Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2016 | Apr. 28, 2016 | |
Document Information [Line Items] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2016 | |
Document Fiscal Year Focus | 2,016 | |
Document Fiscal Period Focus | Q1 | |
Trading Symbol | CERS | |
Entity Registrant Name | CERUS CORP | |
Entity Central Index Key | 1,020,214 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 101,710,815 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Mar. 31, 2016 | Dec. 31, 2015 |
Current assets: | ||
Cash and cash equivalents | $ 20,791 | $ 71,018 |
Short-term investments | 70,513 | 25,698 |
Investment in marketable equity securities | 5,082 | 11,163 |
Accounts receivable | 4,086 | 5,794 |
Inventories | 11,255 | 10,812 |
Prepaid expenses | 1,377 | 1,166 |
Other current assets | 6,333 | 4,755 |
Total current assets | 119,437 | 130,406 |
Non-current assets: | ||
Property and equipment, net | 3,380 | 3,549 |
Goodwill | 1,316 | 1,316 |
Intangible assets, net | 890 | 940 |
Restricted cash | 574 | 612 |
Other assets | 2,341 | 2,579 |
Total assets | 127,938 | 139,402 |
Current liabilities: | ||
Accounts payable | 6,238 | 5,217 |
Accrued liabilities | 9,221 | 9,853 |
Manufacturing and development obligations-current | 2,219 | 3,282 |
Debt-current | 4,527 | 2,956 |
Deferred revenue-current | 613 | 554 |
Total current liabilities | 22,818 | 21,862 |
Non-current liabilities: | ||
Debt-non-current | 15,301 | 16,848 |
Deferred income taxes | 131 | 122 |
Manufacturing and development obligations-non-current | 4,840 | 4,542 |
Other non-current liabilities | 1,314 | 1,263 |
Total liabilities | $ 44,404 | $ 44,637 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Common stock | $ 101 | $ 99 |
Additional paid-in capital | 694,741 | 685,189 |
Accumulated other comprehensive income | 3,367 | 7,289 |
Accumulated deficit | (614,675) | (597,812) |
Total stockholders' equity | 83,534 | 94,765 |
Total liabilities and stockholders' equity | $ 127,938 | $ 139,402 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Revenue | $ 7,632 | $ 7,692 |
Cost of revenue | 4,263 | 4,714 |
Gross profit | 3,369 | 2,978 |
Operating expenses: | ||
Research and development | 6,917 | 5,581 |
Selling, general and administrative | 11,747 | 11,718 |
Amortization of intangible assets | 50 | 50 |
Total operating expenses | 18,714 | 17,349 |
Loss from operations | (15,345) | (14,371) |
Non-operating (expense) income, net: | ||
Gain from revaluation of warrant liability | 6,296 | |
Foreign exchange loss | (117) | (1,113) |
Interest expense | (655) | (255) |
Other income, net | 66 | 2 |
Total non-operating (expense) income, net | (706) | 4,930 |
Loss before income taxes | (16,051) | (9,441) |
Provision for income taxes | 812 | 19 |
Net loss | $ (16,863) | $ (9,460) |
Net loss per share: | ||
Basic | $ (0.17) | $ (0.10) |
Diluted | $ (0.17) | $ (0.17) |
Weighted average shares outstanding used for calculating net loss per share: | ||
Basic | 99,471 | 93,411 |
Diluted | 99,471 | 94,662 |
CONDENSED CONSOLIDATED STATEME4
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Net loss | $ (16,863) | $ (9,460) |
Other comprehensive (loss) income: | ||
Unrealized (losses) gains on available-for-sale investments, net of taxes of ($2,058) and zero for the three months ended March 31, 2016 and 2015, respectively | (3,922) | 19 |
Comprehensive loss | $ (20,785) | $ (9,441) |
CONDENSED CONSOLIDATED STATEME5
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Unrealized (losses) gains on available-for-sale investments, taxes | $ (2,058) | $ 0 |
CONDENSED CONSOLIDATED STATEME6
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Operating activities | ||
Net loss | $ (16,863) | $ (9,460) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 476 | 443 |
Stock-based compensation | 1,776 | 1,474 |
Changes in valuation of warrant liability | (6,296) | |
Non-cash interest expense | 300 | 64 |
Deferred income taxes | 9 | 1 |
Non-cash tax expense from other unrealized loss on available-for-sale securities | 768 | |
Changes in operating assets and liabilities: | ||
Accounts receivable | 1,708 | 340 |
Inventories | (488) | (1,220) |
Other assets | (213) | (116) |
Accounts payable | 995 | 484 |
Accrued liabilities | (639) | (1,488) |
Manufacturing and development obligations | (924) | |
Deferred revenue | 52 | 23 |
Net cash used in operating activities | (13,043) | (15,751) |
Investing activities | ||
Capital expenditures | (43) | (59) |
Purchases of investments | (50,544) | (69,982) |
Proceeds from maturities of investments | 5,500 | 4,400 |
Restricted cash | 38 | 47 |
Net cash used in investing activities | (45,049) | (65,594) |
Financing activities | ||
Net proceeds from the issuance of common stock in connection with equity incentive plans | 698 | 999 |
Net proceeds from public offering | 7,199 | 75,527 |
Repayment of debt | (32) | (28) |
Net cash provided by financing activities | 7,865 | 76,498 |
Net decrease in cash and cash equivalents | (50,227) | (4,847) |
Cash and cash equivalents, beginning of year | 71,018 | 22,781 |
Cash and cash equivalents, end of year | $ 20,791 | $ 17,934 |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2016 | |
Summary of Significant Accounting Policies | Note 1. Summary of Significant Accounting Policies Principles of Consolidation and Basis of Presentation The accompanying unaudited condensed consolidated financial statements include those of Cerus Corporation and its subsidiary, Cerus Europe B.V. (together with Cerus Corporation, hereinafter “Cerus” or the “Company”) after elimination of all intercompany accounts and transactions. These unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”). Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, all adjustments, consisting of normal recurring entries, considered necessary for a fair presentation have been made. Operating results for the three months ended March 31, 2016, are not necessarily indicative of the results that may be expected for the year ending December 31, 2016, or for any future periods. These unaudited condensed consolidated financial statements and notes thereto should be read in conjunction with the Company’s audited consolidated financial statements and notes thereto for the year ended December 31, 2015, which were included in the Company’s 2015 Annual Report on Form 10-K, filed with the SEC on March 9, 2016. The accompanying condensed consolidated balance sheet as of December 31, 2015, has been derived from the Company’s audited consolidated financial statements as of that date, except as described in the New Accounting Pronouncement section below related to the adoption of Accounting Standards Update (“ASU”) No. 2015-03, Interest—Imputation of Interest (Subtopic 835-30): Simplifying the Presentation of Debt Issuance Costs 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,” 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 products 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. 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,” The Company’s use of estimates in recording accrued liabilities for R&D activities (see “Use of Estimates” above) affects the amounts of R&D 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”), and are designated as available-for-sale and classified as short-term investments or investment in marketable equity securities, in accordance with ASC Topic 320, “ Accounting for Certain Investments in Debt and Equity Securities The Company also reviews its available-for-sale 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 unaudited condensed consolidated statements of operations. Restricted Cash The Company holds a certificate of deposit with a domestic bank for any potential decommissioning resulting from the Company’s possession of radioactive material. The certificate of deposit is held to satisfy the financial surety requirements of the California Department of Health Services and is recorded in “Other assets” on the Company’s unaudited 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, available-for-sale securities and accounts receivable. Pursuant to the Company’s investment policy, substantially all of the Company’s cash, cash equivalents and available-for-sale securities are maintained at major financial institutions 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 March 31, 2016, the fair value of the Company’s marketable equity securities of Aduro is subject to the underlying volatility of Aduro’s stock price. At March 31, 2016, the Company does not believe there is significant financial risk from non-performance by the issuers of the Company’s cash equivalents and short-term investments. Concentrations of credit risk with respect to trade receivables exist. 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 unaudited condensed consolidated balance sheets and records a charge on its unaudited condensed consolidated statements of operations as a component of selling, general and administrative expenses. The Company had two customers and three customers that accounted for more than 10% of the Company’s outstanding trade receivables at March 31, 2016 and December 31, 2015, respectively. These customers cumulatively represented approximately 48% and 49% of the Company’s outstanding trade receivables at March 31, 2016 and December 31, 2015, respectively. To date, the Company has not experienced collection difficulties from these customers. Inventories At March 31, 2016 and December 31, 2015, inventory consisted of work-in-process and finished goods only. Finished goods include INTERCEPT disposable kits, 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 March 31, 2016 and December 31, 2015, 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 March 31, 2016 and December 31, 2015, the Company had $1.6 million and $1.8 million, respectively, recorded for potential obsolete, expiring or unsalable product. Property and Equipment, net Property and equipment is comprised of furniture, equipment, leasehold improvements, 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. 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,” 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 three months ended March 31, 2016 and 2015. 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. For stock-based awards issued to non-employees, the Company follows ASC Topic 505-50, Equity Based Payment to Non-Employees See Note 11 in the Notes to Unaudited Condensed Consolidated Financial Statements for further information regarding the Company’s stock-based compensation expenses. Income Taxes The Company accounts for income taxes using an asset and liability approach in accordance with ASC Topic 740, Accounting for Income Taxes 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 three months ended March 31, 2016 and 2015, as their inclusion would have been anti-dilutive. The following table sets forth the reconciliation of the numerator and denominator used in the computation of basic and diluted net loss per share for the three months ended March 31, 2016 and 2015 (in thousands, except per share amounts): Three Months Ended 2016 2015 Numerator for Basic and Diluted: Net loss used for basic calculation $ (16,863 ) $ (9,460 ) Effect of revaluation of warrant liability — (6,296 ) Adjusted net loss used for diluted calculation $ (16,863 ) $ (15,756 ) Denominator: Basic weighted average number of shares outstanding 99,471 93,411 Effect of dilutive potential shares — 1,251 Diluted weighted average number of shares outstanding 99,471 94,662 Net loss per share: Basic $ (0.17 ) $ (0.10 ) Diluted $ (0.17 ) $ (0.17 ) The table below presents shares underlying stock options, employee stock purchase plan rights, 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 are excluded from the calculation due to their anti-dilutive effect for the three months ended March 31, 2016 and 2015 (shares in thousands): Three Months Ended 2016 2015 Weighted average number of anti-dilutive potential shares—outstanding options 14,986 13,439 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 March 31, 2016 and December 31, 2015. 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 prior to the expiration and exercise of the warrants in November 2015. 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 corporate debt and U.S. government agency securities holdings. 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. The Company assesses any transfers among fair value measurement levels at the end of each reporting period. See Notes 2 in the Notes to Unaudited Condensed Consolidated Financial Statements for further information regarding the Company’s valuation of financial instruments. New Accounting Pronouncements In May 2014, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606), Revenue from Contracts with Customers (Topic 606), Deferral of the Effective Date Revenue from Contracts with Customers (Topic 606): Principal versus Agent Considerations (Reporting Revenue Gross versus Net) Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing In August 2014, the FASB issued ASU No. 2014-15, Presentation of Financial Statements—Going Concern In April 2015, the FASB issued ASU No. 2015-03, Interest—Imputation of Interest (Subtopic 835-30): Simplifying the Presentation of Debt Issuance Costs In January 2016, the FASB issued ASU No. 2016-01, Financial Instruments-Overall (Subtopic 825-10), In February 2016, the FASB issued ASU No. 2016-02, Leases, In March 2016, the FASB issued ASU No. 2016-09, Compensation-Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting, |
Fair Value on Financial Instrum
Fair Value on Financial Instruments | 3 Months Ended |
Mar. 31, 2016 | |
Fair Value on Financial Instruments | Note 2. 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: • Level 1: Quoted prices in active markets for identical instruments • Level 2: Other significant observable inputs (including quoted prices in active markets for similar instruments) • Level 3: Significant unobservable inputs (including assumptions in determining the fair value of certain investments) Money market funds are highly liquid investments and are actively traded. The pricing information on these investment instruments are readily available and can be independently validated as of the measurement date. This approach results in the classification of these securities as Level 1 of the fair value hierarchy. To estimate the fair value of Level 2 debt securities as of March 31, 2016, 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 March 31, 2016 (in thousands): Balance sheet classification Total Quoted Significant Significant Money market funds Cash and cash equivalents $ 6,648 $ 6,648 $ — $ — United States government agency securities Short-term investments 9,997 — 9,997 — Corporate debt securities Short-term investments 60,516 — 60,516 — Marketable equity securities Marketable equity securities 5,082 5,082 — — Total financial assets $ 82,243 $ 11,730 $ 70,513 $ — 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 Significant Significant (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 Company did not have any transfers among fair value measurement levels during the three months ended March 31, 2016 or the year ended December 31, 2015. The Company did not have any financial assets or liabilities classified as level 3 financial instruments at March 31, 2016 and December 31, 2015. |
Available-for-sale Securities
Available-for-sale Securities | 3 Months Ended |
Mar. 31, 2016 | |
Available-for-sale Securities | Note 3. Available-for-sale Securities The following is a summary of available-for-sale securities at March 31, 2016 (in thousands): March 31, 2016 Amortized Cost Gross Unrealized Gain Gross Unrealized Loss Fair Value Money market funds $ 6,648 $ — $ — $ 6,648 United States government agency securities 9,996 1 — 9,997 Corporate debt securities 60,465 72 (21 ) 60,516 Marketable equity securities — 5,082 — 5,082 Total available-for-sale securities $ 77,109 $ 5,155 $ (21 ) $ 82,243 The following is a summary of available-for-sale securities at December 31, 2015 (in thousands): December 31, 2015 Amortized Cost Gross Unrealized Gain Gross Unrealized 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 $ 11,163 $ (49 ) $ 96,163 Available-for-sale securities at March 31, 2016 and December 31, 2015, consisted of the following by contractual maturity (in thousands): March 31, 2016 December 31, 2015 Amortized Cost Fair Value Amortized Cost Fair Value One year or less $ 56,934 $ 56,934 $ 85,049 $ 85,000 Marketable equity securities — 5,082 — 11,163 Greater than one year and less than five years 20,175 20,227 — — Total available-for-sale securities $ 77,109 $ 82,243 $ 85,049 $ 96,163 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): March 31, 2016 Less than 12 Months 12 Months or Greater Total Fair Value Unrealized Loss Fair Value Unrealized Loss Fair Value Unrealized Loss Corporate debt securities $ 18,137 $ (21 ) $ — $ — $ 18,137 $ (21 ) Total available-for-sale securities $ 18,137 $ (21 ) $ — $ — $ 18,137 $ (21 ) December 31, 2015 Less than 12 Months 12 Months or Greater Total Fair Value Unrealized Loss Fair Value Unrealized Loss Fair Value Unrealized Loss Corporate debt securities $ 20,170 $ (46 ) $ 5,528 $ (3 ) $ 25,698 $ (49 ) Total available-for-sale securities $ 20,170 $ (46 ) $ 5,528 $ (3 ) $ 25,698 $ (49 ) As of March 31, 2016, 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 three months ended March 31, 2016 and 2015, 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 did not record any gross realized gains from the sale or maturity of available-for-sale investments during the three months ended March 31, 2016 and 2015. The Company did not record any gross realized losses from the sale or maturity of available-for-sale investments during the three months ended March 31, 2016 and 2015. |
Inventories
Inventories | 3 Months Ended |
Mar. 31, 2016 | |
Inventories | Note 4. Inventories Inventories at March 31, 2016 and December 31, 2015, consisted of the following (in thousands): March 31, December 31, Work-in-process $ 2,966 $ 3,187 Finished goods 8,289 7,625 Total inventories $ 11,255 $ 10,812 |
Goodwill and Intangible Assets,
Goodwill and Intangible Assets, net | 3 Months Ended |
Mar. 31, 2016 | |
Goodwill and Intangible Assets, net | Note 5. Goodwill and Intangible Assets, net Goodwill During the three months ended March 31, 2016, the Company did not dispose of or recognize additional goodwill. The Company expects to perform its annual review of goodwill on August 31, 2016, unless indicators of impairment are identified prior to that date. As of March 31, 2016, the Company has not identified any indicators of goodwill impairment. Intangible Assets, net The following is a summary of intangible assets, net at March 31, 2016 (in thousands): March 31, 2016 Gross Carrying Accumulated Net Carrying Acquisition-related intangible assets: Reacquired license—INTERCEPT Asia $ 2,017 $ (1,127 ) $ 890 Total intangible assets $ 2,017 $ (1,127 ) $ 890 The following is a summary of intangible assets, net at December 31, 2015 (in thousands): December 31, 2015 Gross Carrying Accumulated Net Carrying Acquisition-related intangible assets: Reacquired license—INTERCEPT Asia $ 2,017 $ (1,077 ) $ 940 Total intangible assets $ 2,017 $ (1,077 ) $ 940 The Company recognized $0.05 million in amortization expense related to intangible assets for each of the three months ended March 31, 2016 and 2015. During the three months ended March 31, 2016 and 2015, there were no impairment charges recognized related to the acquired intangible assets. At March 31, 2016, the expected annual amortization expense of the intangible assets, net is $0.15 million for the remaining nine months of 2016, $0.2 million annually beginning with the year ending December 31, 2017 through the year ending December 31, 2019, and $0.1 million for the year ending December 31, 2020. |
Marketable Equity Investments
Marketable Equity Investments | 3 Months Ended |
Mar. 31, 2016 | |
Marketable Equity Investments | Note 6. Marketable Equity Investments The Company held an investment in preferred shares of Aduro which it had historically accounted for 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 unaudited condensed consolidated balance sheet (Note 2) 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. |
Accrued Liabilities
Accrued Liabilities | 3 Months Ended |
Mar. 31, 2016 | |
Accrued Liabilities | Note 7. Accrued Liabilities Accrued liabilities at March 31, 2016 and December 31, 2015, consisted of the following (in thousands): March 31, December 31, Accrued compensation and related costs $ 4,664 $ 5,198 Accrued professional services 2,808 2,337 Accrued customer costs 923 987 Accrued insurance premiums 220 438 Other accrued expenses 606 893 Total accrued liabilities $ 9,221 $ 9,853 |
Debt
Debt | 3 Months Ended |
Mar. 31, 2016 | |
Debt | Note 8. Debt Debt consisted of the following (in thousands): March 31, 2016 Principal Unamortized Total Loan and Security Agreement $ 20,000 $ (172 ) $ 19,828 Less: debt—current (4,615 ) 88 (4,527 ) Debt—non-current $ 15,385 $ (84 ) $ 15,301 December 31, 2015 Principal Unamortized Net Carrying Loan and Security Agreement $ 20,000 $ (196 ) $ 19,804 Less: debt—current (3,050 ) 94 (2,956 ) Debt—non-current $ 16,950 $ (102 ) $ 16,848 Principal and interest payments on debt at March 31, 2016, are expected to be as follows * (in thousands): Year ended December 31, Principal Interest Total 2016 $ 3,050 $ 1,003 $ 4,053 2017 6,428 980 7,408 2018 6,892 517 7,409 2019 3,630 1,474 5,104 Total $ 20,000 $ 3,974 $ 23,974 * 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 amendment to the Term Loan Agreement 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. 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 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 March 31, 2016. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2016 | |
Commitments and Contingencies | Note 9. Commitments and Contingencies Operating Leases The Company leases its office facilities, located in Concord, California and Amersfoort, the Netherlands, and certain equipment under non-cancelable operating leases with initial terms in excess of one year that require the Company to pay operating costs, property taxes, insurance and maintenance. The operating leases expire at various dates through 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” 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 March 31, 2016, 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 suppliers for certain components of the INTERCEPT Blood System. Certain of these agreements require minimum purchase commitments from the Company. |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2016 | |
Stockholders' Equity | Note 10. Stockholders’ Equity Sales Agreement On March 21, 2014, the Company entered into Amendment No. 1 to the Controlled Equity Offering SM |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2016 | |
Stock-Based Compensation | Note 11. Stock-Based Compensation 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 March 31, 2016, the Company had 1,551,390 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 Amended 2008 Plan (collectively the “Amended 2008 Plan”) such that the Amended 2008 Plan had 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. Options granted by the Company to employees generally vest over four years. Restricted stock units (RSUs) are measured based on the fair market value of the underlying stock on the date of grant and will generally vest over three 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 March 31, 2016, no performance-based stock options were outstanding. At March 31, 2016, the Company had an aggregate of approximately 21.0 million shares of its common stock subject to outstanding options or RSUs, or remaining available for future issuance under the Amended 2008 Plan, of which approximately 16.0 million shares and 0.6 million shares were subject to outstanding options and outstanding RSUs, respectively, and approximately 4.4 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 or vesting of RSUs. Activity under the Company’s equity incentive plans related to stock options is set forth below (in thousands except per share amounts): Number of Weighted Balances at December 31, 2015 14,119 $ 4.21 Granted 2,075 5.08 Forfeited (37 ) 5.16 Expired (89 ) 9.97 Exercised (127 ) 2.33 Balances at March 31, 2016 15,941 4.31 Activity under the Company’s equity incentive plans related to RSUs is set forth below (in thousands except per share amounts): Number of Weighted Balances at December 31, 2015 — $ — Granted 634 5.06 Forfeited (1 ) 5.06 Vested — — Balances at March 31, 2016 633 5.06 The Company uses the Black-Scholes option pricing model to determine the grant-date fair value of stock options and employee stock purchase plan rights. 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. |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2016 | |
Income Taxes | Note 12. Income Taxes Intraperiod tax allocation rules require the Company to allocate the provision for income taxes between continuing operations and other categories of earnings, such as other comprehensive income. In periods in which the Company has a year-to-date pre-tax loss from continuing operations and pre-tax items in other categories of earnings, such as other comprehensive income, the Company must allocate the tax provision to the other categories of earnings. The Company then records a related tax effect in continuing operations. During the three months ended March 31, 2016, the Company recorded unrealized losses of $3.9 million, net of taxes, on its investments in available-for-sale securities in other comprehensive income. As a result, the Company recorded tax expense of $0.8 million for the three months ended March 31, 2016. |
Development and License Agreeme
Development and License Agreements | 3 Months Ended |
Mar. 31, 2016 | |
Development and License Agreements | Note 13. Development and License Agreements Agreements with Fresenius Through December 31, 2013, Fresenius manufactured and supplied the platelet and plasma systems to the Company under a supply agreement (the “Original Supply Agreement”) entered into by the parties. The Company also had an agreement with Fresenius that required the Company to pay royalties on INTERCEPT Blood System product sales at royalty rates that varied by product. 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 red blood cell system product candidate (the “RBC Sets”). 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 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 March 31, 2016, the Company had paid $1.2 million (€1.1 million) and accrued $7.0 million (€6.2 million) related to the Manufacturing and Development Payments, of which $2.2 million (€1.9 million) was included in “Manufacturing and development obligations—current”, and $4.8 million (€4.3 million) was included in “Manufacturing and development obligations—non-current” on the Company’s Consolidated Balance Sheets. 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 R&D activities and manufacturing efficiency activities. The Company allocated $4.8 million to R&D activities and $2.4 million to manufacturing efficiency activities based on their market value in October 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 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 March 31, 2016 and 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 $3.7 million and $4.1 million, respectively. As of March 31, 2016 and December 31, 2015, the manufacturing efficiency asset was included in “Other assets” on the Company’s Consolidated Balance Sheets at $2.3 million and $2.4 million, respectively. 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 the 2015 Agreement, the Company has the right, but not the obligation, to purchase certain assets and assume certain liabilities from Fresenius. The Company made payments to Fresenius of $3.6 million and $4.7 million relating to the manufacturing of the Company products during the three months ended March 31, 2016 and 2015, respectively. At March 31, 2016 and December 31, 2015, the Company owed Fresenius $3.2 million and $2.5 million, respectively, for platelet and plasma system disposable kits manufactured. At March 31, 2016 and December 31, 2015, amounts due from Fresenius were $0.9 million and $0.2 million, respectively. |
Segment, Customer and Geographi
Segment, Customer and Geographic Information | 3 Months Ended |
Mar. 31, 2016 | |
Segment, Customer and Geographic Information | Note 14. 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 R&D 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, and in the case of non-product revenues, on the location of the collaboration partner. The Company had the following significant customers that accounted for more than 10% of the Company’s total revenue, each of which operates in a country outside of the United States of America, during the three months ended March 31, 2016 and 2015 (in percentages): Three Months Ended March 31 2016 2015 Advanced Technology Comp. KSC 18 % * Etablissement Francais du Sang * 26 % Medical Device ApS 11 % * Rode Kruis Vlaanderen 12 % * * Represents an amount less than 10% of product revenue. |
Subsequent Event
Subsequent Event | 3 Months Ended |
Mar. 31, 2016 | |
Subsequent Event | Note 15. Subsequent Event Sales Agreement On May 5, 2016, the Company entered into Amendment No. 2 (“Amendment No. 2”) to the Controlled Equity Offering SM |
Summary of Significant Accoun22
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2016 | |
Principles of Consolidation and Basis of Presentation | Principles of Consolidation and Basis of Presentation The accompanying unaudited condensed consolidated financial statements include those of Cerus Corporation and its subsidiary, Cerus Europe B.V. (together with Cerus Corporation, hereinafter “Cerus” or the “Company”) after elimination of all intercompany accounts and transactions. These unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”). Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, all adjustments, consisting of normal recurring entries, considered necessary for a fair presentation have been made. Operating results for the three months ended March 31, 2016, are not necessarily indicative of the results that may be expected for the year ending December 31, 2016, or for any future periods. These unaudited condensed consolidated financial statements and notes thereto should be read in conjunction with the Company’s audited consolidated financial statements and notes thereto for the year ended December 31, 2015, which were included in the Company’s 2015 Annual Report on Form 10-K, filed with the SEC on March 9, 2016. The accompanying condensed consolidated balance sheet as of December 31, 2015, has been derived from the Company’s audited consolidated financial statements as of that date, except as described in the New Accounting Pronouncement section below related to the adoption of Accounting Standards Update (“ASU”) No. 2015-03, Interest—Imputation of Interest (Subtopic 835-30): Simplifying the Presentation of Debt Issuance Costs |
Use of Estimates | 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 | Revenue The Company recognizes revenue in accordance with Accounting Standards Codification (“ASC”) Topic 605-25, “Revenue Recognition – Arrangements with Multiple Deliverables,” 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 products 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. 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 | Research and Development Expenses In accordance with ASC Topic 730, “Accounting for Research and Development Expenses,” The Company’s use of estimates in recording accrued liabilities for R&D activities (see “Use of Estimates” above) affects the amounts of R&D expenses recorded. Actual results may differ from those estimates under different assumptions or conditions. |
Cash Equivalents | 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 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”), and are designated as available-for-sale and classified as short-term investments or investment in marketable equity securities, in accordance with ASC Topic 320, “ Accounting for Certain Investments in Debt and Equity Securities The Company also reviews its available-for-sale 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 unaudited condensed consolidated statements of operations. |
Restricted Cash | 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 unaudited 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 | Concentration of Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash equivalents, available-for-sale securities and accounts receivable. Pursuant to the Company’s investment policy, substantially all of the Company’s cash, cash equivalents and available-for-sale securities are maintained at major financial institutions 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 March 31, 2016, the fair value of the Company’s marketable equity securities of Aduro is subject to the underlying volatility of Aduro’s stock price. At March 31, 2016, the Company does not believe there is significant financial risk from non-performance by the issuers of the Company’s cash equivalents and short-term investments. Concentrations of credit risk with respect to trade receivables exist. 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 unaudited condensed consolidated balance sheets and records a charge on its unaudited condensed consolidated statements of operations as a component of selling, general and administrative expenses. The Company had two customers and three customers that accounted for more than 10% of the Company’s outstanding trade receivables at March 31, 2016 and December 31, 2015, respectively. These customers cumulatively represented approximately 48% and 49% of the Company’s outstanding trade receivables at March 31, 2016 and December 31, 2015, respectively. To date, the Company has not experienced collection difficulties from these customers. |
Inventories | Inventories At March 31, 2016 and December 31, 2015, inventory consisted of work-in-process and finished goods only. Finished goods include INTERCEPT disposable kits, 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 March 31, 2016 and December 31, 2015, 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 March 31, 2016 and December 31, 2015, the Company had $1.6 million and $1.8 million, respectively, recorded for potential obsolete, expiring or unsalable product. |
Property and Equipment, net | Property and Equipment, net Property and equipment is comprised of furniture, equipment, leasehold improvements, 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 | 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. 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 | 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,” |
Long-lived Assets | 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 three months ended March 31, 2016 and 2015. |
Foreign Currency Remeasurement | 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 | Stock-Based Compensation The Company accounts for stock-based compensation in accordance with ASC Topic 718, Compensation—Stock Compensation. For stock-based awards issued to non-employees, the Company follows ASC Topic 505-50, Equity Based Payment to Non-Employees See Note 11 in the Notes to Unaudited Condensed Consolidated Financial Statements for further information regarding the Company’s stock-based compensation expenses. |
Income Taxes | Income Taxes The Company accounts for income taxes using an asset and liability approach in accordance with ASC Topic 740, Accounting for Income Taxes |
Net Loss Per Share | 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 three months ended March 31, 2016 and 2015, as their inclusion would have been anti-dilutive. The following table sets forth the reconciliation of the numerator and denominator used in the computation of basic and diluted net loss per share for the three months ended March 31, 2016 and 2015 (in thousands, except per share amounts): Three Months Ended 2016 2015 Numerator for Basic and Diluted: Net loss used for basic calculation $ (16,863 ) $ (9,460 ) Effect of revaluation of warrant liability — (6,296 ) Adjusted net loss used for diluted calculation $ (16,863 ) $ (15,756 ) Denominator: Basic weighted average number of shares outstanding 99,471 93,411 Effect of dilutive potential shares — 1,251 Diluted weighted average number of shares outstanding 99,471 94,662 Net loss per share: Basic $ (0.17 ) $ (0.10 ) Diluted $ (0.17 ) $ (0.17 ) The table below presents shares underlying stock options, employee stock purchase plan rights, 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 are excluded from the calculation due to their anti-dilutive effect for the three months ended March 31, 2016 and 2015 (shares in thousands): Three Months Ended 2016 2015 Weighted average number of anti-dilutive potential shares—outstanding options 14,986 13,439 |
Guarantee and Indemnification Arrangements | 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 March 31, 2016 and December 31, 2015. |
Fair Value of Financial Instruments | 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 prior to the expiration and exercise of the warrants in November 2015. 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 corporate debt and U.S. government agency securities holdings. 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. The Company assesses any transfers among fair value measurement levels at the end of each reporting period. See Notes 2 in the Notes to Unaudited Condensed Consolidated Financial Statements for further information regarding the Company’s valuation of financial instruments. |
New Accounting Pronouncements | New Accounting Pronouncements In May 2014, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606), Revenue from Contracts with Customers (Topic 606), Deferral of the Effective Date Revenue from Contracts with Customers (Topic 606): Principal versus Agent Considerations (Reporting Revenue Gross versus Net) Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing In August 2014, the FASB issued ASU No. 2014-15, Presentation of Financial Statements—Going Concern In April 2015, the FASB issued ASU No. 2015-03, Interest—Imputation of Interest (Subtopic 835-30): Simplifying the Presentation of Debt Issuance Costs In January 2016, the FASB issued ASU No. 2016-01, Financial Instruments-Overall (Subtopic 825-10), In February 2016, the FASB issued ASU No. 2016-02, Leases, In March 2016, the FASB issued ASU No. 2016-09, Compensation-Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting, |
Summary of Significant Accoun23
Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Computation of Basic and Diluted Net Loss per Share | The following table sets forth the reconciliation of the numerator and denominator used in the computation of basic and diluted net loss per share for the three months ended March 31, 2016 and 2015 (in thousands, except per share amounts): Three Months Ended 2016 2015 Numerator for Basic and Diluted: Net loss used for basic calculation $ (16,863 ) $ (9,460 ) Effect of revaluation of warrant liability — (6,296 ) Adjusted net loss used for diluted calculation $ (16,863 ) $ (15,756 ) Denominator: Basic weighted average number of shares outstanding 99,471 93,411 Effect of dilutive potential shares — 1,251 Diluted weighted average number of shares outstanding 99,471 94,662 Net loss per share: Basic $ (0.17 ) $ (0.10 ) Diluted $ (0.17 ) $ (0.17 ) |
Anti-Dilutive Effect of Common Shares | The table below presents shares underlying stock options, employee stock purchase plan rights, 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 are excluded from the calculation due to their anti-dilutive effect for the three months ended March 31, 2016 and 2015 (shares in thousands): Three Months Ended 2016 2015 Weighted average number of anti-dilutive potential shares—outstanding options 14,986 13,439 |
Fair Value on Financial Instr24
Fair Value on Financial Instruments (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Fair Values of Financial Assets and Liabilities | The fair values of the Company’s financial assets and liabilities were determined using the following inputs at March 31, 2016 (in thousands): Balance sheet classification Total Quoted Significant Significant Money market funds Cash and cash equivalents $ 6,648 $ 6,648 $ — $ — United States government agency securities Short-term investments 9,997 — 9,997 — Corporate debt securities Short-term investments 60,516 — 60,516 — Marketable equity securities Marketable equity securities 5,082 5,082 — — Total financial assets $ 82,243 $ 11,730 $ 70,513 $ — 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 Significant Significant (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 $ — |
Available-for-sale Securities (
Available-for-sale Securities (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Summary of Available for Sale Securities | The following is a summary of available-for-sale securities at March 31, 2016 (in thousands): March 31, 2016 Amortized Cost Gross Unrealized Gain Gross Unrealized Loss Fair Value Money market funds $ 6,648 $ — $ — $ 6,648 United States government agency securities 9,996 1 — 9,997 Corporate debt securities 60,465 72 (21 ) 60,516 Marketable equity securities — 5,082 — 5,082 Total available-for-sale securities $ 77,109 $ 5,155 $ (21 ) $ 82,243 The following is a summary of available-for-sale securities at December 31, 2015 (in thousands): December 31, 2015 Amortized Cost Gross Unrealized Gain Gross Unrealized 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 $ 11,163 $ (49 ) $ 96,163 |
Available for Sale Debt Securities by Original Contractual Maturity | Available-for-sale securities at March 31, 2016 and December 31, 2015, consisted of the following by contractual maturity (in thousands): March 31, 2016 December 31, 2015 Amortized Cost Fair Value Amortized Cost Fair Value One year or less $ 56,934 $ 56,934 $ 85,049 $ 85,000 Marketable equity securities — 5,082 — 11,163 Greater than one year and less than five years 20,175 20,227 — — Total available-for-sale securities $ 77,109 $ 82,243 $ 85,049 $ 96,163 |
Available for Sale Marketable Securities in Unrealized Position | 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): March 31, 2016 Less than 12 Months 12 Months or Greater Total Fair Value Unrealized Loss Fair Value Unrealized Loss Fair Value Unrealized Loss Corporate debt securities $ 18,137 $ (21 ) $ — $ — $ 18,137 $ (21 ) Total available-for-sale securities $ 18,137 $ (21 ) $ — $ — $ 18,137 $ (21 ) December 31, 2015 Less than 12 Months 12 Months or Greater Total Fair Value Unrealized Loss Fair Value Unrealized Loss Fair Value Unrealized Loss Corporate debt securities $ 20,170 $ (46 ) $ 5,528 $ (3 ) $ 25,698 $ (49 ) Total available-for-sale securities $ 20,170 $ (46 ) $ 5,528 $ (3 ) $ 25,698 $ (49 ) |
Inventories (Tables)
Inventories (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Inventories | Inventories at March 31, 2016 and December 31, 2015, consisted of the following (in thousands): March 31, December 31, Work-in-process $ 2,966 $ 3,187 Finished goods 8,289 7,625 Total inventories $ 11,255 $ 10,812 |
Goodwill and Intangible Asset27
Goodwill and Intangible Assets, net (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Summary of Intangible Assets | The following is a summary of intangible assets, net at March 31, 2016 (in thousands): March 31, 2016 Gross Carrying Accumulated Net Carrying Acquisition-related intangible assets: Reacquired license—INTERCEPT Asia $ 2,017 $ (1,127 ) $ 890 Total intangible assets $ 2,017 $ (1,127 ) $ 890 The following is a summary of intangible assets, net at December 31, 2015 (in thousands): December 31, 2015 Gross Carrying Accumulated Net Carrying Acquisition-related intangible assets: Reacquired license—INTERCEPT Asia $ 2,017 $ (1,077 ) $ 940 Total intangible assets $ 2,017 $ (1,077 ) $ 940 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Accrued Liabilities | Accrued liabilities at March 31, 2016 and December 31, 2015, consisted of the following (in thousands): March 31, December 31, Accrued compensation and related costs $ 4,664 $ 5,198 Accrued professional services 2,808 2,337 Accrued customer costs 923 987 Accrued insurance premiums 220 438 Other accrued expenses 606 893 Total accrued liabilities $ 9,221 $ 9,853 |
Debt (Tables)
Debt (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Debt | Debt consisted of the following (in thousands): March 31, 2016 Principal Unamortized Total Loan and Security Agreement $ 20,000 $ (172 ) $ 19,828 Less: debt—current (4,615 ) 88 (4,527 ) Debt—non-current $ 15,385 $ (84 ) $ 15,301 December 31, 2015 Principal Unamortized Net Carrying Loan and Security Agreement $ 20,000 $ (196 ) $ 19,804 Less: debt—current (3,050 ) 94 (2,956 ) Debt—non-current $ 16,950 $ (102 ) $ 16,848 |
Expected Principal and Interest Payments on Debt | Principal and interest payments on debt at March 31, 2016, are expected to be as follows * (in thousands): Year ended December 31, Principal Interest Total 2016 $ 3,050 $ 1,003 $ 4,053 2017 6,428 980 7,408 2018 6,892 517 7,409 2019 3,630 1,474 5,104 Total $ 20,000 $ 3,974 $ 23,974 * Unless interest only period extends to December 31, 2016, as described below. |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) - 2008 Equity Incentive Plan | 3 Months Ended |
Mar. 31, 2016 | |
Activity Under Equity Incentive Plans Related to Stock Options | Activity under the Company’s equity incentive plans related to stock options is set forth below (in thousands except per share amounts): Number of Weighted Balances at December 31, 2015 14,119 $ 4.21 Granted 2,075 5.08 Forfeited (37 ) 5.16 Expired (89 ) 9.97 Exercised (127 ) 2.33 Balances at March 31, 2016 15,941 4.31 |
Activity Under Equity Incentive Plans Related to RSUs | Activity under the Company’s equity incentive plans related to RSUs is set forth below (in thousands except per share amounts): Number of Weighted Balances at December 31, 2015 — $ — Granted 634 5.06 Forfeited (1 ) 5.06 Vested — — Balances at March 31, 2016 633 5.06 |
Segment, Customer and Geograp31
Segment, Customer and Geographic Information (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Customer that Accounted for More Than Ten Percent of Total Revenue | The Company had the following significant customers that accounted for more than 10% of the Company’s total revenue, each of which operates in a country outside of the United States of America, during the three months ended March 31, 2016 and 2015 (in percentages): Three Months Ended March 31 2016 2015 Advanced Technology Comp. KSC 18 % * Etablissement Francais du Sang * 26 % Medical Device ApS 11 % * Rode Kruis Vlaanderen 12 % * * Represents an amount less than 10% of product revenue. |
Summary of Significant Accoun32
Summary of Significant Accounting Policies - Additional Information (Detail) | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2016USD ($)CustomerSegment | Mar. 31, 2015USD ($) | Dec. 31, 2015USD ($)Customer | |
Summary Of Significant Accounting Policies [Line Items] | |||
Number of major customers representing outstanding trade receivables | Customer | 2 | 3 | |
Life of inventory | 2 years | ||
Protracted length of inventory | 1 year | ||
Inventory valuation reserves | $ 1,600,000 | $ 1,800,000 | |
Estimated useful life of intangible assets | 10 years | ||
Number of reportable segments | Segment | 1 | ||
Impairment charges on long-lived assets | $ 0 | $ 0 | |
Period of warranty | 1 year | ||
Warranty claim liability | $ 0 | 0 | |
Other current assets | 6,333,000 | 4,755,000 | |
Other assets | 2,341,000 | 2,579,000 | |
Debt - current | 4,527,000 | 2,956,000 | |
Debt - non-current | $ 15,301,000 | 16,848,000 | |
Computer Software, Intangible Asset | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Enterprise resource planning system, estimated useful life | 5 years | ||
Accounting Standards Update 2015-03 | Scenario, Previously Reported | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Other current assets | 32,000 | ||
Other assets | 36,000 | ||
Accounting Standards Update 2015-03 | Scenario, Adjustment | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Other current assets | (32,000) | ||
Other assets | (36,000) | ||
Debt - current | (32,000) | ||
Debt - non-current | $ (36,000) | ||
Trade Accounts Receivable | Customer Concentration Risk | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Concentration risk, percentage | 48.00% | 49.00% | |
Minimum | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Estimated useful life of property and equipment | 3 years | ||
Maximum | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Estimated useful life of property and equipment | 5 years |
Reconciliation of Numerator and
Reconciliation of Numerator and Denominator Used in Computation of Basic and Diluted Net Income Loss per Share (Detail) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Numerator for Basic and Diluted: | ||
Net loss used for basic calculation | $ (16,863) | $ (9,460) |
Effect of revaluation of warrant liability | (6,296) | |
Adjusted net loss used for diluted calculation | $ (16,863) | $ (15,756) |
Denominator: | ||
Basic weighted average number of shares outstanding | 99,471 | 93,411 |
Effect of dilutive potential shares | 1,251 | |
Diluted weighted average number of shares outstanding | 99,471 | 94,662 |
Net loss per share: | ||
Basic | $ (0.17) | $ (0.10) |
Diluted | $ (0.17) | $ (0.17) |
Shares Underlying Stock Options
Shares Underlying Stock Options, Excluded from Calculation of Weighted Average Number of Shares Outstanding used for Calculation of Diluted Net Loss Per Share (Detail) - shares shares in Thousands | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Stock Options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Weighted average number of anti-dilutive potential shares-outstanding options | 14,986 | 13,439 |
Fair Values on Financial Assets
Fair Values on Financial Assets and Liabilities (Detail) - USD ($) $ in Thousands | Mar. 31, 2016 | Dec. 31, 2015 |
Fair value of financial assets and liabilities | ||
Total financial assets | $ 82,243 | $ 96,163 |
Money market funds | ||
Fair value of financial assets and liabilities | ||
Total financial assets | 6,648 | 59,302 |
Corporate debt securities | ||
Fair value of financial assets and liabilities | ||
Total financial assets | 60,516 | 25,698 |
Marketable equity securities | ||
Fair value of financial assets and liabilities | ||
Total financial assets | 5,082 | 11,163 |
United States government agency securities | ||
Fair value of financial assets and liabilities | ||
Total financial assets | 9,997 | |
Level 1 | ||
Fair value of financial assets and liabilities | ||
Total financial assets | 11,730 | 70,465 |
Level 1 | Money market funds | ||
Fair value of financial assets and liabilities | ||
Total financial assets | 6,648 | 59,302 |
Level 1 | Marketable equity securities | ||
Fair value of financial assets and liabilities | ||
Total financial assets | 5,082 | 11,163 |
Level 2 | ||
Fair value of financial assets and liabilities | ||
Total financial assets | 70,513 | 25,698 |
Level 2 | Corporate debt securities | ||
Fair value of financial assets and liabilities | ||
Total financial assets | 60,516 | $ 25,698 |
Level 2 | United States government agency securities | ||
Fair value of financial assets and liabilities | ||
Total financial assets | $ 9,997 |
Summary of Available for Sale S
Summary of Available for Sale Securities (Detail) - USD ($) $ in Thousands | Mar. 31, 2016 | Dec. 31, 2015 |
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $ 77,109 | $ 85,049 |
Gross Unrealized Gain | 5,155 | 11,163 |
Gross Unrealized (Loss) | (21) | (49) |
Fair Value | 82,243 | 96,163 |
Money market funds | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 6,648 | 59,302 |
Fair Value | 6,648 | 59,302 |
Corporate debt securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 60,465 | 25,747 |
Gross Unrealized Gain | 72 | |
Gross Unrealized (Loss) | (21) | (49) |
Fair Value | 60,516 | 25,698 |
Marketable equity securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Gross Unrealized Gain | 5,082 | 11,163 |
Fair Value | 5,082 | $ 11,163 |
United States government agency securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 9,996 | |
Gross Unrealized Gain | 1 | |
Fair Value | $ 9,997 |
Available for Sale Debt Securit
Available for Sale Debt Securities by Original Contractual Maturity (Detail) - USD ($) $ in Thousands | Mar. 31, 2016 | Dec. 31, 2015 |
Schedule of Available-for-sale Securities [Line Items] | ||
One year or less, amortized cost | $ 56,934 | $ 85,049 |
Marketable equity securities | 0 | 0 |
Greater than one year and less than five years, amortized cost | 20,175 | |
Amortized Cost | 77,109 | 85,049 |
One year or less, fair value | 56,934 | 85,000 |
Marketable equity securities | 5,082 | 11,163 |
Greater than one year and less than five years, fair value | 20,227 | |
Total available-for-sale securities fair value | $ 82,243 | $ 96,163 |
Available for Sale Marketable S
Available for Sale Marketable Securities in Unrealized Position (Detail) - USD ($) $ in Thousands | Mar. 31, 2016 | Dec. 31, 2015 |
Schedule of Available-for-sale Securities [Line Items] | ||
Less than 12 Months, Fair Value | $ 18,137 | $ 20,170 |
Less than 12 Months, Unrealized Loss | (21) | (46) |
12 Months or Longer, Fair Value | 5,528 | |
12 Months or Longer, Unrealized Loss | (3) | |
Total, Fair Value | 18,137 | 25,698 |
Total, Unrealized Loss | (21) | (49) |
Corporate debt securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Less than 12 Months, Fair Value | 18,137 | 20,170 |
Less than 12 Months, Unrealized Loss | (21) | (46) |
12 Months or Longer, Fair Value | 5,528 | |
12 Months or Longer, Unrealized Loss | (3) | |
Total, Fair Value | 18,137 | 25,698 |
Total, Unrealized Loss | $ (21) | $ (49) |
Available-for-Sale Securities -
Available-for-Sale Securities - Additional Information (Detail) - USD ($) | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Schedule of Available-for-sale Securities [Line Items] | ||
Other-than-temporary impairment losses | $ 0 | $ 0 |
Gross realized gains from the sale or maturity of available-for-sale investments | 0 | 0 |
Gross realized losses from the sale or maturity of available-for-sale investments | $ 0 | $ 0 |
Inventories (Detail)
Inventories (Detail) - USD ($) $ in Thousands | Mar. 31, 2016 | Dec. 31, 2015 |
Inventory [Line Items] | ||
Work-in-process | $ 2,966 | $ 3,187 |
Finished goods | 8,289 | 7,625 |
Total inventories | $ 11,255 | $ 10,812 |
Goodwill and Intangible Assets
Goodwill and Intangible Assets Net - Additional Information (Detail) - USD ($) | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Acquired Finite-Lived Intangible Assets [Line Items] | ||
Dispose, impair or recognition of additional goodwill | $ 0 | |
Impairment charges on goodwill | 0 | |
Amortization of intangible assets | 50,000 | $ 50,000 |
Impairment losses recognized related to the acquired intangible assets | 0 | $ 0 |
Annual amortization expense of the intangible assets, 2016 (remaining nine months) | 150,000 | |
Annual amortization expense of the intangible assets, 2017 | 200,000 | |
Annual amortization expense of the intangible assets, 2018 | 200,000 | |
Annual amortization expense of the intangible assets, 2019 | 200,000 | |
Annual amortization expense of the intangible assets, 2020 | $ 100,000 |
Summary of Intangible Assets Ne
Summary of Intangible Assets Net (Detail) - USD ($) $ in Thousands | Mar. 31, 2016 | Dec. 31, 2015 |
Acquired Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Amount | $ 2,017 | $ 2,017 |
Accumulated Amortization | (1,127) | (1,077) |
Net Carrying Amount | 890 | 940 |
Reacquired license - INTERCEPT Asia | ||
Acquired Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Amount | 2,017 | 2,017 |
Accumulated Amortization | (1,127) | (1,077) |
Net Carrying Amount | $ 890 | $ 940 |
Marketable Equity investment -
Marketable Equity investment - Additional Information (Detail) - USD ($) | 1 Months Ended | |
Apr. 30, 2015 | Mar. 31, 2016 | |
Investment [Line Items] | ||
Carrying value of investment | $ 0 | |
Aduro | ||
Investment [Line Items] | ||
Preferred shares converted to common stock | 396,700 |
Accrued Liabilities (Detail)
Accrued Liabilities (Detail) - USD ($) $ in Thousands | Mar. 31, 2016 | Dec. 31, 2015 |
Schedule of Accrued Liabilities [Line Items] | ||
Accrued compensation and related costs | $ 4,664 | $ 5,198 |
Accrued professional services | 2,808 | 2,337 |
Accrued customer costs | 923 | 987 |
Accrued insurance premiums | 220 | 438 |
Other accrued expenses | 606 | 893 |
Total accrued liabilities | $ 9,221 | $ 9,853 |
Debt (Detail)
Debt (Detail) - USD ($) $ in Thousands | Mar. 31, 2016 | Dec. 31, 2015 |
Debt Instrument [Line Items] | ||
Less: debt - current, Principal | $ (4,615) | $ (3,050) |
Less: debt - current, Unamortized Discount | 88 | 94 |
Less: debt-current | (4,527) | (2,956) |
Debt - non-current, Principal | 15,385 | 16,950 |
Debt - non-current, Unamortized Discount | (84) | (102) |
Debt-non-current | 15,301 | 16,848 |
Cerus Term Loans | ||
Debt Instrument [Line Items] | ||
Total debt, Principal | 20,000 | 20,000 |
Total debt, Unamortized amount | (172) | (196) |
Total debt | $ 19,828 | $ 19,804 |
Debt - Principal and Interest P
Debt - Principal and Interest Payments on Debt (Detail) $ in Thousands | Mar. 31, 2016USD ($) | [1] |
Debt Instrument [Line Items] | ||
2016, Principal | $ 3,050 | |
2017, Principal | 6,428 | |
2018, Principal | 6,892 | |
2019, Principal | 3,630 | |
Total, Principal | 20,000 | |
2016, Interest | 1,003 | |
2017, Interest | 980 | |
2018, Interest | 517 | |
2019, Interest | 1,474 | |
Total, Interest | 3,974 | |
2016, Total | 4,053 | |
2017, Total | 7,408 | |
2018, Total | 7,409 | |
2019, Total | 5,104 | |
Total | $ 23,974 | |
[1] | Unless interest only period extends to December 31, 2016, as described below. |
Debt - Additional Information (
Debt - Additional Information (Detail) - Cerus Term Loans | Jun. 30, 2014USD ($)Tranche | Mar. 31, 2016 |
Line of Credit Facility [Line Items] | ||
Maximum borrowing limit | $ 30,000,000 | |
Term of agreement | 5 years | |
Number of loan tranches | Tranche | 3 | |
Interest rate, description | 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. | |
Maturity period | Jun. 1, 2019 | |
Principal and interest payments | 36 months | |
Final payment term percent | 7.00% | |
Terms of required periodic payments of interest and principal | 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. | |
Securities Pledged as Collateral | ||
Line of Credit Facility [Line Items] | ||
Percentage of investments made in subsidiary | 35.00% | |
First Tranche (Term Loan A) | ||
Line of Credit Facility [Line Items] | ||
Loan and security agreement | $ 10,000,000 | |
Interest rate | 6.95% | |
Second Tranche (Term Loan B) | ||
Line of Credit Facility [Line Items] | ||
Loan and security agreement | $ 10,000,000 | |
Borrowing conditions | The second tranche of $10.0 million ("Term Loan B") was drawn on June 15, 2015. | |
Interest rate | 7.01% | |
Third Tranche (Term Loan C) | ||
Line of Credit Facility [Line Items] | ||
Loan and security agreement | $ 10,000,000 | |
Borrowing conditions | 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") | |
Interest rate, minimum | 6.95% | |
Interest rate plus the three month U.S. LIBOR | 6.72% |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) $ in Millions | 3 Months Ended | 12 Months Ended |
Mar. 31, 2016 | Dec. 31, 2010 | |
Commitments and Contingencies Disclosure [Line Items] | ||
Minimum term of non-cancellable operating leases | 1 year | |
Expiration of non-cancellable operating leases maximum year | 2,020 | |
Financing for leasehold improvement | $ 1.1 | |
Outstanding liability related to leasehold improvements | $ 0.5 | |
Accrued liabilities | ||
Commitments and Contingencies Disclosure [Line Items] | ||
Leasehold Improvements reflected in Accrued liabilities | 0.1 | |
Other non-current liabilities | ||
Commitments and Contingencies Disclosure [Line Items] | ||
Leasehold Improvements reflected in Other non-current liabilities | $ 0.4 |
Stockholders Equity - Additiona
Stockholders Equity - Additional Information (Detail) - USD ($) shares in Millions | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Stockholders Equity Note [Line Items] | ||
Proceeds from common stock sold | $ 7,199,000 | $ 75,527,000 |
Cantor | Sales Agreement | ||
Stockholders Equity Note [Line Items] | ||
Maximum common stock offering price | $ 70,000,000 | |
Percentage of proceeds payable as compensation to underwriter | 2.00% | |
Common stock, number of shares issued | 1.2 | |
Proceeds from common stock sold | $ 7,100,000 | |
Common stock registered for sale | $ 15,300,000 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) $ in Millions | Jun. 10, 2015shares | Mar. 31, 2016USD ($)Periodshares | Dec. 31, 2015shares | Jun. 12, 2013shares |
Employee Stock Purchase Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Increase in shares of common stock authorized for issuance | 1,500,000 | 1,320,500 | ||
Aggregate number of shares of common stock reserved for future issuance | 1,551,390 | |||
Employee Stock Purchase Plan, offering period | 12 months | |||
Number of purchase periods within each offering period | Period | 2 | |||
Stock-based compensation, option to be granted at percentage of fair value of common stock | 85.00% | |||
2008 Equity Incentive Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Increase in shares of common stock authorized for issuance | 5,000,000 | |||
Aggregate number of shares of common stock reserved for future issuance | 21,000,000 | |||
Stock-based compensation, option to be granted at percentage of fair value of common stock | 100.00% | |||
Employee Stock Purchase Plan, authorized shares for issuance | 19,540,940 | |||
Stock-based compensation, award term | 10 years | |||
Performance-based stock options, outstanding | 0 | |||
Outstanding options and other stock based awards | 15,941,000 | 14,119,000 | ||
Number of shares available for future issuance | 4,400,000 | |||
2008 Equity Incentive Plan | Stock Options | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation, vesting period | 4 years | |||
2008 Equity Incentive Plan | Performance-based Stock or Cash Awards | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Employee Stock Purchase Plan, authorized shares for issuance | 500,000 | |||
Stock option plan granted on cash award | $ | $ 1 | |||
2008 Equity Incentive Plan | Restricted Stock Units (RSUs) | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation, vesting period | 3 years | |||
Number of Restricted Stock Units Outstanding | 633,000 | 0 |
Activity Under Equity Incentive
Activity Under Equity Incentive Plans Related to Stock Options (Detail) - 2008 Equity Incentive Plan shares in Thousands | 3 Months Ended |
Mar. 31, 2016$ / sharesshares | |
Activity under the Company's equity incentive plans related to stock options | |
Number of Options Outstanding, Beginning Balance | shares | 14,119 |
Granted, Number of Options Outstanding | shares | 2,075 |
Forfeited, Number of Options Outstanding | shares | (37) |
Expired, Number of Options Outstanding | shares | (89) |
Exercised, Number of Options Outstanding | shares | (127) |
Number of Options Outstanding, Ending Balance | shares | 15,941 |
Weighted Average Exercise Price per Share | |
Weighted Average Exercise Price per Share, Beginning Balance | $ / shares | $ 4.21 |
Granted, Weighted Average Exercise Price per Share | $ / shares | 5.08 |
Forfeited, Weighted Average Exercise Price per Share | $ / shares | 5.16 |
Expired, Weighted Average Exercise Price per Share | $ / shares | 9.97 |
Exercised, Weighted Average Exercise Price per Share | $ / shares | 2.33 |
Weighted Average Exercise Price per Share, Ending Balance | $ / shares | $ 4.31 |
Activity Under Equity Incenti52
Activity Under Equity Incentive Plans Related to RSUs (Detail) - 2008 Equity Incentive Plan - Restricted Stock Units (RSUs) shares in Thousands | 3 Months Ended |
Mar. 31, 2016$ / sharesshares | |
Activity under the Company's equity incentive plans related to restricted stock units | |
Number of Restricted Stock Units Outstanding, Beginning Balance | shares | 0 |
Granted, Number of Restricted Stock Units Outstanding | shares | 634 |
Forfeited, Number of Restricted Stock Units Outstanding | shares | (1) |
Vested, Number of Restricted Stock Units Outstanding | shares | 0 |
Number of Restricted Stock Units Outstanding, Ending Balance | shares | 633 |
Weighted Average Exercise Price per Share | |
Weighted Average Exercise Price per Share, Beginning Balance | $ / shares | $ 0 |
Granted, Weighted Average Exercise Price per Share | $ / shares | 5.06 |
Forfeited, Weighted Average Exercise Price per Share | $ / shares | 5.06 |
Vested, Weighted Average Exercise Price per Share | $ / shares | 0 |
Weighted Average Exercise Price per Share, Ending Balance | $ / shares | $ 5.06 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Income Tax Disclosure [Line Items] | ||
Unrealized (losses) gains on available-for-sale investments, taxes | $ (3,922) | $ 19 |
Provision (benefit) for income taxes | $ 812 | $ 19 |
Development and License Agree54
Development and License Agreements - Additional Information (Detail) $ in Thousands, € in Millions | 3 Months Ended | 12 Months Ended | ||||||
Mar. 31, 2016USD ($) | Mar. 31, 2016EUR (€) | Mar. 31, 2015USD ($) | Dec. 31, 2016EUR (€) | Mar. 31, 2016USD ($) | Mar. 31, 2016EUR (€) | Dec. 31, 2015USD ($) | Dec. 31, 2015EUR (€) | |
Licenses Agreements [Line Items] | ||||||||
Manufacturing and development obligations-current | $ 2,219 | $ 2,219 | $ 3,282 | |||||
Manufacturing and development obligations-non-current | 4,840 | 4,840 | 4,542 | |||||
Payments made relating to the manufacturing of the products | 3,600 | $ 4,700 | ||||||
Amounts due from Fresenius | 900 | 900 | 200 | |||||
Other current assets | ||||||||
Licenses Agreements [Line Items] | ||||||||
Research and development assets | 3,700 | 3,700 | 4,100 | |||||
Other assets | ||||||||
Licenses Agreements [Line Items] | ||||||||
Manufacturing efficiency assets | 2,300 | 2,300 | 2,400 | |||||
Fresenius | ||||||||
Licenses Agreements [Line Items] | ||||||||
Allocated amount for research and development activities | 4,800 | 4,800 | ||||||
Manufacturing efficiency activity cost | 2,400 | 2,400 | ||||||
Manufacturing and Supply Agreement | ||||||||
Licenses Agreements [Line Items] | ||||||||
Accrual for manufacturing of entity products | 3,200 | 3,200 | 2,500 | |||||
Manufacturing and Supply Agreement | Fresenius | ||||||||
Licenses Agreements [Line Items] | ||||||||
Accrual for manufacturing and development of entity products | 7,000 | $ 7,000 | € 6.2 | 7,800 | € 7.2 | |||
Manufacturing and development obligations, discount rate | 9.72% | |||||||
Manufacturing and development obligations-current | 2,200 | $ 2,200 | 1.9 | 3,300 | 3 | |||
Manufacturing and development obligations-non-current | 4,800 | $ 4,800 | € 4.3 | $ 4,500 | € 4.2 | |||
Manufacturing and development payments | $ 1,200 | € 1.1 | ||||||
Scenario Forecast | Manufacturing and Supply Agreement | Fresenius | ||||||||
Licenses Agreements [Line Items] | ||||||||
Payments made based on the successful achievement of production volumes | € | € 8.6 |
Segment, Customer and Geograp55
Segment, Customer and Geographic Information - Additional Information (Detail) | 3 Months Ended |
Mar. 31, 2016Segment | |
Segment Reporting Information [Line Items] | |
Number of operating segments | 1 |
Significant Customer that Accou
Significant Customer that Accounted for More than Ten Percentage of Total Revenue (Detail) - Customer Concentration Risk - Sales Revenue, Goods, Net | 3 Months Ended | |||
Mar. 31, 2016 | Mar. 31, 2015 | |||
Advanced Technology Company KSC | ||||
Revenue, Major Customer [Line Items] | ||||
Concentration risk, percentage | 18.00% | [1] | ||
Etablissement Francais du Sang | ||||
Revenue, Major Customer [Line Items] | ||||
Concentration risk, percentage | [1] | 26.00% | ||
Medical Device APS | ||||
Revenue, Major Customer [Line Items] | ||||
Concentration risk, percentage | 11.00% | [1] | ||
Rode Kruis Vlaanderen | ||||
Revenue, Major Customer [Line Items] | ||||
Concentration risk, percentage | 12.00% | [1] | ||
[1] | Represents an amount less than 10% of product revenue. |
Subsequent Event - Additional I
Subsequent Event - Additional Information (Detail) - Cantor - Sales Agreement - USD ($) | May. 05, 2016 | Mar. 31, 2016 |
Subsequent Event [Line Items] | ||
Maximum common stock offering price | $ 70,000,000 | |
Subsequent Event | ||
Subsequent Event [Line Items] | ||
Maximum common stock offering price | $ 62,200,000 |