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SEC Filings

HEARTWARE INTERNATIONAL, INC. filed this Form 10-Q on 11/02/2015
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Note 10. Net Loss Per Share

Basic earnings per share was computed by dividing net (loss) income for the period by the weighted-average number of common shares outstanding for each respective period. Diluted earnings per share adjusts basic earnings per share for the dilutive effects of share-based awards as determined under the “treasury stock” method, our convertible notes as determined under the “if-converted” method and other potentially dilutive instruments only in the periods in which the effect is dilutive. Due to our net loss for all periods presented, all potentially dilutive instruments were excluded because their inclusion would have been anti-dilutive. The following instruments were excluded from the calculation of diluted net loss per share, as their effect would be anti-dilutive.


     Three Months Ended
September 30,
     Nine Months Ended
September 30,
     2015      2014      2015      2014  
     (In thousands)  
Common shares issuable upon:            

Conversion of 3.5% convertible senior notes

     425         1,438         425         1,438   

Conversion of 1.75% convertible senior notes

     2,024         —           2,024         —     

Exercise or vesting of share-based awards

     840         837         840         837   

Note 11. Business Segment, Geographic Areas and Major Customers

For financial reporting purposes, we have one reportable segment which designs, manufactures and markets medical devices for the treatment of advanced heart failure. Products are distributed to customers located in the United States through our clinical trials and as commercial products, as commercial products to customers in Europe and under special access in other countries. Product sales attributed to a country or region are based on the location of the customer to whom the products are sold. Long-lived assets are primarily held in the United States.

Product sales by geographic location were as follows:


     Three Months Ended
September 30,
     Nine Months Ended
September 30,
     2015      2014      2015      2014  
     (in thousands)  

United States

   $ 35,578       $ 39,068       $ 120,689       $ 109,801   


     14,870         15,105         40,683         47,187   

International, excluding Germany

     14,718         14,435         47,384         48,223   












   $ 65,166       $ 68,608       $ 208,756       $ 205,211   













As a significant portion of our revenue is generated outside of the United States, we are dependent on favorable economic and regulatory environments for our products in Europe and other countries outside of the United States. For the three and nine months ended September 30, 2015 and 2014, no customer exceeded 10% of product sales individually.

Note 12. Commitments and Contingencies

We received a warning letter from the FDA, dated June 2, 2014, following an inspection of our Miami Lakes, Florida facility conducted in January 2014. The FDA letter cited four categories for us to address: (1) procedures for validating device design, including device labeling; (2) procedures for implementing corrective and preventive action (“CAPA”); (3) maintaining records related to investigations; and (4) validation of computer software used as part of production or quality systems. The warning letter did not require any action by physicians or patients and did not restrict use of our devices.

We sent the FDA our initial response to the warning letter within the required fifteen business days of receipt, and