Abiomed, Inc. (Nasdaq:ABMD), a leading provider of breakthrough heart support technologies, today reported second quarter fiscal 2014 revenue of $44.3 million, up 19% compared to revenue of $37.4 million in the same period of fiscal 2013, and a second quarter fiscal 2014 GAAP net income of $1.1 million or $0.03 per diluted share, compared to $5.5 million or $0.13 per diluted share in the prior year period.

Financial and operating highlights during the second quarter of fiscal 2014 and fiscal year to date include:

  • Fiscal second quarter worldwide Impella® revenue totaled $40.2 million, up 23% compared to revenue of $32.8 million during the same period of the prior year. U.S. Impella revenue grew 21% to $37.0 million from $30.7 million in the prior year with U.S. Impella patient usage up 24% from the prior year.  
  • An additional 30 hospitals purchased Impella 2.5 during the quarter, bringing the total to 805 customer sites. As part of Abiomed's continued Impella CP™ launch, an additional 65 hospitals purchased Impella CP, bringing the total number of Impella CP U.S. sites to 237. Impella 2.5 and Impella CP unit inventory at hospitals averaged 2.4 units, equal to the prior sequential quarter.   
  • Gross margin rate for the second quarter of fiscal 2014 was 79.6% compared to 80.8% in the second quarter of fiscal 2013. There were 172 Impella AIC consoles placed during the quarter compared to 114 in the same period of the prior year.  
  • Income from operations for the second quarter fiscal 2014 was $1.4 million, compared to $5.9 million in the prior year period. Operating expense in the second quarter of fiscal 2014 included $1.9 million related to the Department of Justice subpoena and $0.7 million of medical device tax.  
  • Cash, cash equivalents, short and long-term marketable securities totaled $96.9 million as of September 31, 2013. The Company continues to have no debt and a U.S. federal net operating loss carry-forward of approximately $190 million as of March 31, 2013.  
  • Abiomed today 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 for February 2015.  
  • In October, there were over 25 Impella-related sessions at the Transcatheter Cardiovascular Therapeutics (TCT) 2013 conference in San Francisco.  
  • In August, Abiomed received approval from the U.S. Department of Veterans Affairs to be included on its authorized Veteran's Administration (VA) Federal Supply Schedule, providing the Impella platform to VA medical facilities, Department of Defense (DOD) hospitals and other federal agencies.

"Abiomed achieved many new quarterly records on Impella utilization, including most overall patients, most prophylactic patients and most emergent patients," said Michael R. Minogue, Chairman, President and Chief Executive Officer of Abiomed. "We are on track to transform into a PMA and PMDA company while setting new records in patient utilization and completing enrollment in our Impella RP study."

The Company is maintaining its fiscal year 2014 revenue guidance in the range of $180 million to $185 million, with worldwide Impella revenue forecasted to increase by approximately 20%, and GAAP operating margin of approximately breakeven to 5%.

The Company will host a conference call to discuss the results on Wednesday, November 6, 2013, at 8:00 a.m. ET. Michael R. Minogue, Chairman, President and Chief Executive Officer; Robert L. Bowen, Vice President and Chief Financial Officer; and Susan V. Lisa, Senior Director, Investor Relations and Corporate Development, will host the conference call.

To listen to the call live, please tune into the webcast via http://investor.abiomed.com or dial (877) 638-9567; the international number is (253) 237-1032. A replay of this conference call will be available beginning at 11 a.m. ET November 6, 2013 through 11:59 p.m. ET on November 13, 2013. The replay phone number is (855) 859-2056; the international number is (404) 537-3406. The replay access code is 86905153.

ABOUT ABIOMED

Based in Danvers, Massachusetts, Abiomed, Inc., is a leading provider of medical devices that provide circulatory support. Our products are designed to enable the heart to rest by improving blood flow and/or performing the pumping of the heart. For additional information please visit: www.abiomed.com

FORWARD-LOOKING STATEMENTS

This release contains forward-looking statements, including statements regarding development of Abiomed's existing and new products, the Company's progress toward commercial growth, and future opportunities and expected regulatory approvals. The Company's 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 the Company's filings with the Securities and Exchange Commission, including the most recently filed Annual Report on Form 10-K and Quarterly Report on Form 10-Q. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. The Company undertakes no obligation to publicly release 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 release or to reflect the occurrence of unanticipated events.

Abiomed, Inc. and Subsidiaries
Consolidated Balance Sheets
(Unaudited)
(in thousands, except 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
 
Abiomed, Inc. and Subsidiaries
Consolidated Statements of Operations
(Unaudited)
(in thousands, except 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
CONTACT: For further information please contact:
         Susie Lisa, CFA
         Senior Director, Investor Relations and Corporate Development
         978-646-1590
         slisa@abiomed.com
         
         Aimee Genzler
         Corporate Communications Manager
         978-646-1553
         ir@abiomed.com
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