangible assets, net.

Long-lived Assets

The Company evaluates its long-lived assets for impairment by continually monitoring events and changes in circumstances that could indicate carrying amounts of its long-lived assets may not be recoverable. When such events or changes in circumstances occur, the Company assesses recoverability by determining whether the carrying value of such assets will be recovered through the undiscounted expected future cash flows. If the expected undiscounted future cash flows are less than the carrying amount of these assets, the Company then measures the amount of the impairment loss based on the excess of the carrying amount over the fair value of the assets. The Company did not recognize impairment charges related to its long-lived assets during the years ended December 31, 2012, 2011 and 2010.

Foreign Currency Remeasurement

The functional currency of the Company’s foreign subsidiary is the United States dollar. Monetary assets and liabilities denominated in foreign currencies are remeasured in United States dollars using the exchange rates at the balance sheet date. Non-monetary assets and liabilities denominated in foreign currencies are remeasured in United States dollars using historical exchange rates. Monetary revenues and expenses are remeasured using average exchange rates prevailing during the period. Remeasurements are recorded in the Company’s consolidated statements of operations. The Company recorded foreign currency losses of $0.1 million, $0.5 million and $0.8 million during the years ended December 31, 2012, 2011 and 2010, respectively.

Stock-Based Compensation

The Company accounts for stock-based compensation in accordance with ASC Topic 718, “Compensation—Stock Compensation.” Stock-based compensation expense is measured at the grant-date based on the fair value of the award and is recognized as expense on a straight-line basis over the requisite service period, which is the vesting period, and is adjusted for estimated forfeitures. To the extent that stock options contain performance criteria for vesting, stock-based compensation is recognized once the performance criteria are probable of being achieved.

For stock-based awards issued to non-employees, the Company follows ASC Topic 505-50, “Equity Based Payment to Non-Employees” and considers the measurement date at which the fair value of the stock-based award is measured to be the earlier of (i) the date at which a commitment for performance by the grantee to earn the equity instrument is reached or (ii) the date at which the grantee’s performance is complete. The Company recognizes stock-based compensation expense for the fair value of the vested portion of the non-employee stock-based awards in its consolidated statements of operations.

See Note 14 in the Notes to Consolidated Financial Statements for further information regarding the Company’s stock-based compensation assumptions and expenses.

Warrant Liability

In August 2009, and November 2010, the Company issued warrants to purchase an aggregate of 2.4 million and 3.7 million shares of common stock, respectively. The material terms of the warrants were identical under each issuance except for the exercise price, date issued and expiration date. The Company classifies the warrants as a liability on its consolidated balance sheets as the warrants contain certain material terms which require the Company (or its successor) to purchase the warrants for cash in an amount equal to the value of the unexercised portion of the warrants in connection with certain change of control transactions. In addition, the Company may also be required to pay cash to a warrant holder under certain circumstances if the Company is unable to timely deliver the shares acquired upon warrant exercise to such holder.

The fair value of these outstanding warrants is calculated using a combination of the Black-Scholes model and/or binomial-lattice option-pricing model and is adjusted accordingly at each reporting period. Option-pricing models require that the Company uses significant assumptions and judgment to determine appropriate inputs to the model. Some of the assumptions that the Company relies on include the volatility of the Company’s stock over the life of the warrant, risk-free interest rate and the probability of a change of control occurring. The binomial-lattice option-pricing model also considers a certain number of share price movements and the probability of each outcome happening.

Changes resulting from the revaluation of warrants to fair value are recorded in “Revaluation of warrant liability” on the consolidated statements of operations. Upon the exercise or modification to remove the provisions which require the warrants to be treated as a liability, the fair value of the warrants will be reclassified from a liability to stockholders’ equity on the Company’s consolidated balance sheets and no further adjustment to the fair value would be made in subsequent periods.

See Note 13 in the Notes to Consolidated Financial Statements for further information regarding the Company’s valuation of warrant liability.

Income Taxes

The Company accounts for income taxes using an asset and liability approach in accordance with ASC Topic 740 “Accounting for Income Taxes.” Under this method, deferred tax assets and liabilities are determined based on differences between the financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. ASC Topic 740 requires derecognition of tax positions that do not have a greater than 50% likelihood of being recognized upon review by a taxing authority having full knowledge of all relevant information. Use of a valuation allowance as described in ASC Topic 740 is not an appropriate substitute for the derecognition of a tax position. The Company recognizes accrued interest and penalties related to unrecognized tax benefits in its income tax expense. To date, the Company has not recognized any interest and penalties in its consolidated statements of operations, nor has its accrued for or made payments for interest and penalties. The Company had no unrecognized tax benefits as of December 31, 2012 and 2011. The Company continues to carry a full valuation allowance on all of its deferred tax assets. Although the Company believes it more likely than not that a taxing authority would agree with its current tax positions, there can be no assurance that the tax positions the Company has taken will be substantiated by a taxing authority if reviewed. The Company’s tax years 1998 through 2012 remain subject to examination by the taxing jurisdictions due to unutilized net operating losses and research credits.

Net Loss Per Common Share

Basic net loss per common share is computed by dividing net loss by the weighted average number of common shares outstanding for the period. Diluted net loss per common share gives effect to all potentially dilutive common shares outstanding for the period. The potentially dilutive securities include stock options, employee stock purchase plan rights, warrants and restricted stock units, which are calculated using the treasury stock method, and convertible preferred stock, which is calculated using the if-converted method. Diluted net loss per common share also gives effect to potential adjustments to the numerator for changes resulting from the revaluation of warrants to fair value for the period, even if the Company is in a net loss position if the effect would result in more dilution.

Diluted net loss per common share used the same weighted average number of common shares outstanding for the years ended December 31, 2011 and 2010, as calculated for the basic net loss per common share as the inclusion of any potential dilutive securities would be anti-dilutive. In addition, certain potential dilutive securities were excluded from the dilution calculation for the years ended December 31, 2012, as their inclusion would have been anti-dilutive.

The following table sets forth the reconciliation of the numerator and denominator used in the computation of basic and diluted net loss per common share for the years ended December 31, 2012, 2011 and 2010 (in thousands, except per share amounts):

 

     Year Ended December 31,  
     2012     2011     2010  

Numerator:

      

Net loss

   $ (15,917   $ (16,982   $ (16,911

Effect of revaluation of warrant liability

     (2,059     0        0   
  

 

 

   

 

 

   

 

 

 

Adjusted net loss used for dilution calculation

   $ (17,976   $ (16,982   $ (16,911
  

 

 

   

 

 

   

 

 

 

Denominator:

      

Basic weighted average number of common shares outstanding

     54,515        48,050        40,300   

Effect of dilutive potential common shares resulting from warrants accounted for as liabilities

     546        0        0   
  

 

 

   

 

 

   

 

 

 

Diluted weighted average number of common shares outstanding

     55,061        48,050        40,300   
  

 

 

   

 

 

   

 

 

 

Basic

   $ (0.29   $ (0.35   $ (0.42

Diluted

   $ (0.33   $ (0.35   $ (0.42

The table below presents common shares underlying stock options, employee stock purchase plan rights, warrants, restricted stock units and/or convertible preferred stock that were excluded from the calculation of the weighted average number of common shares outstanding used for the calculation of diluted net loss per common share. These were excluded from the calculation due to their anti-dilutive effect for the years ended December 31, 2012, 2011 and 2010 (shares in thousands):

 

     Year Ended December 31,  
     2012      2011      2010  

Weighted average of anti-dilutive potential common shares

     8,716         13,595         9,867   

Guarantee and Indemnification Arrangements

The Company recognizes the fair value for guarantee and indemnification arrangements issued or modified by the Company after December 31, 2002. In addition, the Company monitors the conditions that are subject to the guarantees and indemnifications in order to identify if a loss has occurred. If the Company determines it is probable that a loss has occurred, then any such estimable loss would be recognized under those guarantees and indemnifications. Some of the agreements that the Company is a party to contain provisions that indemnify the counter party from damages and costs resulting from claims that the Company’s technology infringes the intellectual property rights of a third party or claims that the sale or use of the Company’s products have caused personal injury or other damage or loss. The Company has not received any such requests for indemnification under these provisions and has not been required to make material payments pursuant to these provisions.

The Company generally provides for a one-year warranty on certain of its INTERCEPT blood-safety products covering defects in materials and workmanship. The Company accrues costs associated with warranty obligations when claims become known and are estimable. During the year ended December 31, 2012, the Company provided for and settled the claims for warranty obligations of $0.9 million related to replacement costs for certain of its products that the Company identified were defective or had the potential of being defective. Prior to this incident, there have been very few warranty costs incurred. As a result, the Company had not accrued for any potential future warranty costs at December 31, 2011. In addition, the Company believes that the defective products and those that had the potential of being defective identified during the year ended December 31, 2012 are isolated. Accordingly, the Company has not accrued for any other incremental potential future warranty costs for its products at December 31, 2012.

In connection with the warranty obligations provided for in relation to certain of its products during the year ended December 31, 2012, the Company filed a warranty claim against Fresenius, which Fresenius accepted. As a result, the Company recorded a current asset of $1.8 million on its consolidated balance sheets as of December 31, 2012 representing the full amount of the warranty claim against Fresenius as Fresenius will supply the Company with replacement products or credit notes for those defective or potentially defective products. The Company also wrote-down the value of certain unsalable inventory of $1.7 million related to these products as an offsetting warranty claim against Fresenius.

Fair Value of Financial Instruments

The Company applies the provisions of fair value relating to its financial assets and liabilities. The carrying amounts of accounts receivables, accounts payable, and other accrued liabilities approximate their fair value due to the relative short-term maturities. Based on the borrowing rates currently available to the Company for loans with similar terms, the Company believes the fair value of its debt approximates their carrying amounts. The Company measures and records certain financial assets and liabilities at fair value on a recurring basis, including its available-for-sale securities and warrant liability. The Company classifies instruments within Level 1 if quoted prices are available in active markets for identical assets, which include the Company’s cash accounts and its money market funds. The Company classifies instruments in Level 2 if the instruments are valued using observable inputs to quoted market prices, benchmark yields, reported trades, broker/dealer quotes or alternative pricing sources with reasonable levels of price transparency. These instruments include the Company’s available-for-sale securities related to United States government agencies. The available-for-sale securities are held by a custodian who obtains investment prices from a third party pricing provider that uses standard inputs (observable in the market) to models which vary by asset class. The Company classifies instruments in Level 3 if one or more significant inputs or significant value drivers are unobservable, Level 3 instruments include our warrant liability. The Company assesses any transfers among fair value measurement levels at the end of each reporting period.

See Note 4 and 13 in the Notes to Consolidated Financial Statements for further information regarding the Company’s valuation on financial instruments.

New Accounting Pronouncements

There have been no new accounting pronouncements issued during the year ended December 31, 2012, that are of significance, or potential significance, to the Company.

BioOne Acquisition
BioOne Acquisition

Note 3. BioOne Acquisition

On August 24, 2010, the Company acquired certain assets of BioOne, a privately held Japanese company established to develop technologies to improve the safety of blood products in Asia. The assets included the commercialization licenses that the Company had granted to BioOne for both the platelet and plasma systems, illuminators held as saleable inventory and demonstration illuminators. No liabilities were assumed.

As consideration for the acquired BioOne assets, the Company relinquished all shares of BioOne that had been held by the Company and issued 1,172,357 shares of the Company’s common stock to BioOne, of which 937,886 shares were issued at the close of the acquisition on August 24, 2010 and the remaining 234,471 shares were issued six months from the close of the acquisition date (February 25, 2011). The fair value of the Company’s common stock issued to BioOne on both dates was measured based on the closing price of the Company’s common stock on August 24, 2010, the date of acquisition, and was recorded as part of the total consideration.

The total value of the consideration provided was $3.7 million, of which approximately $3.4 million related to the fair value of the 1,172,357 shares of the Company’s common stock issued to BioOne and approximately $0.3 million related to the fair value of the Company’s non-controlling equity interest in BioOne relinquished as a result of the acquisition. The Company recognized a gain of $0.3 million, which represented the difference between the assumed fair value of the pre-acquisition non-controlling equity interest of BioOne and its carrying value. The Company carried its 13% investment in BioOne at zero as it had previously fully impaired its investment in BioOne. The assumed fair value of the pre-acquisition non-controlling equity interest was calculated by applying the Company’s 13% ownership investment in BioOne to the estimated fair value of the acquired assets (excluding goodwill) of $2.4 million as noted in the table below.

The Company also incurred acquisition related costs of $0.5 million, which were recorded as a component in “Acquisition related costs and impairment of long-term investment in related parties, net” on the consolidated statements of operations during the year ended December 31, 2010.

The BioOne acquisition was accounted for as an acquisition of a business in accordance with ASC Topic 805, “Business Combinations.” The Company determined the fair values of the acquired tangible and intangible assets based on their estimated fair values as of the acquisition date. The excess purchase price over the fair value of the net tangible and identifiable intangible assets was recorded as goodwill. A portion of the goodwill recognized is expected to be deductible for income tax purposes. The factors that contributed to the recognition of goodwill included securing buyer-specific synergies to increase revenue and profits through the commercialization of the INTERCEPT Blood System worldwide. By acquiring these commercialization rights in certain Asian countries, the Company was able to complete the global commercialization rights for its platelet and plasma systems.

The following table summarizes the fair value of assets acquired at the acquisition date (in thousands):

Commercialization rights—Asia

   $ 2,017   

Illuminators—inventory

     270   

Demonstration illuminators

     135   

Goodwill

     1,316   
  

 

 

 

Total

   $ 3,738   
  

 

 

 

The commercialization rights in Asia represent the reacquisition of contractual rights originally granted to BioOne to market the Company’s products in certain countries in Asia. The contractual term of this original agreement was perpetual and the Company estimated the fair value of these acquired rights based on future expected cash flows to be generated over the expected life of the underlying technology. As a result, these intangible assets are subject to periodic amortization over the estimated useful life of ten years. The estimated fair value of inventory illuminators and demonstration illuminators was based on the expected sales price of the inventory, less reasonable profit margins.

The Company’s operating results included the impact of the BioOne acquisition beginning from the acquisition date. The pro forma disclosures for historical periods have not been presented as the impact of the BioOne acquisition was not significant to the results of operations of the Company since BioOne did not have any significant revenues or expenses due to their limited operating activities as a result of a deteriorating financial situation.

Fair Value on Financial Instruments
Fair Value on Financial Instruments

Note 4. Fair Value on Financial Instruments

The fair values of certain of the Company’s financial assets and liabilities were determined using the following inputs at December 31, 2012 (in thousands):

 

     Total      Quoted
Prices in
Active
Markets for
Identical
Assets
(Level 1)
     Significant
Other
Observable
Inputs
(Level 2)
     Significant
Unobservable
Inputs

(Level 3)
 

Money market funds(1)

   $ 10,268       $ 10,268       $ 0       $ 0   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total financial assets

   $ 10,268       $ 10,268       $ 0       $ 0   
  

 

 

    

 

 

    

 

 

    

 

 

 

Warrant liability(2)

   $ 5,903       $ 0       $ 0       $ 5,903   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total financial liabilities

   $ 5,903       $ 0       $ 0       $ 5,903   
  

 

 

    

 

 

    

 

 

    

 

 

 

 

(1) Included in cash and cash equivalents on the Company’s consolidated balance sheets.

 

(2) Included in current liabilities on the Company’s consolidated balance sheets.

 

The fair values of certain of the Company’s financial assets and liabilities were determined using the following inputs at December 31, 2011 (in thousands):

 

     Total      Quoted
Prices in
Active
Markets for
Identical
Assets
(Level 1)
     Significant
Other
Observable
Inputs
(Level 2)
     Significant
Unobservable
Inputs

(Level 3)
 

Money market funds(1)

   $ 8,683       $ 8,683       $ 0       $ 0   

United States government agency securities(2)

     287         0         287         0   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total financial assets

   $ 8,970       $ 8,683       $ 287       $ 0   
  

 

 

    

 

 

    

 

 

    

 

 

 

Warrant liability(3)

   $ 7,979       $ 0       $ 0       $ 7,979   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total financial liabilities

   $ 7,979       $ 0       $ 0       $ 7,979   
  

 

 

    

 

 

    

 

 

    

 

 

 

 

(1) Included in cash and cash equivalents on the Company’s consolidated balance sheets.

 

(2) Included in short-term investments on the Company’s consolidated balance sheets.

 

(3) Included in current liabilities on the Company’s consolidated balance sheets.

A reconciliation of the beginning and ending balances for warrant liability using significant unobservable inputs (Level 3) from December 31, 2010 to December 31, 2012 was as follows (in thousands):

 

Balance at December 31, 2010

   $ 8,465   

Decrease in fair value of warrants

     (486
  

 

 

 

Balance at December 31, 2011

     7,979   

Decrease in fair value of warrants

     (2,059

Settlement of warrants exercised

     (17
  

 

 

 

Balance at December 31, 2012

   $ 5,903   
  

 

 

 

The Company did not have any transfers among fair value measurement levels during the years ended December 31, 2012 and 2011.

Available-for-sale Securities
Available-for-sale Securities

Note 5. Available-for-sale Securities

The following is a summary of available-for-sale securities at December 31, 2012 (in thousands):

 

     December 31, 2012  
     Carrying Value      Gross
    Unrealized Gain    
     Fair Value  

Money market funds

   $ 10,268       $ 0       $ 10,268   
  

 

 

    

 

 

    

 

 

 

Total available-for-sale securities

   $ 10,268       $ 0       $ 10,268   
  

 

 

    

 

 

    

 

 

 

 

The following is a summary of available-for-sale securities at December 31, 2011 (in thousands):

 

     December 31, 2011  
     Carrying Value      Gross
Unrealized Gain
     Fair Value  

Money market funds

   $ 8,683       $ 0       $ 8,683   

United States government agency securities

     287         0         287   
  

 

 

    

 

 

    

 

 

 

Total available-for-sale securities

   $ 8,970       $ 0       $ 8,970   
  

 

 

    

 

 

    

 

 

 

Available-for-sale securities at December 31, 2012 and 2011 consisted of the following by original contractual maturity (in thousands):

 

     December 31, 2012      December 31, 2011  
     Carrying
Value
     Fair Value      Carrying
Value
     Fair Value  

Due in one year or less

   $ 10,268       $ 10,268       $ 8,683       $ 8,683   

Due greater than three years and less than five years

     0         0         287         287   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total available-for-sale securities

   $ 10,268       $ 10,268       $ 8,970       $ 8,970   
  

 

 

    

 

 

    

 

 

    

 

 

 

The maturities of certain short-term investments were estimated primarily based upon assumed prepayment features and credit enhancement characteristics.

The Company recorded minimal gross realized gains from the sale or maturity of available-for-sale investments during the year ended December 31, 2011 and did not record any gross realized gains from the sale or maturity of available-for-sale investments during the years ended December 31, 2012 and 2010. The Company recorded minimal gross realized losses from the sale or maturity of available-for-sale investments during the year ended December 31, 2010 and did not record any gross realized losses during the years ended December 31, 2012 and 2011. The Company did not record losses on investments experiencing an other-than-temporary decline in fair value during the years ended December 31, 2012, 2011 and 2010.

Inventories
Inventories

Note 6. Inventories

Inventories at December 31, 2012 and 2011 consisted of the following (in thousands):

 

     December 31,  
     2012      2011  

Work-in-process

   $ 3,551       $ 2,742   

Finished goods

     6,629         3,702   
  

 

 

    

 

 

 

Total inventories

   $ 10,180       $ 6,444   
  

 

 

    

 

 

 
Property and Equipment, net
Property and Equipment, net

Note 7. Property and Equipment, net

Property and equipment, net at December 31, 2012 and 2011 consisted of the following (in thousands):

 

     December 31,  
     2012     2011  

Leasehold improvements

   $ 5,598      $ 5,598   

Machinery and equipment

     1,594        1,682   

Demonstration equipment

     24        24   

Office furniture

     644        636   

Computer equipment

     550        525   

Computer software

     1,062        1,062   

Consigned demonstration equipment

     493        502   

Construction-in-progress

     55        38   
  

 

 

   

 

 

 

Total property and equipment, gross

     10,020        10,067   

Accumulated depreciation and amortization

     (8,322     (8,035
  

 

 

   

 

 

 

Total property and equipment, net

   $ 1,698      $ 2,032   
  

 

 

   

 

 

 

Depreciation and amortization expense related to property and equipment, net was $0.4 million, $0.6 million and $0.6 million for the years ended December 31, 2012, 2011 and 2010, respectively.

Goodwill and Intangible Assets, net
Goodwill and Intangible Assets, net

Note 8. Goodwill and Intangible Assets, net

Goodwill

During the year ended December 31, 2012, the Company did not dispose of or recognize additional goodwill. On August 31, 2012, the Company performed its annual review of goodwill. As described in Note 2 above, the Company applied the enterprise approach by reviewing the quoted market capitalization of the Company as reported on the Nasdaq Global Market to calculate the fair value. In addition, the Company considered its future forecasted results, the economic environment and overall market conditions. As a result of the Company’s assessment that its fair value of the reporting unit exceeded its carrying amount, the Company determined that goodwill was not impaired. Accordingly, at both December 31, 2012 and 2011, the carrying amount of goodwill was $1.3 million.

Intangible Assets, net

The following is a summary of intangible assets, net at December 31, 2012 (in thousands):

 

     December 31, 2012  
     Gross Carrying
Amount
     Accumulated
Amortization
    Net Carrying
Amount
 

Acquisition-related intangible assets:

       

Reacquired license—INTERCEPT Asia

   $ 2,017       $ (471   $ 1,546   
  

 

 

    

 

 

   

 

 

 

Total intangible assets

   $ 2,017       $ (471   $ 1,546   
  

 

 

    

 

 

   

 

 

 

 

The following is a summary of intangible assets, net at December 31, 2011 (in thousands):

 

     December 31, 2011  
     Gross Carrying
Amount
     Accumulated
Amortization
    Net Carrying
Amount
 

Acquisition-related intangible assets:

       

Reacquired license—INTERCEPT Asia

   $ 2,017       $ (269   $ 1,748   
  

 

 

    

 

 

   

 

 

 

Total intangible assets

   $ 2,017       $ (269   $ 1,748   
  

 

 

    

 

 

   

 

 

 

The Company recognized $0.2 million in amortization expense related to intangible assets for each of the years ended December 31, 2012 and 2011. During the years ended December 31, 2012 and 2011, there were no impairment charges recognized related to the Company’s intangible assets.

At December 31, 2012, the expected annual amortization expense of the intangible assets, net is $0.2 million beginning with the year ending December 31, 2013 and each subsequent year thereafter through the year ending December 31, 2019, and $0.1 million for the year ending December 31, 2020.

Long-Term Investments
Long-Term Investments

Note 9. Long-Term Investments

In connection with the BioOne acquisition in August 2010, the Company relinquished all BioOne shares that the Company held as part of the consideration for certain of these assets and recognized a gain of $0.3 million during the year ended December 31, 2010, which represented the difference between the assumed fair value of the pre-acquisition non-controlling equity interest of BioOne and the carrying value. The Company also incurred acquisition related costs of $0.5 million during the year ended December 31, 2010.

See Note 3 in the Notes to Consolidated Financial Statements for further information regarding the Company’s acquisition and valuation of BioOne.

In connection with the agreements to license the immunotherapy technologies to Aduro BioTech (“Aduro”) in 2009, the Company received preferred shares of Aduro, a privately held company. Pursuant to these license agreements, the Company is eligible to receive a 1% royalty fee on any future sales resulting from the licensed technology. For the years ended December 31, 2012, 2011 and 2010, the Company has not received any royalty payments from Aduro pursuant to this agreement. As of December 31, 2012, the Company’s ownership in Aduro was less than 3% on a fully diluted basis. Since receiving preferred stock in Aduro, the Company has carried its investment in Aduro at zero in its consolidated balance sheet.

Accrued Liabilities
Accrued Liabilities

Note 10. Accrued Liabilities

Accrued liabilities at December 31, 2012 and 2011 consisted of the following (in thousands):

 

     December 31,  
     2012      2011  

Accrued compensation and related costs

   $ 2,692       $ 2,027   

Accrued inventory costs

     2,352         1,417   

Accrued contract and other accrued expenses

     2,575         2,381   
  

 

 

    

 

 

 

Total accrued liabilities

   $ 7,619       $ 5,825   
  

 

 

    

 

 

 
Debt
Debt

Note 11. Debt

Debt at December 31, 2012 consisted of the following (in thousands):

 

     December 31, 2012  
     Principal     Unamortized
Discount
    Total  

Comerica—Growth Capital Loan A, due 2015

   $ 4,583      $ (49   $ 4,534   

Comerica—Revolving Line of Credit, due 2014

     3,190        0        3,190   
  

 

 

   

 

 

   

 

 

 

Total debt

     7,773        (49     7,724   

Less: debt—current

     (4,857     29        (4,828
  

 

 

   

 

 

   

 

 

 

Debt—non-current

   $ 2,916      $ (20   $ 2,896   
  

 

 

   

 

 

   

 

 

 

Debt at December 31, 2011 consisted of the following (in thousands):

 

     December 31, 2011  
     Principal     Unamortized
Discount
    Total  

Comerica—Growth Capital Loan A, due 2015

   $ 5,000      $ (84   $ 4,916   

Comerica—Revolving Line of Credit, due 2014

     2,300        0        2,300   
  

 

 

   

 

 

   

 

 

 

Total debt

     7,300        (84     7,216   

Less: debt—current

     (2,554     35        (2,519
  

 

 

   

 

 

   

 

 

 

Debt—non-current

   $ 4,746      $ (49   $ 4,697   
  

 

 

   

 

 

   

 

 

 

Principal and interest payments on debt at December 31, 2012 are expected to be as follows for each of the following three years (in thousands):

 

Year ended December 31,

      

2013

   $ 2,063   

2014(1)

     5,084   

2015

     1,334   

 

(1) Included outstanding revolving line of credit balance based on the Company’s obligation to repay the outstanding revolving line of credit balance at the end of the revolving line of credit term.

2011 Growth Capital Facility

The Company entered into a loan and security agreement on September 30, 2011, as amended effective on December 13, 2011, and June 30, 2012, with Comerica Bank (“Comerica”) (collectively, the “Amended Credit Agreement”). The Amended Credit Agreement provides for an aggregate borrowing of up to $12.0 million, comprised of a growth capital loan of $5.0 million (“Growth Capital Loan”) and a formula based revolving line of credit (“RLOC”) of up to $7.0 million. The Company pledged all current and future assets, excluding its intellectual property and 35% of the Company’s investment in its subsidiary, Cerus Europe B.V., as security for borrowings under the Amended Credit Agreement.

 

Growth Capital Loan

Concurrent with the execution of the original loan and security agreement in September 2011, the Company borrowed $5.0 million under the Growth Capital Loan, substantially all of which was used to repay the Company’s prior debt with Oxford Finance Corporation (“Oxford”), with the remainder used for general corporate purposes. The Growth Capital Loan, which matures on September 30, 2015, bears a fixed interest rate of 6.37%, with interest–only payments due for the first twelve months, followed by equal principal and interest payments for the remaining 36 months.

In September 2011, the Company incurred a commitment fee of $40,000 and loan fees of $50,000, which were recorded as a discount to its Growth Capital Loan and are being amortized as a component of interest expense using the effective interest method over the term of the Growth Capital Loan (discount was based on an implied interest rate of 7.07%). The Company will also be required to make a final payment fee of 1% of the amounts drawn under Growth Capital Loan due on the earlier of (i) prepayment of the Growth Capital Loan or (ii) the maturity of the Growth Capital Loan. The final payment fee will be accreted to interest expense using the effective interest method over the life of the Growth Capital Loan upon draw.

Revolving Line of Credit

The Amended Credit Agreement also provides for a RLOC of up to $7.0 million (the “RLOC Loan Amount”). The amount available under the RLOC is limited to the lesser of (i) 80% of eligible trade receivables or (ii) the RLOC Loan Amount. At December 31, 2012 and 2011, the Company had $3.2 million and $2.3 million, respectively, outstanding under the RLOC. The Company is required to repay the principal drawn from the RLOC at the end of the RLOC term on June 30, 2014, or earlier if a portion or all of the outstanding RLOC exceeds the amount available under the RLOC. The RLOC bears a floating rate based on the lender’s prime rate plus 1.50%, with interest–only payments due each month. At both December 31, 2012 and 2011, the floating rate of the RLOC was at 4.75%. In September 2011, the Company incurred a commitment fee of $20,000. Upon amendment of the loan and security agreement in June 2012, the Company incurred another annual commitment fee of $20,000 and received a credit for the unused portion of the initial fee. The Company will incur a $20,000 commitment fee at each annual anniversary beginning June 30, 2013.

Compliance with Covenants

The Company is required to maintain compliance with certain customary and routine financial covenants under the Amended Credit Agreement, including maintaining a minimum cash balance of $2.5 million at Comerica and achieving minimum revenue levels, which are measured monthly based on a six-month trailing basis and must be at least 75% of the pre-established future projected revenues for the trailing six-month period. Non-compliance with the covenants could result in the principal of the note becoming due and payable. As of December 31, 2012, the Company was in compliance with the financial covenants as set forth in the Amended Credit Agreement.

2010 Growth Capital Facility

In March 2010, the Company entered into a growth capital facility agreement with Oxford and immediately borrowed and issued a senior secured note for $5.0 million. The note carried a fixed interest rate of 12.04%, with interest—only payments due for the first nine months and then equal principal and interest payments for an additional 30 months. In connection with the issuance of the note, the Company paid an upfront facility fee of $0.1 million and incurred closing costs of $0.1 million, which was recorded as a discount to the note and was amortized as a component of interest expense using the effective interest method over the term of the note (discount was based on an implied interest rate of 13.84%). In addition, the Company agreed to pay a $0.4 million closing fee upon maturity of the note, which was being accreted to interest expense using the effective interest method over the life of the note. For the year ended December 31, 2010, the Company also incurred a non-utilization fee of $0.1 million, which was recognized as an operating expense, as the Company had not drawn down on the additional $5.0 million available to be drawn between September 30, 2010 and December 31, 2010.

In March 2011, the Company amended its growth capital facility with Oxford, which extended the availability of borrowing an additional $5.0 million through September 30, 2011 without incurring additional upfront facility fees and modified the covenant compliance requirements. In September 2011, the Company repaid the outstanding balance of the debt owed to Oxford using the proceeds received from the Credit Agreement as discussed in further detail above. The Company also accelerated and expensed the remaining closing cost and fees of $0.2 million to interest expense during the year ended December 31, 2011.

Commitments and Contingencies
Commitments and Contingencies

Note 12. Commitments and Contingencies

Operating Leases

The Company leases its office facilities, located in Concord, California and Amersfoort, The Netherlands, and certain equipment under non-cancelable operating leases with initial terms in excess of one year that require the Company to pay operating costs, property taxes, insurance and maintenance. The operating leases expire at various dates through 2019, with certain of the leases providing for renewal options, provisions for adjusting future lease payments, which is based on the consumer price index and the right to terminate the lease early, which may occur as early as January 2015. The Company’s leased facilities qualify as operating leases under ASC Topic 840, “Leases” and as such, are not included on its consolidated balance sheets.

Future minimum non-cancelable lease payments under operating leases as of December 31, 2012 are as follows (in thousands):

 

Year ended December 31,

      

2013

   $ 865   

2014

     838   

2015

     350   

2016

     45   

2017

     4   
  

 

 

 

Total minimum non-cancellable lease payments

   $ 2,102   
  

 

 

 

Rent expense for office facilities was $0.6 million, $0.7 million and $0.9 million for the years ended December 31, 2012, 2011 and 2010, respectively.

Financed Leasehold Improvements

In December 2010, the Company financed $1.1 million of leasehold improvements. The Company pays for the financed leasehold improvements as a component of rent and is required to reimburse its landlord over the remaining life of the respective leases. If the Company exercises its right to early terminate the Concord California lease, which may occur as early as January 2015, the Company would be required to repay for any remaining portion of the landlord financed leasehold improvements at such time. At December 31, 2012, the Company had an outstanding liability of $0.8 million related to these leasehold improvements, of which $0.1 million was reflected in “Accrued liabilities” and $0.7 million was reflected in “Other non-current liabilities” on the Company’s consolidated balance sheets.

Purchase Commitments

The Company is party to agreements with certain providers for certain components of INTERCEPT Blood System which the Company purchases from third party manufacturers and supplies to Fresenius at no cost for use in manufacturing finished INTERCEPT disposable kits. Certain of these agreements require minimum purchase commitments from the Company. The Company has paid $7.2 million, $3.6 million and $0.9 million for goods under agreements which are subject to minimum purchase commitments during the years ended December 31, 2012, 2011 and 2010, respectively. As of December 31, 2012, the Company has future minimum purchase commitments under these agreements of $2.5 million for the year ending December 31, 2013 and less than $0.1 million for each subsequent year thereafter through December 31, 2015.

Stockholders' Equity
Stockholders' Equity

Note 13. Stockholders’ Equity

Series B Convertible Preferred Stock

In March 1999, the Company issued 3,327 shares of the Company’s Series B convertible preferred stock to Fresenius. The Series B convertible preferred stock had no voting rights, except with respect to the authorization of any class or series of stock having preference or priority over the Series B convertible preferred stock as to voting, liquidation or conversion or with respect to the determination of fair value of non-publicly traded shares received by the holder of Series B convertible preferred stock in the event of a liquidation, or except as required by Delaware law. At any time, the holder had the ability to convert each share of Series B convertible preferred stock into 100 shares of the Company’s common stock. The Company had the right to redeem the Series B convertible preferred stock prior to conversion for a payment of $9.5 million. In June 2012, Fresenius exercised its right to convert all 3,327 shares of the Company’s Series B convertible preferred stock. As a result, the Company issued 332,700 shares of its common stock to Fresenius and retired the outstanding Series B convertible preferred stock.

Common Stock and Associated Warrant Liability

In August 2009, the Company issued warrants to purchase 2.4 million shares of common stock, exercisable at an exercise price of $2.90 per share (“2009 Warrants”). The 2009 Warrants are exercisable for a period of five years from the issue date. The fair value on the date of issuance of the 2009 Warrants was determined to be $2.8 million using the Black-Scholes model and/or binomial-lattice option valuation model and applying the following assumptions: (i) a risk-free rate of 2.48%, (ii) an expected term of 5.0 years, (iii) no dividend yield and (iv) a volatility of 77%.

In November 2010, the Company received net proceeds of approximately $19.7 million, after deducting underwriting discounts and commissions and stock issuance costs of approximately $1.3 million, from an underwritten public offering of 7.4 million units. Each unit sold consisted of one share of common stock and a warrant to purchase 1/2 of a share of common stock. Each unit was sold for $2.85, resulting in the issuance of 7.4 million shares of common stock and warrants to purchase 3.7 million shares of common stock, exercisable at an exercise price of $3.20 per share (“2010 Warrants”). The warrants issued in November 2010 became exercisable on May 15, 2011 and are exercisable for a period of five years from the issue date. The fair value on the date of issuance of the 2010 Warrants was determined to be $5.8 million using the Black-Scholes model and/or binomial-lattice option valuation model and applying the following assumptions: (i) a risk-free rate of 1.23%, (ii) an expected term of 5.0 years, (iii) no dividend yield and (iv) a volatility of 85%.

 

The fair value of the 2009 Warrants and 2010 Warrants was recorded on the consolidated balance sheets as a liability pursuant to “Accounting for Derivative Instruments and Hedging Activities” and “Accounting for Certain Financial Instruments with Characteristics of Both Liabilities and Equity” Topics of ASC and will be adjusted to fair value at each financial reporting date thereafter until the earlier of exercise or modification to remove the provisions which require the warrants to be treated as a liability, at which time, these warrants would be reclassified into stockholders’ equity. The Company classified the 2009 Warrants and 2010 Warrants as a liability as these warrants contain certain provisions that, under certain circumstances, which may be out of the Company’s control, could require the Company to pay cash to settle the exercise of the warrants or may require the Company to redeem the warrants.

The fair value of the warrants at December 31, 2012 and 2011 consisted of the following (in thousands):

 

     December 31,  
     2012      2011  

2009 Warrants

   $ 2,009       $ 3,010   

2010 Warrants

     3,894         4,969   
  

 

 

    

 

 

 

Total warrant liability

   $ 5,903       $ 7,979   
  

 

 

    

 

 

 

The fair value of the Company’s warrants was based on using the Black-Scholes model and/or binomial-lattice option valuation model and using the following assumptions at December 31, 2012 and 2011:

 

     December 31,
     2012   2011

2009 Warrants:

    

Expected term (in years)

   1.65   2.65

Estimated volatility

   45%   74%

Risk-free interest rate

   0.25%   0.36%

Expected dividend yield

   0%   0%

2010 Warrants:

    

Expected term (in years)

   2.86   3.86

Estimated volatility

   51%   70%

Risk-free interest rate

   0.36%   0.60%

Expected dividend yield

   0%   0%

The Company recorded non-cash gains of $2.1 million, $0.5 million and less than $0.1 million during the years ended December 31, 2012, 2011, and 2010, respectively, in “Revaluation of warrant liability” on the consolidated statements of operations due to the changes in fair value of the warrants. Significant changes to the Company’s market price for its common stock will impact the implied and/or historical volatility used to fair value the warrants. As a result, any significant increases in the Company’s stock price will likely create an increase to the fair value of warrant liability. Similarly, any significant decreases in the Company’s stock price will likely create a decrease to the fair value of warrant liability. In June 2012, 2010 Warrants to purchase 5,084 shares of common stock were exercised. At December 31, 2011, no warrants had been exercised.

Sales Agreements

The Company entered into an At-The-Market Issuance Sales Agreement in June 2011, as amended in January 2012 and August 2012 (collectively, the “MLV Agreement”), with MLV & Co. LLC, formerly McNicoll, Lewis & Vlak LLC (“MLV”) that provides for the issuance and sale of shares of the Company’s common stock over the term of the MLV Agreement having an aggregate offering price of up to $20.0 million through MLV. Under the MLV Agreement, MLV acts as the Company’s sales agent and receives compensation based on an aggregate of 3% of the gross proceeds on the sale price per share of its common stock. The issuance and sale of these shares by the Company pursuant to the MLV Agreement are deemed an “at-the-market” offering and are registered under the Securities Act. During the year ended December 31, 2011, approximately 3.5 million shares of the Company’s common stock were sold under the MLV Agreement for aggregate net proceeds of $9.7 million. During the year ended December 31, 2012, the Company sold approximately 3.1 million additional shares of its common stock under the MLV Agreement for aggregate net proceeds of $9.5 million. At December 31, 2012, the Company had less than $0.1 million of common stock available to be sold under the MLV Agreement.

The Company also entered into a Controlled Equity OfferingSM Sales Agreement (the “Cantor Agreement”) in August 2012, with Cantor Fitzgerald & Co. (“Cantor”) that provides for the issuance and sale of shares of its common stock over the term of the Cantor Agreement having an aggregate offering price of up to $30.0 million through Cantor. Under the Cantor Agreement, Cantor also acts as the Company’s sales agent and receives compensation based on an aggregate of 2% of the gross proceeds on the sale price per share of its common stock. The issuance and sale of these shares by the Company pursuant to the Cantor Agreement are deemed an “at-the-market” offering and are registered under the Securities Act. During the year ended December 31, 2012, approximately 1.4 million shares of the Company’s common stock were sold under the Cantor Agreement for aggregate net proceeds of $4.3 million. At December 31, 2012, the Company had approximately $25.5 million of common stock available to be sold under the Cantor Agreement.

Stockholder Rights Plan

In October 2009, the Company’s Board of Directors adopted an amendment to its 1999 stockholder rights plan, commonly referred to as a “poison pill,” to reduce the exercise price, extend the expiration date and revise certain definitions under the plan. The stockholder rights plan is intended to deter hostile or coercive attempts to acquire the Company. The stockholder rights plan enables stockholders to acquire shares of the Company’s common stock, or the common stock of an acquirer, at a substantial discount to the public market price should any person or group acquire more than 15% of the Company’s common stock without the approval of the Board of Directors under certain circumstances. The Company has designated 250,000 shares of Series C Junior Participating preferred stock for issuance in connection with the stockholder rights plan.

Stock-Based Compensation
Stock-Based Compensation

Note 14. Stock-Based Compensation

Employee Stock Plans

Employee Stock Purchase Plan

The Company maintains an Employee Stock Purchase Plan (the “Purchase Plan”), which is intended to qualify as an employee stock purchase plan within the meaning of Section 423(b) of the Internal Revenue Code. Under the Purchase Plan, the Company’s Board of Directors may authorize participation by eligible employees, including officers, in periodic offerings. Although the Purchase Plan provides for an offering period to be no more than 27 months, the Company currently allows eligible employees to purchase shares of the Company’s common stock at the end of each six-month offering period at a purchase price equal to 85% of the lower of the fair market value per share on the start date of the offering period or the fair market value per share on the purchase date prior to 2012. Prior to June 6, 2012, the Purchase Plan, as amended by the Company’s stockholders, had authorized and provided for issuance an aggregate of 820,500 shares of common stock. On June 6, 2012, the stockholders approved a further amendment to the Purchase Plan to increase the aggregate number of shares of common stock authorized for issuance by 500,000 shares, such that the Purchase Plan has reserved for issuance an amount not to exceed 1,320,500 shares. At December 31, 2012, the Company had 581,879 shares available for future issuance.

2008 Equity Incentive Plan

The Company also maintains an equity compensation plan to provide long-term incentives for employees, contractors, and members of its Board of Directors. The Company currently grants equity awards from one plan, the 2008 Equity Incentive Plan (the “2008 Plan”). The 2008 Plan allows for the issuance of non-statutory and incentive stock options, restricted stock, restricted stock units, stock appreciation rights, other stock-related awards, and performance awards which may be settled in cash, stock, or other property. On June 1, 2011 and June 6, 2012, the stockholders approved amendments to the 2008 Plan (collectively the “Amended 2008 Plan”) which increased the aggregate number of shares of common stock authorized for issuance by 2,000,000 shares and 3,000,000 shares, respectively, such that the Amended 2008 Plan has reserved for issuance an amount not to exceed 13,540,940 shares. Awards under the 2008 Plan generally have a maximum term of 10 years from the date of the award. The 2008 Plan generally requires options to be granted at 100% of the fair market value of the Company’s common stock subject to the option on the date of grant and will generally vest over four years. Performance-based stock or cash awards granted under the Amended 2008 Plan are limited to either 500,000 shares of common stock or $1.0 million per recipient per calendar year. The attainment of any performance-based awards granted shall be conclusively determined by a committee designated by the Company’s Board of Directors. At December 31, 2012, 50,000 performance-based stock options were outstanding, of which 50,000 were granted during the year ended December 31, 2011.

1996 Equity Incentive Plan, 1998 Non-Officer Stock Option Plan, and 1999 Equity Incentive Plan

The Company continues to have equity awards outstanding under its previous stock plans: 1998 Non-Officer Stock Option Plan and 1999 Equity Incentive Plan (collectively, the “Prior Plans”) and 1996 Equity Incentive Plan (the “1996 Plan”). Equity awards issued under the Prior Plans and the 1996 Plan continues to adhere to the terms of those respective stock plans and no further options may be granted under those previous plans. However, at June 2, 2008, any shares that remained available for future grants under the Prior Plans became available for issuance under the 2008 Plan.

At December 31, 2012, the Company had an aggregate of approximately 12.9 million shares of its common stock remaining available for future issuance under the Amended 2008 Plan, the Prior Plans and the 1996 Plan, of which approximately 8.6 million shares were subject to outstanding options and other stock-based awards, and approximately 4.3 million shares were available for future issuance under the Amended 2008 Plan. The Company’s policy is to issue new shares of common stock upon the exercise of options.

 

Activity under the Company’s equity incentive plans related to stock options is set forth below (in thousands except weighted average exercise price):

 

     Number of
Options
Outstanding
    Weighted Average
Exercise Price per
Share
 

Balances at December 31, 2009

     6,565      $ 7.38   

Granted

     981        2.90   

Forfeited

     (28     3.03   

Expired

     (309     19.20   

Exercised

     (202     1.62   
  

 

 

   

Balances at December 31, 2010

     7,007      $ 6.42   

Granted

     2,169        2.36   

Forfeited

     (465     2.45   

Expired

     (1,237     11.52   

Exercised

     (112     0.81   
  

 

 

   

Balances at December 31, 2011

     7,362      $ 4.70   

Granted

     1,782        3.68   

Forfeited

     (98     2.78   

Expired

     (386     30.44   

Exercised

     (156     1.30   
  

 

 

   

Balances at December 31, 2012

     8,504      $ 3.40   
  

 

 

   

Information regarding the Company’s stock options outstanding, stock options vested and expected to vest, and stock options exercisable at December 31, 2012, 2011 and 2010, was as follows (in thousands except weighted average exercise price and contractual term):

 

     Number
of Shares
     Weighted
Average
Exercise
Price
     Weighted
Average
Remaining
Contractual
Term (Years)
     Aggregate
Intrinsic
Value
 

Balances at December 31, 2012

           

Stock options outstanding

     8,504       $ 3.40         6.59       $ 5,433   

Stock options vested and expected to vest

     8,140       $ 3.42         6.49       $ 5,310   

Stock options exercisable

     5,150       $ 3.77         5.43       $ 3,582   

Balances at December 31, 2011

           

Stock options outstanding

     7,362       $ 4.70         6.66       $ 4,065   

Stock options vested and expected to vest

     6,900       $ 4.86         6.47       $ 3,835   

Stock options exercisable

     4,058       $ 6.70         5.00       $ 1,902   

Balances at December 31, 2010

           

Stock options outstanding

     7,007       $ 6.42         6.22       $ 2,761   

Stock options vested and expected to vest

     6,705       $ 6.60         6.08       $ 2,610   

Stock options exercisable

     4,323       $ 8.93         4.83       $ 922   

The aggregate intrinsic value in the table above is calculated as the difference between the exercise price of the stock option and the Company’s closing stock price on the last trading day of each respective fiscal period. The total intrinsic value of options exercised for the years ended December 31, 2012, 2011 and 2010 was $0.3 million, $0.2 million and $0.3 million, respectively.

Restricted Stock Units

The Company has previously granted restricted stock units primarily to its senior management in accordance with the Amended 2008 Plan. Subject to each grantee’s continued employment, the restricted stock units generally vest in three annual installments from the date of grant and are generally issuable at the end of the three-year vesting term. The fair value of restricted stock units which vested during the years ended December 31, 2012, 2011 and 2010 was $0.04 million, $0.1 million and $0.05 million, respectively.

Activity under the Company’s equity incentive plans related to restricted stock units is set forth below:

 

     Number of
RSUs
    Weighted Average
Grant-Date Fair
Value
 

Balances at December 31, 2009

     37,867      $ 6.45   

Granted

     76,532        1.85   

Forfeited

     0        0.00   

Vested

     (25,999     6.20   
  

 

 

   

Balances at December 31, 2010

     88,400      $ 2.54   

Granted

     0        0.00   

Forfeited

     (17,727     1.85   

Vested

     (37,378     3.48   
  

 

 

   

Balances at December 31, 2011

     33,295      $ 1.85   

Granted

     2,000        3.03   

Forfeited

     0        0.00   

Vested

     (18,650     1.98   
  

 

 

   

Balances at December 31, 2012

     16,645      $ 1.85   
  

 

 

   

Stock-based Compensation Expense

Stock-based compensation expense recognized on the Company’s consolidated statements of operations for the years ended December 31, 2012, 2011 and 2010, was as follows (in thousands):

 

     Year Ended December 31,  
     2012      2011      2010  

Stock-based compensation expense by caption:

        

Research and development

   $ 554       $ 450       $ 376   

Selling, general and administrative

     1,987         1,400         1,452   
  

 

 

    

 

 

    

 

 

 

Total stock-based compensation expense

   $ 2,541       $ 1,850       $ 1,828   
  

 

 

    

 

 

    

 

 

 

Stock-based compensation expense in the above table does not reflect any income taxes as the Company has experienced a history of net losses since its inception and has a full valuation allowance on its deferred tax assets. In addition, there was neither income tax benefits realized related to stock-based compensation expense nor any stock-based compensation costs capitalized as part of an asset during the years ended December 31, 2012, 2011 and 2010. The Company has also not recorded any stock-based compensation associated with performance-based stock options during the years ended December 31, 2012, 2011 and 2010 as the performance criteria was not probable of being achieved.

As of December 31, 2012, the Company expects to recognize the remaining unamortized stock-based compensation expense of $4.3 million related to non-vested stock options, net of estimated forfeitures, over an estimated remaining weighted average period of 2.47 years

Valuation Assumptions for Stock-based Compensation

The Company currently uses the Black-Scholes option pricing model to determine the grant-date fair value of stock options and employee stock purchase plan shares. The Black-Scholes option-pricing model is affected by the Company’s stock price, as well as assumptions regarding a number of complex and subjective variables, which include the expected term of the grants, actual and projected employee stock option exercise behaviors, including forfeitures, the Company’s expected stock price volatility, the risk-free interest rate and expected dividends. The Company recognizes the grant-date fair value of the stock award as stock-based compensation expense on a straight-line basis over the requisite service period, which is the vesting period, and is adjusted for estimated forfeitures.

Expected Term

The Company estimates the expected term for stock options based on grouping the population of stock options into discreet, homogeneous groups and then analyzing employee exercise and post-vesting termination behavior. The Company may also average the vesting term and the contractual term of the stock options, as illustrated in SAB 107 and SAB 110, if the Company is unable to obtain sufficient information for a particular homogeneous group of stock options. The expected term for the shares issuable under the employee stock purchase plan is the term of each purchase period, which is six months.

Estimated Forfeiture Rate

The Company estimates the forfeiture rate of stock options at the time of grant and revises those estimates in subsequent periods if actual forfeitures differ from those estimates. The Company uses historical data to estimate pre-vesting option forfeitures and records stock-based compensation expense only for those awards that are expected to vest. The Company estimates the historic pre-vesting forfeiture rates by groups that possess a degree of homogeneity regarding average time to vest and expected term.

Estimated Volatility

The Company estimates the volatility of its common stock by using historical volatility of its common stock. The Company has used significant judgment in making these estimates and will continue to monitor the availability of actively traded stock options on its common stock. The Company may also consider a combination of historical and implied volatility, or solely implied volatility, if the Company determines that sufficient actively traded stock options on its common stock exists.

Risk-Free Interest Rate

The Company uses the risk-free interest rate based on the yield derived from United States Treasury zero-coupon issues with remaining terms similar to the expected term on the stock options.

 

Expected Dividend Yield

The Company does not anticipate paying any cash dividends in the foreseeable future and therefore uses an expected dividend yield of zero.

The weighted average assumptions used to value the Company’s stock-based awards for the years ended December 31, 2012, 2011 and 2010, was as follows:

 

     Year Ended December 31,  
     2012     2011     2010  

Stock Options:

      

Expected term (in years)

     5.54        5.30        5.40   

Estimated volatility

     67     68     82

Risk-free interest rate

     1.03     1.23     1.40

Expected dividend yield

     0     0     0

Employee Stock Purchase Plan Rights:

      

Expected term (in years)

     0.50        0.50        0.50   

Estimated volatility

     101     48     61

Risk-free interest rate

     0.14     0.08     0.89

Expected dividend yield

     0     0     0

The weighted average grant-date fair value of stock options granted during the years ended December 31, 2012, 2011 and 2010, was $2.13 per share, $1.37 per share and $1.94 per share, respectively. The weighted average grant-date fair value of restricted stock units granted during the years ended December 31, 2012 and 2010 was $3.03 per share and $1.85 per share, respectively. The weighted average grant-date fair value of employee stock purchase rights during the years ended December 31, 2012, 2011 and 2010, was $1.43 per share, $0.68 per share and $0.90 per share, respectively.

Retirement Plan
Retirement Plan

Note 15. Retirement Plan

The Company maintains a defined contribution savings plan (the “401(k) Plan”) that qualifies under the provisions of Section 401(k) of the Internal Revenue Code and covers eligible U.S. employees of the Company. Under the terms of the 401(k) Plan, eligible U.S.employees may make pre-tax dollar contributions of up to 60% of their eligible pay up to a maximum cap established by the IRS. The Company may contribute a discretionary percentage of qualified individual employee’s salaries, as defined, to the 401(k) Plan. The Company has not contributed to the 401(k) Plan during the years ended December 31, 2012, 2011 and 2010.

Development and License Agreements
Development and License Agreements

Note 16. Development and License Agreements

Agreements with Fresenius

The Company has certain agreements with Fresenius which require the Company to pay royalties on future INTERCEPT Blood System product sales at royalty rates that vary by product: 10% of product sales for the platelet system, 3% of product sales for the plasma system, 5% of product sales for the red blood cell system, and 6.5% on sales of illuminators. During the years ended December 31, 2012, 2011 and 2010, the Company made royalty payments to Fresenius of $2.7 million, $2.2 million and $2.0 million, respectively. At December 31, 2012 and December 31, 2011, the Company owed Fresenius $0.8 million and $0.7 million, respectively, for royalties.

 

In December 2008, the Company extended its agreement with Fresenius to manufacture finished INTERCEPT disposable kits for the platelet and plasma systems through December 31, 2013. Under the amended manufacturing and supply agreement, the Company pays Fresenius a set price per kit, which is established annually, plus a fixed surcharge per kit. In addition, volume driven manufacturing overhead is to be paid or refunded if actual manufacturing volumes are lower or higher than the estimated production volumes. The Company made payments to Fresenius of $12.2 million, $9.6 million and $8.6 million relating to the manufacturing of the Company products during the years ended December 31, 2012, 2011 and 2010, respectively. At December 31, 2012, and December 31, 2011, the Company owed Fresenius $6.2 million and $3.4 million, respectively, for INTERCEPT disposable kits manufactured. In connection with the warranty claims incurred by the Company and remediation of those claims during the year ended December 31, 2012 (see Note 2 in the Notes to Consolidated Financial Statements under “Guarantee and Indemnification Arrangements” for more detail), the Company filed a warranty claim against Fresenius. Fresenius has accepted the warranty claim and will supply the Company with replacement product or credit notes. As a result, the Company recorded a current asset of $1.8 million on its consolidated balance sheets as of December 31, 2012 representing the full amount of the warranty claim against Fresenius.

Cooperative Agreements with the United States Armed Forces

Since February 2001, the Company had received awards under cooperative agreements with the Army Medical Research Acquisition Activity division of the Department of Defense. The Company received these awards in order to develop its pathogen inactivation technologies for the improved safety and availability of blood that may be used by the United States Armed Forces for medical transfusions. Under the terms of the cooperative agreements, the Company was conducting research on the inactivation of infectious pathogens in blood, including unusual viruses, bacteria and parasites that were of concern to the United States Armed Forces. This funding supported advanced development of the Company’s red blood cell system. The Company recognized $0.1 million, $2.4 million and $1.4 million of revenue under these agreements during the years ended December 31, 2012, 2011 and 2010, respectively. The Company has fully utilized the remaining availability under these existing agreements, accordingly the Company will not recognize any additional revenue associated with these agreements.

Income Taxes
Income Taxes

Note 17. Income Taxes

U.S and foreign components of consolidated loss before income taxes for the years ended December 2012, 2011 and 2010 was as follows (in thousands):

 

     Year Ended December 31,  
     2012     2011     2010  

Income (loss) before income taxes:

      

U.S.

   $ (16,360   $ (17,461   $ (17,256

Foreign

     685        622        439   
  

 

 

   

 

 

   

 

 

 

Loss before income taxes

   $ (15,675   $ (16,839   $ (16,817
  

 

 

   

 

 

   

 

 

 

 

The provision for income taxes for the years ended December 2012, 2011 and 2010 was as follows (in thousands):

 

     Year Ended December 31,  
         2012              2011              2010      

Provision for income taxes:

        

Current:

        

Foreign

   $ 180       $ 143       $ 94   

Federal

     0         0         0   

State

     0         0         0   
  

 

 

    

 

 

    

 

 

 

Total Current

     180         143         94   

Deferred:

        

Foreign

     0         0         0   

Federal

     48         0         0   

State

     14         0         0   
  

 

 

    

 

 

    

 

 

 

Total Deferred

     62       $ 0       $ 0   
  

 

 

    

 

 

    

 

 

 

Provision for income taxes

   $ 242       $ 143       $ 94   
  

 

 

    

 

 

    

 

 

 

The difference between the provision for income taxes and the amount computed by applying the federal statutory income tax rate to loss before taxes for the years ended December 31, 2012, 2011 and 2010 was as follows (in thousands):

 

     Year Ended December 31,  
     2012     2011     2010  

Federal statutory tax

   ($ 5,329   ($ 5,725   ($ 5,718

Stock-based compensation

     99        83        95   

Lobbying expenses

     51        112        112   

Warrants

     (706     (165     (13

Research Grant

     0        0        (166

Gain on investment

     0        0        (107

Foreign rate differential

     (53     (68     (56

Expiration of federal net operating losses and credits - tax effected

     4,352        1,744        (596

Change in valuation allowance

     1,761        4,158        6,544   

Goodwill amortization

     48        0        0   

Other

     19        4        (1
  

 

 

   

 

 

   

 

 

 

Provision for income taxes

   $ 242      $ 143      $ 94   
  

 

 

   

 

 

   

 

 

 

Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes at the enacted rates. The significant components of the Company’s deferred tax assets at December 31, 2012 and 2011 were as follows (in thousands):

 

     December 31,  
     2012     2011  

Deferred tax assets:

    

Net operating loss carryforwards

   $ 137,700      $ 137,800   

Research and development credit carryforwards

     30,800        31,400   

Capitalized inventory costs

     900        500   

Inventory reserve

     700        200   

Capitalized research and development

     9,100        10,300   

Capitalized trademark

     400        200   

Capitalized revenue sharing rights

     300        600   

Asia license intangible

     100        0   

Deferred compensation

     4,800        4,200   

Accrued liabilities

     100        400   

Depreciation

     1,300        1,400   

Acqusition costs

     200        200   

Deferred tenant allowance

     200        200   

Capital loss carryforwards

     3,900        3,900   
  

 

 

   

 

 

 

Total deferred tax assets

     190,500        191,300   

Valuation allowance

     (190,500     (191,300
  

 

 

   

 

 

 

Net deferred tax assets

   $ 0      $ 0   
  

 

 

   

 

 

 

Deferred tax liabilities:

    

Amortization of goodwill

   $ 62      $ 0   
  

 

 

   

 

 

 

Total deferred tax liabilities

   $ 62      $ 0   
  

 

 

   

 

 

 

The valuation allowance decreased by $0.8 million for the year ended December 31, 2012 and increased by $2.0 million and $7.2 million for the years ended December 31, 2011 and 2010, respectively. The Company believes that, based on a number of factors, the available objective evidence creates sufficient uncertainty regarding the realizability of the deferred tax assets such that a full valuation allowance has been recorded. These factors include the Company’s history of net losses since its inception, the need for regulatory approval of the Company’s products prior to commercialization, expected near-term future losses and the absence of taxable income in prior carryback years. The Company expects to maintain a full valuation allowance until circumstances change.

Undistributed earnings of the Company’s foreign subsidiary, Cerus Europe B.V., amounted to approximately $2.1 million at December 31, 2012. The earnings are considered to be permanently reinvested and accordingly, no deferred United States income taxes have been provided thereon. Upon distribution of those earnings in the form of dividends or otherwise, the Company would be subject to United States income taxes. At the Federal statutory income tax rate of 34%, this would result in taxes of approximately $0.7 million. In the event all foreign undistributed earnings were remitted to the U.S., any incremental tax liability would be fully offset by the Company’s domestic net operating loss.

For the year ended December 31, 2012, the Company reported net losses of $15.9 million on its consolidated statement of operations and calculated taxable losses for both federal and state taxes. The difference between reported net loss and taxable loss are due to temporary differences between book accounting and the respective tax laws.

 

At December 31, 2012, the Company had federal and state net operating loss carryforwards of approximately $360.2 million and $293.2 million, respectively. The net operating loss carryforwards for federal and state will expire at various dates beginning in 2018 and 2013, respectively, and ending in 2032.

At December 31, 2012, the Company had federal research and development credit carryforwards of approximately $20.5 million that expire in various years between 2018 and 2032. The state research and development credits are approximately $15.6 million as of December 31, 2012 have an indefinite carryforward period.

The utilization of net operating loss carryforwards, as well as research and development credit carryforwards, is limited by current tax regulations. These net operating loss carryforwards, as well as research and development credit carryforwards, will be utilized in future periods if sufficient income is generated. The Company believes it more likely than not that its tax positions would be recognized upon review by a taxing authority having full knowledge of all relevant information. The Company’s ability to utilize certain loss carryforwards and certain research credit carryforwards are subject to limitations pursuant to the ownership change rules of Internal Revenue Code Section 382.

The Company will recognize accrued interest and penalties related to unrecognized tax benefits in its income tax expense. To date, the Company has not recognized any interest and penalties in its consolidated statements of operations, nor has it accrued for or made payments for interest and penalties. The Company had no unrecognized tax benefits as of December 31, 2012 and 2011. The Company’s tax years 1998 through 2012 remain subject to examination by the taxing jurisdictions due to unutilized net operating losses and research credits.

Segment, Customer and Geographic Information
Segment, Customer and Geographic Information

Note 18. Segment, Customer and Geographic Information

The Company continues to operate in only one segment, blood safety. The Company’s chief executive officer is the chief operating decision maker who evaluates performance based on the net revenues and operating loss of the blood safety segment. The Company considers the sale of all of its INTERCEPT Blood System products to be similar in nature and function, and any revenue earned from services is minimal.

The Company’s operations outside of the United States include a wholly-owned subsidiary headquartered in Europe. The Company’s operations in the United States are responsible for the research and development and global commercialization of the INTERCEPT Blood System, while operations in Europe are responsible for the commercialization efforts of the platelet and plasma systems in Europe, The Commonwealth of Independent States and the Middle East. Product revenues are attributed to each region based on the location of the customer, and in the case of non-product revenues, on the location of the collaboration partner.

The Company had the following significant customers that accounted for more than 10% of the Company’s total product revenue, all of which operate in a country outside of the United States, during the years ended December 31, 2012, 2011 and 2010 (in percentages):

 

     Year Ended December 31,  
         2012             2011             2010      

Etablissement Francais du Sang

     20     24     20

Movaco, S.A.

     19     21     19

Delrus Inc.

     12     12     16

Service Francophone du Sang *

     *        *        12

 

* Represents an amount less than 10% of product revenue.

 

The Company also recognized government grants and cooperative agreements revenue which represented less than 1% of total revenue, 7% of total revenue and 6% of total revenue, during the years ended December 31, 2012, 2011 and 2010, respectively.

Net revenues by geographical location was based on the location of the customer, in the case of product revenues, and in the location of the collaboration partner, in the case of non-product revenues, during the years ended December 31, 2012, 2011 and 2010 and was as follows (in thousands):

 

     Year Ended December 31,  
     2012      2011      2010  

Product Revenue:

        

France

   $ 7,321       $ 7,385       $ 4,432   

Spain and Portugal

     7,061         6,504         4,175   

CIS

     8,016         3,754         3,383   

Belgium

     4,016         3,703         3,710   

Switzerland

     3,866         3,315         1,330   

Other countries

     6,415         5,941         4,647   
  

 

 

    

 

 

    

 

 

 

Total product revenue

     36,695         30,602         21,677   

Government grants and cooperative agreements:

        

United States

     91         2,442         1,432   
  

 

 

    

 

 

    

 

 

 

Total government grants and cooperative agreements

     91         2,442         1,432   
  

 

 

    

 

 

    

 

 

 

Total revenue

   $ 36,786       $ 33,044       $ 23,109   
  

 

 

    

 

 

    

 

 

 

Long-lived assets by geographical location, which consist of property and equipment, net, intangible assets, net, and certain other assets, at December 31, 2012 and 2011 were as follows (in thousands):

 

     December 31,  
      2012      2011  

United States

   $ 2,895       $ 3,299   

Europe

     349         650   
  

 

 

    

 

 

 

Total long-lived assets

   $ 3,244       $ 3,949   
  

 

 

    

 

 

 
Quarterly Financial Information (Unaudited)
Quarterly Financial Information (Unaudited)

Note 19. Quarterly Financial Information (Unaudited)

The following tables summarize the Company’s quarterly financial information for the years ended December 31, 2012 and 2011 (in thousands except per share amounts):

 

     Three Months Ended  
     March 31,
2012
    June 30,
2012
    September 30,
2012
    December 31,
2012
 

Revenue:

        

Product revenue

   $ 8,691      $ 9,224      $ 8,252      $ 10,528   

Cost of product revenue

     5,514        5,574        4,411        5,117   
  

 

 

   

 

 

   

 

 

   

 

 

 

Gross profit on product revenue

     3,177        3,650        3,841        5,411   

Government grants and cooperative agreements revenue

     91        0        0        0   

Operating expenses:

        

Research and development

     1,824        1,712        1,903        2,164   

Selling, general and administrative

     5,966        6,686        6,219        6,794   

Amortization of intangible assets

     50        51        50        51   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     7,840        8,449        8,172        9,009   
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (4,572     (4,799     (4,331     (3,598

Total non-operating income (expense), net

     (4,227     2,933        926        1,993   
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss before income taxes

     (8,799     (1,866     (3,405     (1,605

Provision for income taxes

     35        41        55        111   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (8,834   $ (1,907   $ (3,460   $ (1,716
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per common share:

        

Basic

   $ (0.17   $ (0.04   $ (0.06   $ (0.03

Diluted

   $ (0.17   $ (0.10   $ (0.08   $ (0.07

 

     Three Months Ended  
     March 31,
2011
    June 30,
2011
    September 30,
2011
    December 31,
2011
 

Revenue:

        

Product revenue

   $ 6,183      $ 6,753      $ 7,770      $ 9,896   

Cost of product revenue

     3,529        4,074        4,726        6,206   
  

 

 

   

 

 

   

 

 

   

 

 

 

Gross profit on product revenue

     2,654        2,679        3,044        3,690   

Government grants and cooperative agreements revenue

     436        0        1,479        527   

Operating expenses:

        

Research and development

     1,808        1,994        1,814        1,562   

Selling, general and administrative

     5,528        6,207        5,380        5,938   

Amortization of intangible assets

     50        51        51        50   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     7,386        8,252        7,245        7,550   
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (4,296     (5,573     (2,722     (3,333

Total non-operating income (expense), net

     (779     (809     5,026        (4,353
  

 

 

   

 

 

   

 

 

   

 

 

 

Income (loss) before income taxes

     (5,075     (6,382     2,304        (7,686

Provision for income taxes

     23        27        44        49   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss)

   $ (5,098   $ (6,409   $ 2,260      $ (7,735
  

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss) per common share:

        

Basic

   $ (0.11   $ (0.13   $ 0.05      $ (0.16

Diluted

   $ (0.11   $ (0.13   $ 0.05      $ (0.16
Summary of Significant Accounting Policies (Policies)

Principles of Consolidation

The accompanying consolidated financial statements include those of Cerus Corporation and its subsidiary, Cerus Europe B.V. (collectively hereinafter “Cerus” or the “Company”) after elimination of all intercompany accounts and transactions. These consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”).

Use of Estimates

The preparation of financial statements requires management to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosures of contingent assets and liabilities. On an ongoing basis, the Company evaluates its estimates, including those related to revenue recognition, inventory valuation, certain accrued liabilities, valuation and impairment of purchased intangibles and goodwill, valuation of warrants, valuation of stock options under share-based payments, valuation allowance of its deferred tax assets and uncertain income tax positions. The Company basis its estimates on historical experience and on various other assumptions that the Company believes to be reasonable under the circumstances, the results of which form its basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from those estimates under different assumptions or conditions.

Reclassifications

Certain reclassifications have been made to prior period reported amounts to conform to the current period presentations. Previously the Company had presented its provision for income taxes as a component of other income (expense) , net on the Consolidated Statements of Operations. The Company has reclassified the provision for income taxes to a separate line item in the Consolidated Statements of Operations, and as presented in Note 17 and 19 to the Consolidated Financial Statements. This reclassification had no impact on net loss, total assets or total stockholders’ equity.

Revenue

The Company recognizes revenue in accordance with ASC Topic 605-25, “Revenue Recognition—Arrangements with Multiple Deliverables,” as applicable. Revenue is recognized when (i) persuasive evidence of an agreement exists; (ii) services have been rendered or product has been delivered; (iii) pricing is fixed or determinable; and (iv) collection is reasonably assured. The Company’s main sources of revenues for the years ended December 31, 2012, 2011 and 2010 were product revenue from sales of the INTERCEPT Blood System for platelets and plasma (“platelet and plasma systems”) and United States government grants and awards.

Revenue related to product sales is generally recognized when the Company fulfills its obligations for each element of an agreement. For all sales of the Company’s INTERCEPT Blood System products, the Company uses a binding purchase order and signed sales contract as evidence of a written agreement. The Company sells its platelet and plasma systems directly to blood banks, hospitals, universities, government agencies, as well as to distributors in certain regions. Generally, the Company’s contracts with its customers do not provide for open return rights, except within a reasonable time after receipt of goods in the case of defective or non-conforming product. Deliverables and the units of accounting vary according to the provisions of each purchase order or sales contract. For revenue arrangements with multiple elements, the Company determines whether the delivered elements meet the criteria as separate units of accounting. Such criteria require that the deliverable have stand-alone value to the customer and that if a general right of return exists relative to the delivered item, delivery or performance of the undelivered item(s) is considered probable and substantially in the control of the Company. Once the Company determines if the deliverable meets the criteria for a separate unit of accounting, the Company must determine how the consideration should be allocated between the deliverables and how the separate units of accounting should be recognized as revenue. Consideration received is allocated to elements that are identified as discrete units of accounting based on the best estimated selling price. The Company has determined that vendor specific objective evidence is not discernible due to the Company’s limited history of selling its products and variability in its pricing across the regions into which it sells its products. Since the Company’s products are novel and unique and are not sold by others, third-party evidence of selling price is unavailable.

At both December 31, 2012 and 2011, the Company had $0.1 million of short-term deferred revenue on its consolidated balance sheets related to future performance obligations. Freight costs charged to customers are recorded as a component of revenue under ASC Topic 605, “Accounting for Shipping and Handling Fees and Costs.” Value-added-taxes (“VAT”) that the Company invoices to its customers and remits to governments are recorded on a net basis, which excludes such VAT from product revenue.

Revenue related to the cost reimbursement provisions under development contracts or United States government grants was recognized as the costs on the projects are incurred. The Company has received certain United States government grants and contracts that support research in defined research projects. These grants generally have provided for reimbursement of approved costs incurred as defined in the various grants.

Research and Development Expenses

In accordance with ASC Topic 730, “Accounting for Research and Development Expenses,” research and development expenses are charged to expense when incurred, including cost incurred under each grant that has been awarded to the Company by the United States government or development contracts. Research and development expenses include salaries and related expenses for scientific personnel, payments to consultants, supplies and chemicals used in in-house laboratories, costs of research and development facilities, depreciation of equipment and external contract research expenses, including clinical trials, preclinical safety studies, other laboratory studies, process development and product manufacturing for research use.

The Company’s use of estimates in recording accrued liabilities for research and development activities (see “Use of Estimates” above) affects the amounts of research and development expenses recorded and revenue recorded from development funding and government grants and collaborative agreements. Actual results may differ from those estimates under different assumptions or conditions.

Cash Equivalents

The Company considers all highly liquid investments with original maturities of three months or less from the date of purchase to be classified as cash equivalents. These investments primarily consist of money market instruments, and are classified as available-for-sale.

Short-Term Investments

Investments with original maturities of greater than three months but less than one year from the date of purchase as well as available-for-sale investments with original maturities of greater than one year from the date of purchase, which included United States government agency securities, were classified as short-term investments. In accordance with ASC Topic 320, “Accounting for Certain Investments in Debt and Equity Securities,” the Company classified all debt securities as available-for-sale at the time of purchase and reevaluates such designation as of each balance sheet date. Available-for-sale securities are carried at estimated fair value. Unrealized gains and losses derived by changes in the estimated fair value of available-for-sale securities were recorded in “Net unrealized gains (losses) on available-for-sale securities, net of taxes” on the Company’s consolidated statements of comprehensive loss. Realized gains and losses from the sale or maturity of available-for-sale investments were recorded in “Other income, net” on the Company’s consolidated statements of operations. The cost of securities sold was based on the specific identification method. The Company reported the amortization of any premium and accretion of any discount resulting from the purchase of debt securities as a component of interest income.

The Company also reviewed all of its marketable securities on a regular basis to evaluate whether any security has experienced an other-than-temporary decline in fair value.

Restricted Cash

The Company holds a certificate of deposit with a domestic bank for any potential decommissioning resulting from the Company’s possession of radioactive material. The certificate of deposit is held to satisfy the financial surety requirements of the California Department of Health Services and is recorded in “Restricted cash” on the Company’s consolidated balance sheets.

Concentration of Credit Risk

Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash, cash equivalents and accounts receivable.

Pursuant to the Company’s investment policy, substantially all of the Company’s cash and cash equivalents are maintained at a major financial institution in the United States of high credit standing, which at times, may exceed federally insured limits. The Company has not experienced any losses in its cash accounts and believes it not exposed to any significant risk.

Concentrations of credit risk with respect to trade receivables exist. However, in connection with the Company’s revolving line of credit, as discussed in Note 11 in the Notes to Consolidated Financial Statements, the Company purchased a credit insurance policy that mitigates some of its credit risk, as the policy will pay either the Company or its lender on eligible claims filed on its outstanding receivables. On a regular basis, including at the time of sale, the Company performs credit evaluations of its customers. Generally, the Company does not require collateral from its customers to secure accounts receivable. To the extent that the Company determines specific invoices or customer accounts may be uncollectible, the Company reserves against the accounts receivable on its consolidated balance sheets and records a charge on its consolidated statements of operations.

The Company had three customers and two customers that accounted for more than 10% of the Company’s outstanding trade receivables at December 31, 2012 and 2011, respectively. These customers cumulatively represented approximately 59% and 58% of the Company’s outstanding trade receivables at December 31, 2012 and 2011, respectively. To date, the Company has not experienced collection difficulties from these customers.

Inventories

At December 31, 2012 and 2011, inventory consisted of work-in-process and finished goods only. Finished goods include INTERCEPT disposable kits, UVA illumination devices (“illuminators”), and certain replacement parts for the illuminators. Platelet and plasma systems’ disposable kits generally have a two-year life from the date of manufacture. Illuminators and replacement parts do not have regulated expiration dates. Work-in-process includes certain components that are manufactured over a protracted length of time, which can exceed one year, before being incorporated and assembled by Fresenius Kabi AG (“Fresenius”) into the finished INTERCEPT disposable kits. Fresenius is the successor-in-interest to Fenwal, Inc., or Fenwal, and Baxter International, Inc., or Baxter, under certain agreements which arose from the sale of the transfusion therapies division of Baxter in 2007 to Fenwal. Fenwal was recently acquired by Fresenius, which assumed Fenwal’s rights and obligations under these certain agreements, including the Company’s manufacturing and supply agreement with Fenwal. In these footnotes references to Fresenius include references to its predecessors-in-interest. The Company maintains an inventory balance based on its current sales projections, and at each reporting period, the Company evaluates whether its work-in-process inventory would be consumed for production of finished units in order to sell to existing and prospective customers within the next twelve-month period. It is not customary for the Company’s production cycle for inventory to exceed twelve months. Instead, the Company uses its best judgment to factor in lead times for the production of its finished units to meet the Company’s current demands. If actual results differ from those estimates, work-in-process inventory could potentially accumulate for periods exceeding one year. At December 31, 2012 and 2011, the Company classified its work-in-process inventory as a current asset on its consolidated balance sheets based on its evaluation that the work-in-process inventory would be consumed for production and subsequently sold within each respective subsequent twelve-month period.

Inventory is recorded at the lower of cost, determined on a first-in, first-out basis, or market value. The Company uses significant judgment to analyze and determine if the composition of its inventory is obsolete, slow-moving or unsalable and frequently reviews such determinations. Generally, the Company writes-down specifically identified unusable, obsolete, slow-moving, or known unsalable inventory that has no alternative use to net realizable value in the period that it is first recognized by using a number of factors including product expiration dates, open and unfulfilled orders, and sales forecasts. Any write-down of its inventory to net realizable value establishes a new cost basis and will be maintained even if certain circumstances suggest that the inventory is recoverable in subsequent periods. Costs associated with the write-down of inventory are recorded in “Cost of product revenue” on the Company’s consolidated statements of operations. At December 31, 2012 and 2011, the Company had $0.3 million and $0.6 million, respectively, reserved for potential obsolete, expiring or unsalable product. At December 31, 2012, the Company also wrote-down the value of certain unsalable inventory of $1.7 million for which the Company has an offsetting warranty claim against Fresenius. See below in Note 2 in the Notes to Consolidated Financial Statements under “Guarantee and Indemnification Arrangements” and Note 16 in the Notes to Consolidated Financial Statements for further information regarding the Company’s warranty claim against Fresenius.

Property and Equipment, net

Property and equipment is comprised of furniture, equipment, information technology hardware and software and is recorded at cost. At the time the property and equipment is ready for its intended use, it is depreciated on a straight-line basis over the estimated useful lives of the assets (generally three to five years). Leasehold improvements are amortized on a straight-line basis over the shorter of the lease term or the estimated useful lives of the improvements.

Goodwill and Intangible Assets, net

Additions to goodwill and intangible assets, net are derived at the time of a business acquisition, in which the Company assigns the total consideration transferred to the acquired assets based on each asset’s fair value and any residual amount becomes goodwill, an indefinite life intangible asset. Intangible assets, net, which include a license for the right to commercialize the INTERCEPT Blood System in Asia, are subject to ratable amortization over the estimated useful life of ten years. The amortization of the Company’s intangible assets, net, is recorded in “Amortization of intangible assets” on the Company’s consolidated statements of operations.

Goodwill is not amortized but instead is subject to an impairment test performed on an annual basis, or more frequently if events or changes in circumstances indicate that goodwill may be impaired. Such impairment analysis is performed on August 31 of each fiscal year, or more frequently if indicators of impairment exist. Effective January 1, 2012, the test for goodwill impairment may be assessed using qualitative factors to determine whether it is more likely than not that the fair value of a reporting unit is less than the carrying amount. If the Company determines that it is more likely than not that the fair value of a reporting unit is less than the carrying amount, the Company must then proceed with performing the quantitative two-step process to test goodwill for impairment; otherwise, goodwill is not considered impaired and no further testing is warranted. The Company may choose not to perform the qualitative assessment to test goodwill for impairment and proceed directly to the quantitative two-step process; however, the Company may revert to the qualitative assessment to test goodwill for impairment in any subsequent period. The first step of the two-step process compares the fair value of each reporting unit with its respective carrying amount, including goodwill. The Company has determined that it operates in one reporting unit and estimates the fair value of its one reporting unit using the enterprise approach under which it considers the quoted market capitalization of the Company as reported on the Nasdaq Global Market. The Company considers quoted market prices that are available in active markets to be the best evidence of fair value. The Company also considers other factors, which include future forecasted results, the economic environment and overall market conditions. If the fair value of the reporting unit exceeds its carrying amount, goodwill of the reporting unit is not considered impaired and, therefore, the second step of the impairment test is unnecessary. The second step of the two-step process, which is used to measure the amount of impairment loss, compares the implied fair value of each reporting unit’s goodwill with the respective carrying amount of that goodwill. If the carrying amount of the reporting unit’s goodwill exceeds the implied fair value of that goodwill, an impairment loss is recognized in an amount equal to that excess.

The Company performs an impairment test on its intangible assets, in accordance ASC Topic 360-10, “Property, Plant and Equipment,” if certain events or changes in circumstances occur which indicate that the carrying amounts of its intangible assets may not be recoverable. If the intangible assets are not recoverable, an impairment loss would be recognized by the Company based on the excess amount of the carrying value of the intangible assets over its fair value. For further details regarding the impairment analysis, reference is made to the section below under “Long-lived Assets.” Also, see Note 8 in the Notes to Consolidated Financial Statements for further information regarding the Company’s impairment analysis and the valuation of goodwill and intangible assets, net.

Long-lived Assets

The Company evaluates its long-lived assets for impairment by continually monitoring events and changes in circumstances that could indicate carrying amounts of its long-lived assets may not be recoverable. When such events or changes in circumstances occur, the Company assesses recoverability by determining whether the carrying value of such assets will be recovered through the undiscounted expected future cash flows. If the expected undiscounted future cash flows are less than the carrying amount of these assets, the Company then measures the amount of the impairment loss based on the excess of the carrying amount over the fair value of the assets. The Company did not recognize impairment charges related to its long-lived assets during the years ended December 31, 2012, 2011 and 2010.

Foreign Currency Remeasurement

The functional currency of the Company’s foreign subsidiary is the United States dollar. Monetary assets and liabilities denominated in foreign currencies are remeasured in United States dollars using the exchange rates at the balance sheet date. Non-monetary assets and liabilities denominated in foreign currencies are remeasured in United States dollars using historical exchange rates. Monetary revenues and expenses are remeasured using average exchange rates prevailing during the period. Remeasurements are recorded in the Company’s consolidated statements of operations. The Company recorded foreign currency losses of $0.1 million, $0.5 million and $0.8 million during the years ended December 31, 2012, 2011 and 2010, respectively.

Stock-Based Compensation

The Company accounts for stock-based compensation in accordance with ASC Topic 718, “Compensation—Stock Compensation.” Stock-based compensation expense is measured at the grant-date based on the fair value of the award and is recognized as expense on a straight-line basis over the requisite service period, which is the vesting period, and is adjusted for estimated forfeitures. To the extent that stock options contain performance criteria for vesting, stock-based compensation is recognized once the performance criteria are probable of being achieved.

For stock-based awards issued to non-employees, the Company follows ASC Topic 505-50, “Equity Based Payment to Non-Employees” and considers the measurement date at which the fair value of the stock-based award is measured to be the earlier of (i) the date at which a commitment for performance by the grantee to earn the equity instrument is reached or (ii) the date at which the grantee’s performance is complete. The Company recognizes stock-based compensation expense for the fair value of the vested portion of the non-employee stock-based awards in its consolidated statements of operations.

See Note 14 in the Notes to Consolidated Financial Statements for further information regarding the Company’s stock-based compensation assumptions and expenses.

Warrant Liability

In August 2009, and November 2010, the Company issued warrants to purchase an aggregate of 2.4 million and 3.7 million shares of common stock, respectively. The material terms of the warrants were identical under each issuance except for the exercise price, date issued and expiration date. The Company classifies the warrants as a liability on its consolidated balance sheets as the warrants contain certain material terms which require the Company (or its successor) to purchase the warrants for cash in an amount equal to the value of the unexercised portion of the warrants in connection with certain change of control transactions. In addition, the Company may also be required to pay cash to a warrant holder under certain circumstances if the Company is unable to timely deliver the shares acquired upon warrant exercise to such holder.

The fair value of these outstanding warrants is calculated using a combination of the Black-Scholes model and/or binomial-lattice option-pricing model and is adjusted accordingly at each reporting period. Option-pricing models require that the Company uses significant assumptions and judgment to determine appropriate inputs to the model. Some of the assumptions that the Company relies on include the volatility of the Company’s stock over the life of the warrant, risk-free interest rate and the probability of a change of control occurring. The binomial-lattice option-pricing model also considers a certain number of share price movements and the probability of each outcome happening.

Changes resulting from the revaluation of warrants to fair value are recorded in “Revaluation of warrant liability” on the consolidated statements of operations. Upon the exercise or modification to remove the provisions which require the warrants to be treated as a liability, the fair value of the warrants will be reclassified from a liability to stockholders’ equity on the Company’s consolidated balance sheets and no further adjustment to the fair value would be made in subsequent periods.

See Note 13 in the Notes to Consolidated Financial Statements for further information regarding the Company’s valuation of warrant liability.

Income Taxes

The Company accounts for income taxes using an asset and liability approach in accordance with ASC Topic 740 “Accounting for Income Taxes.” Under this method, deferred tax assets and liabilities are determined based on differences between the financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. ASC Topic 740 requires derecognition of tax positions that do not have a greater than 50% likelihood of being recognized upon review by a taxing authority having full knowledge of all relevant information. Use of a valuation allowance as described in ASC Topic 740 is not an appropriate substitute for the derecognition of a tax position. The Company recognizes accrued interest and penalties related to unrecognized tax benefits in its income tax expense. To date, the Company has not recognized any interest and penalties in its consolidated statements of operations, nor has its accrued for or made payments for interest and penalties. The Company had no unrecognized tax benefits as of December 31, 2012 and 2011. The Company continues to carry a full valuation allowance on all of its deferred tax assets. Although the Company believes it more likely than not that a taxing authority would agree with its current tax positions, there can be no assurance that the tax positions the Company has taken will be substantiated by a taxing authority if reviewed. The Company’s tax years 1998 through 2012 remain subject to examination by the taxing jurisdictions due to unutilized net operating losses and research credits.

Net Loss Per Common Share

Basic net loss per common share is computed by dividing net loss by the weighted average number of common shares outstanding for the period. Diluted net loss per common share gives effect to all potentially dilutive common shares outstanding for the period. The potentially dilutive securities include stock options, employee stock purchase plan rights, warrants and restricted stock units, which are calculated using the treasury stock method, and convertible preferred stock, which is calculated using the if-converted method. Diluted net loss per common share also gives effect to potential adjustments to the numerator for changes resulting from the revaluation of warrants to fair value for the period, even if the Company is in a net loss position if the effect would result in more dilution.

Diluted net loss per common share used the same weighted average number of common shares outstanding for the years ended December 31, 2011 and 2010, as calculated for the basic net loss per common share as the inclusion of any potential dilutive securities would be anti-dilutive. In addition, certain potential dilutive securities were excluded from the dilution calculation for the years ended December 31, 2012, as their inclusion would have been anti-dilutive.

The following table sets forth the reconciliation of the numerator and denominator used in the computation of basic and diluted net loss per common share for the years ended December 31, 2012, 2011 and 2010 (in thousands, except per share amounts):

 

     Year Ended December 31,  
     2012     2011     2010  

Numerator:

      

Net loss

   $ (15,917   $ (16,982   $ (16,911

Effect of revaluation of warrant liability

     (2,059     0        0   
  

 

 

   

 

 

   

 

 

 

Adjusted net loss used for dilution calculation

   $ (17,976   $ (16,982   $ (16,911
  

 

 

   

 

 

   

 

 

 

Denominator:

      

Basic weighted average number of common shares outstanding

     54,515        48,050        40,300   

Effect of dilutive potential common shares resulting from warrants accounted for as liabilities

     546        0        0   
  

 

 

   

 

 

   

 

 

 

Diluted weighted average number of common shares outstanding

     55,061        48,050        40,300   
  

 

 

   

 

 

   

 

 

 

Basic

   $ (0.29   $ (0.35   $ (0.42

Diluted

   $ (0.33   $ (0.35   $ (0.42

The table below presents common shares underlying stock options, employee stock purchase plan rights, warrants, restricted stock units and/or convertible preferred stock that were excluded from the calculation of the weighted average number of common shares outstanding used for the calculation of diluted net loss per common share. These were excluded from the calculation due to their anti-dilutive effect for the years ended December 31, 2012, 2011 and 2010 (shares in thousands):

 

     Year Ended December 31,  
     2012      2011      2010  

Weighted average of anti-dilutive potential common shares

     8,716         13,595         9,867   

Guarantee and Indemnification Arrangements

The Company recognizes the fair value for guarantee and indemnification arrangements issued or modified by the Company after December 31, 2002. In addition, the Company monitors the conditions that are subject to the guarantees and indemnifications in order to identify if a loss has occurred. If the Company determines it is probable that a loss has occurred, then any such estimable loss would be recognized under those guarantees and indemnifications. Some of the agreements that the Company is a party to contain provisions that indemnify the counter party from damages and costs resulting from claims that the Company’s technology infringes the intellectual property rights of a third party or claims that the sale or use of the Company’s products have caused personal injury or other damage or loss. The Company has not received any such requests for indemnification under these provisions and has not been required to make material payments pursuant to these provisions.

The Company generally provides for a one-year warranty on certain of its INTERCEPT blood-safety products covering defects in materials and workmanship. The Company accrues costs associated with warranty obligations when claims become known and are estimable. During the year ended December 31, 2012, the Company provided for and settled the claims for warranty obligations of $0.9 million related to replacement costs for certain of its products that the Company identified were defective or had the potential of being defective. Prior to this incident, there have been very few warranty costs incurred. As a result, the Company had not accrued for any potential future warranty costs at December 31, 2011. In addition, the Company believes that the defective products and those that had the potential of being defective identified during the year ended December 31, 2012 are isolated. Accordingly, the Company has not accrued for any other incremental potential future warranty costs for its products at December 31, 2012.

In connection with the warranty obligations provided for in relation to certain of its products during the year ended December 31, 2012, the Company filed a warranty claim against Fresenius, which Fresenius accepted. As a result, the Company recorded a current asset of $1.8 million on its consolidated balance sheets as of December 31, 2012 representing the full amount of the warranty claim against Fresenius as Fresenius will supply the Company with replacement products or credit notes for those defective or potentially defective products. The Company also wrote-down the value of certain unsalable inventory of $1.7 million related to these products as an offsetting warranty claim against Fresenius.

Fair Value of Financial Instruments

The Company applies the provisions of fair value relating to its financial assets and liabilities. The carrying amounts of accounts receivables, accounts payable, and other accrued liabilities approximate their fair value due to the relative short-term maturities. Based on the borrowing rates currently available to the Company for loans with similar terms, the Company believes the fair value of its debt approximates their carrying amounts. The Company measures and records certain financial assets and liabilities at fair value on a recurring basis, including its available-for-sale securities and warrant liability. The Company classifies instruments within Level 1 if quoted prices are available in active markets for identical assets, which include the Company’s cash accounts and its money market funds. The Company classifies instruments in Level 2 if the instruments are valued using observable inputs to quoted market prices, benchmark yields, reported trades, broker/dealer quotes or alternative pricing sources with reasonable levels of price transparency. These instruments include the Company’s available-for-sale securities related to United States government agencies. The available-for-sale securities are held by a custodian who obtains investment prices from a third party pricing provider that uses standard inputs (observable in the market) to models which vary by asset class. The Company classifies instruments in Level 3 if one or more significant inputs or significant value drivers are unobservable, Level 3 instruments include our warrant liability. The Company assesses any transfers among fair value measurement levels at the end of each reporting period.

See Note 4 and 13 in the Notes to Consolidated Financial Statements for further information regarding the Company’s valuation on financial instruments.

New Accounting Pronouncements

There have been no new accounting pronouncements issued during the year ended December 31, 2012, that are of significance, or potential significance, to the Company.

Summary of Significant Accounting Policies (Tables)

The following table sets forth the reconciliation of the numerator and denominator used in the computation of basic and diluted net loss per common share for the years ended December 31, 2012, 2011 and 2010 (in thousands, except per share amounts):

 

     Year Ended December 31,  
     2012     2011     2010  

Numerator:

      

Net loss

   $ (15,917   $ (16,982   $ (16,911

Effect of revaluation of warrant liability

     (2,059     0        0   
  

 

 

   

 

 

   

 

 

 

Adjusted net loss used for dilution calculation

   $ (17,976   $ (16,982   $ (16,911
  

 

 

   

 

 

   

 

 

 

Denominator:

      

Basic weighted average number of common shares outstanding

     54,515        48,050        40,300   

Effect of dilutive potential common shares resulting from warrants accounted for as liabilities

     546        0        0   
  

 

 

   

 

 

   

 

 

 

Diluted weighted average number of common shares outstanding

     55,061        48,050        40,300   
  

 

 

   

 

 

   

 

 

 

Basic

   $ (0.29   $ (0.35   $ (0.42

Diluted

   $ (0.33   $ (0.35   $ (0.42

The table below presents common shares underlying stock options, employee stock purchase plan rights, warrants, restricted stock units and/or convertible preferred stock that were excluded from the calculation of the weighted average number of common shares outstanding used for the calculation of diluted net loss per common share. These were excluded from the calculation due to their anti-dilutive effect for the years ended December 31, 2012, 2011 and 2010 (shares in thousands):

 

     Year Ended December 31,  
     2012      2011      2010  

Weighted average of anti-dilutive potential common shares

     8,716         13,595         9,867   
BioOne Acquisition (Tables)
Final Allocation of Fair Value of Assets Acquired at Acquisition Date

The following table summarizes the fair value of assets acquired at the acquisition date (in thousands):

Commercialization rights—Asia

   $ 2,017   

Illuminators—inventory

     270   

Demonstration illuminators

     135   

Goodwill

     1,316   
  

 

 

 

Total

   $ 3,738   
  

 

 

 
Fair Value on Financial Instruments (Tables)

The fair values of certain of the Company’s financial assets and liabilities were determined using the following inputs at December 31, 2012 (in thousands):

 

     Total      Quoted
Prices in
Active
Markets for
Identical
Assets
(Level 1)
     Significant
Other
Observable
Inputs
(Level 2)
     Significant
Unobservable
Inputs

(Level 3)
 

Money market funds(1)

   $ 10,268       $ 10,268       $ 0       $ 0   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total financial assets

   $ 10,268       $ 10,268       $ 0       $ 0   
  

 

 

    

 

 

    

 

 

    

 

 

 

Warrant liability(2)

   $ 5,903       $ 0       $ 0       $ 5,903   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total financial liabilities

   $ 5,903       $ 0       $ 0       $ 5,903   
  

 

 

    

 

 

    

 

 

    

 

 

 

 

(1) Included in cash and cash equivalents on the Company’s consolidated balance sheets.

 

(2) Included in current liabilities on the Company’s consolidated balance sheets.

 

The fair values of certain of the Company’s financial assets and liabilities were determined using the following inputs at December 31, 2011 (in thousands):

 

     Total      Quoted
Prices in
Active
Markets for
Identical
Assets
(Level 1)
     Significant
Other
Observable
Inputs
(Level 2)
     Significant
Unobservable
Inputs

(Level 3)
 

Money market funds(1)

   $ 8,683       $ 8,683       $ 0       $ 0   

United States government agency securities(2)

     287         0         287         0   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total financial assets

   $ 8,970       $ 8,683       $ 287       $ 0   
  

 

 

    

 

 

    

 

 

    

 

 

 

Warrant liability(3)

   $ 7,979       $ 0       $ 0       $ 7,979   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total financial liabilities

   $ 7,979       $ 0       $ 0       $ 7,979   
  

 

 

    

 

 

    

 

 

    

 

 

 

 

(1) Included in cash and cash equivalents on the Company’s consolidated balance sheets.

 

(2) Included in short-term investments on the Company’s consolidated balance sheets.

 

(3) Included in current liabilities on the Company’s consolidated balance sheets.

A reconciliation of the beginning and ending balances for warrant liability using significant unobservable inputs (Level 3) from December 31, 2010 to December 31, 2012 was as follows (in thousands):

 

Balance at December 31, 2010

   $ 8,465   

Decrease in fair value of warrants

     (486
  

 

 

 

Balance at December 31, 2011

     7,979   

Decrease in fair value of warrants

     (2,059

Settlement of warrants exercised

     (17
  

 

 

 

Balance at December 31, 2012

   $ 5,903   
  

 

 

 
Available-for-sale Securities (Tables)

The following is a summary of available-for-sale securities at December 31, 2012 (in thousands):

 

     December 31, 2012  
     Carrying Value      Gross
    Unrealized Gain    
     Fair Value  

Money market funds

   $ 10,268       $ 0       $ 10,268   
  

 

 

    

 

 

    

 

 

 

Total available-for-sale securities

   $ 10,268       $ 0       $ 10,268   
  

 

 

    

 

 

    

 

 

 

 

The following is a summary of available-for-sale securities at December 31, 2011 (in thousands):

 

     December 31, 2011  
     Carrying Value      Gross
Unrealized Gain
     Fair Value  

Money market funds

   $ 8,683       $ 0       $ 8,683   

United States government agency securities

     287         0         287   
  

 

 

    

 

 

    

 

 

 

Total available-for-sale securities

   $ 8,970       $ 0       $ 8,970   
  

 

 

    

 

 

    

 

 

 

Available-for-sale securities at December 31, 2012 and 2011 consisted of the following by original contractual maturity (in thousands):

 

     December 31, 2012      December 31, 2011  
     Carrying
Value
     Fair Value      Carrying
Value
     Fair Value  

Due in one year or less

   $ 10,268       $ 10,268       $ 8,683       $ 8,683   

Due greater than three years and less than five years

     0         0         287         287   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total available-for-sale securities

   $ 10,268       $ 10,268       $ 8,970       $ 8,970   
  

 

 

    

 

 

    

 

 

    

 

 

 
Inventories (Tables)
Inventories

Inventories at December 31, 2012 and 2011 consisted of the following (in thousands):

 

     December 31,  
     2012      2011  

Work-in-process

   $ 3,551       $ 2,742   

Finished goods

     6,629         3,702   
  

 

 

    

 

 

 

Total inventories

   $ 10,180       $ 6,444   
  

 

 

    

 

 

 
Property and Equipment, net (Tables)
Property and Equipment, Net

Property and equipment, net at December 31, 2012 and 2011 consisted of the following (in thousands):

 

     December 31,  
     2012     2011  

Leasehold improvements

   $ 5,598      $ 5,598   

Machinery and equipment

     1,594        1,682   

Demonstration equipment

     24        24   

Office furniture

     644        636   

Computer equipment

     550        525   

Computer software

     1,062        1,062   

Consigned demonstration equipment

     493        502   

Construction-in-progress

     55        38   
  

 

 

   

 

 

 

Total property and equipment, gross

     10,020        10,067   

Accumulated depreciation and amortization

     (8,322     (8,035
  

 

 

   

 

 

 

Total property and equipment, net

   $ 1,698      $ 2,032   
  

 

 

   

 

 

 
Goodwill and Intangible Assets, net (Tables)
Summary of Intangible Assets

The following is a summary of intangible assets, net at December 31, 2012 (in thousands):

 

     December 31, 2012  
     Gross Carrying
Amount
     Accumulated
Amortization
    Net Carrying
Amount
 

Acquisition-related intangible assets:

       

Reacquired license—INTERCEPT Asia

   $ 2,017       $ (471   $ 1,546   
  

 

 

    

 

 

   

 

 

 

Total intangible assets

   $ 2,017       $ (471   $ 1,546   
  

 

 

    

 

 

   

 

 

 

 

The following is a summary of intangible assets, net at December 31, 2011 (in thousands):

 

     December 31, 2011  
     Gross Carrying
Amount
     Accumulated
Amortization
    Net Carrying
Amount
 

Acquisition-related intangible assets:

       

Reacquired license—INTERCEPT Asia

   $ 2,017       $ (269   $ 1,748   
  

 

 

    

 

 

   

 

 

 

Total intangible assets

   $ 2,017       $ (269   $ 1,748   
  

 

 

    

 

 

   

 

 

 
Accrued Liabilities (Tables)
Accrued Liabilities

Accrued liabilities at December 31, 2012 and 2011 consisted of the following (in thousands):

 

     December 31,  
     2012      2011  

Accrued compensation and related costs

   $ 2,692       $ 2,027   

Accrued inventory costs

     2,352         1,417   

Accrued contract and other accrued expenses

     2,575         2,381   
  

 

 

    

 

 

 

Total accrued liabilities

   $ 7,619       $ 5,825   
  

 

 

    

 

 

 
Debt (Tables)

Debt at December 31, 2012 consisted of the following (in thousands):

 

     December 31, 2012  
     Principal     Unamortized
Discount
    Total  

Comerica—Growth Capital Loan A, due 2015

   $ 4,583      $ (49   $ 4,534   

Comerica—Revolving Line of Credit, due 2014

     3,190        0        3,190   
  

 

 

   

 

 

   

 

 

 

Total debt

     7,773        (49     7,724   

Less: debt—current

     (4,857     29        (4,828
  

 

 

   

 

 

   

 

 

 

Debt—non-current

   $ 2,916      $ (20   $ 2,896   
  

 

 

   

 

 

   

 

 

 

Debt at December 31, 2011 consisted of the following (in thousands):

 

     December 31, 2011  
     Principal     Unamortized
Discount
    Total  

Comerica—Growth Capital Loan A, due 2015

   $ 5,000      $ (84   $ 4,916   

Comerica—Revolving Line of Credit, due 2014

     2,300        0        2,300   
  

 

 

   

 

 

   

 

 

 

Total debt

     7,300        (84     7,216   

Less: debt—current

     (2,554     35        (2,519
  

 

 

   

 

 

   

 

 

 

Debt—non-current

   $ 4,746      $ (49   $ 4,697   
  

 

 

   

 

 

   

 

 

 

Principal and interest payments on debt at December 31, 2012 are expected to be as follows for each of the following three years (in thousands):

 

Year ended December 31,

      

2013

   $ 2,063   

2014(1)

     5,084   

2015

     1,334   

 

(1) Included outstanding revolving line of credit balance based on the Company’s obligation to repay the outstanding revolving line of credit balance at the end of the revolving line of credit term.
Commitments and Contingencies (Tables)
Future Minimum Non-Cancelable Lease Payments Under Operating Leases

Future minimum non-cancelable lease payments under operating leases as of December 31, 2012 are as follows (in thousands):

 

Year ended December 31,

      

2013

   $ 865   

2014

     838   

2015

     350   

2016

     45   

2017

     4   
  

 

 

 

Total minimum non-cancellable lease payments

   $ 2,102   
  

 

 

 
Stockholders' Equity (Tables)

The fair value of the warrants at December 31, 2012 and 2011 consisted of the following (in thousands):

 

     December 31,  
     2012      2011  

2009 Warrants

   $ 2,009       $ 3,010   

2010 Warrants

     3,894         4,969   
  

 

 

    

 

 

 

Total warrant liability

   $ 5,903       $ 7,979   
  

 

 

    

 

 

 

The fair value of the Company’s warrants was based on using the Black-Scholes model and/or binomial-lattice option valuation model and using the following assumptions at December 31, 2012 and 2011:

 

     December 31,
     2012   2011

2009 Warrants:

    

Expected term (in years)

   1.65   2.65

Estimated volatility

   45%   74%

Risk-free interest rate

   0.25%   0.36%

Expected dividend yield

   0%   0%

2010 Warrants:

    

Expected term (in years)

   2.86   3.86

Estimated volatility

   51%   70%

Risk-free interest rate

   0.36%   0.60%

Expected dividend yield

   0%   0%
Stock-Based Compensation (Tables)

Activity under the Company’s equity incentive plans related to stock options is set forth below (in thousands except weighted average exercise price):

 

     Number of
Options
Outstanding
    Weighted Average
Exercise Price per
Share
 

Balances at December 31, 2009

     6,565      $ 7.38   

Granted

     981        2.90   

Forfeited

     (28     3.03   

Expired

     (309     19.20   

Exercised

     (202     1.62   
  

 

 

   

Balances at December 31, 2010

     7,007      $ 6.42   

Granted

     2,169        2.36   

Forfeited

     (465     2.45   

Expired

     (1,237     11.52   

Exercised

     (112     0.81   
  

 

 

   

Balances at December 31, 2011

     7,362      $ 4.70   

Granted

     1,782        3.68   

Forfeited

     (98     2.78   

Expired

     (386     30.44   

Exercised

     (156     1.30   
  

 

 

   

Balances at December 31, 2012

     8,504      $ 3.40   
  

 

 

   

Information regarding the Company’s stock options outstanding, stock options vested and expected to vest, and stock options exercisable at December 31, 2012, 2011 and 2010, was as follows (in thousands except weighted average exercise price and contractual term):

 

     Number
of Shares
     Weighted
Average
Exercise
Price
     Weighted
Average
Remaining
Contractual
Term (Years)
     Aggregate
Intrinsic
Value
 

Balances at December 31, 2012

           

Stock options outstanding

     8,504       $ 3.40         6.59       $ 5,433   

Stock options vested and expected to vest

     8,140       $ 3.42         6.49       $ 5,310   

Stock options exercisable

     5,150       $ 3.77         5.43       $ 3,582   

Balances at December 31, 2011

           

Stock options outstanding

     7,362       $ 4.70         6.66       $ 4,065   

Stock options vested and expected to vest

     6,900       $ 4.86         6.47       $ 3,835   

Stock options exercisable

     4,058       $ 6.70         5.00       $ 1,902   

Balances at December 31, 2010

           

Stock options outstanding

     7,007       $ 6.42         6.22       $ 2,761   

Stock options vested and expected to vest

     6,705       $ 6.60         6.08       $ 2,610   

Stock options exercisable

     4,323       $ 8.93         4.83       $ 922   

Activity under the Company’s equity incentive plans related to restricted stock units is set forth below:

 

     Number of
RSUs
    Weighted Average
Grant-Date Fair
Value
 

Balances at December 31, 2009

     37,867      $ 6.45   

Granted

     76,532        1.85   

Forfeited

     0        0.00   

Vested

     (25,999     6.20   
  

 

 

   

Balances at December 31, 2010

     88,400      $ 2.54   

Granted

     0        0.00   

Forfeited

     (17,727     1.85   

Vested

     (37,378     3.48   
  

 

 

   

Balances at December 31, 2011

     33,295      $ 1.85   

Granted

     2,000        3.03   

Forfeited

     0        0.00   

Vested

     (18,650     1.98   
  

 

 

   

Balances at December 31, 2012

     16,645      $ 1.85   
  

 

 

   

Stock-based compensation expense recognized on the Company’s consolidated statements of operations for the years ended December 31, 2012, 2011 and 2010, was as follows (in thousands):

 

     Year Ended December 31,  
     2012      2011      2010  

Stock-based compensation expense by caption:

        

Research and development

   $ 554       $ 450       $ 376   

Selling, general and administrative

     1,987         1,400         1,452   
  

 

 

    

 

 

    

 

 

 

Total stock-based compensation expense

   $ 2,541       $ 1,850       $ 1,828   
  

 

 

    

 

 

    

 

 

 

The weighted average assumptions used to value the Company’s stock-based awards for the years ended December 31, 2012, 2011 and 2010, was as follows:

 

     Year Ended December 31,  
     2012     2011     2010  

Stock Options:

      

Expected term (in years)

     5.54        5.30        5.40   

Estimated volatility

     67     68     82

Risk-free interest rate

     1.03     1.23     1.40

Expected dividend yield

     0     0     0

Employee Stock Purchase Plan Rights:

      

Expected term (in years)

     0.50        0.50        0.50   

Estimated volatility

     101     48     61

Risk-free interest rate

     0.14     0.08     0.89

Expected dividend yield

     0     0     0
Income Taxes (Tables)

U.S and foreign components of consolidated loss before income taxes for the years ended December 2012, 2011 and 2010 was as follows (in thousands):

 

     Year Ended December 31,  
     2012     2011     2010  

Income (loss) before income taxes:

      

U.S.

   $ (16,360   $ (17,461   $ (17,256

Foreign

     685        622        439   
  

 

 

   

 

 

   

 

 

 

Loss before income taxes

   $ (15,675   $ (16,839   $ (16,817
  

 

 

   

 

 

   

 

 

 

The provision for income taxes for the years ended December 2012, 2011 and 2010 was as follows (in thousands):

 

     Year Ended December 31,  
         2012              2011              2010      

Provision for income taxes:

        

Current:

        

Foreign

   $ 180       $ 143       $ 94   

Federal

     0         0         0   

State

     0         0         0   
  

 

 

    

 

 

    

 

 

 

Total Current

     180         143         94   

Deferred:

        

Foreign

     0         0         0   

Federal

     48         0         0   

State

     14         0         0   
  

 

 

    

 

 

    

 

 

 

Total Deferred

     62       $ 0       $ 0   
  

 

 

    

 

 

    

 

 

 

Provision for income taxes

   $ 242       $ 143       $ 94   
  

 

 

    

 

 

    

 

 

 

The difference between the provision for income taxes and the amount computed by applying the federal statutory income tax rate to loss before taxes for the years ended December 31, 2012, 2011 and 2010 was as follows (in thousands):

 

     Year Ended December 31,  
     2012     2011     2010  

Federal statutory tax

   ($ 5,329   ($ 5,725   ($ 5,718

Stock-based compensation

     99        83        95   

Lobbying expenses

     51        112        112   

Warrants

     (706     (165     (13

Research Grant

     0        0        (166

Gain on investment

     0        0        (107

Foreign rate differential

     (53     (68     (56

Expiration of federal net operating losses and credits - tax effected

     4,352        1,744        (596

Change in valuation allowance

     1,761        4,158        6,544   

Goodwill amortization

     48        0        0   

Other

     19        4        (1
  

 

 

   

 

 

   

 

 

 

Provision for income taxes

   $ 242      $ 143      $ 94   
  

 

 

   

 

 

   

 

 

 

The significant components of the Company’s deferred tax assets at December 31, 2012 and 2011 were as follows (in thousands):

 

     December 31,  
     2012     2011  

Deferred tax assets:

    

Net operating loss carryforwards

   $ 137,700      $ 137,800   

Research and development credit carryforwards

     30,800        31,400   

Capitalized inventory costs

     900        500   

Inventory reserve

     700        200   

Capitalized research and development

     9,100        10,300   

Capitalized trademark

     400        200   

Capitalized revenue sharing rights

     300        600   

Asia license intangible

     100        0   

Deferred compensation

     4,800        4,200   

Accrued liabilities

     100        400   

Depreciation

     1,300        1,400   

Acqusition costs

     200        200   

Deferred tenant allowance

     200        200   

Capital loss carryforwards

     3,900        3,900   
  

 

 

   

 

 

 

Total deferred tax assets

     190,500        191,300   

Valuation allowance

     (190,500     (191,300
  

 

 

   

 

 

 

Net deferred tax assets

   $ 0      $ 0   
  

 

 

   

 

 

 

Deferred tax liabilities:

    

Amortization of goodwill

   $ 62      $ 0   
  

 

 

   

 

 

 

Total deferred tax liabilities

   $ 62      $ 0   
  

 

 

   

 

 

 
Segment, Customer and Geographic Information (Tables)

The Company had the following significant customers that accounted for more than 10% of the Company’s total product revenue, all of which operate in a country outside of the United States, during the years ended December 31, 2012, 2011 and 2010 (in percentages):

 

     Year Ended December 31,  
         2012             2011             2010      

Etablissement Francais du Sang

     20     24     20

Movaco, S.A.

     19     21     19

Delrus Inc.

     12     12     16

Service Francophone du Sang *

     *        *        12

 

* Represents an amount less than 10% of product revenue.

Net revenues by geographical location was based on the location of the customer, in the case of product revenues, and in the location of the collaboration partner, in the case of non-product revenues, during the years ended December 31, 2012, 2011 and 2010 and was as follows (in thousands):

 

     Year Ended December 31,  
     2012      2011      2010  

Product Revenue:

        

France

   $ 7,321       $ 7,385       $ 4,432   

Spain and Portugal

     7,061         6,504         4,175   

CIS

     8,016         3,754         3,383   

Belgium

     4,016         3,703         3,710   

Switzerland

     3,866         3,315         1,330   

Other countries

     6,415         5,941         4,647   
  

 

 

    

 

 

    

 

 

 

Total product revenue

     36,695         30,602         21,677   

Government grants and cooperative agreements:

        

United States

     91         2,442         1,432   
  

 

 

    

 

 

    

 

 

 

Total government grants and cooperative agreements

     91         2,442         1,432   
  

 

 

    

 

 

    

 

 

 

Total revenue

   $ 36,786       $ 33,044       $ 23,109   
  

 

 

    

 

 

    

 

 

 

Long-lived assets by geographical location, which consist of property and equipment, net, intangible assets, net, and certain other assets, at December 31, 2012 and 2011 were as follows (in thousands):

 

     December 31,  
      2012      2011  

United States

   $ 2,895       $ 3,299   

Europe

     349         650   
  

 

 

    

 

 

 

Total long-lived assets

   $ 3,244       $ 3,949   
  

 

 

    

 

 

 
Quarterly Financial Information (Unaudited) (Tables)
Quarterly Unaudited Financial Data

The following tables summarize the Company’s quarterly financial information for the years ended December 31, 2012 and 2011 (in thousands except per share amounts):

 

     Three Months Ended  
     March 31,
2012
    June 30,
2012
    September 30,
2012
    December 31,
2012
 

Revenue:

        

Product revenue

   $ 8,691      $ 9,224      $ 8,252      $ 10,528   

Cost of product revenue

     5,514        5,574        4,411        5,117   
  

 

 

   

 

 

   

 

 

   

 

 

 

Gross profit on product revenue

     3,177        3,650        3,841        5,411   

Government grants and cooperative agreements revenue

     91        0        0        0   

Operating expenses:

        

Research and development

     1,824        1,712        1,903        2,164   

Selling, general and administrative

     5,966        6,686        6,219        6,794   

Amortization of intangible assets

     50        51        50        51   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     7,840        8,449        8,172        9,009   
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (4,572     (4,799     (4,331     (3,598

Total non-operating income (expense), net

     (4,227     2,933        926        1,993   
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss before income taxes

     (8,799     (1,866     (3,405     (1,605

Provision for income taxes

     35        41        55        111   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (8,834   $ (1,907   $ (3,460   $ (1,716
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per common share:

        

Basic

   $ (0.17   $ (0.04   $ (0.06   $ (0.03

Diluted

   $ (0.17   $ (0.10   $ (0.08   $ (0.07

 

     Three Months Ended  
     March 31,
2011
    June 30,
2011
    September 30,
2011
    December 31,
2011
 

Revenue:

        

Product revenue

   $ 6,183      $ 6,753      $ 7,770      $ 9,896   

Cost of product revenue

     3,529        4,074        4,726        6,206   
  

 

 

   

 

 

   

 

 

   

 

 

 

Gross profit on product revenue

     2,654        2,679        3,044        3,690   

Government grants and cooperative agreements revenue

     436        0        1,479        527   

Operating expenses:

        

Research and development

     1,808        1,994        1,814        1,562   

Selling, general and administrative

     5,528        6,207        5,380        5,938   

Amortization of intangible assets

     50        51        51        50   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     7,386        8,252        7,245        7,550   
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (4,296     (5,573     (2,722     (3,333

Total non-operating income (expense), net

     (779     (809     5,026        (4,353
  

 

 

   

 

 

   

 

 

   

 

 

 

Income (loss) before income taxes

     (5,075     (6,382     2,304        (7,686

Provision for income taxes

     23        27        44        49   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss)

   $ (5,098   $ (6,409   $ 2,260      $ (7,735
  

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss) per common share:

        

Basic

   $ (0.11   $ (0.13   $ 0.05      $ (0.16

Diluted

   $ (0.11   $ (0.13   $ 0.05      $ (0.16
Summary of Significant Accounting Policies - Additional Information (Detail) (USD $)
Share data in Millions, unless otherwise specified
12 Months Ended 12 Months Ended 12 Months Ended
Dec. 31, 2012
Customer
Dec. 31, 2011
Customer
Dec. 31, 2010
Aug. 31, 2009
2009 Unit Offering
Warrant
Nov. 30, 2010
2010 Unit Offering
Warrant
Dec. 31, 2012
Maximum
Dec. 31, 2012
Minimum
Dec. 31, 2011
Minimum
Dec. 31, 2012
Minimum
Available-for-sale Securities
Summary Of Significant Accounting Policies [Line Items]
 
 
 
 
 
 
 
 
 
Deferred revenue
$ 77,000 
$ 111,000 
 
 
 
 
 
 
 
Highly liquid investments, original maturities
 
 
 
 
 
3 months 
 
 
 
Short-term investments, original maturities
 
 
 
 
 
1 year 
3 months 
 
1 year 
Number of major customers representing outstanding trade receivables
 
 
 
 
 
 
 
Cumulative outstanding trade receivables percentage by major customers
59.00% 
58.00% 
 
 
 
 
10.00% 
10.00% 
 
Life of inventory
2 years 
 
 
 
 
 
 
 
 
Protracted length of inventory
P1Y 
 
 
 
 
 
 
 
 
Inventory valuation reserves
300,000 
600,000 
 
 
 
 
 
 
 
Unsalable product having offsetting warranty claim
1,700,000 
 
 
 
 
 
 
 
Estimated useful life of property and equipment
 
 
 
 
 
5 years 
3 years 
 
 
Estimated useful life of intangible assets
10 years 
 
 
 
 
 
 
 
 
Impairment charges on long-lived assets
 
 
 
 
 
 
Foreign currency gains (losses)
86,000 
(529,000)
(816,000)
 
 
 
 
 
 
Warrants to purchase an aggregate shares of common stock
 
 
 
2.4 
3.7 
 
 
 
 
Derecognition of tax positions, Maximum
 
 
 
 
 
50.00% 
 
 
 
Company's tax years subject to examination by the taxing jurisdictions
 
 
 
 
 
2012 
1998 
 
 
Unrecognized Tax Benefits
 
 
 
 
 
 
 
Period of warranty
1 year 
 
 
 
 
 
 
 
 
Warrants obligation provided
900,000 
 
 
 
 
 
 
 
 
Product warranty receivable current
$ 1,800,000 
 
 
 
 
 
 
 
 
Reconciliation of Numerator and Denominator Used in Computation of Basic and Diluted Net Income Loss Per Common Share (Detail) (USD $)
In Thousands, except Per Share data, unless otherwise specified
3 Months Ended 12 Months Ended
Dec. 31, 2012
Sep. 30, 2012
Jun. 30, 2012
Mar. 31, 2012
Dec. 31, 2011
Sep. 30, 2011
Jun. 30, 2011
Mar. 31, 2011
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2010
Numerator:
 
 
 
 
 
 
 
 
 
 
 
Net loss
$ (1,716)
$ (3,460)
$ (1,907)
$ (8,834)
$ (7,735)
$ 2,260 
$ (6,409)
$ (5,098)
$ (15,917)
$ (16,982)
$ (16,911)
Effect of revaluation of warrant liability
 
 
 
 
 
 
 
 
(2,059)
Adjusted net loss used for dilution calculation
 
 
 
 
 
 
 
 
$ (17,976)
$ (16,982)
$ (16,911)
Denominator
 
 
 
 
 
 
 
 
 
 
 
Basic weighted average number of common shares outstanding
 
 
 
 
 
 
 
 
54,515 
48,050 
40,300 
Effect of dilutive potential common shares resulting from warrants accounted for as liabilities
 
 
 
 
 
 
 
 
546 
Diluted weighted average number of common shares outstanding
 
 
 
 
 
 
 
 
55,061 
48,050 
40,300 
Basic
$ (0.03)
$ (0.06)
$ (0.04)
$ (0.17)
$ (0.16)
$ 0.05 
$ (0.13)
$ (0.11)
$ (0.29)
$ (0.35)
$ (0.42)
Diluted
$ (0.07)
$ (0.08)
$ (0.10)
$ (0.17)
$ (0.16)
$ 0.05 
$ (0.13)
$ (0.11)
$ (0.33)
$ (0.35)
$ (0.42)
Common Shares Underlying Stock Options Convertible Preferred Stock Employee Stock Purchase Plan Rights Warrants and Restricted Stock Units Excluded from Calculation of Weighted Average Number of Common Shares Outstanding used for Calculation of Diluted Net Income Loss Per Common Share (Detail)
In Thousands, unless otherwise specified
12 Months Ended
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2010
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
 
 
 
Weighted average of anti-dilutive potential common shares
8,716 
13,595 
9,867 
BioOne Acquisition - Additional Information (Detail) (USD $)
In Millions, except Share data, unless otherwise specified
1 Months Ended 12 Months Ended
Feb. 28, 2011
Aug. 31, 2010
Dec. 31, 2012
Dec. 31, 2010
Business Acquisition [Line Items]
 
 
 
 
Business acquisition, common stock shares issued
234,471 
937,886 
 
 
Business acquisition, close date
 
Aug. 24, 2010 
 
 
Business acquisition, total consideration provided
 
 
 
$ 3.7 
Business acquisition, fair value common stock shares issued
 
 
 
3.4 
Business acquisition, fair value of non-controlling equity interest relinquished
 
 
 
0.3 
Business acquisition, gain recognized
 
 
 
0.3 
Business acquisition, carrying value of investment
 
 
 
Business acquisition, investment percentage
 
 
 
13.00% 
Business acquisition, estimated fair value of acquired assets excluding goodwill
 
 
 
2.4 
Business acquisition, acquisition related costs
 
 
 
$ 0.5 
Business acquisition, intangible assets estimated useful life
 
 
10 years 
 
Common Stock Issuable
 
 
 
 
Business Acquisition [Line Items]
 
 
 
 
Business acquisition, common stock shares issued
 
1,172,357 
 
 
Summary of Final Allocation of Fair Value of Assets Acquired (Detail) (USD $)
In Thousands, unless otherwise specified
Aug. 24, 2010
Business Acquisition [Line Items]
 
Commercialization rights-Asia
$ 2,017 
Illuminators-inventory
270 
Demonstration illuminators
135 
Goodwill
1,316 
Total
$ 3,738 
Fair Value on Financial Assets and Liabilities (Detail) (USD $)
In Thousands, unless otherwise specified
Dec. 31, 2012
Dec. 31, 2011
Fair value of financial assets and liabilities
 
 
Total financial assets
$ 10,268 
$ 8,970 
Total financial liabilities
5,903 
7,979 
Money Market Funds
 
 
Fair value of financial assets and liabilities
 
 
Total financial assets
10,268 1
8,683 1
Warrant Liability
 
 
Fair value of financial assets and liabilities
 
 
Total financial liabilities
5,903 2
7,979 2
United States government agency securities
 
 
Fair value of financial assets and liabilities
 
 
Total financial assets
 
287 3
Quoted Prices in Active Markets for Identical Assets (Level 1)
 
 
Fair value of financial assets and liabilities
 
 
Total financial assets
10,268 
8,683 
Total financial liabilities
Quoted Prices in Active Markets for Identical Assets (Level 1) |
Money Market Funds
 
 
Fair value of financial assets and liabilities
 
 
Total financial assets
10,268 1
8,683 1
Quoted Prices in Active Markets for Identical Assets (Level 1) |
Warrant Liability
 
 
Fair value of financial assets and liabilities
 
 
Total financial liabilities
2
2
Quoted Prices in Active Markets for Identical Assets (Level 1) |
United States government agency securities
 
 
Fair value of financial assets and liabilities
 
 
Total financial assets
 
3
Significant Other Observable Inputs (Level 2)
 
 
Fair value of financial assets and liabilities
 
 
Total financial assets
287 
Total financial liabilities
Significant Other Observable Inputs (Level 2) |
Money Market Funds
 
 
Fair value of financial assets and liabilities
 
 
Total financial assets
1
1
Significant Other Observable Inputs (Level 2) |
Warrant Liability
 
 
Fair value of financial assets and liabilities
 
 
Total financial liabilities
2
2
Significant Other Observable Inputs (Level 2) |
United States government agency securities
 
 
Fair value of financial assets and liabilities
 
 
Total financial assets
 
287 3
Significant Unobservable Inputs (Level 3)
 
 
Fair value of financial assets and liabilities
 
 
Total financial assets
Total financial liabilities
5,903 
7,979 
Significant Unobservable Inputs (Level 3) |
Money Market Funds
 
 
Fair value of financial assets and liabilities
 
 
Total financial assets
1
1
Significant Unobservable Inputs (Level 3) |
Warrant Liability
 
 
Fair value of financial assets and liabilities
 
 
Total financial liabilities
5,903 2
7,979 2
Significant Unobservable Inputs (Level 3) |
United States government agency securities
 
 
Fair value of financial assets and liabilities
 
 
Total financial assets
 
$ 0 3
Reconciliation of Beginning and Ending Balances for Warrant Liability Using Significant Unobservable Inputs (Detail) (USD $)
In Thousands, unless otherwise specified
12 Months Ended
Dec. 31, 2012
Dec. 31, 2011
Reconciliation of fair value measurement on liabilities using significant unobservable inputs
 
 
Beginning balance
$ 7,979 
$ 8,465 
Decrease in fair value of warrants
(2,059)
(486)
Settlement of warrants exercised
(17)
 
Ending balance
$ 5,903 
$ 7,979 
Summary of Available for Sale Securities (Detail) (USD $)
In Thousands, unless otherwise specified
Dec. 31, 2012
Dec. 31, 2011
Schedule of Available-for-sale Securities [Line Items]
 
 
Carrying Value
$ 10,268 
$ 8,970 
Gross Unrealized Gain
Fair Value
10,268 
8,970 
Money Market Funds
 
 
Schedule of Available-for-sale Securities [Line Items]
 
 
Carrying Value
10,268 
8,683 
Gross Unrealized Gain
Fair Value
10,268 
8,683 
United States government agency securities
 
 
Schedule of Available-for-sale Securities [Line Items]
 
 
Carrying Value
 
287 
Gross Unrealized Gain
 
Fair Value
 
$ 287 
Available for Sale Securities by Original Contractual Maturity (Detail) (USD $)
In Thousands, unless otherwise specified
Dec. 31, 2012
Dec. 31, 2011
Carrying Value
 
 
Schedule of Available-for-sale Securities [Line Items]
 
 
Due in one year or less
$ 10,268 
$ 8,683 
Due greater than three years and less than five years
287 
Total available-for-sale securities
10,268 
8,970 
Fair Value
 
 
Schedule of Available-for-sale Securities [Line Items]
 
 
Due in one year or less
10,268 
8,683 
Due greater than three years and less than five years
287 
Total available-for-sale securities
$ 10,268 
$ 8,970 
Available-for-Sale Securities - Additional Information (Detail) (USD $)
12 Months Ended
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2010
Schedule of Available-for-sale Securities [Line Items]
 
 
 
Gross realized gains from the sale or maturity of available-for-sale investments
$ 0 
$ 0 
$ 0 
Gross realized losses excluding other-than-temporary impairments from the sale or maturity of available-for-sale investments
Other-than-temporary impairments from the sale or maturity of available-for-sale investments
$ 0 
$ 0 
$ 0 
Inventories (Detail) (USD $)
In Thousands, unless otherwise specified
Dec. 31, 2012
Dec. 31, 2011
Inventory Disclosure [Line Items]
 
 
Work-in-process
$ 3,551 
$ 2,742 
Finished goods
6,629 
3,702 
Total inventories
$ 10,180 
$ 6,444 
Property and Equipment Net (Detail) (USD $)
In Thousands, unless otherwise specified
Dec. 31, 2012
Dec. 31, 2011
Property, Plant and Equipment [Line Items]
 
 
Leasehold improvements
$ 5,598 
$ 5,598 
Machinery and equipment
1,594 
1,682 
Demonstration equipment
24 
24 
Office furniture
644 
636 
Computer equipment
550 
525 
Computer software
1,062 
1,062 
Construction-in-progress
55 
38 
Total property and equipment, gross
10,020 
10,067 
Accumulated depreciation and amortization
(8,322)
(8,035)
Total property and equipment, net
1,698 
2,032 
Consigned Equipment
 
 
Property, Plant and Equipment [Line Items]
 
 
Demonstration equipment
$ 493 
$ 502 
Property and Equipment Net - Additional Information (Detail) (USD $)
In Millions, unless otherwise specified
12 Months Ended
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2010
Property, Plant and Equipment [Line Items]
 
 
 
Property and equipment, depreciation and amortization expense
$ 0.4 
$ 0.6 
$ 0.6 
Goodwill and Intangible Assets Net - Additional Information (Detail) (USD $)
3 Months Ended 12 Months Ended
Dec. 31, 2012
Sep. 30, 2012
Jun. 30, 2012
Mar. 31, 2012
Dec. 31, 2011
Sep. 30, 2011
Jun. 30, 2011
Mar. 31, 2011
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2010
Acquired Finite-Lived Intangible Assets [Line Items]
 
 
 
 
 
 
 
 
 
 
 
Disposal or recognition of additional goodwill
 
 
 
 
 
 
 
 
$ 0 
 
 
Impairment charges on goodwill
 
 
 
 
 
 
 
 
 
 
Goodwill balance
1,316,000 
 
 
 
1,316,000 
 
 
 
1,316,000 
1,316,000 
 
Amortization expenses of intangible assets
51,000 
50,000 
51,000 
50,000 
50,000 
51,000 
51,000 
50,000 
202,000 
202,000 
67,000 
Impairment charges recognized related to the acquired intangible assets
 
 
 
 
 
 
 
 
 
Annual amortization expense of the intangible assets, 2012
200,000 
 
 
 
 
 
 
 
200,000 
 
 
Annual amortization expense of the intangible assets, 2013
200,000 
 
 
 
 
 
 
 
200,000 
 
 
Annual amortization expense of the intangible assets, 2014
200,000 
 
 
 
 
 
 
 
200,000 
 
 
Annual amortization expense of the intangible assets, 2015
200,000 
 
 
 
 
 
 
 
200,000 
 
 
Annual amortization expense of the intangible assets, 2016
200,000 
 
 
 
 
 
 
 
200,000 
 
 
Annual amortization expense of the intangible assets, 2017
200,000 
 
 
 
 
 
 
 
200,000 
 
 
Annual amortization expense of the intangible assets, 2018
200,000 
 
 
 
 
 
 
 
200,000 
 
 
Annual amortization expense of the intangible assets, 2019
200,000 
 
 
 
 
 
 
 
200,000 
 
 
Annual amortization expense of the intangible assets, 2020
$ 100,000 
 
 
 
 
 
 
 
$ 100,000 
 
 
Summary of Intangible Assets Net (Detail) (USD $)
In Thousands, unless otherwise specified
Dec. 31, 2012
Dec. 31, 2011
Acquired Finite-Lived Intangible Assets [Line Items]
 
 
Gross Carrying Amount
$ 2,017 
$ 2,017 
Accumulated Amortization
(471)
(269)
Net Carrying Amount
1,546 
1,748 
Reacquired license - INTERCEPT Asia
 
 
Acquired Finite-Lived Intangible Assets [Line Items]
 
 
Gross Carrying Amount
2,017 
2,017 
Accumulated Amortization
(471)
(269)
Net Carrying Amount
$ 1,546 
$ 1,748 
Long-Term Investments - Additional Information (Detail) (USD $)
12 Months Ended
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2010
Investment [Line Items]
 
 
 
Business acquisition, gain recognized
 
 
$ 300,000 
Business acquisition, acquisition related costs
 
 
500,000 
Eligibility to receive a royalty fee
1.00% 
 
 
Royalty income, nonoperating
Carrying value of investment
$ 0 
 
 
Maximum
 
 
 
Investment [Line Items]
 
 
 
Ownership percentage under Cost Method for Investments
3.00% 
 
 
Accrued Liabilities (Detail) (USD $)
In Thousands, unless otherwise specified
Dec. 31, 2012
Dec. 31, 2011
Schedule of Accrued Liabilities [Line Items]
 
 
Accrued compensation and related costs
$ 2,692 
$ 2,027 
Accrued inventory costs
2,352 
1,417 
Accrued contract and other accrued expenses
2,575 
2,381 
Total accrued liabilities
$ 7,619 
$ 5,825 
Debt (Detail) (USD $)
In Thousands, unless otherwise specified
Dec. 31, 2012
Dec. 31, 2011
Debt Instrument [Line Items]
 
 
Total debt, Principal
$ 7,773 
$ 7,300 
Total debt, Unamortized amount
(49)
(84)
Total debt
7,724 
7,216 
Less: debt - current, Principal
(4,857)
(2,554)
Less: debt - current, Unamortized Discount
29 
35 
Less: debt - current
(4,828)
(2,519)
Debt - non-current, Principal
2,916 
4,746 
Debt - non-current, Unamortized Discount
(20)
(49)
Debt - non-current
2,896 
4,697 
Comerica - Growth Capital Loan A, due 2015
 
 
Debt Instrument [Line Items]
 
 
Total debt, Principal
4,583 
5,000 
Total debt, Unamortized amount
(49)
(84)
Total debt
4,534 
4,916 
Comerica - Revolving Line of Credit, due 2014
 
 
Debt Instrument [Line Items]
 
 
Total debt, Principal
3,190 
2,300 
Total debt, Unamortized amount
Total debt
$ 3,190 
$ 2,300 
Principal and Interest Payments on Debt (Detail) (USD $)
In Thousands, unless otherwise specified
Dec. 31, 2012
Debt Instrument [Line Items]
 
2013
$ 2,063 
2014
5,084 1
2015
$ 1,334 
Debt - Additional Information (Detail) (USD $)
12 Months Ended 12 Months Ended 1 Months Ended 12 Months Ended 1 Months Ended 6 Months Ended 9 Months Ended 1 Months Ended
Dec. 31, 2012
Dec. 31, 2011
Jun. 30, 2012
Securities Pledged as Collateral
Dec. 31, 2012
Comerica - Growth Capital Facility
Jun. 30, 2012
Comerica - Growth Capital Facility
Dec. 31, 2012
Compliance With Covenants
Mar. 31, 2010
Oxford Growth Capital Facility
Dec. 31, 2012
Oxford Growth Capital Facility
Dec. 31, 2011
Oxford Growth Capital Facility
Dec. 31, 2010
Oxford Growth Capital Facility
Mar. 31, 2011
Oxford Growth Capital Facility
Extended Maturity
Sep. 30, 2011
Revolving Credit Facility
Comerica - Growth Capital Facility
Jun. 30, 2012
Revolving Credit Facility
Comerica - Growth Capital Facility
Sep. 30, 2012
Revolving Credit Facility
Comerica - Growth Capital Facility
Dec. 31, 2012
Revolving Credit Facility
Comerica - Growth Capital Facility
Dec. 31, 2011
Revolving Credit Facility
Comerica - Growth Capital Facility
Sep. 30, 2011
Capital Loan
Comerica - Growth Capital Facility
Jun. 30, 2012
Capital Loan
Comerica - Growth Capital Facility
Line of Credit Facility [Line Items]
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Amended Credit Agreement
 
 
 
 
$ 12,000,000 
 
 
 
 
 
 
 
$ 7,000,000 
 
 
 
 
$ 5,000,000 
Growth capital loan from amended Credit Agreement
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
5,000,000 
 
Percentage of investments made in subsidiary
 
 
35.00% 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Principal and interest payment
 
 
 
 
 
 
Interest-only payments due for the first nine months and then equal principal and interest payments for an additional 30 months. 
 
 
 
 
 
 
 
 
 
Growth Capital Loan, which matures on September 30, 2015, bears a fixed interest rate of 6.37%, with interest-only payments due for the first twelve months, followed by equal principal and interest payments for the remaining 36 months. 
 
Maturity period
 
 
 
 
 
 
 
 
 
 
Sep. 30, 2011 
 
 
Jun. 30, 2014 
 
 
Sep. 30, 2015 
 
Fixed interest rate
 
 
 
 
 
 
12.04% 
 
 
 
 
 
 
 
 
 
6.37% 
 
Interest Only payments Period
 
 
 
12 months 
 
 
 
9 months 
 
 
 
 
 
 
 
 
 
 
Principal and interest payments
 
 
 
36 months 
 
 
 
30 months 
 
 
 
 
 
 
 
 
 
 
Commitment fee
 
 
 
 
 
 
 
 
 
 
 
20,000 
20,000 
 
 
 
40,000 
 
Loan fees
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
50,000 
 
Effective interest rate
 
 
 
 
 
 
 
13.84% 
 
 
 
 
 
 
 
 
7.07% 
 
Final payment fee percentage
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1.00% 
 
Amount under RLOC available to the Company
 
 
 
 
 
 
 
 
 
 
 
 
 
 
80.00% 
 
 
 
Outstanding amounts
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3,200,000 
2,300,000 
 
 
Lender's prime rate plus 1.50%
 
 
 
 
 
 
 
 
 
 
 
 
 
Lender's prime rate plus 1.50% 
 
 
 
 
Margin rate
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1.50% 
 
 
 
Floating rate of interest
 
 
 
 
 
 
 
 
 
 
 
 
 
 
4.75% 
4.75% 
 
 
Frequency of commitment fee
 
 
 
 
 
 
 
 
 
 
 
 
 
Annually on June 30 
 
 
 
 
Commitment fee at each annual anniversary beginning June 30, 2013
 
 
 
 
 
 
 
 
 
 
 
 
 
20,000 
 
 
 
 
Minimum cash balance
 
 
 
 
 
2,500,000 
 
 
 
 
 
 
 
 
 
 
 
 
Minimum revenues levels percentage
 
 
 
 
 
75.00% 
 
 
 
 
 
 
 
 
 
 
 
 
Issuance of senior secured notes
 
 
 
 
 
 
5,000,000 
 
 
 
 
 
 
 
 
 
 
 
Senior secured notes, upfront facility fee
 
 
 
 
 
 
 
 
 
100,000 
 
 
 
 
 
 
 
 
Senior secured notes, closing cost
49,000 
84,000 
 
 
 
 
 
100,000 
 
 
 
 
 
 
 
 
 
 
Senior secured notes, facility fee
 
 
 
 
 
 
 
400,000 
 
 
 
 
 
 
 
 
 
 
Senior secured notes, non utilization fee
 
 
 
 
 
 
 
 
 
100,000 
 
 
 
 
 
 
 
 
Senior secured notes, not drawn amount
 
 
 
 
 
 
 
 
 
5,000,000 
 
 
 
 
 
 
 
 
Closing cost and fees
 
 
 
 
 
 
 
 
$ 0.2 
 
 
 
 
 
 
 
 
 
Commitments and Contingencies - Additional Information (Detail) (USD $)
In Millions, unless otherwise specified
12 Months Ended
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2010
Commitments and Contingencies Disclosure [Line Items]
 
 
 
Minimum term of non-cancelable operating leases
1 year 
 
 
Expiration of non-cancelable operating leases maximum year
2019 
 
 
Operating lease, rent expense
$ 0.6 
$ 0.7 
$ 0.9 
Financing for leasehold improvement
 
 
1.1 
Outstanding liability related to leasehold improvements
0.8 
 
 
Leasehold Improvements reflected in Accrued liabilities
0.1 
 
 
Leasehold Improvements reflected in Other non-current liabilities
0.7 
 
 
Purchase commitment, paid
7.2 
3.6 
0.9 
Future minimum purchase commitment 2013
2.5 
 
 
Future minimum purchase commitment 2014
0.1 
 
 
Future minimum purchase commitment 2015
$ 0.1 
 
 
Concord Lease
 
 
 
Commitments and Contingencies Disclosure [Line Items]
 
 
 
Early termination of non-cancelable operating leases minimum period
2015-01 
 
 
Future Minimum Non-Cancelable Lease Payments Under Operating Leases (Detail) (USD $)
In Thousands, unless otherwise specified
Dec. 31, 2012
Future Minimum Payments Under Non-Cancelable Operating Leases With Initial Terms Of One-Year Or More [Line Items]
 
2013
$ 865 
2014
838 
2015
350 
2016
45 
2017
Total minimum non-cancellable lease payments
$ 2,102 
Stockholders Equity - Additional Information (Detail) (USD $)
12 Months Ended 6 Months Ended 12 Months Ended 6 Months Ended 1 Months Ended 6 Months Ended 12 Months Ended 12 Months Ended
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2010
Dec. 31, 2010
Maximum
Dec. 31, 2012
Stockholder Rights Plan
Jun. 30, 2012
Series B Convertible Preferred Stock
Dec. 31, 2012
Series B Convertible Preferred Stock
Mar. 31, 1999
Series B Convertible Preferred Stock
Jun. 30, 2012
Common Stock
Aug. 31, 2009
Warrant
2009 Unit Offering
Nov. 30, 2010
Warrant
2010 Unit Offering
Jun. 30, 2012
Warrant
2010 Unit Offering
Dec. 31, 2012
Sales Agreement
Mlv
Dec. 31, 2011
Sales Agreement
Mlv
Dec. 31, 2012
Sales Agreement
Mlv
Maximum
Dec. 31, 2012
Sales Agreement
Cantor
Stockholders Equity Note [Line Items]
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Preferred stock issued
3,000 
 
 
 
 
 
3,327 
 
 
 
 
 
 
 
 
Preferred stock conversion basis to common shares
 
 
 
 
 
 
100 
 
 
 
 
 
 
 
 
 
Redeemable preferred stock, amount
 
 
 
 
 
$ 9,500,000 
 
 
 
 
 
 
 
 
 
 
Conversion of preferred stock to Common stock
 
 
 
 
 
3,327 
 
 
 
 
 
 
 
 
 
 
Common stock issued to Fresenius
 
 
 
 
 
 
 
 
332,700 
 
 
 
 
 
 
 
Conversion of preferred stock to common stock date
 
 
 
 
 
 
 
 
Jun. 30, 2012 
 
 
 
 
 
 
 
Warrants to purchase an aggregate shares of common stock
 
 
 
 
 
 
 
 
 
2,400,000 
3,700,000 
 
 
 
 
 
warrant exercise price
 
 
 
 
 
 
 
 
 
2.90 
3.20 
 
 
 
 
 
Exercisable period
 
 
 
 
 
 
 
 
 
5 years 
5 years 
 
 
 
 
 
Warrant liability
5,903,000 
7,979,000 
 
 
 
 
 
 
 
2,800,000 
5,800,000 
 
 
 
 
 
Risk-free rate
 
 
 
 
 
 
 
 
 
2.48% 
1.23% 
 
 
 
 
 
Expected term
 
 
 
 
 
 
 
 
 
5 years 
5 years 
 
 
 
 
 
Dividend yield
 
 
 
 
 
 
 
 
 
0.00% 
0.00% 
 
 
 
 
 
Volatility
 
 
 
 
 
 
 
 
 
77.00% 
85.00% 
 
 
 
 
 
Net proceeds from underwritten public offering
 
 
 
 
 
 
 
 
 
 
19,700,000 
 
 
 
 
 
Payment for underwriting discounts and commissions and stock issuance cost
550,000 
420,000 
1,710,000 
 
 
 
 
 
 
 
1,300,000 
 
 
 
 
 
Number of units sold in underwritten public offering
 
 
 
 
 
 
 
 
 
 
7,400,000 
 
 
 
 
 
Number of common stock in each unit
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Number of common stock shares purchasable with each warrant
 
 
 
 
 
 
 
 
 
 
0.5 
 
 
 
 
 
Units issues, price per unit
 
 
 
 
 
 
 
 
 
 
$ 2.85 
 
 
 
 
 
Common stock, number of shares issued
 
 
 
 
 
 
 
 
 
 
7,400,000 
 
 
 
 
 
Warrants, number of common stock shares
 
 
 
 
 
 
 
 
 
 
3,700,000 
 
 
 
 
 
Warrants exercisable date
 
 
 
 
 
 
 
 
 
 
May 15, 2011 
 
 
 
 
 
Revaluation of warrant liability
2,059,000 
486,000 
39,000 
100,000 
 
 
 
 
 
 
 
 
 
 
 
 
Warrants exercised
 
 
 
 
 
 
 
 
 
 
 
5,084 
 
 
 
 
Maximum common stock offering price
 
 
 
 
 
 
 
 
 
 
 
 
20,000,000 
 
 
30,000,000 
Percentage of proceeds payable as compensation to underwriter
 
 
 
 
 
 
 
 
 
 
 
 
3.00% 
 
 
2.00% 
Common stock, sold
 
 
 
 
 
 
 
 
 
 
 
 
3,100,000 
3,500,000 
 
1,400,000 
Proceeds from common stock sold
$ 14,226,000 
$ 9,273,000 
$ 19,291,000 
 
 
 
 
 
 
 
 
 
$ 9,500,000 
$ 9,700,000 
 
$ 4,300,000 
Common stock available to be sold
 
 
 
 
 
 
 
 
 
 
 
 
 
 
100,000 
25,500,000 
Minimum percentage of common stock acquired by stockholders
 
 
 
 
15.00% 
 
 
 
 
 
 
 
 
 
 
 
Designated preferred stock for future issuance
 
 
 
 
250,000 
 
 
 
 
 
 
 
 
 
 
 
Fair Value of Warrants (Detail) (USD $)
In Thousands, unless otherwise specified
Dec. 31, 2012
Dec. 31, 2011
Class of Warrant or Right [Line Items]
 
 
Warrant liability
$ 5,903 
$ 7,979 
2009 Warrants
 
 
Class of Warrant or Right [Line Items]
 
 
Warrant liability
2,009 
3,010 
2010 Warrants
 
 
Class of Warrant or Right [Line Items]
 
 
Warrant liability
$ 3,894 
$ 4,969 
Fair Value of Warrants Using Valuation Model (Detail)
12 Months Ended
Dec. 31, 2012
Dec. 31, 2011
2009 Warrants
 
 
Class of Warrant or Right [Line Items]
 
 
Expected term (in years)
1 year 7 months 24 days 
2 years 7 months 24 days 
Estimated volatility
45.00% 
74.00% 
Risk-free interest rate
0.25% 
0.36% 
Expected dividend yield
0.00% 
0.00% 
2010 Warrants
 
 
Class of Warrant or Right [Line Items]
 
 
Expected term (in years)
2 years 10 months 10 days 
3 years 10 months 10 days 
Estimated volatility
51.00% 
70.00% 
Risk-free interest rate
0.36% 
0.60% 
Expected dividend yield
0.00% 
0.00% 
Stock-Based Compensation - Additional Information (Detail) (USD $)
In Millions, except Share data, unless otherwise specified
12 Months Ended 12 Months Ended 12 Months Ended
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2010
Dec. 31, 2012
Stock Options
Dec. 31, 2012
Restricted Stock Units (RSUs)
Installment
Dec. 31, 2011
Restricted Stock Units (RSUs)
Dec. 31, 2010
Restricted Stock Units (RSUs)
Dec. 31, 2012
Employee Stock Purchase Plan
Dec. 31, 2011
Employee Stock Purchase Plan
Dec. 31, 2010
Employee Stock Purchase Plan
Jun. 6, 2012
Employee Stock Purchase Plan
Dec. 31, 2012
Employee Stock Purchase Plan
Maximum
Dec. 31, 2012
2008 Equity Incentive Plan
Jun. 6, 2012
2008 Equity Incentive Plan
Jun. 1, 2011
2008 Equity Incentive Plan
Dec. 31, 2012
2008 Equity Incentive Plan
Stock Options
Dec. 31, 2012
2008 Equity Incentive Plan
Performance-based Stock or Cash Awards
Dec. 31, 2011
2008 Equity Incentive Plan
Performance Shares
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Employee Stock Purchase Plan, offering period
 
 
 
 
 
 
 
 
 
 
 
27 months 
 
 
 
 
 
 
Employee Stock Purchase Plan, period for eligible employees to purchase
 
 
 
 
 
 
 
 
 
 
 
6 months 
 
 
 
 
 
 
Employee Stock Purchase Plan, purchase price of common stock as percentage of fair market value
 
 
 
 
 
 
 
85.00% 
 
 
 
 
100.00% 
 
 
 
 
 
Employee Stock Purchase Plan, authorized shares for issuance
 
 
 
 
 
 
 
 
820,500 
 
 
 
 
 
 
 
500,000 
 
Increase in shares of common stock authorized for issuance
 
 
 
 
 
 
 
 
 
 
500,000 
 
 
3,000,000 
2,000,000 
 
 
 
Maximum number of shares of common stock authorized for issuance
 
 
 
 
 
 
 
 
 
 
1,320,500 
 
 
13,540,940 
 
 
 
 
Number of shares available for future issuance
 
 
 
 
 
 
 
581,879 
 
 
 
 
4,300,000 
 
 
 
 
 
Stock-based compensation, award term
 
 
 
 
 
 
 
 
 
 
 
 
10 years 
 
 
 
 
 
Stock-based compensation, vesting period
 
 
 
 
3 years 
 
 
 
 
 
 
 
 
 
 
4 years 
 
 
Stock option plan granted on cash award
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
$ 1.0 
 
Performance-based stock options, outstanding
 
 
 
 
 
 
 
 
 
 
 
 
50,000 
 
 
 
 
 
Stock-based compensation, shares granted
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
50,000 
Aggregate number of shares of common stock reserved for future issuance
12,900,000 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Outstanding options and other stock based awards
8,600,000 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Total intrinsic value of options exercised
0.3 
0.2 
0.3 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Stock-based compensation, number of installments from grant date to vest
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Fair value of restricted stock units which vested during the year
 
 
 
 
0.04 
0.10 
0.05 
 
 
 
 
 
 
 
 
 
 
 
Stock-based compensation expense expected to be recognized
 
 
 
$ 4.3 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Stock-based compensation, weighted average recognition period
 
 
 
2 years 5 months 19 days 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Stock-based compensation, expected dividend yield
0.00% 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Weighted average grant-date fair value of stock options granted
$ 2.13 
$ 1.37 
$ 1.94 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Weighted average grant-date fair value of awards granted
 
 
 
 
$ 3.03 
 
$ 1.85 
$ 1.43 
$ 0.68 
$ 0.90 
 
 
 
 
 
 
 
 
Information Regarding Stock Options Outstanding Stock Options Vested and Expected to Vest and Stock Options Exercisable (Detail) (USD $)
In Thousands, except Per Share data, unless otherwise specified
12 Months Ended
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2010
Dec. 31, 2009
Number of Shares
 
 
 
 
Stock options outstanding
8,504 
7,362 
7,007 
6,565 
Stock options vested and expected to vest
8,140 
6,900 
6,705 
 
Stock options exercisable
5,150 
4,058 
4,323 
 
Weighted Average Exercise Price
 
 
 
 
Stock options outstanding
$ 3.40 
$ 4.70 
$ 6.42 
$ 7.38 
Stock options vested and expected to vest
$ 3.42 
$ 4.86 
$ 6.60 
 
Stock options exercisable
$ 3.77 
$ 6.70 
$ 8.93 
 
Weighted Average Remaining Contractual
 
 
 
 
Stock options outstanding
6 years 7 months 2 days 
6 years 7 months 28 days 
6 years 2 months 19 days 
 
Stock options vested and expected to vest
6 years 5 months 27 days 
6 years 5 months 19 days 
6 years 29 days 
 
Stock options exercisable
5 years 5 months 5 days 
5 years 
4 years 9 months 29 days 
 
Aggregate intrinsic value
 
 
 
 
Stock options outstanding
$ 5,433 
$ 4,065 
$ 2,761 
 
Stock options vested and expected to vest
5,310 
3,835 
2,610 
 
Stock options exercisable
$ 3,582 
$ 1,902 
$ 922 
 
Stock-Based Compensation Recognized on Condensed Consolidated Statements of Operations (Detail) (USD $)
In Thousands, unless otherwise specified
12 Months Ended
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2010
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]
 
 
 
Stock-based compensation expense
$ 2,541 
$ 1,850 
$ 1,828 
Research and Development Expense
 
 
 
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]
 
 
 
Stock-based compensation expense
554 
450 
376 
Selling, General and Administrative Expenses
 
 
 
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]
 
 
 
Stock-based compensation expense
$ 1,987 
$ 1,400 
$ 1,452 
Weighted Average Assumptions Used to Value Stock-Based Awards (Detail)
12 Months Ended
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2010
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
 
 
 
Expected dividend yield
0.00% 
 
 
Stock Option
 
 
 
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
 
 
 
Expected term (in years)
5 years 6 months 15 days 
5 years 3 months 18 days 
5 years 4 months 24 days 
Estimated volatility
67.00% 
68.00% 
82.00% 
Risk-free interest rate
1.03% 
1.23% 
1.40% 
Expected dividend yield
0.00% 
0.00% 
0.00% 
Employee Stock Purchase Plan
 
 
 
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
 
 
 
Expected term (in years)
6 months 
6 months 
6 months 
Estimated volatility
101.00% 
48.00% 
61.00% 
Risk-free interest rate
0.14% 
0.08% 
0.89% 
Expected dividend yield
0.00% 
0.00% 
0.00% 
Retirement Plan - Additional Information (Detail)
12 Months Ended
Dec. 31, 2012
Defined Benefit Plan Disclosure [Line Items]
 
Retirement plan, employees maximum pre-tax contributions percentage
60.00% 
Development and License Agreements - Additional Information (Detail) (USD $)
3 Months Ended 12 Months Ended
Dec. 31, 2012
Sep. 30, 2012
Jun. 30, 2012
Mar. 31, 2012
Dec. 31, 2011
Sep. 30, 2011
Jun. 30, 2011
Mar. 31, 2011
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2010
Licenses Agreements [Line Items]
 
 
 
 
 
 
 
 
 
 
 
Royalty payments on products
 
 
 
 
 
 
 
 
$ 2,700,000 
$ 2,200,000 
$ 2,000,000 
Payments made relating to the manufacturing of the products
 
 
 
 
 
 
 
 
12,200,000 
9,600,000 
8,600,000 
Product warranty receivable current
1,800,000 
 
 
 
 
 
 
 
1,800,000 
 
 
Revenue from cooperative agreement
91,000 
527,000 
1,479,000 
436,000 
91,000 
2,442,000 
1,432,000 
Royalty
 
 
 
 
 
 
 
 
 
 
 
Licenses Agreements [Line Items]
 
 
 
 
 
 
 
 
 
 
 
Royalties owed
800,000 
 
 
 
700,000 
 
 
 
800,000 
700,000 
 
Manufacturing Costs
 
 
 
 
 
 
 
 
 
 
 
Licenses Agreements [Line Items]
 
 
 
 
 
 
 
 
 
 
 
Royalties owed
$ 6,200,000 
 
 
 
$ 3,400,000 
 
 
 
$ 6,200,000 
$ 3,400,000 
 
Platelet system |
Royalty
 
 
 
 
 
 
 
 
 
 
 
Licenses Agreements [Line Items]
 
 
 
 
 
 
 
 
 
 
 
Royalty rate applied towards sale of products
 
 
 
 
 
 
 
 
10.00% 
 
 
Plasma system |
Royalty
 
 
 
 
 
 
 
 
 
 
 
Licenses Agreements [Line Items]
 
 
 
 
 
 
 
 
 
 
 
Royalty rate applied towards sale of products
 
 
 
 
 
 
 
 
3.00% 
 
 
Red blood cell system |
Royalty
 
 
 
 
 
 
 
 
 
 
 
Licenses Agreements [Line Items]
 
 
 
 
 
 
 
 
 
 
 
Royalty rate applied towards sale of products
 
 
 
 
 
 
 
 
5.00% 
 
 
Illuminators |
Royalty
 
 
 
 
 
 
 
 
 
 
 
Licenses Agreements [Line Items]
 
 
 
 
 
 
 
 
 
 
 
Royalty rate applied towards sale of products
 
 
 
 
 
 
 
 
6.50% 
 
 
United States and Foreign Components of Consolidated Loss before Income Taxes (Detail) (USD $)
In Thousands, unless otherwise specified
3 Months Ended 12 Months Ended
Dec. 31, 2012
Sep. 30, 2012
Jun. 30, 2012
Mar. 31, 2012
Dec. 31, 2011
Sep. 30, 2011
Jun. 30, 2011
Mar. 31, 2011
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2010
Schedule Of Income Loss From Continuing Operations [Line Items]
 
 
 
 
 
 
 
 
 
 
 
U.S.
 
 
 
 
 
 
 
 
$ (16,360)
$ (17,461)
$ (17,256)
Foreign
 
 
 
 
 
 
 
 
685 
622 
439 
Loss before income taxes
$ (1,605)
$ (3,405)
$ (1,866)
$ (8,799)
$ (7,686)
$ 2,304 
$ (6,382)
$ (5,075)
$ (15,675)
$ (16,839)
$ (16,817)
Provision Benefit for Income Taxes (Detail) (USD $)
In Thousands, unless otherwise specified
3 Months Ended 12 Months Ended
Dec. 31, 2012
Sep. 30, 2012
Jun. 30, 2012
Mar. 31, 2012
Dec. 31, 2011
Sep. 30, 2011
Jun. 30, 2011
Mar. 31, 2011
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2010
Components Of Income Tax Expense Benefit [Line Items]
 
 
 
 
 
 
 
 
 
 
 
Foreign
 
 
 
 
 
 
 
 
$ 180 
$ 143 
$ 94 
Federal
 
 
 
 
 
 
 
 
State
 
 
 
 
 
 
 
 
Total Current
 
 
 
 
 
 
 
 
180 
143 
94 
Foreign
 
 
 
 
 
 
 
 
Federal
 
 
 
 
 
 
 
 
48 
State
 
 
 
 
 
 
 
 
14 
Total Deferred
 
 
 
 
 
 
 
 
62 
Provision for income taxes
$ 111 
$ 55 
$ 41 
$ 35 
$ 49 
$ 44 
$ 27 
$ 23 
$ 242 
$ 143 
$ 94 
Difference Between Provision for Income Taxes and Amounts Computed by Applying Federal Statutory Income Tax Rate to Loss before Taxes (Detail) (USD $)
In Thousands, unless otherwise specified
3 Months Ended 12 Months Ended
Dec. 31, 2012
Sep. 30, 2012
Jun. 30, 2012
Mar. 31, 2012
Dec. 31, 2011
Sep. 30, 2011
Jun. 30, 2011
Mar. 31, 2011
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2010
Reconciliation of Provision of Income Taxes [Line Items]
 
 
 
 
 
 
 
 
 
 
 
Federal statutory tax
 
 
 
 
 
 
 
 
$ (5,329)
$ (5,725)
$ (5,718)
Stock-based compensation
 
 
 
 
 
 
 
 
99 
83 
95 
Lobbying expenses
 
 
 
 
 
 
 
 
51 
112 
112 
Warrants
 
 
 
 
 
 
 
 
(706)
(165)
(13)
Research Grant
 
 
 
 
 
 
 
 
(166)
Gain on investment
 
 
 
 
 
 
 
 
(107)
Foreign rate differential
 
 
 
 
 
 
 
 
(53)
(68)
(56)
Expiration of federal net operating losses and credits - tax effected
 
 
 
 
 
 
 
 
4,352 
1,744 
(596)
Change in valuation allowance
 
 
 
 
 
 
 
 
1,761 
4,158 
6,544 
Goodwill amortization
 
 
 
 
 
 
 
 
48 
Other
 
 
 
 
 
 
 
 
19 
(1)
Provision for income taxes
$ 111 
$ 55 
$ 41 
$ 35 
$ 49 
$ 44 
$ 27 
$ 23 
$ 242 
$ 143 
$ 94 
Significant Components of Deferred Tax Assets (Detail) (USD $)
In Thousands, unless otherwise specified
Dec. 31, 2012
Dec. 31, 2011
Deferred tax assets:
 
 
Net operating loss carryforwards
$ 137,700 
$ 137,800 
Research and development credit carryforwards
30,800 
31,400 
Capitalized inventory costs
900 
500 
Inventory reserve
700 
200 
Capitalized research and development
9,100 
10,300 
Capitalized intangible asset
100 
Deferred compensation
4,800 
4,200 
Accrued liabilities
100 
400 
Depreciation
1,300 
1,400 
Acqusition costs
200 
200 
Deferred tenant allowance
200 
200 
Capital loss carryforwards
3,900 
3,900 
Total deferred tax assets
190,500 
191,300 
Valuation allowance
(190,500)
(191,300)
Net deferred tax assets
Deferred tax liabilities:
 
 
Amortization of goodwill
62 
Total deferred tax liabilities
62 
Trademarks
 
 
Deferred tax assets:
 
 
Capitalized intangible asset
400 
200 
Capitalized Revenue Sharing Rights
 
 
Deferred tax assets:
 
 
Capitalized intangible asset
$ 300 
$ 600 
Income Tax - Additional Information (Detail) (USD $)
3 Months Ended 12 Months Ended
Dec. 31, 2012
Sep. 30, 2012
Jun. 30, 2012
Mar. 31, 2012
Dec. 31, 2011
Sep. 30, 2011
Jun. 30, 2011
Mar. 31, 2011
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2010
Income Tax Disclosure [Line Items]
 
 
 
 
 
 
 
 
 
 
 
Increase (Decrease) in valuation allowance
 
 
 
 
 
 
 
 
$ (800,000)
$ 2,000,000 
$ 7,200,000 
Federal statutory income tax rate
 
 
 
 
 
 
 
 
34.00% 
 
 
Undistributed earnings, federal statutory income taxes
 
 
 
 
 
 
 
 
(5,329,000)
(5,725,000)
(5,718,000)
Net loss
(1,716,000)
(3,460,000)
(1,907,000)
(8,834,000)
(7,735,000)
2,260,000 
(6,409,000)
(5,098,000)
(15,917,000)
(16,982,000)
(16,911,000)
Research and development tax credit carryforwards
30,800,000 
 
 
 
31,400,000 
 
 
 
30,800,000 
31,400,000 
 
Internal Revenue Service (IRS)
 
 
 
 
 
 
 
 
 
 
 
Income Tax Disclosure [Line Items]
 
 
 
 
 
 
 
 
 
 
 
Net operating loss carryforwards
360,200,000 
 
 
 
 
 
 
 
360,200,000 
 
 
Research and development tax credit carryforwards
20,500,000 
 
 
 
 
 
 
 
20,500,000 
 
 
Internal Revenue Service (IRS) |
Minimum
 
 
 
 
 
 
 
 
 
 
 
Income Tax Disclosure [Line Items]
 
 
 
 
 
 
 
 
 
 
 
Net operating loss carryforwards, expiration year
 
 
 
 
 
 
 
 
2018 
 
 
Internal Revenue Service (IRS) |
Maximum
 
 
 
 
 
 
 
 
 
 
 
Income Tax Disclosure [Line Items]
 
 
 
 
 
 
 
 
 
 
 
Net operating loss carryforwards, expiration year
 
 
 
 
 
 
 
 
2032 
 
 
State and Local Jurisdiction
 
 
 
 
 
 
 
 
 
 
 
Income Tax Disclosure [Line Items]
 
 
 
 
 
 
 
 
 
 
 
Net operating loss carryforwards
293,200,000 
 
 
 
 
 
 
 
293,200,000 
 
 
Research and development tax credit carryforwards
15,600,000 
 
 
 
 
 
 
 
15,600,000 
 
 
State and Local Jurisdiction |
Minimum
 
 
 
 
 
 
 
 
 
 
 
Income Tax Disclosure [Line Items]
 
 
 
 
 
 
 
 
 
 
 
Net operating loss carryforwards, expiration year
 
 
 
 
 
 
 
 
2013 
 
 
State and Local Jurisdiction |
Maximum
 
 
 
 
 
 
 
 
 
 
 
Income Tax Disclosure [Line Items]
 
 
 
 
 
 
 
 
 
 
 
Net operating loss carryforwards, expiration year
 
 
 
 
 
 
 
 
2032 
 
 
Cerus Europe B.V.
 
 
 
 
 
 
 
 
 
 
 
Income Tax Disclosure [Line Items]
 
 
 
 
 
 
 
 
 
 
 
Undistributed earning of foreign subsidiary
 
 
 
 
 
 
 
 
2,100,000 
 
 
Undistributed earnings, federal statutory income taxes
 
 
 
 
 
 
 
 
$ 700,000 
 
 
Significant Customers that Accounted for More than Ten Percentage of Total Product Revenue (Detail)
12 Months Ended
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2010
Etablissement Francais du Sang
 
 
 
Revenue, Major Customer [Line Items]
 
 
 
Percentage of revenue derived from significant customer from Company's total product revenue
20.00% 
24.00% 
20.00% 
Movaco, S.A.
 
 
 
Revenue, Major Customer [Line Items]
 
 
 
Percentage of revenue derived from significant customer from Company's total product revenue
19.00% 
21.00% 
19.00% 
Delrus Inc.
 
 
 
Revenue, Major Customer [Line Items]
 
 
 
Percentage of revenue derived from significant customer from Company's total product revenue
12.00% 
12.00% 
16.00% 
Service Francophone Du Sang
 
 
 
Revenue, Major Customer [Line Items]
 
 
 
Percentage of revenue derived from significant customer from Company's total product revenue
0.00% 1
0.00% 1
12.00% 
Significant Customers that Accounted for More than Ten Percentage of Total Product Revenue (Parenthetical) (Detail)
Dec. 31, 2012
Revenue, Major Customer [Line Items]
 
Product revenue
10.00% 
Segment Customer and Geographic Information - Additional Information (Detail) (Government Grants And Cooperative Agreements)
12 Months Ended
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2010
Government Grants And Cooperative Agreements
 
 
 
Revenue, Major Customer [Line Items]
 
 
 
Company's total product revenue from significant customers
1.00% 
7.00% 
6.00% 
Net Revenue by Geographical Location (Detail) (USD $)
In Thousands, unless otherwise specified
3 Months Ended 12 Months Ended
Dec. 31, 2012
Sep. 30, 2012
Jun. 30, 2012
Mar. 31, 2012
Dec. 31, 2011
Sep. 30, 2011
Jun. 30, 2011
Mar. 31, 2011
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2010
Revenue, Major Customer [Line Items]
 
 
 
 
 
 
 
 
 
 
 
Net revenue by geographical locations foreign
 
 
 
 
 
 
 
 
$ 36,695 
$ 30,602 
$ 21,677 
Total government grants and cooperative agreements
91 
527 
1,479 
436 
91 
2,442 
1,432 
Total revenue
 
 
 
 
 
 
 
 
36,786 
33,044 
23,109 
FRANCE
 
 
 
 
 
 
 
 
 
 
 
Revenue, Major Customer [Line Items]
 
 
 
 
 
 
 
 
 
 
 
Net revenue by geographical locations foreign
 
 
 
 
 
 
 
 
7,321 
7,385 
4,432 
SPAIN
 
 
 
 
 
 
 
 
 
 
 
Revenue, Major Customer [Line Items]
 
 
 
 
 
 
 
 
 
 
 
Net revenue by geographical locations foreign
 
 
 
 
 
 
 
 
7,061 
6,504 
4,175 
CIS
 
 
 
 
 
 
 
 
 
 
 
Revenue, Major Customer [Line Items]
 
 
 
 
 
 
 
 
 
 
 
Net revenue by geographical locations foreign
 
 
 
 
 
 
 
 
8,016 
3,754 
3,383 
BELGIUM
 
 
 
 
 
 
 
 
 
 
 
Revenue, Major Customer [Line Items]
 
 
 
 
 
 
 
 
 
 
 
Net revenue by geographical locations foreign
 
 
 
 
 
 
 
 
4,016 
3,703 
3,710 
SWITZERLAND
 
 
 
 
 
 
 
 
 
 
 
Revenue, Major Customer [Line Items]
 
 
 
 
 
 
 
 
 
 
 
Net revenue by geographical locations foreign
 
 
 
 
 
 
 
 
3,866 
3,315 
1,330 
Other Countries
 
 
 
 
 
 
 
 
 
 
 
Revenue, Major Customer [Line Items]
 
 
 
 
 
 
 
 
 
 
 
Net revenue by geographical locations foreign
 
 
 
 
 
 
 
 
6,415 
5,941 
4,647 
UNITED STATES
 
 
 
 
 
 
 
 
 
 
 
Revenue, Major Customer [Line Items]
 
 
 
 
 
 
 
 
 
 
 
United States
 
 
 
 
 
 
 
 
$ 91 
$ 2,442 
$ 1,432 
Long Lived Assets by Geographical Location (Detail) (USD $)
In Thousands, unless otherwise specified
Dec. 31, 2012
Dec. 31, 2011
Long-Lived Assets by Geographical Areas [Line Items]
 
 
United States
$ 2,895 
$ 3,299 
Europe
349 
650 
Total long-lived assets
$ 3,244 
$ 3,949 
Summary of Quarterly Financial Information (Detail) (USD $)
In Thousands, except Per Share data, unless otherwise specified
3 Months Ended 12 Months Ended
Dec. 31, 2012
Sep. 30, 2012
Jun. 30, 2012
Mar. 31, 2012
Dec. 31, 2011
Sep. 30, 2011
Jun. 30, 2011
Mar. 31, 2011
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2010
Quarterly Financial Information [Line Items]
 
 
 
 
 
 
 
 
 
 
 
Product revenue
$ 10,528 
$ 8,252 
$ 9,224 
$ 8,691 
$ 9,896 
$ 7,770 
$ 6,753 
$ 6,183 
$ 36,695 
$ 30,602 
$ 21,677 
Cost of product revenue
5,117 
4,411 
5,574 
5,514 
6,206 
4,726 
4,074 
3,529 
20,616 
18,535 
12,046 
Gross profit on product revenue
5,411 
3,841 
3,650 
3,177 
3,690 
3,044 
2,679 
2,654 
16,079 
12,067 
9,631 
Government grants and cooperative agreements revenue
91 
527 
1,479 
436 
91 
2,442 
1,432 
Research and development
2,164 
1,903 
1,712 
1,824 
1,562 
1,814 
1,994 
1,808 
7,603 
7,178 
5,195 
Selling, general and administrative
6,794 
6,219 
6,686 
5,966 
5,938 
5,380 
6,207 
5,528 
25,665 
23,053 
21,577 
Amortization of intangible assets
51 
50 
51 
50 
50 
51 
51 
50 
202 
202 
67 
Total operating expenses
9,009 
8,172 
8,449 
7,840 
7,550 
7,245 
8,252 
7,386 
33,470 
30,433 
27,021 
Loss from operations
(3,598)
(4,331)
(4,799)
(4,572)
(3,333)
(2,722)
(5,573)
(4,296)
(17,300)
(15,924)
(15,958)
Total non-operating income (expense), net
1,993 
926 
2,933 
(4,227)
(4,353)
5,026 
(809)
(779)
1,625 
(915)
(859)
Income (loss) before income taxes
(1,605)
(3,405)
(1,866)
(8,799)
(7,686)
2,304 
(6,382)
(5,075)
(15,675)
(16,839)
(16,817)
Provision for income taxes
111 
55 
41 
35 
49 
44 
27 
23 
242 
143 
94 
Net income (loss)
$ (1,716)
$ (3,460)
$ (1,907)
$ (8,834)
$ (7,735)
$ 2,260 
$ (6,409)
$ (5,098)
$ (15,917)
$ (16,982)
$ (16,911)
Basic
$ (0.03)
$ (0.06)
$ (0.04)
$ (0.17)
$ (0.16)
$ 0.05 
$ (0.13)
$ (0.11)
$ (0.29)
$ (0.35)
$ (0.42)
Diluted
$ (0.07)
$ (0.08)
$ (0.10)
$ (0.17)
$ (0.16)
$ 0.05 
$ (0.13)
$ (0.11)
$ (0.33)
$ (0.35)
$ (0.42)