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Note 1. Nature of Operations and Basis of Presentation
Cerus Corporation (the “Company”) was incorporated in September 1991 and is developing and commercializing the INTERCEPT Blood System, which is designed to enhance the safety of blood components through pathogen reduction. The Company has worldwide commercialization rights for the INTERCEPT Blood System for platelets, plasma and red blood cells.
The Company sells its INTERCEPT platelet and plasma systems in the United States of America (“U.S.”), Europe, the Commonwealth of Independent States (“CIS”) countries, the Middle East and selected countries in other regions around the world. The Company conducts significant research, development, testing and regulatory compliance activities on its product candidates that, together with anticipated selling, general, and administrative expenses, are expected to result in substantial additional losses, and the Company may need to adjust its operating plans and programs based on the availability of cash resources. The Company’s ability to achieve a profitable level of operations will depend on successfully completing development, obtaining additional regulatory approvals and achieving widespread market acceptance of its products. There can be no assurance that the Company will ever achieve a profitable level of operations.
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Note 2. Summary of Significant Accounting Policies
Principles of Consolidation
The accompanying consolidated financial statements include those of Cerus Corporation and its subsidiary, Cerus Europe B.V. (together with Cerus Corporation, hereinafter “Cerus” or the “Company”) after elimination of all intercompany accounts and transactions. These consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the U.S. (“GAAP”) and pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”).
Use of Estimates
The preparation of financial statements requires management to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosures of contingent assets and liabilities. On an ongoing basis, 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 the arrangement exists; (ii) delivery has occurred or services have been rendered; (iii) pricing is fixed or determinable; and (iv) collectability is reasonably assured. The Company’s main sources of revenues for the years ended December 31, 2015, 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 or signed sales contract as evidence of an arrangement. 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. The Company regularly reviews best estimated selling price. At December 31, 2015 and 2014, the Company had $0.6 million and $0.4 million, respectively, of short-term deferred revenue on its consolidated balance sheets related to future performance obligations. At each of December 31, 2015 and 2014, the Company had $0.1 million of long-term deferred revenue included in “Other non-current liabilities” on it consolidated balance sheets related to future performance obligations. Freight costs charged to customers are recorded as a component of revenue. Taxes that the Company invoices to its customers and remits to governments are recorded on a net basis, which excludes such tax 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, including cost incurred under each grant that has been awarded to the Company by the U.S. government or development contracts. Research and development expenses include salaries and related expenses for scientific and regulatory 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. 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.
Investments
Investments with original maturities of greater than three months primarily include corporate debt, U.S. government agency securities and marketable equity securities of Aduro Biotech, Inc. (“Aduro”), 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 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 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 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 “Other assets” on the Company’s condensed consolidated balance sheets. The Company also has certain non-U.S. 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 December 31, 2015, the fair value of the Company’s marketable equity securities of Aduro is subject to the underlying volatility of Aduro’s stock price. At December 31, 2015, the Company does not believe there is significant financial risk from non-performance by the issuers of the Company’s cash equivalents.
Concentrations of credit risk with respect to trade receivables exist. On a regular basis, including at the time of sale, the Company performs credit evaluations of its 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 establishes an allowance for doubtful accounts against the accounts receivable on its consolidated balance sheets and records a charge on its consolidated statements of operations as a component of selling, general and administrative expenses.
The Company had three customers and one customer that accounted for more than 10% of the Company’s outstanding trade receivables at December 31, 2015 and 2014, respectively. These customers cumulatively represented approximately 49% and 36% of the Company’s outstanding trade receivables at December 31, 2015 and 2014, respectively. To date, the Company has not experienced collection difficulties from these customers.
Inventories
At December 31, 2015 and 2014, 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 or Fresenius, Inc. (with their 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 December 31, 2015 and 2014, the Company classified its work-in-process inventory as a current asset on its consolidated balance sheets based on its evaluation that the work-in-process inventory would be 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 net realizable 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 consolidated statements of operations. At December 31, 2015, and 2014, the Company had $1.8 million and $0.1 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 as incurred. During the years ended December 31, 2015, and 2014, the Company capitalized costs related to its enterprise resource planning software system of zero and $1.8 million, respectively. At December 31, 2015 and 2014, the Company had $1.3 million and $1.6 million of capitalized cost related to its enterprise resource planning system, 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
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 original estimated useful life of ten years. The amortization of the Company’s intangible assets, net, is recorded in “Amortization of intangible assets” on the Company’s consolidated statements of operations. Goodwill is not amortized but instead is subject to an impairment test performed on an annual basis, or more frequently if events or changes in circumstances indicate that goodwill may be impaired. Such impairment analysis is performed on August 31 of each fiscal year, or more frequently if indicators of impairment exist. The test for goodwill impairment may be assessed using qualitative factors to determine whether it is more likely than not that the fair value of a reporting unit is less than the carrying amount. If the Company determines that it is more likely than not that the fair value of a reporting unit is less than the carrying amount, the Company must then proceed with performing the quantitative two-step process to test goodwill for impairment; otherwise, goodwill is not considered impaired and no further testing is warranted. The Company may choose not to perform the qualitative assessment to test goodwill for impairment and proceed directly to the quantitative two-step process; however, the Company may revert to the qualitative assessment to test goodwill for impairment in any subsequent period. The first step of the two-step process compares the fair value of each reporting unit with its respective carrying amount, including goodwill. The Company has determined that it operates in one reporting unit and estimates the fair value of its one reporting unit using the enterprise approach under which it considers the quoted market capitalization of the Company as reported on the Nasdaq Global Market. The Company considers quoted market prices that are available in active markets to be the best evidence of fair value. The Company also considers other factors, which include future forecasted results, the economic environment and overall market conditions. If the fair value of the reporting unit exceeds its carrying amount, goodwill of the reporting unit is not considered impaired and, therefore, the second step of the impairment test is unnecessary. The second step of the two-step process, which is used to measure the amount of impairment loss, compares the implied fair value of each reporting unit’s goodwill, 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.” See Note 7 for further information regarding the Company’s impairment analysis and the valuation of goodwill and intangible assets, net.
Long-lived Assets
The Company evaluates its long-lived assets for impairment by continually monitoring events and changes in circumstances that could indicate carrying amounts of its long-lived assets may not be recoverable. When such events or changes in circumstances occur, the Company assesses recoverability by determining whether the carrying value of such assets will be recovered through the undiscounted expected future cash flows. If the expected undiscounted future cash flows are less than the carrying amount of these assets, the Company then measures the amount of the impairment loss based on the excess of the carrying amount over the fair value of the assets. The Company did not recognize impairment charges related to its long-lived assets during the years ended December 31, 2015, 2014 or 2013.
Foreign Currency Remeasurement
The functional currency of the Company’s foreign subsidiary is the U.S. dollar. Monetary assets and liabilities denominated in foreign currencies are remeasured in U.S. dollars using the exchange rates at the balance sheet date. Non-monetary assets and liabilities denominated in foreign currencies are remeasured in U.S. 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 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 the vesting period, and is adjusted for estimated forfeitures. To the extent that stock options contain performance criteria for vesting, stock-based compensation is recognized once the performance criteria are probable of being achieved.
For stock-based awards issued to non-employees, the Company follows ASC Topic 505-50, Equity Based Payment to Non-Employees and considers the measurement date at which the fair value of the stock-based award is measured to be the earlier of (i) the date at which a commitment for performance by the grantee to earn the equity instrument is reached or (ii) the date at which the grantee’s performance is complete. The Company recognizes stock-based compensation expense for the fair value of the vested portion of the non-employee stock-based awards in its consolidated statements of operations.
See Note 13 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 its common stock, respectively. The material terms of the warrants were identical under each issuance except for the exercise price, date issued and expiration date. In August 2014, all of the outstanding August 2009 warrants were exercised in full. In November 2015, all of the outstanding November 2010 warrants were exercised in full. The Company classified warrants outstanding on the reporting date as a liability on its consolidated balance sheets as the warrants contained certain material terms which required the Company to purchase the warrants for cash in an amount equal to the value of the unexercised portion of the warrants in connection with certain change of control transactions.
The fair value of outstanding warrants was calculated using the Black-Scholes model and was adjusted accordingly at reporting dates since December 31, 2014. Prior to December 31, 2014, the Company calculated the fair value of these warrants using a combination of the Black-Scholes model and/or binomial-lattice option-pricing model.
Changes resulting from the revaluation of warrants to fair value were recorded in “Gain (loss) from revaluation of warrant liability” on the consolidated statements of operations. Upon the exercise of the warrants, the fair value of the warrants was reclassified from a liability to stockholders’ equity on the Company’s consolidated balance sheets.
See Note 12 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 derecognition of a tax position. The Company recognizes accrued interest and penalties related to unrecognized tax benefits in its income tax expense. To date, the Company has not recognized any interest and penalties in its consolidated statements of operations, nor has its accrued for or made payments for interest and penalties. 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 U.S. federal and California tax years through 2015 remain subject to examination by the taxing jurisdictions due to unutilized net operating losses and research credits. The Company continues to carry a full valuation allowance on all of its net deferred tax assets, except for its indefinite lived intangibles.
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, and convertible preferred stock, which is calculated using the if-converted 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 years ended December 31, 2015 and 2014, as their inclusion would have been anti-dilutive. Diluted net loss per common share used the same weighted average number of common shares outstanding for the year ended December 31, 2013, as calculated for the basic net loss per common share as the inclusion of any potential dilutive securities would be 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 years ended December 31, 2015, 2014 and 2013 (in thousands, except per share amounts):
Year Ended December 31, | ||||||||||||
2015 | 2014 | 2013 | ||||||||||
Numerator for Basic and Diluted: |
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Net loss used for basic calculation |
$ | (55,868 | ) | $ | (38,755 | ) | $ | (43,337 | ) | |||
Effect of revaluation of warrant liability |
(3,566 | ) | (7,708 | ) | — | |||||||
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Adjusted net loss used for dilution calculation |
$ | (59,434 | ) | $ | (46,463 | ) | $ | (43,337 | ) | |||
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Denominator: |
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Basic weighted average number of shares outstanding |
96,068 | 74,767 | 67,569 | |||||||||
Effect of dilutive potential shares |
837 | 1,767 | — | |||||||||
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Diluted weighted average number of shares outstanding |
96,905 | 76,534 | 67,569 | |||||||||
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Net loss per share: |
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Basic |
$ | (0.58 | ) | $ | (0.52 | ) | $ | (0.64 | ) | |||
Diluted |
$ | (0.61 | ) | $ | (0.61 | ) | $ | (0.64 | ) |
The table below presents shares underlying stock options, employee stock purchase plan rights, warrants, restricted stock units and/or convertible preferred stock that were excluded from the calculation of the weighted average number of shares outstanding used for the calculation of diluted net loss per share. These were excluded from the calculation due to their anti-dilutive effect for the years ended December 31, 2015, 2014 and 2013 (shares in thousands):
Year Ended December 31, | ||||||||||||
2015 | 2014 | 2013 | ||||||||||
Weighted average number of anti-dilutive potential shares |
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Outstanding options |
13,681 | 11,722 | 10,296 | |||||||||
Warrants |
— | — | 6,074 | |||||||||
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Total |
13,681 | 11,722 | 16,370 | |||||||||
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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. The Company has not experienced significant or systemic warranty claims nor is it aware of any existing current warranty claims. Accordingly, the Company had not accrued for any future warranty costs for its products at December 31, 2015 or 2014.
Fair Value of Financial Instruments
The Company applies the provisions of fair value relating to its financial assets and liabilities. The carrying amounts of accounts receivables, accounts payable, and other accrued liabilities approximate their fair value due to the relative short-term maturities. Based on the borrowing rates currently available to the Company for loans with similar terms, the Company believes the fair value of its debt approximates their carrying amounts. The Company measures and records certain financial assets and liabilities at fair value on a recurring basis, including its available-for-sale securities and warrant liability. The Company classifies instruments within Level 1 if quoted prices are available in active markets for identical assets, which include the Company’s cash accounts and 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 U.S. 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 3 and 12 for further information regarding the Company’s valuation on 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. In August 2015, the FASB issued ASU No. 2015-14, Revenue from Contracts with Customers (Topic 606), Deferral of the Effective Date, which defers by one year the effective date of ASU No. 2014-09 to annual reporting periods beginning after December 15, 2017 (including interim periods within those periods). Early adoption is permitted to the original effective date of December 15, 2016 (including interim periods within those periods).The ASU’s effective date for the Company will be the first quarter of fiscal year 2018, using one of two retrospective application methods. The Company has not selected a transition method and is currently 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 adoption of this ASU is not expected to have a material impact on the Company’s consolidated financial statements.
In April 2015, the FASB issued ASU No. 2015-03, Interest—Imputation of Interest (Subtopic 835-30), Simplifying the Presentation of Debt Issuance Costs, which requires debt issuance costs related to a recognized debt liability to be presented in the balance sheet as a direct deduction from the corresponding debt liability rather than as an asset. This ASU will be effective for the Company in fiscal year 2016. Early adoption is permitted. The adoption of this ASU is not expected to have a material impact on the Company’s consolidated financial statements.
In July 2015, the FASB issued ASU No. 2015-11, Inventory (Topic 330), Simplifying the Measurement of Inventory, which simplifies the subsequent measurement of inventory by requiring inventory to be measured at the lower of cost and net realizable value. Net realizable value is defined as the “estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal and transportation.” This ASU will be effective for the Company in fiscal year 2017. Early adoption is permitted. The Company has early adopted this ASU in 2015 prospectively and it did not have a material impact on the Company’s consolidated financial statements.
In November 2015, the FASB issued ASU No. 2015-17, Balance Sheet Classification of Deferred Taxes, which requires all deferred tax assets and liabilities, along with any related valuation allowance, be classified as noncurrent on the balance sheet. This ASU may be adopted either prospectively or retrospectively. This ASU will be effective for the Company in fiscal year 2017. Early adoption is permitted. The Company has early adopted this ASU in 2015 prospectively and it did not have a material impact on the Company’s consolidated financial statements.
In January 2016, the FASB issued ASU No. 2016-01, Financial Instruments-Overall (Subtopic 825-10), which requires all equity investments to be measured at fair value with changes in the fair value recognized through net income (other than those accounted for under equity method of accounting or those that result in consolidation of the investee). The amendments also require an entity to present separately in other comprehensive income the portion of the total change in the fair value of a liability resulting from a change in the instrument-specific credit risk when the entity has elected to measure the liability at fair value in accordance with the fair value option for financial instruments. In addition, this ASU eliminates the requirement to disclose the fair value of financial instruments measured at amortized cost for entities that are not public business entities and the requirement for to disclose the method(s) and significant assumptions used to estimate the fair value that is required to be disclosed for financial instruments measured at amortized cost on the balance sheet for public business entities. This ASU will be effective for the Company in fiscal year 2018. Early adoption is permitted. The Company is currently assessing the future impact of this ASU on its consolidated financial statements.
In February 2016, the FASB issued ASU No. 2016-02, Leases, which, for operating leases, requires a lessee to recognize a right-of-use asset and a lease liability, initially measured at the present value of the lease payments, in its balance sheet. The standard also requires a lessee to recognize a single lease cost, calculated so that the cost of the lease is allocated over the lease term, on a generally straight-line basis. This ASU will be effective for the Company in fiscal year 2019. Early adoption is permitted. The Company is currently assessing the future impact of this ASU on its consolidated financial statements and anticipates the new guidance will significantly impact its consolidated financial statements.
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Note 3. Fair Value on Financial Instruments
The Company uses certain assumptions that market participants would use to determine the fair value of an asset or liability 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:
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Level 1: Quoted prices in active markets for identical instruments |
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Level 2: Other significant observable inputs (including quoted prices in active markets for similar instruments) |
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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 December 31, 2015, the Company’s primary service relies on inputs from multiple industry-recognized pricing sources to determine the price for each investment. Corporate debt and U.S. 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 fair values of the Company’s financial assets and liabilities were determined using the following inputs at December 31, 2015 (in thousands):
Balance sheet classification | Total | Quoted Prices in Active Markets for Identical Assets (Level 1) |
Significant Other Observable Inputs (Level 2) |
Significant Unobservable Inputs (Level 3) |
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Money market funds |
Cash and cash equivalents | $ | 59,302 | $ | 59,302 | $ | — | $ | — | |||||||||
Corporate debt securities |
Short-term investments | 25,698 | — | 25,698 | — | |||||||||||||
Marketable equity securities |
Marketable equity securities | 11,163 | 11,163 | — | — | |||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Total financial assets |
$ | 96,163 | $ | 70,465 | $ | 25,698 | $ | — | ||||||||||
|
|
|
|
|
|
|
|
The fair values of the Company’s financial assets and liabilities were determined using the following inputs at December 31, 2014 (in thousands):
Balance sheet classification | Total | Quoted Prices in Active Markets for Identical Assets (Level 1) |
Significant Other Observable Inputs (Level 2) |
Significant Unobservable Inputs (Level 3) |
||||||||||||||
Money market funds |
Cash and cash equivalents | $ | 3,912 | $ | 3,912 | $ | — | $ | — | |||||||||
Corporate debt securities |
Short-term investments | 26,088 | — | 26,088 | — | |||||||||||||
United States government agency securities |
Short-term investments | 3,426 | — | 3,426 | — | |||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Total financial assets |
$ | 33,426 | $ | 3,912 | $ | 29,514 | $ | — | ||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Warrant liability |
Warrant liability | $ | 10,485 | $ | — | $ | — | $ | 10,485 | |||||||||
|
|
|
|
|
|
|
|
|||||||||||
Total financial liabilities |
$ | 10,485 | $ | — | $ | — | $ | 10,485 | ||||||||||
|
|
|
|
|
|
|
|
A reconciliation of the beginning and ending balances for the warrant liability using significant unobservable inputs (Level 3) from December 31, 2013 to December 31, 2015, was as follows (in thousands):
Balance at December 31, 2013 |
$ | 20,390 | ||
Decrease in fair value of warrants |
(7,708 | ) | ||
Settlement of warrants exercised |
(2,197 | ) | ||
|
|
|||
Balance at December 31, 2014 |
10,485 | |||
Decrease in fair value of warrants |
(3,566 | ) | ||
Settlement of warrants exercised |
(6,919 | ) | ||
|
|
|||
Balance at December 31, 2015 |
$ | — | ||
|
|
See Notes 2 and 12 for further information regarding the Company’s valuation techniques and unobservable inputs for the warrant liability using significant unobservable inputs (Level 3).
The Company did not have any transfers among fair value measurement levels during the years ended December 31, 2015 and 2014.
|
Note 4. Available-for-sale Securities
The following is a summary of available-for-sale securities at December 31, 2015 (in thousands):
December 31, 2015 | ||||||||||||
Amortized Cost | Gross Unrealized Gain (Loss) |
Fair Value | ||||||||||
Money market funds |
$ | 59,302 | $ | — | $ | 59,302 | ||||||
Corporate debt securities |
25,747 | (49 | ) | 25,698 | ||||||||
Marketable equity securities |
— | 11,163 | 11,163 | |||||||||
|
|
|
|
|
|
|||||||
Total available-for-sale securities |
$ | 85,049 | $ | 11,114 | $ | 96,163 | ||||||
|
|
|
|
|
|
The following is a summary of available-for-sale securities at December 31, 2014 (in thousands):
December 31, 2014 | ||||||||||||
Amortized Cost | Gross Unrealized Loss |
Fair Value | ||||||||||
Money market funds |
$ | 3,912 | $ | — | $ | 3,912 | ||||||
United States government agency securities |
3,427 | (1 | ) | 3,426 | ||||||||
Corporate debt securities |
26,118 | (30 | ) | 26,088 | ||||||||
|
|
|
|
|
|
|||||||
Total available-for-sale securities |
$ | 33,457 | $ | (31 | ) | $ | 33,426 | |||||
|
|
|
|
|
|
Available-for-sale securities at December 31, 2015 and 2014, consisted of the following by contractual maturity (in thousands):
December 31, 2015 | December 31, 2014 | |||||||||||||||
Amortized Cost |
Fair Value | Amortized Cost |
Fair Value | |||||||||||||
One year or less |
$ | 85,049 | $ | 85,000 | $ | 27,752 | $ | 27,727 | ||||||||
Marketable equity securities |
— | 11,163 | — | — | ||||||||||||
Greater than one year and less than five years |
— | — | 5,705 | 5,699 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total available-for-sale securities |
$ | 85,049 | $ | 96,163 | $ | 33,457 | $ | 33,426 | ||||||||
|
|
|
|
|
|
|
|
The following tables show all available-for-sale marketable securities in an unrealized loss position for which an other-than-temporary impairment has not been recognized and the related gross unrealized losses and fair value, aggregated by investment category and length of time that individual securities have been in a continuous unrealized loss position (in thousands):
December 31, 2015 | ||||||||||||||||||||||||
Less than 12 Months | 12 Months or Greater | Total | ||||||||||||||||||||||
Fair Value | Unrealized Loss |
Fair Value | Unrealized Loss |
Fair Value | Unrealized Loss |
|||||||||||||||||||
Money market funds |
$ | — | $ | — | $ | — | $ | — | $ | — | $ | — | ||||||||||||
Corporate debt securities |
20,170 | (46 | ) | 5,528 | (3 | ) | 25,698 | (49 | ) | |||||||||||||||
Marketable equity securities |
— | — | — | — | — | — | ||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Total available-for-sale securities |
$ | 20,170 | $ | (46 | ) | $ | 5,528 | $ | (3 | ) | $ | 25,698 | $ | (49 | ) | |||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
December 31, 2014 | ||||||||||||||||||||||||
Less than 12 Months | 12 Months or Greater | Total | ||||||||||||||||||||||
Fair Value | Unrealized Loss |
Fair Value | Unrealized Loss |
Fair Value | Unrealized Loss |
|||||||||||||||||||
Money market funds |
$ | — | $ | — | $ | — | $ | — | $ | — | $ | — | ||||||||||||
United States government agency securities |
3,426 | (1 | ) | — | — | 3,426 | (1 | ) | ||||||||||||||||
Corporate debt securities |
22,169 | (30 | ) | — | — | 22,169 | (30 | ) | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Total available-for-sale securities |
$ | 25,595 | $ | (31 | ) | $ | — | $ | — | $ | 25,595 | $ | (31 | ) | ||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, 2015, the Company considered the declines in market value of its marketable securities investment portfolio to be temporary in nature and did not consider any of its investments other-than-temporarily impaired. The Company typically invests in highly-rated securities, and its investment policy limits the amount of credit exposure to any one issuer. The policy generally requires investments to be investment grade, with the primary objective of minimizing the potential risk of principal loss. Fair values were determined for each individual security in the investment portfolio. When evaluating an investment for other-than-temporary impairment, the Company reviews factors such as the length of time and extent to which fair value has been below its cost basis, the financial condition of the issuer and any changes thereto, changes in market interest rates, and the Company’s intent to sell, or whether it is more likely than not it will be required to sell, the investment before recovery of the investment’s cost basis. During the years ended December 31, 2015, 2014, and 2013, the Company did not recognize any other-than-temporary impairment loss. The Company has no current requirement or intent to sell the securities in an unrealized loss position. The Company expects to recover up to (or beyond) the initial cost of investment for securities held.
The Company recorded minimal gross realized gains from the sale or maturity of available-for-sale investments during the years ended December 31, 2015 and 2014, and did not record any gross realized gains from the sale or maturity of available-for-sale investments during the year ended December 31, 2013. The Company recorded insignificant gross realized losses from the sale of available-for-sale investments during the year ended December 31, 2013, and did not record any gross realized losses during the years ended December 31, 2015 and 2014. The Company did not record losses on investments experiencing an other-than-temporary decline in fair value during the years ended December 31, 2015, 2014, and 2013.
|
Note 5. Inventories
Inventories at December 31, 2015 and 2014, consisted of the following (in thousands):
December 31, | ||||||||
2015 | 2014 | |||||||
Work-in-process |
$ | 3,187 | $ | 2,222 | ||||
Finished goods |
7,625 | 12,734 | ||||||
|
|
|
|
|||||
Total inventories |
$ | 10,812 | $ | 14,956 | ||||
|
|
|
|
|
Note 6. Property and Equipment, net
Property and equipment, net at December 31, 2015 and 2014, consisted of the following (in thousands):
December 31, | ||||||||
2015 | 2014 | |||||||
Leasehold improvements |
$ | 5,678 | $ | 5,638 | ||||
Machinery and equipment |
1,603 | 1,351 | ||||||
Demonstration equipment |
145 | 123 | ||||||
Furniture and fixtures |
794 | 783 | ||||||
Computer equipment |
591 | 663 | ||||||
Computer software |
2,935 | 2,913 | ||||||
Consigned equipment |
1,010 | 980 | ||||||
Construction-in-progress |
219 | 150 | ||||||
|
|
|
|
|||||
Total property and equipment, gross |
12,975 | 12,601 | ||||||
Accumulated depreciation and amortization |
(9,426 | ) | (8,820 | ) | ||||
|
|
|
|
|||||
Total property and equipment, net |
$ | 3,549 | $ | 3,781 | ||||
|
|
|
|
Depreciation and amortization expense related to property and equipment, net was $1.1 million, $0.7 million and $0.4 million for the years ended December 31, 2015, 2014 and 2013, respectively.
|
Note 7. Goodwill and Intangible Assets, net
Goodwill
During the year ended December 31, 2015, the Company did not dispose of or recognize additional goodwill. On August 31, 2015, the Company performed its impairment test of goodwill. As described in Note 2 above, the Company applied the enterprise approach by reviewing the quoted market capitalization of the Company as reported on the Nasdaq Global Market to calculate the fair value. In addition, the Company considered its future forecasted results, the economic environment and overall market conditions. As a result of the Company’s assessment that its fair value of the reporting unit exceeded its carrying amount, the Company determined that goodwill was not impaired.
Intangible Assets, net
The following is a summary of intangible assets, net at December 31, 2015 (in thousands):
December 31, 2015 | ||||||||||||
Gross Carrying Amount |
Accumulated Amortization |
Net Carrying Amount |
||||||||||
Acquisition-related intangible assets: |
||||||||||||
Reacquired license—INTERCEPT Asia |
$ | 2,017 | $ | (1,077 | ) | $ | 940 | |||||
|
|
|
|
|
|
|||||||
Total intangible assets |
$ | 2,017 | $ | (1,077 | ) | $ | 940 | |||||
|
|
|
|
|
|
The following is a summary of intangible assets, net at December 31, 2014 (in thousands):
December 31, 2014 | ||||||||||||
Gross Carrying Amount |
Accumulated Amortization |
Net Carrying Amount |
||||||||||
Acquisition-related intangible assets: |
||||||||||||
Reacquired license—INTERCEPT Asia |
$ | 2,017 | $ | (875 | ) | $ | 1,142 | |||||
|
|
|
|
|
|
|||||||
Total intangible assets |
$ | 2,017 | $ | (875 | ) | $ | 1,142 | |||||
|
|
|
|
|
|
During the years ended December 31, 2015, 2014 and 2013, there were no impairment charges recognized related to the Company’s intangible assets.
At December 31, 2015, the expected annual amortization expense of the intangible assets, net is $0.2 million beginning with the year ending December 31, 2016, and each subsequent year thereafter through the year ending December 31, 2019, and $0.1 million for the year ending December 31, 2020.
|
Note 8. Marketable Equity Investments
In connection with the agreements to license the immunotherapy technologies to Aduro in 2009, the Company received preferred shares of Aduro, a privately held company at the time the Company received such shares. Pursuant to these license agreements, the Company was eligible to receive a 1% royalty fee on any future sales resulting from the licensed technology. For the years ended December 31, 2015, 2014 and 2013, the Company has not received any royalty payments from Aduro pursuant to this agreement. The Company historically accounted for the investment under the cost method of accounting with a net carrying value of zero. In April 2015, Aduro’s common stock began trading on the NASDAQ Global Select Market, under the symbol “ADRO”. At the time of Aduro’s initial public offering (“IPO”), the Company’s preferred shares in Aduro converted to 396,700 shares of common stock, and the fair value of the Company’s investment became readily determinable and, as a result became a marketable equity security. Therefore, the Company no longer accounts for the investment in Aduro under the cost basis of accounting. The Company now reflects the investment in Aduro as an available-for-sale security included in investment in marketable equity securities on the Company’s consolidated balance sheet (Note 4) and will adjust the carrying value of this investment to fair value each quarterly reporting period, with changes in fair value recorded within other comprehensive income (loss), net of tax.
|
Note 9. Accrued Liabilities
Accrued liabilities at December 31, 2015 and 2014, consisted of the following (in thousands):
December 31, | ||||||||
2015 | 2014 | |||||||
Accrued compensation and related costs |
$ | 5,198 | $ | 3,951 | ||||
Accrued professional services |
2,337 | 2,123 | ||||||
Accrued inventory costs |
73 | 870 | ||||||
Accrued customer costs |
987 | 385 | ||||||
Accrued insurance premiums |
438 | 264 | ||||||
Other accrued expenses |
820 | 851 | ||||||
|
|
|
|
|||||
Total accrued liabilities |
$ | 9,853 | $ | 8,444 | ||||
|
|
|
|
|
Note 10. Debt
Debt at December 31, 2015, consisted of the following (in thousands):
December 31, 2015 | ||||||||||||
Principal | Unamortized Discount |
Net Carrying Value |
||||||||||
Loan and Security Agreement |
$ | 20,000 | $ | (128 | ) | $ | 19,872 | |||||
Less: debt—current |
(3,050 | ) | 61 | (2,989 | ) | |||||||
|
|
|
|
|
|
|||||||
Debt—non-current |
$ | 16,950 | $ | (67 | ) | $ | 16,883 | |||||
|
|
|
|
|
|
Debt at December 31, 2014, consisted of the following (in thousands):
December 31, 2014 | ||||||||||||
Principal | Unamortized Discount |
Total | ||||||||||
Loan and Security Agreement |
$ | 10,000 | $ | (128 | ) | $ | 9,872 | |||||
Less: debt—current |
— | — | — | |||||||||
|
|
|
|
|
|
|||||||
Debt—non-current |
$ | 10,000 | $ | (128 | ) | $ | 9,872 | |||||
|
|
|
|
|
|
Principal and interest payments on debt at December 31, 2015, are expected to be as follows*:
Year ended December 31, |
Principal | Interest | Total | |||||||||
2016 |
3,050 | 1,352 | 4,402 | |||||||||
2017 |
6,428 | 980 | 7,408 | |||||||||
2018 |
6,892 | 517 | 7,409 | |||||||||
2019 |
3,630 | 1,474 | 5,104 | |||||||||
|
|
|
|
|
|
|||||||
Total |
$ | 20,000 | $ | 4,323 | $ | 24,323 | ||||||
|
|
|
|
|
|
* | Unless interest only period extends to December 31, 2016, as described below. |
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”) was drawn on June 15, 2015. On September 29, 2015, the Term Loan Agreement was amended to extend (i) the period in which the third tranche of $10.0 million (“Term Loan C”) can be drawn and (ii) the interest-only period for all advances under the Term Loan Agreement. The Company determined that the Term Loan Agreement Amendment resulted in a modification. As a result, the Term Loan will continue to be accounted for by using the effective interest method, with a new effective interest rate based on revised cash flows calculated on a prospective basis upon the execution of the amendment to the Term Loan Agreement. As amended, Term Loan C will be available, subject to the Company achieving consolidated trailing six months’ revenue at a specified threshold (the “Revenue Event”), from the date of the achievement of the Revenue Event, to the earlier of (i) June 30, 2016, and (ii) 60 days after the Revenue Event is achieved. Term Loan A bears an interest rate of 6.95%. Term Loan B bears an interest rate of 7.01%. Term Loan C would 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 Term Loan C funding date. All of the Term Loans mature on June 1, 2019. The Company is required to make interest only payments through June 2016, followed by thirty-six months of equal principal and interest payments thereafter; however, if the Revenue Event is achieved no later than May 31, 2016, 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. At December 31, 2015 and 2014, the Company accrued approximately $0.5 million and $0.1 million interest expense associated with the final payment in “Other non-current liabilities” on the Company’s Consolidated Balance Sheets. 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, and $0.1 million of the lender legal fees 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. 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 December 31, 2015.
|
Note 11. 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 2020, with certain of the leases providing for renewal options, provisions for adjusting future lease payments based on the consumer price index, and the right to terminate the lease early. The Company’s leased facilities qualify as operating leases under ASC Topic 840, “Leases” and as such, are not included on its consolidated balance sheets.
Future minimum non-cancelable lease payments under operating leases as of December 31, 2015, are as follows (in thousands):
Year ended December 31, |
||||
2016 |
$ | 1,111 | ||
2017 |
1,016 | |||
2018 |
729 | |||
2019 |
620 | |||
2020 |
14 | |||
|
|
|||
Total minimum non-cancellable lease payments |
$ | 3,490 | ||
|
|
Rent expense for office facilities was $0.8 million, $0.8 million and $0.7 million for the years ended December 31, 2015, 2014 and 2013, respectively.
Financed Leasehold Improvements
In 2010, the Company financed $1.1 million of leasehold improvements. The Company pays for the financed leasehold improvements as a component of rent and is required to reimburse its landlord over the remaining life of the respective leases. At December 31, 2015, the Company had an outstanding liability of $0.5 million related to these leasehold improvements, of which $0.1 million was reflected in “Accrued liabilities” and $0.4 million was reflected in “Other non-current liabilities” on the Company’s consolidated balance sheets.
Purchase Commitments
The Company is party to agreements with certain providers for certain components of INTERCEPT Blood System which the Company purchases from third party manufacturers. Certain of these agreements require minimum purchase commitments from the Company. The Company has paid $7.7 million, $6.8 million and $6.5 million for goods under agreements which are subject to minimum purchase commitments during the years ended December 31, 2015, 2014 and 2013, respectively. As of December 31, 2015, the Company has future minimum purchase commitments under these agreements of $8.4 million for the year ending December 31, 2016, and approximately $0.7 million for the year ending December 31, 2017.
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. The Company is 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. During the year ended December 31, 2015, the Company paid approximately $0.5 million (€0.4 million) associated with this fee. As of December 31, 2015, the Company had accrued $0.1 million (€0.1 million) associated with this fee. As this former distributor remains 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 are offset against the revenue associated with the sale of INTERCEPT disposable kits in those territories.
|
Note 12. Stockholders’ Equity
Public Offering of Common Stock
In January 2015, the Company issued 14,636,363 shares of its common stock, par value $0.001 per share, in an underwritten public offering. The price to the public in the offering was $5.50 per share. The net proceeds from this offering were approximately $75.3 million, net of the underwriting discount and other issuance costs.
Common Stock and Associated Warrant Liability
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 were exercisable for a period of five years from the issue date. In 2015, all outstanding 2010 Warrants were exercised in full.
The fair value of the 2010 Warrants was recorded on the consolidated balance sheets as a liability pursuant to ASC Topic 480-10“Distinguishing Liabilities from Equity” and were adjusted to fair value at each financial reporting date thereafter until exercise, at which time, these warrants were reclassified into stockholders’ equity. The Company classified the 2010 Warrants as a liability as these warrants contained certain provisions that, under certain circumstances, could have been out of the Company’s control and could have required the Company to pay cash to settle the exercise of the 2010 Warrants or required the Company to redeem the 2010 Warrants.
The fair value of the 2010 Warrants was based on option valuation model and using the following assumptions at December 31, 2015 and 2014:
December 31, 2015 |
December 31, 2014 |
|||
2010 Warrants: |
||||
Expected term (in years) |
— | 0.86 | ||
Estimated volatility |
— | 55% | ||
Risk-free interest rate |
— | 0.25% | ||
Expected dividend yield |
— | — |
The Company recorded non-cash gains or losses in “Gain (loss) from revaluation of warrant liability” on the consolidated statements of operations due to the changes in fair value of the 2010 Warrants. During the years ended December 31, 2015, 2014 and 2013, the 2010 Warrants to purchase 3.3 million, 2.6 million and 0.2 million shares of common stock, respectively, were exercised. At December 31, 2015, the Company had no outstanding warrants remaining.
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 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 Securities Act of 1933, as amended. During the year ended December 31, 2015 and 2014, zero and approximately 4.3 million shares, respectively, of the Company’s common stock were sold under the Amended Cantor Agreement for aggregate net proceeds of zero and $18.6 million, respectively. At December 31, 2015, the Company had approximately $22.5 million of common stock registered 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. As of December 31, 2015, no Series C Junior Participating preferred stock has been issued.
|
Note 13. Stock-Based Compensation
Employee Stock Plans
Employee Stock Purchase Plan
The Company maintains an Employee Stock Purchase Plan (the “Purchase Plan”), which is intended to qualify as an employee stock purchase plan within the meaning of Section 423(b) of the Internal Revenue Code. Under the Purchase Plan, the Company’s Board of Directors may authorize participation by eligible employees, including officers, in periodic offerings. Under the Purchase Plan eligible employee participants may purchase shares of common stock of the Company at a purchase price equal to 85% of the lower of the fair market value per share on the start date of the offering period or the fair market value per share on the purchase date. The Purchase Plan consists of a fixed offering period of 12 months with two purchase periods within each offering period. The Purchase Plan was authorized to issue an aggregate of 1,320,500 shares. On June 10, 2015, the Company’s stockholders approved an amendment and restatement of the Purchase Plan that increased the aggregate number of shares of common stock authorized for issuance under the Purchase Plan by 1,500,000 shares. At December 31, 2015, the Company had 1,652,972 shares available for future issuance.
2008 Equity Incentive Plan
The Company also maintains an equity compensation plan to provide long-term incentives for employees, contractors, and members of its Board of Directors. The Company currently grants equity awards from one plan, the 2008 Equity Incentive Plan (the “2008 Plan”). The 2008 Plan allows for the issuance of non-statutory and incentive stock options, restricted stock, restricted stock units, stock appreciation rights, other stock-related awards, and performance awards which may be settled in cash, stock, or other property. On June 6, 2012 and June 12, 2013, the stockholders approved amendments to the 2008 Plan (collectively the “Amended 2008 Plan”) such that the Amended 2008 Plan has reserved for issuance an amount not to exceed 19,540,940 shares. On June 10, 2015, the Company’s stockholders approved an amendment and restatement of the 2008 Plan that increased the aggregate number of shares of common stock authorized for issuance under the 2008 Plan by 5,000,000 shares. Awards under the Amended 2008 Plan generally have a maximum term of 10 years from the date of the award. The Amended 2008 Plan generally requires options to be granted at 100% of the fair market value of the Company’s common stock subject to the option on the date of grant and will generally vest over four years. Performance-based stock or cash awards granted under the Amended 2008 Plan are limited to either 500,000 shares of common stock or $1.0 million per recipient per calendar year. The attainment of any performance-based awards granted shall be conclusively determined by a committee designated by the Company’s Board of Directors. At December 31, 2015, no performance-based stock options were outstanding.
At December 31, 2015, the Company had an aggregate of approximately 21.5 million shares of its common stock subject to outstanding options or remaining available for future issuance under the Amended 2008 Plan, of which approximately 14.1 million shares were subject to outstanding options, and approximately 7.4 million shares were available for future issuance under the Amended 2008 Plan. The Company’s policy is to issue new shares of common stock upon the exercise of options.
Activity under the Company’s equity incentive plans related to stock options is set forth below (in thousands except weighted average exercise price):
Number of Options Outstanding |
Weighted Average Exercise Price per Share |
|||||||
Balances at December 31, 2014 |
11,323 | $ | 4.13 | |||||
Granted |
3,730 | 4.58 | ||||||
Forfeited |
(225 | ) | 5.12 | |||||
Expired |
(223 | ) | 8.55 | |||||
Exercised |
(486 | ) | 2.74 | |||||
|
|
|||||||
Balances at December 31, 2015 |
14,119 | 4.21 | ||||||
|
|
Information regarding the Company’s stock options outstanding, stock options vested and expected to vest, and stock options exercisable at December 31, 2015, was as follows (in thousands except weighted average exercise price and contractual term):
Number of Shares |
Weighted Average Exercise Price |
Weighted Average Remaining Contractual Term (Years) |
Aggregate Intrinsic Value |
|||||||||||||
Balances at December 31, 2015 |
||||||||||||||||
Stock options outstanding |
14,119 | $ | 4.21 | 6.9 | $ | 30,746 | ||||||||||
Stock options vested and expected to vest |
13,606 | 4.19 | 6.8 | 29,973 | ||||||||||||
Stock options exercisable |
8,693 | 3.81 | 5.7 | 22,754 |
The aggregate intrinsic value in the table above is calculated as the difference between the exercise price of the stock option and the Company’s closing stock price on the last trading day of each respective fiscal period.
The total intrinsic value of options exercised for the years ended December 31, 2015, 2014 and 2013, was $1.2 million, $3.8 million and $0.6 million, respectively.
Stock-based Compensation Expense
Stock-based compensation expense recognized on the Company’s consolidated statements of operations for the years ended December 31, 2015, 2014 and 2013, was as follows (in thousands):
Year Ended December 31, | ||||||||||||
2015 | 2014 | 2013 | ||||||||||
Stock-based compensation expense by caption: |
||||||||||||
Research and development |
$ | 1,260 | $ | 998 | $ | 482 | ||||||
Selling, general and administrative |
5,470 | 4,155 | 2,786 | |||||||||
|
|
|
|
|
|
|||||||
Total stock-based compensation expense |
$ | 6,730 | $ | 5,153 | $ | 3,268 | ||||||
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|
|
|
|
|
Stock-based compensation expense in the above table does not reflect any income taxes as the Company has experienced a history of net losses since its inception and has a full valuation allowance on its deferred tax assets. In addition, there was neither income tax benefits realized related to stock-based compensation expense nor any stock-based compensation costs capitalized as part of an asset during the years ended December 31, 2015, 2014 and 2013. The Company has also not recorded any stock-based compensation associated with performance-based stock options during the years ended December 31, 2015, 2014 and 2013.
As of December 31, 2015, the Company expects to recognize the remaining unamortized stock-based compensation expense of $11.0 million related to non-vested stock options, net of estimated forfeitures, over an estimated remaining weighted average period of 2.6 years.
Valuation Assumptions for Stock-based Compensation
The Company currently uses the Black-Scholes option pricing model to determine the grant-date fair value of stock options and employee stock purchase plan shares. The Black-Scholes option-pricing model is affected by the Company’s stock price, as well as assumptions regarding a number of complex and subjective variables, which include the expected term of the grants, actual and projected employee stock option exercise behaviors, including forfeitures, the Company’s expected stock price volatility, the risk-free interest rate and expected dividends. The Company recognizes the grant-date fair value of the stock award as stock-based compensation expense on a straight-line basis over the requisite service period, which is the vesting period, and is adjusted for estimated forfeitures.
The expected life of the stock options is based on observed historical exercise patterns. Groups of employees having similar historical exercise behavior are considered separately for valuation purposes. The Company estimates stock option forfeitures based on historical data for employee groups. The total number of stock options expected to vest is adjusted by actual and estimated forfeitures.
The expected volatility is estimated by using historical volatility of the Company’s common stock. The risk-free interest rate is based on the implied yield on a U.S. Treasury zero-coupon issue with a remaining term commensurate with the expected term of the option. The Company does not anticipate paying any cash dividends in the foreseeable future and therefore uses an expected dividend yield of zero.
The weighted average assumptions used to value the Company’s stock-based awards for the years ended December 31, 2015, 2014 and 2013, was as follows:
Year Ended December 31, | ||||||||||||
2015 | 2014 | 2013 | ||||||||||
Stock Options: |
||||||||||||
Expected term (in years) |
5.66 | 5.71 | 5.59 | |||||||||
Estimated volatility |
56 | % | 61 | % | 60 | % | ||||||
Risk-free interest rate |
1.55 | % | 1.73 | % | 0.87 | % | ||||||
Expected dividend yield |
0 | % | 0 | % | 0 | % | ||||||
Employee Stock Purchase Plan Rights: |
||||||||||||
Expected term (in years) |
0.75 | 0.76 | 0.50 | |||||||||
Estimated volatility |
53 | % | 52 | % | 39 | % | ||||||
Risk-free interest rate |
0.28 | % | 0.10 | % | 0.10 | % | ||||||
Expected dividend yield |
0 | % | 0 | % | 0 | % |
The weighted average grant-date fair value of stock options granted during the years ended December 31, 2015, 2014 and 2013, was $2.35 per share, $3.28 per share and $2.03 per share, respectively. The weighted average grant-date fair value of employee stock purchase rights during the years ended December 31, 2015, 2014 and 2013, was $1.54 per share, $1.42 per share and $1.18 per share, respectively.
|
Note 14. Retirement Plan
The Company maintains a defined contribution savings plan (the “401(k) Plan”) that qualifies under the provisions of Section 401(k) of the Internal Revenue Code and covers eligible U.S. employees of the Company. Under the terms of the 401(k) Plan, eligible U.S. employees may make pre-tax dollar contributions of up to 60% of their eligible pay up to a maximum cap established by the IRS. The Company may contribute a discretionary percentage of qualified individual employee’s salaries, as defined, to the 401(k) Plan. The Company has not contributed to the 401(k) Plan during the years ended December 31, 2015, 2014 and 2013.
|
Note 15. Development and License Agreements
Agreements with Fresenius
The Company had certain agreements with Fresenius which required the Company to pay royalties through June 30, 2015, on INTERCEPT Blood System product sales at royalty rates that varied by product: 10% of product sales for the platelet system and 3% of product sales for the plasma system. During the years ended December 31, 2015, 2014 and 2013, the Company made royalty payments to Fresenius of $1.9 million, $2.5 million and $3.0 million, respectively. At December 31, 2015 and December 31, 2014, the Company owed Fresenius zero and $0.7 million, respectively, for royalties.
Through December 31, 2013, the Company and Fresenius operated under a supply agreement (the “Original Supply Agreement”) for the manufacture of the Company’s platelet and plasma systems. Under the Original Supply Agreement, the Company paid Fresenius a set price per kit, which was established annually, plus a fixed surcharge per kit. In addition, volume driven manufacturing overhead was to be paid or refunded if actual manufacturing volumes were lower or higher than the 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 was obligated to sell, and the Company was 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. The 2013 Amendment also provided for fixed pricing for finished kits with successive decreasing pricing tiers at various annual production volumes. Fresenius was 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.
In October 2015, the Company entered into an Amended and Restated Manufacturing and Supply Agreement (the “2015 Agreement”) with Fresenius, which amended and restated the 2013 Amendment and Original Supply Agreement. Under the 2015 Agreement, Fresenius continues to be obligated to sell and the Company is obligated to purchase finished disposable kits for the Company’s platelet and plasma systems and the Company’s INTERCEPT Blood System for Red Blood Cells (the “RBC Sets”) product candidate. The 2015 Agreement permits the Company to purchase platelet and plasma systems and RBC Sets from third parties to the extent necessary to maintain supply qualifications with such third parties or where local or regional manufacturing is needed to obtain product registrations or sales. Pricing terms are initially fixed and decline at specified annual production levels, and are subject to certain adjustments after the initial pricing term. Under the 2015 Agreement, the Company is no longer required to make royalty payments to Fresenius for the sale of products after June 30, 2015. Under the 2013 Agreement and 2015 Agreement, the Company maintains the amounts due from the components sold to Fresenius as a current asset on its accompanying consolidated balance sheets until such time as the Company purchases finished disposable kits using those components.
The 2015 Agreement also requires the Company to make certain payments totaling €8.6 million (“Manufacturing and Development Payments”) to Fresenius in 2016 and on December 31st of the earlier of (a) the year of achievement of certain production volumes or (b) 2022. Because these payments represent unconditional payment obligations, the Company recognized its liability for these payments at their net present value at discount rate of 9.72% based on the Company’s effective borrowing rate. The Manufacturing and Development Payments liability is accreted through interest expense based on the estimated timing of its ultimate settlement. As of December 31, 2015, the Company had accrued $7.8 million (€7.2 million) related to the Manufacturing and Development Payments, of which $3.3 million (€3.0 million) was included in “Manufacturing and development obligations—current”, and $4.5 million (€4.2 million) was included in “Manufacturing and development obligations—non-current” on the Company’s Consolidated Balance Sheets.
The Manufacturing and Development Payments will be made to support certain projects Fresenius will perform on behalf of the Company related to research and development activities and manufacturing efficiency activities. The Company allocated $4.8 million to research and development activities and $2.4 million to manufacturing efficiency activities based on their market value. The prepaid asset related to amounts paid up front for the R&D activities to be conducted by Fresenius on behalf of the Company is expensed over the period which such activities occur. The manufacturing efficiency asset is expensed on a straight-line basis over the life of the 2015 Agreement. As of December 31, 2015, the prepaid asset related to amounts paid up front for the R&D activities to be conducted by Fresenius on behalf of the Company was included in “Other current assets” on the Company’s Consolidated Balance Sheets at $4.1 million. As of December 31, 2015, the manufacturing efficiency asset was included in “Other assets” on the Company’s Consolidated Balance Sheets at $2.4 million.
The initial term of the 2015 Agreement extends through July 1, 2025 (the “Initial Term”) and is automatically renewed thereafter for additional two year terms (each, a “Renewal Term”), subject to termination by either party upon (i) two years written notice prior to the expiration of the Initial Term or (ii) one year written notice prior to the expiration of any Renewal Term. Under 2015 Agreement the Company shall have the right, but not the obligation, to purchase certain assets and assume certain liabilities from Fresenius.
The Company made payments to Fresenius of $14.9 million, $19.1 million and $15.0 million relating to the manufacturing of the Company products during the years ended December 31, 2015, 2014 and 2013, respectively. At December 31, 2015 and December 31, 2014, the Company owed Fresenius $2.5 million and $5.1 million, respectively, for INTERCEPT disposable kits manufactured. At December 31, 2015 and 2014, amounts due from Fresenius were $0.2 million and $1.3 million respectively.
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Note 16. Income Taxes
U.S and foreign components of consolidated loss before income taxes for the years ended December 2015, 2014 and 2013, was as follows (in thousands):
Year Ended December 31, | ||||||||||||
2015 | 2014 | 2013 | ||||||||||
Loss before income taxes: |
||||||||||||
U.S. |
$ | (59,897 | ) | $ | (38,928 | ) | $ | (44,035 | ) | |||
Foreign |
358 | 368 | 916 | |||||||||
|
|
|
|
|
|
|||||||
Loss before income taxes |
$ | (59,539 | ) | $ | (38,560 | ) | $ | (43,119 | ) | |||
|
|
|
|
|
|
The provision for income taxes for the years ended December 2015, 2014 and 2013, was as follows (in thousands):
Year Ended December 31, | ||||||||||||
2015 | 2014 | 2013 | ||||||||||
Provision for income taxes: |
||||||||||||
Current: |
||||||||||||
Foreign |
$ | 147 | $ | 168 | $ | 191 | ||||||
Federal |
— | — | — | |||||||||
State |
— | 1 | — | |||||||||
|
|
|
|
|
|
|||||||
Total Current |
147 | 169 | 191 | |||||||||
Deferred: |
||||||||||||
Foreign |
— | — | — | |||||||||
Federal |
(3,750 | ) | 22 | 21 | ||||||||
State |
(68 | ) | 4 | 6 | ||||||||
|
|
|
|
|
|
|||||||
Total Deferred |
(3,818 | ) | 26 | 27 | ||||||||
|
|
|
|
|
|
|||||||
(Benefit) provision for income taxes |
$ | (3,671 | ) | $ | 195 | $ | 218 | |||||
|
|
|
|
|
|
The difference between the provision for income taxes and the amount computed by applying the federal statutory income tax rate to loss before taxes for the years ended December 31, 2015, 2014 and 2013, was as follows (in thousands):
Year Ended December 31, | ||||||||||||
2015 | 2014 | 2013 | ||||||||||
Federal statutory tax |
$ | (20,243 | ) | $ | (13,110 | ) | $ | (14,661 | ) | |||
Warrants |
(3,565 | ) | (3,367 | ) | 4,926 | |||||||
Expiration of federal loss carryovers |
3,337 | — | — | |||||||||
Change in valuation allowance |
11,754 | 16,576 | 9,955 | |||||||||
Change in state apportionment |
4,085 | — | — | |||||||||
Other |
961 | 96 | (2 | ) | ||||||||
|
|
|
|
|
|
|||||||
(Benefit) provision for income taxes |
$ | (3,671 | ) | $ | 195 | $ | 218 | |||||
|
|
|
|
|
|
On December 31, 2015, the California Supreme Court issued a decision disallowing the use of an income apportionment method pursuant to the Multistate Tax Compact. Previously the Company had relied on lower court decisions allowing the use of this apportionment method to file its 2013 and 2014 tax returns and to determine its deferred tax balances. As the California Supreme Court decision serves as the current law as of December 31, 2015, this change has been reflected in the determination of deferred tax balances and the respective valuation allowance.
Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes at the enacted rates. The significant components of the Company’s deferred tax assets and liabilities at December 31, 2015 and 2014, were as follows (in thousands):
December 31, | ||||||||
2015 | 2014 | |||||||
Deferred tax assets: |
||||||||
Net operating loss carryforwards |
$ | 165,813 | $ | 151,100 | ||||
Research and development credit carryforwards |
35,131 | 33,800 | ||||||
Capitalized research and development |
17,916 | 15,500 | ||||||
Deferred compensation |
5,908 | 5,800 | ||||||
Capital loss carryforwards |
— | 3,700 | ||||||
Other |
3,911 | 3,200 | ||||||
|
|
|
|
|||||
Total deferred tax assets |
228,679 | 213,100 | ||||||
Valuation allowance |
(224,854 | ) | (213,100 | ) | ||||
|
|
|
|
|||||
Net deferred tax assets |
3,825 | — | ||||||
|
|
|
|
|||||
Deferred tax liabilities: |
||||||||
Unrealized gain on investments |
3,825 | — | ||||||
Amortization of goodwill |
122 | 115 | ||||||
|
|
|
|
|||||
Total deferred tax liabilities |
$ | 3,947 | $ | 115 | ||||
|
|
|
|
The valuation allowance increased by $11.8 million for the year ended December 31, 2015, compared to the increase of $14.1 million and $8.5 million for the years ended December 31, 2014 and 2013, respectively. The Company believes that, based on a number of factors, the available objective evidence creates sufficient uncertainty regarding the realizability of the deferred tax assets such that a valuation allowance has been recorded. These factors include the Company’s history of net losses since its inception, the need for regulatory approval of the Company’s products prior to commercialization, expected near-term future losses and the absence of taxable income in prior carryback years. The Company expects to maintain a valuation allowance until circumstances change.
Undistributed earnings of the Company’s foreign subsidiary, Cerus Europe B.V., amounted to approximately $4.8 million at December 31, 2015. The earnings are considered to be permanently reinvested and accordingly, no deferred U.S. income taxes have been provided thereon. Upon distribution of those earnings in the form of dividends or otherwise, the Company would be subject to U.S. income taxes. The unrecognized deferred tax liability for unrepatriated earnings at December 31, 2015, was approximately $1.6 million. In the event all foreign undistributed earnings were remitted to the U.S., the Company believes any incremental tax liability would be offset by the Company’s domestic net operating losses and credits.
For the year ended December 31, 2015, the Company reported pretax net losses of $59.5 million on its consolidated statement of operations and calculated taxable losses for both federal and state taxes. The difference between reported net loss and taxable loss are due to differences between book accounting and the respective tax laws.
At December 31, 2015, the Company had federal and state net operating loss carryforwards of approximately $466 million and $114 million, respectively. The net operating loss carryforwards for federal and state expire at various dates beginning in 2016 through 2035. The Company’s net operating losses do not include $2.3 million related to windfall tax deductions associated with stock based compensation. The stock based compensation windfall deductions, if utilized, would serve to reduce any income taxes payable with a corresponding credit to additional paid in capital.
At December 31, 2015, the Company had federal research and development credit carryforwards of approximately $23.3 million that expire in various years between 2018 and 2035. The state research and development credits are approximately $18.0 million as of December 31, 2015, and have an indefinite carryover period.
The utilization of net operating loss carryforwards, as well as research and development credit carryforwards, is limited by current tax regulations. These net operating loss carryforwards, as well as research and development credit carryforwards, will be utilized in future periods if sufficient income is generated. The Company believes it more likely than not that its tax positions would be recognized upon review by a taxing authority having full knowledge of all relevant information. The Company’s ability to utilize certain loss carryforwards and certain research credit carryforwards are subject to limitations pursuant to the ownership change rules in accordance with Section 382 of the Internal Revenue Code of 1986 and with Section 383 of the Internal Revenue Code of 1986, as well as similar state provisions.
The Company will recognize accrued interest and penalties related to unrecognized tax benefits in its income tax expense. To date, the Company has not recognized any interest and penalties in its consolidated statements of operations, nor has it accrued for or made payments for interest and penalties. The Company had no unrecognized tax benefits as of December 31, 2015 and 2014. The Company’s tax years through 2015 remain subject to examination by the taxing jurisdictions due to unutilized net operating losses and research credits. There was no income tax audit activity in 2015 nor has the Company been notified by any tax agency of any planned audits.
|
Note 17. 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 U.S. include a wholly-owned subsidiary headquartered in Europe. The Company’s operations in the U.S. are responsible for the research and development and global and domestic commercialization of the INTERCEPT Blood System, while operations in Europe are responsible for the commercialization efforts of the platelet and plasma systems in Europe, the Commonwealth of Independent States and the Middle East. Product revenues are attributed to each region based on the location of the customer.
The Company had the following significant customers that accounted for more than 10% of the Company’s total product revenue, all of which operate in a country outside of the U.S., during the years ended December 31, 2015, 2014 and 2013 (in percentages):
Year Ended December 31, | ||||||||||||
2015 | 2014 | 2013 | ||||||||||
Etablissement Francais du Sang |
23 | % | 25 | % | 17 | % | ||||||
Grifols |
* | * | 18 | % |
* | Represents an amount less than 10% of product revenue. |
Revenues by geographical location was based on the location of the customer during the years ended December 31, 2015, 2014 and 2013, and was as follows (in thousands):
Year Ended December 31, | ||||||||||||
2015 | 2014 | 2013 | ||||||||||
Revenue: |
||||||||||||
France |
$ | 7,732 | $ | 9,184 | $ | 7,030 | ||||||
Spain and Portugal |
4,070 | 2,776 | 7,033 | |||||||||
CIS |
3,361 | 6,636 | 8,220 | |||||||||
Belgium |
5,728 | 4,456 | 3,971 | |||||||||
Switzerland |
2,938 | 3,784 | 4,078 | |||||||||
Other countries |
10,394 | 9,580 | 9,325 | |||||||||
|
|
|
|
|
|
|||||||
Total revenue |
$ | 34,223 | $ | 36,416 | $ | 39,657 | ||||||
|
|
|
|
|
|
Long-lived assets by geographical location, which consist of property and equipment, net and intangible assets, net, at December 31, 2015 and 2014, were as follows (in thousands):
December 31, | ||||||||
2015 | 2014 | |||||||
U.S. |
$ | 4,260 | $ | 4,624 | ||||
Europe & other |
229 | 299 | ||||||
|
|
|
|
|||||
Total long-lived assets |
$ | 4,489 | $ | 4,923 | ||||
|
|
|
|
|
Note 18. Quarterly Financial Information (Unaudited)
The following tables summarize the Company’s quarterly financial information for the years ended December 31, 2015 and 2014 (in thousands except per share amounts):
Three Months Ended | ||||||||||||||||
March 31, 2015 |
June 30, 2015 |
September 30, 2015 |
December 31, 2015 |
|||||||||||||
Revenue |
$ | 7,692 | $ | 8,830 | $ | 8,045 | $ | 9,656 | ||||||||
Gross profit |
2,978 | 1,802 | 2,485 | 3,494 | ||||||||||||
Net loss |
$ | (9,460 | ) | $ | (15,972 | ) | $ | (15,680 | ) | $ | (14,756 | ) | ||||
Net loss per share: |
||||||||||||||||
Basic |
$ | (0.10 | ) | $ | (0.17 | ) | $ | (0.16 | ) | $ | (0.15 | ) | ||||
Diluted |
$ | (0.17 | ) | $ | (0.17 | ) | $ | (0.17 | ) | $ | (0.15 | ) |
Three Months Ended | ||||||||||||||||
March 31, 2014 |
June 30, 2014 |
September 30, 2014 |
December 31, 2014 |
|||||||||||||
Product revenue |
$ | 7,866 | $ | 8,601 | $ | 10,362 | $ | 9,587 | ||||||||
Gross profit |
3,709 | 3,849 | 4,673 | 2,997 | ||||||||||||
Net loss |
$ | (225 | ) | $ | (7,589 | ) | $ | (10,759 | ) | $ | (20,182 | ) | ||||
Net loss per share: |
||||||||||||||||
Basic |
$ | (0.00 | ) | $ | (0.10 | ) | $ | (0.14 | ) | $ | (0.26 | ) | ||||
Diluted |
$ | (0.12 | ) | $ | (0.16 | ) | $ | (0.16 | ) | $ | (0.26 | ) |
|
Principles of Consolidation
The accompanying consolidated financial statements include those of Cerus Corporation and its subsidiary, Cerus Europe B.V. (together with Cerus Corporation, hereinafter “Cerus” or the “Company”) after elimination of all intercompany accounts and transactions. These consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the U.S. (“GAAP”) and pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”).
Use of Estimates
The preparation of financial statements requires management to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosures of contingent assets and liabilities. On an ongoing basis, 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 the arrangement exists; (ii) delivery has occurred or services have been rendered; (iii) pricing is fixed or determinable; and (iv) collectability is reasonably assured. The Company’s main sources of revenues for the years ended December 31, 2015, 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 or signed sales contract as evidence of an arrangement. 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. The Company regularly reviews best estimated selling price. At December 31, 2015 and 2014, the Company had $0.6 million and $0.4 million, respectively, of short-term deferred revenue on its consolidated balance sheets related to future performance obligations. At each of December 31, 2015 and 2014, the Company had $0.1 million of long-term deferred revenue included in “Other non-current liabilities” on it consolidated balance sheets related to future performance obligations. Freight costs charged to customers are recorded as a component of revenue. Taxes that the Company invoices to its customers and remits to governments are recorded on a net basis, which excludes such tax 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, including cost incurred under each grant that has been awarded to the Company by the U.S. government or development contracts. Research and development expenses include salaries and related expenses for scientific and regulatory 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. 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.
Investments
Investments with original maturities of greater than three months primarily include corporate debt, U.S. government agency securities and marketable equity securities of Aduro Biotech, Inc. (“Aduro”), 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 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 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 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 “Other assets” on the Company’s condensed consolidated balance sheets. The Company also has certain non-U.S. 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 December 31, 2015, the fair value of the Company’s marketable equity securities of Aduro is subject to the underlying volatility of Aduro’s stock price. At December 31, 2015, the Company does not believe there is significant financial risk from non-performance by the issuers of the Company’s cash equivalents.
Concentrations of credit risk with respect to trade receivables exist. On a regular basis, including at the time of sale, the Company performs credit evaluations of its 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 establishes an allowance for doubtful accounts against the accounts receivable on its consolidated balance sheets and records a charge on its consolidated statements of operations as a component of selling, general and administrative expenses.
The Company had three customers and one customer that accounted for more than 10% of the Company’s outstanding trade receivables at December 31, 2015 and 2014, respectively. These customers cumulatively represented approximately 49% and 36% of the Company’s outstanding trade receivables at December 31, 2015 and 2014, respectively. To date, the Company has not experienced collection difficulties from these customers.
Inventories
At December 31, 2015 and 2014, 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 or Fresenius, Inc. (with their 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 December 31, 2015 and 2014, the Company classified its work-in-process inventory as a current asset on its consolidated balance sheets based on its evaluation that the work-in-process inventory would be 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 net realizable 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 consolidated statements of operations. At December 31, 2015, and 2014, the Company had $1.8 million and $0.1 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 as incurred. During the years ended December 31, 2015, and 2014, the Company capitalized costs related to its enterprise resource planning software system of zero and $1.8 million, respectively. At December 31, 2015 and 2014, the Company had $1.3 million and $1.6 million of capitalized cost related to its enterprise resource planning system, 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
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 original estimated useful life of ten years. The amortization of the Company’s intangible assets, net, is recorded in “Amortization of intangible assets” on the Company’s consolidated statements of operations. Goodwill is not amortized but instead is subject to an impairment test performed on an annual basis, or more frequently if events or changes in circumstances indicate that goodwill may be impaired. Such impairment analysis is performed on August 31 of each fiscal year, or more frequently if indicators of impairment exist. The test for goodwill impairment may be assessed using qualitative factors to determine whether it is more likely than not that the fair value of a reporting unit is less than the carrying amount. If the Company determines that it is more likely than not that the fair value of a reporting unit is less than the carrying amount, the Company must then proceed with performing the quantitative two-step process to test goodwill for impairment; otherwise, goodwill is not considered impaired and no further testing is warranted. The Company may choose not to perform the qualitative assessment to test goodwill for impairment and proceed directly to the quantitative two-step process; however, the Company may revert to the qualitative assessment to test goodwill for impairment in any subsequent period. The first step of the two-step process compares the fair value of each reporting unit with its respective carrying amount, including goodwill. The Company has determined that it operates in one reporting unit and estimates the fair value of its one reporting unit using the enterprise approach under which it considers the quoted market capitalization of the Company as reported on the Nasdaq Global Market. The Company considers quoted market prices that are available in active markets to be the best evidence of fair value. The Company also considers other factors, which include future forecasted results, the economic environment and overall market conditions. If the fair value of the reporting unit exceeds its carrying amount, goodwill of the reporting unit is not considered impaired and, therefore, the second step of the impairment test is unnecessary. The second step of the two-step process, which is used to measure the amount of impairment loss, compares the implied fair value of each reporting unit’s goodwill, 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.” See Note 7 for further information regarding the Company’s impairment analysis and the valuation of goodwill and intangible assets, net.
Long-lived Assets
The Company evaluates its long-lived assets for impairment by continually monitoring events and changes in circumstances that could indicate carrying amounts of its long-lived assets may not be recoverable. When such events or changes in circumstances occur, the Company assesses recoverability by determining whether the carrying value of such assets will be recovered through the undiscounted expected future cash flows. If the expected undiscounted future cash flows are less than the carrying amount of these assets, the Company then measures the amount of the impairment loss based on the excess of the carrying amount over the fair value of the assets. The Company did not recognize impairment charges related to its long-lived assets during the years ended December 31, 2015, 2014 or 2013.
Foreign Currency Remeasurement
The functional currency of the Company’s foreign subsidiary is the U.S. dollar. Monetary assets and liabilities denominated in foreign currencies are remeasured in U.S. dollars using the exchange rates at the balance sheet date. Non-monetary assets and liabilities denominated in foreign currencies are remeasured in U.S. 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 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 the vesting period, and is adjusted for estimated forfeitures. To the extent that stock options contain performance criteria for vesting, stock-based compensation is recognized once the performance criteria are probable of being achieved.
For stock-based awards issued to non-employees, the Company follows ASC Topic 505-50, Equity Based Payment to Non-Employees and considers the measurement date at which the fair value of the stock-based award is measured to be the earlier of (i) the date at which a commitment for performance by the grantee to earn the equity instrument is reached or (ii) the date at which the grantee’s performance is complete. The Company recognizes stock-based compensation expense for the fair value of the vested portion of the non-employee stock-based awards in its consolidated statements of operations.
See Note 13 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 its common stock, respectively. The material terms of the warrants were identical under each issuance except for the exercise price, date issued and expiration date. In August 2014, all of the outstanding August 2009 warrants were exercised in full. In November 2015, all of the outstanding November 2010 warrants were exercised in full. The Company classified warrants outstanding on the reporting date as a liability on its consolidated balance sheets as the warrants contained certain material terms which required the Company to purchase the warrants for cash in an amount equal to the value of the unexercised portion of the warrants in connection with certain change of control transactions.
The fair value of outstanding warrants was calculated using the Black-Scholes model and was adjusted accordingly at reporting dates since December 31, 2014. Prior to December 31, 2014, the Company calculated the fair value of these warrants using a combination of the Black-Scholes model and/or binomial-lattice option-pricing model.
Changes resulting from the revaluation of warrants to fair value were recorded in “Gain (loss) from revaluation of warrant liability” on the consolidated statements of operations. Upon the exercise of the warrants, the fair value of the warrants was reclassified from a liability to stockholders’ equity on the Company’s consolidated balance sheets.
See Note 12 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 derecognition of a tax position. The Company recognizes accrued interest and penalties related to unrecognized tax benefits in its income tax expense. To date, the Company has not recognized any interest and penalties in its consolidated statements of operations, nor has its accrued for or made payments for interest and penalties. 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 U.S. federal and California tax years through 2015 remain subject to examination by the taxing jurisdictions due to unutilized net operating losses and research credits. The Company continues to carry a full valuation allowance on all of its net deferred tax assets, except for its indefinite lived intangibles.
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, and convertible preferred stock, which is calculated using the if-converted 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 years ended December 31, 2015 and 2014, as their inclusion would have been anti-dilutive. Diluted net loss per common share used the same weighted average number of common shares outstanding for the year ended December 31, 2013, as calculated for the basic net loss per common share as the inclusion of any potential dilutive securities would be 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 years ended December 31, 2015, 2014 and 2013 (in thousands, except per share amounts):
Year Ended December 31, | ||||||||||||
2015 | 2014 | 2013 | ||||||||||
Numerator for Basic and Diluted: |
||||||||||||
Net loss used for basic calculation |
$ | (55,868 | ) | $ | (38,755 | ) | $ | (43,337 | ) | |||
Effect of revaluation of warrant liability |
(3,566 | ) | (7,708 | ) | — | |||||||
|
|
|
|
|
|
|||||||
Adjusted net loss used for dilution calculation |
$ | (59,434 | ) | $ | (46,463 | ) | $ | (43,337 | ) | |||
|
|
|
|
|
|
|||||||
Denominator: |
||||||||||||
Basic weighted average number of shares outstanding |
96,068 | 74,767 | 67,569 | |||||||||
Effect of dilutive potential shares |
837 | 1,767 | — | |||||||||
|
|
|
|
|
|
|||||||
Diluted weighted average number of shares outstanding |
96,905 | 76,534 | 67,569 | |||||||||
|
|
|
|
|
|
|||||||
Net loss per share: |
||||||||||||
Basic |
$ | (0.58 | ) | $ | (0.52 | ) | $ | (0.64 | ) | |||
Diluted |
$ | (0.61 | ) | $ | (0.61 | ) | $ | (0.64 | ) |
The table below presents shares underlying stock options, employee stock purchase plan rights, warrants, restricted stock units and/or convertible preferred stock that were excluded from the calculation of the weighted average number of shares outstanding used for the calculation of diluted net loss per share. These were excluded from the calculation due to their anti-dilutive effect for the years ended December 31, 2015, 2014 and 2013 (shares in thousands):
Year Ended December 31, | ||||||||||||
2015 | 2014 | 2013 | ||||||||||
Weighted average number of anti-dilutive potential shares |
||||||||||||
Outstanding options |
13,681 | 11,722 | 10,296 | |||||||||
Warrants |
— | — | 6,074 | |||||||||
|
|
|
|
|
|
|||||||
Total |
13,681 | 11,722 | 16,370 | |||||||||
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|
|
|
|
|
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. The Company has not experienced significant or systemic warranty claims nor is it aware of any existing current warranty claims. Accordingly, the Company had not accrued for any future warranty costs for its products at December 31, 2015 or 2014.
Fair Value of Financial Instruments
The Company applies the provisions of fair value relating to its financial assets and liabilities. The carrying amounts of accounts receivables, accounts payable, and other accrued liabilities approximate their fair value due to the relative short-term maturities. Based on the borrowing rates currently available to the Company for loans with similar terms, the Company believes the fair value of its debt approximates their carrying amounts. The Company measures and records certain financial assets and liabilities at fair value on a recurring basis, including its available-for-sale securities and warrant liability. The Company classifies instruments within Level 1 if quoted prices are available in active markets for identical assets, which include the Company’s cash accounts and 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 U.S. 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 3 and 12 for further information regarding the Company’s valuation on 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. In August 2015, the FASB issued ASU No. 2015-14, Revenue from Contracts with Customers (Topic 606), Deferral of the Effective Date, which defers by one year the effective date of ASU No. 2014-09 to annual reporting periods beginning after December 15, 2017 (including interim periods within those periods). Early adoption is permitted to the original effective date of December 15, 2016 (including interim periods within those periods).The ASU’s effective date for the Company will be the first quarter of fiscal year 2018, using one of two retrospective application methods. The Company has not selected a transition method and is currently 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 adoption of this ASU is not expected to have a material impact on the Company’s consolidated financial statements.
In April 2015, the FASB issued ASU No. 2015-03, Interest—Imputation of Interest (Subtopic 835-30), Simplifying the Presentation of Debt Issuance Costs, which requires debt issuance costs related to a recognized debt liability to be presented in the balance sheet as a direct deduction from the corresponding debt liability rather than as an asset. This ASU will be effective for the Company in fiscal year 2016. Early adoption is permitted. The adoption of this ASU is not expected to have a material impact on the Company’s consolidated financial statements.
In July 2015, the FASB issued ASU No. 2015-11, Inventory (Topic 330), Simplifying the Measurement of Inventory, which simplifies the subsequent measurement of inventory by requiring inventory to be measured at the lower of cost and net realizable value. Net realizable value is defined as the “estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal and transportation.” This ASU will be effective for the Company in fiscal year 2017. Early adoption is permitted. The Company has early adopted this ASU in 2015 prospectively and it did not have a material impact on the Company’s consolidated financial statements.
In November 2015, the FASB issued ASU No. 2015-17, Balance Sheet Classification of Deferred Taxes, which requires all deferred tax assets and liabilities, along with any related valuation allowance, be classified as noncurrent on the balance sheet. This ASU may be adopted either prospectively or retrospectively. This ASU will be effective for the Company in fiscal year 2017. Early adoption is permitted. The Company has early adopted this ASU in 2015 prospectively and it did not have a material impact on the Company’s consolidated financial statements.
In January 2016, the FASB issued ASU No. 2016-01, Financial Instruments-Overall (Subtopic 825-10), which requires all equity investments to be measured at fair value with changes in the fair value recognized through net income (other than those accounted for under equity method of accounting or those that result in consolidation of the investee). The amendments also require an entity to present separately in other comprehensive income the portion of the total change in the fair value of a liability resulting from a change in the instrument-specific credit risk when the entity has elected to measure the liability at fair value in accordance with the fair value option for financial instruments. In addition, this ASU eliminates the requirement to disclose the fair value of financial instruments measured at amortized cost for entities that are not public business entities and the requirement for to disclose the method(s) and significant assumptions used to estimate the fair value that is required to be disclosed for financial instruments measured at amortized cost on the balance sheet for public business entities. This ASU will be effective for the Company in fiscal year 2018. Early adoption is permitted. The Company is currently assessing the future impact of this ASU on its consolidated financial statements.
In February 2016, the FASB issued ASU No. 2016-02, Leases, which, for operating leases, requires a lessee to recognize a right-of-use asset and a lease liability, initially measured at the present value of the lease payments, in its balance sheet. The standard also requires a lessee to recognize a single lease cost, calculated so that the cost of the lease is allocated over the lease term, on a generally straight-line basis. This ASU will be effective for the Company in fiscal year 2019. Early adoption is permitted. The Company is currently assessing the future impact of this ASU on its consolidated financial statements and anticipates the new guidance will significantly impact its consolidated financial statements.
|
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 years ended December 31, 2015, 2014 and 2013 (in thousands, except per share amounts):
Year Ended December 31, | ||||||||||||
2015 | 2014 | 2013 | ||||||||||
Numerator for Basic and Diluted: |
||||||||||||
Net loss used for basic calculation |
$ | (55,868 | ) | $ | (38,755 | ) | $ | (43,337 | ) | |||
Effect of revaluation of warrant liability |
(3,566 | ) | (7,708 | ) | — | |||||||
|
|
|
|
|
|
|||||||
Adjusted net loss used for dilution calculation |
$ | (59,434 | ) | $ | (46,463 | ) | $ | (43,337 | ) | |||
|
|
|
|
|
|
|||||||
Denominator: |
||||||||||||
Basic weighted average number of shares outstanding |
96,068 | 74,767 | 67,569 | |||||||||
Effect of dilutive potential shares |
837 | 1,767 | — | |||||||||
|
|
|
|
|
|
|||||||
Diluted weighted average number of shares outstanding |
96,905 | 76,534 | 67,569 | |||||||||
|
|
|
|
|
|
|||||||
Net loss per share: |
||||||||||||
Basic |
$ | (0.58 | ) | $ | (0.52 | ) | $ | (0.64 | ) | |||
Diluted |
$ | (0.61 | ) | $ | (0.61 | ) | $ | (0.64 | ) |
The table below presents shares underlying stock options, employee stock purchase plan rights, warrants, restricted stock units and/or convertible preferred stock that were excluded from the calculation of the weighted average number of shares outstanding used for the calculation of diluted net loss per share. These were excluded from the calculation due to their anti-dilutive effect for the years ended December 31, 2015, 2014 and 2013 (shares in thousands):
Year Ended December 31, | ||||||||||||
2015 | 2014 | 2013 | ||||||||||
Weighted average number of anti-dilutive potential shares |
||||||||||||
Outstanding options |
13,681 | 11,722 | 10,296 | |||||||||
Warrants |
— | — | 6,074 | |||||||||
|
|
|
|
|
|
|||||||
Total |
13,681 | 11,722 | 16,370 | |||||||||
|
|
|
|
|
|
|
The fair values of the Company’s financial assets and liabilities were determined using the following inputs at December 31, 2015 (in thousands):
Balance sheet classification | Total | Quoted Prices in Active Markets for Identical Assets (Level 1) |
Significant Other Observable Inputs (Level 2) |
Significant Unobservable Inputs (Level 3) |
||||||||||||||
Money market funds |
Cash and cash equivalents | $ | 59,302 | $ | 59,302 | $ | — | $ | — | |||||||||
Corporate debt securities |
Short-term investments | 25,698 | — | 25,698 | — | |||||||||||||
Marketable equity securities |
Marketable equity securities | 11,163 | 11,163 | — | — | |||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Total financial assets |
$ | 96,163 | $ | 70,465 | $ | 25,698 | $ | — | ||||||||||
|
|
|
|
|
|
|
|
The fair values of the Company’s financial assets and liabilities were determined using the following inputs at December 31, 2014 (in thousands):
Balance sheet classification | Total | Quoted Prices in Active Markets for Identical Assets (Level 1) |
Significant Other Observable Inputs (Level 2) |
Significant Unobservable Inputs (Level 3) |
||||||||||||||
Money market funds |
Cash and cash equivalents | $ | 3,912 | $ | 3,912 | $ | — | $ | — | |||||||||
Corporate debt securities |
Short-term investments | 26,088 | — | 26,088 | — | |||||||||||||
United States government agency securities |
Short-term investments | 3,426 | — | 3,426 | — | |||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Total financial assets |
$ | 33,426 | $ | 3,912 | $ | 29,514 | $ | — | ||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Warrant liability |
Warrant liability | $ | 10,485 | $ | — | $ | — | $ | 10,485 | |||||||||
|
|
|
|
|
|
|
|
|||||||||||
Total financial liabilities |
$ | 10,485 | $ | — | $ | — | $ | 10,485 | ||||||||||
|
|
|
|
|
|
|
|
A reconciliation of the beginning and ending balances for the warrant liability using significant unobservable inputs (Level 3) from December 31, 2013 to December 31, 2015, was as follows (in thousands):
Balance at December 31, 2013 |
$ | 20,390 | ||
Decrease in fair value of warrants |
(7,708 | ) | ||
Settlement of warrants exercised |
(2,197 | ) | ||
|
|
|||
Balance at December 31, 2014 |
10,485 | |||
Decrease in fair value of warrants |
(3,566 | ) | ||
Settlement of warrants exercised |
(6,919 | ) | ||
|
|
|||
Balance at December 31, 2015 |
$ | — | ||
|
|
|
The following is a summary of available-for-sale securities at December 31, 2015 (in thousands):
December 31, 2015 | ||||||||||||
Amortized Cost | Gross Unrealized Gain (Loss) |
Fair Value | ||||||||||
Money market funds |
$ | 59,302 | $ | — | $ | 59,302 | ||||||
Corporate debt securities |
25,747 | (49 | ) | 25,698 | ||||||||
Marketable equity securities |
— | 11,163 | 11,163 | |||||||||
|
|
|
|
|
|
|||||||
Total available-for-sale securities |
$ | 85,049 | $ | 11,114 | $ | 96,163 | ||||||
|
|
|
|
|
|
The following is a summary of available-for-sale securities at December 31, 2014 (in thousands):
December 31, 2014 | ||||||||||||
Amortized Cost | Gross Unrealized Loss |
Fair Value | ||||||||||
Money market funds |
$ | 3,912 | $ | — | $ | 3,912 | ||||||
United States government agency securities |
3,427 | (1 | ) | 3,426 | ||||||||
Corporate debt securities |
26,118 | (30 | ) | 26,088 | ||||||||
|
|
|
|
|
|
|||||||
Total available-for-sale securities |
$ | 33,457 | $ | (31 | ) | $ | 33,426 | |||||
|
|
|
|
|
|
Available-for-sale securities at December 31, 2015 and 2014, consisted of the following by contractual maturity (in thousands):
December 31, 2015 | December 31, 2014 | |||||||||||||||
Amortized Cost |
Fair Value | Amortized Cost |
Fair Value | |||||||||||||
One year or less |
$ | 85,049 | $ | 85,000 | $ | 27,752 | $ | 27,727 | ||||||||
Marketable equity securities |
— | 11,163 | — | — | ||||||||||||
Greater than one year and less than five years |
— | — | 5,705 | 5,699 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total available-for-sale securities |
$ | 85,049 | $ | 96,163 | $ | 33,457 | $ | 33,426 | ||||||||
|
|
|
|
|
|
|
|
The following tables show all available-for-sale marketable securities in an unrealized loss position for which an other-than-temporary impairment has not been recognized and the related gross unrealized losses and fair value, aggregated by investment category and length of time that individual securities have been in a continuous unrealized loss position (in thousands):
December 31, 2015 | ||||||||||||||||||||||||
Less than 12 Months | 12 Months or Greater | Total | ||||||||||||||||||||||
Fair Value | Unrealized Loss |
Fair Value | Unrealized Loss |
Fair Value | Unrealized Loss |
|||||||||||||||||||
Money market funds |
$ | — | $ | — | $ | — | $ | — | $ | — | $ | — | ||||||||||||
Corporate debt securities |
20,170 | (46 | ) | 5,528 | (3 | ) | 25,698 | (49 | ) | |||||||||||||||
Marketable equity securities |
— | — | — | — | — | — | ||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Total available-for-sale securities |
$ | 20,170 | $ | (46 | ) | $ | 5,528 | $ | (3 | ) | $ | 25,698 | $ | (49 | ) | |||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
December 31, 2014 | ||||||||||||||||||||||||
Less than 12 Months | 12 Months or Greater | Total | ||||||||||||||||||||||
Fair Value | Unrealized Loss |
Fair Value | Unrealized Loss |
Fair Value | Unrealized Loss |
|||||||||||||||||||
Money market funds |
$ | — | $ | — | $ | — | $ | — | $ | — | $ | — | ||||||||||||
United States government agency securities |
3,426 | (1 | ) | — | — | 3,426 | (1 | ) | ||||||||||||||||
Corporate debt securities |
22,169 | (30 | ) | — | — | 22,169 | (30 | ) | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Total available-for-sale securities |
$ | 25,595 | $ | (31 | ) | $ | — | $ | — | $ | 25,595 | $ | (31 | ) | ||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
Inventories at December 31, 2015 and 2014, consisted of the following (in thousands):
December 31, | ||||||||
2015 | 2014 | |||||||
Work-in-process |
$ | 3,187 | $ | 2,222 | ||||
Finished goods |
7,625 | 12,734 | ||||||
|
|
|
|
|||||
Total inventories |
$ | 10,812 | $ | 14,956 | ||||
|
|
|
|
|
Property and equipment, net at December 31, 2015 and 2014, consisted of the following (in thousands):
December 31, | ||||||||
2015 | 2014 | |||||||
Leasehold improvements |
$ | 5,678 | $ | 5,638 | ||||
Machinery and equipment |
1,603 | 1,351 | ||||||
Demonstration equipment |
145 | 123 | ||||||
Furniture and fixtures |
794 | 783 | ||||||
Computer equipment |
591 | 663 | ||||||
Computer software |
2,935 | 2,913 | ||||||
Consigned equipment |
1,010 | 980 | ||||||
Construction-in-progress |
219 | 150 | ||||||
|
|
|
|
|||||
Total property and equipment, gross |
12,975 | 12,601 | ||||||
Accumulated depreciation and amortization |
(9,426 | ) | (8,820 | ) | ||||
|
|
|
|
|||||
Total property and equipment, net |
$ | 3,549 | $ | 3,781 | ||||
|
|
|
|
|
The following is a summary of intangible assets, net at December 31, 2015 (in thousands):
December 31, 2015 | ||||||||||||
Gross Carrying Amount |
Accumulated Amortization |
Net Carrying Amount |
||||||||||
Acquisition-related intangible assets: |
||||||||||||
Reacquired license—INTERCEPT Asia |
$ | 2,017 | $ | (1,077 | ) | $ | 940 | |||||
|
|
|
|
|
|
|||||||
Total intangible assets |
$ | 2,017 | $ | (1,077 | ) | $ | 940 | |||||
|
|
|
|
|
|
The following is a summary of intangible assets, net at December 31, 2014 (in thousands):
December 31, 2014 | ||||||||||||
Gross Carrying Amount |
Accumulated Amortization |
Net Carrying Amount |
||||||||||
Acquisition-related intangible assets: |
||||||||||||
Reacquired license—INTERCEPT Asia |
$ | 2,017 | $ | (875 | ) | $ | 1,142 | |||||
|
|
|
|
|
|
|||||||
Total intangible assets |
$ | 2,017 | $ | (875 | ) | $ | 1,142 | |||||
|
|
|
|
|
|
|
Accrued liabilities at December 31, 2015 and 2014, consisted of the following (in thousands):
December 31, | ||||||||
2015 | 2014 | |||||||
Accrued compensation and related costs |
$ | 5,198 | $ | 3,951 | ||||
Accrued professional services |
2,337 | 2,123 | ||||||
Accrued inventory costs |
73 | 870 | ||||||
Accrued customer costs |
987 | 385 | ||||||
Accrued insurance premiums |
438 | 264 | ||||||
Other accrued expenses |
820 | 851 | ||||||
|
|
|
|
|||||
Total accrued liabilities |
$ | 9,853 | $ | 8,444 | ||||
|
|
|
|
|
Debt at December 31, 2015, consisted of the following (in thousands):
December 31, 2015 | ||||||||||||
Principal | Unamortized Discount |
Net Carrying Value |
||||||||||
Loan and Security Agreement |
$ | 20,000 | $ | (128 | ) | $ | 19,872 | |||||
Less: debt—current |
(3,050 | ) | 61 | (2,989 | ) | |||||||
|
|
|
|
|
|
|||||||
Debt—non-current |
$ | 16,950 | $ | (67 | ) | $ | 16,883 | |||||
|
|
|
|
|
|
Debt at December 31, 2014, consisted of the following (in thousands):
December 31, 2014 | ||||||||||||
Principal | Unamortized Discount |
Total | ||||||||||
Loan and Security Agreement |
$ | 10,000 | $ | (128 | ) | $ | 9,872 | |||||
Less: debt—current |
— | — | — | |||||||||
|
|
|
|
|
|
|||||||
Debt—non-current |
$ | 10,000 | $ | (128 | ) | $ | 9,872 | |||||
|
|
|
|
|
|
Principal and interest payments on debt at December 31, 2015, are expected to be as follows*:
Year ended December 31, |
Principal | Interest | Total | |||||||||
2016 |
3,050 | 1,352 | 4,402 | |||||||||
2017 |
6,428 | 980 | 7,408 | |||||||||
2018 |
6,892 | 517 | 7,409 | |||||||||
2019 |
3,630 | 1,474 | 5,104 | |||||||||
|
|
|
|
|
|
|||||||
Total |
$ | 20,000 | $ | 4,323 | $ | 24,323 | ||||||
|
|
|
|
|
|
* | Unless interest only period extends to December 31, 2016, as described below. |
|
Future minimum non-cancelable lease payments under operating leases as of December 31, 2015, are as follows (in thousands):
Year ended December 31, |
||||
2016 |
$ | 1,111 | ||
2017 |
1,016 | |||
2018 |
729 | |||
2019 |
620 | |||
2020 |
14 | |||
|
|
|||
Total minimum non-cancellable lease payments |
$ | 3,490 | ||
|
|
|
The fair value of the 2010 Warrants was based on option valuation model and using the following assumptions at December 31, 2015 and 2014:
December 31, 2015 |
December 31, 2014 |
|||
2010 Warrants: |
||||
Expected term (in years) |
— | 0.86 | ||
Estimated volatility |
— | 55% | ||
Risk-free interest rate |
— | 0.25% | ||
Expected dividend yield |
— | — |
|
Activity under the Company’s equity incentive plans related to stock options is set forth below (in thousands except weighted average exercise price):
Number of Options Outstanding |
Weighted Average Exercise Price per Share |
|||||||
Balances at December 31, 2014 |
11,323 | $ | 4.13 | |||||
Granted |
3,730 | 4.58 | ||||||
Forfeited |
(225 | ) | 5.12 | |||||
Expired |
(223 | ) | 8.55 | |||||
Exercised |
(486 | ) | 2.74 | |||||
|
|
|||||||
Balances at December 31, 2015 |
14,119 | 4.21 | ||||||
|
|
Information regarding the Company’s stock options outstanding, stock options vested and expected to vest, and stock options exercisable at December 31, 2015, was as follows (in thousands except weighted average exercise price and contractual term):
Number of Shares |
Weighted Average Exercise Price |
Weighted Average Remaining Contractual Term (Years) |
Aggregate Intrinsic Value |
|||||||||||||
Balances at December 31, 2015 |
||||||||||||||||
Stock options outstanding |
14,119 | $ | 4.21 | 6.9 | $ | 30,746 | ||||||||||
Stock options vested and expected to vest |
13,606 | 4.19 | 6.8 | 29,973 | ||||||||||||
Stock options exercisable |
8,693 | 3.81 | 5.7 | 22,754 |
Stock-based compensation expense recognized on the Company’s consolidated statements of operations for the years ended December 31, 2015, 2014 and 2013, was as follows (in thousands):
Year Ended December 31, | ||||||||||||
2015 | 2014 | 2013 | ||||||||||
Stock-based compensation expense by caption: |
||||||||||||
Research and development |
$ | 1,260 | $ | 998 | $ | 482 | ||||||
Selling, general and administrative |
5,470 | 4,155 | 2,786 | |||||||||
|
|
|
|
|
|
|||||||
Total stock-based compensation expense |
$ | 6,730 | $ | 5,153 | $ | 3,268 | ||||||
|
|
|
|
|
|
The weighted average assumptions used to value the Company’s stock-based awards for the years ended December 31, 2015, 2014 and 2013, was as follows:
Year Ended December 31, | ||||||||||||
2015 | 2014 | 2013 | ||||||||||
Stock Options: |
||||||||||||
Expected term (in years) |
5.66 | 5.71 | 5.59 | |||||||||
Estimated volatility |
56 | % | 61 | % | 60 | % | ||||||
Risk-free interest rate |
1.55 | % | 1.73 | % | 0.87 | % | ||||||
Expected dividend yield |
0 | % | 0 | % | 0 | % | ||||||
Employee Stock Purchase Plan Rights: |
||||||||||||
Expected term (in years) |
0.75 | 0.76 | 0.50 | |||||||||
Estimated volatility |
53 | % | 52 | % | 39 | % | ||||||
Risk-free interest rate |
0.28 | % | 0.10 | % | 0.10 | % | ||||||
Expected dividend yield |
0 | % | 0 | % | 0 | % |
|
U.S and foreign components of consolidated loss before income taxes for the years ended December 2015, 2014 and 2013, was as follows (in thousands):
Year Ended December 31, | ||||||||||||
2015 | 2014 | 2013 | ||||||||||
Loss before income taxes: |
||||||||||||
U.S. |
$ | (59,897 | ) | $ | (38,928 | ) | $ | (44,035 | ) | |||
Foreign |
358 | 368 | 916 | |||||||||
|
|
|
|
|
|
|||||||
Loss before income taxes |
$ | (59,539 | ) | $ | (38,560 | ) | $ | (43,119 | ) | |||
|
|
|
|
|
|
The provision for income taxes for the years ended December 2015, 2014 and 2013, was as follows (in thousands):
Year Ended December 31, | ||||||||||||
2015 | 2014 | 2013 | ||||||||||
Provision for income taxes: |
||||||||||||
Current: |
||||||||||||
Foreign |
$ | 147 | $ | 168 | $ | 191 | ||||||
Federal |
— | — | — | |||||||||
State |
— | 1 | — | |||||||||
|
|
|
|
|
|
|||||||
Total Current |
147 | 169 | 191 | |||||||||
Deferred: |
||||||||||||
Foreign |
— | — | — | |||||||||
Federal |
(3,750 | ) | 22 | 21 | ||||||||
State |
(68 | ) | 4 | 6 | ||||||||
|
|
|
|
|
|
|||||||
Total Deferred |
(3,818 | ) | 26 | 27 | ||||||||
|
|
|
|
|
|
|||||||
(Benefit) provision for income taxes |
$ | (3,671 | ) | $ | 195 | $ | 218 | |||||
|
|
|
|
|
|
The difference between the provision for income taxes and the amount computed by applying the federal statutory income tax rate to loss before taxes for the years ended December 31, 2015, 2014 and 2013, was as follows (in thousands):
Year Ended December 31, | ||||||||||||
2015 | 2014 | 2013 | ||||||||||
Federal statutory tax |
$ | (20,243 | ) | $ | (13,110 | ) | $ | (14,661 | ) | |||
Warrants |
(3,565 | ) | (3,367 | ) | 4,926 | |||||||
Expiration of federal loss carryovers |
3,337 | — | — | |||||||||
Change in valuation allowance |
11,754 | 16,576 | 9,955 | |||||||||
Change in state apportionment |
4,085 | — | — | |||||||||
Other |
961 | 96 | (2 | ) | ||||||||
|
|
|
|
|
|
|||||||
(Benefit) provision for income taxes |
$ | (3,671 | ) | $ | 195 | $ | 218 | |||||
|
|
|
|
|
|
The significant components of the Company’s deferred tax assets and liabilities at December 31, 2015 and 2014, were as follows (in thousands):
December 31, | ||||||||
2015 | 2014 | |||||||
Deferred tax assets: |
||||||||
Net operating loss carryforwards |
$ | 165,813 | $ | 151,100 | ||||
Research and development credit carryforwards |
35,131 | 33,800 | ||||||
Capitalized research and development |
17,916 | 15,500 | ||||||
Deferred compensation |
5,908 | 5,800 | ||||||
Capital loss carryforwards |
— | 3,700 | ||||||
Other |
3,911 | 3,200 | ||||||
|
|
|
|
|||||
Total deferred tax assets |
228,679 | 213,100 | ||||||
Valuation allowance |
(224,854 | ) | (213,100 | ) | ||||
|
|
|
|
|||||
Net deferred tax assets |
3,825 | — | ||||||
|
|
|
|
|||||
Deferred tax liabilities: |
||||||||
Unrealized gain on investments |
3,825 | — | ||||||
Amortization of goodwill |
122 | 115 | ||||||
|
|
|
|
|||||
Total deferred tax liabilities |
$ | 3,947 | $ | 115 | ||||
|
|
|
|
|
The Company had the following significant customers that accounted for more than 10% of the Company’s total product revenue, all of which operate in a country outside of the U.S., during the years ended December 31, 2015, 2014 and 2013 (in percentages):
Year Ended December 31, | ||||||||||||
2015 | 2014 | 2013 | ||||||||||
Etablissement Francais du Sang |
23 | % | 25 | % | 17 | % | ||||||
Grifols |
* | * | 18 | % |
* | Represents an amount less than 10% of product revenue. |
Revenues by geographical location was based on the location of the customer during the years ended December 31, 2015, 2014 and 2013, and was as follows (in thousands):
Year Ended December 31, | ||||||||||||
2015 | 2014 | 2013 | ||||||||||
Revenue: |
||||||||||||
France |
$ | 7,732 | $ | 9,184 | $ | 7,030 | ||||||
Spain and Portugal |
4,070 | 2,776 | 7,033 | |||||||||
CIS |
3,361 | 6,636 | 8,220 | |||||||||
Belgium |
5,728 | 4,456 | 3,971 | |||||||||
Switzerland |
2,938 | 3,784 | 4,078 | |||||||||
Other countries |
10,394 | 9,580 | 9,325 | |||||||||
|
|
|
|
|
|
|||||||
Total revenue |
$ | 34,223 | $ | 36,416 | $ | 39,657 | ||||||
|
|
|
|
|
|
Long-lived assets by geographical location, which consist of property and equipment, net and intangible assets, net, at December 31, 2015 and 2014, were as follows (in thousands):
December 31, | ||||||||
2015 | 2014 | |||||||
U.S. |
$ | 4,260 | $ | 4,624 | ||||
Europe & other |
229 | 299 | ||||||
|
|
|
|
|||||
Total long-lived assets |
$ | 4,489 | $ | 4,923 | ||||
|
|
|
|
|
The following tables summarize the Company’s quarterly financial information for the years ended December 31, 2015 and 2014 (in thousands except per share amounts):
Three Months Ended | ||||||||||||||||
March 31, 2015 |
June 30, 2015 |
September 30, 2015 |
December 31, 2015 |
|||||||||||||
Revenue |
$ | 7,692 | $ | 8,830 | $ | 8,045 | $ | 9,656 | ||||||||
Gross profit |
2,978 | 1,802 | 2,485 | 3,494 | ||||||||||||
Net loss |
$ | (9,460 | ) | $ | (15,972 | ) | $ | (15,680 | ) | $ | (14,756 | ) | ||||
Net loss per share: |
||||||||||||||||
Basic |
$ | (0.10 | ) | $ | (0.17 | ) | $ | (0.16 | ) | $ | (0.15 | ) | ||||
Diluted |
$ | (0.17 | ) | $ | (0.17 | ) | $ | (0.17 | ) | $ | (0.15 | ) |
Three Months Ended | ||||||||||||||||
March 31, 2014 |
June 30, 2014 |
September 30, 2014 |
December 31, 2014 |
|||||||||||||
Product revenue |
$ | 7,866 | $ | 8,601 | $ | 10,362 | $ | 9,587 | ||||||||
Gross profit |
3,709 | 3,849 | 4,673 | 2,997 | ||||||||||||
Net loss |
$ | (225 | ) | $ | (7,589 | ) | $ | (10,759 | ) | $ | (20,182 | ) | ||||
Net loss per share: |
||||||||||||||||
Basic |
$ | (0.00 | ) | $ | (0.10 | ) | $ | (0.14 | ) | $ | (0.26 | ) | ||||
Diluted |
$ | (0.12 | ) | $ | (0.16 | ) | $ | (0.16 | ) | $ | (0.26 | ) |
|
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