CORINDUS VASCULAR ROBOTICS, INC., 10-Q filed on 5/10/2016
Quarterly Report
Document and Entity Information
3 Months Ended
Mar. 31, 2016
May 6, 2016
Document And Entity Information [Abstract]
 
 
Entity Central Index Key
0001528557 
 
Entity Registrant Name
Corindus Vascular Robotics, Inc. 
 
Document Type
10-Q 
 
Amendment Flag
false 
 
Document Period End Date
Mar. 31, 2016 
 
Trading Symbol
CVRS 
 
Current Fiscal Year End Date
--12-31 
 
Entity Well-known Seasoned Issuer
No 
 
Entity Current Reporting Status
Yes 
 
Entity Voluntary Filers
No 
 
Entity Filer Category
Accelerated Filer 
 
Entity Common Stock, Shares Outstanding
 
118,934,152 
Document Fiscal Period Focus
Q1 
 
Document Fiscal Year Focus
2016 
 
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (USD $)
In Thousands, unless otherwise specified
Mar. 31, 2016
Dec. 31, 2015
Current Assets:
 
 
Cash and cash equivalents
$ 23,639 
$ 22,142 
Marketable securities
11,677 
20,524 
Accounts receivable
1,271 
878 
Inventories, net
1,465 
1,329 
Due from related party
125 
 
Prepaid expenses and other current assets
352 
591 
Total current assets
38,529 
45,464 
Property and equipment, net
1,150 
1,382 
Deposits and other assets
155 
157 
Notes receivable due from stockholders
71 
136 
Total assets
39,905 
47,139 
Current liabilities:
 
 
Accounts payable
1,995 
1,538 
Accrued expenses
2,080 
1,199 
Deferred revenue
631 
701 
Current portion of long-term debt
4,212 
4,033 
Total current liabilities
8,918 
7,471 
Long-term liabilities:
 
 
Deferred revenue, net of current portion
198 
106 
Other liabilities
33 
42 
Long-term debt, net of current portion
2,575 
3,673 
Total long-term liabilities
2,806 
3,821 
Total liabilities
11,724 
11,292 
Commitments and Contingencies
 
   
Stockholders' equity:
 
 
Preferred stock, $0.0001 par value; 10,000,000 shares authorized; none issued and outstanding
 
   
Common stock, $0.0001 par value; 250,000,000 shares authorized; 118,832,441 shares and issued and outstanding at December 31, 2015 and 119,682,994 shares and issued and outstanding at March 31, 2016
12 
12 
Additional paid-in capital
149,432 
149,489 
Accumulated other comprehensive inceome (loss)
(14)
Accumulated deficit
(121,267)
(113,640)
Total stockholders' equity
28,181 
35,847 
Total liabilities and stockholders' equity
$ 39,905 
$ 47,139 
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (Parenthetical) (USD $)
Mar. 31, 2016
Dec. 31, 2015
Statement of Financial Position [Abstract]
 
 
Preferred stock, par value
$ 0.0001 
$ 0.0001 
Preferred stock, authorized shares
10,000,000 
10,000,000 
Preferred stock, issued shares
Preferred stock, outstanding shares
Common stock, par value
$ 0.0001 
$ 0.0001 
Common stock, authorized shares
250,000,000 
250,000,000 
Common stock, issued shares
119,682,994 
118,832,441 
Common stock, outstanding shares
119,682,994 
118,832,441 
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Unaudited) (USD $)
In Thousands, except Share data, unless otherwise specified
3 Months Ended
Mar. 31, 2016
Mar. 31, 2015
Income Statement [Abstract]
 
 
Revenue
$ 1,108 
$ 776 
Cost of revenue
1,078 
801 
Gross loss
30 
(25)
Operating expenses:
 
 
Research and development
2,310 
2,763 
Selling, general and administrative
4,965 
3,984 
Total operating expenses
7,275 
6,747 
Operating loss
(7,245)
(6,772)
Other income (expense):
 
 
Interest and other income (expense)
(382)
(397)
Total other expense, net
(382)
(397)
Net loss
(7,627)
(7,169)
Net loss per share-basic and diluted
$ (0.06)
$ (0.07)
Weighted-average common shares used in computing net loss per share-basic and diluted
119,046,243 
105,883,157 
Other comprehensive loss:
 
 
Net loss
(7,627)
(7,169)
Unrealized gain on marketable securities
18 
 
Comprehensive loss
$ (7,609)
$ (7,169)
CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS' EQUITY (Unaudited) (USD $)
In Thousands, except Share data
Common Stock [Member]
Additional Paid-in Capital [Member]
Accumulated Other Comprehensive Loss [Member]
Accumnulated Deficit [Member]
Total
Beginning balance at Dec. 31, 2015
$ 12 
$ 149,489 
$ (14)
$ (113,640)
$ 35,847 
Beginning balance, shares at Dec. 31, 2015
118,832,441 
 
 
 
 
Stock-based compensation expense
 
346 
 
 
346 
Issuance of common stock upon exercise of stock options
 
(403)
 
 
(403)
Issuance of common stock upon exercise of stock options, shares
762,092 
 
 
 
 
Issuance of common stock upon exercise of warrants, shares
88,461 
 
 
 
 
Change in fair value of marketable securities
 
 
18 
 
18 
Net loss
 
 
 
(7,627)
(7,627)
Ending balance at Mar. 31, 2016
$ 12 
$ 149,432 
$ 4 
$ (121,267)
$ 28,181 
Ending balance, shares at Mar. 31, 2016
119,682,994 
 
 
 
 
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) (USD $)
In Thousands, unless otherwise specified
3 Months Ended
Mar. 31, 2016
Mar. 31, 2015
Operating activities
 
 
Net loss
$ (7,627)
$ (7,169)
Adjustments to reconcile net loss to net cash flows used in operating activities:
 
 
Loss on disposal of fixed assets
41 
 
Depreciation and amortization
209 
166 
Stock-based compensation expense
346 
98 
Accretion on interest expense
130 
158 
Accretion on available-for-sale securities
(8)
 
Changes in operating assets and liabilities:
 
 
Accounts receivable
(393)
251 
Prepaid expenses and other current assets
239 
41 
Deferred inventory costs
   
102 
Inventories
(136)
(213)
Deposits and other assets
48 
Due from related party
(125)
(125)
Accounts payable, accrued expenses and other liabilities
919 
508 
Deferred revenue
22 
(223)
Net cash used in operating activities
(6,381)
(6,358)
Investing activities
 
 
Maturities of available-for-sale securities
8,873 
 
Collections of notes receivable
65 
 
Purchases of property and equipment
(18)
(103)
Net cash provided by (used in) investing activities
8,920 
(103)
Financing activities
 
 
Payments of financing costs from issuance of long-term debt and warrants
 
(50)
Proceeds from exercise of stock options
 
Payments on long term debt
(1,049)
 
Net cash used in financing activities
(1,042)
(50)
Net increase (decease) in cash and cash equivalents
1,497 
(6,511)
Cash and cash equivalents at beginning of period
22,142 
28,526 
Cash and cash equivalents at end of period
23,639 
22,015 
Supplemental Disclosure of Cash Flow Information:
 
 
Transfer from inventories to property and equipment in the field
 
92 
Deferred public offering costs in accounts payable and accrued expenses
 
41 
Accrued statutory minimum withholding taxes on stock option exercises
410 
 
Interest paid
$ 170 
$ 225 
Nature of Operations
Nature of Operations
Note 1 Nature of Operations

 

The Company

 

Corindus Vascular Robotics, Inc. (the “Company”), a Nevada corporation (formerly named Your Internet Defender, Inc. (“YIDI”)), acquired Corindus, Inc., a privately-held company, in a reverse acquisition on August 12, 2014. The Company’s corporate headquarters and research and development facility are in Waltham, Massachusetts and the Company is engaged in the design, manufacture and sale of precision vascular robotic-assisted systems (“CorPath System”) for use in interventional vascular procedures.

 

Since its inception on March 21, 2002, the Company has devoted its efforts principally to research and development, business development activities, and raising capital. In July 2012, the Company received clearance from the United States Food and Drug Administration (“FDA”) to market its CorPath System in the United States and shipped its first commercial product under this clearance in September 2012. In 2013, the Company moved into the growth stage, investing in sales and marketing in order to build its customer base. While the Company is initially cleared for and is targeting percutaneous coronary intervention (“PCI”) procedures, the Company believes its technology platform has the capability to be developed in the future for other segments of the vascular market, including neurointerventional and other more complex cardiac interventions, such as structural heart.

 

In October 2015, the Company announced that the FDA had given 510(k) clearance for its robotic-assisted CorPath System to be used during percutaneous coronary interventions performed via radial access. The 510(k) clearance was based on results of a clinical trial conducted at Spectrum Health, Grand Rapids, Michigan, and St. Joseph’s Hospital Health Center, Syracuse, New York.

 

On March 29, 2016, the Company announced that the FDA had given 510(k) clearance for its robotic-assisted CorPath System for use in peripheral vascular interventions. This 510(k) clearance for peripheral intervention was based on results of a clinical trial known as the RAPID (Robotic-assisted Peripheral Intervention for Peripheral Artery Disease) Study conducted at Medical University Graz in Austria.

 

The Company’s future capital requirements will depend upon many factors, including progress with developing, manufacturing and marketing its technologies, the time and costs involved in preparing, filing, prosecuting, maintaining and enforcing patent claims and other proprietary rights, its ability to establish collaborative arrangements, marketing activities and competing technological and market developments, including regulatory changes affecting medical procedure reimbursement, and overall economic conditions in the Company’s target markets.

 

Liquidity

 

The Company has incurred losses since inception and has funded its operations primarily through the issuance of capital stock and debt. As of March 31, 2016, the Company had an accumulated deficit of $121,267, and net borrowings outstanding of $6,796, of which $4,217 is contractually due over the next 12 months.

 

The Company has cash, cash equivalents and marketable securities of $35,316 and working capital of $29,606. The Company believes that these available resources will be sufficient to meet the Company’s cash requirements through at least the next twelve months, including funding its anticipated losses and scheduled debt maturities. Additionally, the Company is in compliance with its debt covenant requirements as of March 31, 2016 and expects to remain in compliance over the next 12 months. As the Company continues to incur losses, a transition to profitability is dependent upon achieving a level of revenues adequate to support the Company’s cost structure. The Company may never achieve profitability, and unless and until doing so, intends to fund future operations through additional debt or equity offerings. There can be no assurances, however, that additional funding will be available on terms acceptable to the Company, if at all.

Significant Accounting Policies
Significant Accounting Policies
Note 2 Significant Accounting Policies

 

Basis of Presentation

 

In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all adjustments, consisting of normal recurring adjustments, necessary for a fair presentation of the Company’s financial statements for interim periods in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”). The information included in this quarterly report on Form 10-Q should be read in conjunction with the audited consolidated financial statements and the accompanying notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015 (“2015 Form 10-K”). The Company’s accounting policies are described in the “Notes to Consolidated Financial Statements” in the 2015 Form 10-K and are updated, as necessary, in this Form 10-Q. The year-end condensed consolidated balance sheet data presented for comparative purposes was derived from the audited financial statements, but does not include all disclosures required by U.S. GAAP. The results of operations for the three months ended March 31, 2016 are not necessarily indicative of the operating results for the full year or for any other subsequent interim period.

 

Principles of Consolidation

 

The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries, Corindus, Inc. and Corindus Security Corporation. All intercompany transactions and balances have been eliminated in consolidation. The functional currency of both wholly-owned subsidiaries is the U.S. dollar and, therefore, the Company has not recorded any currency translation adjustments.

 

In the fourth quarter of 2014, the Company participated in the formation of a not-for-profit, which was established to generate awareness of the health risks linked to the use of fluoroscopy in hospital catheterization. As of May 4, 2016, the Company’s Chief Executive Officer and one of its senior executives represented two of the four voting members of the board of directors of the entity. As a result, under the voting model used for the consolidation of related parties, which are controlled by a company, the Company has consolidated the financial statements of the entity, and recognized expenses of $104 and $42 for the three months ended March 31, 2015 and 2016, respectively.  The entity had assets and liabilities of $11 and $19 respectively, on the Company’s balance sheet at March 31, 2016 and $56 and $75, respectively, on its balance sheet at December 31, 2015. 

 

Reclassification

 

Certain amounts as of December 31, 2015 have been reclassified to confirm to the current year presentation.  As a result of the adoption of ASU 2015-03, Interest - Imputation of Interest, the Company has adopted this guidance retrospectively and reclassified the unamortized deferred financing costs from deposits and other assets to current portion of long-term debt, net of current portion, on the condensed consolidated balance sheets.

 

Segment Information

 

The Company operates in one business segment, which is the development, marketing and sale of robotic-assisted vascular interventions. Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker in making decisions regarding resource allocation and assessing performance. To date, the chief operating decision maker has made such decisions and assessed performance at the company level, as one segment. The Company’s chief operating decision maker is the Chief Executive Officer.

 

Use of Estimates

 

The process of preparing financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of assets and liabilities at the date of the financial statements. Such management estimates include those relating to revenue recognition, inventory valuation, assumptions used in the valuation of stock-based awards, and valuation allowances against deferred income tax assets. Actual results could differ from those estimates.

 

Significant Customers

 

The Company had the following customers that accounted for greater than 10% of its revenues for the quarters ended March 31, 2015 and 2016, respectively:

    Three months ended March 31,
Customer   2015   2016
A   29%    
B   28%    
C   16%   11%
D       71%

 

The Company had two other customers that accounted for 76% of the accounts receivable balance at December 31, 2015. Additionally, Customer D and one other customer comprised 88% of the accounts receivable balance at March 31, 2016, exclusive of amounts due from related party, which are disclosed in Note 7.

Fair Value Measurements

 

In accordance with ASC 820, Fair Value Measurements and Disclosures, the Company generally defines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date (exit price). The Company uses a three-tier fair value hierarchy, which classifies the inputs used in measuring fair values. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to unobservable inputs (Level 3 measurements). The three levels of the fair value hierarchy are described below:

 

· Level 1inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date.

 

· Level 2—inputs are inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. If the asset or liability has a specified (contractual) term, a Level 2 input must be observable for substantially the full term of the asset or liability.

 

· Level 3—inputs are unobservable inputs for the asset or liability in which there is little, if any, market activity for the asset or liability at the measurement date.

 

The following table sets forth the Company’s assets that are measured at fair value on a recurring basis, by measurement category:

 

    December 31, 2015  
    Total     Quoted prices
active markets
(Level 1)
    Significant
other
observable
inputs 
(Level 2)
    Significant
unobservable
inputs
(Level 3)
 
Assets:                                
   Cash equivalents   $ 6,356     $ 6,107     $ 249     $  
   Marketable securities                                
      U.S. government treasuries     15,876       15,876              
      Certificates of deposit     4,648             4,648        
Total assets   $ 26,880     $ 21,983     $ 4,897     $  

 

    March 31, 2016  
    Total     Quoted prices
active markets
(Level 1)
    Significant
other
observable
inputs
(Level 2)
    Significant
unobservable
inputs
(Level 3)
 
Assets:                                
   Cash equivalents   $ 6,107     $ 6,107     $     $  
   Marketable securities                                
      U.S. government treasuries     9,194       9,194              
      Certificates of deposit     2,483             2,483        
Total assets   $ 17,784     $ 15,301     $ 2,483     $  

 

The Company’s financial instruments of deposits and notes receivable are carried at cost and approximate their fair values given the liquid nature of such items. The fair value of the Company’s long-term debt is calculated based on discounted cash flow analysis, which includes Level 3 inputs and fair value approximates recorded amounts.

 

Cash Equivalents

 

The Company considers highly liquid short-term investments, which consists of money market funds and certificates of deposits with original maturity dates of three months or less at the date of purchase to be cash equivalents. From time to time, the Company’s cash balances may exceed federal deposit insurance limits.

 

Marketable Securities

 

The Company determines the appropriate classification of marketable securities at the time of purchase and reevaluates such designation at each balance sheet date. The Company has classified all of its marketable securities at March 31, 2016 as “available-for-sale” pursuant to ASC 320, Investments – Debt and Equity Securities. The Company records available-for-sale securities at fair value, with the unrealized gains and losses included in accumulated other comprehensive gain (loss) in stockholders’ equity.

 

The Company adjusts the cost of available-for-sale debt securities for amortization of premiums and accretion of discounts to maturity. The Company includes such amortization and accretion in interest and other income (expense). The cost of securities sold is based on the specific identification method. The Company includes interest income on securities classified as available-for-sale in interest and other income (expense).

 

The Company reviews marketable securities for other-than-temporary impairment whenever the fair value of a marketable security is less than the amortized cost and evidence indicates that a marketable security’s carrying amount is not recoverable within a reasonable period of time. Other-than-temporary impairments of investments are recognized in the consolidated statements of operations if the Company has experienced a credit loss, has the intent to sell the marketable security, or if it is more likely than not that the Company will be required to sell the marketable security before recovery of the amortized cost basis.

 

At March 31, 2016, the balance in the Company’s accumulated other comprehensive loss was composed solely of activity related to the Company’s available-for-sale securities. There were no realized gains or losses recognized on the maturity of available-for-sale securities during the three months ended March 31, 2016, and as a result, the Company did not reclassify any amount out of accumulated other comprehensive income during that same period.

 

The Company did not hold any securities with a fair value in an unrealized loss position as of March 31, 2016.  No available-for-sale securities held as of March 31, 2016 have remaining maturities greater than one year. The Company determined that there was no material change in the credit risk of the above investments. As a result, the Company determined it did not hold any investments with an other-than-temporary impairment as of March 31, 2016.

 

The following table summarizes available-for-sale securities held:

 

    Amortized Cost     Unrealized Gain     Unrealized Loss     Fair Value  
                         
December 31, 2015                                
                                 
U.S. government treasuries   $ 15,885     $ 1     $ (10 )   $ 15,876  
Certificates of deposit     4,653             (5 )     4,648  
Total assets   $ 20,538     $ 1     $ (15 )   $ 20,524  

  

    Amortized Cost     Unrealized Gain     Unrealized Loss     Fair Value  
                         
March 31, 2016                                
                                 
U.S. government treasuries   $ 9,193     $ 1     $     $ 9,194  
Certificates of deposit     2,480       3             2,483  
Total assets   $ 11,673     $ 4     $     $ 11,677  

 

Certain short-term securities with original maturities of less than 90 days are included in cash and cash equivalents on the consolidated balance sheet at December 31, 2015 and are not included in the table above.

 

Inventories

 

Inventories are valued at the lower of cost or market using the first-in, first-out (“FIFO”) method. The Company routinely monitors the recoverability of its inventory and records the lower of cost or market reserves based on current selling prices and reserves for excess and obsolete inventory based on historical and forecasted usage, as required. Scrap and excess manufacturing costs are charged to cost of revenue as incurred and not capitalized as part of inventories. The Company only capitalizes pre-launch inventories when purchased for commercial use and it deems regulatory approval to be probable.

 

Revenue Recognition

 

The CorPath System is a capital medical device used by hospitals and surgical centers to perform heart catheterizations. Use of the CorPath System requires a sterile, single-use cassette (the “CorPath Cassette”), which are sold separately, for each procedure. Products are sold to customers with no rights of return. The Company recognizes revenue on the sale of products when the following criteria are met:

 

· Persuasive evidence of an arrangement exists
· The price to the buyer is fixed or determinable
· Collectability is reasonably assured
· Risk of loss transfers and the product is delivered

 

In each arrangement, the Company is responsible for installation of the CorPath System and initial user training, which services are deemed essential to the functionality of the system. Therefore, the Company recognizes system revenue when the CorPath System is delivered and installed, and accepted by the end user customer.

 

Each CorPath System is sold with a standard one year warranty, which provides that the CorPath System will function as intended and during that one year period, the Company will either replace the product or a portion thereof or provide the necessary repair service during the Company’s normal service hours. The Company accrues for the estimated costs of the warranty once the CorPath System revenue is recognized.

 

The Company generally enters into multiple element arrangements, which include the sale of a CorPath System with an initial order of CorPath Cassettes, and may include either a basic service plan or a premium service plan. The basic service plan provides for an extended warranty period and the premium service plan provides for the extended warranty as well as component upgrades, when and if they become available during the service plan period. Deliverables, which are accounted for as separate units of accounting under multiple-element arrangements include: (a) the CorPath System, including installation and initial training, which are subject to customer acceptance and (b) the initial shipment of CorPath Cassettes to the customer, and may include either (c) an extended warranty or (d) component upgrades.

 

The Company recognizes revenue on multiple-element arrangements in accordance with Accounting Standards Update (“ASU”) 2009-13, Revenue Recognition (Topic 605): Multiple Deliverable Revenue Arrangements, based on the estimated selling price of each element. In accordance with ASU 2009-13, the Company uses vendor-specific objective evidence (“VSOE”), if available, to determine the selling price of each element. If VSOE is not available, the Company uses third-party evidence (“TPE”) to determine the selling price. If TPE is not available, the Company uses its best estimate to develop the estimated selling price (“BESP”). The Company uses BESP to determine the selling price of its systems as well as the basic and premium service plans. BESP is determined based on estimated costs plus a reasonable margin, and has generally been consistent with the price charged to the customer for such products and services. The determination of BESP also considers the price of the service plans charged to customers when such services are sold separately in subsequent transactions. The Company also uses BESP to determine the selling price of the initial order of cassettes, which considers the price at which it charges its customers when the cassettes are sold separately.

 

Revenue related to basic service plans is recognized on a straight-line basis over the life of the service contract. Revenue related to premium service plans is recognized over the life of the service contract, with consideration given to the expected timing of costs to be incurred related to the delivery of component upgrades. Revenues from accessories are recorded upon delivery and services provided by the Company outside of a basic or premium service contract are recognized as the services are provided.

 

There are no performance, cancellation, termination, or refund-type provisions under the Company’s multiple element arrangements.

 

On January 21, 2011, the Company entered into a distributor agreement with Philips Medical Systems Nederland, B.V. (“Philips”) appointing Philips to be the sole worldwide distributor for the promotion and sale of the Company’s CorPath System. Under the agreement, Philips sold the equipment directly to the end user and the Company was responsible for installation and initial training. Revenue was recognized on a net basis based on the amount billed to Philips and upon acceptance of the system by the end-user customer. This agreement with Philips expired on August 7, 2014. The Company continues to sell CorPath Systems through Philips on a sale by sale basis under a non-exclusive arrangement under mutually agreeable terms, which may include a continued level of discounted pricing, until such time the Company either executes a new distribution arrangement with Philips or the Company no longer does business with Philips. At December 31, 2015, there were no amounts outstanding from Philips and at March 31, 2016, there was $125 outstanding from Philips included in due from related party in the accompanying condensed consolidated balance sheet.

 

The Company also sells CorPath Cassettes under a CorPath Utilization Program (“CUP”), which is a multi-year arrangement that involves the placement of a CorPath System at a customer’s site free of charge and the customer agrees to purchase a minimum number of CorPath Cassettes each month at a premium over the regular price. The Company records revenue upon shipment of the cassettes based on the selling price of the CorPath Cassettes. The system is capitalized as field equipment in property and equipment and is depreciated on a straight line basis through cost of revenue over the estimated useful life of the system, which generally approximates the length of the CUP program contract, which is typically 36 months.

 

The Company also uses a One-Stent program to demonstrate its confidence in the CorPath System’s ability to help accurately measure anatomy and precisely place only one stent per lesion. The Company provides eligible customers registered under the program a $1 credit against future CorPath Cassette purchases for a qualifying CorPath PCI procedure which uses more than one stent per lesion. The estimated cost of honoring the potential obligation under the stent program is recorded as a reduction of revenue at the time of shipment. These costs have not been significant to date.

 

The Company records shipping and handling costs as a selling expense in the period incurred, and records payments from customers for shipping costs as a reduction of selling expenses. Such amounts have not been material in the periods presented.

 

Warrants

 

The Company reviews the terms of warrants issued in connection with the applicable accounting guidance and classifies warrants as a long-term liability on the consolidated balance sheets if the warrant may conditionally obligate the Company to transfer assets, including repurchase of the Company’s capital stock, at some point in the future. Warrants to purchase shares of redeemable convertible preferred stock had previously met these criteria and therefore required liability-classification. Liability-classified warrants are subject to re-measurement at each balance sheet date, and any change in fair value is recognized as a component of other income (expense) in the consolidated statements of operations. The Company classifies warrants within stockholders’ equity on the consolidated balance sheets if the warrants are considered to be indexed to the Company’s own capital stock, and otherwise would be recorded in stockholders’ equity.

 

During the quarter ended March 31, 2016, warrants to purchase 124,160 shares of the Company’s common stock at an exercise price of approximately $0.76 per share were exercised on a cashless basis resulting in the issuance of 88,461 shares of common stock during the first quarter.

 

The table below is a summary of the Company’s warrant activity during the three months ended March 31, 2016:

 

    Number of warrants   Weighted-average exercise price
Outstanding at December 31, 2015     5,207,379     $ 1.08  
Granted     —        —   
Exercised     (124,160 )     0.76  
Expired     —        —   
Outstanding at March 31, 2016     5,083,219     $ 1.08  

 

Stock-Based Compensation

 

The Company recognizes compensation costs resulting from the issuance of stock-based awards to employees and directors as an expense in the consolidated statements of operations over the requisite service period based on a measurement of fair value for each stock award. The awards issued to date have been stock options with service-based vesting periods over two or four years. The Company recognizes compensation costs resulting from the issuance of stock-based awards to non-employees as an expense in the consolidated statements of operations over the service period based on a measurement of fair value for each stock award at each performance date and period end.

 

Income Taxes

 

The Company accounts for income taxes using the liability method, whereby deferred tax asset and liability account balances are determined based on differences between financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates that will be in effect when the differences are expected to reverse. The Company provides a valuation allowance, if necessary, to reduce deferred tax assets to amounts that are realizable. Consistent with all prior periods, the Company did not record any income tax benefit for its operating losses for the three months ended March 31, 2015 and 2016 due to uncertainty regarding future taxable income.

 

Comprehensive Loss

 

Comprehensive loss is comprised of net loss and changes in the unrealized gains and losses on marketable securities. Accumulated other comprehensive income (loss), a component of stockholders’ equity, is comprised of the cumulative unrealized gains and/or losses from the change in fair market value of the Company’s marketable securities. Accumulated other comprehensive loss was $14 at December 31, 2015 and accumulated other comprehensive income was $4 as of March 31, 2016.

 

New Accounting Pronouncements

 

Except as described below, there have been no new accounting pronouncements or changes to accounting pronouncements during the three months ended March 31, 2016, as compared to the recent accounting pronouncements described in Note 2 of the Company's Annual Report on Form 10-K for the year ended December 31, 2015, that are of significance or potential significance to the Company.     

 

In August 2014, the FASB issued ASU 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern. The amendments in this update will explicitly require a company’s management to assess an entity’s ability to continue as a going concern, and to provide related footnote disclosures in certain circumstances. The new standard will be effective for annual period ending after December 15, 2016, and all annual and interim periods thereafter. Early application is permitted. If this update had been adopted as of March 31, 2016, the Company believes that it would have concluded there was not substantial doubt about its ability to continue as a going concern.  However, the Company faces certain risks and uncertainties, as further described in Note 1, Nature of Operations, that could have affected this analysis.

 

In January 2015, the FASB issued Financial Accounting Standards Update—Simplifying Income Statement Presentation by Eliminating the Concept of Extraordinary Items. Subtopic 225-20, Income Statement—Extraordinary and Unusual Items, previously required that an entity separately classify, present, and disclose extraordinary events and transactions. This update is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2015 and may be applied prospectively or retrospectively to all prior periods presented in the financial statements. The Company adopted this update in the first quarter of 2016 and it had no impact to its consolidated financial statements or disclosures.

 

In February 2015, the FASB issued ASU 2015-02, Consolidation (Topic 810) to address financial reporting considerations for the evaluation as to the requirement to consolidate certain legal entities. ASU 2015-02 is effective for fiscal years and for interim periods within those fiscal years beginning after December 15, 2015. The Company adopted this update in the first quarter of 2016 and it had no impact to its consolidated financial statements or disclosures.

 

In April 2015, the FASB issued ASU 2015-03, Interest—Imputation of Interest (Subtopic 835-30) as part of the initiative to reduce complexity in accounting standards. The update requires that debt issuance costs related to a recognized debt liability be presented in the balance sheet as a direct deduction from the carrying amount of that debt liability, consistent with debt discounts. ASU 2015-03 is effective for annual periods beginning after December 15, 2015 and for interim periods within those fiscal years. The Company adopted this update in the first quarter of 2016. The adoption resulted in the reclassification of current and long-term debt issuance costs from deposits and other assets to current portion of long-term debt and long-term debt, net of current portion, at December 31, 2015 and at March 31, 2016.

 

In March 2016, the FASB issued ASU 2016-09, Compensation-Stock Compensation (Topic 718), which simplifies several aspects of accounting for share-based payment transactions. It is effective for fiscal years, and interim periods within those years, beginning after December 15, 2016 and, depending on the amendment, must be applied using a prospective transition method, retrospective transition method, modified retrospective transition method, prospectively and/or retroactively, with early adoption permitted. The Company is currently evaluating the impact of this update on its consolidated financial statements.

Inventories
Inventories
Note 3 Inventories

 

Inventories are valued at the lower of cost or market using the FIFO method and consist of the following:

 

    December 31, 2015     March 31, 2016  
Raw material   $ 483     $ 630  
Work in progress     79       35  
Finished goods     767       800  
     Total   $ 1,329     $ 1,465  

 

Long-Term Debt
Long-Term Debt
Note 4 Long-Term Debt

 

On June 11, 2014, the Company entered into a Loan and Security Agreement pursuant to which the lender agreed to make available to the Company $10,000 in two separate $5,000 loans under secured promissory notes. The initial note was made on June 11, 2014 in an aggregate principal amount equal to $5,000 (the “Initial Promissory Note”) and is repayable in equal monthly installments of principal and interest over 27 months beginning on July 1, 2015. Prior to July 1, 2015, the Company was required to make interest only payments. The Initial Promissory Note bears interest at a rate equal to the greater of (a) 11.25% or (b) 11.25% plus the Wall Street Journal Prime Rate, less 3.25%, and includes an additional interest payment of $125 due no later than October 1, 2017, which is accreted over the term of the loan. The effective interest rate of the Initial Promissory Note was 11.50% at March 31, 2016.

 

On December 31, 2014, the Company borrowed the additional $5,000 (the “Second Promissory Note”) under the Loan and Security Agreement. The Second Promissory note is also repayable in equal monthly installments of principal and interest over 27 months beginning on July 1, 2015. Prior to July 1, 2015, the Company is required to make interest only payments. The Second Promissory Note bears interest at a rate equal to the greater of (a) 9.95% or (b) 9.95% plus the Wall Street Journal Prime Rate, less 3.25%, and also includes an additional interest payment of $125 due no later than October 1, 2017, which is accreted over the term of the loan. The effective interest rate of the Second Promissory Note was 10.20% at March 31, 2016. The notes are secured by substantially all the assets of the Company.

 

In connection with the Initial Promissory Note, the Company issued the lender warrants to purchase 177,514 shares of the Company’s common stock at an exercise price of $1.41 per share. The fair value of the warrant issued to the lender was determined to be $230 at the date of issuance, and was recorded as a discount on the debt. Additionally, in connection with the Second Promissory Note, the Company issued the lender warrants to purchase 177,514 shares of the Company’s common stock at an exercise price of $1.41 per share. The fair value of the warrant issued to the lender was determined to be $619 at the date of issuance, and was recorded as a discount on the debt. The Company amortizes the debt discount to interest expense over the term of the debt using the effective interest method.

 

The Loan and Security Agreement also contains covenants which include certain restrictions with respect to subsequent indebtedness, liens, loans and investments, asset sales and share repurchases and other restricted payments, subject to certain exceptions. The Loan and Security Agreement also contains financial reporting obligations. An event of default under the Loan and Security Agreement includes, but is not limited to, breach of covenants, insolvency, and occurrence of any default under any agreement or obligation of the Company. In addition, the Loan and Security Agreement contains a customary material adverse effect clause which states that in the event of a material adverse effect, an event of default would occur and the lender has the option to accelerate and demand payment of all or any part of the loan. A material adverse effect is defined in the Loan and Security Agreement as a material change in the Company’s business, operations, properties, assets or financial condition or a material impairment of its ability to perform all obligations under its Loan and Security Agreement. The Company was not in default of any conditions under the Loan and Security Agreements as of March 31, 2016.

 

Stock-based Compensation
Stock-based Compensation
Note 5 Stock-based Compensation

 

Stock-based compensation expense was allocated based on the employees’ or non-employees’ function as follows:

 

    Three Months Ended March 31,  
    2015     2016  
Research and development   $ 17     $ 33  
Selling, general and administrative     81       313  
     Total   $ 98     $ 346  

 

The Company granted options to purchase 117,500 shares of common stock at an exercise price of $4.25 per share during the three months ended March 31, 2015. The Company granted options to purchase 8,366,906 shares of common stock at exercise prices ranging from $0.99 to $2.03 per share during the three months ended March 31, 2016. The weighted-average fair value of the stock options granted was $2.94 per share and $0.72 per share for the three months ended March 31, 2015 and 2016, respectively.

 

The following assumptions were used to estimate the fair value of stock options granted using the Black-Scholes Merton option-pricing model (“Black Scholes Model”):

 

    Three Months Ended March 31,
    2015   2016
Risk-free interest     1.28 %     1.44%-1.58 %
Expected term in years     6.25       6.08  
Expected volatility     80 %     52 %
Expected dividend yield     0 %     0 %

 

Net Loss per Share
Net Loss per Share
Note 6 Net Loss per Share

 

Basic net loss per share is computed by dividing net loss by the weighted average shares of common stock outstanding for each period. Diluted net loss per share is the same as basic net loss per share since the Company has net losses for each period presented. The following common stock equivalents were excluded from the calculation of diluted net loss per share for the periods indicated because including them would have had an anti-dilutive effect:

 

    Three Months Ended March 31,  
    2015     2016  
Options to purchase common stock     8,779,622       13,703,113  
Warrants to purchase common stock     5,207,379       5,083,219  
     Total     13,987,001       18,786,332  

 

Related Party Transactions
Related Party Transactions
Note 7 Related Party Transactions

 

Philips Medical Systems Nederland B.V.

 

On January 21, 2011, Corindus, Inc. entered into a distributor agreement with Philips, a shareholder of the Company and represented on the Company’s board of directors, appointing Philips to be a distributor for the promotion and sale of the Company’s CorPath System. This agreement provided that it would remain in force for two years from (a) the later of FDA approval of the CorPath System or (b) the date of notification by the Company to Philips of minimum inventory levels available for shipment. As required by the agreement, the Company notified Philips on August 7, 2012 of the commencement of the two-year term and the distribution agreement expired on August 7, 2014. The Company continues to sell CorPath Systems through Philips on a sale by sale basis under a non-exclusive arrangement under mutually agreeable terms, which may include a continued level of discounted pricing, until such time the Company either executes a new distribution arrangement with Philips or the Company no longer does business with Philips.

 

For both the three month periods ended March 31, 2015 and 2016, the Company recorded revenues of $125 from shipments to Philips. At December 31, 2015 and March 31, 2016, Philips owed the Company $0 and $125, respectively, resulting from selling activity under the agreement.

 

Shareholder Loans

 

On June 14, 2010, the Company loaned funds to certain stockholders of the Company for tax payments to be made to the Israel Tax Authority in connection with a tax ruling related to a reorganization that took place in 2008 and the Company received non-interest bearing notes receivable, which documented such loans. Total amount of notes receivable issued was $145.

 

The notes receivable are repayable upon the disposition of the Company’s common stock by the existing shareholder. Notes receivable amounted to $136 and $71 at December 31, 2015 and March 31, 2016, respectively. The Company assessed the notes receivable for impairment and concluded that there were no impairment indicators at December 31, 2015 and March 31, 2016. The Company does not believe there is any significant collection risk associated with the notes receivable at March 31, 2016.

 

Significant Accounting Policies (Policies)

Principles of Consolidation

 

The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries, Corindus, Inc. and Corindus Security Corporation. All intercompany transactions and balances have been eliminated in consolidation. The functional currency of both wholly-owned subsidiaries is the U.S. dollar and, therefore, the Company has not recorded any currency translation adjustments.

 

In the fourth quarter of 2014, the Company participated in the formation of a not-for-profit, which was established to generate awareness of the health risks linked to the use of fluoroscopy in hospital catheterization. As of May 4, 2016, the Company’s Chief Executive Officer and one of its senior executives represented two of the four voting members of the board of directors of the entity. As a result, under the voting model used for the consolidation of related parties, which are controlled by a company, the Company has consolidated the financial statements of the entity, and recognized expenses of $104 and $42 for the three months ended March 31, 2015 and 2016, respectively.  The entity had assets and liabilities of $11 and $19 respectively, on the Company’s balance sheet at March 31, 2016 and $56 and $75, respectively, on its balance sheet at December 31, 2015. 

 

Reclassification

 

Certain amounts as of December 31, 2015 have been reclassified to confirm to the current year presentation.  As a result of the adoption of ASU 2015-03, Interest - Imputation of Interest, the Company has adopted this guidance retrospectively and reclassified the unamortized deferred financing costs from deposits and other assets to current portion of long-term debt, net of current portion, on the condensed consolidated balance sheets.

Segment Information

 

The Company operates in one business segment, which is the development, marketing and sale of robotic-assisted vascular interventions. Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker in making decisions regarding resource allocation and assessing performance. To date, the chief operating decision maker has made such decisions and assessed performance at the company level, as one segment. The Company’s chief operating decision maker is the Chief Executive Officer.

Use of Estimates

 

The process of preparing financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of assets and liabilities at the date of the financial statements. Such management estimates include those relating to revenue recognition, inventory valuation, assumptions used in the valuation of stock-based awards, and valuation allowances against deferred income tax assets. Actual results could differ from those estimates.

 

Significant Customers

 

The Company had the following customers that accounted for greater than 10% of its revenues for the quarters ended March 31, 2015 and 2016, respectively:

    Three months ended March 31,
Customer   2015   2016
A   29%    
B   28%    
C   16%   11%
D       71%

 

The Company had two other customers that accounted for 76% of the accounts receivable balance at December 31, 2015. Additionally, Customer D and one other customer comprised 88% of the accounts receivable balance at March 31, 2016, exclusive of amounts due from related party, which are disclosed in Note 7.

Fair Value Measurements

 

In accordance with ASC 820, Fair Value Measurements and Disclosures, the Company generally defines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date (exit price). The Company uses a three-tier fair value hierarchy, which classifies the inputs used in measuring fair values. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to unobservable inputs (Level 3 measurements). The three levels of the fair value hierarchy are described below:

 

· Level 1inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date.

 

· Level 2—inputs are inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. If the asset or liability has a specified (contractual) term, a Level 2 input must be observable for substantially the full term of the asset or liability.

 

· Level 3—inputs are unobservable inputs for the asset or liability in which there is little, if any, market activity for the asset or liability at the measurement date.

 

The following table sets forth the Company’s assets that are measured at fair value on a recurring basis, by measurement category:

 

    December 31, 2015  
    Total     Quoted prices
active markets
(Level 1)
    Significant
other
observable
inputs 
(Level 2)
    Significant
unobservable
inputs
(Level 3)
 
Assets:                                
   Cash equivalents   $ 6,356     $ 6,107     $ 249     $  
   Marketable securities                                
      U.S. government treasuries     15,876       15,876              
      Certificates of deposit     4,648             4,648        
Total assets   $ 26,880     $ 21,983     $ 4,897     $  

 

    March 31, 2016  
    Total     Quoted prices
active markets
(Level 1)
    Significant
other
observable
inputs
(Level 2)
    Significant
unobservable
inputs
(Level 3)
 
Assets:                                
   Cash equivalents   $ 6,107     $ 6,107     $     $  
   Marketable securities                                
      U.S. government treasuries     9,194       9,194              
      Certificates of deposit     2,483             2,483        
Total assets   $ 17,784     $ 15,301     $ 2,483     $  

 

The Company’s financial instruments of deposits and notes receivable are carried at cost and approximate their fair values given the liquid nature of such items. The fair value of the Company’s long-term debt is calculated based on discounted cash flow analysis, which includes Level 3 inputs and fair value approximates recorded amounts.

 

Cash Equivalents

 

The Company considers highly liquid short-term investments, which consists of money market funds and certificates of deposits with original maturity dates of three months or less at the date of purchase to be cash equivalents. From time to time, the Company’s cash balances may exceed federal deposit insurance limits.

 

Marketable Securities

 

The Company determines the appropriate classification of marketable securities at the time of purchase and reevaluates such designation at each balance sheet date. The Company has classified all of its marketable securities at March 31, 2016 as “available-for-sale” pursuant to ASC 320, Investments – Debt and Equity Securities. The Company records available-for-sale securities at fair value, with the unrealized gains and losses included in accumulated other comprehensive gain (loss) in stockholders’ equity.

 

The Company adjusts the cost of available-for-sale debt securities for amortization of premiums and accretion of discounts to maturity. The Company includes such amortization and accretion in interest and other income (expense). The cost of securities sold is based on the specific identification method. The Company includes interest income on securities classified as available-for-sale in interest and other income (expense).

 

The Company reviews marketable securities for other-than-temporary impairment whenever the fair value of a marketable security is less than the amortized cost and evidence indicates that a marketable security’s carrying amount is not recoverable within a reasonable period of time. Other-than-temporary impairments of investments are recognized in the consolidated statements of operations if the Company has experienced a credit loss, has the intent to sell the marketable security, or if it is more likely than not that the Company will be required to sell the marketable security before recovery of the amortized cost basis.

 

At March 31, 2016, the balance in the Company’s accumulated other comprehensive loss was composed solely of activity related to the Company’s available-for-sale securities. There were no realized gains or losses recognized on the maturity of available-for-sale securities during the three months ended March 31, 2016, and as a result, the Company did not reclassify any amount out of accumulated other comprehensive income during that same period.

 

The Company did not hold any securities with a fair value in an unrealized loss position as of March 31, 2016.  No available-for-sale securities held as of March 31, 2016 have remaining maturities greater than one year. The Company determined that there was no material change in the credit risk of the above investments. As a result, the Company determined it did not hold any investments with an other-than-temporary impairment as of March 31, 2016.

 

The following table summarizes available-for-sale securities held:

 

    Amortized Cost     Unrealized Gain     Unrealized Loss     Fair Value  
                         
December 31, 2015                                
                                 
U.S. government treasuries   $ 15,885     $ 1     $ (10 )   $ 15,876  
Certificates of deposit     4,653             (5 )     4,648  
Total assets   $ 20,538     $ 1     $ (15 )   $ 20,524  

  

    Amortized Cost     Unrealized Gain     Unrealized Loss     Fair Value  
                         
March 31, 2016                                
                                 
U.S. government treasuries   $ 9,193     $ 1     $     $ 9,194  
Certificates of deposit     2,480       3             2,483  
Total assets   $ 11,673     $ 4     $     $ 11,677  

 

Certain short-term securities with original maturities of less than 90 days are included in cash and cash equivalents on the consolidated balance sheet at December 31, 2015 and are not included in the table above.

 

Inventories

 

Inventories are valued at the lower of cost or market using the first-in, first-out (“FIFO”) method. The Company routinely monitors the recoverability of its inventory and records the lower of cost or market reserves based on current selling prices and reserves for excess and obsolete inventory based on historical and forecasted usage, as required. Scrap and excess manufacturing costs are charged to cost of revenue as incurred and not capitalized as part of inventories. The Company only capitalizes pre-launch inventories when purchased for commercial use and it deems regulatory approval to be probable.

 

Revenue Recognition

 

The CorPath System is a capital medical device used by hospitals and surgical centers to perform heart catheterizations. Use of the CorPath System requires a sterile, single-use cassette (the “CorPath Cassette”), which are sold separately, for each procedure. Products are sold to customers with no rights of return. The Company recognizes revenue on the sale of products when the following criteria are met:

 

· Persuasive evidence of an arrangement exists

· The price to the buyer is fixed or determinable

· Collectability is reasonably assured

· Risk of loss transfers and the product is delivered

 

In each arrangement, the Company is responsible for installation of the CorPath System and initial user training, which services are deemed essential to the functionality of the system. Therefore, the Company recognizes system revenue when the CorPath System is delivered and installed, and accepted by the end user customer.

 

Each CorPath System is sold with a standard one year warranty, which provides that the CorPath System will function as intended and during that one year period, the Company will either replace the product or a portion thereof or provide the necessary repair service during the Company’s normal service hours. The Company accrues for the estimated costs of the warranty once the CorPath System revenue is recognized.

 

The Company generally enters into multiple element arrangements, which include the sale of a CorPath System with an initial order of CorPath Cassettes, and may include either a basic service plan or a premium service plan. The basic service plan provides for an extended warranty period and the premium service plan provides for the extended warranty as well as component upgrades, when and if they become available during the service plan period. Deliverables, which are accounted for as separate units of accounting under multiple-element arrangements include: (a) the CorPath System, including installation and initial training, which are subject to customer acceptance and (b) the initial shipment of CorPath Cassettes to the customer, and may include either (c) an extended warranty or (d) component upgrades.

 

The Company recognizes revenue on multiple-element arrangements in accordance with Accounting Standards Update (“ASU”) 2009-13, Revenue Recognition (Topic 605): Multiple Deliverable Revenue Arrangements, based on the estimated selling price of each element. In accordance with ASU 2009-13, the Company uses vendor-specific objective evidence (“VSOE”), if available, to determine the selling price of each element. If VSOE is not available, the Company uses third-party evidence (“TPE”) to determine the selling price. If TPE is not available, the Company uses its best estimate to develop the estimated selling price (“BESP”). The Company uses BESP to determine the selling price of its systems as well as the basic and premium service plans. BESP is determined based on estimated costs plus a reasonable margin, and has generally been consistent with the price charged to the customer for such products and services. The determination of BESP also considers the price of the service plans charged to customers when such services are sold separately in subsequent transactions. The Company also uses BESP to determine the selling price of the initial order of cassettes, which considers the price at which it charges its customers when the cassettes are sold separately.

 

Revenue related to basic service plans is recognized on a straight-line basis over the life of the service contract. Revenue related to premium service plans is recognized over the life of the service contract, with consideration given to the expected timing of costs to be incurred related to the delivery of component upgrades. Revenues from accessories are recorded upon delivery and services provided by the Company outside of a basic or premium service contract are recognized as the services are provided.

 

There are no performance, cancellation, termination, or refund-type provisions under the Company’s multiple element arrangements.

 

On January 21, 2011, the Company entered into a distributor agreement with Philips Medical Systems Nederland, B.V. (“Philips”) appointing Philips to be the sole worldwide distributor for the promotion and sale of the Company’s CorPath System. Under the agreement, Philips sold the equipment directly to the end user and the Company was responsible for installation and initial training. Revenue was recognized on a net basis based on the amount billed to Philips and upon acceptance of the system by the end-user customer. This agreement with Philips expired on August 7, 2014. The Company continues to sell CorPath Systems through Philips on a sale by sale basis under a non-exclusive arrangement under mutually agreeable terms, which may include a continued level of discounted pricing, until such time the Company either executes a new distribution arrangement with Philips or the Company no longer does business with Philips. At December 31, 2015, there were no amounts outstanding from Philips and at March 31, 2016, there was $125 outstanding from Philips included in due from related party in the accompanying condensed consolidated balance sheet.

 

The Company also sells CorPath Cassettes under a CorPath Utilization Program (“CUP”), which is a multi-year arrangement that involves the placement of a CorPath System at a customer’s site free of charge and the customer agrees to purchase a minimum number of CorPath Cassettes each month at a premium over the regular price. The Company records revenue upon shipment of the cassettes based on the selling price of the CorPath Cassettes. The system is capitalized as field equipment in property and equipment and is depreciated on a straight line basis through cost of revenue over the estimated useful life of the system, which generally approximates the length of the CUP program contract, which is typically 36 months.

 

The Company also uses a One-Stent program to demonstrate its confidence in the CorPath System’s ability to help accurately measure anatomy and precisely place only one stent per lesion. The Company provides eligible customers registered under the program a $1 credit against future CorPath Cassette purchases for a qualifying CorPath PCI procedure which uses more than one stent per lesion. The estimated cost of honoring the potential obligation under the stent program is recorded as a reduction of revenue at the time of shipment. These costs have not been significant to date.

 

The Company records shipping and handling costs as a selling expense in the period incurred, and records payments from customers for shipping costs as a reduction of selling expenses. Such amounts have not been material in the periods presented.

 

Warrants

 

The Company reviews the terms of warrants issued in connection with the applicable accounting guidance and classifies warrants as a long-term liability on the consolidated balance sheets if the warrant may conditionally obligate the Company to transfer assets, including repurchase of the Company’s capital stock, at some point in the future. Warrants to purchase shares of redeemable convertible preferred stock had previously met these criteria and therefore required liability-classification. Liability-classified warrants are subject to re-measurement at each balance sheet date, and any change in fair value is recognized as a component of other income (expense) in the consolidated statements of operations. The Company classifies warrants within stockholders’ equity on the consolidated balance sheets if the warrants are considered to be indexed to the Company’s own capital stock, and otherwise would be recorded in stockholders’ equity.

 

During the quarter ended March 31, 2016, warrants to purchase 124,160 shares of the Company’s common stock at an exercise price of approximately $0.76 per share were exercised on a cashless basis resulting in the issuance of 88,461 shares of common stock during the first quarter.

 

The table below is a summary of the Company’s warrant activity during the three months ended March 31, 2016:

 

    Number of warrants   Weighted-average exercise price
Outstanding at December 31, 2015     5,207,379     $ 1.08  
Granted     —         —    
Exercised     (124,160 )     0.76  
Expired     —         —    
Outstanding at March 31, 2016     5,083,219     $ 1.08  

 

Stock-Based Compensation

 

The Company recognizes compensation costs resulting from the issuance of stock-based awards to employees and directors as an expense in the consolidated statements of operations over the requisite service period based on a measurement of fair value for each stock award. The awards issued to date have been stock options with service-based vesting periods over two or four years. The Company recognizes compensation costs resulting from the issuance of stock-based awards to non-employees as an expense in the consolidated statements of operations over the service period based on a measurement of fair value for each stock award at each performance date and period end.

 

Income Taxes

 

The Company accounts for income taxes using the liability method, whereby deferred tax asset and liability account balances are determined based on differences between financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates that will be in effect when the differences are expected to reverse. The Company provides a valuation allowance, if necessary, to reduce deferred tax assets to amounts that are realizable. Consistent with all prior periods, the Company did not record any income tax benefit for its operating losses for the three months ended March 31, 2015 and 2016 due to uncertainty regarding future taxable income.

Comprehensive Loss

 

Comprehensive loss is comprised of net loss and changes in the unrealized gains and losses on marketable securities. Accumulated other comprehensive income (loss), a component of stockholders’ equity, is comprised of the cumulative unrealized gains and/or losses from the change in fair market value of the Company’s marketable securities. Accumulated other comprehensive loss was $14 at December 31, 2015 and accumulated other comprehensive income was $4 as of March 31, 2016.

 

New Accounting Pronouncements

 

Except as described below, there have been no new accounting pronouncements or changes to accounting pronouncements during the three months ended March 31, 2016, as compared to the recent accounting pronouncements described in Note 2 of the Company's Annual Report on Form 10-K for the year ended December 31, 2015, that are of significance or potential significance to the Company.     

 

In August 2014, the FASB issued ASU 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern. The amendments in this update will explicitly require a company’s management to assess an entity’s ability to continue as a going concern, and to provide related footnote disclosures in certain circumstances. The new standard will be effective for annual period ending after December 15, 2016, and all annual and interim periods thereafter. Early application is permitted. If this update had been adopted as of March 31, 2016, the Company believes that it would have concluded there was not substantial doubt about its ability to continue as a going concern.  However, the Company faces certain risks and uncertainties, as further described in Note 1, Nature of Operations, that could have affected this analysis.

 

In January 2015, the FASB issued Financial Accounting Standards Update—Simplifying Income Statement Presentation by Eliminating the Concept of Extraordinary Items. Subtopic 225-20, Income Statement—Extraordinary and Unusual Items, previously required that an entity separately classify, present, and disclose extraordinary events and transactions. This update is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2015 and may be applied prospectively or retrospectively to all prior periods presented in the financial statements. The Company adopted this update in the first quarter of 2016 and it had no impact to its consolidated financial statements or disclosures.

 

In February 2015, the FASB issued ASU 2015-02, Consolidation (Topic 810) to address financial reporting considerations for the evaluation as to the requirement to consolidate certain legal entities. ASU 2015-02 is effective for fiscal years and for interim periods within those fiscal years beginning after December 15, 2015. The Company adopted this update in the first quarter of 2016 and it had no impact to its consolidated financial statements or disclosures.

 

In April 2015, the FASB issued ASU 2015-03, Interest—Imputation of Interest (Subtopic 835-30) as part of the initiative to reduce complexity in accounting standards. The update requires that debt issuance costs related to a recognized debt liability be presented in the balance sheet as a direct deduction from the carrying amount of that debt liability, consistent with debt discounts. ASU 2015-03 is effective for annual periods beginning after December 15, 2015 and for interim periods within those fiscal years. The Company adopted this update in the first quarter of 2016. The adoption resulted in the reclassification of current and long-term debt issuance costs from deposits and other assets to current portion of long-term debt and long-term debt, net of current portion, at December 31, 2015 and at March 31, 2016.

 

In March 2016, the FASB issued ASU 2016-09, Compensation-Stock Compensation (Topic 718), which simplifies several aspects of accounting for share-based payment transactions. It is effective for fiscal years, and interim periods within those years, beginning after December 15, 2016 and, depending on the amendment, must be applied using a prospective transition method, retrospective transition method, modified retrospective transition method, prospectively and/or retroactively, with early adoption permitted. The Company is currently evaluating the impact of this update on its consolidated financial statements.

Significant Accounting Policies (Tables)

The Company had the following customers that accounted for greater than 10% of its revenues for the quarters ended March 31, 2015 and 2016, respectively:

    Three months ended March 31,
Customer   2015   2016
A   29%    
B   28%    
C   16%   11%
D       71%

 

The following table sets forth the Company’s assets that are measured at fair value on a recurring basis, by measurement category:

 

    December 31, 2015  
    Total     Quoted prices
active markets
(Level 1)
    Significant
other
observable
inputs 
(Level 2)
    Significant
unobservable
inputs
(Level 3)
 
Assets:                                
   Cash equivalents   $ 6,356     $ 6,107     $ 249     $  
   Marketable securities                                
      U.S. government treasuries     15,876       15,876              
      Certificates of deposit     4,648             4,648        
Total assets   $ 26,880     $ 21,983     $ 4,897     $  

 

    March 31, 2016  
    Total     Quoted prices
active markets
(Level 1)
    Significant
other
observable
inputs
(Level 2)
    Significant
unobservable
inputs
(Level 3)
 
Assets:                                
   Cash equivalents   $ 6,107     $ 6,107     $     $  
   Marketable securities                                
      U.S. government treasuries     9,194       9,194              
      Certificates of deposit     2,483             2,483        
Total assets   $ 17,784     $ 15,301     $ 2,483     $  

 

The following table summarizes available-for-sale securities held:

 

    Amortized Cost     Unrealized Gain     Unrealized Loss     Fair Value  
                         
December 31, 2015                                
                                 
U.S. government treasuries   $ 15,885     $ 1     $ (10 )   $ 15,876  
Certificates of deposit     4,653             (5 )     4,648  
Total assets   $ 20,538     $ 1     $ (15 )   $ 20,524  

  

    Amortized Cost     Unrealized Gain     Unrealized Loss     Fair Value  
                         
March 31, 2016                                
                                 
U.S. government treasuries   $ 9,193     $ 1     $     $ 9,194  
Certificates of deposit     2,480       3             2,483  
Total assets   $ 11,673     $ 4     $     $ 11,677  

 

The table below is a summary of the Company’s warrant activity during the three months ended March 31, 2016:

 

    Number of warrants   Weighted-average exercise price
Outstanding at December 31, 2015     5,207,379     $ 1.08  
Granted     —        —   
Exercised     (124,160 )     0.76  
Expired     —        —   
Outstanding at March 31, 2016     5,083,219     $ 1.08  

 

Inventories (Tables)
Schedule of Inventories

Inventories are valued at the lower of cost or market using the FIFO method and consist of the following:

 

    December 31, 2015     March 31, 2016  
Raw material   $ 483     $ 630  
Work in progress     79       35  
Finished goods     767       800  
     Total   $ 1,329     $ 1,465  

 

Stock-based Compensation (Tables)
Stock-based compensation expense was allocated based on the employees’ or non-employees’ function as follows:

 

    Three Months Ended March 31,  
    2015     2016  
Research and development   $ 17     $ 33  
Selling, general and administrative     81       313  
     Total   $ 98     $ 346  

 

The following assumptions were used to estimate the fair value of stock options granted using the Black-Scholes Merton option-pricing model (“Black Scholes Model”):

 

    Three Months Ended March 31,
    2015   2016
Risk-free interest     1.28 %     1.44%-1.58 %
Expected term in years     6.25       6.08  
Expected volatility     80 %     52 %
Expected dividend yield     0 %     0 %

 

Net Loss per Share (Tables)
Schedule of Securities Excluded from Computation of Net Loss per Share

The following common stock equivalents were excluded from the calculation of diluted net loss per share for the periods indicated because including them would have had an anti-dilutive effect:

 

    Three Months Ended March 31,  
    2015     2016  
Options to purchase common stock     8,779,622       13,703,113  
Warrants to purchase common stock     5,207,379       5,083,219  
     Total     13,987,001       18,786,332  

 

Nature of Operations - additonal information (Detail) (USD $)
In Thousands, unless otherwise specified
Mar. 31, 2016
Organization, Consolidation and Presentation of Financial Statements [Abstract]
 
Cash, cash equivalents and marketable securities
$ 35,316 
Borrowings outstanding
6,796 
Borrowings outstanding, current
4,217 
Working capital
$ 29,606 
Significant Accounting Policies - Additional Information (Detail) (USD $)
In Thousands, unless otherwise specified
3 Months Ended 3 Months Ended 12 Months Ended 3 Months Ended
Mar. 31, 2016
Dec. 31, 2015
Mar. 31, 2016
Philips Medical Systems [Member]
Dec. 31, 2015
Philips Medical Systems [Member]
Mar. 31, 2016
Accounts Receivable [Member]
Customer D and One Other Customer [Member]
Dec. 31, 2015
Accounts Receivable [Member]
Two Customers [Member]
Mar. 31, 2016
Not-For-Profit Subsidiary [Member]
Mar. 31, 2015
Not-For-Profit Subsidiary [Member]
Dec. 31, 2015
Not-For-Profit Subsidiary [Member]
Number of segments
 
 
 
 
 
 
 
 
Recognized expenses
 
 
 
 
 
 
$ 42 
$ 104 
 
Concentration percentage
 
 
 
 
88.00% 
76.00% 
 
 
 
Credit provided to eligible customers
 
 
 
 
 
 
 
 
Assets
39,905 
47,139 
 
 
 
 
11 
 
56 
Liabilities
11,724 
11,292 
 
 
 
 
19 
 
75 
Due from related party
$ 125 
 
$ 125 
$ 0 
 
 
 
 
 
Significant Accounting Policies - Schedule of customer concentration (Detail) (Sales Revenue [Member])
3 Months Ended
Mar. 31, 2016
Mar. 31, 2015
Customer A [Member]
 
 
Concentration percentage
 
29.00% 
Customer B [Member]
 
 
Concentration percentage
28.00% 
 
Customer C [Member]
 
 
Concentration percentage
16.00% 
11.00% 
Customer D [Member]
 
 
Concentration percentage
 
71.00% 
Significant Accounting Policies - Schedule of Assets Measured at Fair Value on Recurring Basis (Detail) (USD $)
In Thousands, unless otherwise specified
Mar. 31, 2016
Dec. 31, 2015
Assets:
 
 
Marketable securities
$ 11,677 
$ 20,524 
Certificates of Deposit [Member]
 
 
Assets:
 
 
Marketable securities
2,483 
4,648 
Recurring [Member]
 
 
Assets:
 
 
Cash equivalents
6,107 
6,356 
Total assets
17,784 
26,880 
Recurring [Member] |
Fair Value, Inputs, Level 1 [Member]
 
 
Assets:
 
 
Cash equivalents
6,107 
6,107 
Total assets
15,301 
21,983 
Recurring [Member] |
Fair Value, Inputs, Level 2 [Member]
 
 
Assets:
 
 
Cash equivalents
 
249 
Total assets
2,483 
4,897 
Recurring [Member] |
US Government Treasuries [Member]
 
 
Assets:
 
 
Marketable securities
9,194 
15,876 
Recurring [Member] |
US Government Treasuries [Member] |
Fair Value, Inputs, Level 1 [Member]
 
 
Assets:
 
 
Marketable securities
9,194 
15,885 
Recurring [Member] |
Certificates of Deposit [Member]
 
 
Assets:
 
 
Marketable securities
2,483 
4,648 
Recurring [Member] |
Certificates of Deposit [Member] |
Fair Value, Inputs, Level 2 [Member]
 
 
Assets:
 
 
Marketable securities
$ 2,483 
$ 4,648 
Significant Accounting Policies - Summary of Available-for-Sale Securities (Detail) (USD $)
In Thousands, unless otherwise specified
Mar. 31, 2016
Dec. 31, 2015
Available-for-sale Securities, Amortized Cost
$ 11,673 
$ 20,538 
Available-for-sale Securities, Gross Unrealized Gains
Available-for-sale Securities, Gross Unrealized Losses
 
(15)
Available-for-sale Securities, Fair Value
11,677 
20,524 
Certificates of Deposit [Member]
 
 
Available-for-sale Securities, Amortized Cost
2,480 
4,653 
Available-for-sale Securities, Gross Unrealized Gains
 
Available-for-sale Securities, Gross Unrealized Losses
 
(5)
Available-for-sale Securities, Fair Value
2,483 
4,648 
US Government Treasuries [Member]
 
 
Available-for-sale Securities, Amortized Cost
9,193 
15,885 
Available-for-sale Securities, Gross Unrealized Gains
Available-for-sale Securities, Gross Unrealized Losses
 
(10)
Available-for-sale Securities, Fair Value
$ 9,194 
$ 15,876 
Significant Accounting Policies - Schedule of warrant activity (Detail) (USD $)
3 Months Ended
Mar. 31, 2016
Accounting Policies [Abstract]
 
Beginning balance
5,207,379 
Exercised
(124,160)
Ending balance
5,083,219 
Weighted-Average Exercise Price
 
Beginning balance
$ 1.08 
Exercised
$ 0.76 
Ending balance
$ 1.08 
Inventories - Schedule of Inventories Valued under FIFO Method (Detail) (USD $)
In Thousands, unless otherwise specified
Mar. 31, 2016
Dec. 31, 2015
Inventory Disclosure [Abstract]
 
 
Raw material
$ 630 
$ 483 
Work in progress
35 
79 
Finished goods
800 
767 
Inventories, net
$ 1,465 
$ 1,329 
Long-Term Debt - Additional Information (Detail) (USD $)
In Thousands, except Share data, unless otherwise specified
3 Months Ended 0 Months Ended 0 Months Ended
Mar. 31, 2015
Mar. 31, 2016
Minimum [Member]
Jun. 11, 2014
Initial Promissory Note [Member]
Mar. 31, 2016
Initial Promissory Note [Member]
Jun. 11, 2014
Initial Promissory Note [Member]
Minimum [Member]
Dec. 31, 2014
Second Promissory Note [Member]
Dec. 31, 2014
Second Promissory Note [Member]
Minimum [Member]
Available borrowing under Loan and Security Agreement
 
 
$ 10,000 
 
 
 
 
Amount of each separate note
 
 
5,000 
 
 
5,000 
 
Note issuance date
 
 
Jun. 11, 2014 
 
 
 
 
Frequency of debt payments
 
 
Monthly 
 
 
Monthly 
 
Term of debt payments
 
 
27 months 
 
 
27 months 
 
Date of first required payment
 
 
Jul. 01, 2015 
 
 
Jul. 01, 2015 
 
Effective interest rate
 
 
 
11.50% 
11.25% 
10.20% 
9.95% 
Interest rate, description of maximum
 
 
11.25% plus the Wall Street Journal Prime Rate, less 3.25% 
 
 
9.95% plus the Wall Street Journal Prime Rate, less 3.25% 
 
Spread on variable rate
 
 
(3.25%)
 
 
(3.25%)
 
Additional interest payment
 
 
125 
 
 
125 
 
Due date of additional interest payment
 
 
Oct. 01, 2017 
 
 
Oct. 01, 2017 
 
Number of warrants issued with debt (shares)
 
 
177,514 
 
 
177,514 
 
Exercise price of warrant
$ 4.25 
$ 0.99 
$ 1.41 
 
 
$ 1.41 
 
Fair value of the warrant issued
 
 
$ 230 
 
 
$ 619 
 
Stock-Based Compensation - Additional Information (Detail) (USD $)
3 Months Ended
Mar. 31, 2016
Mar. 31, 2015
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
 
 
Options granted to purchase common stock (shares)
8,366,906 
117,500 
Exercise price of options granted
 
$ 4.25 
Weighted average grant date fair value options
$ 0.72 
$ 2.94 
Minimum [Member]
 
 
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
 
 
Exercise price of options granted
$ 0.99 
 
Maximum [Member]
 
 
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
 
 
Exercise price of options granted
$ 2.03 
 
Stock-Based Compensation - Schedule of Stock-Based Compensation Expense (Detail) (USD $)
In Thousands, unless otherwise specified
3 Months Ended
Mar. 31, 2016
Mar. 31, 2015
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
 
 
Stock-based compensation expense
$ 346 
$ 98 
Research and Development Expense [Member]
 
 
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
 
 
Stock-based compensation expense
33 
17 
Selling General And Administrative Expense [Member]
 
 
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
 
 
Stock-based compensation expense
$ 313 
$ 81 
Stock-Based Compensation - Assumptions Used to Estimate Fair Value of Stock Options Granted Using Black Scholes Model (Detail) (Stock Option Plans [Member])
3 Months Ended
Mar. 31, 2016
Mar. 31, 2015
Risk-free interest rate
 
1.28% 
Expected term in years
6 years 29 days 
6 years 3 months 
Expected volatility
52.00% 
80.00% 
Expected dividend yield
0.00% 
0.00% 
Minimum [Member]
 
 
Risk-free interest rate
1.44% 
 
Maximum [Member]
 
 
Risk-free interest rate
1.58% 
 
Net Loss per Share - Schedule of Securities Excluded from Computation of Net Loss per Share (Detail)
3 Months Ended
Mar. 31, 2016
Mar. 31, 2015
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
 
 
Number of anti-dilutive securities
18,786,332 
13,987,001 
Stock Option Plans [Member]
 
 
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
 
 
Number of anti-dilutive securities
13,703,113 
8,779,622 
Warrant [Member]
 
 
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
 
 
Number of anti-dilutive securities
5,083,219 
5,207,379 
Related Party Transactions - Additional Information (Detail) (USD $)
In Thousands, unless otherwise specified
0 Months Ended 3 Months Ended
Mar. 31, 2016
Dec. 31, 2015
Jun. 14, 2010
Shareholders [Member]
Mar. 31, 2016
Philips Medical Systems [Member]
Mar. 31, 2015
Philips Medical Systems [Member]
Dec. 31, 2015
Philips Medical Systems [Member]
Revenue from related party
 
 
 
$ 125 
$ 125 
 
Due from related party
125 
 
 
125 
 
Issuance of notes receivable due from stockholder
 
 
145 
 
 
 
Notes receivable due from stockholders
$ 71 
$ 136