Table of Contents

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 10-Q

 

 

(Mark One)

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

For the quarterly period ended September 30, 2013

OR

 

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

For the transition period from                      to                     

Commission file number 001-09585

 

 

ABIOMED, INC.

(Exact name of registrant as specified in its charter)

 

 

 

DELAWARE   04-2743260

(State or other jurisdiction of

incorporation or organization)

 

(IRS Employer

Identification No.)

22 CHERRY HILL DRIVE

DANVERS, MASSACHUSETTS 01923

(Address of principal executive offices, including zip code)

(978) 646-1400

(Registrant’s telephone number, including area code)

 

 

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   x     No   ¨

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate website, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 229.405 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   x     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. (Check one):

 

Large accelerated filer   x    Accelerated filer   ¨
Non-accelerated filer   ¨   (Do not check if a smaller reporting company)    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   x

As of October 31, 2013, 39,453,797 shares of the registrant’s common stock, $.01 par value, were outstanding.

 

 

 


Table of Contents

ABIOMED, INC. AND SUBSIDIARIES

TABLE OF CONTENTS

 

         Page  
PART I - FINANCIAL INFORMATION:   
Item 1.  

Financial Statements

     3   
 

Consolidated Balance Sheets as of September 30, 2013 (unaudited) and March 31, 2013

     3   
 

Consolidated Statements of Operations for the three and six months ended September 30, 2013 and 2012 (unaudited)

     4   
 

Consolidated Statements of Comprehensive Income for the three and six months ended September 30, 2013 and 2012 (unaudited)

     5   
 

Consolidated Statements of Cash Flows for the three and six months ended September 30, 2013 and 2012 (unaudited)

     6   
 

Notes to Consolidated Financial Statements (unaudited)

     7   
Item 2.  

Management’s Discussion and Analysis of Financial Condition and Results of Operations

     16   
Item 3.  

Quantitative and Qualitative Disclosures About Market Risk

     24   
Item 4.  

Controls and Procedures

     24   
PART II - OTHER INFORMATION:   
Item 1.  

Legal Proceedings

     25   
Item 1A.  

Risk Factors

     25   
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   
SIGNATURES      28   

ABIOMED, ABIOCOR, IMPELLA, and Symphony are trademarks of ABIOMED, Inc., and are registered in the U.S. and certain foreign countries. The U.S. Trademark Application for IMPELLA CP is pending and additional foreign applications will be filed taking advantage of the U.S. filing date. BVS is a trademark of ABIOMED, Inc. and is registered in the U.S. AB5000 is a trademark of ABIOMED, Inc. IMPELLA and RECOVER are trademarks of Abiomed Europe GmbH, a subsidiary of ABIOMED, Inc., and are registered in the U.S. and certain foreign countries.

 

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PART 1. FINANCIAL INFORMATION

 

ITEM 1: FINANCIAL STATEMENTS

ABIOMED, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share data)

 

     September 30, 2013     March 31, 2013  
     (unaudited)        

ASSETS

    

Current assets:

    

Cash and cash equivalents

   $ 10,120      $ 9,451   

Short-term marketable securities

     60,950        67,256   

Accounts receivable, net

     21,119        22,946   

Inventories

     15,636        14,930   

Prepaid expenses and other current assets

     2,789        2,022   
  

 

 

   

 

 

 

Total current assets

     110,614        116,605   

Long-term marketable securities

     25,811        11,406   

Property and equipment, net

     6,444        6,549   

Goodwill

     37,349        35,410   

Other assets

     801        29   
  

 

 

   

 

 

 

Total assets

   $ 181,019      $ 169,999   
  

 

 

   

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

    

Current liabilities:

    

Accounts payable

   $ 6,182      $ 7,696   

Accrued expenses

     13,722        15,162   

Deferred revenue

     4,142        4,198   
  

 

 

   

 

 

 

Total current liabilities

     24,046        27,056   

Long-term deferred tax liability

     6,007        5,554   

Other long-term liabilities

     262        309   
  

 

 

   

 

 

 

Total liabilities

     30,315        32,919   
  

 

 

   

 

 

 

Commitments and contingencies (Note 9)

    

Stockholders’ equity:

    

Class B Preferred Stock, $.01 par value

     —          —     

Authorized - 1,000,000 shares; Issued and outstanding - none

    

Common stock, $.01 par value

     406        397   

Authorized - 100,000,000 shares; Issued - 40,659,164 shares at September 30, 2013 and 39,788,383 shares at March 31, 2013;

    

Outstanding - 39,452,797 shares at September 30, 2013 and 38,601,384 shares at March 31, 2013

    

Additional paid in capital

     427,183        414,810   

Accumulated deficit

     (258,925     (258,261

Treasury stock at cost - 1,206,367 shares at September 30, 2013 and 1,186,999 shares at March 31, 2013

     (16,554     (16,129

Accumulated other comprehensive loss

     (1,406     (3,737
  

 

 

   

 

 

 

Total stockholders’ equity

     150,704        137,080   
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 181,019      $ 169,999   
  

 

 

   

 

 

 

The accompanying notes are an integral part of the consolidated financial statements (unaudited)

 

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ABIOMED, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

(in thousands, except per share data)

 

     Three Months Ended
September 30,
    Six Months Ended
September 30,
 
     2013      2012     2013     2012  

Revenue:

         

Product revenue

   $ 44,288       $ 37,319      $ 86,897      $ 75,966   

Funded research and development

     57        98       118       234   
  

 

 

    

 

 

   

 

 

   

 

 

 
     44,345         37,417        87,015        76,200   
  

 

 

    

 

 

   

 

 

   

 

 

 

Costs and expenses:

         

Cost of product revenue

     9,027         7,194        17,750        14,640   

Research and development

     7,721        5,854       15,008       12,566   

Selling, general and administrative

     26,199         18,437        54,166        39,390   

Amortization of intangible assets

     —           —          —          111   
  

 

 

    

 

 

   

 

 

   

 

 

 
     42,947         31,485        86,924        66,707   
  

 

 

    

 

 

   

 

 

   

 

 

 

Income from operations

     1,398        5,932       91       9,493   
  

 

 

    

 

 

   

 

 

   

 

 

 

Other income (expense):

         

Investment income (expense), net

     25        1       41       (1

Other income (expense), net

     6        (9 )     (15 )     (13
  

 

 

    

 

 

   

 

 

   

 

 

 
     31        (8 )     26       (14
  

 

 

    

 

 

   

 

 

   

 

 

 

Income before income tax provision

     1,429        5,924       117       9,479   

Income tax provision

     370        455       781       891   
  

 

 

    

 

 

   

 

 

   

 

 

 

Net income (loss)

   $ 1,059      $ 5,469     $ (664 )   $ 8,588   
  

 

 

    

 

 

   

 

 

   

 

 

 

Basic net income (loss) per share

   $ 0.03      $ 0.14     $ (0.02 )   $ 0.22   

Basic weighted average shares outstanding

     39,260        39,431       38,971       39,288   

Diluted net income (loss) per share

   $ 0.03      $ 0.13     $ (0.02 )   $ 0.21   

Diluted weighted average shares outstanding

     41,337        41,722       38,971       41,645   

The accompanying notes are an integral part of the consolidated financial statements (unaudited)

 

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ABIOMED, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME

(Unaudited)

(in thousands, except per share data)

 

     Three Months Ended
September 30,
     Six Months Ended
September 30,
 
     2013      2012      2013     2012  

Net income (loss)

   $ 1,059      $ 5,469      $ (664 )   $ 8,588   

Other comprehensive income (loss):

          

Foreign currency translation gains (losses)

     1,795        850        2,321       (1,727

Net unrealized gains on marketable securities

     31        —           10       —     
  

 

 

    

 

 

    

 

 

   

 

 

 

Other comprehensive income (loss)

     1,826        850        2,331       (1,727
  

 

 

    

 

 

    

 

 

   

 

 

 

Comprehensive income

   $ 2,885      $ 6,319      $ 1,667     $ 6,861   
  

 

 

    

 

 

    

 

 

   

 

 

 

The accompanying notes are an integral part of the consolidated financial statements (unaudited)

 

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ABIOMED, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

(in thousands)

 

     Six Months Ended September 30,  
     2013     2012  

Operating activities:

    

Net (loss) income

   $ (664   $ 8,588   

Adjustments required to reconcile net (loss) income to net cash provided by operating activities:

    

Depreciation and amortization

     1,322       1,449   

Bad debt expense

     15        6   

Stock-based compensation

     6,719       4,963   

Write-down of inventory

     537        598   

Deferred tax provision

     453       317   

Changes in assets and liabilities:

    

Accounts receivable

     1,912       1,606   

Inventories

     (876 )     (4,208

Prepaid expenses and other assets

     (762 )     (93

Accounts payable

     (1,494 )     (1,155

Accrued expenses and other long-term liabilities

     (1,978 )     (813

Deferred revenue

     (62 )     (126
  

 

 

   

 

 

 

Net cash provided by operating activities

     5,122       11,132   

Investing activities:

    

Purchases of marketable securities

     (33,849 )     (18,750

Proceeds from the sale and maturity of marketable securities

     25,750       5,500   

Purchase of other investment

     (750 )     —     

Purchases of property and equipment

     (1,236 )     (1,623
  

 

 

   

 

 

 

Net cash used for investing activities

     (10,085 )     (14,873

Financing activities:

    

Proceeds from the exercise of stock options

     5,318       2,493   

Payments in lieu of issuance of common stock for minimum payroll taxes

     (426 )     (238

Proceeds from the issuance of stock under employee stock purchase plan

     312       270   
  

 

 

   

 

 

 

Net cash provided by financing activities

     5,204       2,525   

Effect of exchange rate changes on cash

     428       (277
  

 

 

   

 

 

 

Net increase (decrease) in cash and cash equivalents

     669       (1,493

Cash and cash equivalents at beginning of period

     9,451       5,990   
  

 

 

   

 

 

 

Cash and cash equivalents at end of period

   $ 10,120     $ 4,497   
  

 

 

   

 

 

 

Supplemental disclosures:

    

Fixed asset expenditures incurred, not yet paid

   $ 92     $ 93   

The accompanying notes are an integral part of the consolidated financial statements (unaudited)

 

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ABIOMED, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)

(In thousands, except share data)

Note 1. Nature of Business and Basis of Preparation

Abiomed, Inc. (the “Company” or “Abiomed”) is a leading provider of mechanical circulatory support devices and offers a continuum of care in heart recovery to heart failure patients. The Company develops, manufactures and markets proprietary products that are designed to enable the heart to rest, heal and recover by improving blood flow and/or performing the pumping function of the heart. The Company’s products are used in the cardiac catheterization lab, or cath lab, by interventional cardiologists and in the heart surgery suite by heart surgeons for patients who are in need of hemodynamic support prophylactically or emergently before, during or after angioplasty or heart surgery procedures.

The accompanying unaudited consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles, or GAAP, for interim financial reporting and in accordance with Article 10 of Regulation S-X. Accordingly, they do not include all of the information and note disclosures required by GAAP for complete financial statements. These statements should be read in conjunction with the consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended March 31, 2013 that has been filed with the Securities and Exchange Commission, or SEC.

In the opinion of management, the accompanying unaudited consolidated financial statements include all adjustments, which are of a normal recurring nature, necessary for a fair presentation of results for the interim periods presented. The results of operations for any interim period may not be indicative of results for the full fiscal year.

There have been no changes in the Company’s significant accounting policies for the three and six months ended September 30, 2013 as compared to the significant accounting policies described in the Company’s Annual Report on Form 10-K for the fiscal year ended March 31, 2013 that has been filed with the SEC.

 

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Note 2. Net Income (Loss) Per Share

Basic net income (loss) per share is computed by dividing net income (loss) by the weighted average number of common shares outstanding during the period. Diluted net income (loss) per share is computed by dividing net income (loss) by the weighted average number of dilutive common shares outstanding during the period. Diluted shares outstanding are calculated by adding to the weighted average shares outstanding any potential dilutive securities outstanding for the period. Potential dilutive securities include stock options, restricted stock awards, restricted stock units, performance-based stock awards and shares to be purchased under the Company’s employee stock purchase plan. In periods when a net loss is reported, all common stock equivalents are excluded from the calculation because they would have an anti-dilutive effect, meaning the loss per share would be reduced. Therefore, in periods when a loss is reported, basic and dilutive loss per share are the same. The Company’s basic and diluted net income (loss) per share for the three and six months ended September 30, 2013 and 2012 were as follows (in thousands, except per share data):

 

     Three Months Ended
September 30,
     Six Months Ended
September 30,
 
     2013      2012      2013     2012  

Basic Net Income (Loss) Per Share

          

Net income (loss)

   $ 1,059      $ 5,469      $ (664 )   $ 8,588   
  

 

 

    

 

 

    

 

 

   

 

 

 

Weighted average shares used in computing basic net income (loss) per share

     39,260        39,431        38,971       39,288   
  

 

 

    

 

 

    

 

 

   

 

 

 

Net income (loss) per share - basic

   $ 0.03      $ 0.14      $ (0.02 )   $ 0.22   
  

 

 

    

 

 

    

 

 

   

 

 

 

 

     Three Months Ended
September 30,
     Six Months Ended
September 30,
 
     2013      2012      2013     2012  

Diluted Net Income (Loss) Per Share

          

Net income (loss)

   $ 1,059      $ 5,469      $ (664 )   $ 8,588   
  

 

 

    

 

 

    

 

 

   

 

 

 

Weighted average shares used in computing basic net income (loss) per share

     39,260        39,431        38,971       39,288   

Effect of dilutive securities

     2,077        2,291        —          2,357   
  

 

 

    

 

 

    

 

 

   

 

 

 

Weighted average shares used in computing diluted net income (loss) per share

     41,337        41,722        38,971       41,645   

Net income (loss) per share - diluted

   $ 0.03      $ 0.13      $ (0.02 )   $ 0.21   
  

 

 

    

 

 

    

 

 

   

 

 

 

For the three months ended September 30, 2013, approximately 297,000 shares underlying stock options and approximately 85,000 restricted shares primarily related to out-of-the-money stock options and performance-based awards where milestones were not met, were not included in the computation of diluted earnings per share because their inclusion would have been anti-dilutive.

For the six months ended September 30, 2013, approximately 3,923,000 shares underlying stock options and approximately 1,198,000 restricted shares were excluded from the calculation of diluted weighted average shares outstanding because the Company incurred a loss in the period and to include them would have been anti-dilutive.

Approximately 647,000 and 505,000 shares underlying outstanding securities were not included in the computation of diluted earnings per share for the three and six months ended September 30, 2012, respectively. The excluded shares primarily related to out-of-the-money stock options and performance-based awards where milestones were not met.

 

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Note 3. Marketable Securities and Fair Value Measurements

Marketable Securities

The Company’s marketable securities are classified as available-for-sale securities and, accordingly, are recorded at fair value. The difference between amortized cost and fair value is included in stockholders’ equity.

The Company’s marketable securities at September 30, 2013 and March 31, 2013 are invested in the following:

 

     Amortized
Cost
     Gross
Unrealized
Gains
     Gross
Unrealized
Losses
    Fair
Market
Value
 
     (in $000’s)  

At September 30, 2013:

          

US Treasury securities

   $ 36,986       $ —         $ —        $ 36,986   

Short-term government-backed securities

     23,957        7        —          23,964   

Long-term government-backed securities

     25,806         7         (2     25,811   
  

 

 

    

 

 

    

 

 

   

 

 

 
   $ 86,749      $ 14      $ (2 )   $ 86,761   
  

 

 

    

 

 

    

 

 

   

 

 

 
     Amortized
Cost
     Gross
Unrealized
Gains
     Gross
Unrealized
Losses
    Fair
Market
Value
 
     (in $000’s)  

At March 31, 2013:

          

US Treasury securities

   $ 59,020       $ —         $ —        $ 59,020   

Short-term government-backed securities

     8,235        1        —          8,236   

Long-term government-backed securities

     11,405         3         (2     11,406   
  

 

 

    

 

 

    

 

 

   

 

 

 
   $ 78,660      $ 4      $ (2 )   $ 78,662   
  

 

 

    

 

 

    

 

 

   

 

 

 

Fair Value Hierarchy

Fair value is defined as the price that would be received upon the sale of an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three categories:

Level 1: Quoted market prices in active markets for identical assets or liabilities.

Level 2: Observable market based inputs or unobservable inputs that are corroborated by market data.

Level 3: Unobservable inputs that are not corroborated by market data.

Level 1 primarily consists of financial instruments whose values are based on quoted market prices such as exchange-traded instruments and listed equities.

Level 2 includes financial instruments that are valued using models or other valuation methodologies. These models are primarily industry-standard models that consider various assumptions, including time value, yield curve, volatility factors, prepayment speeds, default rates, loss severity, current market and contractual prices for the underlying financial instruments, as well as other relevant economic measures. Substantially all of these assumptions are observable in the marketplace, can be derived from observable data or are supported by observable levels at which transactions are executed in the marketplace.

Level 3 is comprised of unobservable inputs that are supported by little or no market activity. Financial assets are considered Level 3 when their fair values are determined using pricing models, discounted cash flows or similar techniques and at least one significant model assumption or input is unobservable.

 

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The following table presents the Company’s financial instruments recorded at fair value in the consolidated balance sheet, classified according to the three categories described above:

 

     Level 1      Level 2      Level 3      Total  
     (in $000’s)  

At September 30, 2013:

  

U.S. Treasury securities

   $ —         $ 36,986       $ —         $ 36,986   

Short-term government-backed securities

     —           23,964         —           23,964   

Long-term government-backed securities

     —           25,811         —           25,811   
  

 

 

    

 

 

    

 

 

    

 

 

 
   $ —         $ 86,761       $ —         $ 86,761   
  

 

 

    

 

 

    

 

 

    

 

 

 
     Level 1      Level 2      Level 3      Total  
     (in $000’s)  

At March 31, 2013:

  

U.S. Treasury securities

   $ —         $ 59,020       $ —         $ 59,020   

Short-term government-backed securities

     —           8,236         —           8,236   

Long-term government-backed securities

     —           11,406         —           11,406   
  

 

 

    

 

 

    

 

 

    

 

 

 
   $ —         $ 78,662       $ —         $ 78,662   
  

 

 

    

 

 

    

 

 

    

 

 

 

In May 2013, the Company invested $0.8 million in preferred stock of a private technology company. In addition, the Company committed to invest an additional $0.7 million if the private technology company achieves certain milestones or otherwise at the Company’s option. This other investment is accounted for using the cost method and is measured at fair value on a nonrecurring basis only if there are identified events or changes in circumstance that may have a significant adverse effect on the fair value of these investments. The aggregate carrying amount of this other investment was $0.8 million as of September 30, 2013 and is classified within other assets in the unaudited condensed consolidated balance sheets.

Note 4. Inventories

The components of inventories are as follows:

 

     September 30,
2013
     March 31,
2013
 
     (in $000’s)  

Raw materials and supplies

   $ 6,707      $ 6,267   

Work-in-progress

     6,672         5,296   

Finished goods

     2,257        3,367   
  

 

 

    

 

 

 
   $ 15,636       $ 14,930   
  

 

 

    

 

 

 

The Company’s inventories relate to its circulatory care product lines, primarily the Impella and AB5000 product platforms. Finished goods and work-in-process inventories consist of direct material, labor and overhead. During the six months ended September 30, 2013 and 2012, the Company recorded $0.5 million and $0.6 million, respectively, in write-downs of inventory.

 

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Note 5. Goodwill

The carrying amount of goodwill at September 30, 2013 and March 31, 2013 was $37.3 million and $35.4 million, respectively, and has been recorded in connection with the Company’s acquisition of Impella Cardiosystems AG, or Impella, in 2005. The goodwill activity for the six months ended September 30, 2013 is as follows:

 

     (in $000’s)  

Balance at March 31, 2013

   $ 35,410   

Exchange rate impact

     1,939   
  

 

 

 

Balance at September 30, 2013

   $ 37,349   
  

 

 

 

Note 6. Accrued Expenses

Accrued expenses consist of the following:

 

     September 30,
2013
     March 31,
2013
 
     (in $000’s)  

Employee compensation

   $ 8,273      $ 9,664   

Sales and income taxes

     1,746         2,107   

Research and development

     1,259        1,025   

Professional, legal and accounting fees

     1,079         1,100   

Warranty

     682        708   

Other

     683         558   
  

 

 

    

 

 

 
   $ 13,722      $ 15,162   
  

 

 

    

 

 

 

Employee compensation consists primarily of accrued bonuses, accrued commissions and accrued employee benefits at September 30, 2013 and March 31, 2013.

 

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Note 7. Stock-Based Compensation

The following table summarizes stock-based compensation expense by financial statement line item in the Company’s consolidated statements of operations for the three and six months ended September 30, 2013 and 2012:

 

     Three Months Ended
September 30,
     Six Months Ended
September 30,
 
     2013      2012      2013      2012  
     (in $000’s)      (in $000’s)  

Cost of product revenue

   $ 139      $ 101      $ 347      $ 247   

Research and development

     540         435         1,285         998   

Selling, general and administrative

     2,119        1,748        5,087        3,718   
  

 

 

    

 

 

    

 

 

    

 

 

 
   $ 2,798       $ 2,284       $ 6,719       $ 4,963   
  

 

 

    

 

 

    

 

 

    

 

 

 

The components of stock-based compensation for the three and six months ended September 30, 2013 and 2012 were as follows:

 

     Three Months Ended
September 30,
     Six Months Ended
September 30,
 
     2013      2012      2013      2012  
     (in $000’s)      (in $000’s)  

Restricted stock units

   $ 2,151      $ 1,542      $ 4,795      $ 2,865   

Stock options

     598        582        1,523        1,552   

Restricted stock

     11        122        303        460   

Employee stock purchase plan

     38        38        98        86   
  

 

 

    

 

 

    

 

 

    

 

 

 
   $ 2,798      $ 2,284      $ 6,719      $ 4,963   
  

 

 

    

 

 

    

 

 

    

 

 

 

Stock Options

The following table summarizes the stock option activity for the six months ended September 30, 2013:

 

     Shares
Underlying
Options
(in thousands)
    Weighted
Average
Exercise
Price
     Weighted
Average
Remaining
Contractual
Term (years)
     Aggregate
Intrinsic
Value
(in thousands)
 

Outstanding at April 1, 2013

     4,228      $ 11.49        5.37     

Granted

     299        23.10         

Exercised

     (596     8.81        

Cancelled and expired

     (8     10.24         
  

 

 

   

 

 

       

Outstanding at September 30, 2013

     3,923      $ 12.78        5.31      $ 26,958   
  

 

 

   

 

 

       

Exercisable at September 30, 2013

     3,094      $ 11.12         4.44       $ 24,856   
  

 

 

   

 

 

       

Options vested and expected to vest at September 30, 2013

     3,825      $ 12.71        5.24      $ 26,500   
  

 

 

   

 

 

       

The aggregate intrinsic value of options exercised was $8.6 million for the six months ended September 30, 2013. The total fair value of options vested during the six months ended September 30, 2013 was $2.2 million.

The remaining unrecognized stock-based compensation expense for unvested stock option awards at September 30, 2013 was approximately $5.4 million, net of forfeitures, and the weighted-average period over which this cost will be recognized is 2.9 years.

The Company estimates the fair value of each stock option granted at the grant date using the Black-Scholes option valuation model. The weighted average grant-date fair value for options granted during the six months ended September 30, 2013 and 2012 was $9.67 and $10.12 per share, respectively.

 

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The fair value of options granted during the three months ended September 30, 2013 and 2012 were calculated using the following weighted average assumptions:

 

     Three Months Ended     Six Months Ended  
     September 30,     September 30,  
     2013     2012     2013     2012  

Risk-free interest rate

     1.39     0.68 %     0.85     1.72

Expected option life (years)

     4.23        4.20        4.26        5.29   

Expected volatility

     50.6     56.2 %     51.9     51.8

The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant for a term consistent with the expected life of the stock options. Volatility assumptions are calculated based on the historical volatility of the Company’s stock and adjustments for factors not reflected in historical volatility that may be more indicative of future volatility. The Company estimates the expected term of options based on historical exercise experience and estimates of future exercises of unexercised options. An expected dividend yield of zero is used in the option valuation model because the Company does not pay cash dividends and does not expect to pay any cash dividends in the foreseeable future. The Company estimates forfeitures based on an analysis of actual historical forfeitures, adjusted to reflect that historical forfeitures may not be indicative of forfeitures in the future.

Restricted Stock and Restricted Stock Units

In addition to stock option grants, the Company also has the ability to grant restricted stock and restricted stock units. Similar to stock options, these restricted stock and restricted stock unit grants are subject to certain vesting criteria. The following table summarizes the activity for the six months ended September 30, 2013:

 

     Number of
Shares
    Weighted
Average
Grant Date
Fair Value
 
     (in thousands)     (per share)  

Outstanding at April 1, 2013

     1,022     $ 18.44   

Granted

     553        23.18   

Vested

     (364 )     16.58   

Forfeited

     (13     21.01   
  

 

 

   

 

 

 

Outstanding at September 30, 2013

     1,198     $ 21.16   
  

 

 

   

 

 

 

The remaining unrecognized compensation expense for outstanding restricted stock awards and restricted stock units, including performance-based awards, as of September 30, 2013 was $13.8 million and the weighted-average period over which this cost will be recognized is 2.1 years.

The weighted average grant-date fair value for restricted stock and restricted stock units granted during the six months ended September 30, 2013 and 2012 was $23.18 and $22.32 per share, respectively. The total fair value of restricted stock and restricted stock units vested during the six months ended September 30, 2013 and 2012 was $6.0 million and $3.0 million, respectively.

Performance Based Awards

Included in the restricted stock and restricted stock units activity discussed above are certain awards that vest subject to certain performance-based criteria.

In May 2013, performance-based awards of restricted stock units for the potential issuance of 268,988 shares of common stock were issued to certain executive officers and employees, all of which vest upon achievement of prescribed service milestones by the award recipients and performance milestones by the Company. As of September 30, 2013, the Company is recognizing compensation expense based on the probable outcome related to the prescribed performance targets on these awards.

In May 2012, performance-based awards of restricted stock units for the potential issuance of 195,188 shares of common stock were issued to certain executive officers and employees of the Company, all of which will vest upon achievement of prescribed service milestones by the award recipients and performance milestones by the Company. As of September 30, 2013, the Company has met the prescribed performance milestones for these awards. These awards are still subject to service requirements for vesting for these employees and the compensation expense is being recognized accordingly.

In May 2011 and June 2011, performance-based awards of restricted stock units for the potential issuance of 284,000 shares of common stock were issued to certain executive officers and members of the senior management of the Company, all of which will

 

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vest upon achievement of prescribed service milestones by the award recipients and performance milestones by the Company. As of September 30, 2013, the Company has met the prescribed milestones for 234,000 shares underlying these awards and believes it is probable that the prescribed performance milestones will be met for the remaining 50,000 shares, and the compensation expense is being recognized accordingly.

During the three and six months ended September 30, 2013, the Company recorded $1.1 million and $2.8 million in stock-based compensation expense for equity awards in which the prescribed performance milestones have been achieved or are probable of being achieved. The remaining unrecognized compensation expense related to these equity awards at September 30, 2013 is $5.8 million based on the Company’s current assessment of probability of achieving the performance milestones. The weighted-average period over which this cost will be recognized is 2.1 years.

Note 8. Income Taxes

Deferred income taxes are recognized for the tax consequences in future years of differences between the tax bases of assets and liabilities and their financial reporting amounts at each fiscal year end based on enacted tax laws and statutory tax rates applicable to the periods in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce net deferred tax assets to the amount that is more likely than not to be realized.

The Company regularly assesses its ability to realize its deferred tax assets. Assessing the realization of deferred tax assets requires significant management judgment. In determining whether its deferred tax assets are more likely than not realizable, the Company evaluated all available positive and negative evidence, and weighted the evidence based on its objectivity. Evidence the Company considered included net operating losses incurred from the Company’s inception to March 31, 2011, expiration of various federal and state tax attributes, the uncertainty relative to the Department of Justice investigation of the Company and the Company’s planned PMA application for its Impella products, profits before tax for fiscal 2012 and 2013, year to date net loss and forecasted results for fiscal 2014. Based on its review of all available evidence, the Company determined that the objectively verifiable negative evidence outweighed the positive evidence and continues to record a valuation allowance to reduce its deferred tax assets to the amount that is more likely than not to be realizable as of September 30, 2013 and March 31, 2013.

As of September 30, 2013, the Company has accumulated a net deferred tax liability of $6.0 million which is the result of the difference in accounting for the Company’s goodwill, which is amortizable over 15 years for tax purposes but not amortizable for book purposes. The net deferred tax liability cannot be offset against the Company’s deferred tax assets since it relates to an indefinite-lived asset and is not anticipated to reverse in the same period.

The Company and its subsidiaries are subject to U.S. federal income tax, as well as income tax of multiple state and foreign jurisdictions. The Company has accumulated significant losses since its inception in 1981. All tax years remain subject to examination by major tax jurisdictions, including the federal government and the Commonwealth of Massachusetts. However, because the Company has net operating loss and tax credit carryforwards which may be utilized in future years to offset taxable income, those years may also be subject to review by relevant taxing authorities if the carryforwards are utilized.

Note 9. Commitments and Contingencies

Commitments

In July 2013, the Company entered into a lease agreement to continue renting its existing space in Aachen, Germany through July 31, 2023. The building serves as the Company’s European headquarters and houses most of the manufacturing operations for its Impella product line. The lease payments are approximately 34,500€ (euro) (approximately U.S. $45,000 at September 30, 2013 exchange rates) per month.

Litigation

From time to time, the Company is involved in legal and administrative proceedings and claims of various types. In some actions, the claimants seek damages, as well as other relief, which, if granted, would require significant expenditures. The Company records a liability in its consolidated financial statements for these matters when a loss is known or considered probable and the amount can be reasonably estimated. The Company reviews these estimates each accounting period as additional information is known and adjusts the loss provision when appropriate. If a matter is both probable to result in liability and the amounts of loss can be reasonably estimated, the Company estimates and discloses the possible loss or range of loss. If the loss is not probable or cannot be reasonably estimated, a liability is not recorded in its consolidated financial statements.

On October 26, 2012, the Company was informed that the United States Attorney’s Office for the District of Columbia is conducting an investigation that is focused on the Company’s marketing and labeling of the Impella 2.5. On October 31, 2012, the Company accepted service of a subpoena related to this investigation. The subpoena seeks documents related to the Impella 2.5. The Company is in the process of responding and intends to cooperate fully with the subpoena. We expect to complete the requested document production by the end of fiscal 2014. On September 13, 2013, the Company entered into a tolling agreement with the United States Attorney’s Office, pursuant to which the Company and the United States

 

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Attorney’s Office mutually agreed to toll the applicable statutes of limitations for all criminal, civil and administrative offenses and violations that could be charged or claimed against the Company as of that date until June 2, 2014. Because the investigation is in the early stages, management is unable to predict the ultimate outcome or determine whether a liability has been incurred or make an estimate of the reasonably possible liability, if any, that could result from any unfavorable outcome associated with this inquiry. The Company can anticipate, however, that it will incur significant expenses related to this investigation.

On November 16 and 19, 2012, two purported class action complaints were filed against the Company and certain of its officers in the U.S. District Court for the District of Massachusetts by alleged purchasers of its common stock, on behalf of themselves and persons or entities that purchased or acquired securities of the Company between August 5, 2011 and October 31, 2012. The complaints alleged that the defendants violated the federal securities laws in connection with disclosures related to the U.S. Food and Drug Administration and the marketing and labeling of the Company’s Impella 2.5 product and seek damages in an unspecified amount. The Court has consolidated these complaints and a consolidated amended complaint was filed by the plaintiffs on May 20, 2013. On July 8, 2013, the Company filed a motion to dismiss the consolidated complaint.

On February 4, 2013, an alleged stockholder of the Company filed a derivative action on the Company’s behalf against each of the Company’s directors in the U.S. District Court for the District of Massachusetts. The complaint alleged that the directors breached their fiduciary duties to the Company and its stockholders in connection with disclosures related to the FDA and the marketing and labeling of the Company’s Impella 2.5 product and sought damages in an unspecified amount. On March 22, 2013, the Company filed a motion to dismiss the derivative action due to the plaintiff’s failure to make a proper demand on the Company’s board of directors. On June 21, 2013, the District Court entered an order granting the Company’s motion and dismissing the derivative action in its entirety. On July 19, 2013, the plaintiff filed an appeal of the dismissal in the U.S. First Circuit Court of Appeals.

The Company is unable to estimate its potential liability with respect to the Department of Justice investigation, the purported class action claim and the appeal of the dismissal of the derivative claims. There are numerous factors that make it difficult to meaningfully estimate possible loss or range of loss at this stage of the investigation and lawsuits, including that: the proceedings are in relatively early stages, there are significant factual and legal issues to be resolved, information obtained or rulings made during any lawsuits or investigations could affect the methodology for calculation. In addition, with respect to claims where damages are the requested relief, no amount of loss or damages has been specified. Therefore, the Company is unable at this time to estimate its possible losses and accordingly, no adjustment has been made to the financial statements to reflect the outcome of these uncertainties.

Note 10. Segment and Enterprise Wide Disclosures

The Company operates in one business segment—the research, development and sale of medical devices to assist or replace the pumping function of the failing heart. The Company’s chief operating decision maker (determined to be the Chief Executive Officer) does not manage any part of the Company separately, and the allocation of resources and assessment of performance are based on the Company’s consolidated operating results. Approximately 71% of the Company’s total consolidated assets are located within the U.S. as of September 30, 2013 and March 31, 2013. The remaining assets are located primarily in Germany and include goodwill of $37.3 million and $35.4 million at September 30, 2013 and March 31, 2013, respectively, associated with the Impella acquisition in May 2005. Total assets outside of the U.S. excluding goodwill amounted to 9% and 8% of total consolidated assets as of September 30, 2013 and March 31, 2013, respectively. International sales (sales outside the U.S. and primarily in Europe) accounted for 7% and 8% of total revenue for the three and six months ended September 30, 2013, respectively, and 6% of total revenue for each of the three and six months ended September 30, 2012.

 

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ITEM 2: MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Forward Looking Statements

Abiomed’s discussion of financial condition and results of operations may contain “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Our actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including uncertainties associated with development, testing and related regulatory approvals, including the potential for future losses, complex manufacturing, high quality requirements, dependence on limited sources of supply, competition, technological change, government regulation, litigation matters, future capital needs and uncertainty of additional financing and other risks and challenges detailed in our filings with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this Report. In particular, we encourage you to review the risks and uncertainties discussed under Item 1A of Part I of our Annual Report on Form 10-K, for the year ended March 31, 2013. We undertake no obligation to release publicly the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this Report or to reflect the occurrence of unanticipated events.

Overview

We are a leading provider of mechanical circulatory support devices and we offer a continuum of care to heart failure patients. We develop, manufacture and market proprietary products that are designed to enable the heart to rest, heal and recover by improving blood flow and/or performing the pumping function of the heart. Our products are used in the cardiac catheterization lab, or cath lab, by interventional cardiologists and in the heart surgery suite by heart surgeons for patients who are in need of hemodynamic support prophylactically or emergently before, during or after angioplasty or heart surgery procedures. We believe heart recovery is the optimal clinical outcome for patients experiencing heart failure because it restores their quality of life. In addition, we believe that for the care of such patients, heart recovery is the most cost-effective solution for the healthcare system.

Our strategic focus and the driver of the majority of our revenue growth is the market penetration of our Impella family of products. Our Impella 2.5 product received 510(k) clearance in June 2008 from the U.S. Food and Drug Administration, or FDA, for partial circulatory support for up to six hours and has been placed at 805 sites since initial launch.

We received 510(k) clearance in April 2009 for our Impella 5.0 and Impella LD devices for circulatory support for up to six hours. These devices are larger and provide more blood flow to patients than the Impella 2.5.

In September 2012, our Impella CP product received 510(k) clearance from the FDA for partial circulatory support for up to six hours. The Impella CP received CE Mark approval to market the device in the European Union and Health Canada approval to market the device in Canada. As of September 30, 2013 we have placed Impella CP at approximately 237 U.S. hospitals.

In November 2012, we announced that the Impella RP received Investigational Device Exemption, or IDE, approval from the FDA for use in RECOVER RIGHT, a pivotal clinical study in the U.S. The Impella RP is a percutaneous catheter-based axial flow pump that is designed to allow greater than four liters of flow per minute and is intended to provide the flow and pressure needed to compensate for right side heart failure. In April 2013, we announced the enrollment of the first patient in RECOVER RIGHT and we expect to enroll up to 30 patients with signs of right side heart failure who require hemodynamic support and are being treated in the cath lab or surgery suite. In November 2013, we announced that the Impella RP RECOVER RIGHT study has enrolled more than 50% of the required patients in this clinical study. We are also conducting initial patient use trials of the Impella RP outside of the U.S. This product is not currently available for commercial use.

In December 2012, as part of the FDA’s 515 Program Initiative, an FDA panel voted to recommend continuation of Class III status for temporary ventricular support devices within the non-roller type cardiopulmonary bypass blood pumps category, which includes our Impella products. The panel’s recommendation of Class III for this category of device is consistent with the current Class III designation for these device types. If the FDA accepts the panel’s determination and issues a final order classifying these devices in Class III, we will be required to file a Pre-Market Approval, or PMA application for our Impella products. Under the 515 Program Initiative, we will be permitted to continue to market our Impella products pursuant to the 510(k) clearance for a sufficient period of time to allow for the submission and review of PMA applications relating to our Impella products.

We intend to submit a modular PMA submission for Impella 2.5 by the end of fiscal 2014. A modular PMA allows for a parallel submission of preclinical and manufacturing data for review while still preparing the clinical module. We are working with the FDA to prepare this modular PMA application for our Impella products. In July 2013, we received written notification that the FDA has reviewed our proposed PMA shell for modular review of the Impella 2.5 System. The FDA has confirmed that it agrees with our proposed shell and we have submitted 4 of the 5 modules required by the FDA as part of the planned modular PMA submission.

In November 2011, we announced Symphony, a synchronized minimally invasive implantable cardiac assist device designed to treat chronic patients with moderate heart failure by improving patient hemodynamics and potentially improving their quality of life.

 

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The device is designed with the primary goal of stabilizing the progression of heart failure and recovering or remodeling the heart. We are currently conducting first-in-human clinical trials of Symphony outside the U.S. This product is not currently approved by the FDA for sale in the U.S.

On October 26, 2012, we were informed that the United States Attorney’s Office for the District of Columbia is conducting an investigation that is focused on the Company’s marketing and labeling of the Impella 2.5. On October 31, 2012, we accepted service of a subpoena related to this investigation. The subpoena seeks documents related to the Impella 2.5. We are in the process of responding and we intend to cooperate fully with the subpoena. We expect to complete the requested document production by the end of fiscal 2014. On September 13, 2013, we entered into a tolling agreement with the United States Attorney’s Office, pursuant to which we and the United States Attorney’s Office mutually agreed to toll the applicable statutes of limitations for all criminal, civil and administrative offenses and violations that could be charged or claimed against us as of that date until June 2, 2014. Because the investigation is in the early stages, management is unable to predict the ultimate outcome or determine whether a liability has been incurred or make an estimate of the reasonably possible liability, if any, that could result from any unfavorable outcome associated with this inquiry. We can anticipate, however, that we will incur significant expenses related to this investigation.

On November 16 and 19, 2012, two purported class action complaints were filed against us and certain of our officers in the U.S. District Court for the District of Massachusetts by alleged purchasers of our common stock, on behalf of themselves and persons or entities that purchased or acquired our securities between August 5, 2011 and October 31, 2012. The complaints alleged that the defendants violated the federal securities laws in connection with disclosures related to the FDA and the marketing and labeling of our Impella 2.5 product and seek damages in an unspecified amount. The Court has consolidated these complaints and a consolidated amended complaint was filed by the plaintiffs on May 20, 2013. On July 8, 2013, we filed a motion to dismiss the consolidated class action.

On February 4, 2013, an alleged stockholder of the Company filed a derivative action on our behalf against each of our directors in the U.S. District Court for the District of Massachusetts. The complaint alleged that the directors breached their fiduciary duties to us and our stockholders in connection with disclosures related to the FDA and the marketing and labeling of our Impella 2.5 product and sought damages in an unspecified amount. On March 22, 2013, we filed a motion to dismiss the derivative action due to the plaintiff’s failure to make a proper demand on our board of directors. On June 21, 2013, the District Court entered an order granting our motion and dismissing the derivative action in its entirety. On July 19, 2013, the plaintiff filed an appeal of the dismissal in the U.S. First Circuit Court of Appeals.

Our revenues are primarily generated from our Impella line of products. Revenues from our non-Impella products, largely focused on the heart surgery suite, have been lower over the past several years as we have strategically shifted our sales and marketing efforts towards our Impella products and the cath lab. We expect revenues from our non-Impella products, including BVS and AB5000, will continue to decrease as we continue to focus on our Impella products.

For the three and six months ended September 30, 2013, we recognized a net income of $1.1 million and a net loss of $0.7 million, respectively. We may incur additional losses in the future as we continue to invest in research and development related to our products, conduct clinical studies and registries on our products, expand our commercial infrastructure, pay additional excise taxes as a result of the implementation of the medical device tax in the U.S. in January 2013, incur additional legal fees to comply with the subpoena received from the Department of Justice in October 2012, defend ourselves from other legal claims, incur additional costs in preparing our PMA application and invest in new markets such as Japan.

Impella 2.5

The Impella 2.5 catheter is a percutaneous micro heart pump with an integrated motor and sensors. The device is designed primarily for use by interventional cardiologists to support patients in the cath lab who may require assistance to maintain their circulation. The Impella 2.5 device received 510(k) clearance from the FDA in June 2008 for partial circulatory support for up to six hours, has CE mark approval in Europe for up to five days of use and is approved for use in over 40 countries.

The Impella 2.5 catheter can be quickly inserted via the femoral artery to reach the left ventricle of the heart where it is directly deployed to draw blood out of the ventricle and deliver it to the circulatory system. This function is intended to reduce ventricular work and provide flow to vital organs. The Impella 2.5 is introduced with normal interventional cardiology procedures and can pump up to 2.5 liters of blood per minute.

In August 2007, we received approval from the FDA to begin a high-risk percutaneous coronary intervention, or PCI, pivotal clinical trial, known as the Protect II study, for the Impella 2.5. This pivotal study was a superiority study to determine the safety and effectiveness of the Impella 2.5 as compared to medical management with an intra-aortic balloon, or IAB, during “high-risk” angioplasty procedures. In December 2010, we announced the termination of the Protect II study based on a futility determination at the planned interim analysis regarding the primary end-point, which we view as likely to have resulted from how rotational atherectomy was performed by investigators in the study.

 

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In November 2011, we announced additional analysis of the results from the Protect II study, including those patients enrolled following the initiation of the interim analysis, which showed a statistically significant 22% relative reduction in major adverse events compared to an intraortic balloon pump, or IAB, at 90 days per protocol (p=0.023), a 52% relative reduction in repeat revascularization (p=0.024) and a 56% relative reduction in material adverse events post hospital discharge (p=0.002). Furthermore, additional data analysis of the clinical data from the Protect II trial revealed that more aggressive revascularization is beneficial for patients with coronary artery disease and reduced left ventricular function.

A November 2011 update to the American College of Cardiology Foundation (ACCF) /American Heart Association (AHA) Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions Guidelines for Percutaneous Coronary Intervention, for the first time, included Impella in both the emergent and prophylactic hemodynamic support settings. In addition, a December 2012 update to the AHA’s Recommendations for the Use of Mechanical Circulatory Support: Device Strategies and Patient Selection recommended Impella for use in mechanical circulatory support; a December 2012 update to the ACCF/AHA Guidelines for the Management of ST-Elevation Myocardial Infarction (STEMI) included Impella for use in patients requiring urgent coronary artery bypass grafting with STEMI and in treatment of patients with cardiogenic shock complications after STEMI; and a January 2013 update to the International Society for Heart and Lung Transplantation Guidelines for Mechanical Circulatory Support included Impella for the first time for patients with multi-organ failure.

We are currently conducting USpella, the first U.S. multicenter observational registry collecting clinical data and outcomes for general use patients supported with Impella 2.5, CP, and 5.0 during procedures. In December 2012, as part of the FDA’s 515 Program Initiative, an FDA panel voted to recommend continuation of Class III status for temporary ventricular support devices within the non-roller type cardiopulmonary bypass blood pumps category, which includes our Impella products. The panel’s recommendation of Class III for this category of device is consistent with the current Class III designation for these device types. If the FDA accepts the panel’s determination and issues a final order classifying these devices in Class III, we will be required to file a PMA application for our Impella products. Under the 515 Program Initiative, we will be permitted to continue to market our Impella products pursuant to the 510(k) clearance for a sufficient period of time to allow for the submission and review of PMA applications relating to our Impella products.

We intend to submit a modular PMA submission for Impella 2.5 by the end of fiscal 2014. A modular PMA allows for a parallel submission of preclinical and manufacturing data for review while still preparing the clinical module. We are working with the FDA to prepare this modular PMA application for our Impella products. In July 2013, we received written notification that the FDA has reviewed our proposed PMA shell for modular review of the Impella 2.5 System. The FDA has confirmed that it agrees with our proposed shell and we have submitted 4 of the 5 modules required by the FDA as part of the planned modular PMA submission.

Impella CP

In September 2012, we announced that the Impella CP received 510(k) clearance from the FDA. The Impella CP provides blood flow of approximately one liter more per minute than the Impella 2.5 and is indicated for up to six hours of partial circulatory support using an extracorporeal bypass control unit. It is also intended to be used to provide partial circulatory support, for up to six hours, during procedures not requiring cardiopulmonary bypass. The Impella CP received CE Mark approval to market the device in the European Union in April 2012 and Health Canada approval to market the device in Canada in June 2012. We initiated a controlled launch with top heart hospitals in the U.S. during the second quarter of fiscal 2013, which we expect to continue in fiscal 2014.

Impella 5.0 and Impella LD

The Impella 5.0 catheter and Impella LD are percutaneous micro heart pumps with integrated motors and sensors for use primarily in the heart surgery suite. These devices are designed to support patients who require higher levels of circulatory support as compared to the Impella 2.5. The Impella 5.0 and Impella LD devices received 510(k) clearance in April 2009, for circulatory support for up to six hours and have CE Mark approval in Europe for up to ten days duration and are approved for use in over 40 countries.

The Impella 5.0 can be quickly implanted via a small incision in the femoral artery in the groin using a guide wire to reach the left ventricle of the heart where it can then be directly deployed to draw blood out of the ventricle, deliver it to the arterial system and perfuse the heart muscle. This function is intended to reduce ventricular work. The Impella LD is similar to the Impella 5.0 but is implanted directly through an aortic graft. The Impella 5.0 and Impella LD can pump up to five liters of blood per minute, providing full circulatory support.

Impella RP

In November 2012, we announced that the Impella RP received IDE approval from the FDA for use in RECOVER RIGHT, a pivotal clinical study in the U.S. The Impella RP is a percutaneous catheter-based axial flow pump that is designed to allow greater than four liters of flow per minute and is intended to provide the flow and pressure needed to compensate for right heart failure. The study will enroll up to 30 patients at 15 sites that present with signs of right side heart failure, require hemodynamic support, and are being

 

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treated in the catheterization lab or cardiac surgery suite. We announced the first enrollment of a patient in RECOVER RIGHT in April 2013. The study will collect safety and effectiveness data on the percutaneous use of the Impella RP and will be applied towards the submission of a Humanitarian Device Exemption, or HDE. In November 2013, we announced that the Impella RP RECOVER RIGHT study has enrolled more than 50% of the required patients and as a result, HDE approval is forecasted in late fiscal 2015. An HDE is similar to a PMA application but is intended for patient populations of 4,000 or less per year in the U.S and the approval relies on the demonstration of safety and probable benefit, which is a lower success criteria than the safety and effectiveness requirement of a PMA. In order to receive an HDE, there must be no comparable devices approved under PMA that are available to treat the targeted population. An approved HDE authorizes sales of the device to any hospital after Institutional Review Board review. We are currently conducting initial patient use trials aimed at CE Mark approval outside of the U.S. of the Impella RP. This product is not currently available for commercial use.

AB5000 and BVS 5000

We manufacture and sell the AB5000 Circulatory Support System and the BVS 5000 Biventricular Support System for the temporary support of acute heart failure patients in profound shock, including patients suffering from cardiogenic shock after a heart attack, post-cardiotomy cardiogenic shock, or myocarditis. We believe the AB5000 and BVS 5000 systems are the only commercially available cardiac assist devices that are approved by the FDA for all indications where heart recovery is the desired outcome, including patients who have undergone successful cardiac surgery and subsequently develop low cardiac output, or patients who suffer from acute cardiac disorders leading to hemodynamic instability. We are currently only actively selling the BVS 5000 upon request. We have transitioned our sales focus in the surgery market from the BVS 5000 to the AB5000, the Impella 5.0, and the Impella LD.

Symphony

In November 2011, we announced Symphony, a synchronized minimally invasive implantable cardiac assist device designed to treat chronic patients with moderate heart failure by improving patient hemodynamics and potentially improving their quality of life. The device is designed with the primary goal of stabilizing the progression of heart failure and recovering or remodeling the heart. We are currently conducting first-in-human clinical trials of Symphony outside the U.S. This product is not currently approved by the FDA for sale in the U.S.

Critical Accounting Policies

There have been no significant changes in our critical accounting policies during the six months ended September 30, 2013, as compared to the critical accounting policies disclosed in Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form 10-K for the fiscal year ended March 31, 2013.

 

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Results of Operations

The following table sets forth certain consolidated statements of operations data for the periods indicated as a percentage of total revenues for the three and six months ended September 30, 2013 and 2012, respectively:

 

     Three Months Ended
September 30,
    Six Months Ended
September 30,
 
     2013     2012     2013     2012  

Revenues:

        

Product

     99.9     99.7     99.9     99.7

Funded research and development

     0.1       0.3       0.1       0.3  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total revenues

     100.0        100.0        100.0        100.0   
  

 

 

   

 

 

   

 

 

   

 

 

 

Costs and expenses:

        

Cost of product revenue

     20.3       19.2       20.4       19.2  

Research and development

     17.4        15.6        17.2        16.5   

Selling, general and administrative

     59.1       49.3       62.3       51.7  

Amortization of intangible assets

     —          —          —          0.1   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total costs and expenses

     96.8       84.1       99.9       87.5  
  

 

 

   

 

 

   

 

 

   

 

 

 

Income from operations

     3.2        15.9        0.1        12.5   
  

 

 

   

 

 

   

 

 

   

 

 

 

Income tax provision

     0.8        1.3        0.9        1.2   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss)

     2.4     14.6 %     (0.8 )%      11.3
  

 

 

   

 

 

   

 

 

   

 

 

 

Three and six months ended September 30, 2013 compared with the three and six months ended September 30, 2012

Revenues

Our revenues are comprised of the following:

 

     Three Months Ended
September 30,
     Six Months Ended
September 30,
 
     2013      2012      2013      2012  
     (in $000’s)      (in $000’s)  

Impella product revenue

   $ 40,167      $ 32,843      $ 78,821      $ 67,519   

Service and other revenue

     2,574        2,312        5,190        4,165   

Other products

     1,547        2,164        2,886        4,282   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total product revenues

     44,288        37,319        86,897        75,966   

Funded research and development

     57        98        118        234   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total revenues

   $ 44,345      $ 37,417      $ 87,015      $ 76,200   
  

 

 

    

 

 

    

 

 

    

 

 

 

Impella product revenue encompasses Impella 2.5, Impella CP, Impella 5.0, and Impella LD product sales. Other product revenue includes AB5000, BVS5000 and cannulae product sales. Service and other revenue represents revenue earned on preventative maintenance service contracts and maintenance calls.

Total revenues for the three months ended September 30, 2013 increased by $6.9 million, or 18%, to $44.3 million from $37.4 million for the three months ended September 30, 2012. Total revenues for the six months ended September 30, 2013 increased by $10.8 million, or 14%, to $87.0 million from $76.2 million for the six months ended September 30, 2012. The increase in total revenue was primarily due to higher Impella revenue due to greater utilization in the U.S., which was attributable in part to the introduction of Impella CP in the second half of fiscal 2013.

Impella product revenues for the three months ended September 30, 2013 increased by $7.4 million, or 23% to $40.2 million from $32.8 million for the three months ended September 30, 2012. Impella revenues for the six months ended September 30, 2013 increased by $11.3 million, or 17% to $78.8 million from $67.5 million for the six months ended September 30, 2012. Most of our increase in Impella revenue was from disposable catheter sales in the U.S., as we focus on increasing utilization of our disposable catheter products through continued investment in our field organization and physician training programs. In the second half of fiscal 2013, we began our launch of Impella CP in the U.S. We will continue our controlled commercial launch of Impella CP during the remainder of fiscal 2014 and we expect Impella revenues to increase as we add new customer sites and increase utilization at existing customer sites.

 

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Service and other revenue for the three months ended September 30, 2013 increased by $0.3 million, or 13%, to $2.6 million from $2.3 million for the three months ended September 30, 2012. Service revenue for the six months ended September 30, 2013 increased by $1.0 million, or 24%, to $5.2 million from $4.2 million for the six months ended September 30, 2012. The increase in service revenue was primarily due to an increase in service contracts, primarily for Impella consoles.

Other product revenues for the three months ended September 30, 2013 decreased by $0.7 million, or 32%, to $1.5 million from $2.2 million for the three months ended September 30, 2012. Other product revenues for the six months ended September 30, 2013 decreased by $1.4 million, or 33%, to $2.9 million from $4.3 million for the six months ended September 30, 2012. The decrease in other product revenue was due to a decline in BVS 5000 and AB5000 disposable sales. We are currently only actively selling the BVS 5000 upon request. We also expect that AB5000 revenue will continue to decline during the remainder of fiscal 2014 as we focus our sales efforts in the surgical suite on Impella 5.0 and LD.

Cost of Product Revenues

Cost of product revenues for the three months ended September 30, 2013 and 2012, respectively, was $9.0 million and $7.2 million. Gross margin was 80% for the three months ended September 30, 2013 compared to 81% for the three months ended September 30, 2012. Cost of product revenues for the six months ended September 30, 2013 and 2012, respectively, was $17.8 million and $14.6 million. Gross margin was 80% for the six months ended September 30, 2013 compared to 81% for the six months ended September 30, 2012. The increase in cost of product revenues was related to increased Impella demand and costs to support the higher demand for Impella products. The decrease in gross margin was related primarily to increased investment in expanding manufacturing capacity to support future demand for Impella products and increased shipments of AIC consoles.

Research and Development Expenses

Research and development expenses for the three months ended September 30, 2013 increased by $1.8 million, or 31%, to $7.7 million from $5.9 million for the three months ended September 30, 2012. Research and development expenses for the six months ended September 30, 2013 increased by $2.4 million, or 19%, to $15.0 million from $12.6 million for the six months ended September 30, 2012.

The increase in research and development expenses was due primarily to an increase in spending associated with our PMA application for our existing Impella products and product development initiatives associated with Impella RP, CP and Symphony. We expect research and development expenses to increase in the remainder of fiscal 2014 as we continue to pursue our PMA application for our existing Impella products available for sale in the U.S. and as we apply for regulatory approval for our Impella products in Japan. In addition, we expect to incur additional research and development costs as we continue to focus on new product development initiatives associated with Impella RP, Impella CP and Symphony.

Selling, General and Administrative Expenses

Selling, general and administrative expenses for the three months ended September 30, 2013 increased by $7.8 million, or 42%, to $26.2 million from $18.4 million for the three months ended September 30, 2012. Selling, general and administrative expenses for the six months ended September 30, 2013 increased by $14.8 million, or 38%, to $54.2 million from $39.4 million for the six months ended September 30, 2012.

The increase in selling, general and administrative expenses was primarily due to increased personnel expenses related to increased U.S. field sales and clinical headcount, increased spending on marketing initiatives as we continue to educate physicians on the benefits of hemodynamic support, higher stock-based compensation expense, implementation of the medical device tax and increases in legal expenses. During the three and six months ended September 30, 2013, we incurred legal expenses of approximately $1.7 million and $4.2 million, respectively, in connection with complying with the subpoena received from the Department of Justice in October 2012 and defense of other legal claims. We also incurred $0.7 million and $1.3 million of expenses in the three and six months ended September 30, 2013, respectively, as a result of the medical device tax, which was implemented in the U.S. in January 2013.

We expect to continue to increase our expenditures on sales and marketing activities, with particular investments in field sales and clinical personnel with cath lab expertise. We also plan to increase our marketing, service, and training investments to support the efforts of the sales and field clinical teams to drive recovery awareness for acute heart failure patients. In addition, we will continue to incur expenses as a result of the recently implemented medical device tax. We also expect to continue to incur significant legal expenses related to the Department of Justice investigation, our defense of the purported class action, and our defense of the appeal of the dismissal of the derivative action for the foreseeable future.

 

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Provision for Income Taxes

During the three months ended September 30, 2013 and 2012, we recorded a provision for income taxes of $0.4 million and $0.5 million, respectively. During the six months ended September 30, 2013 and 2012, we recorded an income tax provision of $0.8 million and $0.9 million, respectively. The income tax provision for the three and six months ended September 30, 2013 is primarily due to income taxes related to our deferred tax liability associated with goodwill, income taxes in Germany that we do not expect will be offset by our net operating loss carryforwards in Germany, that we will pay in cash and certain state income taxes that we do not expect to be offset by state net operating loss carryforwards.

Net Income (Loss)

During the three months ended September 30, 2013, we recorded net income of $1.1 million, or $0.03 per basic and diluted share, compared to net income of $5.5 million, or $0.14 per basic share and $0.13 per diluted share, for the three months ended September 30, 2012. During the six months ended September 30, 2013, we incurred net loss of $0.7 million, or $0.02 per basic and diluted share, compared to a net income of $8.6 million, or $0.22 per basic share and $0.21 per diluted share, for the six months ended September 30, 2012. The decrease in net income in for the three and six months ended September 30, 2013 was due to higher operating expenses from expanding our commercial infrastructure, additional research and development costs, the implementation of the medical device tax in the U.S. in January 2013, and additional legal fees to comply with the subpoena received from the Department of Justice in October 2012 and defend ourselves from other legal claims. We may incur additional losses in the future as we continue to invest in research and development related to our products, conduct clinical studies and registries on our products, prepare our PMA application, expand our commercial infrastructure, pay additional excise taxes, incur additional legal fees and invest in new markets such as Japan.

Liquidity and Capital Resources

At September 30, 2013, our cash, cash equivalents and short and long-term marketable securities totaled $96.9 million, compared to $88.1 million in cash, cash equivalents and short and long-term marketable securities at March 31, 2013. We believe that our revenues from product sales together with existing resources will be sufficient to fund our operations for at least the next twelve months, exclusive of activities involving any future acquisitions of products or companies that complement or augment our existing line of products.

Our primary liquidity requirements are to fund the expansion of our commercial infrastructure in the U.S., increase our Impella manufacturing capacity, increase our inventory levels in order to meet increasing customer demand for Impella in the U.S., fund new product development, pay for legal fees related to the Department of Justice investigation and our defense of legal actions brought against us, and provide for general working capital needs. Through September 30, 2013, we have funded our operations principally from product sales and through the sale of equity securities.

Marketable securities at September 30, 2013 consisted of $86.8 million held in funds that invest in U.S. Treasury and government-backed securities. We are not a party to any interest rate swaps, currency hedges or derivative contracts of any type and have no exposure to commercial paper or auction rate securities markets.

During the six months ended September 30, 2013, net cash provided by operating activities was $5.1 million, compared to $11.1 million during the same period in the prior year. The decrease in cash provided by operations was primarily attributable to our net loss of $0.7 million for the six months ended September 30, 2013 compared to net income of $8.6 million for the six months ended September 30, 2012 a $1.5 million increase in accounts payable and accrued expenses primarily due to higher legal expenses. This was partially offset by a $3.3 million decrease in cash used for inventories, a $0.3 million increase in cash provided by accounts receivable due to increases in revenue and timing of receivable collections, $1.8 million increase in stock-based compensation and a $0.7 million increase in prepaid expenses and other assets.

During the six months ended September 30, 2013, net cash used for investing activities was $10.1 million, compared to $14.9 million during the same period in the prior year. The decrease in cash used for investing activities was primarily attributable to a $20.3 million increase in proceeds from the sale and maturity of marketable securities, offset by a $15.1 million increase in purchases of marketable securities. We also paid $0.8 million for an investment in a private medical technology company and had a $0.4 million decrease in cash used for capital expenditures due to a decrease in amounts spent in leasehold improvements in fiscal 2014.

During the six months ended September 30, 2013, net cash provided by financing activities was $5.2 million, compared to $2.5 million during the same period in the prior year. The increase in net cash provided by financing activities was primarily attributable to a $2.8 million increase in proceeds from the exercise of stock options offset by a $0.2 million increase in payments in lieu of issuance of common stock for payroll withholding taxes upon vesting of certain equity awards.

 

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Table of Contents

Capital expenditures for fiscal 2014 are estimated to range from $3.0 to $5.0 million, and are expected to relate primarily to capital expenditures for manufacturing capacity increases for Impella, leasehold improvements and software development projects.

Cash and cash equivalents held by our foreign subsidiaries totaled $2.9 million and $2.8 million at September 30, 2013 and March 31, 2013, respectively. Our operating income outside the U.S. is deemed to be permanently reinvested in foreign jurisdictions. We do not intend or currently foresee a need to repatriate cash and cash equivalents held by our foreign subsidiaries. If these funds are needed in the U.S., we would be required to accrue and pay U.S. taxes to repatriate these funds.

Our liquidity is influenced by our ability to sell our products in a competitive industry and our customers’ ability to pay for our products. Factors that may affect liquidity include our ability to penetrate existing and new markets for our products, maintain or reduce the length of the selling cycle, and collect cash from clients after our products are sold. We also expect to continue to incur additional legal expenses related to the Department of Justice investigation, and to defend ourselves from other legal claims. We continue to review our cash needs on a regular basis. At September 30, 2013, we had no long-term debt outstanding.

 

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Table of Contents
ITEM 3: QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK

Primary Market Risk Exposures

Our cash, cash equivalents and marketable securities are subject to interest rate risk and will fall in value if market interest rates increase. Marketable securities at September 30, 2013 consist of $86.8 million held in funds that invest in U.S. Treasury and government-backed securities. If market interest rates were to increase immediately and uniformly by 10 percent from levels at September 30, 2013, we believe the decline in fair market value of our investment portfolio would be immaterial.

Currency Exchange Rates

We have foreign currency exposure to exchange rate fluctuations and particularly with respect to the euro, British pound sterling and Japanese yen. Therefore, our investment in our subsidiaries is sensitive to fluctuations in currency exchange rates. The effect of a change in currency exchange rates on our net investment in international subsidiaries is reflected in the accumulated other comprehensive (loss) income component of stockholders’ equity. If rates of exchange for the euro, British pound and Japanese yen were to have depreciated immediately and uniformly by 10% relative to the U.S. dollar from levels at September 30, 2013, the result would have been a reduction of stockholders’ equity of approximately $4.1 million.

Fair Value of Financial Instruments

At September 30, 2013, our financial instruments consist primarily of cash and cash equivalents, short-term and long-term marketable securities, accounts receivable, and accounts payable. The estimated fair values of the financial instruments have been determined by us using available market information and appropriate valuation techniques. Considerable judgment is required, however, to interpret market data to develop the estimates of fair value. The use of different market assumptions and/or estimation methodologies may have a material effect on the estimated fair value amounts.

 

ITEM 4. CONTROLS AND PROCEDURES

Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our principal executive officer and principal financial officer, has evaluated the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)), as of September 30, 2013. Based on this evaluation, our principal executive officer and principal financial officer concluded that, as of September 30, 2013, these disclosure controls and procedures are effective to provide reasonable assurance that material information required to be disclosed by us, including our consolidated subsidiaries, in reports that we file or submit under the Exchange Act, is recorded, processed, summarized and reported, within the time periods specified in the Commission rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Act is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure.

Evaluation of Changes in Internal Control over Financial Reporting

During the second quarter of our fiscal year ending March 31, 2014, there were no changes in our internal control over financial reporting that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

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Table of Contents

PART II — OTHER INFORMATION

 

Item 1. Legal Proceedings

We are from time to time involved in various legal actions, the outcomes of which are not within our complete control and may not be known for prolonged periods of time. In some actions, the claimants seek damages, as well as other relief, which, if granted, would require significant expenditures. We record a liability in our consolidated financial statements for these actions when a loss is known or considered probable and the amount can be reasonably estimated. We review these estimates each accounting period as additional information is known and adjust the loss provision when appropriate. If the loss is not probable or cannot be reasonably estimated, a liability is not recorded in the consolidated financial statements.

On October 26, 2012, we were informed that the United States Attorney’s Office for the District of Columbia is conducting an investigation that is focused on the Company’s marketing and labeling of the Impella 2.5. On October 31, 2012, we accepted service of a subpoena related to this investigation. The subpoena seeks documents related to the Impella 2.5. We are in the process of responding and we intend to cooperate fully with the subpoena. We expect to complete the requested document production by the end of fiscal 2014. On September 13, 2013, we entered into a tolling agreement with the United States Attorney’s Office for the District of Columbia, pursuant to which we agreed to toll the applicable statutes of limitations for all criminal, civil and administrative offenses and violations that could be charged or claimed against us as of that date until June 2, 2014.

On November 16 and 19, 2012, two purported class action complaints were filed against us and certain of our officers in the U.S. District Court for the District of Massachusetts by alleged purchasers of our common stock, on behalf of themselves and persons or entities that purchased or acquired our securities between August 5, 2011 and October 31, 2012. The complaints alleged that the defendants violated the federal securities laws in connection with disclosures related to the FDA and the marketing and labeling of our Impella 2.5 product and seek damages in an unspecified amount. The Court has consolidated these complaints and a consolidated amended complaint was filed by the plaintiffs on May 20, 2013. On July 8, 2013, we filed a motion to dismiss the consolidated class action.

On February 4, 2013, an alleged holder of our common stock filed a derivative action on our behalf against each of our directors in the U.S. District Court for the District of Massachusetts. The complaint alleged that the directors breached their fiduciary duties to us and our stockholders in connection with disclosures related to the FDA and the marketing and labeling of our Impella 2.5 product and sought damages in an unspecified amount. On March 22, 2013, we filed a motion to dismiss the derivative action due to the plaintiff’s failure to make a proper demand on our board of directors. On June 21, 2013, the District Court entered an order granting our motion and dismissing the derivative action in its entirety due to the plaintiff’s failure to make a proper demand on our board of directors. On July 19, 2013, the plaintiff filed an appeal of the dismissal in the U.S. First Circuit Court of Appeals.

 

Item 1A. Risk Factors

Investing in our common stock involves a high degree of risk. In addition to the other information set forth in this report, you should carefully consider the factors discussed in Part 1, “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended March 31, 2013, which could materially affect our business, financial condition or future results. To the best of our knowledge, as of the date of this report there has been no material change in any of the risk factors described in our Annual Report on Form 10-K, other than the addition of information to the risk factor entitled “ Changes in health care reimbursement systems in the U.S. and abroad could reduce our revenues and profitability,” detailed below.

Risks Related to our Business

Changes in health care reimbursement systems in the U.S. and abroad could reduce our revenues and profitability.

In March 2010, the federal government enacted healthcare reform legislation. The legislation has changed the manner in which healthcare services are provided and paid for in the U.S. These changes may impact reimbursement for health care services, including reimbursement to hospitals and physicians. States may also enact further legislation that impacts Medicaid payments to hospitals and physicians. In addition, the Centers for Medicare & Medicaid Services (CMS), the federal agency responsible for administering the Medicare program, has established new payment levels for hospitals and physicians in line with the new legislation, which can increase or decrease payment to such entities.

The healthcare reform legislation and any future legislative, regulatory and reimbursement initiatives or changes to the reimbursement for our products could adversely affect demand for our products and have a material adverse impact on our revenues. Our business and results of operations could therefore be adversely affected by the current healthcare reform legislation as well as future healthcare reform or regulatory actions.

CMS uses International Classification of Diseases (ICD) codes to determine hospital reimbursement, which are aggregated into groups called Diagnosis Related Groups (DRGs) according to procedure and patient types, as well as other factors. On October 1, 2014, CMS will transition from the use of ICD-9 codes to the use of ICD-10 codes. ICD-9 codes have 4 numerical digits whereas ICD-10 codes have 7 alpha-numeric characters, each of which signifies a specific usage or characteristic. Of note, CMS’ intent for ICD-10 is to be more descriptive, not to change DRG mapping or payment. On October 30, 2013, an update was posted by CMS with a proposed code for the Impella family of devices to be mapped to DRGs 216, 217, 218, 219, 220, and 221, consistent with the most common current DRG mapping for the Impella pump.

Internationally, medical reimbursement systems vary significantly from country to country, with some countries limiting medical centers’ spending through fixed budgets, regardless of levels of patient treatment, and other countries requiring application for, and approval of, government or third-party reimbursement. Even if we succeed in bringing our new products to market, uncertainties regarding future healthcare policy, legislation and regulation, as well as private market practices, could affect our ability to sell our products in commercially acceptable quantities at profitable prices.

 

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Table of Contents
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

 

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Table of Contents
Item 6. Exhibits

 

Exhibit
No.

  

Description

  

Filed with

This

Form 10-Q

    

Incorporated by Reference

 
                

Form

    

Filing Date

    

Exhibit
No.

 
    3.1    Restated Certificate of Incorporation.         S-3         September 29, 1997         3.1   
    3.2    Restated By-Laws, as amended.         10-K         May 27, 2004         3.2   
    3.3    Certificate of Designations of Series A Junior Participating Preferred Stock.         S-3         September 29, 1997         3.3   
    3.4    Amendment to the Company’s Restated Certificate of Incorporation to increase the authorized shares of common stock from 25,000,000 to 100,000,000.         8-K         March 21, 2007         3.4   
    4.1    Specimen Certificate of common stock.         S-1         June 5, 1987         4.1   
  10.1    Lease agreement dated July 29, 2013 for the facility located in Aachen, Germany.      X            
  11.1    Statement regarding computation of Per Share Earnings (see Note 2, Notes to Consolidated Financial Statements).      X            
  31.1    Rule 13a-14(a)/15d-14(a) certification of principal executive officer.      X            
  31.2    Rule 13a-14(a)/15d-14(a) certification of principal accounting officer.      X            
  32.1    Section 1350 certification.      X            
101    The following financial information from the ABIOMED, Inc. Quarterly Report on Form 10-Q for the quarter ended September 30, 2013, formatted in Extensible Business Reporting Language (XBRL): (i) Consolidated Balance Sheets as of September 30, 2013 and March 31, 2013; (ii) Consolidated Statements of Operations for the three and six months ended September 30, 2013 and September 30, 2012; (iii) Consolidated Statements of Comprehensive Income for the three and six months ended September 30, 2013 and September 30, 2012; (iv) Consolidated Statements of Cash Flows for the six months ended September 30, 2013 and September 30, 2012; and (v) Notes to Consolidated Financial Statements.      X            

 

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ABIOMED, INC. AND SUBSIDIARIES

PART II. OTHER INFORMATION

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.

 

      Abiomed, Inc.
Date: November 8, 2013      

/ S /    R OBERT L. B OWEN        

      Robert L. Bowen
     

Vice President and Chief Financial Officer

(Principal Accounting and Financial Officer)

 

28

Exhibit 10.1

Lease agreement dated July 29, 2013 for the facility located in Aachen, Germany

 

MIETVERTRAG FÜR GEWERBLICHE RÄUME     LEASE AGREEMENT FOR BUSINESS PREMISES
Mieter-Nummer: 7944/1115/1/3505     Tenant number: 7944/1115/1/3505
zwischen     between

gewoge AG

Kleinmarschierstr. 54-58, 52062 Aachen

vertreten durch den Vorstand

   

gewoge AG

Kleinmarschierstr. 54-58, 52062 Aachen

represented by the management board

- nachstehend Vermieter genannt -     - hereinafter referred to as Landlord -
und     and

Abiomed Europe GmbH

Neuenhofer Weg 3, 52074 Aachen

vertreten durch die Geschäftsführung

   

Abiomed Europe GmbH

Neuenhofer Weg 3, 52074 Aachen

represented by the management

- nachstehend Mieter genannt -     - hereinafter referred to as Tenant -
wird folgender Mietvertrag geschlossen:     the following Rental Contract is concluded:
Präambel     Preamble
Dieser Mietvertrag für gewerbliche Räume ersetzt den am 06./13.02.2003 zwischen der Impella CardioSystems AG und der gewoge AG geschlossenen Mietvertrag mit all seinen Nachträgen.     This Rental Contract for commercial premises supersedes the Rental Contract, including all its amendments, concluded on 06/13 February 2003 between Impella CardioSystems AG and gewoge AG.
§ 1 - Mietobjekt     § 1 - Rental Property

(1)    Der Vermieter vermietet dem Mieter im Objekt 52074 Aachen, Neuenhofer Weg 3 - 5, nachstehende Flächen:

 

   

(1)    The Landlord rents to the Tenant the following areas in the rental property 52074 Aachen, Neuenhofer Weg 3 - 5:

 

Untergeschoß

   Büro-/Nebenfläche      296,51 m²   
   Grau-/Reinraum      604,79 m²   
   Lagerfläche      616,80 m²   

Basement

   Office and adjacent area      296.51 m²   
   Gray room/clean room      604.79 m²   
  

Storage area

     616.80 m²   
 

 

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Erdgeschoß  

Büro-/Nebenfläche

    324,06 m²   
 

Labor-/Nebenfläche

    213,19 m²   
 

Lagerfläche

    11,34 m²   
II. Obergeschoß  

Büro-/Nebenfläche

    756,00 m²   
IV. Obergeschoß  

Büro-/Nebenfläche

    280,00 m²   
   

 

 

 
Gesamt       3.102,69 m²   
Ground floor   

Office and adjacent area

   324.06 m²
  

Laboratory and adjacent area

   213.19 m²
  

Storage area

   11.34 m²
II. Second floor   

Office and adjacent areas

   756.00 m²
IV. Second floor   

Office and adjacent areas

   280.00 m²
Total:       3,102.69 m²
     
 

 

Die gesamte vermietete Fläche ist mit 3.102 m² vereinbart und wird im folgenden “ Mietobjekt ” genannt.

Mit vermietet werden: 27 Tiefgaragenstellplätze

                                     33 Außenstellplätze

Die genaue Lage der angemieteten Flächen ergibt sich aus den beigefügten Grundrisszeichnungen. Diese werden als Anlage I Bestandteil des Mietvertrages. Da die bei Vertragsschluss vorliegenden Grundrisszeichnungen nicht aktuell sind, vereinbaren die Parteien, dass der Vermieter bis zum 31.10.2013 eine aktuelle Fassung der Anlage I erstellen wird, die sodann Bestandteil des Mietvertrages wird. Bestandteil des Mietvertrags sind zudem die als Anlage II beigefügten Fluchtpläne.

(2)    Sollten sich bei nachträglicher Vermessung Abweichungen von der in Nr. 1 angegebenen Größe der Räumlichkeiten ergeben, so ist keine der Parteien berechtigt, deswegen eine Änderung des Mietpreises zu fordern.

(3)    Der Vermieter leistet keine Gewähr dafür, dass die gemieteten Räume den in Frage

The total rented area has been agreed as 3,102 m² and is hereinafter referred to as the “ rental property ”.

Also rented will be: 27 underground garage parking spaces

                                 33 exterior parking spaces

The exact location of the rented areas is shown on the attached floor plans. These form part of the Rental Contract as Appendix I. As the floor plans provided at signing are not up to date, the parties agree that the Landlord shall provide an up to date version of Appendix I until 31 October 2013 which shall then form part of the Rental Contract. The escape plans attached as Appendix II also form part of the Rental Contract.

 

(2)    If any deviation from the size of the premises stated in No. 1 results from subsequent measurement, neither party is entitled thereby to demand a change in the rental price.

 

(3)    The Landlord does not guarantee that the rented premises in question meet the general

 

 

2/23


kommenden allgemeinen technischen Anforderungen sowie den behördlichen und anderen Vorschriften entsprechen. Der Mieter hat behördliche Auflagen auf eigene Kosten zu erfüllen.

  

technical requirements or the administrative or other regulations. The Tenant has to meet regulatory requirements at its own cost.

Die Räume dürfen nur für die nach den jeweiligen behördlichen Bestimmungen zulässigen Zwecke benutzt werden.

  

The premises may be used only for the authorized purposes in accordance with the respective governmental regulations.

§ 2    - Mietzweck

  

§ 2    - Rental Purpose

(1)    Das Mietobjekt ist ausschließlich zum Zwecke und zur Nutzung der Abiomed Europe GmbH als Büro-, Labor-, Grau-, Rein- und Lagerräume vermietet.

  

(1)    The rental property is leased for the sole purpose and use of Abiomed Europe GmbH as office, laboratory, gray, clean and storage rooms.

(2)    Der Mieter verpflichtet sich, das Mietobjekt für die Dauer des Mietvertrages entsprechend dem mietvertraglich vereinbarten Mietzweck zu nutzen.

  

(2)    The Tenant agrees to use the rented property for the duration of the Rental Contract in accordance with the rental purpose agreed in this Contract.

(3)    Der Mieter wird alle mit seinem Betrieb in Verbindung stehenden erforderlichen behördlichen Genehmigungen und Konzessionen auf eigene Kosten einholen, soweit diese auf die Person des Mieters und dessen Unternehmen bezogen sind. Der Vermieter ist berechtigt, sich die entsprechenden Unterlagen jederzeit nachweisen zu lassen.

  

(3)    The Tenant will obtain all regulatory authorizations and concessions that are required in connection with its enterprise at its own expense, as far as these are related to the person of the Tenant and its business. The Landlord is entitled to have the appropriate documents provided to it at any time.

Soweit die Berechtigung entfällt, ist der Vermieter berechtigt, das Mietverhältnis ohne Einhaltung einer Kündigungsfrist zu kündigen.

  

If there is no authorization, the Landlord is entitled to terminate the Rental Contract without notice.

(4)    Behördlich geforderte in das Mietobjekt einzubauende Einrichtungs- und Sicherheitsmaßnahmen, auch für mietereigene EDV- und Produktionsanlagen, hat der Mieter auf eigene Kosten einzubauen.

  

(4)    The Tenant is required to install the furnishings and security measures which are officially required for the rental property at its own expense, including the Tenant’s own EDP and production equipment.

 

3/23


(5)    Bei Verweigerung der Genehmigung für die vertragliche Nutzung aus Gründen, die allein mietobjektbezogen sind, kann der Mieter das Mietverhältnis außerordentlich kündigen. Schadenersatzansprüche des Mieters gegen den Vermieter sind jedoch ausgeschlossen.

  

(5)    If authorization for the contractual usage is refused for reasons related solely to the rental property, the Tenant may terminate the lease as an exceptional circumstance. Damage claims by the Tenant against the Landlord, however, are excluded.

§ 3    Mietzeit und Kündigung

  

§ 3    Rental Period and Termination

(1)    Das Mietverhältnis besteht seit dem 01.01.2003 und endet am31.07.2013, ohne dass es einer Kündigung bedarf. Das Mietverhältnis wird ab 01.08.2013 neu begründet und endet am 31.07.2023, ohne dass es einer Kündigung bedarf. § 545 BGB findet keine Anwendung; das Mietverhältnis wird nicht dadurch fortgesetzt, dass nach Ablauf der Vertragszeit der Gebrauch der Mietsache durch den Mieter fortgesetzt wird.

  

(1)    The Rental Contract is valid as of 01 January 2003 and ends on 31 July 2013, without any prior notice. The Rental Contract shall be re-established on 01 August 2013 and end on 31 July 2023 without any prior notice. § 545 of the German Civil Code (BGB) does not apply; the tenancy will not be continued merely as a result of the continued use of the rental object by the Tenant after the expiry of the contractual period.

(2)    Dem Mieter wird ein Optionsrecht von weiteren fünf Jahren, d.h. bis zum31.07.2028, eingeräumt. Das Optionsrecht muss mindestens bis zum 31.01.2023 schriftlich durch den Mieter geltend gemacht werden.

  

(2)    The Tenant is entitled to exercise an option for an additional five years, i.e., until 31 July 2028. The option must be claimed by the Tenant in writing by at least 31 January 2023.

Danach wird ein weiteres Optionsrecht um ganze Jahre, maximal jedoch um fünf Jahre, d. h. bis zum 31.07.2033 eingeräumt. Dieses Optionsrecht muss spätestens bis zum 31.01.2028 schriftlich durch den Mieter geltend gemacht werden.

  

After that, another option will be granted for whole years, but not exceeding five years, i.e., until 31 July 2033. This option must be claimed by the Tenant in writing by no later than 31 January 2028.

Sollte der Vermieter beabsichtigen, das Objekt zu verkaufen, wird dem Mieter ein Vorkaufsrecht eingeräumt. Die Parteien des Mietvertrages kommen überein, dass auf die dingliche Absicherung dieses Vorkaufsrechts verzichtet wird.

  

If the Landlord intends to sell the property, the Tenant will be granted a right of first refusal. The parties to the Rental Contract agree to waive the material collateralization of this right of first refusal.

(3)    Der Vermieter kann den Mietvertrag aus wichtigem Grund mit sofortiger Wirkung ohne Einhaltung einer Kündigungsfrist kündigen,

  

(3)    The Landlord may terminate the lease for good cause with immediate effect and without notice,

 

4/23


wenn der Mieter für zwei aufeinanderfolgende Termine mit der Entrichtung des Mietzinses oder eines nicht unerheblichen Teils des Mietzinses in Verzug ist,

  

if the Tenant is in arrears for two consecutive deadlines regarding the payment of rent or a substantial portion of the rent,

wenn der Mieter in einem Zeitraum, der sich über mehr als zwei Termine erstreckt, mit der Entrichtung des Mietzinses in Höhe eines Betrages in Verzug gekommen ist, der den Mietzins für zwei Monatsmieten erreicht,

  

if the Tenant is in arrears regarding the payment of rent for an amount equal to two months’ rent and for a period extending over more than two deadlines,

wenn der Mieter ungeachtet einer schriftlichen Abmahnung des Vermieters einen vertragswidrigen Gebrauch der Mietsache fortsetzt,

  

if, in spite of a written warning from the Landlord, the Tenant continues to use the rental property contrary to the Rental Contract,

bei unberechtigter Untervermietung und sonstige Gebrauchsüberlassung an Dritte, bei Eröffnung des Insolvenzverfahrens über den Mieter oder bei Zahlungsunfähigkeit des Mieters,

  

in the case of unauthorized subletting and other transfer of use to third parties, upon the opening of insolvency proceedings against the Tenant or in the case of the insolvency of the Tenant,

wenn der Mieter in einem solchen Maße trotz Abmahnung ihre Verpflichtungen verletzt, dass der Vermieter die Fortsetzung des Mietverhältnisses nicht zugemutet werden kann,

  

if, despite warning, the Tenant breaches his obligations to such an extent that the Landlord cannot be expected to continue the tenancy,

aus sonstigem wichtigen Grunde.

  

for other good cause.

Die Kündigung hat schriftlich zu erfolgen.

  

Termination must be in writing.

(4)    Im Falle einer Kündigung ohne Einhaltung einer Kündigungsfrist haftet der Mieter für den Ausfall an Miete, Nebenabgaben und sonstigen Leistungen.

  

(4)    In the event of termination without notice, the Tenant is liable for the loss of rent, ancillary costs and other services.

 

5/23


§ 4    Miete und Nebenkosten

        

(1)    Ab 01.08.2013

       

Raumart

  Fläche/
Anzahl
   
Preis/
je PP
    Summe €     Gesamt €  

Büro-/Nebenfläche

    1.656,57 m²        11,50        19.050,56     

Laborfläche

    213,19 m²        12,00        2.558,28     

Grau-/Reinraumfläche

    604,79 m²        12,00        7.257,48     

Lagerfläche

    628,14 m²        6,00        3.768,84     

Tiefgaragenstellplätze

    27        45,00  ,      1.215,00     

Außenstellplätze

    33        20,00  ,      660,00     

Gesamt

          34.510,16   

Vorauszahlung Betriebskosten

          4.830,00   

Vorauszahlung Heizkosten

          2.212,00   

Gesamt Netto

          41.552,16   

19% MwSt

          7.894,91   

Gesamt Brutto

          49.447,07   

§ 4    Rent and Utilities

        

(1)    As of 01 August 2013

       

Type of room

  Area/
number
    Price
per m²/per
parking
space
    Sum     Total  

Office and adjacent area

    1,656.57 m²        11.50        19,050.56     

Laboratory area

    213.19 m²        12.00        2,558.28       

 

Laboratory

area

  

  

Gray and clean room areas

    604.79 m²        12.00        7,257.48     

Storage area

    628.14 m²        6.00        3,768.84     

Underground garage parking spaces

    27        45.00        1,215.00     

Exterior parking spaces

    33        20.00        660.00     

Total

          34,510.16   

Prepayment of operating costs

          4,830.00   

Prepayment of heating costs

          2,212.00   

Total net

          41,552.16   

19% VAT

          7,894.91   

Total gross

          49,447.07   
 

 

6/23


(2a)  Die Betriebskostenvorauszahlung beinhaltet im Einzelnen:

   Verteilerschlüssel:
Wasser    nach Verbrauch
Schmutzwassergebühr    nach Verbrauch
Niederschlagswassergebühr    Nutzfläche
Wartung, Notrufeinrichtung, TÜV Aufzug    Nutzfläche
Straßenreinigung    Nutzfläche
Schornsteinreinigung    Nutzfläche
Müllentsorgung (dem Objekt zugeordnete Müllgefäße)    Objekteinheit
Pflege der Außenanlage    Nutzfläche
Kosten zur Reinigung des Gebäudes und der Nebenanlagen    Nutzfläche
Allgemeinstrom    Nutzfläche
Strom Kältemengenzähler    Objekteinheit
Strom Tiefgarage   

Anzahl

Stellplätze

Tiefgarage

Gebäudeversicherung    Nutzfläche
(2a) The prepayment of operating costs includes in detail:
   Distribution Key
Water    based on consumption
Waste water charge    based on consumption
Rainwater fee    Floor space
Maintenance, emergency call equipment, German Technical Control Board (TÜV) elevator    Floor space
Street cleaning    Floor space
Chimney cleaning    Floor space
Waste disposal (garbage containers belonging to the property)    Property unit
Maintenance of exterior grounds    Floor space
Costs for cleaning the building and auxiliary equipment    Floor space
General power    Floor space
Power - cooling energy meter    Property unit
Underground garage power    Number of underground garage parking spaces
Building insurance    Floor space
 

 

7/23


Hauswartleistung incl. winterl.       Caretaker service incl. winter traffic safety    Floor space
Verkehrssicherung    Nutzfläche      
Wartung Sicherheitsvorkehrungen    Nutzfläche    Maintenance - safety measures    Floor space
Wartung Lüftungsanlage    Nutzfläche    Maintenance - ventilation system    Floor space
Wartung Kompressor    Objekteinheit    Maintenance - compressor    Property unit
Grundsteuer    Nutzfläche    Property tax    Floor space
Die Wartung der techn. Einrichtung in den Labor-, Grau- u. Reinraumtechnikräumen erfolgt durch den Vermieter. Diese Kosten gehen zu Lasten des Mieters und werden unter Vorlage entsprechender Wartungsbelege und –nachweise im Rahmen der Betriebskostenabrechnung mit abgerechnet.    Maintenance of the technical equipment in the laboratory, gray room and clean room technical areas is performed by the Landlord. These costs are borne by the Tenant and are included in the calculation of operating costs, under the condition of the producing of the appropriate maintenance receipts and certificates.
Die Betriebskosten für die Tiefgarage wie z.B. Pflege, Wartung, Allgemeinstrom u. Reinigung werden nach dem Verhältnis der angemieteten Stellplätze zu den gesamten Stellplätzen abgerechnet.    The operating costs for the underground garage, such as maintenance, service, general electricity and cleaning, will be charged according to the ratio of rented parking spaces to total parking spaces.

(2b)  Vorauszahlung auf Heizkosten

  

(2b)  Prepayment of heating costs

 

die Kosten des Betriebs der zentralen Heizungsanlage

  

 

70 % n. Verbrauch/

30 % n. m²-Nutzfläche

  

 

The cost of operating the central heating system

  

 

70 % based on consumption/

30 % based on m² of floor space

 

(3)    Der Umlegungsmaßstab (Verteilungsschlüssel) für in vorstehenden Abs. (2a) und (2b) genannte Betriebskostenarten kann während der Vertragslaufzeit vom Vermieter durch schriftliche Mitteilung bei berechtigtem Interesse des Vermieters und unter Berücksichtigung der wirtschaftlichen

  

 

(3)    During the term of this contract, the apportionment scale (distribution key) for the operating cost types set forth in paragraphs (2a) and (2b) above can, in case of a legitimate interest of the Landlord and in consideration of the economic interest of the Tenant as well as of any provisions stated by law be changed by the Landlord

 

8/23


Interessen des Mieters sowie gesetzlicher Vorschriften mit Wirkung für künftige Abrechnungszeiträume geändert werden. Die Vorauszahlungen können den Kostenveränderungen angepasst werden. Für nicht in vorstehenden Abs. (2a) und (2b) genannte Betriebskosten, die zukünftig vom Mieter zu tragen sind, legt der Vermieter den Umlegungsmaßstab (Verteilungsschlüssel) unter Berücksichtigung der wirtschaftlichen Interessen des Mieters sowie gesetzlicher Vorschriften fest.

  

by written notice for future billing periods. The advance payments can be adjusted to the changes in costs. For operating costs which are to be borne by the Tenant in the future and which are not included in paragraphs (2a) and (2b) above, the Landlord shall determine the apportionment scale (distribution key) in consideration of the economic interests of the Tenant as well as of any provisions stated by law.

Der Vermieter wird einmal jährlich zum 31.12. abrechnen; dies gilt auch für den Fall der vorzeitigen Beendigung des Mietverhältnisses - der ausziehende Mieter wird pro rata temporis für jeden angefangenen Monat belastet. Der Mieter kann nach Eingang der Abrechnung in den Geschäftsräumen des Vermieters nach vorheriger Terminabsprache Einsicht in die Abrechnungsunterlagen nehmen.

  

The Landlord will render accounts once annually on the 31st of December; this also applies in the event of early termination of the Rental Contract—the vacating Tenant will be charged pro rata temporis for each month commenced. The Tenant may inspect the account statement after receipt of the statement at the offices of the Landlord and by appointment.

(4)    Werden Nebenkosten, insbesondere öffentliche Abgaben erhöht oder die in Abs. 2 genannten Nebenkosten oder sonstige Allgemeinkosten neu eingeführt, so ist der Mieter verpflichtet, den entsprechenden Mehrbetrag vom Zeitpunkt der Entstehung an zu zahlen, und zwar auch dann, wenn bei der betreffenden Nebenabgabe kein Betrag oder Verteilungsschlüssel angegeben ist. Dabei kann ohne Rücksicht auf den Entstehungsgrund jede Erhöhung einer Nebenabgabe umgelegt werden, die der Vermieter nicht zu vertreten hat.

  

(4)    If ancillary costs are increased, especially public charges, or if the ancillary costs referred to in paragraph 2 or other general costs are newly introduced, the Tenant is obliged to pay the respective surplus amount as of the time they arise, even if no amount or distribution key is stated for the relevant ancillary charge. In this case, regardless of the cause, any increase of an ancillary cost for which the Landlord is not responsible can be apportioned.

§ 5    Neufestsetzung der Miete

  

§ 5    Amendment of the Rent

(1)    Bei Ausübung des Optionsrechtes richtet sich der Mietpreis nach dem Verbraucherpreisindex.

  

(1)    If the option is exercised, the rent shall be adapted according to the consumer price index.

 

9/23


Sollte sich der Verbraucherpreisindex für die Lebenshaltung aller privaten Haushalte für Gesamtdeutschland, Basisjahr 2010 = 100, um mehr als 10 Prozent nach den Feststellungen des Statistischen Bundesamtes gegenüber dem Zeitpunkt des Vertragsabschlusses oder der letzten Mietänderung aufgrund dieser Wertsicherungsklausel ändern, so erhöht oder ermäßigt sich die Grundmiete gem. § 4 Abs. 1 dieses Vertrages in Höhe des Prozentsatzes, der sich aus der Punktänderung ergibt, maximal jedoch um fünf Prozent.

  

If the consumer price index for the standard of living of all private households for Germany, basic year 2010 = 100, changes according to the determinations of the German Federal Statistical Office by more than 10 percent compared to the point of time of the conclusion of the contract or the last adaptation of the rent based on this clause, the basic rent set forth in § 4 para. 1 of this contract is adapted by the percentage resulting from the amendment of the index, however, not more than by five percent.

Die Prüfung, ob eine Anpassung der Miete verlangt werden kann, erfolgt jährlich im Kalendermonat des Vertragsbeginns. Die Mietanpassung tritt mit Beginn des nächsten Monats in Kraft, der auf das Aufforderungsschreiben des Vermieters bzw. des Mieters folgt.

  

The review of whether an adaptation of the rent can be required is done once a year in the month this contract was concluded. The adaptation of the rent shall start with the month following the letter of request of the Landlord or the Tenant.

Sollte das Statistische Bundesamt die Weiterführung dieses Index ganz oder teilweise einstellen, so tritt an seine Stelle der entsprechende Nachfolgeindex bzw. ein Index, der die von den Vertragsparteien beabsichtigte Wertsicherung des Mietzinses im gleichen Umfang gewährleistet wie der zuletzt für sie maßgeblich gewesene Index.

  

If the German Federal Statistical Office discontinues this index in whole or in part, the successor index or an index equally ensuring the stability of the rent shall replace the index.

§ 6    Zahlung von Miete und Nebenkosten

  

§ 6    Payment of Rent and Ancillary Costs

(1)    Die Gesamtmiete ist monatlich jeweils bis zum 3. Werktag im Voraus auf das Konto 96923658 bei der Aareal Bank AG Wiesbaden, BLZ: 550 104 00 zu entrichten.

  

(1)    The total rent is to be paid monthly in advance by each respective third working day to account 96923658 at Aareal Bank AG, Wiesbaden, bank identification number: 550 104 00.

 

10/23


(2)    Vom Vermieter angeforderte Nachzahlungen für die Nebenkosten sind innerhalb von vier Wochen, spätestens aber mit der übernächsten Mietzahlung zu entrichten

  

(2)    Subsequent payments demanded by the Landlord for the ancillary costs are to be paid within four weeks, latest however with the next rent payment but one.

(3)    Bei verspäteter Zahlung ist der Vermieter berechtigt, etwaige Mahnkosten und Verzugszinsen zu erheben.

  

(3)    In case of late payment, the Landlord is entitled to charge any dunning expenses or default interest.

§ 7    Minderung, Aufrechnungs- und Zurückbehaltungsrecht

  

§ 7    Offsetting, Rent Reduction, Right of Retention

Der Mieter kann gegenüber den Forderungen des Vermieters aus diesem Vertrag mit einer Gegenforderung nur aufrechnen oder ein Minderungs- oder Zurückbehaltungsrecht nur ausüben, wenn seine Forderung unbestritten oder rechtskräftig festgestellt ist. In diesem Fall muss der Mieter dem Vermieter wenigstens einen Monat vor Fälligkeit der Mietzinsforderung, gegen welche aufgerechnet bzw. zurückbehalten werden soll, schriftlich benachrichtigen.

  

The Tenant may only offset a claim against the claims of the Landlord, claim a reduction of the rent or exercise a right of retention, if its claim is uncontested or has been recognized by declaratory judgment. In this case the Tenant shall inform the Landlord in writing at least one month before the claim for the rent which shall be offset or retained is due.

§ 8    Mietkaution

  

§ 8     Rental Deposit

(1)    Der Mieter wird bei Vertragsbeginn ab 01.08.2013 eine Sicherheitsleistung erbringen, die das Dreifache der monatlichen Nettomiete (drei x 34.510,16 Euro) also insgesamt 103.530,48 Euro (in Worten Einhundertdreitausendfünfhundertdreißig 48/100 Euro) beträgt.

  

(1)    The Tenant will provide a surety as of 01 August 2013 which is three times the monthly net rent (three x € 34,510.16) for a total of € 103,530.48 (in words, one hundred and three thousand, five hundred thirty Euro and forty-eight cents).

Die vorstehende Sicherheitsleistung ist vom Mieter beim Vermieter in Form einer Bankbürgschaft mit dem Zusatz „auf erste Anforderung“ für die Laufzeit des Mietvertrages zu hinterlegen.

  

The above-mentioned surety is to be provided by the Tenant to the Landlord in the form of a bank guarantee with the notation “on first demand” for the duration of the Rental Contract.

 

11/23


(2)    Der Vermieter darf sich für Forderungen, die er gegen den Mieter während oder nach Beendigung der Mietdauer im Zusammenhang mit dem Mietvertrag erlangt hat, aus der Kaution befriedigen. Der Mieter ist verpflichtet, den in Anspruch genommenen Kautionsbetrag unverzüglich wieder auf die vereinbarte Höhe aufzustocken.

  

(2)    The Landlord may use the deposit to satisfy expenses for any outstanding accounts it has incurred with regard to the Tenant during or after the termination of the rental period in connection with the Rental Contract. The Tenant is obliged to immediately replenish the claimed deposit to the agreed amount.

Der Vermieter ist berechtigt, die Übergabe des Mietobjekts zu verweigern, wenn der Mieter die Kaution nicht gestellt hat. Unbeschadet der verweigerten Übergabe des Mietobjektes ist der Mieter zur Zahlung der Miete ab dem Zeitpunkt verpflichtet, in dem die Übergabe bei rechtzeitiger Stellung der Kaution hätte stattfinden können.

  

The Landlord is entitled to refuse the transfer of the rental property if the Tenant has not provided the deposit. Notwithstanding the refused transfer of the rental property, the Tenant shall pay the rent as of the required date upon which the transfer could have taken place if the deposit had been paid on time.

Der Vermieter hat die Kaution drei Monate nach vertragsgemäßer Rückgabe des Mietobjektes zurückzugeben. Wegen noch ausstehender Nebenkostenabrechnungen kann der Vermieter einen Teil der Kaution in Höhe der voraussichtlich zu erwartenden Nachforderung auch länger als drei Monate bis zum nächsten Fälligkeitszeitpunkt der letzten Nebenkostenabrechnung zurückbehalten.

  

The Landlord must return the deposit three months after the contractual return of the rental property. For any outstanding payments of ancillary costs, the Landlord can retain a portion of the deposit in the amount of the expected additional charge for even longer than three months, until the next due date of the last settlement of ancillary costs.

§ 9    Betriebshaftpflichtversicherung

  

§ 9    Public Liability Insurance

Der Mieter ist verpflichtet, eine Betriebshaftpflichtversicherung abzuschließen und für die Dauer dieses Mietvertrages aufrecht zu erhalten. Als Mindestdeckungssummen sollen hier:

 

1.500.000 € für Personenschäden

1.500.000 € für Sachschäden

1.500.000 € für Umwelthaftungs-Basisschäden

150.000 € für Mietsachschäden an Immobilien

  

The Tenant is obliged to take out public liability insurance and to maintain the policy for the duration of this Rental Contract. The minimum limits of liability for this purpose shall be:

 

€ 1.5 million for personal injury

€ 1.5 million for property damage

€ 1.5 million for environmental liability based damage

€ 150,000 for damage to rented real estate property

 

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nicht unterschritten werden. Der Mieter hat dem Vermieter den Bestand einer entsprechenden Versicherung unverzüglich nach Mietbeginn unaufgefordert nachzuweisen.    and these must be the minimum values. Of his own accord, the Tenant must inform the Landlord of the existence of an appropriate insurance policy immediately upon commencement of tenancy.

§ 10 Zustand der Mieträume

  

§ 10 Condition of the Rental Premises

(1)    Dem Mieter ist der Zustand der Mieträume zu § 1 bekannt. Er erkennt sie als ordnungsgemäß, zweckentsprechend und zum vertragsgemäßen Gebrauch als tauglich an. Er verpflichtet sich, die Räume pfleglich zu behandeln und in ordnungsgemäßem Zustand zu erhalten und zurückzugeben.

  

(1)    The Tenant is familiar with the condition of the rented premises, as per § 1. It recognizes them as proper, appropriate for the intended purpose, and suited to the contractual usage. It undertakes to treat the premises with care and to maintain and return them in proper condition.

(2)    Der Vermieter wird sich an den folgenden Maßnahmen, ausgenommen sind die in Anlage III aufgeführten Maßnahmen, in Höhe von 40.000 EUR brutto beteiligen: Klimatisierung des Grauraumes, die Klimatisierung des Testinglabors, die Erweiterung der Frischluftanlage im Untergeschoss, die Kühlung der Patchräume im Erdgeschoss und im 2. Obergeschoss, die Kühlung des Kompressorraumes sowie die Teilereinigung bei der Wasserzuleitung und beim Wasserabfluss.

 

Diese Summe wird als einmaliger Baukostenzuschuss für die vorstehend genannten Umbaumaßnahmen und ggf. für Maßnahmen, die damit in engem Zusammenhang stehen bzw. für die vorstehend genannten Maßnahmen erforderlich sind, getätigt und wird bis spätestens zum 15.01.2014 erstattet. Die Gesamtkosten der Maßnahmen, die nicht die Arbeiten im Reinraum (Anlage III) umfassen, belaufen sich auf ca. 40.000 EUR. Sollten die beschriebenen Maßnahmen den vorgenannten

  

(2)    The Landlord shall contribute financially to the following measures - except for the measures described in Appendix III - with an amount of gross 40,000 EUR: Air conditioning of the grey room, air conditioning of the testing laboratory, extension of the fresh air system in the basement, cooling system of the patch rooms on the first floor and on the third floor, cooling system of the compressor room as well as cleaning of the parts for the water supply and discharge lines.

 

This amount shall be a one-time subsidy of the construction costs for the aforementioned reconstruction measures and possibly for measures closely related to the aforementioned measures or which are required for the aforementioned measures. It shall be reimbursed until no later than 15 January 2014. The overall costs of the measures, which do not include the works in the clean room (Appendix III), amount to approx. 40,000 EUR. Should the aforementioned measures exceed the above mentioned subsidy of the construction costs in an amount of 40,000 EUR, the Tenant shall bear the exceeding costs.

 

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Baukostenzuschuss in Höhe von 40.000 EUR überschreiten, trägt der Mieter die Kostenüberschreitung.

 

Der Mieter verpflichtet sich, für die aufgeführten und in Anlage III hinterlegten Umbaumaßnahmen, auf seine Kosten sämtliche mit den Ausbauarbeiten zusammenhängenden Auflagen zu erfüllen und hierfür erforderliche Genehmigungen zu besorgen. Dies gilt nicht für die bauliche Eignung des Mietgegenstandes zum Vertragszweck. Die Kosten der Wartung und die Instandhaltung der eingebrachten Gegenstände trägt der Mieter.

 

Die Ausbauarbeiten müssen unter Beachtung der öffentlich-rechtlichen, insbesondere baurechtlichen und brandschutztechnischen Bestimmungen und nach den anerkannten Regeln der Technik ausgeführt werden. Der Mieter wird die mit den Ausbauarbeiten beauftragten Werkunternehmer entsprechend verpflichten. Der Mieter darf weitere Mieter in dem Mietobjekt und sonstige Dritte durch die Ausbauarbeiten nicht stören. Die Vermieterin ist berechtigt, die ordnungsgemäße Ausführung auch vor Ort durch eigene Beauftragte überwachen zu lassen.

 

Die im Rahmen der Umbaumaßnahme eingebrachten Gegenstände gehen nach Vertragsende in das Eigentum des Vermieters über.

 

Während der Ausbauarbeiten trägt der Mieter die Verkehrssicherungspflicht in den durch die Arbeiten betroffenen Innen- und Außenbereichen. Der Mieter hält die Vermieterin von sämtlichen

  

The Tenant is obliged, on his own account, to comply with all requirements for the construction measures set forth in Appendix III and to obtain all authorizations required. This does not apply to the constructional suitability of the rental property for the contractual purpose. The maintenance and preventive maintenance costs of any objects installed by the Tenant in the rental property shall be borne by the Tenant.

 

The construction measures must be carried out in compliance with public law, in particular with construction law and fire protection law, and they must be in accordance with the accepted rules of engineering. The Tenant shall engage the contractors for the construction measures accordingly. The Tenant may not disturb other tenants in the rental object or other third parties. The Landlord is entitled to supervise the proper implementation on site by its own representatives.

 

The objects introduced along with the reconstruction measures shall, upon termination of the Rental Contract, become the Landlord’s property.

 

During the construction works, the Tenant shall be responsible for the safety in the inside and outside areas affected by the works. The Tenant shall reimburse the Landlord for all claims under private and public law which arise from the construction works or from a violation of the safety obligation. Furthermore, the Tenant shall be liable towards the Landlord for all damages including consequential damages arising through the construction measures.

 

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privatrechtlichen und öffentlich-rechtlichen Inanspruchnahmen, die sich aus den Ausbauarbeiten ergeben bzw. wegen der Verletzung der Verkehrssicherungspflicht eintreten, frei. Weiterhin haftet der Mieter der Vermieterin für alle Schäden, auch Folgeschäden, die durch die Baumaßnahmen entstehen.

 

Aufgrund der Ausbauarbeiten besteht für den Mieter kein Recht zur Mietminderung.

  

The Tenant is not entitled to a reduction of the rent based on the construction works.

§ 11 Untervermietung, Konzession

  

§ 11 Subleasing, Concessions

(1)    Der Mieter darf die Mieträume nur zu den in § 1 genannten gewerblichen Zwecken benutzen. Abänderungen des Nutzungszweckes bedürfen der schriftlichen Zustimmung des Vermieters.

  

(1)    The Tenant may use the leased premises only for those commercial purposes stated in § 1. Amendments to the purpose of use require the written consent of the Landlord.

(2)    Der Mieter ist berechtigt, Räumlichkeiten, gesamt oder in Teilen, an Personen/Unternehmen, sofern gegen die Person/das Unternehmen oder die Bonität des Untermieters keine Bedenken bestehen und die Untervermietung dem Unternehmen des Mieters branchenverwandt bzw. zweckdienlich ist, unter zu vermieten.

  

(2)    The Tenant is entitled to sublease the premises, wholly or in part, to persons/companies insofar as there is no concern regarding the person/company or the solvency of the sub-lessee and the subleasing is related to the professional sector and purpose of the Tenant.

Der Mieter verpflichtet sich, dem Vermieter die Untervermietung schriftlich unter Angabe von Name und Anschrift sowie Beginn Kenntnis zu geben.

  

The Tenant agrees to inform the Landlord in writing of the sublease, stating the name and address as well as the date of commencement.

(3)    Im Falle einer Untervermietung oder Gebrauchsüberlassung haftet der Mieter

  

(3)    In the case of subletting or transfer for use to third parties, the Tenant is responsible

 

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für alle Handlungen oder Unterlassungen des Untermieters oder desjenigen, dem er den Gebrauch der Mieträume überlassen hat.

  

         for all acts or omissions of the sub-lessee or those to whom it has transferred the use of the premises.

(4)    Dem Mieter obliegt die Beibringung und Aufrechterhaltung der für den Betrieb der Geschäftsräume, der Praxis oder des sonstigen Gewerbes evtl. erforderlichen Konzession oder sonstigen behördlichen Genehmigungen. Der Vermieter ist berechtigt, sich die entsprechenden Unterlagen jederzeit nachweisen zu lassen.

  

(4)    The Tenant shall obtain and maintain the concessions and other regulatory authorizations possibly required for the operation of the business space, the practice or other activity. The Landlord is entitled to have the appropriate documents provided to it at any time.

Soweit die Berechtigung für den Mieter entfällt, ist der Vermieter berechtigt, das Mietverhältnis ohne Einhaltung einer Kündigungsfrist zu kündigen.

  

If there is no authorization, the Landlord is entitled to terminate the Rental Contract without notice.

§ 12 Belastung der Stockwerkdecken

  

§ 12 Floor Load

Der Mieter hat sich zu vergewissern, dass die bauaufsichtsamtlich zulässige Belastung der Stockwerkdecken nicht überschritten wird. Bei Zuwiderhandlungen hat er jeden dem Vermieter oder Dritten dadurch entstandenen Schaden zu ersetzen.

  

The Tenant must ensure that the floor load permitted by the building authorities is not exceeded. In the case of noncompliance, it must compensate the Landlord or any third parties for all damages caused.

§ 13 Werbemaßnahmen

  

§ 13 Advertisement

(1)    Der Mieter ist zur Anbringung eines Schildes in üblicher Größe an mit dem Vermieter zu vereinbarender Stelle berechtigt.

  

(1)    The Tenant is permitted to affix a sign of the usual size to a place which is to be agreed upon with the Landlord.

(2)    Andere Vorrichtungen, die der Werbung oder dem Verkauf dienen, dürfen an den Außenflächen des Hauses (Firmenschilder, Firmenzeichen, Werbetexte, Schaukästen, Verkaufsautomaten usw.) nur mit ausdrücklicher schriftlicher Erlaubnis des Vermieters angebracht werden.

  

(2)    Other equipment used for promotions or sales (company signs, logos, advertisements, show cases, vending machines, etc.) may only be affixed to the exterior surfaces of the building with the express written permission of the Landlord.

Die Erlaubnis kann widerrufen werden. In diesem Falle, wie auch bei Räumung der Mieträume, ist der Mieter zur Wiederherstellung des alten Zustandes verpflichtet.

  

Permission can be revoked. In this case, as with the vacating of the leased premises, the Tenant is responsible for restoration to the original condition.

 

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(3)    Der Mieter haftet für alle Schäden, die in Zusammenhang mit diesen Vorrichtungen entstehen.

  

(3)    The Tenant is liable for all damages incurred in connection with this equipment.

(4)    Die Beachtung der allgemeinen technischen und behördlichen Vorschriften für die Art, Anbringung und Unterhaltung und die deswegen erforderlichen Maßnahmen obliegen ausschließlich dem Mieter.

  

(4)    Observance of the general technical and regulatory requirements for the type, attachment and maintenance and the necessary measures required for the same are the sole responsibility of the Tenant.

§ 14 Ausbesserung und bauliche Veränderungen durch den Vermieter

  

§ 14 Repairs and Structural Modifications by the Landlord

(1)    Der Vermieter darf Ausbesserungen und bauliche Veränderungen, die zur Erhaltung des Hauses oder der Mieträume oder zur Abwendung drohender Gefahren oder zur Beseitigung von Schäden notwendig werden, auch ohne Zustimmung des Mieters vornehmen. Dies gilt auch für Arbeiten, die zwar nicht notwendig, aber zweckmäßig sind, z. B. Modernisierung des Gebäudes und der Mieträume. Der Mieter hat die betroffenen Räume zugänglich zu halten; die Ausführung der Arbeiten darf von ihm nicht behindert oder verzögert werden.

  

(1)    The Landlord may conduct improvements and structural changes necessary to maintain the building or the rented premises, to prevent imminent danger or to repair damages, even without the consent of the Tenant. This also applies to work that, although perhaps not necessary, is expedient, such as modernization of the building and the rented premises. The Tenant must keep the areas in question accessible; it may not delay or hinder the execution of the work.

(2)    Wird die Nutzung der Räume während der Arbeiten erheblich beeinträchtigt, ist der Mieter berechtigt, die Kaltmiete ohne Heiz- und Nebenkosten entsprechend zu mindern.

  

(2)    If the use of the premises is significantly affected during the work, the Tenant is entitled to accordingly reduce the base rent, without heating and utility costs.

§ 15 Bauliche Veränderungen durch den Mieter

  

§ 15 Structural Modifications by the Tenant

(1)    Es besteht Einigkeit darüber, dass für die bis zum 31.03.2014 vom Mieter durchgeführten Um- und Einbauten keine Rückbauverpflichtung besteht, außer für:

  

(1)    It is agreed that for the building alterations and installations already conducted by the Tenant as of 31 March 2014, no restoration liability exists, except for:

Zugang/Tür vom Konferenzraum im II. OG zum Nachbarbüro

  

Entrance/door from the conference room on the 3rd floor to the adjoining office

 

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Originalglaselemente ohne Durchgangsbohrung für Klimageräte (3 x II. OG, 1 x EG)

  

Original glass elements without through boring for air conditioners (3 x on the 3rd floor, 1 x on the ground floor)

Die Änderungen, die den Reinraum betreffen, ergeben sich aus den Grundrisszeichnungen, mit den Einträgen der getätigten Veränderungen im Untergeschoss, sowie einer Auflistung, die gemeinsam als Anlage III Bestandteil dieses Vertrages sind.

  

The changes related to the clean room, are set forth on the floor plans with the entries of the changes made in the basement as well as on a list which, together with the floor plans, forms part of this Contract as Appendix III.

Der Mieter verzichtet auf jegliche Ersatzansprüche bzgl. der hierzu getätigten Investitionen.

  

The Tenant shall waive any claims with respect to the investments made for this purpose.

(2)    Nach dem 01.04.2014 beabsichtigte Um- und Einbauten in den Mieträumen dürfen nur mit vorheriger Zustimmung des Vermieters vorgenommen werden. Die Zustimmung darf nicht ohne wichtigen Grund verweigert werden. Für die Einholung der behördlichen Genehmigungen ist der Mieter verantwortlich. Die Kosten hat ebenfalls der Mieter zu tragen. Zu Beginn der Vornahme solcher Um- und Einbauten vereinbaren die Parteien, ob der Mieter bei Beendigung des Mietverhältnisses den früheren Zustand herstellt. Kommt es zu keiner Einigung, kann der Vermieter im Einzelfall verlangen, dass bei Beendigung des Mietverhältnisses der frühere Zustand wieder hergestellt wird, es sei denn, es handelt sich um Maßnahmen, denen der Vermieter schriftlich zugestimmt hat, ohne einen Vorbehalt hinsichtlich des Rückbaus zum Ende des Mietverhältnisses zu klären.

  

(2)    After 01 April 2014, intended alterations of and installations in the rental premises may only be conducted with the previous agreement of the Landlord. Such consent may not be withheld without good cause. The Tenant is responsible for obtaining the regulatory approvals. The costs shall also be borne by the Tenant. At the beginning of such alterations and installations, the parties shall agree upon whether the Tenant shall restore the former condition. If the parties do not come to an agreement regarding the restoration, on a case by case basis, the Landlord can require that upon termination of the lease, the former condition be restored, unless measures are involved to which the Landlord had agreed in writing without stating any reservation about the refurbishment at the end of the tenancy.

 

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(3)    Der Mieter haftet für alle Schäden, die in Zusammenhang mit den von ihm vorgenommenen Baumaßnahmen entstehen.

  

(3)    The Tenant is liable for all damages incurred in connection with any construction projects it carries out.

(4)    Der Vermieter kann jedoch nicht verlangen, dass vom Mieter geschaffene Einrichtungen in den gemieteten Räumen belassen werden.

  

(4)    The Landlord cannot require that the installations conducted by the Tenant be left in the rented premises.

§ 16 Schönheitsreparaturen/Instandhaltung der Mieträume, Haftungen

  

§ 16 Cosmetic Repairs/Maintenance of the Leased Premises, Liability

(1)    Während der Mietzeit sind Schönheitsreparaturen in den Innenräumen, soweit sie nicht auf bauliche Mängel, welche der Vermieter zu vertreten hat oder auf Außeneinwirkung zurückzuführen sind, vom Mieter durchzuführen, spätestens jedoch bei Beendigung des Mietverhältnisses, sofern Schönheitsreparaturen dann erforderlich sind.

  

(1)    During the rental period, the Tenant will conduct any cosmetic repairs in the interior, as long as they have not been caused by structural defects for which the Landlord is liable or which are the result of external influences. This is to occur at the latest by the end of the Rental Contract, provided that cosmetic repairs are necessary at that time.

Der Mieter trägt die Kosten für kleine Instandhaltungen, soweit die Kosten für die einzelne Reparatur 250,— €( Zweihundertundfünfzig Euro) nicht übersteigen. Die Gesamtbelastung des Mieters durch die Instandsetzungen pro Jahr darf insgesamt 2.000,— € nicht überschreiten.

  

The Tenant shall pay for small maintenance procedures, provided that the cost for each repair does not exceed €250 (two hundred and fifty Euro). The Tenant’s total expenditure due to repairs per year may not exceed a total of €2,000.

Kleine Instandhaltungen umfassen das Beheben kleiner Schäden an den Installationsgegenständen für Elektrizität, Wasser und Gas, den Heiz- und Kocheinrichtungen, den Fenster und Türverschlüssen sowie den Verschluss-Einrichtungen der Fensterläden.

  

Small maintenance procedures include correcting minor damage to the installation equipment for electricity, water, gas, heating and cooking appliances, the windows and door locks, and the closures of the window shutters.

 

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(2)    Schäden am und im Hause und in den Mieträumen sind dem Vermieter oder seinem Beauftragten sofort anzuzeigen. Für durch verspätete Anzeige verursachte weitere Schäden haftet der Mieter.

  

(2)    Damages to and in the building and in the rented premises are to be shown immediately to the Landlord or his agent. The Tenant is liable for any further damages due to delayed notification.

(3)    Der Mieter haftet dem Vermieter für Schäden, die durch Verletzung der ihm obliegenden Sorgfaltspflicht schuldhaft verursacht werden. Leitungsverstopfungen bis zum Hauptrohr hat der Mieter auf jeden Fall auf seine Kosten zu beseitigen. Der Mieter haftet in gleicher Weise für Schäden, die durch seine Angehörigen, Arbeiter, Angestellten, Untermieter, Besucher, Lieferanten, Handwerker usw. schuldhaft verursacht worden sind.

  

(3)    The Tenant is liable to the Landlord for damages culpably caused by breach of the Tenant’s own obligation of due diligence. The Tenant is obliged in all cases to remove blockages to the main pipe at his own expense. The Tenant is equally liable for damages that have been culpably caused by his company members, workers, employees, sub-leasers, visitors, contractors, tradesmen, etc.

(4)    Der Vermieter haftet nicht für Schäden, die dem Mieter an den ihm gehörenden Waren und Einrichtungsgegenständen durch Feuchtigkeitseinwirkung entstehen, gleichgültig welcher Art, Herkunft und Dauer und welchen Umfanges die Feuchtigkeitseinwirkung ist; es sei denn, dass der Vermieter den Schaden vorsätzlich herbeigeführt hat.

  

(4)    The Landlord is not liable for damages of the Tenant’s goods and fixtures resulting from humidity irrespective of the kind, origin, duration and extent of the humidity, unless the Landlord wilfully caused the damages.

(5)    Der Mieter hat Schäden, für die er einstehen muss, sofort zu beseitigen. Kommt er dieser Verpflichtung auch nach schriftlicher Mahnung innerhalb angemessener Frist nicht nach, so kann der Vermieter die erforderlichen Arbeiten auf Kosten des Mieters vornehmen lassen. Bei gefahrdrohenden Schäden oder unbekanntem Aufenthalt des Mieters bedarf es der schriftlichen Mahnung und Fristsetzung nicht.

  

(5)    The Tenant is obliged to immediately repair damages for which it is responsible. If it does not fulfill this obligation within an appropriate period, even after a written request, then the Landlord can have the necessary work carried out at the expense of the Tenant. In the case of imminent danger or unknown occupancy of the Tenant, written warning and the setting of a deadline are not required.

 

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§ 17 Betreten der Mieträume durch den Vermieter

  

§ 17 Landlord Entering the Rental Premises

(1)    Der Vermieter oder seine Beauftragten können das Mietobjekt während der Öffnungszeiten nach vorheriger Anmeldung zur Prüfung seines Zustandes betreten. In allen Fällen der Gefahr ist das Betreten des Mietobjektes zu jeder Tages- und Nachtzeit gestattet.

  

(1)    The Landlord or his agents may access the rental property during opening hours by previous appointment inspect its condition. In all cases of danger, entering the rental property will be permitted at any time of the day or night.

(2)    Der Mieter hat dafür zu sorgen, dass die Räume auch während seiner Abwesenheit betreten werden können.

  

(2)    The Tenant is responsible for ensuring that the premises can also be entered during his absence.

§ 18 Pflichten des Mieters bei Beendigung des Mietverhältnisses

  

§ 18 Obligations of the Tenant upon Termination of the Rental Contract

(1)    Der Mieter ist verpflichtet, das Mietobjekt nach Beendigung des Mietverhältnisses vollständig geräumt zurückzugeben und das von ihm eingebaute Zubehör und sonstige Einbauten zu entfernen, sofern sie nicht gemäß § 15 im Gebäude verbleiben. Verkabelungen, Reklameanlagen und Werbeschilder sind zu beseitigen.

  

(1)    The Tenant is obliged to return the rental property fully vacated upon termination of the lease and to remove any built-in accessories and other fixtures that it may have installed, provided that they do not remain in the building as per § 15. Cabling, publicity equipment and advertising signs shall be removed.

(2)    Beim Auszug muss der Mieter alle Schlüssel zurückgeben. Andernfalls ist der Vermieter berechtigt, auf Kosten des Mieters neue Schlösser einbauen zu lassen. Die Parteien erstellen nach Räumung des Mietobjekts bei Rückgabe ein Übergabeprotokoll.

  

(2)    Upon vacating, the Tenant must return all keys. Otherwise, the Landlord is entitled to have new locks installed at the Tenant’s expense. After the vacating and return of the premises, the parties shall compile a completion certificate.

§ 19 Vermieterpfandrecht

  

§ 19 Landlord’s Lien

§ 562 BG findet keine Anwendung. Dem Vermieter steht daher für seine Forderungen aus dem Mietverhältnis kein Pfandrecht an den eingebrachten Sachen des Mieters zu.

  

§ 562 of the German Civil Code does not apply. Therefore, for his claims according to the Rental Contract, the Landlord has no lien on the items brought in by the Tenant.

 

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§ 20 Exklusives Optionsrecht zur Flächenerweiterung bzw. Flächentausch

  

§ 20 Exclusive Option for a Space Extension or Space Exchange

Dem Mieter wird nach Verfügbarkeit ein Optionsrecht auf frei werdende Flächen im Objekt Neuenhofer Weg 3 - 5 wie folgt eingeräumt.

  

Upon availability, the Tentant is granted an option for space in the object Neuenhofer Weg 3 - 5 becoming vacant as follows:

Der Vermieter räumt dem Mieter ein Vorrecht zur Anmietung frei werdender Flächen im I. Obergeschoss des Hauses 4 und des Lagers im Untergeschoss des Hauses 5 ein.

  

The Landlord grants the Tenant the right to rent any space that becomes vacant on the 2nd floor of building 4 and in the storage area in the basement of building 5.

Des Weiteren erhält der Mieter eine Option zur Anmietung von weiteren Tiefgaragen- bzw. Aussenstellplätzen im gleichen Verhältnis zu den zusätzlich noch anzumietenden Flächen.

  

In addition, the Tenant is granted a right to rent further underground garage and exterior parking spaces in a number corresponding to the space to be rented.

Der Vermieter wird dem Mieter die frei werdenden Flächen nach Kenntnis des Freiwerdens anbieten. Der Mieter hat innerhalb eines Monats nach Zugang eines entsprechenden Angebots des Vermieters das Anmietrecht durch Rücksendung seiner schriftlichen Annahme auszuüben.

  

As soon as it is aware that they will become available, the Landlord will offer the Tenant such space for rent. The Tenant will have one month after receipt of a relevant offer from the Landlord to exercise his right of rental in writing.

Die zu entrichtende Miete hat der in diesem Mietvertrag für die verschiedenen Flächen (Büro, Labor, Lager, Grau-/Reinraum) vereinbarten Miete zu entsprechen.

  

The rent to be paid must correspond to the rent agreed upon in this Rental Contract for the different areas (office, laboratory, storage, grey/clean room).

§ 21 Allgemeines

  

§ 21 General

(1)    Dieser Vertrag enthält alle zwischen den Vertragsparteien vereinbarten Bestimmungen bezüglich des Mietverhältnisses. Mündliche Nebenabreden bestehen nicht. Änderungen und Ergänzungen dieses Vertrages bedürfen der Schriftform. Dieses gilt auch für die Aufhebung des Schriftformerfordernisses.

  

(1)    This Contract contains all the terms agreed between the contractual parties regarding the Rental Contract. There are no verbal side agreements. Modifications and amendments to this Contract must be made in written form. This also applies to the waiver of the requirement for the written form.

(2)    Mehrere Personen als Mieter haften für alle Verpflichtungen aus dem Mietvertrag als Gesamtschuldner. Für die Rechtswirksamkeit einer Erklärung des Vermieters genügt es, wenn sie gegenüber einem Mieter abgegeben wird.

  

(2)    Several persons as Tenants are liable for all obligations under the Rental Contract as joint debtors. For a statement from the Landlord to have legal validity, it is sufficient if it is given to one Tenant.

 

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(3)    Der Gerichtsstand ist Aachen.

  

(3)    The place of jurisdiction is Aachen.

(4)    Sollte eine Bestimmung dieses Vertrages nichtig oder anfechtbar oder aus einem sonstigen Grunde unwirksam sein, so bleibt der übrige Vertrag dennoch wirksam. Die Vertragsparteien verpflichten sich in einem solchen Falle, statt der nichtigen, anfechtbaren oder unwirksamen Bestimmung eine solche zu vereinbaren, die ihrem Sinne möglichst nahe kommt und einen entsprechenden wirtschaftlichen Erfolg gewährleistet.

  

(4)    If any provision of this Contract becomes void or contestable, or ineffective for any other reason, the remainder of the Contract will nonetheless remain effective. The contractual parties undertake in such a case, instead of the void, contestable or ineffective provision, to agree one which comes closest to its meaning and which ensures appropriate financial success.

(5)    Wesentlicher Bestandteil dieses Vertrages sind folgende Anlagen:

  

(5)    The following appendices are essential parts of this Contract:

 

Anlage I    Grundrisszeichnungen (werden bis zum 31.10.2013 aktualisiert)      Appendix I    Floor Plans (will be updated as of 31 October 2013)
Anlage II    Fluchtpläne - Stand: Februar 2013      Appendix II    Escape Plans (As at February 2013)
Anlage III    Zusammenstellung der Umbaumaßnahmen nach Gewerk inkl. Bauzeitenplan      Appendix III    Compilation of the construction measures according to trade including time schedule

 

(6)    Der Mieter ist davon informiert, dass im Rahmen der Mietvertragsverwaltung die das Vertragsverhältnis betreffenden Daten auf Datenträger gespeichert und nach den Bestimmungen des Bundesdatenschutzgesetzes verarbeitet werden.

  

(6)    The Tenant is informed that within the scope of the management of the Rental Contract, any data relevant to the Rental Contract will be recorded on data storage devices and processed according to the provisions of the German Federal Data Protection Act.

Aachen, den    Aachen, den    Aachen, the    Aachen, the

/s/ Frank Adolphs

/s/ Sebastian Albers

  

/s/ Dirk Michels

/s/ Rolf Maseizik

  

/s/ Frank Adolphs

/s/ Sebastian Albers

  

/s/ Dirk Michels

/s/ Rolf Maseizik

gewoge AG

(Vermieter)

  

Abiomed Europe GmbH

(Mieter)

  

gewoge AG

(Landlord)

  

Abiomed Europe GmbH

(Tenant)

 

23/23

Exhibit 31.1

CERTIFICATIONS

I, Michael R. Minogue certify that:

1. I have reviewed this Quarterly Report on Form 10-Q of ABIOMED, 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 the 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.

 

Date: November 8, 2013    

/s/ Michael R. Minogue

    Michael R. Minogue
   

Chairman, President and Chief Executive Officer

(Principal Executive Officer)

Exhibit 31.2

I, Robert L. Bowen certify that:

1. I have reviewed this Quarterly Report on Form 10-Q of ABIOMED, 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 the 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.

 

Date: November 8, 2013    

/s/ Robert L. Bowen

    Robert L. Bowen
   

Vice President and Chief Financial Officer

(Principal Accounting and Financial Officer)

Exhibit 32.1

CERTIFICATION PURSUANT TO

18 U.S.C. § 1350

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report on Form 10-Q of ABIOMED, Inc., (the “Company”) for the quarter ended September 30, 2013, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), each of the undersigned President and Chief Executive Officer, and Corporate Controller, of the Company, certifies, to the best knowledge and belief of the signatory, pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 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.

 

/s/ Michael R. Minogue

   

/s/ Robert L. Bowen

Chairman, President and Chief Executive Officer     Vice President and Chief Financial Officer
Date: November 8, 2013     Date: November 8, 2013