CERUS CORP, 10-Q filed on 8/4/2017
Quarterly Report
Document and Entity Information
6 Months Ended
Jun. 30, 2017
Jul. 27, 2017
Document And Entity Information [Abstract]
 
 
Document Type
10-Q 
 
Amendment Flag
false 
 
Document Period End Date
Jun. 30, 2017 
 
Document Fiscal Year Focus
2017 
 
Document Fiscal Period Focus
Q2 
 
Trading Symbol
CERS 
 
Entity Registrant Name
CERUS CORP 
 
Entity Central Index Key
0001020214 
 
Current Fiscal Year End Date
--12-31 
 
Entity Filer Category
Accelerated Filer 
 
Entity Common Stock, Shares Outstanding
 
109,137,885 
CONDENSED CONSOLIDATED BALANCE SHEETS (USD $)
In Thousands, unless otherwise specified
Jun. 30, 2017
Dec. 31, 2016
Current assets:
 
 
Cash and cash equivalents
$ 20,278 
$ 22,560 
Short-term investments
30,628 
45,116 
Investment in marketable equity securities
 
3,952 
Accounts receivable
7,932 
6,868 
Inventories
12,213 
12,531 
Other current assets
3,256 
3,078 
Total current assets
74,307 
94,105 
Non-current assets:
 
 
Property and equipment, net
2,673 
2,985 
Goodwill
1,316 
1,316 
Intangible assets, net
637 
738 
Restricted cash
248 
184 
Other assets
4,304 
4,148 
Total assets
83,485 
103,476 
Current liabilities:
 
 
Accounts payable
9,564 
8,587 
Accrued liabilities
9,787 
11,218 
Debt - current
5,548 
6,934 
Deferred product revenue - current
398 
149 
Total current liabilities
25,297 
26,888 
Non-current liabilities:
 
 
Debt - non-current
11,914 
12,441 
Manufacturing and development obligations - non-current
5,351 
4,770 
Other non-current liabilities
1,632 
1,590 
Total liabilities
44,194 
45,689 
Commitments and contingencies
   
   
Stockholders' equity:
 
 
Common stock
109 
103 
Additional paid-in capital
735,600 
718,299 
Accumulated other comprehensive (loss) income
(19)
103 
Accumulated deficit
(696,399)
(660,718)
Total stockholders' equity
39,291 
57,787 
Total liabilities and stockholders' equity
$ 83,485 
$ 103,476 
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (USD $)
In Thousands, except Per Share data, unless otherwise specified
3 Months Ended 6 Months Ended
Jun. 30, 2017
Jun. 30, 2016
Jun. 30, 2017
Jun. 30, 2016
Income Statement [Abstract]
 
 
 
 
Product revenue
$ 9,525 
$ 9,251 
$ 16,531 
$ 16,883 
Cost of product revenue
4,360 
4,976 
8,054 
9,239 
Gross profit on product revenue
5,165 
4,275 
8,477 
7,644 
Government contracts revenue
1,667 
 
3,095 
 
Operating expenses:
 
 
 
 
Research and development
8,891 
8,557 
18,041 
15,474 
Selling, general and administrative
14,094 
12,406 
27,727 
24,153 
Amortization of intangible assets
51 
51 
101 
101 
Total operating expenses
23,036 
21,014 
45,869 
39,728 
Loss from operations
(16,204)
(16,739)
(34,297)
(32,084)
Non-operating income (expense), net:
 
 
 
 
Foreign exchange (loss) gain
(14)
101 
(59)
(16)
Interest expense
(501)
(658)
(1,032)
(1,313)
Other income, net
3,512 
113 
3,618 
179 
Total non-operating income (expense), net
2,997 
(444)
2,527 
(1,150)
Loss before income taxes
(13,207)
(17,183)
(31,770)
(33,234)
Provision for income taxes
3,876 
983 
3,911 
1,795 
Net loss
$ (17,083)
$ (18,166)
$ (35,681)
$ (35,029)
Net loss per share:
 
 
 
 
Basic
$ (0.16)
$ (0.18)
$ (0.34)
$ (0.35)
Diluted
$ (0.16)
$ (0.18)
$ (0.34)
$ (0.35)
Weighted average shares outstanding used for calculating net loss per share:
 
 
 
 
Basic
105,044 
101,563 
104,308 
100,517 
Diluted
105,044 
101,563 
104,308 
100,517 
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (USD $)
In Thousands, unless otherwise specified
3 Months Ended 6 Months Ended
Jun. 30, 2017
Jun. 30, 2016
Jun. 30, 2017
Jun. 30, 2016
Statement Of Income And Comprehensive Income [Abstract]
 
 
 
 
Net loss
$ (17,083)
$ (18,166)
$ (35,681)
$ (35,029)
Other comprehensive gains (losses):
 
 
 
 
Unrealized gains (losses) on available-for-sale investments, net of taxes of zero and $(205) for the three months ended June 30, 2017 and 2016, respectively, and zero and $(2,263) for the six months ended June 30, 2017 and 2016, respectively
124 
(389)
(122)
(4,311)
Comprehensive loss
$ (16,959)
$ (18,555)
$ (35,803)
$ (39,340)
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (Parenthetical) (USD $)
In Thousands, unless otherwise specified
3 Months Ended 6 Months Ended
Jun. 30, 2017
Jun. 30, 2016
Jun. 30, 2017
Jun. 30, 2016
Statement Of Income And Comprehensive Income [Abstract]
 
 
 
 
Unrealized gains (losses) on available-for-sale investments, taxes
$ 0 
$ (205)
$ 0 
$ (2,263)
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (USD $)
In Thousands, unless otherwise specified
6 Months Ended
Jun. 30, 2017
Jun. 30, 2016
Operating activities
 
 
Net loss
$ (35,681)
$ (35,029)
Adjustments to reconcile net loss to net cash used in operating activities:
 
 
Depreciation and amortization
904 
964 
Stock-based compensation
4,617 
3,862 
Bad debt expense
658 
 
Non-cash interest expense
285 
603 
Deferred income taxes
12 
18 
Non-cash tax expense from other unrealized loss on available-for-sale securities
3,825 
1,702 
Gain on sale of investment in marketable equity securities
(3,466)
 
Changes in operating assets and liabilities:
 
 
Accounts receivable
(1,722)
645 
Inventories
237 
(1,318)
Other assets
704 
435 
Accounts payable
1,085 
1,902 
Accrued liabilities
(1,457)
(458)
Manufacturing and development obligations
419 
(1,082)
Deferred product revenue
233 
189 
Net cash used in operating activities
(29,347)
(27,567)
Investing activities
 
 
Capital expenditures
(353)
(118)
Purchases of investments
(20,749)
(70,560)
Proceeds from maturities and sale of investments
38,465 
19,500 
Net cash provided by (used in) investing activities
17,363 
(51,178)
Financing activities
 
 
Net proceeds from equity incentives
2,052 
907 
Net proceeds from public offering
9,644 
14,547 
Repayment of debt
(1,930)
(60)
Net cash provided by financing activities
9,766 
15,394 
Net decrease in cash, cash equivalents and restricted cash
(2,218)
(63,351)
Cash, cash equivalents and restricted cash, beginning of period
22,744 
71,630 
Cash, cash equivalents and restricted cash, end of period
$ 20,526 
$ 8,279 
Summary of Significant Accounting Policies
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, or U.S. (“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 and six months ended June 30, 2017, are not necessarily indicative of the results that may be expected for the year ending December 31, 2017, 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, 2016, which were included in the Company’s 2016 Annual Report on Form 10-K, filed with the SEC on March 8, 2017. The accompanying condensed consolidated balance sheet as of December 31, 2016, has been derived from the Company’s audited consolidated financial statements as of that date.

Use of Estimates

The preparation of financial statements requires management to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosures of contingent assets and liabilities. On an ongoing basis, management evaluates its estimates, including those related to the accounts receivable, inventory reserves, fair values of investments, stock-based compensation, intangible assets and goodwill, useful lives of intangible assets and property and equipment, income taxes, and accrued liabilities, among others. The Company bases its estimates on historical experience, future projections, and on various other assumptions that are believed to be reasonable under the circumstances. Actual results may differ from those estimates under different assumptions or conditions.

Revenue

The Company recognizes revenue in accordance with Accounting Standards Codification (“ASC”) Topic 605-25, “Revenue Recognition – Arrangements with Multiple Deliverables,” as applicable. Revenue is recognized when (i) persuasive evidence of the arrangement exists; (ii) delivery has occurred or services have been rendered; (iii) pricing is fixed or determinable; and (iv) collectability is reasonably assured. The Company’s main sources of revenues for the three and six months ended June 30, 2017 and 2016 were product revenue from sales of the INTERCEPT Blood System for platelets and plasma (“platelet and plasma systems” or “disposable kits”) and UVA illumination devices (“illuminators”).

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 product 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.

The Company receives reimbursement under its U.S. government contract that supports research and development of defined projects. The contract generally provides for reimbursement of approved costs incurred under the terms of the contract. Revenue related to the cost reimbursement provisions under the Company’s U.S. government contract are recognized as the qualified direct and indirect costs on the projects are incurred. The Company invoices under its U.S. government contract using the provisional rates in the government contract and thus is subject to future audits at the discretion of government. These audits could result in an adjustment to revenue previously reported, which adjustments potentially could be significant. The Company believes that revenue for periods not yet audited has been recorded in amounts that are expected to be realized upon final audit and settlement. Costs incurred related to services performed under the contract are included as a component of research and development or selling, general and administrative expenses in the Company’s consolidated statements of operations. The Company’s use of estimates in recording accrued liabilities for government contract activities (see “Use of Estimates” above) affects the revenue recorded from development funding and under the government contract.

Research and Development Expenses

In accordance with ASC Topic 730, “Accounting for Research and Development Expenses,” research and development (“R&D”) expenses are charged to expense when incurred, including cost incurred pursuant to the terms of any contract that has been awarded to the Company by the U.S. government. Research and development expenses include salaries and related expenses for scientific and regulatory personnel, payments to consultants, supplies and chemicals used in in-house laboratories, costs of R&D facilities, depreciation of equipment and external contract research expenses, including clinical trials, preclinical safety studies, other laboratory studies, process development and product manufacturing for research use.

The Company’s use of estimates in recording accrued liabilities for R&D activities (see “Use of Estimates” above) affects the amounts of R&D expenses recorded from development funding and under the government contract. 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 and U.S. government agency securities 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”. Available-for-sale securities are carried at estimated fair value. The Company views its available-for-sale portfolio as available for use in its current operations. Unrealized gains and losses derived by changes in the estimated fair value of available-for-sale securities were recorded in “Net unrealized (losses) gains on available-for-sale investments, net of taxes” on the Company’s unaudited condensed consolidated statements of comprehensive loss. Realized gains (losses) from the sale of available-for-sale investments were recorded in “Other income, net” on the Company’s unaudited condensed consolidated statements of operations. The costs of securities sold are based on the specific identification method, if applicable. The Company reported the amortization of any premium and accretion of any discount resulting from the purchase of debt securities as a component of interest income.

The Company also reviews its 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

As of June 30, 2017 and December 31, 2016, the Company had 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 June 30, 2017, 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 three customers that accounted for more than 10% of the Company’s outstanding trade receivables at June 30, 2017 and December 31, 2016. These customers cumulatively represented approximately 46% of the Company’s outstanding trade receivables at both June 30, 2017 and December 31, 2016. To date, the Company has not experienced collection difficulties from these customers.

Inventories

At June 30, 2017 and December 31, 2016, 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 June 30, 2017 and December 31, 2016, 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 product revenue” on the Company’s consolidated statements of operations. At both June 30, 2017 and December 31, 2016, the Company had $0.2 million recorded for potential obsolete, expiring or unsalable product.

Property and Equipment, net

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

Goodwill and Intangible Assets, net

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 goodwill impairment test. The Company may choose not to perform the qualitative assessment to test goodwill for impairment and proceed directly to the quantitative impairment test; however, the Company may revert to the qualitative assessment to test goodwill for impairment in any subsequent period. The quantitative goodwill impairment test 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 considered not impaired. 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, limited to the carrying amount of goodwill in the Company’s one reporting unit.

The Company performs an impairment test on its intangible assets, in accordance ASC Topic 360-10, “Property, Plant and Equipment,” if certain events or changes in circumstances occur which indicate that the carrying amounts of its intangible assets may not be recoverable. If the intangible assets are not recoverable, an impairment loss would be recognized by the Company based on the excess amount of the carrying value of the intangible assets over its fair value. For further details regarding the impairment analysis, reference is made to the section below under “Long-lived Assets.” See Note 4 in the Notes to Unaudited Condensed Consolidated Financial Statements for further information regarding the Company’s impairment analysis and the valuation of goodwill and intangible assets, net.

Long-lived Assets

The Company evaluates its long-lived assets for impairment by continually monitoring events and changes in circumstances that could indicate carrying amounts of its long-lived assets may not be recoverable. When such events or changes in circumstances occur, the Company assesses recoverability by determining whether the carrying value of such assets will be recovered through the undiscounted expected future 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 and six months ended June 30, 2017 and 2016.

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. Product revenues and expenses are remeasured using average exchange rates prevailing during the period. Remeasurements are recorded in the Company’s consolidated statements of operations.

Stock-Based Compensation

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

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

See Note 10 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. Under this method, deferred tax assets and liabilities are determined based on differences between the financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. ASC Topic 740 requires derecognition of tax positions that do not have a greater than 50% likelihood of being recognized upon review by a taxing authority having full knowledge of all relevant information. Use of a valuation allowance as described in ASC Topic 740 is not an appropriate substitute for derecognition of a tax position. The Company recognizes accrued interest and penalties related to unrecognized tax benefits in its income tax expense. To date, the Company has not recognized any interest and penalties in its unaudited condensed consolidated statements of operations, nor has it accrued for or made payments for interest and penalties. Although the Company believes it more likely than not that a taxing authority would agree with its current tax positions, there can be no assurance that the tax positions the Company has taken will be substantiated by a taxing authority if reviewed. The Company’s U.S. federal tax years 1998 through 2015 and California tax years through 2015 remain subject to examination by the taxing jurisdictions due to unutilized net operating losses and research credits. The Company continues to carry a full valuation allowance on all of its net deferred tax assets, except for its indefinite lived intangibles.

Net Loss Per Share

Basic net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding for the period. Diluted net loss per share gives effect to all potentially dilutive common shares outstanding for the period. The potentially dilutive securities include stock options, employee stock purchase plan rights and restricted stock units, which are calculated using the treasury stock method.

For the three and six months ended June 30, 2017 and 2016, all potentially dilutive securities outstanding have been excluded from the computation of dilutive weighted average shares outstanding because such securities have an antidilutive impact due to losses reported.

 

The table below presents shares underlying stock options, restricted stock units, and employee stock purchase plan rights 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 and six months ended June 30, 2017 and 2016 (shares in thousands):

 

 

 

Three Months Ended

 

 

Six Months Ended

 

 

 

June 30,

 

 

June 30,

 

 

 

2017

 

 

2016

 

 

2017

 

 

2016

 

Weighted average number of anti-dilutive potential shares:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock options

 

 

17,966

 

 

 

15,891

 

 

 

17,321

 

 

 

15,331

 

Restricted stock units

 

 

1,350

 

 

 

640

 

 

 

1,159

 

 

 

428

 

Employee stock purchase plan rights

 

 

43

 

 

 

27

 

 

 

75

 

 

 

19

 

Total

 

 

19,359

 

 

 

16,558

 

 

 

18,555

 

 

 

15,778

 

 

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 June 30, 2017 and December 31, 2016.

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. 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), which provides a single comprehensive model for entities to use in accounting for revenue arising from contracts with customers and will supersede most current revenue recognition guidance. This ASU is based on the principle that revenue is recognized to depict the transfer of goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The ASU also requires additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract. In August 2015, the FASB issued ASU No. 2015-14, Revenue from Contracts with Customers (Topic 606), Deferral of the Effective Date, which defers by one year the effective date of ASU No. 2014-09 to annual reporting periods beginning after December 15, 2017 (including interim periods within those periods). Early adoption is permitted to the original effective date of December 15, 2016 (including interim periods within those periods). In March 2016, the FASB issued ASU No. 2016-08, Revenue from Contracts with Customers (Topic 606): Principal versus Agent Considerations (Reporting Revenue Gross versus Net), which clarifies how to identify the unit of accounting for the principal versus agent evaluation and how to apply the control principle to certain types of arrangements. In April 2016, the FASB issued ASU No. 2016-10, Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing, which clarifies the implementation guidance on identifying performance obligations and licensing. In May 2016, the FASB issued ASU No. 2016-12, Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients, which addresses certain issues on assessing collectability, presentation of sales taxes, noncash consideration, and completed contracts and contract modifications at transition. In December 2016, the FASB issued ASU No. 2016-20, Technical Corrections and Improvements to Topic 606, Revenue from Contracts with Customers, which makes technical corrections and improvements to the new revenue standard. These ASUs will be effective for the Company in the first quarter of fiscal year 2018, using one of two retrospective application methods. The Company will adopt this ASU on January 1, 2018, using the modified retrospective approach. To date the Company has primarily derived its revenues from product sales of its INTERCEPT Blood System and reimbursement under its U.S. government contract. The Company has categorized its current revenue streams into homogenous populations based on the terms and conditions included in the contracts of its customers to date. The Company is currently in the process of evaluating the impact of the adoption to the Company’s financial statements as well as the disclosure requirements under the new standard. The Company will continue to monitor industry activities and any additional guidance provided by regulators, standards setters, or the accounting profession as an ongoing component of its assessment and implementation plans.

In January 2016, the FASB issued ASU No. 2016-01, Financial Instruments-Overall (Subtopic 825-10), which requires all equity investments to be measured at fair value with changes in the fair value recognized through net income (other than those accounted for under equity method of accounting or those that result in consolidation of the investee). The amendments also require an entity to present separately in other comprehensive income the portion of the total change in the fair value of a liability resulting from a change in the instrument-specific credit risk when the entity has elected to measure the liability at fair value in accordance with the fair value option for financial instruments. In addition, this ASU eliminates the requirement to disclose the fair value of financial instruments measured at amortized cost for entities that are not public business entities and the requirement to disclose the method(s) and significant assumptions used to estimate the fair value that is required to be disclosed for financial instruments measured at amortized cost on the balance sheet for public business entities. The standard is effective for annual periods beginning after December 15, 2017, and interim periods thereafter, with early application permitted. The Company does not anticipate early adoption of the new standard and is currently assessing the future impact of this ASU on the Company’s consolidated financial statements.

In February 2016, the FASB issued ASU No. 2016-02, Leases, which, for operating leases, requires a lessee to recognize a right-of-use asset and a lease liability, initially measured at the present value of the lease payments, in its balance sheet. The standard also requires a lessee to recognize a single lease cost, calculated so that the cost of the lease is allocated over the lease term, on a generally straight-line basis. The standard is effective for annual periods beginning after December 15, 2018, and interim periods thereafter, with early application permitted. The Company does not anticipate early adoption of the new standard and is currently assessing the future impact of this ASU on its consolidated financial statements. The Company anticipates that the Company’s operating lease commitments will be subject to the new standard and recognized as operating lease liabilities and right-of-use assets upon the adoption of this ASU, which will increase the Company’s total assets and total liabilities.

In March 2016, the FASB issued ASU No. 2016-09, Compensation-Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting, which requires entities to record all excess tax benefits and tax deficiencies as income tax expense or benefit in the income statement when awards vest or are settled, and eliminates additional paid-in capital pools. The ASU also changes the accounting for an employee’s use of shares to satisfy the employer’s statutory income tax withholding obligation, and the accounting for forfeitures, and provides two practical expedients for nonpublic entities. The Company has adopted this ASU in the first quarter of fiscal year 2017 and it did not have a significant impact on the Company’s consolidated financial statements.

In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, which requires measurement and recognition of expected credit losses for financial assets held. The standard is effective for annual periods beginning after December 15, 2019, and interim periods thereafter, with early application permitted. The Company does not anticipate early adoption of the new standard and is currently assessing the future impact of this ASU on the Company’s consolidated financial statements.

In January 2017, the FASB issued ASU No. 2017-04, Intangibles—Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment, which removes Step 2 from the goodwill impairment test and modifies the goodwill impairment to be the amount by which a reporting unit’s carrying value exceeds its fair value, not to exceed the carrying amount of goodwill allocated to that report unit. The standard is effective for annual periods beginning after December 15, 2019, and interim periods thereafter, with early application permitted for impairment tests performed after January 1, 2017. The Company has adopted this ASU in the first quarter of fiscal year 2017 and it had no impact on the Company’s consolidated financial statements.

In May 2017, the FASB issued ASU No. 2017-09, Compensation-Stock Compensation (Topic 718): Scope of Modification Accounting, which provides guidance about which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting in Topic 718. The standard is effective for annual periods beginning after December 15, 2017, and interim periods thereafter, with early application permitted. The Company does not anticipate early adoption of the new standard and is currently assessing the future impact of this ASU on the Company’s consolidated financial statements.

 

Available-for-sale Securities and Fair Value on Financial Instruments
Available-for-sale Securities and Fair Value on Financial Instruments

Note 2. Available-for-sale Securities and Fair Value on Financial Instruments

Available-for-sale Securities

The following is a summary of available-for-sale securities at June 30, 2017 (in thousands):

 

 

 

June 30, 2017

 

 

 

Amortized Cost

 

 

Gross

Unrealized Gain

 

 

Gross

Unrealized Loss

 

 

Fair Value

 

Money market funds

 

$

6,143

 

 

$

 

 

$

 

 

$

6,143

 

United States government agency securities

 

 

19,142

 

 

 

1

 

 

 

(14

)

 

 

19,129

 

Corporate debt securities

 

 

12,012

 

 

 

 

 

 

(6

)

 

 

12,006

 

Total available-for-sale securities

 

$

37,297

 

 

$

1

 

 

$

(20

)

 

$

37,278

 

 

 

The following is a summary of available-for-sale securities at December 31, 2016 (in thousands):

 

 

 

December 31, 2016

 

 

 

Amortized Cost

 

 

Gross

Unrealized Gain

 

 

Gross

Unrealized Loss

 

 

Fair Value

 

Money market funds

 

$

8,991

 

 

$

 

 

$

 

 

$

8,991

 

United States government agency securities

 

 

8,030

 

 

 

 

 

 

(1

)

 

 

8,029

 

Corporate debt securities

 

 

37,110

 

 

 

 

 

 

(23

)

 

 

37,087

 

Marketable equity securities

 

 

 

 

 

3,952

 

 

 

 

 

 

3,952

 

Total available-for-sale securities

 

$

54,131

 

 

$

3,952

 

 

$

(24

)

 

$

58,059

 

 

 

 

Available-for-sale securities at June 30, 2017 and December 31, 2016, consisted of the following by contractual maturity (in thousands):

 

 

 

June 30, 2017

 

 

December 31, 2016

 

 

 

Amortized Cost

 

 

Fair Value

 

 

Amortized Cost

 

 

Fair Value

 

One year or less

 

$

37,297

 

 

$

37,278

 

 

$

54,131

 

 

$

54,107

 

Marketable equity securities

 

 

 

 

 

 

 

 

 

 

 

3,952

 

Greater than one year and less than five years

 

 

 

 

 

 

 

 

 

 

 

 

Total available-for-sale securities

 

$

37,297

 

 

$

37,278

 

 

$

54,131

 

 

$

58,059

 

 

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):

 

 

 

June 30, 2017

 

 

 

Less than 12 Months

 

 

12 Months or Greater

 

 

Total

 

 

 

Fair Value

 

 

Unrealized Loss

 

 

Fair Value

 

 

Unrealized Loss

 

 

Fair Value

 

 

Unrealized Loss

 

United States government

   agency securities

 

$

13,039

 

 

$

(14

)

 

$

 

 

$

 

 

$

13,039

 

 

$

(14

)

Corporate debt securities

 

 

10,505

 

 

 

(6

)

 

 

 

 

 

 

 

 

10,505

 

 

 

(6

)

Total available-for-sale

   securities

 

$

23,544

 

 

$

(20

)

 

$

 

 

$

 

 

$

23,544

 

 

$

(20

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

December 31, 2016

 

 

 

Less than 12 Months

 

 

12 Months or Greater

 

 

Total

 

 

 

Fair Value

 

 

Unrealized Loss

 

 

Fair Value

 

 

Unrealized Loss

 

 

Fair Value

 

 

Unrealized Loss

 

United States government

   agency securities

 

$

6,035

 

 

$

(1

)

 

$

 

 

$

 

 

$

6,035

 

 

$

(1

)

Corporate debt securities

 

 

34,086

 

 

 

(23

)

 

 

 

 

 

 

 

 

34,086

 

 

 

(23

)

Total available-for-sale

   securities

 

$

40,121

 

 

$

(24

)

 

$

 

 

$

 

 

$

40,121

 

 

$

(24

)

 

As of June 30, 2017, 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 and six months ended June 30, 2017 and 2016, 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 recognized $3.4 million and $3.5 million of realized gains from the sale of available-for-sale investments during the three and six months ended June 30, 2017, which were reclassified out of accumulated other comprehensive income into “Other income, net” on the Company’s consolidated statements of operations. The Company did not record any gross realized losses from the sale or maturity of available-for-sale investments during the three and six months ended June 30, 2016.

Fair Value Disclosures

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 June 30, 2017, 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 June 30, 2017 (in thousands):

 

 

Balance sheet

 

 

 

 

 

Quoted

Prices in

Active

Markets for Identical

Assets

 

 

Significant

Other

Observable

Inputs

 

 

Significant Unobservable Inputs

 

 

 

classification

 

Total

 

 

(Level 1)

 

 

(Level 2)

 

 

(Level 3)

 

Money market funds

 

Cash and cash equivalents

 

$

6,143

 

 

$

6,143

 

 

$

 

 

$

 

United States government agency securities

 

Short-term investments

 

 

19,129

 

 

 

 

 

 

19,129

 

 

 

 

Corporate debt securities

 

Short-term investments

 

 

12,006

 

 

 

 

 

 

12,006

 

 

 

 

Total financial assets

 

 

 

$

37,278

 

 

$

6,143

 

 

$

31,135

 

 

$

 

 

The fair values of the Company’s financial assets and liabilities were determined using the following inputs at December 31, 2016 (in thousands):

 

 

 

Balance sheet

 

 

 

 

 

Quoted

Prices in

Active

Markets for Identical

Assets

 

 

Significant

Other

Observable

Inputs

 

 

Significant Unobservable Inputs

 

 

 

classification

 

Total

 

 

(Level 1)

 

 

(Level 2)

 

 

(Level 3)

 

Money market funds

 

Cash and cash equivalents

 

$

8,991

 

 

$

8,991

 

 

$

 

 

$

 

United States government agency securities

 

Short-term investments

 

 

8,029

 

 

 

 

 

 

8,029

 

 

 

 

Corporate debt securities

 

Short-term investments

 

 

37,087

 

 

 

 

 

 

37,087

 

 

 

 

Marketable equity securities

 

Marketable equity securities

 

 

3,952

 

 

 

3,952

 

 

 

 

 

 

 

Total financial assets

 

 

 

$

58,059

 

 

$

12,943

 

 

$

45,116

 

 

$

 

 

 

The Company did not have any transfers among fair value measurement levels during the three and six months ended June 30, 2017.

Inventories
Inventories

Note 3. Inventories

Inventories at June 30, 2017 and December 31, 2016, consisted of the following (in thousands):

 

 

 

June 30,

 

 

December 31,

 

 

 

2017

 

 

2016

 

Work-in-process

 

$

4,053

 

 

$

5,044

 

Finished goods

 

 

8,160

 

 

 

7,487

 

Total inventories

 

$

12,213

 

 

$

12,531

 

 

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

Note 4. Goodwill and Intangible Assets, net

Goodwill

During the three and six months ended June 30, 2017, the Company did not dispose of or recognize additional goodwill. The Company expects to perform its annual review of goodwill on August 31, 2017, unless indicators of impairment are identified prior to that date. As of June 30, 2017, the Company has not identified any indicators of goodwill impairment.

Intangible Assets, net

The following is a summary of intangible assets, net at June 30, 2017 (in thousands):

 

 

 

June 30, 2017

 

 

 

Gross

Carrying

Amount

 

 

Accumulated Amortization

 

 

Net

Carrying

Amount

 

Acquisition-related intangible assets:

 

 

 

 

 

 

 

 

 

 

 

 

Reacquired license - INTERCEPT Asia

 

$

2,017

 

 

$

(1,380

)

 

$

637

 

Total intangible assets

 

$

2,017

 

 

$

(1,380

)

 

$

637

 

 

The following is a summary of intangible assets, net at December 31, 2016 (in thousands):

 

 

 

December 31, 2016

 

 

 

Gross

Carrying

Amount

 

 

Accumulated Amortization

 

 

Net

Carrying

Amount

 

Acquisition-related intangible assets:

 

 

 

 

 

 

 

 

 

 

 

 

Reacquired license - INTERCEPT Asia

 

$

2,017

 

 

$

(1,279

)

 

$

738

 

Total intangible assets

 

$

2,017

 

 

$

(1,279

)

 

$

738

 

 

During the three and six months ended June 30, 2017 and 2016, there were no impairment charges recognized related to the acquired intangible assets.

At June 30, 2017, the expected amortization expense of the intangible assets, net is $0.1 million for the remaining six months of 2017, $0.2 million annually beginning with the year ending December 31, 2018, through the year ending December 31, 2019, and $0.1 million for the year ending December 31, 2020.

Marketable Equity Investments
Marketable Equity Investments

Note 5. 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 accounted for the investment in Aduro under the cost basis of accounting. The Company reflected 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 adjusted 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. During the six months ended June 30, 2017, the Company sold its remaining shares of Aduro common stock and recognized a gain of $3.5 million in “Other income, net” on the Company’s consolidated statements of operations. As of June 30, 2017, the Company had no remaining investment in Aduro’s common stock.

Accrued Liabilities
Accrued Liabilities

Note 6. Accrued Liabilities

Accrued liabilities at June 30, 2017 and December 31, 2016, consisted of the following (in thousands):

 

 

 

June 30,

 

 

December 31,

 

 

 

2017

 

 

2016

 

Accrued compensation and related costs

 

$

5,000

 

 

$

7,098

 

Accrued professional services

 

 

3,707

 

 

 

2,511

 

Accrued customer costs

 

 

456

 

 

 

534

 

Accrued insurance premiums

 

 

 

 

 

476

 

Other accrued expenses

 

 

624

 

 

 

599

 

Total accrued liabilities

 

$

9,787

 

 

$

11,218

 

 

Debt
Debt

Note 7. Debt

Debt at June 30, 2017, consisted of the following (in thousands):

 

 

 

June 30, 2017

 

 

 

Principal

 

 

Unamortized Discount

 

 

Total

 

Loan and Security Agreement

 

$

17,631

 

 

$

(169

)

 

$

17,462

 

Less: debt - current

 

 

(5,674

)

 

 

126

 

 

 

(5,548

)

Debt - non-current

 

$

11,957

 

 

$

(43

)

 

$

11,914

 

 

 

Debt at December 31, 2016, consisted of the following (in thousands):

 

 

 

December 31, 2016

 

 

 

Principal

 

 

Unamortized Discount

 

 

Net Carrying

Value

 

Loan and Security Agreement

 

$

19,499

 

 

$

(124

)

 

$

19,375

 

Less: debt - current

 

 

(7,013

)

 

 

79

 

 

 

(6,934

)

Debt - non-current

 

$

12,486

 

 

$

(45

)

 

$

12,441

 

 

 

Principal and interest payments on debt at June 30, 2017, are expected to be as follows (in thousands):

 

Year ended December 31,

 

Principal

 

 

Interest

 

 

Total

 

2017

 

$

 

 

$

615

 

 

$

615

 

2018

 

 

11,548

 

 

 

866

 

 

 

12,414

 

2019

 

 

6,083

 

 

 

1,524

 

 

 

7,607

 

Total

 

$

17,631

 

 

$

3,005

 

 

$

20,636

 

 

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. Term Loan A bore an interest rate of 6.95%. Term Loan B bore an interest rate of 7.01%. Term Loans A and B were set to mature on June 1, 2019.

On September 29, 2015, the Term Loan Agreement was amended to extend (i) the period in which the third tranche could have been drawn and (ii) the interest-only period for all advances under the Term Loan Agreement. The Company was required to make interest only payments through June 2016, followed by thirty-six months of equal principal and interest payments thereafter. On July 28, 2016, the Term Loan Agreement was amended to include an additional interest-only period for all advances under the Term Loan Agreement. As amended, the Company was required to make interest only payments from August 2016 through January 2017, followed by twenty-nine months of equal principal and interest payments thereafter. On April 27, 2017, the Term Loan Agreement was amended to include an additional interest-only period for all advances under the Term Loan Agreement. As amended, the Company was required to make interest only payments from May 2017 through December 2017, followed by eighteen months of equal principal and interest payments thereafter. The Company determined that these amendments to the Term Loan Agreement resulted in debt modifications. As a result, the accounting treatment for the Term Loan continues under the interest method, with a new effective interest rate based on revised cash flows calculated on a prospective basis upon the execution of each of these amendments to the Term Loan Agreement. The Company was 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 could 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 contained certain nonfinancial covenants, with which the Company was in compliance at June 30, 2017. As discussed in Note 14, on July 31, 2017, the Company entered into the five year Amended and Restated Loan and Security Agreement with Oxford Finance LLC to borrow up to $40.0 million in term loans in two tranches.

Commitments and Contingencies
Commitments and Contingencies

Note 8. 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 2021, with certain of the leases providing for renewal options, provisions for adjusting future lease payments based on the consumer price index, and the right to terminate the lease early. The Company’s leased facilities qualify as operating leases under ASC Topic 840, “Leases” and as such, are not included on its consolidated balance sheets.

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 June 30, 2017, the Company had an outstanding liability of $0.3 million related to these leasehold improvements, of which $0.1 million was reflected in “Accrued liabilities” and $0.2 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

Note 9. Stockholders’ Equity

Sales Agreement

On May 5, 2016, the Company entered into Amendment No. 2 to the Controlled Equity OfferingSM Sales Agreement, dated August 31, 2012, as previously amended on March 21, 2014, (together, the “Amended Cantor Agreement”) with Cantor Fitzgerald & Co. (“Cantor”) that provides for the issuance and sale of shares of the Company’s common stock over the term of the Amended Cantor Agreement having an aggregate offering price of up to $132.2 million through Cantor. As a result of Amendment No. 2, at May 5, 2016, the Company had $70 million of common stock available to be sold under the Amended Cantor Agreement. Under the Amended Cantor Agreement, Cantor also acts as the Company’s sales agent and receives compensation based on an aggregate of 2% of the gross proceeds on the sale price per share of its common stock. The issuance and sale of these shares by the Company pursuant to the Amended Cantor Agreement are deemed an “at-the-market” offering and are registered under the Securities Act of 1933, as amended. During the six months ended June 30, 2017, 4.2 million shares of the Company’s common stock were sold under the Amended Cantor Agreement for net proceeds of $10.7 million. At June 30, 2017, the Company had $51.4 million of common stock available to be sold under the Amended Cantor Agreement. See Note 14 regarding Amendment No. 3 to the Amended Cantor Agreement to increase the amount of common stock available to be sold thereunder.

Stock-Based Compensation
Stock-Based Compensation

Note 10. 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. At June 30, 2017, the Company had 1,325,010 shares available for future issuance.

2008 Equity Incentive Plan and Inducement 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 (“RSUs”), stock appreciation rights, other stock-related awards, and performance awards which may be settled in cash, stock, or other property. On June 6, 2012 and June 12, 2013, the stockholders approved amendments to the 2008 Plan (collectively the “Amended 2008 Plan”) such that the Amended 2008 Plan had reserved for issuance an amount not to exceed 19.5 million 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. On June 7, 2017, 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 6,000,000 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. 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. On August 31, 2016, the Company’s Board of Directors adopted the Cerus Corporation Inducement Plan (the “Inducement Plan”), and reserved 1,250,000 shares of its common stock under the Inducement Plan to be used exclusively for the issuance of non-statutory stock options and restricted stock units to individuals who were not previously employees or directors of the Company, or who had experienced a bona fide period of non-employment, as an inducement material to the individual’s entry into employment with the Company within the meaning of Rule 5635(c)(4) of the NASDAQ Listing Rules. The Inducement Plan was approved by the Company’s Board of Directors without stockholder approval pursuant to Rule 5635(c)(4), and the terms and conditions of the Inducement Plan are substantially similar to the Amended 2008 Plan.  Effective June 7, 2017, the Company no longer issues shares from the Inducement Plan.

At June 30, 2017, the Company had an aggregate of approximately 26.4 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 17.7 million shares and 1.4 million shares were subject to outstanding options and outstanding RSUs, respectively, and approximately 7.3 million shares were available for future issuance under the Amended 2008 Plan. The Company’s policy is to issue new shares of common stock upon the exercise of options 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

Options Outstanding

 

 

Weighted

Average

Exercise

Price per

Share

 

Balances at December 31, 2016

 

 

15,787

 

 

$

4.39

 

Granted

 

 

3,120

 

 

 

4.23

 

Forfeited

 

 

(642

)

 

 

5.34

 

Expired

 

 

(80

)

 

 

6.00

 

Exercised

 

 

(523

)

 

 

3.15

 

Balances at June 30, 2017

 

 

17,662

 

 

 

4.36

 

 

Activity under the Company’s equity incentive plans related to RSUs is set forth below (in thousands except per share amounts):

 

 

 

Number of

Shares

Outstanding

 

 

Weighted

Average

Grant Date

Fair Value

per Share

 

Balances at December 31, 2016

 

 

739

 

 

$

5.26

 

Granted (1)

 

 

918

 

 

 

4.18

 

Forfeited

 

 

(43

)

 

 

4.76

 

Vested

 

 

(251

)

 

 

5.28

 

Balances at June 30, 2017

 

 

1,363

 

 

 

4.54

 

 

 

(1)

Includes the maximum number of shares issuable under the performance-based restricted stock unit awards granted during the six months ended June 30, 2017.

 

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

Note 11. Income Taxes

For the three and six months ended June 30, 2017, the Company recorded a tax expense of $3.9 million, which was primarily due to the sale of the Company’s shares of Aduro. For the three and six months ended June 30, 2016, the Company recorded a tax expense of $1.0 million and $1.8 million, respectively, which was largely the result of changes in the fair value of the Company’s investments, primarily shares in Aduro.

Development and License Agreements
Development and License Agreements

Note 12. Development and License Agreements

Agreements with Fresenius

Fresenius manufactures and supplies the platelet and plasma systems to the Company under a supply agreement. Under the previous agreements with Fresenius, the Company was required to pay royalties to Fenwal Inc. (“Fenwal”), a subsidiary of Fresenius, on INTERCEPT Blood System product sales at royalty rates that varied by product. In addition, 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 pricing was fixed 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 its previous agreements. 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 per unit 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 Fenwal 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 31 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 at that time. The Manufacturing and Development Payments liability is accreted through interest expense based on the estimated timing of its ultimate settlement. As of June 30, 2017, the Company had paid $3.4 million (€3.1 million) and accrued $5.4 million (€4.7 million) related to the Manufacturing and Development Payments, which was included in “Manufacturing and development obligations - non-current” on the Company’s Consolidated Balance Sheets. As of December 31, 2016, the Company had accrued $4.8 million (€4.5 million) related to the Manufacturing and Development Payments, which 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 June 30, 2017 and December 31, 2016, 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” and “Other assets” on the Company’s Consolidated Balance Sheets at $0.2 million and $0.9 million, respectively, and at $2.3 million and $2.0 million, respectively. As of June 30, 2017 and December 31, 2016, the manufacturing efficiency asset was included in “Other assets” on the Company’s Consolidated Balance Sheets at $2.0 million and $2.1 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 $3.2 million and $3.5 million relating to the manufacturing of the Company’s products during the three months ended June 30, 2017 and 2016, respectively. At June 30, 2017 and December 31, 2016, the Company owed Fresenius $2.8 million and $3.0 million, respectively, for INTERCEPT disposable kits manufactured. At June 30, 2017 and December 31, 2016, amounts due from Fresenius were $0.5 million and $0.3 million, respectively, and were included in Other current assets in the Company’s condensed consolidated balance sheet.

Agreement with BARDA

In June 2016, the Company entered into an agreement with the Biomedical Advanced Research and Development Authority (“BARDA”) to support the Company’s development and implementation of pathogen reduction technology for platelet, plasma, and red blood cells.

The five-year agreement with BARDA includes a base period (the “Base Period”) and options (each an “Option Period”) with committed funding of up to $88.2 million for clinical development of the INTERCEPT Blood System for red blood cells (the “red blood cell system”) and subsequent Option Periods that, if exercised by BARDA and completed, would bring the total funding opportunity to $186.2 million over the five-year contract period. If exercised by BARDA, subsequent options would fund activities related to broader implementation of the platelet and plasma system or the red blood cell system in areas of Zika virus risk, clinical and regulatory development programs in support of the potential licensure of the red blood cell system in the U.S., and development, manufacturing and scale-up activities for the red blood cell system. The Company is responsible for co-investment of $5.0 million and would be responsible for an additional $9.6 million, if certain options were to be exercised. BARDA will make periodic assessments of the Company’s progress and the continuation of the agreement is based on the Company’s success in completing the required tasks under the Base Period and each Option Period (if and to the extent any Option Periods are exercised by BARDA). BARDA has rights under certain contract clauses to terminate the agreement, including the ability to terminate the agreement for convenience at any time.

Under the contract, the Company is reimbursed and recognizes revenue as allowable direct contract costs are incurred plus allowable indirect costs, based on approved provisional indirect billing rates, which permit recovery of fringe benefits, overhead and general and administrative expenses. As of June 30, 2017 and December 31, 2016, $1.4 million and $1.0 million, respectively, of billed and unbilled amounts were included in accounts receivable on the Company’s Consolidated Balance Sheets related to BARDA.

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

Note 13. Segment, Customer and Geographic Information

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

The Company’s operations outside of the 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 product revenue, each of which operates in a country outside of the U.S., during the three and six months ended June 30, 2017 and 2016 (in percentages):

 

 

 

Three Months Ended

 

Six Months Ended

 

 

 

June 30,

 

June 30,

 

 

 

2017

 

 

2016

 

2017

 

2016

 

EFS

 

 

13%

 

 

*

 

*

 

*

 

Advanced Technology Comp. KSC

 

 

10%

 

 

*

 

*

 

*

 

Rode Kruis Vlaanderen

 

 

10%

 

 

*

 

*

 

 

10%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

 

 

 

 

 

 

 

 

 

 

 

Subsequent Events
Subsequent Events

Note 14. Subsequent Events

 

Loan and Security Agreement

 

On July 31, 2017, the Company entered into an Amended and Restated Loan and Security Agreement (the “Restated Term Loan Agreement”) with Oxford Finance LLC (“Oxford”), as collateral agent, and the lenders party thereto, which amends and restates in its entirety the Company’s prior Term Loan Agreement (See Note 7). The Restated Term Loan Agreement provides for secured growth capital loans of up to $40.0 million (the “Term Loans”). All of the Company’s current and future assets, excluding its intellectual property and 35% of the Company’s investment in Cerus Europe B.V., are secured for its borrowings under the Restated Term Loan Agreement. On July 31, 2017, the Company received $30.0 million from the first tranche under the Restated Term Loan Agreement, and settled its prior Term Loan Agreement. The second tranche of $10.0 million will be available subject to the Company achieving consolidated trailing six months’ revenue at a specified threshold no later than January 31, 2019. The Term Loans shall be interest-only through February 1, 2019 followed by 42 months of equal principal and interest. However, if the Company draws the Term Loan Two, then the interest-only period will be extended through August 1, 2019, and the amortization period will be reduced to 36 months. All of the Term Loans mature on July 1, 2022 (the “Maturity Date”). The interest rate of the term loans is 6.72% plus the index rate, which is floating and will be reset monthly as the greater of (i) 8.01% and (ii) the sum of the three-month U.S. LIBOR rate plus (b) 6.72%. The Company will also be required to make a final payment fee of 8.00% of the amounts of the Term Loans drawn payable on the earlier of (i) the prepayment of the Term Loans or (ii) the Maturity Date. The term loans contain certain financial covenants.

 

Sales Agreement

 

On August 4, 2017, the Company entered into Amendment No. 3 (“Amendment No. 3”) to the Controlled Equity OfferingSM Sales Agreement, dated August 31, 2012, as previously amended on March 21, 2014 and May 5, 2016 (as amended, the “Amended Cantor Agreement”) with Cantor. In connection with Amendment No. 3, the Company intends to file a new shelf registration statement on Form S-3 (the “New Registration Statement”). Amendment No. 3 will become effective upon the effectiveness of the New Registration Statement. As amended by Amendment No. 3, the Amended Cantor Agreement will provide for the issuance and sale of shares of the Company’s common stock following the effectiveness of the New Registration Statement having an aggregate offering price of up to $70.0 million through Cantor, which amount includes any unsold shares of Common Stock previously available for sale under the Amended Cantor Agreement prior to the effectiveness of the New Registration Statement. The Company can make no assurance regarding the initial or continued effectiveness of the New Registration Statement.

Summary of Significant Accounting Policies (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, or U.S. (“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 and six months ended June 30, 2017, are not necessarily indicative of the results that may be expected for the year ending December 31, 2017, 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, 2016, which were included in the Company’s 2016 Annual Report on Form 10-K, filed with the SEC on March 8, 2017. The accompanying condensed consolidated balance sheet as of December 31, 2016, has been derived from the Company’s audited consolidated financial statements as of that date.

Use of Estimates

The preparation of financial statements requires management to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosures of contingent assets and liabilities. On an ongoing basis, management evaluates its estimates, including those related to the accounts receivable, inventory reserves, fair values of investments, stock-based compensation, intangible assets and goodwill, useful lives of intangible assets and property and equipment, income taxes, and accrued liabilities, among others. The Company bases its estimates on historical experience, future projections, and on various other assumptions that are believed to be reasonable under the circumstances. Actual results may differ from those estimates under different assumptions or conditions.

Revenue

The Company recognizes revenue in accordance with Accounting Standards Codification (“ASC”) Topic 605-25, “Revenue Recognition – Arrangements with Multiple Deliverables,” as applicable. Revenue is recognized when (i) persuasive evidence of the arrangement exists; (ii) delivery has occurred or services have been rendered; (iii) pricing is fixed or determinable; and (iv) collectability is reasonably assured. The Company’s main sources of revenues for the three and six months ended June 30, 2017 and 2016 were product revenue from sales of the INTERCEPT Blood System for platelets and plasma (“platelet and plasma systems” or “disposable kits”) and UVA illumination devices (“illuminators”).

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 product 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.

The Company receives reimbursement under its U.S. government contract that supports research and development of defined projects. The contract generally provides for reimbursement of approved costs incurred under the terms of the contract. Revenue related to the cost reimbursement provisions under the Company’s U.S. government contract are recognized as the qualified direct and indirect costs on the projects are incurred. The Company invoices under its U.S. government contract using the provisional rates in the government contract and thus is subject to future audits at the discretion of government. These audits could result in an adjustment to revenue previously reported, which adjustments potentially could be significant. The Company believes that revenue for periods not yet audited has been recorded in amounts that are expected to be realized upon final audit and settlement. Costs incurred related to services performed under the contract are included as a component of research and development or selling, general and administrative expenses in the Company’s consolidated statements of operations. The Company’s use of estimates in recording accrued liabilities for government contract activities (see “Use of Estimates” above) affects the revenue recorded from development funding and under the government contract.

Research and Development Expenses

In accordance with ASC Topic 730, “Accounting for Research and Development Expenses,” research and development (“R&D”) expenses are charged to expense when incurred, including cost incurred pursuant to the terms of any contract that has been awarded to the Company by the U.S. government. Research and development expenses include salaries and related expenses for scientific and regulatory personnel, payments to consultants, supplies and chemicals used in in-house laboratories, costs of R&D facilities, depreciation of equipment and external contract research expenses, including clinical trials, preclinical safety studies, other laboratory studies, process development and product manufacturing for research use.

The Company’s use of estimates in recording accrued liabilities for R&D activities (see “Use of Estimates” above) affects the amounts of R&D expenses recorded from development funding and under the government contract. 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 and U.S. government agency securities 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”. Available-for-sale securities are carried at estimated fair value. The Company views its available-for-sale portfolio as available for use in its current operations. Unrealized gains and losses derived by changes in the estimated fair value of available-for-sale securities were recorded in “Net unrealized (losses) gains on available-for-sale investments, net of taxes” on the Company’s unaudited condensed consolidated statements of comprehensive loss. Realized gains (losses) from the sale of available-for-sale investments were recorded in “Other income, net” on the Company’s unaudited condensed consolidated statements of operations. The costs of securities sold are based on the specific identification method, if applicable. The Company reported the amortization of any premium and accretion of any discount resulting from the purchase of debt securities as a component of interest income.

The Company also reviews its 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

As of June 30, 2017 and December 31, 2016, the Company had 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 June 30, 2017, 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 three customers that accounted for more than 10% of the Company’s outstanding trade receivables at June 30, 2017 and December 31, 2016. These customers cumulatively represented approximately 46% of the Company’s outstanding trade receivables at both June 30, 2017 and December 31, 2016. To date, the Company has not experienced collection difficulties from these customers.

Inventories

At June 30, 2017 and December 31, 2016, 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 June 30, 2017 and December 31, 2016, 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 product revenue” on the Company’s consolidated statements of operations. At both June 30, 2017 and December 31, 2016, the Company had $0.2 million recorded for potential obsolete, expiring or unsalable product.

Property and Equipment, net

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

Goodwill and Intangible Assets, net

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 goodwill impairment test. The Company may choose not to perform the qualitative assessment to test goodwill for impairment and proceed directly to the quantitative impairment test; however, the Company may revert to the qualitative assessment to test goodwill for impairment in any subsequent period. The quantitative goodwill impairment test 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 considered not impaired. 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, limited to the carrying amount of goodwill in the Company’s one reporting unit.

The Company performs an impairment test on its intangible assets, in accordance ASC Topic 360-10, “Property, Plant and Equipment,” if certain events or changes in circumstances occur which indicate that the carrying amounts of its intangible assets may not be recoverable. If the intangible assets are not recoverable, an impairment loss would be recognized by the Company based on the excess amount of the carrying value of the intangible assets over its fair value. For further details regarding the impairment analysis, reference is made to the section below under “Long-lived Assets.” See Note 4 in the Notes to Unaudited Condensed Consolidated Financial Statements for further information regarding the Company’s impairment analysis and the valuation of goodwill and intangible assets, net.

Long-lived Assets

The Company evaluates its long-lived assets for impairment by continually monitoring events and changes in circumstances that could indicate carrying amounts of its long-lived assets may not be recoverable. When such events or changes in circumstances occur, the Company assesses recoverability by determining whether the carrying value of such assets will be recovered through the undiscounted expected future 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 and six months ended June 30, 2017 and 2016.

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. Product revenues and expenses are remeasured using average exchange rates prevailing during the period. Remeasurements are recorded in the Company’s consolidated statements of operations.

Stock-Based Compensation

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

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

See Note 10 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. Under this method, deferred tax assets and liabilities are determined based on differences between the financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. ASC Topic 740 requires derecognition of tax positions that do not have a greater than 50% likelihood of being recognized upon review by a taxing authority having full knowledge of all relevant information. Use of a valuation allowance as described in ASC Topic 740 is not an appropriate substitute for derecognition of a tax position. The Company recognizes accrued interest and penalties related to unrecognized tax benefits in its income tax expense. To date, the Company has not recognized any interest and penalties in its unaudited condensed consolidated statements of operations, nor has it accrued for or made payments for interest and penalties. Although the Company believes it more likely than not that a taxing authority would agree with its current tax positions, there can be no assurance that the tax positions the Company has taken will be substantiated by a taxing authority if reviewed. The Company’s U.S. federal tax years 1998 through 2015 and California tax years through 2015 remain subject to examination by the taxing jurisdictions due to unutilized net operating losses and research credits. The Company continues to carry a full valuation allowance on all of its net deferred tax assets, except for its indefinite lived intangibles.

Net Loss Per Share

Basic net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding for the period. Diluted net loss per share gives effect to all potentially dilutive common shares outstanding for the period. The potentially dilutive securities include stock options, employee stock purchase plan rights and restricted stock units, which are calculated using the treasury stock method.

For the three and six months ended June 30, 2017 and 2016, all potentially dilutive securities outstanding have been excluded from the computation of dilutive weighted average shares outstanding because such securities have an antidilutive impact due to losses reported.

 

The table below presents shares underlying stock options, restricted stock units, and employee stock purchase plan rights 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 and six months ended June 30, 2017 and 2016 (shares in thousands):

 

 

 

Three Months Ended

 

 

Six Months Ended

 

 

 

June 30,

 

 

June 30,

 

 

 

2017

 

 

2016

 

 

2017

 

 

2016

 

Weighted average number of anti-dilutive potential shares:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock options

 

 

17,966

 

 

 

15,891

 

 

 

17,321

 

 

 

15,331

 

Restricted stock units

 

 

1,350

 

 

 

640

 

 

 

1,159

 

 

 

428

 

Employee stock purchase plan rights

 

 

43

 

 

 

27

 

 

 

75

 

 

 

19

 

Total

 

 

19,359

 

 

 

16,558

 

 

 

18,555

 

 

 

15,778

 

 

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 June 30, 2017 and December 31, 2016.

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. 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), which provides a single comprehensive model for entities to use in accounting for revenue arising from contracts with customers and will supersede most current revenue recognition guidance. This ASU is based on the principle that revenue is recognized to depict the transfer of goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The ASU also requires additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract. In August 2015, the FASB issued ASU No. 2015-14, Revenue from Contracts with Customers (Topic 606), Deferral of the Effective Date, which defers by one year the effective date of ASU No. 2014-09 to annual reporting periods beginning after December 15, 2017 (including interim periods within those periods). Early adoption is permitted to the original effective date of December 15, 2016 (including interim periods within those periods). In March 2016, the FASB issued ASU No. 2016-08, Revenue from Contracts with Customers (Topic 606): Principal versus Agent Considerations (Reporting Revenue Gross versus Net), which clarifies how to identify the unit of accounting for the principal versus agent evaluation and how to apply the control principle to certain types of arrangements. In April 2016, the FASB issued ASU No. 2016-10, Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing, which clarifies the implementation guidance on identifying performance obligations and licensing. In May 2016, the FASB issued ASU No. 2016-12, Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients, which addresses certain issues on assessing collectability, presentation of sales taxes, noncash consideration, and completed contracts and contract modifications at transition. In December 2016, the FASB issued ASU No. 2016-20, Technical Corrections and Improvements to Topic 606, Revenue from Contracts with Customers, which makes technical corrections and improvements to the new revenue standard. These ASUs will be effective for the Company in the first quarter of fiscal year 2018, using one of two retrospective application methods. The Company will adopt this ASU on January 1, 2018, using the modified retrospective approach. To date the Company has primarily derived its revenues from product sales of its INTERCEPT Blood System and reimbursement under its U.S. government contract. The Company has categorized its current revenue streams into homogenous populations based on the terms and conditions included in the contracts of its customers to date. The Company is currently in the process of evaluating the impact of the adoption to the Company’s financial statements as well as the disclosure requirements under the new standard. The Company will continue to monitor industry activities and any additional guidance provided by regulators, standards setters, or the accounting profession as an ongoing component of its assessment and implementation plans.

In January 2016, the FASB issued ASU No. 2016-01, Financial Instruments-Overall (Subtopic 825-10), which requires all equity investments to be measured at fair value with changes in the fair value recognized through net income (other than those accounted for under equity method of accounting or those that result in consolidation of the investee). The amendments also require an entity to present separately in other comprehensive income the portion of the total change in the fair value of a liability resulting from a change in the instrument-specific credit risk when the entity has elected to measure the liability at fair value in accordance with the fair value option for financial instruments. In addition, this ASU eliminates the requirement to disclose the fair value of financial instruments measured at amortized cost for entities that are not public business entities and the requirement to disclose the method(s) and significant assumptions used to estimate the fair value that is required to be disclosed for financial instruments measured at amortized cost on the balance sheet for public business entities. The standard is effective for annual periods beginning after December 15, 2017, and interim periods thereafter, with early application permitted. The Company does not anticipate early adoption of the new standard and is currently assessing the future impact of this ASU on the Company’s consolidated financial statements.

In February 2016, the FASB issued ASU No. 2016-02, Leases, which, for operating leases, requires a lessee to recognize a right-of-use asset and a lease liability, initially measured at the present value of the lease payments, in its balance sheet. The standard also requires a lessee to recognize a single lease cost, calculated so that the cost of the lease is allocated over the lease term, on a generally straight-line basis. The standard is effective for annual periods beginning after December 15, 2018, and interim periods thereafter, with early application permitted. The Company does not anticipate early adoption of the new standard and is currently assessing the future impact of this ASU on its consolidated financial statements. The Company anticipates that the Company’s operating lease commitments will be subject to the new standard and recognized as operating lease liabilities and right-of-use assets upon the adoption of this ASU, which will increase the Company’s total assets and total liabilities.

In March 2016, the FASB issued ASU No. 2016-09, Compensation-Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting, which requires entities to record all excess tax benefits and tax deficiencies as income tax expense or benefit in the income statement when awards vest or are settled, and eliminates additional paid-in capital pools. The ASU also changes the accounting for an employee’s use of shares to satisfy the employer’s statutory income tax withholding obligation, and the accounting for forfeitures, and provides two practical expedients for nonpublic entities. The Company has adopted this ASU in the first quarter of fiscal year 2017 and it did not have a significant impact on the Company’s consolidated financial statements.

In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, which requires measurement and recognition of expected credit losses for financial assets held. The standard is effective for annual periods beginning after December 15, 2019, and interim periods thereafter, with early application permitted. The Company does not anticipate early adoption of the new standard and is currently assessing the future impact of this ASU on the Company’s consolidated financial statements.

In January 2017, the FASB issued ASU No. 2017-04, Intangibles—Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment, which removes Step 2 from the goodwill impairment test and modifies the goodwill impairment to be the amount by which a reporting unit’s carrying value exceeds its fair value, not to exceed the carrying amount of goodwill allocated to that report unit. The standard is effective for annual periods beginning after December 15, 2019, and interim periods thereafter, with early application permitted for impairment tests performed after January 1, 2017. The Company has adopted this ASU in the first quarter of fiscal year 2017 and it had no impact on the Company’s consolidated financial statements.

In May 2017, the FASB issued ASU No. 2017-09, Compensation-Stock Compensation (Topic 718): Scope of Modification Accounting, which provides guidance about which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting in Topic 718. The standard is effective for annual periods beginning after December 15, 2017, and interim periods thereafter, with early application permitted. The Company does not anticipate early adoption of the new standard and is currently assessing the future impact of this ASU on the Company’s consolidated financial statements.

Summary of Significant Accounting Policies (Tables)
Anti-Dilutive Effect of Common Shares

The table below presents shares underlying stock options, restricted stock units, and employee stock purchase plan rights 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 and six months ended June 30, 2017 and 2016 (shares in thousands):

 

 

 

Three Months Ended

 

 

Six Months Ended

 

 

 

June 30,

 

 

June 30,

 

 

 

2017

 

 

2016

 

 

2017

 

 

2016

 

Weighted average number of anti-dilutive potential shares:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock options

 

 

17,966

 

 

 

15,891

 

 

 

17,321

 

 

 

15,331

 

Restricted stock units

 

 

1,350

 

 

 

640

 

 

 

1,159

 

 

 

428

 

Employee stock purchase plan rights

 

 

43

 

 

 

27

 

 

 

75

 

 

 

19

 

Total

 

 

19,359

 

 

 

16,558

 

 

 

18,555

 

 

 

15,778

 

 

Available-for-sale Securities and Fair Value on Financial Instruments (Tables)

The following is a summary of available-for-sale securities at June 30, 2017 (in thousands):

 

 

 

June 30, 2017

 

 

 

Amortized Cost

 

 

Gross

Unrealized Gain

 

 

Gross

Unrealized Loss

 

 

Fair Value

 

Money market funds

 

$

6,143

 

 

$

 

 

$

 

 

$

6,143

 

United States government agency securities

 

 

19,142

 

 

 

1

 

 

 

(14

)

 

 

19,129

 

Corporate debt securities

 

 

12,012

 

 

 

 

 

 

(6

)

 

 

12,006

 

Total available-for-sale securities

 

$

37,297

 

 

$

1

 

 

$

(20

)

 

$

37,278

 

The following is a summary of available-for-sale securities at December 31, 2016 (in thousands):

 

 

 

December 31, 2016

 

 

 

Amortized Cost

 

 

Gross

Unrealized Gain

 

 

Gross

Unrealized Loss

 

 

Fair Value

 

Money market funds

 

$

8,991

 

 

$

 

 

$

 

 

$

8,991

 

United States government agency securities

 

 

8,030

 

 

 

 

 

 

(1

)

 

 

8,029

 

Corporate debt securities

 

 

37,110

 

 

 

 

 

 

(23

)

 

 

37,087

 

Marketable equity securities

 

 

 

 

 

3,952

 

 

 

 

 

 

3,952

 

Total available-for-sale securities

 

$

54,131

 

 

$

3,952

 

 

$

(24

)

 

$

58,059

 

 

Available-for-sale securities at June 30, 2017 and December 31, 2016, consisted of the following by contractual maturity (in thousands):

 

 

 

June 30, 2017

 

 

December 31, 2016

 

 

 

Amortized Cost

 

 

Fair Value

 

 

Amortized Cost

 

 

Fair Value

 

One year or less

 

$

37,297

 

 

$

37,278

 

 

$

54,131

 

 

$

54,107

 

Marketable equity securities

 

 

 

 

 

 

 

 

 

 

 

3,952

 

Greater than one year and less than five years

 

 

 

 

 

 

 

 

 

 

 

 

Total available-for-sale securities

 

$

37,297

 

 

$

37,278

 

 

$

54,131

 

 

$

58,059

 

 

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):

 

 

 

June 30, 2017

 

 

 

Less than 12 Months

 

 

12 Months or Greater

 

 

Total

 

 

 

Fair Value

 

 

Unrealized Loss

 

 

Fair Value

 

 

Unrealized Loss

 

 

Fair Value

 

 

Unrealized Loss

 

United States government

   agency securities

 

$

13,039

 

 

$

(14

)

 

$

 

 

$

 

 

$

13,039

 

 

$

(14

)

Corporate debt securities

 

 

10,505

 

 

 

(6

)

 

 

 

 

 

 

 

 

10,505

 

 

 

(6

)

Total available-for-sale

   securities

 

$

23,544

 

 

$

(20

)

 

$

 

 

$

 

 

$

23,544

 

 

$

(20

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

December 31, 2016

 

 

 

Less than 12 Months

 

 

12 Months or Greater

 

 

Total

 

 

 

Fair Value

 

 

Unrealized Loss

 

 

Fair Value

 

 

Unrealized Loss

 

 

Fair Value

 

 

Unrealized Loss

 

United States government

   agency securities

 

$

6,035

 

 

$

(1

)

 

$

 

 

$

 

 

$

6,035

 

 

$

(1

)

Corporate debt securities

 

 

34,086

 

 

 

(23

)

 

 

 

 

 

 

 

 

34,086

 

 

 

(23

)

Total available-for-sale

   securities

 

$

40,121

 

 

$

(24

)

 

$

 

 

$

 

 

$

40,121

 

 

$

(24

)

 

The fair values of the Company’s financial assets and liabilities were determined using the following inputs at June 30, 2017 (in thousands):

 

 

Balance sheet

 

 

 

 

 

Quoted

Prices in

Active

Markets for Identical

Assets

 

 

Significant

Other

Observable

Inputs

 

 

Significant Unobservable Inputs

 

 

 

classification

 

Total

 

 

(Level 1)

 

 

(Level 2)

 

 

(Level 3)

 

Money market funds

 

Cash and cash equivalents

 

$

6,143

 

 

$

6,143

 

 

$

 

 

$

 

United States government agency securities

 

Short-term investments

 

 

19,129

 

 

 

 

 

 

19,129

 

 

 

 

Corporate debt securities

 

Short-term investments

 

 

12,006

 

 

 

 

 

 

12,006

 

 

 

 

Total financial assets

 

 

 

$

37,278

 

 

$

6,143

 

 

$

31,135

 

 

$

 

 

The fair values of the Company’s financial assets and liabilities were determined using the following inputs at December 31, 2016 (in thousands):

 

 

 

Balance sheet

 

 

 

 

 

Quoted

Prices in

Active

Markets for Identical

Assets

 

 

Significant

Other

Observable

Inputs

 

 

Significant Unobservable Inputs

 

 

 

classification

 

Total

 

 

(Level 1)

 

 

(Level 2)

 

 

(Level 3)

 

Money market funds

 

Cash and cash equivalents

 

$

8,991

 

 

$

8,991

 

 

$

 

 

$

 

United States government agency securities

 

Short-term investments

 

 

8,029

 

 

 

 

 

 

8,029

 

 

 

 

Corporate debt securities

 

Short-term investments

 

 

37,087

 

 

 

 

 

 

37,087

 

 

 

 

Marketable equity securities

 

Marketable equity securities

 

 

3,952

 

 

 

3,952

 

 

 

 

 

 

 

Total financial assets

 

 

 

$

58,059

 

 

$

12,943

 

 

$

45,116

 

 

$

 

 

Inventories (Tables)
Inventories

Inventories at June 30, 2017 and December 31, 2016, consisted of the following (in thousands):

 

 

 

June 30,

 

 

December 31,

 

 

 

2017

 

 

2016

 

Work-in-process

 

$

4,053

 

 

$

5,044

 

Finished goods

 

 

8,160

 

 

 

7,487

 

Total inventories

 

$

12,213

 

 

$

12,531

 

 

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

The following is a summary of intangible assets, net at June 30, 2017 (in thousands):

 

 

 

June 30, 2017

 

 

 

Gross

Carrying

Amount

 

 

Accumulated Amortization

 

 

Net

Carrying

Amount

 

Acquisition-related intangible assets:

 

 

 

 

 

 

 

 

 

 

 

 

Reacquired license - INTERCEPT Asia

 

$

2,017

 

 

$

(1,380

)

 

$

637

 

Total intangible assets

 

$

2,017

 

 

$

(1,380

)

 

$

637

 

 

The following is a summary of intangible assets, net at December 31, 2016 (in thousands):

 

 

 

December 31, 2016

 

 

 

Gross

Carrying

Amount

 

 

Accumulated Amortization

 

 

Net

Carrying

Amount

 

Acquisition-related intangible assets:

 

 

 

 

 

 

 

 

 

 

 

 

Reacquired license - INTERCEPT Asia

 

$

2,017

 

 

$

(1,279

)

 

$

738

 

Total intangible assets

 

$

2,017

 

 

$

(1,279

)

 

$

738

 

 

Accrued Liabilities (Tables)
Accrued Liabilities

Accrued liabilities at June 30, 2017 and December 31, 2016, consisted of the following (in thousands):

 

 

 

June 30,

 

 

December 31,

 

 

 

2017

 

 

2016

 

Accrued compensation and related costs

 

$

5,000

 

 

$

7,098

 

Accrued professional services

 

 

3,707

 

 

 

2,511

 

Accrued customer costs

 

 

456

 

 

 

534

 

Accrued insurance premiums

 

 

 

 

 

476

 

Other accrued expenses

 

 

624

 

 

 

599

 

Total accrued liabilities

 

$

9,787

 

 

$

11,218

 

 

Debt (Tables)

Debt at June 30, 2017, consisted of the following (in thousands):

 

 

 

June 30, 2017

 

 

 

Principal

 

 

Unamortized Discount

 

 

Total

 

Loan and Security Agreement

 

$

17,631

 

 

$

(169

)

 

$

17,462

 

Less: debt - current

 

 

(5,674

)

 

 

126

 

 

 

(5,548

)

Debt - non-current

 

$

11,957

 

 

$

(43

)

 

$

11,914

 

 

 

Debt at December 31, 2016, consisted of the following (in thousands):

 

 

 

December 31, 2016

 

 

 

Principal

 

 

Unamortized Discount

 

 

Net Carrying

Value

 

Loan and Security Agreement

 

$

19,499

 

 

$

(124

)

 

$

19,375

 

Less: debt - current

 

 

(7,013

)

 

 

79

 

 

 

(6,934

)

Debt - non-current

 

$

12,486

 

 

$

(45

)

 

$

12,441

 

 

 

Principal and interest payments on debt at June 30, 2017, are expected to be as follows (in thousands):

 

Year ended December 31,

 

Principal

 

 

Interest

 

 

Total

 

2017

 

$

 

 

$

615

 

 

$

615

 

2018

 

 

11,548

 

 

 

866

 

 

 

12,414

 

2019

 

 

6,083

 

 

 

1,524

 

 

 

7,607

 

Total

 

$

17,631

 

 

$

3,005

 

 

$

20,636

 

 

Stock-Based Compensation (Tables) (2008 Equity Incentive Plan)

Activity under the Company’s equity incentive plans related to stock options is set forth below (in thousands except per share amounts):

 

 

 

Number of

Options Outstanding

 

 

Weighted

Average

Exercise

Price per

Share

 

Balances at December 31, 2016

 

 

15,787

 

 

$

4.39

 

Granted

 

 

3,120

 

 

 

4.23

 

Forfeited

 

 

(642

)

 

 

5.34

 

Expired

 

 

(80

)

 

 

6.00

 

Exercised

 

 

(523

)

 

 

3.15

 

Balances at June 30, 2017

 

 

17,662

 

 

 

4.36

 

 

Activity under the Company’s equity incentive plans related to RSUs is set forth below (in thousands except per share amounts):

 

 

 

Number of

Shares

Outstanding

 

 

Weighted

Average

Grant Date

Fair Value

per Share

 

Balances at December 31, 2016

 

 

739

 

 

$

5.26

 

Granted (1)

 

 

918

 

 

 

4.18

 

Forfeited

 

 

(43

)

 

 

4.76

 

Vested

 

 

(251

)

 

 

5.28

 

Balances at June 30, 2017

 

 

1,363

 

 

 

4.54

 

 

 

(1)

Includes the maximum number of shares issuable under the performance-based restricted stock unit awards granted during the six months ended June 30, 2017.

Segment, Customer and Geographic Information (Tables)
Customer that Accounted for More Than Ten Percent of Total Product Revenue

The Company had the following significant customers that accounted for more than 10% of the Company’s total product revenue, each of which operates in a country outside of the U.S., during the three and six months ended June 30, 2017 and 2016 (in percentages):

 

 

 

Three Months Ended

 

Six Months Ended

 

 

 

June 30,

 

June 30,

 

 

 

2017

 

 

2016

 

2017

 

2016

 

EFS

 

 

13%

 

 

*

 

*

 

*

 

Advanced Technology Comp. KSC

 

 

10%

 

 

*

 

*

 

*

 

Rode Kruis Vlaanderen

 

 

10%

 

 

*

 

*

 

 

10%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

 

 

 

 

 

 

 

 

 

 

 

Summary of Significant Accounting Policies - Additional Information (Detail) (USD $)
3 Months Ended 6 Months Ended 6 Months Ended 12 Months Ended
Jun. 30, 2017
Customer
Jun. 30, 2016
Jun. 30, 2017
Segment
Customer
Jun. 30, 2016
Dec. 31, 2016
Customer
Jun. 30, 2017
Minimum
Jun. 30, 2017
Maximum
Jun. 30, 2017
Trade Accounts Receivable
Customer Concentration Risk
Dec. 31, 2016
Trade Accounts Receivable
Customer Concentration Risk
Summary Of Significant Accounting Policies [Line Items]
 
 
 
 
 
 
 
 
 
Number of major customers representing outstanding trade receivables
 
 
 
 
 
 
Concentration risk, percentage
 
 
 
 
 
 
 
46.00% 
46.00% 
Life of inventory
 
 
2 years 
 
 
 
 
 
 
Protracted length of inventory
 
 
1 year 
 
 
 
 
 
 
Inventory valuation reserves
$ 200,000 
 
$ 200,000 
 
$ 200,000 
 
 
 
 
Estimated useful life of property and equipment
 
 
 
 
 
3 years 
5 years 
 
 
Estimated useful life of intangible assets
 
 
10 years 
 
 
 
 
 
 
Number of reportable segments
 
 
 
 
 
 
 
 
Impairment charges on long-lived assets
 
 
 
 
 
Period of warranty
 
 
1 year 
 
 
 
 
 
 
Warranty claim liability
$ 0 
 
$ 0 
 
$ 0 
 
 
 
 
Shares Underlying Stock Options, Excluded from Calculation of Weighted Average Number of Shares Outstanding used for Calculation of Diluted Net Loss Per Share (Detail)
In Thousands, unless otherwise specified
3 Months Ended 6 Months Ended
Jun. 30, 2017
Jun. 30, 2016
Jun. 30, 2017
Jun. 30, 2016
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
 
 
 
 
Weighted average number of anti-dilutive potential shares
19,359 
16,558 
18,555 
15,778 
Stock Options
 
 
 
 
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
 
 
 
 
Weighted average number of anti-dilutive potential shares
17,966 
15,891 
17,321 
15,331 
Restricted Stock Units
 
 
 
 
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
 
 
 
 
Weighted average number of anti-dilutive potential shares
1,350 
640 
1,159 
428 
Employee Stock Purchase Plan Rights
 
 
 
 
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
 
 
 
 
Weighted average number of anti-dilutive potential shares
43 
27 
75 
19 
Summary of Available-for-Sale Securities (Detail) (USD $)
In Thousands, unless otherwise specified
Jun. 30, 2017
Dec. 31, 2016
Schedule of Available-for-sale Securities [Line Items]
 
 
Amortized Cost
$ 37,297 
$ 54,131 
Gross Unrealized Gain
3,952 
Gross Unrealized Loss
(20)
(24)
Fair Value
37,278 
58,059 
Money market funds
 
 
Schedule of Available-for-sale Securities [Line Items]
 
 
Amortized Cost
6,143 
8,991 
Fair Value
6,143 
8,991 
United States government agency securities
 
 
Schedule of Available-for-sale Securities [Line Items]
 
 
Amortized Cost
19,142 
8,030 
Gross Unrealized Gain
 
Gross Unrealized Loss
(14)
(1)
Fair Value
19,129 
8,029 
Corporate debt securities
 
 
Schedule of Available-for-sale Securities [Line Items]
 
 
Amortized Cost
12,012 
37,110 
Gross Unrealized Loss
(6)
(23)
Fair Value
12,006 
37,087 
Marketable equity securities
 
 
Schedule of Available-for-sale Securities [Line Items]
 
 
Gross Unrealized Gain
 
3,952 
Fair Value
 
$ 3,952 
Available-for-Sale Debt Securities by Original Contractual Maturity (Detail) (USD $)
In Thousands, unless otherwise specified
Jun. 30, 2017
Dec. 31, 2016
Investments Debt And Equity Securities [Abstract]
 
 
One year or less, amortized cost
$ 37,297 
$ 54,131 
Marketable equity securities, amortized cost
Amortized Cost
37,297 
54,131 
One year or less, fair value
37,278 
54,107 
Marketable equity securities, fair value
 
3,952 
Total available-for-sale securities fair value
$ 37,278 
$ 58,059 
Available-for-Sale Marketable Securities in Unrealized Position (Detail) (USD $)
In Thousands, unless otherwise specified
Jun. 30, 2017
Dec. 31, 2016
Schedule of Available-for-sale Securities [Line Items]
 
 
Less than 12 Months, Fair Value
$ 23,544 
$ 40,121 
Less than 12 Months, Unrealized Loss
(20)
(24)
Total, Fair Value
23,544 
40,121 
Total, Unrealized Loss
(20)
(24)
United States government agency securities
 
 
Schedule of Available-for-sale Securities [Line Items]
 
 
Less than 12 Months, Fair Value
13,039 
6,035 
Less than 12 Months, Unrealized Loss
(14)
(1)
Total, Fair Value
13,039 
6,035 
Total, Unrealized Loss
(14)
(1)
Corporate debt securities
 
 
Schedule of Available-for-sale Securities [Line Items]
 
 
Less than 12 Months, Fair Value
10,505 
34,086 
Less than 12 Months, Unrealized Loss
(6)
(23)
Total, Fair Value
10,505 
34,086 
Total, Unrealized Loss
$ (6)
$ (23)
Available-for-sale Securities and Fair Value on Financial Instruments - Additional Information (Detail) (USD $)
3 Months Ended 6 Months Ended
Jun. 30, 2017
Jun. 30, 2016
Jun. 30, 2017
Jun. 30, 2016
Investments Debt And Equity Securities [Abstract]
 
 
 
 
Other-than-temporary impairment losses
$ 0 
$ 0 
$ 0 
$ 0 
Gross realized gains from the sale of available-for-sale investments
3,400,000 
 
3,500,000 
 
Gross realized losses from the sale or maturity of available-for-sale investments
 
$ 0 
 
$ 0 
Fair Values on Financial Assets and Liabilities (Detail) (USD $)
In Thousands, unless otherwise specified
Jun. 30, 2017
Dec. 31, 2016
Fair value of financial assets and liabilities
 
 
Total financial assets
$ 37,278 
$ 58,059 
Money market funds
 
 
Fair value of financial assets and liabilities
 
 
Total financial assets
6,143 
8,991 
United States government agency securities
 
 
Fair value of financial assets and liabilities
 
 
Total financial assets
19,129 
8,029 
United States government agency securities |
Short-term Investments
 
 
Fair value of financial assets and liabilities
 
 
Total financial assets
19,129 
8,029 
Corporate debt securities
 
 
Fair value of financial assets and liabilities
 
 
Total financial assets
12,006 
37,087 
Marketable equity securities
 
 
Fair value of financial assets and liabilities
 
 
Total financial assets
 
3,952 
Level 1
 
 
Fair value of financial assets and liabilities
 
 
Total financial assets
6,143 
12,943 
Level 1 |
Money market funds
 
 
Fair value of financial assets and liabilities
 
 
Total financial assets
6,143 
8,991 
Level 1 |
Marketable equity securities
 
 
Fair value of financial assets and liabilities
 
 
Total financial assets
 
3,952 
Level 2
 
 
Fair value of financial assets and liabilities
 
 
Total financial assets
31,135 
45,116 
Level 2 |
United States government agency securities |
Short-term Investments
 
 
Fair value of financial assets and liabilities
 
 
Total financial assets
19,129 
8,029 
Level 2 |
Corporate debt securities
 
 
Fair value of financial assets and liabilities
 
 
Total financial assets
$ 12,006 
$ 37,087 
Inventories (Detail) (USD $)
In Thousands, unless otherwise specified
Jun. 30, 2017
Dec. 31, 2016
Inventory Disclosure [Abstract]
 
 
Work-in-process
$ 4,053 
$ 5,044 
Finished goods
8,160 
7,487 
Total inventories
$ 12,213 
$ 12,531 
Goodwill and Intangible Assets Net - Additional Information (Detail) (USD $)
3 Months Ended 6 Months Ended
Jun. 30, 2017
Jun. 30, 2016
Jun. 30, 2017
Jun. 30, 2016
Goodwill And Intangible Assets Disclosure [Abstract]
 
 
 
 
Dispose, impair or recognition of additional goodwill
$ 0 
 
$ 0 
 
Impairment losses recognized related to the acquired intangible assets
Annual amortization expense of the intangible assets, 2017 (remaining nine months)
100,000 
 
100,000 
 
Annual amortization expense of the intangible assets, 2018
200,000 
 
200,000 
 
Annual amortization expense of the intangible assets, 2019
200,000 
 
200,000 
 
Annual amortization expense of the intangible assets, 2020
$ 100,000 
 
$ 100,000 
 
Summary of Intangible Assets Net (Detail) (USD $)
In Thousands, unless otherwise specified
Jun. 30, 2017
Dec. 31, 2016
Acquired Finite-Lived Intangible Assets [Line Items]
 
 
Gross Carrying Amount
$ 2,017 
$ 2,017 
Accumulated Amortization
(1,380)
(1,279)
Net Carrying Amount
637 
738 
Reacquired license - INTERCEPT Asia
 
 
Acquired Finite-Lived Intangible Assets [Line Items]
 
 
Gross Carrying Amount
2,017 
2,017 
Accumulated Amortization
(1,380)
(1,279)
Net Carrying Amount
$ 637 
$ 738 
Marketable Equity Investments - Additional Information (Detail) (USD $)
1 Months Ended 6 Months Ended
Apr. 30, 2015
Jun. 30, 2017
Investment [Line Items]
 
 
Carrying value of investment
 
$ 0 
Gain on sale of investment in marketable equity securities
 
3,466,000 
Aduro
 
 
Investment [Line Items]
 
 
Preferred shares converted to common stock
396,700 
 
Gain on sale of investment in marketable equity securities
 
$ 3,500,000 
Common stock, shares outstanding
 
Accrued Liabilities (Detail) (USD $)
In Thousands, unless otherwise specified
Jun. 30, 2017
Dec. 31, 2016
Payables And Accruals [Abstract]
 
 
Accrued compensation and related costs
$ 5,000 
$ 7,098 
Accrued professional services
3,707 
2,511 
Accrued customer costs
456 
534 
Accrued insurance premiums
 
476 
Other accrued expenses
624 
599 
Total accrued liabilities
$ 9,787 
$ 11,218 
Debt (Detail) (USD $)
In Thousands, unless otherwise specified
Jun. 30, 2017
Dec. 31, 2016
Debt Instrument [Line Items]
 
 
Total debt, Principal
$ 17,631 
 
Less: debt-current
(5,548)
(6,934)
Debt-non-current
11,914 
12,441 
Cerus Term Loans
 
 
Debt Instrument [Line Items]
 
 
Total debt, Principal
17,631 
19,499 
Total debt, Unamortized Discount
(169)
(124)
Total debt
17,462 
19,375 
Less: debt - current, Principal
(5,674)
(7,013)
Less: debt - current, Unamortized Discount
126 
79 
Less: debt-current
(5,548)
(6,934)
Debt - non-current, Principal
11,957 
12,486 
Debt - non-current, Unamortized Discount
(43)
(45)
Debt-non-current
$ 11,914 
$ 12,441 
Debt - Principal and Interest Payments on Debt (Detail) (USD $)
In Thousands, unless otherwise specified
Jun. 30, 2017
Debt Disclosure [Abstract]
 
2018, Principal
$ 11,548 
2019, Principal
6,083 
Total, Principal
17,631 
2017, Interest
615 
2018, Interest
866 
2019, Interest
1,524 
Total, Interest
3,005 
2017, Total
615 
2018, Total
12,414 
2019, Total
7,607 
Total
$ 20,636 
Debt - Additional Information (Detail) (USD $)
0 Months Ended 6 Months Ended 0 Months Ended 6 Months Ended 0 Months Ended 6 Months Ended
Apr. 27, 2017
Cerus Term Loans
Jul. 28, 2016
Cerus Term Loans
Jun. 30, 2014
Cerus Term Loans
Tranche
Jun. 30, 2017
Cerus Term Loans
Jul. 31, 2017
Cerus Restated Term Loan Agreement
Subsequent Event
Tranche
Jun. 30, 2017
First Tranche (Term Loan A)
Cerus Term Loans
Jun. 30, 2014
First Tranche (Term Loan A)
Cerus Term Loans
Jul. 31, 2017
First Tranche (Term Loan A)
Cerus Restated Term Loan Agreement
Subsequent Event
Jun. 30, 2017
Second Tranche (Term Loan B)
Cerus Term Loans
Jun. 30, 2014
Second Tranche (Term Loan B)
Cerus Term Loans
Jun. 30, 2014
Securities Pledged as Collateral
Cerus Term Loans
Jul. 31, 2017
Securities Pledged as Collateral
Cerus Restated Term Loan Agreement
Subsequent Event
Line of Credit Facility [Line Items]
 
 
 
 
 
 
 
 
 
 
 
 
Maximum borrowing limit
 
 
$ 30,000,000 
 
$ 40,000,000 
 
 
 
 
 
 
 
Term of agreement
 
 
5 years 
 
5 years 
 
 
 
 
 
 
 
Number of loan tranches
 
 
 
 
 
 
 
 
 
 
 
Loan and security agreement
 
 
 
 
 
 
$ 10,000,000 
$ 30,000,000 
 
$ 10,000,000 
 
 
Borrowing conditions
 
 
 
 
However, if the Company draws the Term Loan Two, then the interest-only period will be extended through August 1, 2019, and the amortization period will be reduced to 36 months. 
 
 
 
The second tranche of $10.0 million (“Term Loan B”) was drawn on June 15, 2015. 
 
 
 
Interest rate
 
 
 
 
 
 
6.95% 
 
7.01% 
 
 
 
Interest rate, description
 
 
 
Term Loan A bore an interest rate of 6.95%. Term Loan B bore an interest rate of 7.01%. 
The interest rate of the term loans is 6.72% plus the index rate, which is floating and will be reset monthly as the greater of (i) 8.01% and (ii) the sum of the three-month U.S. LIBOR rate plus (b) 6.72%. The Company will also be required to make a final payment fee of 8.00% of the amounts of the Term Loans drawn payable on the earlier of (i) the prepayment of the Term Loans or (ii) the Maturity Date. 
 
 
 
 
 
 
 
Maturity period
 
 
 
 
Jul. 01, 2022 
Jun. 01, 2019 
 
 
Jun. 01, 2019 
 
 
 
Principal and interest payments
18 months 
29 months 
36 months 
 
 
 
 
42 months 
 
 
 
 
Final payment term percent
 
 
7.00% 
 
8.00% 
 
 
 
 
 
 
 
Terms of required periodic payments of interest and principal
 
 
 
On September 29, 2015, the Term Loan Agreement was amended to extend (i) the period in which the third tranche could have been drawn and (ii) the interest-only period for all advances under the Term Loan Agreement. The Company was required to make interest only payments through June 2016, followed by thirty-six months of equal principal and interest payments thereafter. On July 28, 2016, the Term Loan Agreement was amended to include an additional interest-only period for all advances under the Term Loan Agreement. As amended, the Company was required to make interest only payments from August 2016 through January 2017, followed by twenty-nine months of equal principal and interest payments thereafter. On April 27, 2017, the Term Loan Agreement was amended to include an additional interest-only period for all advances under the Term Loan Agreement. As amended, the Company was required to make interest only payments from May 2017 through December 2017, followed by eighteen months of equal principal and interest payments thereafter. The Company determined that these amendments to the Term Loan Agreement resulted in debt modifications. As a result, the accounting treatment for the Term Loan continues under the interest method, with a new effective interest rate based on revised cash flows calculated on a prospective basis upon the execution of each of these amendments to the Term Loan Agreement. The Company was 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 Restated Term Loan Agreement provides for secured growth capital loans of up to $40.0 million (the “Term Loans”). All of the Company’s current and future assets, excluding its intellectual property and 35% of the Company’s investment in Cerus Europe B.V., are secured for its borrowings under the Restated Term Loan Agreement. On July 31, 2017, the Company received $30.0 million from the first tranche under the Restated Term Loan Agreement, and settled its prior Term Loan Agreement. The second tranche of $10.0 million will be available subject to the Company achieving consolidated trailing six months’ revenue at a specified threshold no later than January 31, 2019. The Term Loans shall be interest-only through February 1, 2019 followed by 42 months of equal principal and interest. 
 
 
 
 
 
 
 
Percentage of investments made in subsidiary
 
 
 
 
 
 
 
 
 
 
35.00% 
35.00% 
Number of tranches
 
 
 
 
 
 
 
 
 
 
 
Commitments and Contingencies - Additional Information (Detail) (USD $)
In Millions, unless otherwise specified
6 Months Ended 12 Months Ended
Jun. 30, 2017
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
2021 
 
Financing for leasehold improvement
 
$ 1.1 
Outstanding liability related to leasehold improvements
0.3 
 
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
$ 0.2 
 
Stockholders' Equity - Additional Information (Detail) (USD $)
6 Months Ended
Jun. 30, 2017
Jun. 30, 2016
Jun. 30, 2017
Cantor
Sales Agreement
Amendment No. 2
May 5, 2016
Cantor
Sales Agreement
Amendment No. 2
Stockholders Equity Note [Line Items]
 
 
 
 
Maximum common stock offering price
 
 
$ 132,200,000 
 
Common stock registered for sale
 
 
51,400,000 
70,000,000 
Percentage of proceeds payable as compensation to underwriter
 
 
2.00% 
 
Common stock, number of shares issued
 
 
4,200,000 
 
Net proceeds from issuance of common stock
$ 9,644,000 
$ 14,547,000 
$ 10,700,000 
 
Stock-Based Compensation - Additional Information (Detail) (USD $)
In Millions, except Share data, unless otherwise specified
6 Months Ended 0 Months Ended 6 Months Ended 6 Months Ended 6 Months Ended
Jun. 30, 2017
Employee Stock Purchase Plan
Period
Jun. 7, 2017
2008 Equity Incentive Plan
Jun. 10, 2015
2008 Equity Incentive Plan
Jun. 30, 2017
2008 Equity Incentive Plan
Dec. 31, 2016
2008 Equity Incentive Plan
Jun. 12, 2013
2008 Equity Incentive Plan
Jun. 30, 2017
2008 Equity Incentive Plan
Stock Options
Jun. 30, 2017
2008 Equity Incentive Plan
Restricted Stock Units (RSUs)
Dec. 31, 2016
2008 Equity Incentive Plan
Restricted Stock Units (RSUs)
Jun. 30, 2017
2008 Equity Incentive Plan
Performance-based Stock or Cash Awards
Jun. 30, 2017
Cerus Corporation Inducement Plan
Aug. 31, 2016
Cerus Corporation Inducement Plan
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
 
 
 
 
 
 
 
 
 
 
 
 
Stock-based compensation, option to be granted at percentage of fair value of common stock
85.00% 
 
 
100.00% 
 
 
 
 
 
 
 
 
Employee Stock Purchase Plan, offering period
12 months 
 
 
 
 
 
 
 
 
 
 
 
Number of purchase periods within each offering period
 
 
 
 
 
 
 
 
 
 
 
Aggregate number of shares of common stock reserved for future issuance
1,325,010 
 
 
26,400,000 
 
 
 
 
 
 
 
1,250,000 
Employee Stock Purchase Plan, authorized shares for issuance
 
 
 
 
 
19,500,000 
 
 
 
500,000 
 
 
Increase in shares of common stock authorized for issuance
 
6,000,000 
5,000,000 
 
 
 
 
 
 
 
 
 
Stock-based compensation, award term
 
 
 
10 years 
 
 
 
 
 
 
 
 
Stock-based compensation, vesting period
 
 
 
 
 
 
4 years 
3 years 
 
 
 
 
Stock option plan granted on cash award
 
 
 
 
 
 
 
 
 
$ 1.0 
 
 
Share based compensation modification terms
 
 
 
 
 
 
 
 
 
 
Effective June 7, 2017, the Company no longer issues shares from the Inducement Plan. 
 
Outstanding options and other stock based awards
 
 
 
17,662,000 
15,787,000 
 
 
 
 
 
 
 
Number of Restricted Stock Units Outstanding
 
 
 
 
 
 
 
1,363,000 
739,000 
 
 
 
Number of shares available for future issuance
 
 
 
7,300,000 
 
 
 
 
 
 
 
 
Income Taxes - Additional Information (Detail) (USD $)
In Thousands, unless otherwise specified
3 Months Ended 6 Months Ended
Jun. 30, 2017
Jun. 30, 2016
Jun. 30, 2017
Jun. 30, 2016
Income Tax Disclosure [Line Items]
 
 
 
 
Income tax expense
$ 3,876 
$ 983 
$ 3,911 
$ 1,795 
Aduro
 
 
 
 
Income Tax Disclosure [Line Items]
 
 
 
 
Income tax expense
$ 3,900 
$ 1,000 
$ 3,900 
$ 1,800 
Development and License Agreements - Additional Information (Detail)
3 Months Ended 6 Months Ended 1 Months Ended 6 Months Ended 12 Months Ended
Jun. 30, 2017
USD ($)
Jun. 30, 2016
USD ($)
Jun. 30, 2017
BARDA Agreement
USD ($)
Dec. 31, 2016
BARDA Agreement
USD ($)
Jun. 30, 2016
BARDA Agreement
USD ($)
Jun. 30, 2017
Other current assets
USD ($)
Dec. 31, 2016
Other current assets
USD ($)
Jun. 30, 2017
Other assets
USD ($)
Dec. 31, 2016
Other assets
USD ($)
Jun. 30, 2017
Fresenius
USD ($)
Jun. 30, 2016
Cerus Corporation
BARDA Agreement
USD ($)
Jun. 30, 2017
Manufacturing and Supply Agreement
USD ($)
Dec. 31, 2016
Manufacturing and Supply Agreement
USD ($)
Jun. 30, 2017
Manufacturing and Supply Agreement
Fresenius
USD ($)
Jun. 30, 2017
Manufacturing and Supply Agreement
Fresenius
EUR (€)
Dec. 31, 2016
Manufacturing and Supply Agreement
Fresenius
EUR (€)
Dec. 31, 2016
Manufacturing and Supply Agreement
Fresenius
USD ($)
Licenses Agreements [Line Items]
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Payments made based on the successful achievement of production volumes
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
€ 8,600,000 
 
Accrual for manufacturing and development of entity products
 
 
 
 
 
 
 
 
 
 
 
 
 
5,400,000 
4,700,000 
4,500,000 
4,800,000 
Manufacturing and development obligations, discount rate
 
 
 
 
 
 
 
 
 
 
 
 
 
9.72% 
9.72% 
 
 
Manufacturing and development payments
 
 
 
 
 
 
 
 
 
 
 
 
 
3,400,000 
3,100,000 
 
 
Allocated amount for research and development activities
 
 
 
 
 
 
 
 
 
4,800,000 
 
 
 
 
 
 
 
Manufacturing efficiency activity cost
 
 
 
 
 
 
 
 
 
2,400,000 
 
 
 
 
 
 
 
Research and development assets
 
 
 
 
 
200,000 
900,000 
2,300,000 
2,000,000 
 
 
 
 
 
 
 
 
Manufacturing efficiency assets
 
 
 
 
 
 
 
2,000,000 
2,100,000 
 
 
 
 
 
 
 
 
Payments made relating to the manufacturing of the products
3,200,000 
3,500,000 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Accrual for manufacturing of entity products
 
 
 
 
 
 
 
 
 
 
 
2,800,000 
3,000,000 
 
 
 
 
Amounts due from Fresenius
 
 
 
 
 
500,000 
300,000 
 
 
 
 
 
 
 
 
 
 
Committed fund receivable
 
 
 
 
88,200,000 
 
 
 
 
 
 
 
 
 
 
 
 
Committed fund receivable
 
 
 
 
186,200,000 
 
 
 
 
 
 
 
 
 
 
 
 
Period of agreement
 
 
5 years 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Co-investment by the company
 
 
 
 
 
 
 
 
 
 
5,000,000 
 
 
 
 
 
 
Additional co-investment by the company
 
 
 
 
 
 
 
 
 
 
9,600,000 
 
 
 
 
 
 
Accounts receivable of billed and unbilled amounts
 
 
$ 1,400,000 
$ 1,000,000 
 
 
 
 
 
 
 
 
 
 
 
 
 
Segment, Customer and Geographic Information - Additional Information (Detail)
6 Months Ended
Jun. 30, 2017
Segment
Segment Reporting [Abstract]
 
Number of operating segments
Significant Customer that Accounted for More than Ten Percentage of Total Product Revenue (Detail) (Customer Concentration Risk, Sales Revenue, Goods, Net)
3 Months Ended 6 Months Ended
Jun. 30, 2017
Jun. 30, 2016
EFS
 
 
Revenue, Major Customer [Line Items]
 
 
Concentration risk, percentage
13.00% 
 
Advanced Technology Company KSC
 
 
Revenue, Major Customer [Line Items]
 
 
Concentration risk, percentage
10.00% 
 
Rode Kruis Vlaanderen
 
 
Revenue, Major Customer [Line Items]
 
 
Concentration risk, percentage
10.00% 
10.00% 
Subsequent Events - Additional Information (Detail) (Subsequent Event, USD $)
0 Months Ended 0 Months Ended
Aug. 4, 2017
Cantor
Sales Agreement
Amendment No. 3
Jul. 31, 2017
Cerus Restated Term Loan Agreement
Jul. 31, 2017
Cerus Restated Term Loan Agreement
Three-month U.S. LIBOR
Jul. 31, 2017
Cerus Restated Term Loan Agreement
Minimum
Jul. 31, 2017
Cerus Restated Term Loan Agreement
First Tranche
Jul. 31, 2017
Cerus Restated Term Loan Agreement
Second Tranche
Jul. 31, 2017
Cerus Restated Term Loan Agreement
Securities Pledged as Collateral
Subsequent Event [Line Items]
 
 
 
 
 
 
 
Maximum borrowing limit
 
$ 40,000,000 
 
 
 
 
 
Percentage of investments made in subsidiary
 
 
 
 
 
 
35.00% 
Loan and security agreement
 
 
 
 
30,000,000 
 
 
Loan and security agreement available upon revenue achievement
 
 
 
 
 
10,000,000 
 
Interest-only payment date
 
 
 
 
Feb. 01, 2019 
 
 
Principal and interest payments
 
 
 
 
42 months 
 
 
Interest-only period extension date
 
 
 
 
 
Aug. 01, 2019 
 
Amortization Period
 
 
 
 
 
36 months 
 
Maturity period
 
Jul. 01, 2022 
 
 
 
 
 
Debt, applicable margin
 
 
6.72% 
 
 
 
 
Debt instrument floating interest rate percentage
 
 
 
8.01% 
 
 
 
Final payment term percent
 
8.00% 
 
 
 
 
 
Terms of required periodic payments of interest and principal
 
The Restated Term Loan Agreement provides for secured growth capital loans of up to $40.0 million (the “Term Loans”). All of the Company’s current and future assets, excluding its intellectual property and 35% of the Company’s investment in Cerus Europe B.V., are secured for its borrowings under the Restated Term Loan Agreement. On July 31, 2017, the Company received $30.0 million from the first tranche under the Restated Term Loan Agreement, and settled its prior Term Loan Agreement. The second tranche of $10.0 million will be available subject to the Company achieving consolidated trailing six months’ revenue at a specified threshold no later than January 31, 2019. The Term Loans shall be interest-only through February 1, 2019 followed by 42 months of equal principal and interest. 
 
 
 
 
 
Borrowing conditions
 
However, if the Company draws the Term Loan Two, then the interest-only period will be extended through August 1, 2019, and the amortization period will be reduced to 36 months. 
 
 
 
 
 
Interest rate, description
 
The interest rate of the term loans is 6.72% plus the index rate, which is floating and will be reset monthly as the greater of (i) 8.01% and (ii) the sum of the three-month U.S. LIBOR rate plus (b) 6.72%. The Company will also be required to make a final payment fee of 8.00% of the amounts of the Term Loans drawn payable on the earlier of (i) the prepayment of the Term Loans or (ii) the Maturity Date. 
 
 
 
 
 
Common stock registered for sale
$ 70,000,000