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8-K - FORM 8-K - ABIOMED INCd350678d8k.htm

Exhibit 99.1

 

LOGO

ABIOMED ANNOUNCES RECORD FOURTH QUARTER REVENUE OF $37.3 MILLION, UP 31% AND ACHIEVES PROFITABILITY FOR FULL FISCAL YEAR

 

   

Worldwide Impella® Fourth Quarter Revenue Grows 43% Based on Record Utilization

DANVERS, Mass. — May 16, 2012 Abiomed, Inc. (NASDAQ: ABMD), a leading provider of breakthrough heart support technologies, today reported fourth quarter fiscal 2012 revenue of $37.3 million, up 31% compared to revenue of $28.5 million in the same period of fiscal 2011, and GAAP net income of $2.6 million or $0.06 per diluted share compared to GAAP net loss of $1.8 million or a loss of $0.05 per basic and diluted share in the prior year. For the full fiscal year, total revenue was $126.4 million, up 25% compared to revenue of $101.2 million in the prior fiscal year and GAAP net income was $1.5 million or $0.04 per diluted share compared to GAAP net loss of $11.8 million or a loss of $0.32 per basic and diluted share in the prior year.

Financial and operating highlights during the fourth quarter of fiscal 2012 include:

 

   

Fiscal fourth quarter worldwide Impella revenue totaled $32.3 million, up 43% compared to revenue of $22.6 million during the same period of the prior year. U.S. Impella revenue grew 44% to $29.9 million.

 

   

Full year worldwide Impella revenue totaled $106.9 million, up 37% compared to revenue of $78.2 million during the same period of the prior year. U.S. Impella revenue grew 37% to $99.1 million.

 

   

As targeted, an additional 26 hospitals purchased Impella 2.5 during the quarter, bringing the total to 631 customer sites.

 

   

Gross margin rate for the fourth quarter FY 2012 was 81.8% compared to 79.5% in the prior year. For the full fiscal year, gross margin rate was 80.6% compared to 78.3% in the prior year.

 

   

Non-GAAP net income for the fourth fiscal quarter, which is described later in this press release, was $5.3 million or $0.13 per diluted share compared to $0.6 million or $0.01 per diluted share in the prior year. For the full fiscal year, non-GAAP net income was $12.1 million or $0.30 per diluted share compared to a non-GAAP net loss of $2.1 or a loss of $0.06 per share in the prior year.

 

   

Cash, cash equivalents and short-term marketable securities totaled $77.2 million as of March 31, 2012, an increase of $7.6 million from December 31, 2011; the company continues to have no debt.

 

   

Abiomed announced in April the successful first human use outside the U.S. of the Impella cVADTM device, a new percutaneous Impella heart pump that provides peak flow of approximately four liters of blood per minute.1

 

   

Abiomed also announced in April that it received CE Marking approval in the European Union to market the Impella cVAD device.1

 

   

At the American College of Cardiology Scientific Sessions in March, there were multiple presentations on the Impella platform, including first-in-man experience outside the U.S. with the Impella RP, a new percutaneous heart pump designed to treat right-sided heart failure.1


   

The fourth quarter fiscal 2012 represented the first full quarter after the November 2011 release of the ACCF/AHA/SCAI 2011 Guidelines for Percutaneous Coronary Intervention (PCI), which incorporated Impella support for both the emergent and prophylactic settings.

“We are happy to report the best quarter and year in company history, in terms of number of patients supported, revenue growth, and profitability,” said Michael R. Minogue, Chairman, President and Chief Executive Officer of Abiomed. “Abiomed is highly motivated to help thousands of patients and create significant shareholder value.”

Based on current expectations and consistent with Abiomed’s seasonal utilization, the company anticipates fiscal year 2013 revenues to increase by 20% to 24% and to be in the range of $152 million to $157 million. Worldwide Impella revenues are forecasted to increase by approximately 30%.

The company will host a conference call to discuss the fourth quarter and full fiscal year 2012 results on Wednesday, May 16, 2012, at 8:00 a.m. ET with Michael R. Minogue, Chairman, President and Chief Executive Officer; Robert L. Bowen, Vice President and Chief Financial Officer; and Susan V. Lisa, Senior Director of Investor Relations and Corporate Development.

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 11:00 a.m. ET on May 16, 2012 through 11:59 p.m. ET on May 23, 2012. The replay phone number is (855) 859-2056; the international number is (404) 537-3406. The replay access code is 47634386.

1The Impella cVAD and the Impella RP are not currently cleared for sale or use in the United States.

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 anticipated future losses, complex manufacturing, high quality requirements, dependence on limited sources of supply, competition, technological change, government regulation, 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 Annual Report filed on Form 10-K and most recently filed 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.

For further information please contact:

Susie Lisa, CFA

Senior Director, Investor Relations and Corporate Development

978-646-1590

slisa@abiomed.com


Aimee Maillett

Corporate Communications Manager

978-646-1553

ir@abiomed.com


Abiomed, Inc. and Subsidiaries

Consolidated Balance Sheets

(Unaudited)

(in thousands, except share data)

 

     March 31,  
     2012     2011  

ASSETS

    

Current assets:

    

Cash and cash equivalents

   $ 5,990      $ 5,831   

Short-term marketable securities

     71,233        54,481   

Accounts receivable, net

     20,458        15,376   

Inventories

     11,142        7,505   

Prepaid expenses and other current assets

     1,716        1,544   
  

 

 

   

 

 

 

Total current assets

     110,539        84,737   

Property and equipment, net

     6,378        6,273   

Intangible assets, net

     115        1,632   

Goodwill

     36,846        38,946   

Other long-term assets

     33        —     
  

 

 

   

 

 

 

Total assets

   $ 153,911      $ 131,588   
  

 

 

   

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

    

Current liabilities:

    

Accounts payable

   $ 6,910      $ 6,283   

Accrued expenses

     12,480        14,078   

Deferred revenue

     3,025        1,982   
  

 

 

   

 

 

 

Total current liabilities

     22,415        22,343   

Long-term deferred tax liability

     4,799        4,010   

Other long-term liabilities

     400        492   
  

 

 

   

 

 

 

Total liabilities

     27,614        26,845   
  

 

 

   

 

 

 

Commitments and contingencies

    

Stockholders’ equity:

    

Class B Preferred Stock, $.01 par value

     —          —     

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

    

Common stock, $.01 par value

     393        377   

Authorized - 100,000,000 shares; Issued - 39,323,708 shares at March 31, 2012 and 37,756,719 shares at March 31, 2011;

    

Outstanding - 39,272,754 shares at March 31, 2012 and 37,705,765 shares at March 31, 2011

    

Additional paid-in-capital

     401,771        379,218   

Accumulated deficit

     (273,275     (274,770

Treasury stock at cost - 50,954 shares

     (827     (827

Accumulated other comprehensive (loss) income

     (1,765     745   
  

 

 

   

 

 

 

Total stockholders’ equity

     126,297        104,743   
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 153,911      $ 131,588   
  

 

 

   

 

 

 


Abiomed, Inc. and Subsidiaries

Consolidated Statements of Operations

(Unaudited)

(in thousands, except share data)

 

     Three Months Ended
March 31,
    Year Ended
March 31,
 
     2012     2011     2012     2011  

Revenue:

        

Product

   $ 37,237      $ 28,103      $ 125,286      $ 99,837   

Funded research and development

     107        426        1,089        1,314   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total Revenue

     37,344        28,529        126,375        101,151   
  

 

 

   

 

 

   

 

 

   

 

 

 

Costs and expenses:

        

Cost of product revenue excluding amortization of intangibles

     6,786        5,848        24,507        21,977   

Research and development

     7,236        6,843        27,159        26,677   

Selling, general and administrative

     20,028        16,888        71,711        62,287   

Amortization of intangible assets

     352        361        1,478        1,395   
  

 

 

   

 

 

   

 

 

   

 

 

 
     34,402        29,940        124,855        112,336   
  

 

 

   

 

 

   

 

 

   

 

 

 

Income (loss) from operations

     2,942        (1,411     1,520        (11,185
  

 

 

   

 

 

   

 

 

   

 

 

 

Other income (expense):

        

Investment income (expense), net

     1        8        (3     9   

Gain on sale of WorldHeart stock

     —          —          —          456   

Gain on settlement of investment

     —          —          1,017        —     

Other (expense) income, net

     (15     (126     9        (143
  

 

 

   

 

 

   

 

 

   

 

 

 
     (14     (118     1,023        322   
  

 

 

   

 

 

   

 

 

   

 

 

 

Income (loss) before provision for income taxes

     2,928        (1,529     2,543        (10,863

Income tax provision

     361        243        1,048        892   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss)

   $ 2,567      $ (1,772   $ 1,495      $ (11,755
  

 

 

   

 

 

   

 

 

   

 

 

 

Basic net income (loss) per share

   $ 0.07      $ (0.05   $ 0.04      $ (0.32

Basic weighted average shares outstanding

     38,840        37,231        38,374        37,167   

Diluted net income (loss) per share

   $ 0.06      $ (0.05   $ 0.04      $ (0.32

Diluted weighted average shares outstanding

     41,251        37,231        40,172        37,167   


Abiomed, Inc. and Subsidiaries

Reconciliation of GAAP to Non-GAAP Net Income (Loss)

(in thousands, except for per share data)

 

     Three Months Ended
March 31,
    Year Ended
March 31,
 
     2012      2011     2012     2011  

Net income (loss) on a GAAP basis

   $ 2,567       $ (1,772   $ 1,495      $ (11,755

Share-based compensation expense:

         

- Cost of product revenue

     66         51        282        214   

- Research & development

     450         252        1,719        1,001   

- Selling, general and administrative

     1,353         1,100        5,772        4,206   

Athlone lease exit charge

         

- Selling, general and administrative

     —           —          —          791   

Amortization of intangible assets

     352         361        1,478        1,395   

Depreciation

     530         579        2,337        2,553   

Gain on investment

         

- Other income (expense)

     —           —          (1,017     —     

Sale of World Heart Stock

         

- Other income (expense)

     —           —          —          (456

Income tax effect of non-GAAP adjustments

     —           —          —          —     
  

 

 

    

 

 

   

 

 

   

 

 

 

Net income (loss) on a non-GAAP basis

   $ 5,318       $ 571      $ 12,066      $ (2,051
  

 

 

    

 

 

   

 

 

   

 

 

 

Net Income (Loss) Per Share Reconciliation

(in thousands, except for per share data)

  

  

     Three Months Ended
March 31,
    Year Ended
March 31,
 
     2012      2011     2012     2011  

Net income (loss) per diluted share on a GAAP basis

   $ 0.06       $ (0.05   $ 0.04      $ (0.32

Share-based compensation expense:

         

- Cost of product revenue

     0.01         —          0.01        0.01   

- Research & development

     0.01         0.01        0.04        0.03   

- Selling, general and administrative

     0.03         0.03        0.14        0.11   

Athlone fair value charge - Selling, general and administrative

     —           —          —          0.02   

Amortization of intangible assets

     0.01         0.01        0.04        0.04   

Depreciation

     0.01         0.01        0.06        0.06   

Gain on investment

         

- Other income (expense)

     —           —          (0.03     —     

Sale of World Heart Stock

         

- Other income (expense)

     —           —          —          (0.01

Income tax effect of non-GAAP adjustments

     —           —          —          —     
  

 

 

    

 

 

   

 

 

   

 

 

 

Net income (loss) per diluted share on a non-GAAP basis

   $ 0.13       $ 0.01      $ 0.30      $ (0.06

Shares used in calculation of net income (loss) per

     41,251         38,323        40,172        37,167   

diluted share on a non-GAAP basis