0001387131-16-007784.txt : 20161109 0001387131-16-007784.hdr.sgml : 20161109 20161109060223 ACCESSION NUMBER: 0001387131-16-007784 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 52 CONFORMED PERIOD OF REPORT: 20160930 FILED AS OF DATE: 20161109 DATE AS OF CHANGE: 20161109 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Corindus Vascular Robotics, Inc. CENTRAL INDEX KEY: 0001528557 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 300687898 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 001-37406 FILM NUMBER: 161982678 BUSINESS ADDRESS: STREET 1: 309 WAVERLEY OAKS ROAD STREET 2: SUITE 105 CITY: WALTHAM STATE: MA ZIP: 02452 BUSINESS PHONE: 508-653-3335 MAIL ADDRESS: STREET 1: 309 WAVERLEY OAKS ROAD STREET 2: SUITE 105 CITY: WALTHAM STATE: MA ZIP: 02452 FORMER COMPANY: FORMER CONFORMED NAME: Your Internet Defender, Inc DATE OF NAME CHANGE: 20110824 10-Q 1 cvrs-10q_093016.htm QUARTERLY REPORT
 

 

UNITED STATES  

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 


 

FORM 10-Q

 


(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended September 30, 2016

 

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from                       to                       

 

Commission File No. 001-37406

 


 

CORINDUS VASCULAR ROBOTICS, INC.

(Exact name of registrant as specified in its charter)

 


   
Delaware 30-0687898

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer 

Identification No.)

   
309 Waverley Oaks Rd., Suite 105, Waltham, MA 02452 (508) 653-3335
(Address of principal executive offices) (Registrant’s Telephone Number)

 

N/A

(Former name, former address and former fiscal year, if changed since last report)

 


 

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒   No ☐

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes ☒    No☐

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. 

       
Large accelerated filer  ☐ Accelerated filer
       
Non-accelerated filer    ☐ Smaller reporting company

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes ☐   No ☒

 

The number of shares outstanding of the issuer’s common stock as of November 4, 2016 was 119,025,221.

 

 

 

 

 

 

CORINDUS VASCULAR ROBOTICS, INC.
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
INDEX

 

        Page
PART I - FINANCIAL INFORMATION    
         
  Item 1. Financial Statements    
         
  Unaudited Condensed Consolidated Balance Sheets as of December 31, 2015 and September 30, 2016   3
         
  Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Nine Months Ended September 30, 2015 and 2016   4
         
  Unaudited Condensed Consolidated Statements of Stockholders’ Equity for the Nine Months Ended September 30, 2016   5
         
  Unaudited Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2015 and 2016   6
         
  Notes to Unaudited Condensed Consolidated Financial Statements   7
         
  Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations   18
         
  Item 3. Quantitative and Qualitative Disclosures about Market Risk   25
         
  Item 4. Controls and Procedures   25
         
PART II - OTHER INFORMATION    
         
  Item 1. Legal Proceedings   26
         
  Item 1A. Risk Factors   26
         
  Item 2. Unregistered Sales of Equity Securities and Use of Proceeds   26
         
  Item 3. Defaults Upon Senior Securities   26
         
  Item 4. Mine Safety Disclosures   26
         
  Item 5. Other Information   26
         
  Item 6. Exhibits   27

  

 

 

 

CORINDUS VASCULAR ROBOTICS, INC.
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)
             
    December 31,     September 30,  
    2015     2016  
Assets                
Current Assets:                
Cash and cash equivalents   $ 22,142     $ 18,079  
Marketable securities     20,524        
Accounts receivable     878       531  
Inventories, net     1,329       1,619  
Prepaid expenses and other current assets     591       305  
Total current assets     45,464       20,534  
                 
Property and equipment, net     1,382       1,064  
Deposits and other assets     157       153  
Notes receivable due from stockholders     136       71  
Total assets   $ 47,139     $ 21,822  
                 
Liabilities and stockholders’ equity                
Current Liabilities:                
Accounts payable   $ 1,538     $ 1,845  
Accrued expenses     1,199       1,580  
Deferred revenue     701       281  
Current portion of long-term debt     4,033       4,597  
Total current liabilities     7,471       8,303  
                 
Long-term Liabilities:                
Deferred revenue, net of current portion     106       148  
Other liabilities     42       13  
Long-term debt, net of current portion     3,673       217  
Total long-term liabilities     3,821       378  
Total liabilities     11,292       8,681  
                 
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 at December 31, 2015 and 119,025,221 shares at September 30, 2016 issued and outstanding     12       12  
Additional paid-in capital     149,489       150,056  
Accumulated other comprehensive income (loss)     (14 )      
Accumulated deficit     (113,640 )     (136,927 )
Total stockholders’ equity     35,847       13,141  
Total liabilities and stockholders’ equity   $ 47,139     $ 21,822  

 

The accompanying notes are an integral part of the condensed consolidated financial statements.

 

3
 

 

CORINDUS VASCULAR ROBOTICS, INC.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS
(In thousands, except share and per share amounts)

 

      Three Months Ended       Nine Months Ended  
      September 30,       September 30,  
    2015     2016     2015     2016  
                                 
Revenue   $ 212     $ 688     $ 1,897   $ 2,304  
Cost of revenue     722       1,220       2,464       3,412  
Gross loss     (510 )     (532 )     (567 )     (1,108 )
                                 
Operating expenses:                                
Research and development     2,263       2,728       7,851       7,373  
Selling, general and administrative     3,885       4,585       11,883       13,987  
Total operating expenses     6,148       7,313       19,734       21,360  
                                 
Operating loss     (6,658 )     (7,845 )     (20,301 )     (22,468 )
                                 
Other expense:                                
Interest and other expense, net     (404 )     (221 )     (1,233 )     (819 )
Total other expense     (404 )     (221 )     (1,233 )     (819 )
                                 
Net loss   $ (7,062 )   $ (8,066 )   $ (21,534 ) $ (23,287 )
                                 
Net loss per share--basic and diluted   $ (0.06 )   $ (0.07 )   $ (0.19 ) $ (0.20 )
                               
Weighted-average common shares used in computing net loss
per share--basic and diluted
    118,541,168       118,958,430       111,446,296       119,017,846  
                                 
Other comprehensive loss:                                
Net loss   $ (7,062 )   $ (8,066 )   $ (21,534 ) $ (23,287 )
Unrealized gain (loss) on marketable securities     (7 )     (9 )     (7 )     14  
Comprehensive loss   $ (7,069 )   $ (8,075 )   $ (21,541 ) $ (23,273 )

 

The accompanying notes are an integral part of the condensed consolidated financial statements.

 

4
 

 

CORINDUS VASCULAR ROBOTICS, INC.

UNAUDITED CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS’ EQUITY

(In thousands, except share and per share amounts)

 

                Accumulated          
            Additional     Other          
    Common Stock, $0.0001 Par Value     Paid-in     Comprehensive     Accumulated      
    Shares     Amount     Capital     Income (Loss)     Deficit     Total  
                         
Balance at December 31, 2015   118,832,441     $ 12     $ 149,489     $ (14 )   $ (113,640 )   $ 35,847  
Stock-based compensation expense               1,646                   1,646  
Issuance of common stock upon exercise of stock options   848,297             (338 )                 (338 )
Issuance of common stock upon exercise of warrants   93,325                                
Common stock repurchase and retirement   (748,842 )           (741 )                 (741 )
Change in fair value of marketable securities                     14             14  
Net loss                           (23,287 )     (23,287 )
Balance at September 30, 2016   119,025,221     $ 12     $ 150,056     $     $ (136,927 )   $ 13,141  

 

The accompanying notes are an integral part of the condensed consolidated financial statements.

 

5  
 

 

CORINDUS VASCULAR ROBOTICS, INC.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

   
    Nine Months Ended
September 30,
 
    2015     2016  
         
Operating activities                
Net loss   $ (21,534 )   $ (23,287 )
Adjustments to reconcile net loss to net cash flows used in operating activities:                
Loss on disposal of fixed assets           59  
Depreciation and amortization     510       564  
Stock-based compensation expense     313       1,646  
Accretion of interest expense     480       343  
Accretion of available-for-sale securities     (3 )     (15 )
Changes in operating assets and liabilities:                
Accounts receivable     (93 )     347  
Prepaid expenses and other current assets     (370 )     286  
Deferred inventory costs     102        
Inventories     (456 )     (290 )
Deposits and other assets     53       4  
Accounts payable, accrued expenses and other liabilities     (441 )     659  
Deferred revenue     (93 )     (378 )
Net cash used in operating activities     (21,532 )     (20,062 )
                 
Investing activities                
Purchases of available-for-sale securities     (20,593 )      
Maturities of available-for-sales securities           20,553  
Collection of notes receivable           65  
Purchases of property and equipment     (281 )     (305 )
Net cash provided by (used in) investing activities     (20,874 )     20,313  
                 
Financing activities                
Payments of financing costs from issuance of long-term debt and warrants     (50 )      
Proceeds from issuance of common stock, net of offering costs     44,643        
Proceeds from exercise of stock options     20       72  
Payment for common stock repurchase and retirement           (741 )
Payments for withholding taxes on stock option exercises           (410 )
Payments on long-term debt     (998 )     (3,235 )
Net cash provided by (used in) financing activities     43,615       (4,314 )
                 
Net increase (decrease) in cash and cash equivalents     1,209       (4,063 )
Cash and cash equivalents at beginning of period     28,526       22,142  
Cash and cash equivalents at end of period   $ 29,735     $ 18,079  
                 
Supplemental Disclosure of Cash Flow Information:                
Transfer from inventories to property and equipment in the field   $ 365     $  
Deferred public offering costs in accounts payable and accrued expenses   $ 251     $  
Interest paid   $ 746     $ 534  

 

The accompanying notes are an integral part of the condensed consolidated financial statements.

 

6  
 

 

CORINDUS VASCULAR ROBOTICS, INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(In thousands, except share and per share amounts)

 

Note 1 Nature of Operations

 

The Company

 

Corindus Vascular Robotics, Inc. (the “Company”), formerly named Your Internet Defender, Inc. (“YIDI”), acquired Corindus, Inc., a privately-held company, in a reverse acquisition on August 12, 2014. The Company was previously a Nevada corporation, but effective June 28, 2016, the Company changed its state of incorporation from the State of Nevada to the State of Delaware. 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.

 

On October 27, 2016, the Company announced that it had received 510(k) clearance from the FDA for its CorPath GRX, the second generation of its CorPath System.  The Company expects to commence commercialization of CorPath GRX in the first quarter of 2017.

 

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 September 30, 2016, the Company had an accumulated deficit of $136,927, and borrowings outstanding of $4,960, of which $4,742 is contractually due over the next 12 months.

 

As of September 30, 2016, the Company had cash and cash equivalents of $18,079 and working capital of $12,231. The Company believes that these available resources will be sufficient to meet the Company’s cash requirements through the first quarter of 2017, including funding its anticipated losses and scheduled debt maturities.  Accordingly, the Company will need to raise additional funds to support its operating and capital needs.  The Company will attempt to obtain additional funding through public or private financing, collaborative arrangements with strategic partners, or through additional credit lines or other debt financing sources to increase the funds available to fund operations. Additionally, the Company is in compliance with its debt covenant requirements as of September 30, 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.

 

7
 

 

CORINDUS VASCULAR ROBOTICS, INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(In thousands, except share and per share amounts)

 

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 nine months ended September 30, 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 September 30, 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 $120 and $12 for the three months ended September 30, 2015 and 2016, respectively, and $337 and $94 for the nine months ended September 30, 2015 and 2016, respectively. The entity had both assets and liabilities of $9 on its balance sheet at September 30, 2016 and assets and liabilities of $56 and $75, respectively, on its balance sheet at December 31, 2015.

 

Reclassification

 

Certain amounts as of December 31, 2015 have been reclassified to conform 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 and 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.

 

8
 

 

CORINDUS VASCULAR ROBOTICS, INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(In thousands, except share and per share amounts)

 

Significant Customers

 

The table below sets forth the Company’s customers that accounted for greater than 10% of its revenues for the three- and nine-month periods ended September 30, 2015 and 2016, respectively:

 

      Three months ended
September 30,
    Nine months ended
September 30,
 
Customer     2015     2016     2015     2016  
A       11 %     5 %     4 %     4 %
B       11 %     3 %     2 %     2 %
C       8 %     4 %     10 %     4 %
D       %     %     14 %     %
E       %     4 %     12 %     2 %
F       %     %     11 %     2 %
G       %     49 %     %     15 %
H       %     %     %     34 %

 

The Company had two other customers that together accounted for 76% of the Company’s accounts receivable balance at December 31, 2015. Additionally, Customer G comprised 69% of the Company’s accounts receivable balance at September 30, 2016. Given the current revenue levels, in a period in which the Company sells a system, the purchaser of such system is likely to represent a significant customer.

 

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.

 

9
 

 

CORINDUS VASCULAR ROBOTICS, INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(In thousands, except share and per share amounts)

 

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     $  

 

 

    September 30, 2016  
     

Total

      Quoted prices active markets (Level 1)      

Significant other

observable inputs

(Level 2)

     

Significant unobservable inputs

(Level 3)

 
Assets:                                
Cash equivalents   $ 10,164     $ 10,164     $     $  
Total assets   $ 10,164     $ 10,164     $     $  

 

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 had classified all of its marketable securities during 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.

 

10
 

 

CORINDUS VASCULAR ROBOTICS, INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(In thousands, except share and per share amounts)

 

During 2016, the activity in the Company’s accumulated other comprehensive income 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 nine months ended September 30, 2016, and as a result, the Company did not reclassify any amount out of accumulated other comprehensive income during that same period.

 

The Company’s marketable securities matured in accordance with stated terms during the nine months ended September 30, 2016.

 

The following table summarizes available-for-sale securities held at December 31, 2015:

 

    Amortized Cost     Unrealized Gain     Unrealized Loss     Fair Value  
                                 
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  

 

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.

 

11
 

 

CORINDUS VASCULAR ROBOTICS, INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(In thousands, except share and per share amounts)

 

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 and premium service plans is recognized on a straight-line basis over the life of the service contract. 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 and September 30, 2016, there were no amounts outstanding from Philips.

 

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.

 

12
 

 

CORINDUS VASCULAR ROBOTICS, INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(In thousands, except share and per share amounts)

 

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 nine months ended September 30, 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 93,325 shares of common stock during the year.

 

The table below is a summary of the Company’s warrant activity during the nine months ended September 30, 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 September 30, 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 or nine months ended September 30, 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 and $0 at December 31, 2015 and September 30, 2016, respectively.

 

13
 

 

CORINDUS VASCULAR ROBOTICS, INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(In thousands, except share and per share amounts)

 

New Accounting Pronouncements

 

Except as described below, there have been no new accounting pronouncements or changes to accounting pronouncements during the nine months ended September 30, 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 periods ending after December 15, 2016, and all annual and interim periods thereafter. Early application is permitted. The Company faces certain risks and uncertainties, as further described in Note 1, Nature of Operations. Upon adoption of this update, the Company will be required to make additional disclosures regarding its forecasts and financing plans.

 

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 September 30, 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.

 

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
    September 30,
2016
 
Raw material   $ 483     $ 621  
Work in progress     79       93  
Finished goods     767       905  
Total   $ 1,329     $ 1,619  

 

14
 

 

CORINDUS VASCULAR ROBOTICS, INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(In thousands, except share and per share amounts)

 

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 September 30, 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 September 30, 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 September 30, 2016.

 

Note 5 Stock-based Compensation

 

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

 

    Three Months Ended
September 30,
    Nine Months Ended
September 30,
 
    2015     2016     2015     2016  
Research and development   $ 19     $ 45     $ 56     $ 113  
Selling, general and administrative     85       617       257       1,533  
Total   $ 104     $ 662     $ 313     $ 1,646  

 

The Company granted options to purchase 299,486 shares of common stock at exercise prices ranging from of $3.26 to $4.44 per share during the nine months ended September 30, 2015. The Company granted options to purchase 10,097,994 shares of common stock at exercise prices ranging from $0.99 to $2.03 per share during the nine months ended September 30, 2016. The weighted-average fair value of the stock options granted was $2.40 per share and $0.71 per share for the nine months ended September 30, 2015 and 2016, respectively.

 

15
 

 

CORINDUS VASCULAR ROBOTICS, INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(In thousands, except share and per share amounts)

 

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”):

 

    Nine Months Ended
September 30,
 
    2015     2016  
Risk-free interest     1.5%-2.0%       1.3%-1.6%  
Expected term in years     6.1       6.1  
Expected volatility     50%-80%       48%-53%  
Expected dividend yield     0 %     0 %

 

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:

 

    As of September 30,  
    2015     2016  
Options to purchase common stock     8,078,961       15,164,711  
Warrants to purchase common stock     5,207,379       5,083,219  
 Total     13,286,340       20,247,930  

 

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 nine month periods ended September 30, 2015 and 2016, the Company recorded revenues of $125 from shipments to Philips. At December 31, 2015 and September 30, 2016, there were no amounts owed from Phillips to the Company 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 September 30, 2016, respectively. The Company assessed the notes receivable for impairment and concluded that there were no impairment indicators at December 31, 2015 and September 30, 2016. The Company does not believe there is any significant collection risk associated with the notes receivable at September 30, 2016.

 

16
 

 

CORINDUS VASCULAR ROBOTICS, INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(In thousands, except share and per share amounts)

 

Common Stock Repurchase and Retirement

 

On April 15, 2016, the Company repurchased and retired 748,842 shares of its common stock for an aggregate amount of approximately $741 pursuant to the terms of a privately negotiated transaction with the Company’s former Chief Executive Officer.

 

Note 8 Subsequent Event

 

On October 24, 2016, the Company entered into an agreement to extend its building lease for the period from February 1, 2018 through January 31, 2021 with monthly payments ranging from $53 to $55 during the new extended period.

 

17
 

 

Item 2.    Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

General

 

The following discussion and analysis provides information which our management believes to be relevant to an assessment and understanding of the results of operations and financial condition of Corindus Vascular Robotics, Inc. (“we,” “us,” “our,” or the “Company”). This discussion should be read together with our condensed consolidated financial statements and the notes included therein, which are included in this Quarterly Report on Form 10-Q (the “Report”). This information should also be read in conjunction with the information contained in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 11, 2016 including the audited consolidated financial statements and notes included therein as of and for the year ended December 31, 2015. The reported results will not necessarily reflect future results of operations or financial condition. Unless otherwise defined herein, all initially capitalized terms herein shall be as defined in our Annual Report on Form 10-K.

 

Overview

 

We design, manufacture and sell precision vascular robotic-assisted systems for use in interventional vascular procedures (the “CorPath® System”). Our first and current product, the CorPath 200 System, is the only vascular robotic system cleared by the U.S. Food and Drug Administration (“FDA”) to bring precision and accuracy to stent placement in percutaneous coronary intervention (“PCI”) procedures. During the procedure, the interventional cardiologist sits at a radiation-shielded interventional cockpit to advance stents and guidewires with millimeter-by-millimeter precision. The interventional cockpit allows the physician greater control and the freedom from wearing heavy lead protective equipment that causes musculoskeletal injuries. The CorPath System brings robotic precision to radial and complex PCI procedures to help optimize clinical outcomes and minimize the costs associated with complications of improper stent placement with manual PCI procedures.We initially were cleared and targeted PCI procedures; subsequently we were cleared for Peripheral indications and recently we were cleared for our second generation system, the CorPath GRX. We will continue to invest in developing capabilities to address these markets and believe that our 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. As of September 30, 2016, we have installed 41 CorPath Systems, including three CorPath Systems in hospitals outside of the U.S.

 

Results of Operations

 

In the following discussion, all dollar amounts are reported in thousands:

 

Three months ended September 30, 2015 compared to three months ended September 30, 2016

 

    Three months ended 
September 30,
       
    2015     2016     Change  
    (in thousands)  
Revenue   $ 212     $ 688     $ 476  
Cost of revenue     722       1,220       498  
Gross loss     (510 )     (532 )     (22 )
Operating expense:                        
Research and development     2,263       2,728       465  
Selling, general and administrative     3,885       4,585       700  
Total operating expense     6,148       7,313       1,165  
Operating loss     (6,658 )     (7,845 )     (1,187 )
Other expense:                        
Interest and other expense, net     (404 )     (221 )     183  
Total other expense     (404 )     (221 )     183  
Net loss   $ (7,062 )   $ (8,066 )   $ (1,004 )

 

Revenue

 

Revenue increased from $212 for the three months ended September 30, 2015 to $688 for the three months ended September 30, 2016 due primarily to an increase in revenue from our CorPath Systems.

 

Our revenue associated with CorPath System sales increased from no revenue during the three months ended September 30, 2015 as compared to $325 for the three months ended September 30, 2016. We did not sell any CorPath Systems during the three months ended September 30, 2015 and we sold one CorPath System during the three months ended September 30, 2016. We have experienced, and we expect to continue to experience, some unevenness in the number and trend of units sold and the average selling price of units sold on a quarterly basis given the early stage of commercialization of our product and market acceptance along with the continued development of a dedicated and consistent sales force.

 

 

18
 

 

Our revenue from CorPath Cassettes and accessories increased from $138 for the three months ended September 30, 2015 as compared to $171 for the three months ended September 30, 2016. The volume and average price of our CorPath Cassettes increased by 38 units and increased by 6.5%, respectively, from the three months ended September 30, 2015 to the three months ended September 30, 2016. Revenues under our CorPath Utilization Program (“CUP”) represented 35.7% and 22.9% for the three months ended September 30, 2015 and 2016, respectively, of our total revenues for the sale of consumables. We expect variability in the sales of our consumables until our product receives wider market acceptance.

 

Our revenue associated with services performed increased from $73 for the three months ended September 30, 2015 as compared to $192 for the three months ended September 30, 2016. The increase relates to revenue recognized under the terms of outstanding service agreements and an increase in service projects performed for the three months ended September 30, 2016. We have experienced, and expect to continue to experience, fluctuations in our service revenues based upon whether or not customers elect to purchase service contracts with their CorPath Systems and the related deferral of any expected services to be performed under such arrangements.

 

Given the relatively small number of customers due to the early stage of the commercialization and the higher price of the CorPath System relative to consumables, customers that purchase a CorPath System in a specific period tend to make up a significant percentage of revenue in that period.

 

Cost of Revenue

 

Cost of revenue increased from $722 for the three months ended September 30, 2015 to $1,220 for the three months ended September 30, 2016. Cost of revenues for both the three month periods ended September 30, 2015 and September 30, 2016 included the effect of under-utilization of our production facilities, which we expect to continue for the remainder of 2016.

 

Cost of revenue represents the cost of materials for the CorPath System and CorPath Cassettes, as well as labor and overhead at our production facility. At current volumes, our cost to manufacture the CorPath System and CorPath Cassettes is approximately $400 and $2, respectively. We expect these costs to decrease as we obtain economies of scale with respect to purchasing and production and continue to incorporate design enhancements.

 

Gross Loss

 

Our gross loss increased from $510 for the three months ended September 30, 2015 to $532 for the three months ended September 30, 2016, based on the changes in revenue and cost of revenues as discussed above. For the three months ended September 30, 2016, we did not generate enough sales volume of CorPath Systems and CorPath Cassettes to significantly offset our manufacturing costs, including the effect of the under-utilization of our production facility, a portion of which represents excess manufacturing capacity, and we have therefore generated a gross loss.

 

Research and Development

 

Research and development expenses increased from $2,263 for the three months ended September 30, 2015 to $2,728 for the three months ended September 30, 2016 primarily due to increased spending for consulting services of $68, patent and licensing fees of $75, and incremental purchases of prototype materials of $101 related to work performed on the next generation CorPath System during the three months ended September 30, 2016, as well as increased compensation expense of $156 for employees hired subsequent to September 30, 2015.

 

Selling, General and Administrative

 

Selling, general and administrative expenses increased from $3,885 for the three months ended September 30, 2015 to $4,585 for the three months ended September 30, 2016. This increase is primarily due to incremental stock-based compensation expense of $532 for the three months ended September 30, 2016 associated with stock options granted during 2016. The remaining increase relates to increased sales commissions of $282 and travel-related expenses of $163, partially offset by decreases in certain marketing activities of $144 and recruiting expense of $113 during the three months ended September 30, 2016.

 

 

19
 

 

Other Expense

 

Other expense decreased from $404 for the three months ended September 30, 2015 to $221 for the same period in 2016. The other expense for both periods was primarily the result of interest expense on borrowings under the Company’s Loan and Security Agreement (as defined below). The decrease in other expense for the three months ended September 30, 2016 as compared to the prior year period is primarily due to lower interest expense as a result of a reduction in our overall debt balance through contractual principal payments over the past year.

 

Income Taxes

 

We have not recorded any benefit related to operating losses due to uncertainty about future taxable income.

 

Net Loss

 

Net loss increased from $7,062 for the three months ended September 30, 2015 to $8,066 for the three months ended September 30, 2016 due to the factors noted above.

 

Nine months ended September 30, 2015 compared to nine months ended September 30, 2016

 

    Nine months ended 
September 30,
       
    2015     2016     Change  
    (in thousands)  
Revenue   $ 1,897     $ 2,304     $ 407  
Cost of revenue     2,464       3,412       948  
Gross loss     (567 )     (1,108 )     (541 )
Operating expense:                        
Research and development     7,851       7,373       (478 )
Selling, general and administrative     11,883       13,987       2,104  
Total operating expense     19,734       21,360       1,626  
Operating loss     (20,301 )     (22,468 )     (2,167 )
Other expense:                        
Interest and other expense, net     (1,233 )     (819 )     414  
Total other expense     (1,233 )     (819 )     414  
Net loss   $ (21,534 )   $ (23,287 )   $ (1,753 )

 

Revenue

 

Revenue increased from $1,897 for the nine months ended September 30, 2015 to $2,304 for the nine months ended September 30, 2016 due primarily to an increase in revenue for our CorPath Systems.

 

Our revenue associated with CorPath System sales increased from $1,209 during the nine months ended September 30, 2015 as compared to $1,228 for the nine months ended September 30, 2016. We sold five and three CorPath Systems during the nine months ended September 30, 2015 and 2016, respectively. Our average selling price associated with the Systems sold during the nine months ended September 30, 2015 as compared to the Systems sold during the nine months ended September 30, 2016 increased by 103.3% primarily due to the inclusion of a significant international sale during the nine months ended September 30, 2016. We expect to experience some unevenness in the trend of the number of units sold and the average selling price of units sold given the early stage of commercialization of our product and market acceptance along with the continued development of a dedicated and consistent sales force.

 

Our revenue for CorPath Cassettes and accessories decreased slightly from $470 for the nine months ended September 30, 2015 as compared to $460 for the nine months ended September 30, 2016. The volume and average price of our CorPath Cassettes and accessories decreased by 52 units and increased by 5.4%, respectively, from the nine months ended September 30, 2015 to the nine months ended September 30, 2016. Revenues under CUP represented 28.7% and 23.9% for the nine months ended September 30, 2015 and 2016, respectively, of our total revenues for the sale of consumables. We expect variability in the sales of our consumables until our product receives wider market acceptance.

 

 

20
 

 

Our revenue associated with services performed increased from $218 for the nine months ended September 30, 2015 as compared to $616 for the nine months ended September 30, 2016. The increase relates to revenue recognized under the terms of outstanding service agreements. We have experienced, and expect to continue to experience, fluctuations in our service revenues based upon whether or not customers elect to purchase service contracts with their CorPath Systems and the related deferral of any expected services to be performed under such arrangements.

 

Given the relatively small number of customers due to the early stage of the commercialization and the higher price of the CorPath System relative to consumables, customers that purchase a CorPath System in a specific period tend to make up a significant percentage of revenue in that period.

 

Cost of Revenue

 

Cost of revenue increased from $2,464 for the nine months ended September 30, 2015 to $3,412 for the nine months ended September 30, 2016. Cost of revenues for both the nine month periods ended September 30, 2015 and September 30, 2016 included the effect of under-utilization of our production facilities, which we expect to continue for the remainder of 2016.

 

Cost of revenue represents the cost of materials for the CorPath System and CorPath Cassettes, as well as labor and overhead at our production facility. At current volumes, our cost to manufacture the CorPath System and CorPath Cassettes is approximately $400 and $2, respectively. We expect these costs to decrease as we obtain economies of scale with respect to purchasing and production and continue to incorporate design enhancements.

 

Gross Loss

 

Our gross loss increased from $567 for the nine months ended September 30, 2015 to $1,108 for the nine months ended September 30, 2016, based on the changes in revenue and cost of revenues as discussed above. For the nine months ended September 30, 2016, we have not generated enough sales volume of CorPath Systems and CorPath Cassettes to significantly offset our manufacturing costs, including the effect of the under-utilization of our production facility, a portion of which represents excess manufacturing capacity, and we have therefore generated a gross loss.

 

Research and Development

 

Research and development expenses decreased from $7,851 for the nine months ended September 30, 2015 to $7,373 for the nine months ended September 30, 2016 primarily due to higher purchases of prototype materials of approximately $555 and increased spending for consulting services of $421 in the nine months ended September 30, 2015, partially offset by increased compensation expense of $410 for employees hired subsequent to September 30, 2015.

 

Selling, General and Administrative

 

Selling, general and administrative expenses increased from $11,883 for the nine months ended September 30, 2015 to $13,987 for the nine months ended September 30, 2016. This increase is primarily due to incremental costs of $528 associated with the transition of the Company’s former Chief Executive Officer that was completed in March 2016, incremental stock-based compensation expense of $1,276 in the nine months ended September 30, 2016 associated with stock options granted in 2016. 

 

Other Expense

 

Other expense decreased from $1,233 for the nine months ended September 30, 2015 to $819 for the same period in 2016. The other expense for both periods was primarily the result of interest expense on borrowings under the Company’s Loan and Security Agreement (as defined below). The decrease in other expense for the nine months ended September 30, 2016 as compared to the prior year period is primarily due to lower interest expense as a result of a reduction in our overall debt balance through contractual principal payments made over the past year.

 

Income Taxes

 

We have not recorded any benefit related to operating losses due to uncertainty about future taxable income.

 

Net Loss

 

Net loss increased from $21,534 for the nine months ended September 30, 2015 to $23,287 for the nine months ended September 30, 2016 due to the factors noted above.

 

 

21
 

 

Liquidity and Capital Resources

 

We began our medical device business in 2002 and began selling FDA-cleared robotic medical devices in 2012. Our management does not contemplate attaining profitable operations until 2019, nor is there any assurance that such an operating level can ever be achieved. Since inception, we have financed our operations primarily through private sales of capital stock, a public offering of common stock in May 2015 and borrowing arrangements totaling approximately $155.9 million, as well as limited revenues from the sale of our products.

 

As of September 30, 2016, we had an accumulated deficit of $136.9 million and gross borrowings outstanding of $5.0 million, of which $1.1 million is contractually due during the remainder of 2016. As we continue to incur losses and generate negative gross margins, the transition to profitability and positive gross margins is dependent upon achieving a level of revenues adequate to support our cost structure as well as reducing the cost of the CorPath System. We may never achieve profitability, and unless and until doing so, it will be necessary for us to attempt to raise additional capital, which may not be available or available on terms acceptable to us.

 

As of September 30, 2016, we had approximately $18.1 million of cash and cash equivalents.  Cash equivalents are comprised of highly liquid money market accounts.  We believe that our working capital of $12.2 million at September 30, 2016 will provide us the liquidity to meet our operating needs and service our debt through the first quarter of 2017.  Accordingly, we will need to raise additional funds to support our operating and capital needs. We will attempt to obtain additional funding through public or private financing, collaborative arrangements with strategic partners, or through additional credit lines or other debt financing sources to increase the funds available to fund operations.

 

On June 11, 2014, we entered into a Loan and Security Agreement (the “Loan and Security Agreement”) pursuant to which the lender agreed to make available to Corindus, Inc. $10 million in the aggregate under two $5 million secured promissory notes. The Initial Note was made on June 11, 2014 (the “Initial Note”) and the Second Note was made on December 31, 2014 (the “Second Note” and, together with the Initial Note, the “Secured Promissory Notes”). The Secured Promissory Notes are repayable over a term of 27 months which began on July 1, 2015. The Initial Note bears interest at a rate equal to the greater of (w) 11.25% or (x) 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 Second Note bears interest at a rate equal to the greater of (y) 9.95% or (z) 9.95% 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 borrowings require a final payment in the amount of $0.3 million in addition to the interest and principal amounts due during the term of the Loan and Security Agreement. The Loan and Security Agreement also contains, among other things, covenants which include certain restrictions with respect to subsequent indebtedness, liens, loans and investments, financial reporting obligations, asset sales, share repurchase and other restricted payments, subject to certain exceptions. 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 our business, operations, properties, assets or financial condition or a material impairment of our ability to perform all obligations under this Loan and Security Agreement. Future principal payments under the borrowing arrangement as of September 30, 2016 are as follows (in thousands):

 

Year ending December 31,          
2016 (remainder of year)     $ 1,138  
2017       3,822  
Total     $ 4,960  

 

 

22
 

 

In summary, our cash flows were as follows:

 

    Nine Months Ended 
September 30,
 
    2015     2016  
Net cash used in operating activities   $ (21,532 )   $ (20,062 )
Net cash provided by (used in) investing activities   $ (20,874 )   $ 20,313  
Net cash provided by (used in) financing activities   $ 43,615     $ (4,314 )

 

Operating Activities

 

Operating activities used cash of $21,532 for the nine months ended September 30, 2015 compared to $20,062 for the nine months ended September 30, 2016. The $1,470 decrease in the use of cash for operating activities was primarily due to changes in working capital.

 

Investing Activities

 

Net cash used in investing activities was $20,874 for the nine months ended September 30, 2015 compared to net cash provided by investing activities of $20,313 for the nine months ended September 30, 2016. The change was primarily due to maturities of available-for-sale securities in 2016.

 

Financing Activities

 

For the nine months ended September 30, 2015, cash flows from financing activities totaled $43,615 primarily related to net proceeds received from the issuance of common stock. Net cash used in financing activities for the nine months ended September 30, 2016 totaled $4,314 and was primarily due to contractual payments on long-term debt and payments for the repurchase and retirement of common stock.

 

Off-Balance Sheet Arrangements

 

We have no off-balance sheet arrangements (as that term is defined in Item 303(a)(4)(ii) of Regulation S-K) as of September 30, 2016 that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources.

 

Contractual Obligations

 

The Company extended its building lease for the period from February 1, 2018 through January 31, 2021 with monthly payments ranging from $53 to $55 during the new extended period. There have been no other material changes to our contractual obligations set forth under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2015.

 

Critical Accounting Policies and Estimates

 

Management’s discussion and analysis of financial condition and results of operations is based upon our condensed consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States (U.S. GAAP). The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses, as well as related disclosures. We base our estimates and judgments on historical experience and other assumptions that we believe to be reasonable at the time and under the circumstances, and we evaluate these estimates and judgments on an ongoing basis. Information concerning our critical accounting policies with respect to these items is available in Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2015 filed with the SEC on March 11, 2016.

 

New Accounting Pronouncements

 

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 periods ending after December 15, 2016, and all annual and interim periods thereafter. Early application is permitted. We face certain risks and uncertainties, as further described in Note 1, Nature of Operations, to the unaudited condensed consolidated financial statements. Upon adoption of this update, we will be required to make additional disclosures regarding our forecasts and financing plans.

 

 

23
 

 

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. We adopted this update in the first quarter of 2016 and it had no impact to our 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. We adopted this update in the first quarter of 2016 and it had no impact to our 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. We 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 September 30, 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. We are currently evaluating the impact of this update on our consolidated financial statements.

 

Forward Looking Statements

 

Statements made in this Form 10-Q that are not statements of historical or current facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of Corindus to be materially different from historical results or from any future results or projections expressed or implied by such forward-looking statements. Accordingly, readers should not place undue reliance on any forward looking statements. In addition to statements that explicitly describe such risks and uncertainties, readers are urged to consider statements in the conditional or future tenses or that includes terms such as “believes,” “belief,” “expects,” “estimates,” “intends,” “anticipates” or “plans” to be uncertain and forward-looking. Forward-looking statements may include comments as to Corindus’ beliefs and expectations as to future events and trends affecting its business and are necessarily subject to uncertainties, many of which are outside Corindus’ control.

 

Examples of such statements include the following:

 

Our belief that the CorPath System brings robotic precision to radial and complex PCI procedures to help optimize clinical outcomes and minimize the costs associated with complications of improper stent placement with manual PCI procedures.
Our expectation that we will continue to invest in development capabilities to address these markets and believe that our 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.
Our expectation that we may continue to experience some unevenness in the number and trend of units sold and the average selling price of units sold on a quarterly basis given the early stage of commercialization of our product and market acceptance along with the continued development of a dedicated and consistent sales force.
Our expectation of variability in the sales of our consumables until our product receives wider market acceptance.

 

 

24
 

 

We have experienced, and expect to continue to experience, fluctuations in our service revenues based upon whether or not customers elect to purchase service contracts with their CorPath Systems and the related deferral of any expected services to be performed under such arrangements.
We expect costs of materials for the CorPath System and CorPath Cassettes to decrease as we obtain economies of scale with respect to purchasing and production and continue to incorporate design enhancements.
Our management does not contemplate attaining profitable operations until 2019.
Our estimation that our transition to profitability and positive gross margins is dependent upon achieving a level of revenues adequate to support our cost structure as well as reducing the cost of the CorPath System. 
Our belief that our working capital of $12.2 million at September 30, 2016 will provide us the liquidity to meet our operating needs and service our debt through the first quarter of 2017. 
That we do not expect our operating results to be affected to any significant degree by a change in market interest rates on our money market funds.

 

Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are described in the sections titled “Risk Factors” in the company’s filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as reports on Form 8-K, including, but not limited to the following: the rate of adoption of our CorPath System and the rate of use of our cassettes; risks associated with market acceptance, including pricing and reimbursement; our ability to enforce our intellectual property rights; our need for additional funds to support our operations; our ability to manage expenses and cash flow; factors relating to engineering, regulatory, manufacturing, sales and customer service challenges; potential safety and regulatory issues that could slow or suspend our sales; and the effect of credit, financial and economic conditions on capital spending by our potential customers. Forward looking statements speak only as of the date they are made. Corindus undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise that occur after that date. 

 

Item 3.   Quantitative and Qualitative Disclosures about Market Risk

 

We are exposed to market risk related to changes in interest rates. We had cash and cash equivalents of $18.1 million as of September 30, 2016. The cash and cash equivalents as of September 30, 2016 consist of cash in bank deposits and money market funds. Our primary exposure to market risk is interest rate sensitivity, which is affected by changes in the general level of U.S. interest rates, particularly because our investment strategy is primarily to invest in short term securities. We do not expect our operating results to be affected to any significant degree by a change in market interest rates on our money market funds.

 

We pay interest on our outstanding long-term debt at interest rates that fluctuate based upon changes in various base interest rates. The carrying value of our long-term debt, including the current portion, was $4.8 million at September 30, 2016. See “Item 2 - Management’s Discussion and Analysis of Financial Condition and Results of Operations — Liquidity and Capital Resources” and Note 4 — “Long-Term Debt” to the unaudited condensed consolidated financial statements for additional information regarding our outstanding long-term debt. The effect of an immediate hypothetical 10% change in variable interest rates would not have a material effect on our consolidated financial statements. We have generated losses from operations to date and depend on funds raised through other sources. One possible source of funding is through further equity offerings. Our ability to raise funds in this manner depends upon capital market forces affecting our stock price.

 

Item 4.   Controls and Procedures

 

Disclosure Controls and Procedures

 

As required by Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the "Exchange Act"), we carried out an evaluation under the supervision and with the participation of our senior management, including our Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures as of September 30, 2016. Based upon their evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures are effective to ensure that material information relating to the Company required to be disclosed by the Company in reports we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in Securities and Exchange Commission rules and forms and to ensure that such information is accumulated and communicated to senior management, including our Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, our management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurances of achieving the desired control objectives, and management necessarily was required to apply its judgment in designing and evaluating the controls and procedures.

 

 

25
 

 

We continue to review our disclosure controls and procedures, and our internal control over financial reporting, and may from time to time make changes aimed at enhancing their effectiveness and to ensure that our systems evolve with our business.

 

Changes in Internal Controls Over Financial Reporting

 

During the three months ended September 30, 2016, there were no changes in our internal control over financial reporting that occurred that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

PART II - OTHER INFORMATION

 

Item 1.   Legal Proceedings.

 

From time to time, we may become involved in various lawsuits and legal proceedings that arise in the ordinary course of business. Litigation is subject to inherent uncertainties and an adverse result in these or other matters may arise from time to time that may harm our business. We are currently not aware of any such legal proceedings or claims that we believe will have a material adverse effect on our business, financial condition or operating results.

 

Item 1A.   Risk Factors.

 

Please see Risk Factors found in our Annual Report on Form 10-K for the year ended December 31, 2015 filed with the SEC on March 11, 2016.

 

Item 2.   Unregistered Sales of Equity Securities and Use of Proceeds.

 

None.

 

Item 3.   Defaults Upon Senior Securities.

 

None.

 

Item 4.   Mine Safety Disclosures.

 

Not applicable.

 

Item 5.   Other Information.

 

None.

 

 

26
 

 

Item 6.    Exhibits.

 

Exhibit
No.

 

Date of
Document

 

Name of Document

10.1   09/27/16   Directors’ Compensation Policy 2016/2017 – As Amended and Restated Effective October 1, 2016*
10.2   10/24/16   First Amendment to Commercial Lease*
10.3   10/03/16   Employment Agreement between Corindus Vascular Robotics, Inc. and Jeff Lemaster*
31.1   11/09/16   Certification of Principal Executive Officer of Periodic Report pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.*
31.2   11/09/16   Certification of Principal Financial Officer of Periodic Report pursuant to Section 203 of the Sarbanes-Oxley Act of 2002.*
32.1   11/09/16   Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350.*
32.2   11/09/16   Certification of Principal Financial Officer pursuant to 18 U.S.C. Section 1350.*
101.INS   n/a   XBRL Instance Document*
101.SCH   n/a   XBRL Taxonomy Extension Schema Document*
101.CAL   n/a   XBRL Taxonomy Extension Calculation Linkbase Document*
101.DEF   n/a   XBRL Taxonomy Extension Definition Linkbase Document*
101.LAB   n/a   XBRL Taxonomy Extension Label Linkbase Document*
101.PRE   n/a   XBRL Taxonomy Extension Presentation Linkbase Document*

 

 

* Filed herewith.

 

27  
 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

DATE: November 9, 2016

     
  CORINDUS VASCULAR ROBOTICS, INC.
     
  By:

/s/ Mark J. Toland

    Mark J. Toland
    Chief Executive Officer and President
     
  By:

/s/ David W. Long

    David W. Long
    Chief Financial Officer and Senior Vice President
       
28  
EX-10.1 2 ex10-1.htm DIRECTORS COMPENSATION POLICY
 

Corindus Vascular Robotics, Inc. 10-Q

 

EXHIBIT 10.1

 

Directors’ Compensation Policy - 2016/17

as Amended and Restated Effective October 1, 2016

 

 

Overview

 

The Board of Directors of Corindus Vascular Robotics, Inc. (the “Board”) has approved the following Director Compensation Policy (“Policy”) to provide an inducement to attract and retain the services of qualified persons to serve as directors.

 

Eligibility

 

This Policy shall apply to each director of the Board of Directors of Corindus Vascular Robotics, Inc. (the “Board”) who is not an employee of, or compensated consultant to, Corindus or any of its affiliates (a “non-employee director”). Employees of Corindus and their affiliates are not eligible to receive compensation under this Policy.

 

Director Compensation

 

Each non-employee director shall be compensated as follows:

 

Outside Directors
Annual Board Cash Retainer $10,000
Annual Equity Award (Stock Options) $30,000
Additional Board Chair Retainer $8,000
Additional Audit Committee Chair Retainer $8,000
Additional Compensation Committee Chair Retainer $6,000
Additional Nominating Committee Chair Retainer $4,000
Additional Audit Committee Member Retainer $4,000
Additional Compensation Committee Member Retainer $3,000
Additional Nominating Committee Member Retainer $2,000

 

Committee-related retainers will be pro-rated in the event of absence/s for scheduled committee meetings.

 

Equity Grants

 

Each Outside Director shall be granted under Corindus’ 2014 Stock Award Plan or any successor plan (the “Stock Award Plan”) stock options for shares of Corindus’ common stock each year at the annual meeting of the Board coincident with or immediately following Corindus’ annual meeting of stockholders beginning in calendar year 2016. The exercise price shall equal the closing price of a share of Corindus’ common stock on the grant date. The number of shares subject to the stock options shall be determined based on the closing price of a share of Corindus Common stock on the grant date. The Option shall not be exercisable as of the Grant Date. After the Grant Date, to the extent not previously exercised and provided that the Participant has not experienced a Termination of Service, the Option shall become vested and exercisable in full upon the three year anniversary of the Grant Date, vesting 33.33% on the first anniversary of the grant date and 8.334% at the end of each quarter thereafter.

 

  1  
 

 

 

The grants shall vest in full immediately upon a Change in Control (as defined in the Stock Award Plan). If a non-employee Director leaves the Board prior to the vesting in full of a particular award, the Board has the right, but not the obligation, to accelerate (in whole or in part) the vesting of such award. A non-employee director who joins the Board shall receive a pro-rata grant of stock options based on the number of days remaining until the next stockholder’s meeting.

 

Payment Term for Cash Fees and Retainer

 

Cash payments to non-employee directors shall be paid quarterly in advance as of the first day of each fiscal quarter. Cash fees and retainers in the amounts described in this Policy shall commence effective as of October 1, 2016. A non-employee director shall receive his or her cash compensation after first being elected or appointed to the Board on a pro-rated basis during the first fiscal quarter in which he or she was initially appointed or elected for the number of days during which he or she provides service.

 

Expense Reimbursement

 

Upon presentation of documentation of such expenses reasonably satisfactory to Corindus, each non-employee director shall be reimbursed for his or her reasonable out-of-pocket business expenses incurred in connection with attending meetings of the Board and its committees or in connection with other business related to the Board. Each non-employee director shall also be reimbursed for his or her reasonable out-of-pocket business expenses authorized by the Board or one of its committees that are incurred in connection with attendance at meetings with Corindus’ management. Each non-employee director shall abide by Corindus’ travel and other policies applicable to company personnel.

 

Policy Review / Amendments

 

The Compensation Committee or the Board shall review this Policy from time to time to assess whether any amendments in the type and amount of compensation provided herein should be adjusted in order to fulfill the objectives of this Policy. This Policy may only be amended by the Board.

 

  2  
 

 

 

EX-10.2 3 ex10-2.htm FIRST AMENDMENT TO COMMERCIAL LEASE
 

Corindus Vascular Robotics, Inc. 10-Q

EXHIBIT 10.2

First Amendment to Commercial Lease

The Parties hereto, Beaver Group LLC, (“LESSOR”) and Corindus, Inc. (“LESSEE”) are Parties under a certain Commercial Lease (“Lease Agreement”) dated October 24, 2012, for approximately 26,402 rentable square feet on the first floor at 309 Waverley Oaks Road, Suite 105, Waltham, MA and hereby agree as follows:

Whereas, the Parties have agreed to amend the Lease Agreement by this First Amendment to the Commercial Lease (“First Amendment”) to extend the Term of the Lease Agreement and to adjust relevant provisions of the Lease Agreement pursuant to the terms and conditions stated herein. Unless otherwise expressly stated, all references to “lease” or “Lease” shall apply to and include the Lease Agreement and this First Amendment.

Now therefore, for mutual consideration, the receipt of which is hereby acknowledged by both parties, effective on and after the date this First Amendment is fully executed by both Parties the Lease Agreement is hereby amended to reflect the following changes:

3.       TERM:

This paragraph is hereby deleted and replaced with the following:

The Initial Term of this Lease shall be for five (5) years and one and one-half months (1.5), commencing on the Commencement Date of December 12, 2012 and ending on January 31, 2018. The First Extended Term of the Lease shall be for three (3) years commencing on February 1, 2018 and ending on January 31, 2021. Unless otherwise expressly stated, all references to “Term” or “lease term” shall apply to and include the Initial Term and, as of February 1, 2018, the First Extended Term.

4.       RENT:

This paragraph is hereby amended with the addition of the following:

During the First Extended Term, the LESSEE shall pay to the LESSOR base rent, payable in advance, in equal monthly installments in accordance with the schedule noted below. Provided no event of LESSEE default has occurred, LESSEE’S payment of base rent shall be deferred for the first (1st) month of the First Extended Term (not to exceed 28 days) and commence on March 1, 2018. Notwithstanding the above, it is expressly understood the LESSEE’S obligations to pay utilities, whether separately sub-metered or not, are not subject to any deferral, abatements, or holiday. During the Term of the Lease, LESSEE shall pay base rent and additional rent to the LESSOR monthly, in advance, not later than the first day of each calendar month.

Base Rent:

  Year       PRSF       Annual       Monthly  
  2/1/2018 – 2/28/2018     $ 0.00     $ 0.00     $ 0.00  
  3/1/2018 – 1/31/2019     $ 24.00     $ 633,648.00     $ 52,804.00  
  2/1/2019 – 1/31/2020     $ 24.60     $ 649,489.20     $ 54,124.10  
  2/1/2020 – 1/31/2021     $ 25.22     $ 665,858.44     $ 55,488.20  

 

 
 

 

6.        RENT ADJUSTMENT

This paragraph is hereby amended with the addition of the following:

A.1 TAX ESCALATION: Commencing as of February 1, 2018, if any tax year commencing with the fiscal year ending June 30, 2019, the real estate taxes on the land and buildings, of which the Leased Premises are a part, are in excess of the amount of the real estate taxes thereon for the fiscal year ending June 30, 2018 (hereinafter called the “Base Year”), LESSEE will pay to LESSOR as additional rent hereunder, when and as designated by notice in writing by LESSOR, 18.51% of such excess that may occur in each year of the term of this lease or any extension or renewal thereof and proportionately for any part of a fiscal year. If the LESSOR obtains an abatement of any such excess real estate tax, a proportionate share of such abatement, less the reasonable fees and costs incurred in obtaining the same, if any, shall be refunded to the LESSEE. The LESSEE shall, effective July 1, 2018, make estimated installment payments as additional rent as and when the payment of base rent is due. During the fiscal year ending June 30, 2019 (July 1, 2018 – June 30, 2019) the LESSEE’S estimated installment payments shall be based on 105% of the actual real estate taxes assessed during the fiscal year ending June 30, 2018 (July 1, 2017 – June 30, 2018) less the Base Year amount. Thereafter, estimated real estate tax payments shall be based on 105% of the prior year’s actual real estate taxes less the Base Year amount. Actual real estate taxes will not be known at the beginning of each fiscal year and therefore retroactive adjustment to estimated payments shall be necessary when actual real estate taxes are known. After the end of each fiscal year, as and when the actual real estate taxes are available, LESSOR shall provide LESSEE written notice in reasonable detail of LESSEE’S pro rata share of the actual real estate taxes for such fiscal year less the Base Year amount, the estimated payments made by LESSEE on account thereof, and the new estimated payments calculated in accordance with the above. The LESSEE shall pay LESSOR within thirty (30) days of receiving such written notice, the balance owed due to insufficient estimated payments made in accordance with the above, and the LESSOR shall credit the LESSEE’S account for any excess estimated payments made in accordance with the above or refund such amount to LESSEE at the end of the Term if such credit cannot be fully applied against rent. Taxes for which LESSEE is obligated to reimburse LESSOR hereunder shall not include any penalties or interest for late or partial payment nor any income, franchise, inheritance, estate, transfer, excise, gift or capital gain taxes, that are or may be payable by LESSOR or that may be imposed against LESSOR or against the rents payable hereunder; provided, however, if at any time during the Lease term the present method of taxation shall be changed so that in lieu of the whole or any part of any real estate taxes levied, assessed, reassessed or imposed on the property of which the Leased Premises is a part and the improvements thereon, there shall be levied, assessed reassessed or imposed on LESSOR a capital levy or other tax directly on the rents received therefrom and/or a franchise tax, assessment, levy or charge measured by or based, in whole or in part, upon such rents or the present or any future building or buildings in and on the property of which the Leased Premises is a part, then all such taxes, assessments, reassessments, levies or charges, or the part thereof so measured or based, shall be deemed to be included within the term “real estate taxes” for the purpose hereof. LESSOR shall elect to pay, or real estate taxes due from LESSEE shall be calculated as if LESSEE elected to pay, all real estate taxes and betterments and special assessments over the longest period permitted under applicable law and real estate taxes due from LESSEE shall include only those installments which become due during or with respect to the Lease term (and an interest charged thereon as a result of such installment treatment).

 
 

 

B.1 OPERATING COST ESCALATION: Commencing as of February 1, 2018, the LESSEE shall pay to the LESSOR as additional rent hereunder when and as designated by notice in writing by LESSOR, 18.51% of any increase in operating expenses over those incurred during the calendar year 2018. Operating expenses are defined for the purposes of this agreement in Exhibit E-1 hereto (as so defined, “Operating Expenses”). The LESSEE shall, effective January 1, 2019 make estimated installment payments as additional rent as and when the payment of base rent is due. During the calendar year 2019, the LESSEE’S estimated installment payments shall be based on 105% of actual Operating Expenses assessed during calendar year 2018 less the Operating Expenses base year amount or refund such amount to LESSEE at the end of the Term if such credit cannot be fully applied against rent. Thereafter, estimated Operating Expenses shall be based on 105% of the prior year’s actual Operating Expenses less the Operating Expenses base year amount. Actual Operating Expenses will not be known until after the conclusion of each calendar year, retroactive adjustment to estimated payments shall be necessary when actual Operating Expenses are known. After the end of each calendar year, as and when the actual Operating Expenses are available (with LESSOR endeavoring to provide same by April 30th of each year), LESSOR shall provide LESSEE written notice in reasonable detail of LESSEE’S pro rata share of the actual Operating Expenses for such calendar year less the Operating Expenses base year amount, the estimated payments made by LESSEE on account thereof, and the new estimated payments calculated in accordance with the above. The LESSEE shall pay LESSOR, within thirty (30) days of receiving written notice thereof, the balance owed due to insufficient estimated payments made in accordance with the above, and the LESSOR shall credit the LESSEE’S account for any excess estimated payments made in accordance with the above.

20.       NOTICE:

This paragraph is hereby amended with the addition of the following:

LESSOR’S address as contained in this paragraph 20 and throughout the Lease is hereby changed to 465 Waverley Oaks Road, Suite 500, Waltham, MA 02452.

23.       BROKERAGE:

This paragraph is hereby amended with the addition of the following:

LESSOR and LESSEE represent to each other that neither party has dealt with any broker, or any other person, in connection with showing the property or Leased Premises for the First Extended Term or this First Amendment other than Avison Young. LESSOR agrees to pay Avison Young a full fee pursuant to a separate agreement. LESSOR and LESSEE agree that each will hold harmless and indemnify the other from any loss, costs, damage and expense, including reasonable attorney’s fees incurred by LESSOR or LESSEE for a commission or finder’s fee as a result of the falseness of this representation.

25.        OPTION TO EXTEND:

This paragraph is hereby amended with the addition of the following:

The First Extended Term shall not be considered an exercise of the Option to Extend, pursuant to this paragraph 25. The Parties acknowledge LESSEE shall retain its Option to Extend the Lease term beyond the First Extended Term, pursuant to the terms and conditions contained herein.

 
 

 

28.        OTHER PROVISIONS:

Paragraph 28(B), only, is hereby deleted and replaced with the following:

It is also understood and agreed that the following items which are attached to either the Lease Agreement or this First Amendment are part of this agreement and all other Exhibits or items previously contained in this paragraph are hereby deleted.

(B)          It is also understood and agreed that the following attached items are part of this lease.

         Addendum

         Exhibit A - Floor Plans: Title sheet, A1, A2, A3, A4, A5 & C2

         Exhibit B - LESSOR’S Work

         Exhibit C - Building Rules and Regulations

         Exhibit D - Description of Real Property (“Property”) on which Leased Premises are located

         Exhibit E-1 - Building Operating Expenses

         Exhibit F - Cleaning Schedules

         Exhibit G – Form of Letter of Credit

Notwithstanding the above, LESSEE accepts the Leased Premises in its current “AS IS” condition and acknowledges that the Leased Premises are currently occupied by the LESSEE and that the Leased Premises, as delivered and currently constituted, is suitable for the LESSEE’S intended use. LESSEE acknowledges that all work, if any, contemplated in the Lease Agreement, including but not limited to the Exhibit B thereto, to be performed by the LESSOR has been completed to the full satisfaction of the LESSEE.

The Parties acknowledge that the Lease Agreement and this First Amendment represent the entire agreement between the Parties and that no other modification, written or otherwise, exists between the Parties. The normal rule of construction that any ambiguities be resolved against the drafting party shall not apply to the interpretation of the Lease Agreement or this First Amendment or any exhibits or amendments thereto.

All other terms and provisions under the Lease Agreement shall remain unchanged and are hereby ratified and affirmed.

IN WITNESS WHEREOF, the said Parties hereto set their hands and seals this 24th day of October, 2016.

LESSEE LESSOR
Corindus, Inc. Beaver Group LLC
_______________________________ ____________________________________
Mark J. Toland, CEO Robert L. Duffy Jr., Member
Duly Authorized Duly Authorized

 

 
 

 

 

EXHIBIT E-1

BUILDING OPERATING EXPENSES

I. Operating Expenses shall consist by way of example the following items of Building and Property costs:
1. Labor, materials, supplies and services for all maintenance and cleaning of the Building, its machinery and other personal property; and for maintenance, cleaning, snow removal and landscape care on the exterior of premises.
2. Allowance equal to 5% of rent for general supervisory, administrative expenses and management fees.
3. Cost of waste disposal.
4. Costs of license, inspection and permit fees.
5. Heat, air conditioning and ventilation for the Building and lighting and power for common areas and property.
6. Janitorial and cleaning services for all office spaces (excluding any laboratory, storage or manufacturing, data-center, medical, environmentally-sensitive, high-security or similar specialized, non-office use portion(s) of the Leased Premises for which LESSEE must engage its own contractor).
7. Maintenance, repair, and service contracts.
8. Security expenses including watchmen, guards and security services (if necessary).
9. Insurance including fire, casualty, general liability, property damage, etc.
10. If, at any time during the term of the Lease, LESSOR installs or makes an alteration, improvement, repair or replacement which is classified as a capital expenditure, the cost of such expenditure amortized over its useful life, consistently applied, with interest, shall be included in Operating Expenses, provided, however, such capital expenditures must meet one of the following requirements: (A) be intended as a labor saving device or to effect other economies in the operation or maintenance of the Building, (B) be required under any applicable law first enacted or enforced after the date of this First Amendment, or (C) be, in Landlord’s reasonable judgement, consistent with sound property management practices necessary to maintain the Building in good condition and repair.
11. Water, sewer and general utility charges.
II. Notwithstanding anything to the contrary set forth in the Lease, Operating Expenses shall not include the following:
1. Cost of permits, licenses and inspection fees incurred by LESSOR to prepare, renovate, repaint, or redecorate any space leased to any existing tenant or prospective tenant, other than LESSEE, of the Building;
2. Advertising and promotional expenditures incurred to lease space to new tenants or retain existing tenants, other than LESSEE;
3. Legal fees and expenses incurred by LESSOR to resolve disputes with tenants, other than LESSEE;

 

 
 

 

4. Cost of replacement of any items covered under warranty so long as such warranty is in effect and honored;
5. Compensation paid to any employee to the extent that the same is not fairly allocable to the work or service provided by such employee to the Building.
6. Costs of any items which are reimbursed to LESSOR by other tenants or third parties other than through Operating Expenses pass-through provisions in the leases of other tenants in the Building (if any);
7. Expenses paid by LESSOR to affiliates unless same are reasonably consistent with fees charged by third-party professional property managers and operators providing reasonably comparable services in the metropolitan Boston market;
8. The purchase or maintenance of any artwork or sculpture;
9. Fines and penalties; and
10. Costs for remediating or abating asbestos or other hazardous materials or to remove chloro-flouro carbons, unless mandated by laws coming into force and effect from and after the date of this Lease.
11. Legal fees, brokerage fees, leasing commissions, advertising costs and other fees associated with any subsequent renting of the Premises or any other space in the Building;
12. Costs associated with LESSOR’s violation of any other lease for space in the Building;
13 Any general overhead expenses of LESSOR not related to the Leased Premises, Building or Property; executive salaries or salaries of service personnel to the extent that such personnel perform services not in connection with the management or operations of the Building or Property, except as otherwise provided above and in the Lease;
14. Capital expenditures except to the extent expressly provided above;
15. Financing and refinancing costs in respect of any mortgage placed upon the Building, including points and commissions in connection therewith;
16. Interest or penalties for any late payments by LESSOR;
17. Rent or other charges payable under any ground or underlying lease;
18. An amount equal to all amounts received by LESSOR through proceeds of insurance to the extent the proceeds are compensation for expenses which (i) previously were included in operating costs hereunder, (ii) are included in operating costs for the Operating Year in which the insurance proceeds are received or (iii) will be included as operating costs in a subsequent Operating Year;
19. Legal fees, accounting fees and other expenses related to (i) the defense of LESSOR’s title to or interest in the Leased Premises, (ii) negotiations of leases or disputes arising from leases with other tenants or (iii) enforcement of the obligations of any other tenant; payment of debt service on loans secured by a mortgage on the Building;
20. Depreciation on the Building; and
21. All costs which are reimbursable to LESSOR by third parties, including but not limited to expenses for repair or replacement paid by proceeds of insurance or condemnation awards (but only, in each case, after actual receipt by LESSOR of such reimbursement).

 

 

 
 

 

 

EX-10.3 4 ex10-3.htm EMPLOYMENT AGREEMENT - JEFF LEMASTER
 

Corindus Vascular Robotics, Inc. 10-Q

 

EXHIBIT 10.3

EMPLOYMENT AGREEMENT

THIS EMPLOYMENT AGREEMENT (this “Agreement”) is entered into on October 10, 2016 by and between Corindus Vascular Robotics, Inc., a Delaware corporation with its principal office in Waltham, Massachusetts (the “Company”), and Jeff Lemaster (the “Executive”). Any reference herein to “Corindus” shall mean Corindus, Inc., a wholly-owned subsidiary of the Company.

WHEREAS, subject to the terms and conditions set forth herein, the Company desires to employ the Executive as its Chief Commercial Officer, and the Executive wishes to enter into such employment on the basis set forth in this Agreement.

NOW, THEREFORE, in consideration of the mutual covenants herein contained, and upon the other terms and conditions hereinafter provided, the parties hereby agree as follows:

1.       Period of Employment. The Company hereby agrees to employ the Executive, and the Executive hereby accepts employment with the Company upon the terms set forth in this Agreement, on an at will basis for the period commencing on October 10, 2016 (the ”Commencement Date”) and ending on the date the Executive’s employment is terminated pursuant to the terms of this Agreement (with such period being referred to herein as the ”Employment Period”). The Executive’s employment with the Company is voluntary and he is free to resign at any time, subject to the provisions of this Agreement. Further, the Company will be free to terminate the Executive’s employment at any time, with or without cause and without further obligation or liability, subject to the provisions of this Agreement.

2.       Title; Capacity.

2.1       The Executive shall serve as Chief Commercial Officer of the Company and as the Chief Executive Officer shall determine from time to time, including but not limited to as an officer of any subsidiary or affiliate of the Company, including Corindus. The Executive’s job duties are set forth in the Chief Commercial Officer Job Description attached hereto as Exhibit A, and such other duties as are assigned to the Executive by the Chief Executive Officer as are consistent with his position as Chief Commercial Officer. The Executive shall generally perform his duties from his home office, located at [       ]; provided that, the Executive understands and agrees that he will be required to travel to and from the Company’s headquarters in Waltham, Massachusetts or such other place or places as are necessary to satisfactorily perform his job duties. The Executive shall be subject to the supervision of, and shall have such authority as is delegated to the Executive by the Chief Executive Officer.

2.2       The Executive hereby accepts such employment and agrees to undertake the duties and responsibilities inherent in such position (including but not limited to those set forth in the charter or bylaws of the Company and on Exhibit A) and such other duties and responsibilities as the Chief Executive Officer shall from time to time reasonably assign to the Executive. The Executive agrees to abide by the rules, regulations, instructions, personnel practices and policies of the Company and any changes therein which may be adopted from time to time by the Company. The compensation and benefits specified under this Agreement shall constitute the sole remuneration for the duties and responsibilities described in this Section 2.

 

 
 

 

3.       Compensation and Benefits.

3.1       Base Salary. The Company or Corindus shall pay the Executive, in periodic installments in accordance with the Company’s customary payroll practices, an annual base salary of $300,000 subject to annual review for adjustment as determined by the Board, it being understood that such review may be conducted by the compensation committee designated by the Board (the “Committee”). The parties agree that the compensation hereunder was set in advance of the Commencement Date, is fair market value for the Services, is consistent with arms-length bargaining and is unrelated to the volume or value of other business between the parties.

3.2       Annual Bonus. The Executive will be eligible for a bonus payment of up to 25% (or such higher percentage set by the Board) of his annual salary for the year immediately preceding payment of such bonus based on achievement of performance objectives (as reasonably determined by the Board) contained in an annual plan approved by the Board. Any bonus award will be paid on or before March 15 of the fiscal year following the fiscal year in which the bonus is earned, and conditioned upon the Executive’s employment with the Company at the end of the immediately preceding fiscal year. For the 2016 fiscal year, the Executive will not be eligible for a bonus.

3.3       Commission. The Executive will also be eligible to participate in the Corindus variable compensation plan, with an annual target of $150,000 based on 100% completion of the goals and objectives established by Corindus. Corindus will guarantee variable income at 70% ($105,000) to target for the first months (12) months of the Executive’s employment to be paid in equal installments in the next pay cycle following the end of the month and contingent upon completion of quarterly MBOs (Management By Objectives) which will be mutually defined and agreed upon by the Executive and the Chief Executive Officer.

3.4       Stock Option. The Company will grant the Executive effective on the Commencement Date a non-qualified stock option for the purchase of an aggregate of 550,000 shares of Common Stock of the Company pursuant to the terms of the Corindus Vascular Robotics, Inc. 2014 Stock Award Plan (the ”Stock Plan”) and the Company’s standard form of non-qualified stock option agreement with a strike price equal to the closing stock price on the date of grant (the “Option”). Subject to the Executive’s continued employment, the Option shall vest over a period of four (4) years, with the first 25% of the Option vesting on the one (1) year anniversary of the Commencement Date and the remaining 75% vesting ratably monthly over the following three (3) years.

3.5       Fringe Benefits; Vacation. The Executive shall be entitled to participate in all fringe benefit programs that the Company established and makes available to its employees, if any, in accordance with such terms of such programs. The Executive shall be entitled to four (4) weeks paid vacation per year, to be taken at such times as may be approved by the Chief Executive Officer. Nothing contained herein shall be construed to limit the time the Company’s ability to amend, suspend, or terminate any fringe benefit program at any time without providing the Executive notice, and the right to do so expressly reserved.

 
 

 

3.6       Reimbursement of Expenses. The Company shall reimburse the Executive for all reasonable travel, lodging and other expenses incurred or paid by the Executive in connection with, or related to, the performance of his duties, responsibilities or services under this Agreement, in accordance with policies and procedures, and subject to limitations, adopted by the Company from time to time.

3.7       Withholding; Section 409A. All salary and other compensation payable to the Executive shall be subject to applicable withholding taxes. All reimbursements and in-kind benefits provided under this Agreement shall be made or provided in accordance with the requirements of Section 409A of the Internal Revenue Code and the guidance issued thereunder (“Section 409A”) to the extent that such reimbursements or in-kind benefits are subject to Section 409A, including, where applicable, the requirements that (a) any reimbursement be for expenses incurred during Executive’s lifetime (or during a shorter period of time specified in this Agreement), (b) the amount of expenses eligible for reimbursement during a calendar year may not affect the expenses eligible for reimbursement in any other calendar year, (c) the reimbursement of an eligible expense will be made on or before the last day of the calendar year following the year in which the expense is incurred and (d) the right to reimbursement is not subject to set off or liquidation or exchange for any other benefit.

4.       Termination of Employment Period. The employment of the Executive by the Company pursuant to this Agreement shall terminate upon the occurrence of any of the following:

4.1       At the election of the Company, for Cause (as defined below), immediately upon written notice by the Company to the Executive. For the purposes of this Section 4.1 and this Agreement, “Cause” shall mean (a) the Executive has failed or refused to perform his assigned duties for the Company, (b) the Executive has engaged in dishonesty, breach of fiduciary duty, embezzlement, fraud, gross negligence, misconduct, a breach of the Company’s Code of Ethics, or a violation of the Sarbanes-Oxley requirements for officers of public companies, (c) the Executive’s commission of, conviction of, or plea of guilty or nolo contendere to, any crime involving moral turpitude or any felony, or (d) a material breach by the Executive of this Agreement.

4.2       Upon the death or disability of the Executive. As used in this Agreement, the term “disability” shall mean the inability of the Executive, due to a physical or mental disability, for a period of ninety (90) days, whether or not consecutive, during any 360-day period to perform the services contemplated under this Agreement, with or without reasonable accommodation as that term is defined under state or federal law. A determination of disability shall be made by a physician selected by the Company.

4.3       At the discretion of either party upon thirty (30) days’ written notice of termination. In the event of termination for any reason hereunder, the parties will not enter into a similar agreement on differing financial terms until at least one (1) calendar year following the Commencement Date.

 
 

 

5.       Effect of Termination. In the event that the Executive’s employment is terminated for any reason, by either the Company or the Executive, the Company shall provide the Executive with (a) all accrued but unpaid base salary through the date of employment termination, and (b) any unpaid or unreimbursed expenses incurred through the date of employment termination in accordance with Section 3.4 above (the “Accrued Obligations”). The Accrued Obligations shall be the sole amounts owing to the Executive upon termination of the Executive’s employment and Executive shall not be eligible for any other payments or other forms of compensation or benefits.

6.       Change In Control Stock Option Acceleration. Upon a Change in Control, one hundred percent (100%) of the Executive’s outstanding unvested Options will automatically vest upon a Change in Control, provided that the Executive is then employed with the Company. For purposes of this Agreement, a “Change in Control” shall mean a “Change in Control” as defined under the Stock Plan, as in effect on the Commencement Date.

7.       Non-Competition and Non-Solicitation.

7.1       Restricted Activities. While the Executive is employed by the Company and for a period of twelve (12) months after the termination or cessation of such employment for any reason, the Executive will not directly or indirectly:

(a)       Engage in any business or enterprise (whether as owner, partner, officer, director, employee, consultant, investor, lender or otherwise, except as the holder of not more than 1% of the outstanding stock of a publicly-held company) that is competitive with the Company’s Business, including but not limited to any business or enterprise that develops, manufactures, markets, licenses, sells or provides any product or service that competes with any product or service developed, manufactured, marketed, licensed, sold or provided, or planned to be developed, manufactured, marketed, licensed, sold or provided, by the Company while the Executive was employed by the Company; or

(b)       Either alone or in association with others (i) solicit, or permit any organization directly or indirectly controlled by the Executive to solicit, any employee of the Company to leave the employ of the Company, or (ii) solicit for employment, hire or engage as an independent contractor, or permit any organization directly or indirectly controlled by the Executive to solicit for employment, hire or engage as an independent contractor, any person who was employed by the Company during the last two (2) years of the Executive’s employment with the Company.

(c)       For purposes of this Section 7.1, “Company’s Business” shall mean the development, manufacture, marketing, licensing or sales of the products or services of the Company in the field of vascular robotics.

(d)       For purposes of Section 7 and Section 8, the term “Company” includes the Company’s subsidiaries, including Corindus.

7.2       Extension. If the Executive violates the provisions of Section 7.1, the Executive shall continue to be bound by the restrictions set forth in Section 7.1 until a period of twelve (12) months has expired without any violation of such provisions.

 
 

 

7.3       Interpretation. If any restriction set forth in Section 7.1 is found by any court of competent jurisdiction to be unenforceable because it extends for too long a period of time or over too great a range of activities or in too broad a geographic area, it shall be interpreted to extend only over the maximum period of time, range of activities or geographic area as to which it may be enforceable.

7.4       Equitable Remedies. The restrictions contained in this Section 7 are necessary for the protection of the business and goodwill of the Company and are considered by the Executive to be reasonable for such purpose. The Executive agrees that any breach of this Section 7 is likely to cause the Company substantial and irrevocable damage which is difficult to measure. Therefore, in the event of any such breach or threatened breach, the Executive agrees that the Company, in addition to such other remedies which may be available, shall have the right to apply for an injunction from a court restraining such a breach or threatened breach and the right to specific performance of the provisions of this Section 7.

8.       Proprietary Information and Developments.

8.1       Proprietary Information.

(a)       The Executive agrees that all information, whether or not in writing, of a private, secret or confidential nature concerning the Company’s business, business relationships, technologies, products, product development and marketing strategies or financial affairs (collectively, “Proprietary Information”) is and shall be the exclusive property of the Company. By way of illustration, but not limitation, Proprietary Information may include inventions, products, processes, methods, trade secrets, formulas, compositions, compounds, projects, developments, plans, research data, clinical data, financial data, personnel data, computer programs, customer and supplier lists, and knowledge of customers or prospective customers of the Company. The Executive will not disclose any Proprietary Information to any person or entity other than employees of the Company or use the same for any purposes (other than in the performance of his duties as an employee of the Company) without written approval by an officer of the Company, either during or after his employment with the Company, unless and until such Proprietary Information has become public knowledge without fault by the Executive.

(b)       The Executive agrees that all files, letters, memoranda, reports, records, data, sketches, drawings, laboratory notebooks, program listings, or other written, photographic, or other tangible material containing Proprietary Information, whether created by the Executive or others, which shall come into his custody or possession, shall be and are the exclusive property of the Company to be used by the Executive only in the performance of his duties for the Company. All such materials or copies thereof and all tangible property of the Company in the custody or possession of the Executive shall be delivered to the Company, upon the earlier of (i) a request by the Company or (ii) termination of his employment. After such delivery, the Executive shall not retain any such materials or copies thereof or any such tangible property.

(c)       The Executive agrees that his obligation not to disclose or to use information and materials of the types set forth in paragraphs (a) and (b) above, and his obligation to return materials and tangible property, set forth in paragraph (b) above, also extends to such types of information, materials and tangible property of customers of the Company or suppliers to the Company or other third parties who may have disclosed or entrusted the same to the Company or to the Executive.

 
 

 

8.2       Developments.

(a)       The Executive will make full and prompt disclosure to the Company of all inventions, improvements, discoveries, methods, developments, software, and works of authorship, whether patentable or not, which are created, made, conceived or reduced to practice by him or under his direction or jointly with others during his employment by the Company, whether or not during normal working hours or on the premises of the Company (all of which are collectively referred to in this Agreement as “Developments”).

(b)       The Executive agrees to assign and does hereby assign to the Company (or any person or entity designated by the Company) all his right, title and interest in and to all Developments and all related patents, patent applications, copyrights and copyright applications. However, this paragraph (b) shall not apply to Developments which do not relate to the business or research and development conducted or planned to be conducted by the Company at the time such Development is created, made, conceived or reduced to practice and which are made and conceived by the Executive not during normal working hours, not on the Company’s premises and not using the Company’s tools, devices, equipment or Proprietary Information. The Executive understands that, to the extent this Agreement shall be construed in accordance with the laws of any state which precludes a requirement in an employee agreement to assign certain classes of inventions made by an employee, this paragraph (b) shall be interpreted not to apply to any invention which a court rules and/or the Company agrees falls within such classes. The Executive also hereby waives all claims to moral rights in any Developments.

(c)       The Executive agrees to cooperate fully with the Company, both during and after his employment with the Company, with respect to the procurement, maintenance and enforcement of copyrights, patents and other intellectual property rights (both in the United States and foreign countries) relating to Developments; provided that, after his employment with the Company, such cooperation shall be conditioned upon reimbursement by the Company of the Executive’s reasonable costs and expenses incurred in connection therewith. The Executive shall sign all papers, including, without limitation, copyright applications, patent applications, declarations, oaths, formal assignments, assignments of priority rights, and powers of attorney, which the Company may deem necessary or desirable in order to protect its rights and interests in any Development. The Executive further agrees that if the Company is unable, after reasonable effort, to secure the signature of the Executive on any such papers, any executive officer of the Company shall be entitled to execute any such papers as the agent and the attorney-in-fact of the Executive, and the Executive hereby irrevocably designates and appoints each executive officer of the Company as his agent and attorney-in-fact to execute any such papers on his behalf, and to take any and all actions as the Company may deem necessary or desirable in order to protect its rights and interests in any Development, under the conditions described in this sentence,

8.3       United States Government Obligations. The Executive acknowledges that the Company from time to time may have agreements with other parties or with the United States Government, or agencies thereof, which impose obligations or restrictions on the Company regarding inventions made during the course of work under such agreements or regarding the confidential nature of such work. The Executive agrees to be bound by all such obligations and restrictions which are made known to the Executive and to take all appropriate action necessary to discharge the obligations of the Company under such agreements.

 
 

 

8.4       Equitable Remedies. The restrictions contained in this Section 8 are necessary for the protection of the business and goodwill of the Company and are considered by the Executive to be reasonable for such purpose. The Executive agrees that any breach of this Section 8 may cause the Company substantial and irrevocable damage which is difficult to measure. Therefore, in the event of any such breach or threatened breach, the Executive agrees that the Company, in addition to such other remedies which may be available, shall have the right to apply for an injunction from a court restraining such a breach or threatened breach and the right to specific performance of the provisions of this Section 8.

9.       Miscellaneous.

9.1       Notices. Any notices delivered under this Agreement shall be deemed duly delivered four (4) business days after it is sent by registered or certified mail, return receipt requested, postage prepaid, or one business day after it is sent for next-business day delivery via a reputable nationwide overnight courier service, in each case to the address of the recipient set forth in the introductory paragraph hereto. Either party may change the address to which notices are to be delivered by giving notice of such change to the other party in the manner set forth in this Section 9.1.

9.2       Pronouns. Whenever the context may require, any pronouns used in this Agreement shall include the corresponding masculine, feminine or neuter forms, and the singular forms of nouns and pronouns shall include the plural, and vice versa.

9.3       Entire Agreement. This Agreement contains the entire understanding between the parties and supersedes all prior agreements and understandings, whether written or oral, relating to the subject matter of this Agreement. No provision of this Agreement shall be interpreted to mean that Executive is subject to receiving fewer benefits than those available to him without reference to this Agreement.

9.4       Amendment. This Agreement may be amended or modified only by a written instrument executed by both the Company and the Executive.

9.5       Governing Law. This Agreement shall be governed by and construed in accordance with the laws of The Commonwealth of Massachusetts (without reference to the conflicts of laws provisions thereof). Any action, suit or other legal proceeding arising under or relating to any provision of this Agreement shall be commenced only in a court of The Commonwealth of Massachusetts (or, if appropriate, a federal court located within Massachusetts), and the Company and the Executive each consents to the jurisdiction of such a court.

9.6       Successors and Assigns; Third Party Beneficiaries. This Agreement shall be binding upon and inure to the benefit of both the Company and its successors and assigns, including any corporation with which, or into which, the Company may be merged or which may succeed to the Company’s assets or business; provided, however, that the obligations of the Executive are personal and shall not be assigned by him. Corindus and each of the Company’s other direct and indirect subsidiaries are designated as a third party beneficiary of this Agreement and shall be entitled to enforce the terms hereof as if it were a party hereto.

 
 

 

9.7       Section 409A. The parties agree that this Agreement shall be interpreted to comply with or be exempt from Section 409A, and all provisions of this Agreement shall be construed in a manner consistent with the requirements for avoiding taxes or penalties under Section 409A. Notwithstanding the immediately preceding sentence, in no event shall the Company, Corindus or any of their respective subsidiaries be liable for any additional tax, interest, or penalties that may be imposed on Executive as a result of Section 409A or any damages for failing to comply with Section 409A (other than for withholding obligations or other obligations applicable to employers under the Code).

9.8       Waivers. No delay or omission by the Company in exercising any right under this Agreement shall operate as a waiver of that or any other right. A waiver or consent given by the Company on any one occasion shall be effective only in that instance and shall not be construed as a bar or waiver of any right on any other occasion.

9.9       Captions. The captions of the sections of this Agreement are for convenience of reference only and in no way define, limit or affect the scope or substance of any section of this Agreement.

9.10     Severability. In case any provision of this Agreement shall be invalid, illegal or otherwise unenforceable, the validity, legality and enforceability of the remaining provisions shall in no way be affected or impaired thereby.

9.11     Survival. Anything in this Agreement to the contrary notwithstanding, to the extent applicable, Sections 5, 7, 8, 9.1, 9.2, 9.3, 9.4, 9.5, 9.6, 9.8, 9.9, 9.10, and 9.11 shall survive the termination of this Agreement for any reason.

9.12     Compliance with Laws. The Company and the Executive will at all times comply with all applicable state and federal laws, rules, regulations and standards of any and all governmental authorities and regulatory and accreditation bodies.

9.13     Employment Eligibility. The Immigration Reform and Control Act requires employers to verify the employment eligibility and identity of new employees. The Executive shall provide the Company with the appropriate documentation for verification prior to the Commencement Date.

[signature page immediately follows]

 
 

 

THE EXECUTIVE ACKNOWLEDGES THAT HE HAS READ THIS AGREEMENT CAREFULLY AND UNDERSTANDS AND AGREES TO ALL OF THE PROVISIONS IN THIS AGREEMENT.

IN WITNESS WHEREOF, the parties hereto have executed this agreement as of the day and year set forth above.

CORINDUS VASCULAR ROBOTICS, INC.  
     
By:   /s/ Mark J. Toland  
  Mark Toland  
  President and Chief Executive Officer  
     
EXECUTIVE  
   
/s/ Jeff Lemaster  
Jeff Lemaster  
 
 

EXHIBIT A

CHIEF COMMERCIAL OFFICE JOB DESCRIPTION

Role and Responsibilities

Chief Commercial Officer Job Description

The Chief Commercial Officer is a key member of the Senior Executive team. This role will be responsible for Marketing and Sales and is responsible for driving profitable revenue growth and market adoption, working closely with the senior leadership team to devise and implement strategies to grow relationships with existing customers, as well as to penetrate and expand within new key customers.

Specific Duties

The Chief Commercial Officer’s duties shall include, but not be limited to:

•  Lead and execute revenue and commercial strategy for the organization, driving predictable and profitable revenue growth.

•  Develop and provide leadership for a high performing product management team to drive the execution of strategic marketing plans for meeting overall business objectives.

•  Participate in strategic planning to define the company’s strategy and execution plans.

•  Work closely with other functional heads to ensure alignment and delivery of all functional needs as it relates to the Sales, Marketing and other Commercial Functions.

•  Introduce and continuously improve best practice business processes related to sales operations – build all processes for managing, measuring and reporting sales force performance.

•  Recruit and develop world class commercial talent and build organizational capability through goal setting, coaching, performance management, and succession planning.

•  Active engagement in business development opportunities to include alliances, partnerships, and acquisitions.

Desired Qualifications:

•  Highly accomplished commercial leader with 15 years + management experience.

•  Minimum of 10 years experience in medical device with a focus on interventional cardiology.

•  Strategic and innovative thinker with proven ability to communicate a vision and drive results.

•  Demonstrated management, organizational and interpersonal skills.

•  Ability to solve problems and execute on initiatives.

•  Ability to work collaboratively internally and externally.

•  Self-assured and results oriented.

 

 
 

 

 

 

 

EX-31.1 5 ex31-1.htm CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER
 

Corindus Vascular Robotics, Inc. 10-Q

 

EXHIBIT 31.1

 

CERTIFICATION PURSUANT TO 

SECTION 302 OF 

THE SARBANES-OXLEY ACT OF 2002

 

I, Mark J. Toland, certify that:

 

(1) I have reviewed this quarterly report on Form 10-Q of Corindus Vascular Robotics, Inc.;

 

(2) Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

(3) Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

(4) The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

(5) The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent functions):

 

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

November 9, 2016  
  /s/ Mark J. Toland
  Mark J. Toland
  Chief Executive Officer and President
  (Principal Executive Officer)

 

 

 

EX-31.2 6 ex31-2.htm CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER
 

Corindus Vascular Robotics, Inc. 10-Q 

  

Exhibit 31.2

 

CERTIFICATION PURSUANT TO 

SECTION 302 OF 

THE SARBANES-OXLEY ACT OF 2002

 

I, David W. Long, certify that:

 

(1) I have reviewed this quarterly report on Form 10-Q of Corindus Vascular Robotics, Inc.;

 

(2) Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

(3) Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

(4) The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

(5) The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent functions):

 

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

November 9, 2016  
  /s/ David W. Long
  David W. Long
  Chief Financial Officer and Senior Vice President
  (Principal Financial and Accounting Officer)

 

 

 

EX-32.1 7 ex32-1.htm CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER
 

Corindus Vascular Robotics, Inc. 10-Q 

  

EXHIBIT 32.1

 

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO 

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

In connection with the quarterly report of Corindus Vascular Robotics, Inc. (the “Company”) on Form 10-Q for the period ending September 30, 2016, as filed with the Securities and Exchange Commission (the “Report”), I, Mark J. Toland, Principal Executive Officer of the Company, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, to my knowledge, that:

 

(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

November 9, 2016

   

/s/ Mark J. Toland

 
Mark J. Toland  
Chief Executive Officer and President  
(Principal Executive Officer)  

 

A signed original of this certification has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.

 

 

EX-32.2 8 ex32-2.htm CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER
 

Corindus Vascular Robotics, Inc. 10-Q 

 

EXHIBIT 32.2

 

CERTIFICATION PURSUANT TO 

18 U.S.C. SECTION 1350, 

AS ADOPTED PURSUANT TO 

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

In connection with the quarterly report of Corindus Vascular Robotics, Inc. (the “Company”) on Form 10-Q for the period ending September 30, 2016, as filed with the Securities and Exchange Commission (the “Report”), I, David W. Long, Principal Financial and Accounting Officer of the Company, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, to my knowledge, that:

 

(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

November 9, 2016

   

/s/ David W. Long

 
David W. Long  
Chief Financial Officer and Senior Vice President  
(Principal Financial and Accounting Officer)  

 

A signed original of this certification has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.

 

 

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Document and Entity Information - shares
9 Months Ended
Sep. 30, 2016
Nov. 04, 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 Sep. 30, 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   119,025,221
Document Fiscal Period Focus Q3  
Document Fiscal Year Focus 2016  
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CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) - USD ($)
$ in Thousands
Sep. 30, 2016
Dec. 31, 2015
Current Assets:    
Cash and cash equivalents $ 18,079 $ 22,142
Marketable securities 20,524
Accounts receivable 531 878
Inventories, net 1,619 1,329
Prepaid expenses and other current assets 305 591
Total current assets 20,534 45,464
Property and equipment, net 1,064 1,382
Deposits and other assets 153 157
Notes receivable due from stockholders 71 136
Total assets 21,822 47,139
Current liabilities:    
Accounts payable 1,845 1,538
Accrued expenses 1,580 1,199
Deferred revenue 281 701
Current portion of long-term debt 4,597 4,033
Total current liabilities 8,303 7,471
Long-term liabilities:    
Deferred revenue, net of current portion 148 106
Other liabilities 13 42
Long-term debt, net of current portion 217 3,673
Total long-term liabilities 378 3,821
Total liabilities 8,681 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 at December 31, 2015 and 119,025,221 shares at September 30, 2016 issued and outstanding 12 12
Additional paid-in capital 150,056 149,489
Accumulated other comprehensive income (loss) (14)
Accumulated deficit (136,927) (113,640)
Total stockholders' equity 13,141 35,847
Total liabilities and stockholders' equity $ 21,822 $ 47,139
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CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (Parenthetical) - $ / shares
Sep. 30, 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 0 0
Preferred stock, outstanding shares 0 0
Common stock, par value $ 0.0001 $ 0.0001
Common stock, authorized shares 250,000,000 250,000,000
Common stock, issued shares 119,025,221 118,832,441
Common stock, outstanding shares 119,025,221 118,832,441
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Unaudited) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2016
Sep. 30, 2015
Sep. 30, 2016
Sep. 30, 2015
Income Statement [Abstract]        
Revenue $ 688 $ 212 $ 2,304 $ 1,897
Cost of revenue 1,220 722 3,412 2,464
Gross loss (532) (510) (1,108) (567)
Operating expenses:        
Research and development 2,728 2,263 7,373 7,851
Selling, general and administrative 4,585 3,885 13,987 11,883
Total operating expenses 7,313 6,148 21,360 19,734
Operating loss (7,845) (6,658) (22,468) (20,301)
Other expense:        
Interest and other expense (net) (221) (404) (819) (1,233)
Total other expense (221) (404) (819) (1,233)
Net loss $ (8,066) $ (7,062) $ (23,287) $ (21,534)
Net loss per share-basic and diluted $ (0.07) $ (0.06) $ (0.20) $ (0.19)
Weighted-average common shares used in computing net loss per share-basic and diluted 118,958,430 118,541,168 119,017,846 111,446,296
Other comprehensive loss:        
Net loss $ (8,066) $ (7,062) $ (23,287) $ (21,534)
Unrealized gain (loss) on marketable securities (9) (7) 14 (7)
Comprehensive loss $ (8,075) $ (7,069) $ (23,273) $ (21,541)
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CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS' EQUITY (Unaudited) - 9 months ended Sep. 30, 2016 - USD ($)
$ in Thousands
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   1,646     1,646
Issuance of common stock upon exercise of stock options   (338)     (338)
Issuance of common stock upon exercise of stock options, shares 848,297        
Issuance of common stock upon exercise of warrants, shares 93,325        
Common stock repurchase and retirement   (741)     (741)
Common stock repurchase and retirement, shares (748,842)        
Change in fair value of marketable securities     $ 14   14
Net loss       (23,287) (23,287)
Ending balance at Sep. 30, 2016 $ 12 $ 150,056   $ (136,927) $ 13,141
Ending balance, shares at Sep. 30, 2016 119,025,221        
XML 20 R6.htm IDEA: XBRL DOCUMENT v3.5.0.2
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($)
$ in Thousands
9 Months Ended
Sep. 30, 2016
Sep. 30, 2015
Operating activities    
Net loss $ (23,287) $ (21,534)
Adjustments to reconcile net loss to net cash flows used in operating activities:    
Loss on disposal of fixed assets 59
Depreciation and amortization 564 510
Stock-based compensation expense 1,646 313
Accretion on interest expense 343 480
Accretion on available-for-sale securities (15) (3)
Changes in operating assets and liabilities:    
Accounts receivable 347 (93)
Prepaid expenses and other current assets 286 (370)
Deferred inventory costs 102
Inventories (290) (456)
Deposits and other assets 4 53
Accounts payable, accrued expenses and other liabilities 659 (441)
Deferred revenue (378) (93)
Net cash used in operating activities (20,062) (21,532)
Investing activities    
Purchases of available-for-sale securities (20,593)
Maturities of available-for-sale securities 20,553  
Collections of notes receivable 65  
Purchases of property and equipment (305) (281)
Net cash provided by (used in) investing activities 20,313 (20,874)
Financing activities    
Payments of financing costs from issuance of long-term debt and warrants (50)
Proceeds from issuance of common stock, net of offering costs 44,643
Proceeds from exercise of stock options 72 20
Payment for common stock repurchase and retirement (741)  
Payments for withholding taxes on stock option exercises (410)  
Payments on long term debt (3,235) (998)
Net cash provided by (used in) financing activities (4,314) 43,615
Net increase (decease) in cash and cash equivalents (4,063) 1,209
Cash and cash equivalents at beginning of period 22,142 28,526
Cash and cash equivalents at end of period 18,079 29,735
Supplemental Disclosure of Cash Flow Information:    
Transfer from inventories to property and equipment in the field 365
Deferred public offering costs in accounts payable and accrued expenses 251
Interest paid $ 534 $ 746
XML 21 R7.htm IDEA: XBRL DOCUMENT v3.5.0.2
Nature of Operations
9 Months Ended
Sep. 30, 2016
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Nature of Operations
Note 1 Nature of Operations

 

The Company

 

Corindus Vascular Robotics, Inc. (the “Company”), formerly named Your Internet Defender, Inc. (“YIDI”), acquired Corindus, Inc., a privately-held company, in a reverse acquisition on August 12, 2014. The Company was previously a Nevada corporation, but effective June 28, 2016, the Company changed its state of incorporation from the State of Nevada to the State of Delaware. 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.

 

On October 27, 2016, the Company announced that it had received 510(k) clearance from the FDA for its CorPath GRX, the second generation of its CorPath System.  The Company expects to commence commercialization of CorPath GRX in the first quarter of 2017.

 

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 September 30, 2016, the Company had an accumulated deficit of $136,927, and borrowings outstanding of $4,960, of which $4,742 is contractually due over the next 12 months.

 

As of September 30, 2016, the Company had cash and cash equivalents of $18,079 and working capital of $12,231. The Company believes that these available resources will be sufficient to meet the Company’s cash requirements through the first quarter of 2017, including funding its anticipated losses and scheduled debt maturities.  Accordingly, the Company will need to raise additional funds to support its operating and capital needs.  The Company will attempt to obtain additional funding through public or private financing, collaborative arrangements with strategic partners, or through additional credit lines or other debt financing sources to increase the funds available to fund operations. Additionally, the Company is in compliance with its debt covenant requirements as of September 30, 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.

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Significant Accounting Policies
9 Months Ended
Sep. 30, 2016
Accounting Policies [Abstract]  
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 nine months ended September 30, 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 September 30, 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 $120 and $12 for the three months ended September 30, 2015 and 2016, respectively, and $337 and $94 for the nine months ended September 30, 2015 and 2016, respectively. The entity had both assets and liabilities of $9 on its balance sheet at September 30, 2016 and assets and liabilities of $56 and $75, respectively, on its balance sheet at December 31, 2015.

 

Reclassification

 

Certain amounts as of December 31, 2015 have been reclassified to conform 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 and 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 table below sets forth the Company’s customers that accounted for greater than 10% of its revenues for the three- and nine-month periods ended September 30, 2015 and 2016, respectively:

 

      Three months ended
September 30,
    Nine months ended
September 30,
 
Customer     2015     2016     2015     2016  
A       11 %     5 %     4 %     4 %
B       11 %     3 %     2 %     2 %
C       8 %     4 %     10 %     4 %
D       %     %     14 %     %
E       %     4 %     12 %     2 %
F       %     %     11 %     2 %
G       %     49 %     %     15 %
H       %     %     %     34 %

 

The Company had two other customers that together accounted for 76% of the Company’s accounts receivable balance at December 31, 2015. Additionally, Customer G comprised 69% of the Company’s accounts receivable balance at September 30, 2016. Given the current revenue levels, in a period in which the Company sells a system, the purchaser of such system is likely to represent a significant customer.

 

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     $  

 

 

    September 30, 2016  
     

Total

      Quoted prices active markets (Level 1)      

Significant other

observable inputs

(Level 2)

     

Significant unobservable inputs

(Level 3)

 
Assets:                                
Cash equivalents   $ 10,164     $ 10,164     $     $  
Total assets   $ 10,164     $ 10,164     $     $  

 

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 had classified all of its marketable securities during 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.

 

During 2016, the activity in the Company’s accumulated other comprehensive income 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 nine months ended September 30, 2016, and as a result, the Company did not reclassify any amount out of accumulated other comprehensive income during that same period.

 

The Company’s marketable securities matured in accordance with stated terms during the nine months ended September 30, 2016.

 

The following table summarizes available-for-sale securities held at December 31, 2015:

 

    Amortized Cost     Unrealized Gain     Unrealized Loss     Fair Value  
                                 
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  

 

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 and premium service plans is recognized on a straight-line basis over the life of the service contract. 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 and September 30, 2016, there were no amounts outstanding from Philips.

 

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 nine months ended September 30, 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 93,325 shares of common stock during the year.

 

The table below is a summary of the Company’s warrant activity during the nine months ended September 30, 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 September 30, 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 or nine months ended September 30, 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 and $0 at December 31, 2015 and September 30, 2016, respectively.

 

New Accounting Pronouncements

 

Except as described below, there have been no new accounting pronouncements or changes to accounting pronouncements during the nine months ended September 30, 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 periods ending after December 15, 2016, and all annual and interim periods thereafter. Early application is permitted. The Company faces certain risks and uncertainties, as further described in Note 1, Nature of Operations. Upon adoption of this update, the Company will be required to make additional disclosures regarding its forecasts and financing plans.

 

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 September 30, 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.

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Inventories
9 Months Ended
Sep. 30, 2016
Inventory Disclosure [Abstract]  
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
   September 30,
2016
 
Raw material  $483   $621 
Work in progress   79    93 
Finished goods   767    905 
Total  $1,329   $1,619 

 

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Long-Term Debt
9 Months Ended
Sep. 30, 2016
Debt Disclosure [Abstract]  
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 September 30, 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 September 30, 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 September 30, 2016.

XML 25 R11.htm IDEA: XBRL DOCUMENT v3.5.0.2
Stock-based Compensation
9 Months Ended
Sep. 30, 2016
Disclosure of Compensation Related Costs, Share-based Payments [Abstract]  
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
September 30,
   Nine Months Ended
September 30,
 
   2015   2016   2015   2016 
Research and development  $19   $45   $56   $113 
Selling, general and administrative   85    617    257    1,533 
Total  $104   $662   $313   $1,646 

 

The Company granted options to purchase 299,486 shares of common stock at exercise prices ranging from of $3.26 to $4.44 per share during the nine months ended September 30, 2015. The Company granted options to purchase 10,097,994 shares of common stock at exercise prices ranging from $0.99 to $2.03 per share during the nine months ended September 30, 2016. The weighted-average fair value of the stock options granted was $2.40 per share and $0.71 per share for the nine months ended September 30, 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”):

 

   Nine Months Ended
September 30,
 
   2015   2016 
Risk-free interest   1.5%-2.0%    1.3%-1.6% 
Expected term in years   6.1    6.1 
Expected volatility   50%-80%    48%-53% 
Expected dividend yield   0%   0%

 

XML 26 R12.htm IDEA: XBRL DOCUMENT v3.5.0.2
Net Loss per Share
9 Months Ended
Sep. 30, 2016
Earnings Per Share [Abstract]  
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:

 

   As of September 30, 
   2015   2016 
Options to purchase common stock   8,078,961    15,164,711 
Warrants to purchase common stock   5,207,379    5,083,219 
 Total   13,286,340    20,247,930 

 

XML 27 R13.htm IDEA: XBRL DOCUMENT v3.5.0.2
Related Party Transactions
9 Months Ended
Sep. 30, 2016
Related Party Transactions [Abstract]  
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 nine month periods ended September 30, 2015 and 2016, the Company recorded revenues of $125 from shipments to Philips. At December 31, 2015 and September 30, 2016, there were no amounts owed from Phillips to the Company 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 September 30, 2016, respectively. The Company assessed the notes receivable for impairment and concluded that there were no impairment indicators at December 31, 2015 and September 30, 2016. The Company does not believe there is any significant collection risk associated with the notes receivable at September 30, 2016.

 

Common Stock Repurchase and Retirement

 

On April 15, 2016, the Company repurchased and retired 748,842 shares of its common stock for an aggregate amount of approximately $741 pursuant to the terms of a privately negotiated transaction with the Company’s former Chief Executive Officer.

 

XML 28 R14.htm IDEA: XBRL DOCUMENT v3.5.0.2
Subsequent Event
9 Months Ended
Sep. 30, 2016
Subsequent Events [Abstract]  
Subsequent Event
Note 8 Subsequent Event

 

On October 24, 2016, the Company entered into an agreement to extend its building lease for the period from February 1, 2018 through January 31, 2021 with monthly payments ranging from $53 to $55 during the new extended period.

 

XML 29 R15.htm IDEA: XBRL DOCUMENT v3.5.0.2
Significant Accounting Policies (Policies)
9 Months Ended
Sep. 30, 2016
Accounting Policies [Abstract]  
Principles of Consolidation

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 September 30, 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 $120 and $12 for the three months ended September 30, 2015 and 2016, respectively, and $337 and $94 for the nine months ended September 30, 2015 and 2016, respectively. The entity had both assets and liabilities of $9 on its balance sheet at September 30, 2016 and assets and liabilities of $56 and $75, respectively, on its balance sheet at December 31, 2015.

Reclassification

Reclassification

 

Certain amounts as of December 31, 2015 have been reclassified to conform 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 and long-term debt, net of current portion, on the condensed consolidated balance sheets.

Segment Information

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

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

Significant Customers

 

The table below sets forth the Company’s customers that accounted for greater than 10% of its revenues for the three- and nine-month periods ended September 30, 2015 and 2016, respectively:

 

      Three months ended
September 30,
    Nine months ended
September 30,
 
Customer     2015     2016     2015     2016  
A       11 %     5 %     4 %     4 %
B       11 %     3 %     2 %     2 %
C       8 %     4 %     10 %     4 %
D       %     %     14 %     %
E       %     4 %     12 %     2 %
F       %     %     11 %     2 %
G       %     49 %     %     15 %
H       %     %     %     34 %

 

The Company had two other customers that together accounted for 76% of the Company’s accounts receivable balance at December 31, 2015. Additionally, Customer G comprised 69% of the Company’s accounts receivable balance at September 30, 2016. Given the current revenue levels, in a period in which the Company sells a system, the purchaser of such system is likely to represent a significant customer.

Fair Value Measurements

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   $ 

 

 

   September 30, 2016 
    

Total

    Quoted prices active markets (Level 1)    

Significant other

observable inputs

(Level 2)

    

Significant unobservable inputs

(Level 3)

 
Assets:                    
Cash equivalents  $10,164   $10,164   $   $ 
Total assets  $10,164   $10,164   $   $ 

 

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

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

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 had classified all of its marketable securities during 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.

 

During 2016, the activity in the Company’s accumulated other comprehensive income 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 nine months ended September 30, 2016, and as a result, the Company did not reclassify any amount out of accumulated other comprehensive income during that same period.

 

The Company’s marketable securities matured in accordance with stated terms during the nine months ended September 30, 2016.

 

The following table summarizes available-for-sale securities held at December 31, 2015:

 

   Amortized Cost   Unrealized Gain   Unrealized Loss   Fair Value 
                     
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 

 

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

 

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

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 and premium service plans is recognized on a straight-line basis over the life of the service contract. 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 and September 30, 2016, there were no amounts outstanding from Philips.

 

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

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 nine months ended September 30, 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 93,325 shares of common stock during the year.

 

The table below is a summary of the Company’s warrant activity during the nine months ended September 30, 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 September 30, 2016    5,083,219   $1.08 

 

Stock-Based Compensation

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

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 or nine months ended September 30, 2015 and 2016 due to uncertainty regarding future taxable income.

 

Comprehensive Loss

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 and $0 at December 31, 2015 and September 30, 2016, respectively.

New Accounting Pronouncements

New Accounting Pronouncements

 

Except as described below, there have been no new accounting pronouncements or changes to accounting pronouncements during the nine months ended September 30, 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 periods ending after December 15, 2016, and all annual and interim periods thereafter. Early application is permitted. The Company faces certain risks and uncertainties, as further described in Note 1, Nature of Operations. Upon adoption of this update, the Company will be required to make additional disclosures regarding its forecasts and financing plans.

 

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 September 30, 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.

XML 30 R16.htm IDEA: XBRL DOCUMENT v3.5.0.2
Significant Accounting Policies (Tables)
9 Months Ended
Sep. 30, 2016
Accounting Policies [Abstract]  
Schedule of customers that accounted for greater than 10% of revenues

The table below sets forth the Company’s customers that accounted for greater than 10% of its revenues for the three- and nine-month periods ended September 30, 2015 and 2016, respectively:

 

    Three months ended
September 30,
   Nine months ended
September 30,
 
Customer   2015   2016   2015   2016 
A    11%   5%   4%   4%
B    11%   3%   2%   2%
C    8%   4%   10%   4%
D    %   %   14%   %
E    %   4%   12%   2%
F    %   %   11%   2%
G    %   49%   %   15%
H    %   %   %   34%

 

Schedule of assets that are measured at fair value on a recurring basis

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   $ 

 

 

   September 30, 2016 
    

Total

    Quoted prices active markets (Level 1)    

Significant other

observable inputs

(Level 2)

    

Significant unobservable inputs

(Level 3)

 
Assets:                    
Cash equivalents  $10,164   $10,164   $   $ 
Total assets  $10,164   $10,164   $   $ 

 

Summary of available-for-sale securities

The following table summarizes available-for-sale securities held at December 31, 2015:

 

   Amortized Cost   Unrealized Gain   Unrealized Loss   Fair Value 
                     
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 

 

Schedule of warrant activity

The table below is a summary of the Company’s warrant activity during the nine months ended September 30, 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 September 30, 2016    5,083,219   $1.08 

 

XML 31 R17.htm IDEA: XBRL DOCUMENT v3.5.0.2
Inventories (Tables)
9 Months Ended
Sep. 30, 2016
Inventory Disclosure [Abstract]  
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
   September 30,
2016
 
Raw material  $483   $621 
Work in progress   79    93 
Finished goods   767    905 
Total  $1,329   $1,619 

 

XML 32 R18.htm IDEA: XBRL DOCUMENT v3.5.0.2
Stock-based Compensation (Tables)
9 Months Ended
Sep. 30, 2016
Disclosure of Compensation Related Costs, Share-based Payments [Abstract]  
Schedule of stock-based compensation expense

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

 

   Three Months Ended
September 30,
   Nine Months Ended
September 30,
 
   2015   2016   2015   2016 
Research and development  $19   $45   $56   $113 
Selling, general and administrative   85    617    257    1,533 
Total  $104   $662   $313   $1,646 

 

Schedule of assumptions used to estimate the fair value of stock options

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”):

 

   Nine Months Ended
September 30,
 
   2015   2016 
Risk-free interest   1.5%-2.0%    1.3%-1.6% 
Expected term in years   6.1    6.1 
Expected volatility   50%-80%    48%-53% 
Expected dividend yield   0%   0%

 

XML 33 R19.htm IDEA: XBRL DOCUMENT v3.5.0.2
Net Loss per Share (Tables)
9 Months Ended
Sep. 30, 2016
Earnings Per Share [Abstract]  
Schedule of securities excluded from the calculation of diluted 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:

 

   As of September 30, 
   2015   2016 
Options to purchase common stock   8,078,961    15,164,711 
Warrants to purchase common stock   5,207,379    5,083,219 
 Total   13,286,340    20,247,930 

 

XML 34 R20.htm IDEA: XBRL DOCUMENT v3.5.0.2
Nature of Operations - additonal information (Detail) - USD ($)
$ in Thousands
Sep. 30, 2016
Dec. 31, 2015
Sep. 30, 2015
Dec. 31, 2014
Organization, Consolidation and Presentation of Financial Statements [Abstract]        
Cash and cash equivalents $ 18,079 $ 22,142 $ 29,735 $ 28,526
Borrowings outstanding 4,960      
Borrowings outstanding, current 4,742      
Accumulated deficit (136,927) $ (113,640)    
Working capital $ 12,231      
XML 35 R21.htm IDEA: XBRL DOCUMENT v3.5.0.2
Significant Accounting Policies - Additional Information (Detail) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended 12 Months Ended
Sep. 30, 2016
Sep. 30, 2015
Sep. 30, 2016
Sep. 30, 2015
Dec. 31, 2015
Number of segments     1    
Assets $ 21,822   $ 21,822   $ 47,139
Liabilities 8,681   $ 8,681   $ 11,292
Length of CorPath Utilization Program     36 months    
Customer credit - future purchase 1   $ 1    
Accounts Receivable [Member] | Customer G [Member]          
Concentration percentage     69.00%    
Accounts Receivable [Member] | Two Customers [Member]          
Concentration percentage         76.00%
Not-For-Profit Subsidiary [Member]          
Recognized expenses 12 $ 120 $ 94 $ 337  
Assets 9   9   $ 56
Liabilities $ 9   $ 9   $ 75
XML 36 R22.htm IDEA: XBRL DOCUMENT v3.5.0.2
Significant Accounting Policies - Schedule of customer concentration (Detail) - Sales Revenue [Member]
3 Months Ended 9 Months Ended
Sep. 30, 2016
Sep. 30, 2015
Sep. 30, 2016
Sep. 30, 2015
Customer A [Member]        
Concentration percentage 5.00% 11.00% 4.00% 4.00%
Customer B [Member]        
Concentration percentage 3.00% 11.00% 2.00% 2.00%
Customer C [Member]        
Concentration percentage 4.00% 8.00% 4.00% 10.00%
Customer D [Member]        
Concentration percentage   14.00%
Customer E [Member]        
Concentration percentage 4.00%   2.00% 12.00%
Customer F [Member]        
Concentration percentage   2.00% 11.00%
Customer G [Member]        
Concentration percentage 49.00%   15.00%  
Customer H [Member]        
Concentration percentage     34.00%  
XML 37 R23.htm IDEA: XBRL DOCUMENT v3.5.0.2
Significant Accounting Policies - Schedule of Assets Measured at Fair Value on Recurring Basis (Detail) - USD ($)
$ in Thousands
Sep. 30, 2016
Dec. 31, 2015
Assets:    
Marketable securities   $ 20,524
Certificates of Deposit [Member]    
Assets:    
Marketable securities   4,648
Recurring [Member]    
Assets:    
Cash equivalents $ 10,164 6,356
Total assets 10,164 26,880
Recurring [Member] | Fair Value, Inputs, Level 1 [Member]    
Assets:    
Cash equivalents 10,164 6,107
Total assets $ 10,164 21,983
Recurring [Member] | Fair Value, Inputs, Level 2 [Member]    
Assets:    
Cash equivalents   249
Total assets   4,897
Recurring [Member] | US Government Treasuries [Member]    
Assets:    
Marketable securities   15,876
Recurring [Member] | US Government Treasuries [Member] | Fair Value, Inputs, Level 1 [Member]    
Assets:    
Marketable securities   15,876
Recurring [Member] | Certificates of Deposit [Member]    
Assets:    
Marketable securities   4,648
Recurring [Member] | Certificates of Deposit [Member] | Fair Value, Inputs, Level 2 [Member]    
Assets:    
Marketable securities   $ 4,648
XML 38 R24.htm IDEA: XBRL DOCUMENT v3.5.0.2
Significant Accounting Policies - Summary of Available-for-Sale Securities (Detail)
$ in Thousands
Dec. 31, 2015
USD ($)
Amortized Cost $ 20,538
Unrealized Gain 1
Unrealized Loss (15)
Fair Value 20,524
Certificates of Deposit [Member]  
Amortized Cost 4,653
Unrealized Loss (5)
Fair Value 4,648
US Government Treasuries [Member]  
Amortized Cost 15,885
Unrealized Gain 1
Unrealized Loss (10)
Fair Value $ 15,876
XML 39 R25.htm IDEA: XBRL DOCUMENT v3.5.0.2
Significant Accounting Policies - Schedule of warrant activity (Detail)
9 Months Ended
Sep. 30, 2016
$ / shares
shares
Accounting Policies [Abstract]  
Beginning balance | shares 5,207,379
Exercised | shares (124,160)
Ending balance | shares 5,083,219
Weighted-Average Exercise Price  
Beginning balance | $ / shares $ 1.08
Exercised | $ / shares .76
Ending balance | $ / shares $ 1.08
XML 40 R26.htm IDEA: XBRL DOCUMENT v3.5.0.2
Inventories - Schedule of Inventories Valued under FIFO Method (Detail) - USD ($)
$ in Thousands
Sep. 30, 2016
Dec. 31, 2015
Inventory Disclosure [Abstract]    
Raw material $ 621 $ 483
Work in progress 93 79
Finished goods 905 767
Inventories, net $ 1,619 $ 1,329
XML 41 R27.htm IDEA: XBRL DOCUMENT v3.5.0.2
Long-Term Debt - Additional Information (Detail) - USD ($)
$ / shares in Units, $ in Thousands
9 Months Ended
Dec. 31, 2014
Jun. 11, 2014
Sep. 30, 2016
Sep. 30, 2015
Minimum [Member]        
Exercise price of warrant     $ .99 $ 3.26
Initial Promissory Note [Member]        
Available borrowing under Loan and Security Agreement   $ 10,000    
Amount of each separate note   $ 5,000    
Note issuance date   Jun. 11, 2014    
Frequency of debt payments   Monthly    
Term of debt payments   27 months    
Date of first required payment   Jul. 01, 2015    
Effective interest rate     11.50%  
Interest rate, description of maximum   11.25% plus the Wall Street Journal Prime Rate, less 3.25%    
Spread on variable rate   (3.25%)    
Additional interest payment   $ 125    
Due date of additional interest payment   Oct. 01, 2017    
Number of warrants issued with debt (shares)   177,514    
Exercise price of warrant   $ 1.41    
Fair value of the warrant issued   $ 230    
Initial Promissory Note [Member] | Minimum [Member]        
Effective interest rate   11.25%    
Second Promissory Note [Member]        
Amount of each separate note $ 5,000      
Frequency of debt payments Monthly      
Term of debt payments 27 months      
Date of first required payment Jul. 01, 2015      
Effective interest rate     10.20%  
Interest rate, description of maximum 9.95% plus the Wall Street Journal Prime Rate, less 3.25%      
Spread on variable rate (3.25%)      
Additional interest payment $ 125      
Due date of additional interest payment Oct. 01, 2017      
Number of warrants issued with debt (shares) 177,514      
Exercise price of warrant $ 1.41      
Fair value of the warrant issued $ 619      
Second Promissory Note [Member] | Minimum [Member]        
Effective interest rate 9.95%      
XML 42 R28.htm IDEA: XBRL DOCUMENT v3.5.0.2
Stock-Based Compensation - Additional Information (Detail) - $ / shares
9 Months Ended
Sep. 30, 2016
Sep. 30, 2015
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]    
Options granted to purchase common stock (shares) 10,097,994 299,486
Weighted average grant date fair value options $ 0.71 $ 2.40
Minimum [Member]    
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]    
Exercise price of options granted .99 3.26
Maximum [Member]    
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]    
Exercise price of options granted $ 2.03 $ 4.44
XML 43 R29.htm IDEA: XBRL DOCUMENT v3.5.0.2
Stock-Based Compensation - Schedule of Stock-Based Compensation Expense (Detail) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2016
Sep. 30, 2015
Sep. 30, 2016
Sep. 30, 2015
Stock-based compensation expense $ 662 $ 104 $ 1,646 $ 313
Research and Development Expense [Member]        
Stock-based compensation expense 45 19 113 56
Selling General And Administrative Expense [Member]        
Stock-based compensation expense $ 617 $ 85 $ 1,533 $ 257
XML 44 R30.htm IDEA: XBRL DOCUMENT v3.5.0.2
Stock-Based Compensation - Assumptions Used to Estimate Fair Value of Stock Options Granted Using Black Scholes Model (Detail) - Stock Options [Member]
9 Months Ended
Sep. 30, 2016
Sep. 30, 2015
Expected term in years 6 years 1 month 6 days 6 years 1 month 6 days
Expected dividend yield 0.00% 0.00%
Minimum [Member]    
Risk-free interest rate 1.30% 1.50%
Expected volatility 48.00% 50.00%
Maximum [Member]    
Risk-free interest rate 1.60% 2.00%
Expected volatility 53.00% 80.00%
XML 45 R31.htm IDEA: XBRL DOCUMENT v3.5.0.2
Net Loss per Share - Schedule of Securities Excluded from Computation of Net Loss per Share (Detail) - shares
9 Months Ended
Sep. 30, 2016
Sep. 30, 2015
Number of anti-dilutive securities 20,247,930 13,286,340
Stock Options [Member]    
Number of anti-dilutive securities 15,164,711 8,078,961
Warrant [Member]    
Number of anti-dilutive securities 5,083,219 5,207,379
XML 46 R32.htm IDEA: XBRL DOCUMENT v3.5.0.2
Related Party Transactions - Additional Information (Detail) - USD ($)
$ in Thousands
9 Months Ended
Apr. 15, 2016
Jun. 14, 2010
Sep. 30, 2016
Sep. 30, 2015
Dec. 31, 2015
Notes receivable due from stockholders     $ 71   $ 136
Common stock repurchase and retirement     (741)    
Shareholders [Member]          
Issuance of notes receivable due from stockholder   $ 145      
Philips Medical Systems [Member]          
Revenue from related party     $ 125 $ 125  
Former Chief Executive Officer [Member]          
Common stock repurchase and retirement $ 741        
Common stock repurchase and retirement (shares) 748,842        
XML 47 R33.htm IDEA: XBRL DOCUMENT v3.5.0.2
Subsequent Event (Details Narrative) - Building Lease [Member]
$ in Thousands
Oct. 24, 2016
USD ($)
Minimum [Member]  
Operating lease renewal - monthly rent $ 53
Maximum [Member]  
Operating lease renewal - monthly rent $ 55
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