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Note 1. Summary of Significant Accounting Policies
Principles of Consolidation and Basis of Presentation
The accompanying unaudited condensed consolidated financial statements include those of Cerus Corporation and its subsidiary, Cerus Europe B.V. (collectively referred to hereinafter as “Cerus” or the “Company”) after elimination of all intercompany accounts and transactions. These condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”). Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, all adjustments, consisting only of normal recurring entries, considered necessary for a fair presentation have been made. Operating results for the three and nine months ended September 30, 2014, are not necessarily indicative of the results that may be expected for the year ending December 31, 2014, or for any future periods.
These accompanying unaudited condensed consolidated financial statements and notes thereto should be read in conjunction with the Company’s audited consolidated financial statements and notes thereto for the year ended December 31, 2013, which were included in the Company’s 2013 Annual Report on Form 10-K, filed with the SEC on March 7, 2014. The accompanying condensed consolidated balance sheet as of December 31, 2013, has been derived from the Company’s audited consolidated financial statements as of that date.
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, management evaluates its estimates, which are based on historical experience and on various other assumptions that are believed to be reasonable under the circumstances. Actual results may differ from those estimates under different assumptions or conditions.
Revenue
The Company recognizes revenue in accordance with Accounting Standards Codification (“ASC”) Topic 605-25, “Revenue Recognition – Arrangements with Multiple Deliverables,” as applicable. Revenue is recognized when (i) persuasive evidence of an agreement with the funding party 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 three and nine months ended September 30, 2014 and 2013, were product revenue from sales of the INTERCEPT Blood System for platelets and plasma (“platelet and plasma systems”).
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. Because the Company has no vendor specific objective evidence or third party evidence for its systems due to the Company’s variability in its pricing across the regions into which it sells its products, the allocation of revenue is based on best estimated selling price for the systems sold. The objective of best estimated selling price is to determine the price at which the Company would transact a sale, had the product been sold on a stand-alone basis. The Company determines best estimated selling price for its systems by considering multiple factors, including, but not limited to, features and functionality of the system, geographies, type of customer, and market conditions. The Company regularly reviews best estimated selling price and maintains internal controls over the establishment and updates of these estimates.
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.
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. 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 securities.
Investments
Investments with original maturities of greater than three months including corporate debt and United States government agency securities are designated as available-for-sale and classified as short-term investments, in accordance with ASC Topic 320, “Accounting for Certain Investments in Debt and Equity Securities”. 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 losses on available-for-sale securities, net of taxes” on the Company’s condensed consolidated statements of comprehensive loss. Realized gains (losses) from the sale of available-for-sale investments were recorded in “Other income, net” on the Company’s condensed 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 reviews its marketable securities on a regular basis to evaluate whether any security has experienced an other-than-temporary decline in fair value. Other-than-temporary declines in market value if any, are recorded in “Other income, net” on the Company’s condensed consolidated statements of operations.
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 condensed consolidated balance sheets. The Company also has certain non-US dollar denominated deposits recorded as “Restricted cash” in compliance with certain foreign contractual requirements.
Concentration of Credit Risk
Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash equivalents, short-term investments and accounts receivable.
Pursuant to the Company’s investment policy, substantially all of the Company’s cash, cash equivalents and short-term investments are maintained at a major financial institution of high credit standing. The Company monitors the financial credit worthiness of the issuers of its investments and limits the concentration in individual securities and types of investments that exist within its investment portfolio. Generally, all of the Company’s investments carry high credit quality ratings, which is in accordance with its investment policy. At September 30, 2014, the Company does not believe there is significant financial risk from non-performance by the issuers of the Company’s cash equivalents and short-term investments.
Concentrations of credit risk with respect to trade receivables exist. However, for certain customers, the Company purchases 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 significant customers that it expects to sell to on credit terms. 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 condensed consolidated balance sheets and records a charge on its condensed consolidated statements of operations. At September 30, 2014 and December 31, 2013, the Company had not recorded any reserves for potentially uncollectible accounts.
The Company had four and two customers that accounted for more than 10% of the Company’s outstanding trade receivables at each of September 30, 2014 and December 31, 2013, respectively. These customers cumulatively represented approximately 77% and 55% of the Company’s outstanding trade receivables, at September 30, 2014 and December 31, 2013, respectively. To date, the Company has not experienced collection difficulties from these customers.
Inventories
At September 30, 2014 and December 31, 2013, 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 before being sold to, and ultimately incorporated and assembled by Fresenius Kabi Deutschland GmbH Fresenius, Inc. (with its affiliates, “Fresenius”) into the finished INTERCEPT disposable kits. 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 sold to Fresenius 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 work-in-process and finished units to meet the Company’s forecasted demands. If actual results differ from those estimates, work-in-process inventory could potentially accumulate for periods exceeding one year. At September 30, 2014 and December 31, 2013, the Company classified its work-in-process inventory as a current asset on its condensed consolidated balance sheets based on its evaluation that the work-in-process inventory would be sold to Fresenius for finished disposable kit production 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. The Company writes-down specifically identified unusable, obsolete, slow-moving, or known unsalable inventory that has no alternative use 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 revenue” on the Company’s condensed consolidated statements of operations. At September 30, 2014 and December 31, 2013, the Company had $0.1 million and $0.4 million, respectively, recorded for potential obsolete, expiring or unsalable product.
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.
Capitalization of Software Costs
The Company capitalizes certain significant costs incurred in the acquisition and development of software for internal use, including the costs of the software, materials, and consultants during the application development stage. Costs incurred prior to the application development stage, costs incurred once the application is substantially complete and ready for its intended use, and other costs not qualifying for capitalization, including training and maintenance costs, are charged to expense. The Company capitalized costs for enhancement of the enterprise resource planning software system and other internal use software of $1.8 million and zero during the nine months ended September 30, 2014 and 2013, respectively. The capitalized costs associated with the enterprise resource planning system are being amortized over the estimated useful life of five years.
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 condensed 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. 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 segment and has 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, based on the present value of future cash flows, 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 5 in the notes to unaudited condensed 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 net cash flows. If the expected undiscounted future net 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 three and nine months ended September 30, 2014 and 2013.
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. Revenues and expenses are remeasured using average exchange rates prevailing during the period. Remeasurements are recorded in the Company’s condensed consolidated statements of operations.
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 generally 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 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 condensed consolidated statements of operations.
See Note 11 in the notes to unaudited condensed 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. As of September 30, 2014, there were no remaining warrants issued in August 2009 that remained outstanding. The Company classified the warrants as a liability on its accompanying unaudited condensed 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 (as determined in accordance with the Black-Scholes option pricing model) 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 outstanding warrants is calculated using a Black-Scholes option-pricing model and is adjusted accordingly at each reporting period.
Changes resulting from the revaluation of warrants to fair value are recorded in “gain (loss) from revaluation of warrant liability” on the accompanying unaudited condensed 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 accompanying unaudited condensed consolidated balance sheets and no further adjustment to the fair value would be made in subsequent periods.
See Note 10 in the notes to unaudited condensed 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 accompanying unaudited condensed consolidated statements of operations, nor has its accrued for or made payments for interest and penalties. 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 2013 remain subject to examination by the taxing jurisdictions due to unutilized net operating losses and research credits.
Net Loss Per Share
Basic net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding for the period. Diluted net loss per 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. Diluted net loss per share also gives effect to potential adjustments to the numerator for gains 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.
Certain potential dilutive securities were excluded from the dilution calculation for the three and nine months ended September 30, 2014 and 2013, 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 share for the three and nine months ended September 30, 2014 and 2013 (in thousands, except per share amounts):
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Three Months Ended September 30, |
Nine Months Ended September 30, |
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| 2014 | 2013 | 2014 | 2013 | |||||||||||||
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Numerator for Basic and Diluted: |
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Net loss used for basic calculation |
$ | (10,759) | $ | (20,501) | $ | (18,573) | $ | (37,477) | ||||||||
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Effect of revaluation of warrant liability |
(1,738) | 0 | (14,263) | 0 | ||||||||||||
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Adjusted net loss used for diluted calculation |
$ | (12,497) | $ | (20,501) | $ | (32,836) | $ | (37,477) | ||||||||
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Denominator: |
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Basic weighted average number of shares outstanding |
75,194 | 69,791 | 73,407 | 66,464 | ||||||||||||
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Effect of dilutive potential shares |
909 | 0 | 2,030 | 0 | ||||||||||||
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Diluted weighted average number of shares outstanding |
76,103 | 69,791 | 75,437 | 66,464 | ||||||||||||
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Net loss per share: |
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Basic |
$ | (0.14) | $ | (0.29) | $ | (0.25) | $ | (0.56) | ||||||||
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Diluted |
$ | (0.16) | $ | (0.29) | $ | (0.44) | $ | (0.56) | ||||||||
The table below presents shares underlying stock options, employee stock purchase plan rights and restricted stock units that are excluded from the calculation of the weighted average number of shares outstanding used for the calculation of diluted net loss per share. Warrants are excluded from the table below in periods for which the warrants are included in the calculation of diluted net loss per share. These are excluded from the calculation due to their anti-dilutive effect for the three and nine months ended September 30, 2014 and 2013 (shares in thousands):
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Three Months Ended September 30, |
Nine Months Ended September 30, |
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| 2014 | 2013 | 2014 | 2013 | |||||||||||||
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Weighted average number of anti-dilutive potential shares |
12,032 | 16,651 | 11,737 | 16,301 | ||||||||||||
Guarantee and Indemnification Arrangements
The Company recognizes the fair value for guarantee and indemnification arrangements issued or modified by the Company. 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.
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 its 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 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 corporate debt and United States government agency securities. 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, which include its warrant liability. The Company assesses any transfers among fair value measurement levels at the end of each reporting period.
See Notes 2 and 10 in the notes to unaudited condensed consolidated financial statements for further information regarding the Company’s valuation of financial instruments.
New Accounting Pronouncements
In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2014-09, Revenue from Contracts with Customers (Topic 606), which provides a single comprehensive model for entities to use in accounting for revenue arising from contracts with customers and will supersede most current revenue recognition guidance. This ASU is based on the principle that revenue is recognized to depict the transfer of goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The ASU also requires additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract. The ASU’s effective date for the Company will be the first quarter of fiscal year 2017, using one of two retrospective application methods. Early adoption is not permitted. The Company is assessing the potential effects of this ASU on its consolidated financial statements.
In August 2014, the FASB issued ASU No. 2014-15, Presentation of Financial Statements — Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern, which requires management to evaluate, in connection with preparing financial statements for each annual and interim reporting period, whether there are conditions or events, considered in the aggregate, that raise substantial doubt about an entity’s ability to continue as a going concern within one year after the date that the financial statements are issued and provide related disclosures. This ASU will be effective for the Company in fiscal year 2016. Early adoption is permitted. The Company is currently assessing the future impact of this ASU on its consolidated financial statements.
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Note 2. Fair Value on Financial Instruments
The Company determines the fair value of an asset or liability based on the assumptions that market participants would use in pricing the asset or liability in an orderly transaction between market participants at the measurement date. The identification of market participant assumptions provides a basis for determining what inputs are to be used for pricing each asset or liability. A fair value hierarchy has been established which gives precedence to fair value measurements calculated using observable inputs over those using unobservable inputs. This hierarchy prioritized the inputs into three broad levels as follows:
| • | Level 1: Quoted prices in active markets for identical instruments |
| • | Level 2: Other significant observable inputs (including quoted prices in active markets for similar instruments) |
| • | Level 3: Significant unobservable inputs (including assumptions in determining the fair value of certain investments) |
Money market funds are highly liquid investments and are actively traded. The pricing information on these investment instruments are readily available and can be independently validated as of the measurement date. This approach results in the classification of these securities as Level 1 of the fair value hierarchy.
To estimate the fair value of Level 2 debt securities as of September 30, 2014, the Company’s primary pricing service relies on inputs from multiple industry-recognized pricing sources to determine the price for each investment. Corporate debt and United States government agency securities are systematically priced by this service as of the close of business each business day. If the primary pricing service does not price a specific asset, a secondary pricing service is utilized.
The Company’s financial assets and liabilities were recorded at fair value in the condensed consolidated balance sheets at September 30, 2014, as follows (in thousands):
| Total | Level 1 | Level 2 | Level 3 | |||||||||||||
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Money market funds (1) |
$ | 6,185 | $ | 6,185 | $ | 0 | $ | 0 | ||||||||
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Corporate debt securities (2) |
21,802 | 0 | 21,802 | 0 | ||||||||||||
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United States government agency securities (2) |
3,429 | 0 | 3,429 | 0 | ||||||||||||
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Total financial assets |
$ | 31,416 | $ | 6,185 | $ | 25,231 | $ | 0 | ||||||||
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Warrant liability (3) |
$ | 3,931 | $ | 0 | $ | 0 | $ | 3,931 | ||||||||
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Total financial liabilities |
$ | 3,931 | $ | 0 | $ | 0 | $ | 3,931 | ||||||||
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| (1) | Included in cash and cash equivalents on the Company’s accompanying unaudited condensed consolidated balance sheets. |
| (2) | Included in short-term investments on the Company’s accompanying unaudited condensed consolidated balance sheets. |
| (3) | Included in current liabilities on the Company’s accompanying unaudited condensed consolidated balance sheets. |
The Company’s financial assets and liabilities were recorded at fair value in the accompanying unaudited condensed consolidated balance sheets at December 31, 2013, as follows (in thousands):
| Total | Level 1 | Level 2 | Level 3 | |||||||||||||
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Money market funds (1) |
$ | 8,650 | $ | 8,650 | $ | 0 | $ | 0 | ||||||||
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Corporate debt securities (2) |
23,173 | 0 | 23,173 | 0 | ||||||||||||
|
United States government agency securities (2) |
5,018 | 0 | 5,018 | 0 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
|
Total financial assets |
$ | 36,841 | $ | 8,650 | $ | 28,191 | $ | 0 | ||||||||
|
|
|
|
|
|
|
|
|
|||||||||
|
Warrant liability (3) |
$ | 20,390 | $ | 0 | $ | 0 | $ | 20,390 | ||||||||
|
|
|
|
|
|
|
|
|
|||||||||
|
Total financial liabilities |
$ | 20,390 | $ | 0 | $ | 0 | $ | 20,390 | ||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| (1) | Included in cash and cash equivalents on the Company’s accompanying unaudited condensed consolidated balance sheets. |
| (2) | Included in short-term investments on the Company’s accompanying unaudited condensed consolidated balance sheets. |
| (3) | Included in current liabilities on the Company’s accompanying unaudited condensed consolidated balance sheets. |
A reconciliation of the beginning and ending balances for the warrant liability using significant unobservable inputs (Level 3) from December 31, 2013 to September 30, 2014, was as follows (in thousands):
|
Balance at December 31, 2013 |
$ | 20,390 | ||||
|
Decrease in fair value of warrants |
(14,263) | |||||
|
Settlement of warrants exercised |
(2,196) | |||||
|
|
|
|||||
|
Balance at September 30, 2014 |
$ | 3,931 | ||||
|
|
|
See Notes 1 and 10 in the notes to unaudited condensed consolidated financial statements for further information regarding the Company’s valuation techniques and unobservable inputs for warrant liability using significant unobservable inputs (Level 3).
The Company did not have any transfers among fair value measurement levels during nine months ended September 30, 2014, or the year ended December 31, 2013.
|
|||
Note 3. Available-for-sale Securities
The following is a summary of available-for-sale securities at September 30, 2014 (in thousands):
| September 30, 2014 | ||||||||||||
| Carrying Value | Net Unrealized Gain |
Fair Value | ||||||||||
|
Money market funds |
$ | 6,185 | $ | 0 | $ | 6,185 | ||||||
|
Corporate debt securities |
21,813 | (11) | 21,802 | |||||||||
|
United States government agency securities |
3,429 | 0 | 3,429 | |||||||||
|
|
|
|
|
|
|
|||||||
|
Total available-for-sale securities |
$ | 31,427 | $ | (11) | $ | 31,416 | ||||||
|
|
|
|
|
|
|
|||||||
The following is a summary of available-for-sale securities at December 31, 2013 (in thousands):
| December 31, 2013 | ||||||||||||
| Carrying Value | Net Unrealized Gain |
Fair Value | ||||||||||
|
Money market funds |
$ | 8,650 | $ | 0 | $ | 8,650 | ||||||
|
Corporate debt securities |
23,165 | 8 | 23,173 | |||||||||
|
United States government agency securities |
5,019 | (1) | 5,018 | |||||||||
|
|
|
|
|
|
|
|||||||
|
Total available-for-sale securities |
$ | 36,834 | $ | 7 | $ | 36,841 | ||||||
|
|
|
|
|
|
|
|||||||
Available-for-sale securities at September 30, 2014 and December 31, 2013, consisted of the following by original contractual maturity (in thousands):
| September 30, 2014 | December 31, 2013 | |||||||||||||||
| Carrying Value | Fair Value | Carrying Value | Fair Value | |||||||||||||
|
Due in one year or less |
$ | 29,396 | $ | 29,389 | $ | 30,700 | $ | 30,701 | ||||||||
|
Due greater than one year and less than three years |
2,031 | 2,027 | 6,134 | 6,140 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
|
Total cash equivalents and short-term investments |
$ | 31,427 | $ | 31,416 | $ | 36,834 | $ | 36,841 | ||||||||
|
|
|
|
|
|
|
|
|
|||||||||
The Company recognized insignificant realized gains from the sale or maturity of available-for-sale investments during the three and nine months ended September 30, 2014 and did not record any realized gains from the sale or maturity of available-for-sale investments during the three and nine months ended September 30, 2013. The Company did not experience other-than-temporary declines in fair value on its investments.
The aggregate fair value of investments with unrealized losses at September 30, 2013 and December 31, 2013, were $16.8 million and $12.0 million, respectively.
|
|||
Note 4. Inventories
Inventories at September 30, 2014 and December 31, 2013, consisted of the following (in thousands):
| September 30, 2014 |
December 31, 2013 |
|||||||||
|
Work-in-process |
$ | 2,354 | $ | 4,863 | ||||||
|
Finished goods |
11,149 | 8,200 | ||||||||
|
|
|
|
|
|||||||
|
Total inventories |
$ | 13,503 | $ | 13,063 | ||||||
|
|
|
|
|
|||||||
|
|||
Note 5. Goodwill and Intangible Assets, net
Goodwill
During the three and nine months ended September 30, 2014, the Company did not dispose of, impair or recognize additional goodwill. Accordingly at both September 30, 2014, and December 31, 2013, the carrying amount of goodwill was $1.3 million. The Company performed its annual review of goodwill on August 31, 2014, and noted no impairment as of that date.
Intangible Assets, net
The following is a summary of intangible assets, net at September 30, 2014 (in thousands):
| September 30, 2014 | ||||||||||||
| Gross Carrying Amount |
Accumulated Amortization |
Net Carrying Amount |
||||||||||
|
Acquisition-related intangible assets: |
||||||||||||
|
Reacquired license - INTERCEPT Asia |
$ | 2,017 | $ | (824) | $ | 1,193 | ||||||
|
|
|
|
|
|
|
|||||||
|
Total intangible assets |
$ | 2,017 | $ | (824) | $ | 1,193 | ||||||
|
|
|
|
|
|
|
|||||||
The following is a summary of intangible assets, net at December 31, 2013 (in thousands):
| December 31, 2013 | ||||||||||||
| Gross Carrying Amount |
Accumulated Amortization |
Net Carrying Amount |
||||||||||
|
Acquisition-related intangible assets: |
||||||||||||
|
Reacquired license - INTERCEPT Asia |
$ | 2,017 | $ | (673) | $ | 1,344 | ||||||
|
|
|
|
|
|
|
|||||||
|
Total intangible assets |
$ | 2,017 | $ | (673) | $ | 1,344 | ||||||
|
|
|
|
|
|
|
|||||||
During the three and nine months ended September 30, 2014 and 2013, there were no impairment losses recognized related to the acquired intangible assets.
At September 30, 2014, the expected annual amortization expense of the intangible assets, net is $0.05 million for the remaining three months of 2014, $0.2 million annually beginning with the year ending December 31, 2015, through the year ending December 31, 2019 and $0.1 million for the year ending December 31, 2020.
|
|||
Note 6. Long-Term Investments
In connection with the agreements to license the immunotherapy technologies to Aduro BioTech, Inc. (“Aduro”) in 2009, the Company received shares of preferred stock of Aduro. Pursuant to these license agreements, the Company is eligible to receive a 1% royalty fee on any future sales resulting from the licensed technology. As of September 2014, the Company’s ownership in Aduro was less than 1% on a fully diluted basis. Since receiving preferred stock in Aduro, the Company has carried its investment in Aduro at zero in its condensed consolidated balance sheets. As of September 30, 2014, the Company has not received any royalties under this agreement.
|
|||
Note 7. Accrued Liabilities
Accrued liabilities at September 30, 2014 and December 31, 2013, consisted of the following (in thousands):
| September 30, | December 31, | |||||||||
| 2014 | 2013 | |||||||||
|
Accrued compensation and related costs |
$ | 2,956 | $ | 2,527 | ||||||
|
Accrued inventory costs |
4,610 | 3,553 | ||||||||
|
Accrued professional services |
2,928 | 2,722 | ||||||||
|
Other accrued expenses |
2,053 | 1,011 | ||||||||
|
|
|
|
|
|||||||
|
Total accrued liabilities |
$ | 12,547 | $ | 9,813 | ||||||
|
|
|
|
|
|||||||
|
|||
Note 8. Debt
Loan and Security Agreement
On June 30, 2014, the Company entered into a five year loan and security agreement with Oxford Finance LLC (the “Term Loan Agreement”) to borrow up to $30.0 million in term loans in three equal tranches (the “Term Loans”). On June 30, 2014, the Company received $10.0 million from the first tranche (“Term Loan A”). The second tranche of $10.0 million (“Term Loan B”) is contingent upon the approval, if it occurs, by the U.S. Food and Drug Administration (“FDA”) of the Company’s premarket approval application for either the plasma or platelet system (the “PMA Approval”). The availability of Term Loan B expires at the earlier of (i) six months after receiving PMA Approval or (ii) June 30, 2015. The third tranche of $10.0 million (“Term Loan C”) will be available from July 1, 2015 through December 31, 2015, contingent upon both (i) obtaining PMA Approval and (ii) the Company achieving trailing six months’ revenue at a specified threshold (the “Revenue Event”). Term Loan A bears an interest rate of 6.95%. Term Loan B and Term Loan C will bear an interest rate calculated at the greater of 6.95% or 6.72% plus the three month U.S. LIBOR rate in effect three business days prior to the applicable Term Loan funding date. All of the Term Loans mature on June 1, 2019. The Company is required to make interest only payments through December 2015 followed by forty-two months of equal principal and interest payments thereafter; however, if the Revenue Event is achieved no later than November 30, 2015, then the interest-only period may be extended through December 31, 2016, and the amortization period will be reduced to thirty months. The Company is also required to make a final payment equal to 7% of the principal amounts of the Term Loans drawn payable on the earlier to occur of maturity or prepayment. The costs associated with the final payment are recognized as interest expense over the life of the Term Loans. The Company may prepay at any time the Term Loans subject to declining prepayment fees over the term of the Term Loan Agreement. The Company paid the lender a $0.2 million commitment fee related to the Term Loan Agreement which has been recorded as a discount on the Term Loans and will be amortized to interest expense using the effective interest method over the life of the Term Loans. In addition, the Company paid $0.1 million of the lender legal fees, which are capitalized in prepaid expenses on the Company’s condensed consolidated balance sheets and will be recognized using the effective interest method over the life of the Term Loans. 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 Term Loan Agreement. The Term Loan Agreement contains certain nonfinancial covenants, with which the Company was in compliance at September 30, 2014.
Revolving Line of Credit
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 (collectively, the “Amended Credit Agreement”). The Amended Credit Agreement provided for a formula-based revolving line of credit (“RLOC”) of up to $7.0 million. At December 31, 2013, the Company had $3.4 million outstanding under the RLOC, which was repaid in May 2014. The Amended Credit Agreement expired in June 2014.
Debt at September 30, 2014, consisted of the following (in thousands):
| September 30, 2014 | ||||||||||||
| Principal |
Unamortized Discount |
Total | ||||||||||
|
Loan and Security Agreement |
$ | 10,000 | $ | 140 | $ | 9,860 | ||||||
|
Less: debt - current |
0 | 0 | 0 | |||||||||
|
|
|
|
|
|
|
|||||||
|
Debt - non-current |
$ | 10,000 | $ | 140 | $ | 9,860 | ||||||
|
|
|
|
|
|
|
|||||||
Debt at December 31, 2013, consisted of the following (in thousands):
| December 31, 2013 | ||||||||||||
| Principal |
Unamortized Discount |
Total | ||||||||||
|
Comerica - Revolving Line of Credit |
$ | 3,366 | $ | 0 | $ | 3,366 | ||||||
|
Less: debt - current |
(3,366) | 0 | (3,366) | |||||||||
|
|
|
|
|
|
|
|||||||
|
Debt - non-current |
$ | 0 | $ | 0 | $ | 0 | ||||||
|
|
|
|
|
|
|
|||||||
Principal and interest payments on debt at September 30, 2014, are expected to be as follows (in thousands):
|
Year ended December 31, |
||||||
|
2014 (remaining three months) |
$ | 174 | ||||
|
2015 |
695 | |||||
|
2016 |
3,227 | |||||
|
2017 |
3,227 | |||||
|
2018 |
3,227 | |||||
|
2019 |
2,314 | |||||
|
|
|
|||||
| $ | 12,864 | |||||
|
|
|
|
|||
Note 9. 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 February 2016. In June 2013, the Company entered into a new lease for additional space in Concord. The lease has a two year initial term with four (4) two year options for the Company to renew. The lease commenced on August 1, 2013, and obligates the Company to pay rent payments of approximately $39,000 for the remaining three months of 2014 and approximately $90,000 for fiscal year 2015. The Company’s leased facilities qualify as operating leases under ASC Topic 840, “Leases” and as such, are not included on its condensed consolidated balance sheets.
Financed Leasehold Improvements
In 2010, the Company financed $1.1 million of leasehold improvements at one of its facilities in Concord, California. 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 lease. At September 30, 2014, the Company had an outstanding liability of $0.6 million related to these leasehold improvements, of which $0.1 million was reflected in “Accrued liabilities” and $0.5 million was reflected in “Other non-current liabilities” on the Company’s condensed 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.
In June 2014, the Company terminated its distribution agreement with one of its distributors in certain countries and entered into an agreement to provide for specific post-termination obligations (the “Transition Agreement”). The Transition Agreement expired September 30, 2014. At September 30, 2014, the Company recorded a liability for the repurchase of spare parts at the price originally paid by the distributor and 2,000 INTERCEPT disposable kits purchased by the distributor during the third quarter of 2014 resulting in deferred revenue. The Company is also required to pay this former distributor a fee of €10 per disposable kit for platelet systems sold by the Company to any customer in certain countries commencing with the termination of the agreement through April 1, 2018, subject to a maximum payment of €3 million. As this former distributor will remain as a customer in other countries, in accordance with ASC Topic 605-50 “Customer Payments and Incentives” any fees paid to the former distributor related to INTERCEPT disposable kits will be offset against the revenue associated with the sale of INTERCEPT disposable kits in those territories.
|
|||
Note 10. Stockholders’ Equity
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”).
In November 2010, the Company issued warrants to purchase 3.7 million shares of common stock, exercisable at an exercise price of $3.20 per share. The warrants issued in November 2010 (“2010 Warrants”) became exercisable on May 15, 2011, and are exercisable for a period of five years from the issue date.
The fair value of the 2009 Warrants and 2010 Warrants was recorded on the condensed consolidated balance sheets as a liability pursuant to “Accounting for Certain Financial Instruments with Characteristics of Both Liabilities and Equity” Topics of ASC and are adjusted to fair value at each financial reporting date thereafter until the earlier of exercise, expiration 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 September 30, 2014 and December 31, 2013, consisted of the following (in thousands):
| September 30, | December 31, | |||||||||
| 2014 | 2013 | |||||||||
|
2009 Warrants |
$ | 0 | $ | 8,542 | ||||||
|
2010 Warrants |
3,931 | 11,848 | ||||||||
|
|
|
|
|
|||||||
|
Total warrant liability |
$ | 3,931 | $ | 20,390 | ||||||
|
|
|
|
|
|||||||
The fair value of the Company’s warrants was based on option valuation models and using the following assumptions at September 30, 2014 and December 31, 2013:
| December 31, | ||||||
| 2013 | ||||||
|
2009 Warrants: |
||||||
|
Expected term (in years) |
0.65 | |||||
|
Estimated volatility |
45% | |||||
|
Risk-free interest rate |
0.10% | |||||
|
Expected dividend yield |
0% | |||||
| September 30, | December 31, | |||||
| 2014 | 2013 | |||||
|
2010 Warrants: |
||||||
|
Expected term (in years) |
1.11 | 1.86 | ||||
|
Estimated volatility |
47% | 41% | ||||
|
Risk-free interest rate |
0.13% | 0.38% | ||||
|
Expected dividend yield |
0% | 0% |
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. Any significant increases in the Company’s stock price will likely create an increase to the fair value of the warrant liability. Similarly, any significant decreases in the Company’s stock price will likely create a decrease to the fair value of the warrant liability. During the three months ended September 30, 2014, warrants to purchase 2,400,000 shares of common stock were exercised from the outstanding 2009 Warrants and as such there were no outstanding 2009 Warrants remaining at September 30, 2014. During the nine months ended September 30, 2014, warrants to purchase 157,894 shares of common stock were exercised from the outstanding 2010 Warrants. As of September 30, 2014, 3.3 million of the 2010 warrants were outstanding.
Sales Agreement
On March 21, 2014, the Company entered into Amendment No. 1 to the Controlled Equity OfferingSM Sales Agreement, dated August 31, 2012 (as amended, the “Amended Cantor Agreement”) with Cantor Fitzgerald & Co. (“Cantor”) that provides for the issuance and sale of shares of its common stock over the term of the Amended Cantor Agreement having an aggregate offering price of up to $70.0 million through Cantor. Under the Amended 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 Amended Cantor Agreement are deemed an “at-the-market” offering and are registered under the 1933 Securities Act. During the year ended December 31, 2013, approximately 5.4 million shares of the Company’s common stock were sold under the Amended Cantor Agreement for aggregate proceeds of $23.5 million. During the nine months ended September 30, 2014, 1.7 million shares of the Company’s common stock were sold under the Amended Cantor Agreement for aggregate proceeds of $7.1 million. At September 30, 2014, the Company had approximately $34.4 million of common stock available to be sold under the Amended 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.
|
|||
Note 11. Stock-Based Compensation
The Company 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. 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 continue 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. On June 6, 2012 and June 12, 2013, the Company’s stockholders approved amendments to the 2008 Plan (“Amended 2008 Plan”) which increased the aggregate number of shares of common stock authorized for issuance by 3,000,000 and 6,000,000 shares, respectively, such that the Amended 2008 Plan has reserved for issuance an amount not to exceed 19,540,940 shares effective June 12, 2013. At September 30, 2014, the Company had an aggregate of approximately 17.6 million shares of its common stock reserved for issuance under the Amended 2008 Plan, the Prior Plans and the 1996 Plan, of which approximately 5.6 million shares were available for future issuance under the Amended 2008 Plan.
The Company also 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. On June 6, 2012, the stockholders approved an 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 September 30, 2014, the Company had approximately 0.4 million shares available for future issuance under the Purchase Plan.
Activity under the Company’s equity incentive plans related to stock options is set forth below (in thousands except per share amounts):
| Number of Options Outstanding |
Weighted Average Exercise Price per Share |
|||||||||||||
|
Balance at December 31, 2013 |
10,405 | $ | 3.46 | |||||||||||
|
Granted |
2,734 | 5.93 | ||||||||||||
|
Forfeited |
(134) | 4.77 | ||||||||||||
|
Expired |
(40) | 8.61 | ||||||||||||
|
Exercised |
(967) | 2.41 | ||||||||||||
|
|
|
|||||||||||||
|
Balance at September 30, 2014 |
11,998 | $ | 4.08 | |||||||||||
|
|
|
|||||||||||||
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.
Stock-based compensation recognized on the Company’s condensed consolidated statements of operations for the three and nine months ended September 30, 2014 and 2013, was as follows (in thousands):
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2014 | 2013 | 2014 | 2013 | |||||||||||||
|
Stock-based compensation expense by caption: |
||||||||||||||||
|
Research and development |
$ | 281 | $ | 132 | $ | 740 | $ | 341 | ||||||||
|
Selling, general and administrative |
1,197 | 729 | 3,024 | 2,074 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
|
Total stock-based compensation expense |
$ | 1,478 | $ | 861 | $ | 3,764 | $ | 2,415 | ||||||||
|
|
|
|
|
|
|
|
|
|||||||||
|
|||
Note 12. Development and License Agreements
The Company has certain agreements with Fresenius which require the Company to pay royalties on INTERCEPT Blood System product sales at royalty rates that vary by product: 10% of product sales for the platelet system and 3% of product sales for the plasma system which it records as a liability in accounts payable on the Company’s unaudited condensed consolidated balance sheet. During the three months ended September 30, 2014 and 2013, the Company made royalty payments to Fresenius of $0.6 million and $0.8 million, respectively. During the nine months ended September 30, 2014 and 2013, the Company made royalty payments to Fresenius of $1.9 million and $2.3 million, respectively. At September 30, 2014 and December 31, 2013, accrued royalties due to Fresenius were $0.6 million and $0.7 million, respectively.
The Company also paid Fresenius certain costs associated with the amended manufacturing and supply agreement the Company executed with Fresenius in December 2008 (the “Original Supply Agreement”), for the manufacture of INTERCEPT finished disposable kits for the Company’s platelet and plasma systems through December 31, 2013. Under the Original Supply Agreement, the Company paid Fresenius a set price per disposable kit, which was established annually, plus a fixed surcharge per disposable kit. In addition, volume driven manufacturing overhead was paid or refunded if actual manufacturing volumes were higher or lower than the annually estimated production volumes.
In November 2013, the Company amended the Original Supply Agreement with Fresenius, with the new terms effective January 1, 2014 (the “2013 Amendment”). Under the 2013 Amendment, Fresenius is obligated to sell, and the Company is obligated to purchase, up to a certain specified annual volume of finished disposable kits for the platelet and plasma systems from Fresenius for both clinical and commercial use. Once the specified annual volume of disposable kits is purchased from Fresenius, the Company is able to purchase additional quantities of disposable kits from other third-party manufacturers. The 2013 Amendment also provides for fixed pricing for finished kits with successive decreases in pricing at certain annual production volumes. In addition, the 2013 Amendment requires the Company to purchase additional specified annual volumes of sets per annum if and when an additional Fresenius manufacturing site is identified and qualified to make INTERCEPT disposable kits subject to mutual agreement on pricing for disposable kits manufactured at the additional site. Fresenius is also obligated to purchase and maintain specified inventory levels of the Company’s proprietary inactivation compounds and adsorption media from the Company at fixed prices. The Company sold such components to Fresenius in an aggregate amount of $2.2 million during the three months ended September 30, 2014, and $6.0 million during the nine months ended September 30, 2014. The Company maintains the amounts due from the components sold to Fresenius as a current asset on its accompanying unaudited condensed consolidated balance sheets until such time as the Company purchases finished disposable kits using those components. The term of the 2013 Amendment extends through December 31, 2018, subject to termination by either party upon thirty months prior written notice, in the case of Fresenius, or twenty-four months prior written notice, in the Company’s case. The Company and Fresenius each have normal and customary termination rights, including termination for material breach.
The Company made payments to Fresenius of $4.3 million and $4.2 million relating to the manufacturing of the Company products during the three months ended September 30, 2014 and 2013, respectively and $13.9 million and $11.8 million during the nine months ended September 30, 2014 and 2013, respectively. At September 30, 2014 and December 31, 2013, accrued amounts due to Fresenius were $4.1 million and $4.3 million, respectively, for INTERCEPT disposable kits manufactured. At September 30, 2014 and December 31, 2013, amounts due from Fresenius were $2.0 million and zero, respectively.
|
|||
Note 13. 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 of America include a wholly-owned subsidiary headquartered in Europe. The Company’s operations in the United States of America are responsible for the research and development and global commercialization of the INTERCEPT Blood System, as discussed in further detail below, 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 revenue, all of which operate in a country outside of the United States of America, during the three and nine months ended September 30, 2014 and 2013:
| Three Months Ended | Nine Months Ended | |||||||
| September 30, | September 30, | |||||||
| 2014 | 2013 | 2014 | 2013 | |||||
|
Etablissement Francais du Sang |
30% | 20% | 26% | 18% | ||||
|
Grifols |
* | 22% | * | 20% | ||||
|
Bravo Pacific Limited |
* | 11% | * | * | ||||
|
Advanced Technology Company KSC |
* | 10% | * | * | ||||
* Represents an amount less than 10% of product revenue.
|
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Principles of Consolidation and Basis of Presentation
The accompanying unaudited condensed consolidated financial statements include those of Cerus Corporation and its subsidiary, Cerus Europe B.V. (collectively referred to hereinafter as “Cerus” or the “Company”) after elimination of all intercompany accounts and transactions. These condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”). Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, all adjustments, consisting only of normal recurring entries, considered necessary for a fair presentation have been made. Operating results for the three and nine months ended September 30, 2014, are not necessarily indicative of the results that may be expected for the year ending December 31, 2014, or for any future periods.
These accompanying unaudited condensed consolidated financial statements and notes thereto should be read in conjunction with the Company’s audited consolidated financial statements and notes thereto for the year ended December 31, 2013, which were included in the Company’s 2013 Annual Report on Form 10-K, filed with the SEC on March 7, 2014. The accompanying condensed consolidated balance sheet as of December 31, 2013, has been derived from the Company’s audited consolidated financial statements as of that date.
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, management evaluates its estimates, which are based on historical experience and on various other assumptions that are believed to be reasonable under the circumstances. Actual results may differ from those estimates under different assumptions or conditions.
Revenue
The Company recognizes revenue in accordance with Accounting Standards Codification (“ASC”) Topic 605-25, “Revenue Recognition – Arrangements with Multiple Deliverables,” as applicable. Revenue is recognized when (i) persuasive evidence of an agreement with the funding party 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 three and nine months ended September 30, 2014 and 2013, were product revenue from sales of the INTERCEPT Blood System for platelets and plasma (“platelet and plasma systems”).
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. Because the Company has no vendor specific objective evidence or third party evidence for its systems due to the Company’s variability in its pricing across the regions into which it sells its products, the allocation of revenue is based on best estimated selling price for the systems sold. The objective of best estimated selling price is to determine the price at which the Company would transact a sale, had the product been sold on a stand-alone basis. The Company determines best estimated selling price for its systems by considering multiple factors, including, but not limited to, features and functionality of the system, geographies, type of customer, and market conditions. The Company regularly reviews best estimated selling price and maintains internal controls over the establishment and updates of these estimates.
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.
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. 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 securities.
Investments
Investments with original maturities of greater than three months including corporate debt and United States government agency securities are designated as available-for-sale and classified as short-term investments, in accordance with ASC Topic 320, “Accounting for Certain Investments in Debt and Equity Securities”. 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 losses on available-for-sale securities, net of taxes” on the Company’s condensed consolidated statements of comprehensive loss. Realized gains (losses) from the sale of available-for-sale investments were recorded in “Other income, net” on the Company’s condensed 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 reviews its marketable securities on a regular basis to evaluate whether any security has experienced an other-than-temporary decline in fair value. Other-than-temporary declines in market value if any, are recorded in “Other income, net” on the Company’s condensed consolidated statements of operations.
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 condensed consolidated balance sheets. The Company also has certain non-US dollar denominated deposits recorded as “Restricted cash” in compliance with certain foreign contractual requirements.
Concentration of Credit Risk
Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash equivalents, short-term investments and accounts receivable.
Pursuant to the Company’s investment policy, substantially all of the Company’s cash, cash equivalents and short-term investments are maintained at a major financial institution of high credit standing. The Company monitors the financial credit worthiness of the issuers of its investments and limits the concentration in individual securities and types of investments that exist within its investment portfolio. Generally, all of the Company’s investments carry high credit quality ratings, which is in accordance with its investment policy. At September 30, 2014, the Company does not believe there is significant financial risk from non-performance by the issuers of the Company’s cash equivalents and short-term investments.
Concentrations of credit risk with respect to trade receivables exist. However, for certain customers, the Company purchases 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 significant customers that it expects to sell to on credit terms. 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 condensed consolidated balance sheets and records a charge on its condensed consolidated statements of operations. At September 30, 2014 and December 31, 2013, the Company had not recorded any reserves for potentially uncollectible accounts.
The Company had four and two customers that accounted for more than 10% of the Company’s outstanding trade receivables at each of September 30, 2014 and December 31, 2013, respectively. These customers cumulatively represented approximately 77% and 55% of the Company’s outstanding trade receivables, at September 30, 2014 and December 31, 2013, respectively. To date, the Company has not experienced collection difficulties from these customers.
Inventories
At September 30, 2014 and December 31, 2013, 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 before being sold to, and ultimately incorporated and assembled by Fresenius Kabi Deutschland GmbH Fresenius, Inc. (with its affiliates, “Fresenius”) into the finished INTERCEPT disposable kits. 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 sold to Fresenius 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 work-in-process and finished units to meet the Company’s forecasted demands. If actual results differ from those estimates, work-in-process inventory could potentially accumulate for periods exceeding one year. At September 30, 2014 and December 31, 2013, the Company classified its work-in-process inventory as a current asset on its condensed consolidated balance sheets based on its evaluation that the work-in-process inventory would be sold to Fresenius for finished disposable kit production 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. The Company writes-down specifically identified unusable, obsolete, slow-moving, or known unsalable inventory that has no alternative use 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 revenue” on the Company’s condensed consolidated statements of operations. At September 30, 2014 and December 31, 2013, the Company had $0.1 million and $0.4 million, respectively, recorded for potential obsolete, expiring or unsalable product.
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.
Capitalization of Software Costs
The Company capitalizes certain significant costs incurred in the acquisition and development of software for internal use, including the costs of the software, materials, and consultants during the application development stage. Costs incurred prior to the application development stage, costs incurred once the application is substantially complete and ready for its intended use, and other costs not qualifying for capitalization, including training and maintenance costs, are charged to expense. The Company capitalized costs for enhancement of the enterprise resource planning software system and other internal use software of $1.8 million and zero during the nine months ended September 30, 2014 and 2013, respectively. The capitalized costs associated with the enterprise resource planning system are being amortized over the estimated useful life of five years.
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 condensed 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. 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 segment and has 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, based on the present value of future cash flows, 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 5 in the notes to unaudited condensed 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 net cash flows. If the expected undiscounted future net 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 three and nine months ended September 30, 2014 and 2013.
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. Revenues and expenses are remeasured using average exchange rates prevailing during the period. Remeasurements are recorded in the Company’s condensed consolidated statements of operations.
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 generally 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 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 condensed consolidated statements of operations.
See Note 11 in the notes to unaudited condensed 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. As of September 30, 2014, there were no remaining warrants issued in August 2009 that remained outstanding. The Company classified the warrants as a liability on its accompanying unaudited condensed 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 (as determined in accordance with the Black-Scholes option pricing model) 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 outstanding warrants is calculated using a Black-Scholes option-pricing model and is adjusted accordingly at each reporting period.
Changes resulting from the revaluation of warrants to fair value are recorded in “gain (loss) from revaluation of warrant liability” on the accompanying unaudited condensed 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 accompanying unaudited condensed consolidated balance sheets and no further adjustment to the fair value would be made in subsequent periods.
See Note 10 in the notes to unaudited condensed 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 accompanying unaudited condensed consolidated statements of operations, nor has its accrued for or made payments for interest and penalties. 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 2013 remain subject to examination by the taxing jurisdictions due to unutilized net operating losses and research credits.
Net Loss Per Share
Basic net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding for the period. Diluted net loss per 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. Diluted net loss per share also gives effect to potential adjustments to the numerator for gains 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.
Certain potential dilutive securities were excluded from the dilution calculation for the three and nine months ended September 30, 2014 and 2013, 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 share for the three and nine months ended September 30, 2014 and 2013 (in thousands, except per share amounts):
|
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
| 2014 | 2013 | 2014 | 2013 | |||||||||||||
|
Numerator for Basic and Diluted: |
||||||||||||||||
|
Net loss used for basic calculation |
$ | (10,759) | $ | (20,501) | $ | (18,573) | $ | (37,477) | ||||||||
|
Effect of revaluation of warrant liability |
(1,738) | 0 | (14,263) | 0 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
|
Adjusted net loss used for diluted calculation |
$ | (12,497) | $ | (20,501) | $ | (32,836) | $ | (37,477) | ||||||||
|
|
|
|
|
|
|
|
|
|||||||||
|
Denominator: |
||||||||||||||||
|
Basic weighted average number of shares outstanding |
75,194 | 69,791 | 73,407 | 66,464 | ||||||||||||
|
Effect of dilutive potential shares |
909 | 0 | 2,030 | 0 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
|
Diluted weighted average number of shares outstanding |
76,103 | 69,791 | 75,437 | 66,464 | ||||||||||||
|
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|
|
|
|
|
|
|
|||||||||
|
Net loss per share: |
||||||||||||||||
|
Basic |
$ | (0.14) | $ | (0.29) | $ | (0.25) | $ | (0.56) | ||||||||
|
Diluted |
$ | (0.16) | $ | (0.29) | $ | (0.44) | $ | (0.56) | ||||||||
The table below presents shares underlying stock options, employee stock purchase plan rights and restricted stock units that are excluded from the calculation of the weighted average number of shares outstanding used for the calculation of diluted net loss per share. Warrants are excluded from the table below in periods for which the warrants are included in the calculation of diluted net loss per share. These are excluded from the calculation due to their anti-dilutive effect for the three and nine months ended September 30, 2014 and 2013 (shares in thousands):
|
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
| 2014 | 2013 | 2014 | 2013 | |||||||||||||
|
Weighted average number of anti-dilutive potential shares |
12,032 | 16,651 | 11,737 | 16,301 | ||||||||||||
Guarantee and Indemnification Arrangements
The Company recognizes the fair value for guarantee and indemnification arrangements issued or modified by the Company. 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.
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 its 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 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 corporate debt and United States government agency securities. 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, which include its warrant liability. The Company assesses any transfers among fair value measurement levels at the end of each reporting period.
See Notes 2 and 10 in the notes to unaudited condensed consolidated financial statements for further information regarding the Company’s valuation of financial instruments.
New Accounting Pronouncements
In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2014-09, Revenue from Contracts with Customers (Topic 606), which provides a single comprehensive model for entities to use in accounting for revenue arising from contracts with customers and will supersede most current revenue recognition guidance. This ASU is based on the principle that revenue is recognized to depict the transfer of goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The ASU also requires additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract. The ASU’s effective date for the Company will be the first quarter of fiscal year 2017, using one of two retrospective application methods. Early adoption is not permitted. The Company is assessing the potential effects of this ASU on its consolidated financial statements.
In August 2014, the FASB issued ASU No. 2014-15, Presentation of Financial Statements — Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern, which requires management to evaluate, in connection with preparing financial statements for each annual and interim reporting period, whether there are conditions or events, considered in the aggregate, that raise substantial doubt about an entity’s ability to continue as a going concern within one year after the date that the financial statements are issued and provide related disclosures. This ASU will be effective for the Company in fiscal year 2016. Early adoption is permitted. The Company is currently assessing the future impact of this ASU on its consolidated financial statements.
|
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The following table sets forth the reconciliation of the numerator and denominator used in the computation of basic and diluted net loss per share for the three and nine months ended September 30, 2014 and 2013 (in thousands, except per share amounts):
|
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
| 2014 | 2013 | 2014 | 2013 | |||||||||||||
|
Numerator for Basic and Diluted: |
||||||||||||||||
|
Net loss used for basic calculation |
$ | (10,759) | $ | (20,501) | $ | (18,573) | $ | (37,477) | ||||||||
|
Effect of revaluation of warrant liability |
(1,738) | 0 | (14,263) | 0 | ||||||||||||
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|
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|
|
|
|||||||||
|
Adjusted net loss used for diluted calculation |
$ | (12,497) | $ | (20,501) | $ | (32,836) | $ | (37,477) | ||||||||
|
|
|
|
|
|
|
|
|
|||||||||
|
Denominator: |
||||||||||||||||
|
Basic weighted average number of shares outstanding |
75,194 | 69,791 | 73,407 | 66,464 | ||||||||||||
|
Effect of dilutive potential shares |
909 | 0 | 2,030 | 0 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
|
Diluted weighted average number of shares outstanding |
76,103 | 69,791 | 75,437 | 66,464 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
|
Net loss per share: |
||||||||||||||||
|
Basic |
$ | (0.14) | $ | (0.29) | $ | (0.25) | $ | (0.56) | ||||||||
|
Diluted |
$ | (0.16) | $ | (0.29) | $ | (0.44) | $ | (0.56) | ||||||||
The table below presents shares underlying stock options, employee stock purchase plan rights and restricted stock units that are excluded from the calculation of the weighted average number of shares outstanding used for the calculation of diluted net loss per share. Warrants are excluded from the table below in periods for which the warrants are included in the calculation of diluted net loss per share. These are excluded from the calculation due to their anti-dilutive effect for the three and nine months ended September 30, 2014 and 2013 (shares in thousands):
|
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
| 2014 | 2013 | 2014 | 2013 | |||||||||||||
|
Weighted average number of anti-dilutive potential shares |
12,032 | 16,651 | 11,737 | 16,301 | ||||||||||||
|
|||
The Company’s financial assets and liabilities were recorded at fair value in the condensed consolidated balance sheets at September 30, 2014, as follows (in thousands):
| Total | Level 1 | Level 2 | Level 3 | |||||||||||||
|
Money market funds (1) |
$ | 6,185 | $ | 6,185 | $ | 0 | $ | 0 | ||||||||
|
Corporate debt securities (2) |
21,802 | 0 | 21,802 | 0 | ||||||||||||
|
United States government agency securities (2) |
3,429 | 0 | 3,429 | 0 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
|
Total financial assets |
$ | 31,416 | $ | 6,185 | $ | 25,231 | $ | 0 | ||||||||
|
|
|
|
|
|
|
|
|
|||||||||
|
Warrant liability (3) |
$ | 3,931 | $ | 0 | $ | 0 | $ | 3,931 | ||||||||
|
|
|
|
|
|
|
|
|
|||||||||
|
Total financial liabilities |
$ | 3,931 | $ | 0 | $ | 0 | $ | 3,931 | ||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| (1) | Included in cash and cash equivalents on the Company’s accompanying unaudited condensed consolidated balance sheets. |
| (2) | Included in short-term investments on the Company’s accompanying unaudited condensed consolidated balance sheets. |
| (3) | Included in current liabilities on the Company’s accompanying unaudited condensed consolidated balance sheets. |
The Company’s financial assets and liabilities were recorded at fair value in the accompanying unaudited condensed consolidated balance sheets at December 31, 2013, as follows (in thousands):
| Total | Level 1 | Level 2 | Level 3 | |||||||||||||
|
Money market funds (1) |
$ | 8,650 | $ | 8,650 | $ | 0 | $ | 0 | ||||||||
|
Corporate debt securities (2) |
23,173 | 0 | 23,173 | 0 | ||||||||||||
|
United States government agency securities (2) |
5,018 | 0 | 5,018 | 0 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
|
Total financial assets |
$ | 36,841 | $ | 8,650 | $ | 28,191 | $ | 0 | ||||||||
|
|
|
|
|
|
|
|
|
|||||||||
|
Warrant liability (3) |
$ | 20,390 | $ | 0 | $ | 0 | $ | 20,390 | ||||||||
|
|
|
|
|
|
|
|
|
|||||||||
|
Total financial liabilities |
$ | 20,390 | $ | 0 | $ | 0 | $ | 20,390 | ||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| (1) | Included in cash and cash equivalents on the Company’s accompanying unaudited condensed consolidated balance sheets. |
| (2) | Included in short-term investments on the Company’s accompanying unaudited condensed consolidated balance sheets. |
| (3) | Included in current liabilities on the Company’s accompanying unaudited condensed consolidated balance sheets. |
A reconciliation of the beginning and ending balances for the warrant liability using significant unobservable inputs (Level 3) from December 31, 2013 to September 30, 2014, was as follows (in thousands):
|
Balance at December 31, 2013 |
$ | 20,390 | ||||
|
Decrease in fair value of warrants |
(14,263) | |||||
|
Settlement of warrants exercised |
(2,196) | |||||
|
|
|
|||||
|
Balance at September 30, 2014 |
$ | 3,931 | ||||
|
|
|
|
|||
The following is a summary of available-for-sale securities at September 30, 2014 (in thousands):
| September 30, 2014 | ||||||||||||
| Carrying Value | Net Unrealized Gain |
Fair Value | ||||||||||
|
Money market funds |
$ | 6,185 | $ | 0 | $ | 6,185 | ||||||
|
Corporate debt securities |
21,813 | (11) | 21,802 | |||||||||
|
United States government agency securities |
3,429 | 0 | 3,429 | |||||||||
|
|
|
|
|
|
|
|||||||
|
Total available-for-sale securities |
$ | 31,427 | $ | (11) | $ | 31,416 | ||||||
|
|
|
|
|
|
|
|||||||
The following is a summary of available-for-sale securities at December 31, 2013 (in thousands):
| December 31, 2013 | ||||||||||||
| Carrying Value | Net Unrealized Gain |
Fair Value | ||||||||||
|
Money market funds |
$ | 8,650 | $ | 0 | $ | 8,650 | ||||||
|
Corporate debt securities |
23,165 | 8 | 23,173 | |||||||||
|
United States government agency securities |
5,019 | (1) | 5,018 | |||||||||
|
|
|
|
|
|
|
|||||||
|
Total available-for-sale securities |
$ | 36,834 | $ | 7 | $ | 36,841 | ||||||
|
|
|
|
|
|
|
|||||||
Available-for-sale securities at September 30, 2014 and December 31, 2013, consisted of the following by original contractual maturity (in thousands):
| September 30, 2014 | December 31, 2013 | |||||||||||||||
| Carrying Value | Fair Value | Carrying Value | Fair Value | |||||||||||||
|
Due in one year or less |
$ | 29,396 | $ | 29,389 | $ | 30,700 | $ | 30,701 | ||||||||
|
Due greater than one year and less than three years |
2,031 | 2,027 | 6,134 | 6,140 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
|
Total cash equivalents and short-term investments |
$ | 31,427 | $ | 31,416 | $ | 36,834 | $ | 36,841 | ||||||||
|
|
|
|
|
|
|
|
|
|||||||||
|
|||
Inventories at September 30, 2014 and December 31, 2013, consisted of the following (in thousands):
| September 30, 2014 |
December 31, 2013 |
|||||||||
|
Work-in-process |
$ | 2,354 | $ | 4,863 | ||||||
|
Finished goods |
11,149 | 8,200 | ||||||||
|
|
|
|
|
|||||||
|
Total inventories |
$ | 13,503 | $ | 13,063 | ||||||
|
|
|
|
|
|||||||
|
|||
The following is a summary of intangible assets, net at September 30, 2014 (in thousands):
| September 30, 2014 | ||||||||||||
| Gross Carrying Amount |
Accumulated Amortization |
Net Carrying Amount |
||||||||||
|
Acquisition-related intangible assets: |
||||||||||||
|
Reacquired license - INTERCEPT Asia |
$ | 2,017 | $ | (824) | $ | 1,193 | ||||||
|
|
|
|
|
|
|
|||||||
|
Total intangible assets |
$ | 2,017 | $ | (824) | $ | 1,193 | ||||||
|
|
|
|
|
|
|
|||||||
The following is a summary of intangible assets, net at December 31, 2013 (in thousands):
| December 31, 2013 | ||||||||||||
| Gross Carrying Amount |
Accumulated Amortization |
Net Carrying Amount |
||||||||||
|
Acquisition-related intangible assets: |
||||||||||||
|
Reacquired license - INTERCEPT Asia |
$ | 2,017 | $ | (673) | $ | 1,344 | ||||||
|
|
|
|
|
|
|
|||||||
|
Total intangible assets |
$ | 2,017 | $ | (673) | $ | 1,344 | ||||||
|
|
|
|
|
|
|
|||||||
|
|||
Accrued liabilities at September 30, 2014 and December 31, 2013, consisted of the following (in thousands):
| September 30, | December 31, | |||||||||
| 2014 | 2013 | |||||||||
|
Accrued compensation and related costs |
$ | 2,956 | $ | 2,527 | ||||||
|
Accrued inventory costs |
4,610 | 3,553 | ||||||||
|
Accrued professional services |
2,928 | 2,722 | ||||||||
|
Other accrued expenses |
2,053 | 1,011 | ||||||||
|
|
|
|
|
|||||||
|
Total accrued liabilities |
$ | 12,547 | $ | 9,813 | ||||||
|
|
|
|
|
|||||||
|
|||
Debt at September 30, 2014, consisted of the following (in thousands):
| September 30, 2014 | ||||||||||||
| Principal |
Unamortized Discount |
Total | ||||||||||
|
Loan and Security Agreement |
$ | 10,000 | $ | 140 | $ | 9,860 | ||||||
|
Less: debt - current |
0 | 0 | 0 | |||||||||
|
|
|
|
|
|
|
|||||||
|
Debt - non-current |
$ | 10,000 | $ | 140 | $ | 9,860 | ||||||
|
|
|
|
|
|
|
|||||||
Debt at December 31, 2013, consisted of the following (in thousands):
| December 31, 2013 | ||||||||||||
| Principal |
Unamortized Discount |
Total | ||||||||||
|
Comerica - Revolving Line of Credit |
$ | 3,366 | $ | 0 | $ | 3,366 | ||||||
|
Less: debt - current |
(3,366) | 0 | (3,366) | |||||||||
|
|
|
|
|
|
|
|||||||
|
Debt - non-current |
$ | 0 | $ | 0 | $ | 0 | ||||||
|
|
|
|
|
|
|
|||||||
Principal and interest payments on debt at September 30, 2014, are expected to be as follows (in thousands):
|
Year ended December 31, |
||||||
|
2014 (remaining three months) |
$ | 174 | ||||
|
2015 |
695 | |||||
|
2016 |
3,227 | |||||
|
2017 |
3,227 | |||||
|
2018 |
3,227 | |||||
|
2019 |
2,314 | |||||
|
|
|
|||||
| $ | 12,864 | |||||
|
|
|
|
|||
The fair value of the warrants at September 30, 2014 and December 31, 2013, consisted of the following (in thousands):
| September 30, | December 31, | |||||||||
| 2014 | 2013 | |||||||||
|
2009 Warrants |
$ | 0 | $ | 8,542 | ||||||
|
2010 Warrants |
3,931 | 11,848 | ||||||||
|
|
|
|
|
|||||||
|
Total warrant liability |
$ | 3,931 | $ | 20,390 | ||||||
|
|
|
|
|
|||||||
The fair value of the Company’s warrants was based on option valuation models and using the following assumptions at September 30, 2014 and December 31, 2013:
| December 31, | ||||||
| 2013 | ||||||
|
2009 Warrants: |
||||||
|
Expected term (in years) |
0.65 | |||||
|
Estimated volatility |
45% | |||||
|
Risk-free interest rate |
0.10% | |||||
|
Expected dividend yield |
0% | |||||
| September 30, | December 31, | |||||
| 2014 | 2013 | |||||
|
2010 Warrants: |
||||||
|
Expected term (in years) |
1.11 | 1.86 | ||||
|
Estimated volatility |
47% | 41% | ||||
|
Risk-free interest rate |
0.13% | 0.38% | ||||
|
Expected dividend yield |
0% | 0% |
|
|||
Activity under the Company’s equity incentive plans related to stock options is set forth below (in thousands except per share amounts):
| Number of Options Outstanding |
Weighted Average Exercise Price per Share |
|||||||||||||
|
Balance at December 31, 2013 |
10,405 | $ | 3.46 | |||||||||||
|
Granted |
2,734 | 5.93 | ||||||||||||
|
Forfeited |
(134) | 4.77 | ||||||||||||
|
Expired |
(40) | 8.61 | ||||||||||||
|
Exercised |
(967) | 2.41 | ||||||||||||
|
|
|
|||||||||||||
|
Balance at September 30, 2014 |
11,998 | $ | 4.08 | |||||||||||
|
|
|
|||||||||||||
Stock-based compensation recognized on the Company’s condensed consolidated statements of operations for the three and nine months ended September 30, 2014 and 2013, was as follows (in thousands):
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2014 | 2013 | 2014 | 2013 | |||||||||||||
|
Stock-based compensation expense by caption: |
||||||||||||||||
|
Research and development |
$ | 281 | $ | 132 | $ | 740 | $ | 341 | ||||||||
|
Selling, general and administrative |
1,197 | 729 | 3,024 | 2,074 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
|
Total stock-based compensation expense |
$ | 1,478 | $ | 861 | $ | 3,764 | $ | 2,415 | ||||||||
|
|
|
|
|
|
|
|
|
|||||||||
|
|||
The Company had the following significant customers that accounted for more than 10% of the Company’s total revenue, all of which operate in a country outside of the United States of America, during the three and nine months ended September 30, 2014 and 2013:
| Three Months Ended | Nine Months Ended | |||||||
| September 30, | September 30, | |||||||
| 2014 | 2013 | 2014 | 2013 | |||||
|
Etablissement Francais du Sang |
30% | 20% | 26% | 18% | ||||
|
Grifols |
* | 22% | * | 20% | ||||
|
Bravo Pacific Limited |
* | 11% | * | * | ||||
|
Advanced Technology Company KSC |
* | 10% | * | * | ||||
* Represents an amount less than 10% of product revenue.
|
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