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8-K - FORM 8-K - ABIOMED INCd8k.htm

Exhibit 99.1

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ABIOMED REPORTS REVENUE OF $27.4 MILLION, UP 25% OVER PRIOR YEAR, FOR

FIRST QUARTER OF FISCAL 2012

 

  - Impella Revenues Grow 33% to $22.2 Million

DANVERS, Mass. — August 4, 2011 – Abiomed, Inc. (NASDAQ: ABMD), a leading provider of breakthrough heart support technologies, today reported first quarter fiscal 2012 revenue of $27.4 million, up 25% compared to revenue of $22.0 million in the same period of fiscal 2011.

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

 

   

Fiscal first quarter worldwide Impella revenue totaled $22.2 million, up 33% compared to revenue of $16.7 million during the same period of the prior year. U.S. Impella revenues of $20.5 million were up 31% from the prior year. Impella revenue from outside the U.S. totaled $1.7 million, up 70% from the prior year.

 

   

In alignment with the Company’s strategy to open fewer sites and drive deeper utilization at existing customer sites, an additional 25 U.S. hospitals purchased Impella 2.5 during the quarter, bringing the total to 546 customer sites.

 

   

Revenue from the sales of BVS5000, AB5000, related accessories and funded research and development was $3.6 million for the first quarter of fiscal 2012, 12% lower than $4.1 million in the first quarter of fiscal 2011.

 

   

Service revenue totaled $1.6 million in the first quarter of fiscal 2012, up 33% from $1.2 million in the prior year.

 

   

Total U.S. revenues of $25.4 million were up 25% from $20.4 million in the prior year. Revenue from outside the U.S. totaled $2.0 million, up 25% from $1.6 million in the prior year.

 

   

Gross margin rate for the first quarter of fiscal 2012 was 78.5% compared to 76.0% in the first quarter of fiscal 2011.

 

   

Operating expenses for the first quarter of fiscal 2012 were $25.8 million, up 13% from $22.8 million in the prior year, largely as a result of the continued build-out of the U.S. commercial organization to support sales and marketing initiatives related to the Impella platform.

 

   

Non-GAAP net loss, which is described later in this press release, for the first quarter of fiscal 2012 was $1.2 million, or $0.03 per basic and diluted share compared to a non-GAAP net loss of $3.1 million or $0.08 per basic and diluted share, in the first quarter of fiscal 2011.

 

   

GAAP net loss for the first quarter of fiscal 2012 was $4.6 million, or $0.12 per basic and diluted share, compared to GAAP net loss of $6.0 million, or $0.16 per basic and diluted share for the first quarter of fiscal 2011.

 

   

Cash, cash equivalents and short-term marketable securities totaled $59.1 million at June 30, 2011 compared to $60.3 million at March 31, 2011.

 

   

The PROTECT II analysis was presented at the American College of Cardiology 2011 Scientific


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Session in New Orleans on April 3, 2011 and Society for Cardiovascular Angiography Interventions (SCAI) 2011 Scientific Sessions in Baltimore on May 6, 2011, and at EuroPCR in Paris on May 20, 2011.

 

   

Additional cost-saving benefits with Impella were substantiated in the economic sub-study presented at SCAI 2011 and in the April 2011 Cardiovascular Business article, “PinnacleHealth Heart Recovery Program Aims to Stabilize Unstable Shock Patients.”

 

   

In April 2011, Abiomed filed a formal Impella submission to the Pharmaceuticals and Medical Devices Agency (PMDA) and the Japanese Ministry of Health and Welfare for approval of Impella in Japan.

Based on the 25% revenue growth in the first quarter fiscal 2012 and current expectations, the Company is reiterating fiscal year 2012 revenue guidance to increase by 20% to 24% and be in the range of $120 million to $125 million.

“The Impella platform continues to expand with a wave of clinical evidence, patient success stories and U.S. reimbursement confirmation,” said Michael R. Minogue, Chairman, President and Chief Executive Officer of Abiomed. “We remain committed to leading in innovation and technology and will be announcing specific investor updates on new Impella enhancements, new products and the Japan submission, later this year.”

The Company will host a conference call to discuss the results on Thursday, August 4, 2011, at 8:00 a.m. ET. Michael R. Minogue, Chairman, President and Chief Executive Officer and Robert L. Bowen, Vice President and Chief Financial Officer, will host the conference call.

To listen to the call live, please tune into the webcast via http://investor.abiomed.com or dial 866.396.2298; the international number is 617.847.8708. The access participant code is 96584140. A replay of this conference call will be available beginning at 11:00 a.m. ET on August 4, 2011 through 11:59 p.m. ET on August 18, 2011. The replay phone number is 888.286.8010; the international number is 617.801.6888. The replay access code is 10196776.

ABOUT ABIOMED

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

USE OF NON-GAAP MEASURES

In addition to financial measures prepared in accordance with generally accepted accounting principles (GAAP), this earnings announcement also contains non-GAAP financial measures of net income, net income per share, net loss and net loss per share, in each case excluding, where appropriate, stock-based compensation, intangibles amortization and other costs, expenses or income, all as further detailed in the financial tables accompanying this earnings announcement, which management believes are useful supplemental information to management and investors regarding the performance of the company’s business operations, provide a greater transparency with respect to key metrics used by management in its decision making, facilitate comparisons of results for current periods and assist in analyzing future trends. We believe that the inclusion of these non-GAAP financial measures in this earnings announcement helps investors to gain a meaningful understanding of our core operating results and future prospects, and can also help investors who wish to make comparisons between us and other companies on both a GAAP and a non-GAAP basis, particularly with respect to stock based compensation expenses. The non-GAAP financial measures included in this earnings announcement are not meant to be considered superior to or a substitute for results of operations prepared in accordance with GAAP. In addition, the non-GAAP financial measures included in this earnings announcement may be different from, and therefore may not be comparable to, similar measures used by other companies. Although certain non-GAAP financial measures used in this release exclude the accounting treatment of stock based compensation expense and other items outlined in this release, these


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non-GAAP measures should not be relied upon independently, as they ignore the contribution to our operating results that is generated by the incentive and compensation effects of the underlying stock based compensation programs.

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, the Company’s projected revenues, 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, regulatory approvals, 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. 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:

Aimee Maillett

Corporate Communications Manager

978-646-1553

ir@abiomed.com

###


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Abiomed, Inc. and Subsidiaries

Consolidated Balance Sheets

(in thousands, except share data)

 

     June 30, 2011     March 31, 2011  
     (unaudited)        

ASSETS

    

Current assets:

    

Cash and cash equivalents

   $ 4,151      $ 5,831   

Short-term marketable securities

     54,982        54,481   

Accounts receivable, net

     14,541        15,376   

Inventories

     8,879        7,505   

Prepaid expenses and other current assets

     1,339        1,544   
  

 

 

   

 

 

 

Total current assets

     83,892        84,737   

Property and equipment, net

     6,214        6,273   

Intangible assets, net

     1,279        1,632   

Goodwill

     39,752        38,946   
  

 

 

   

 

 

 

Total assets

   $ 131,137      $ 131,588   
  

 

 

   

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

    

Current liabilities:

    

Accounts payable

   $ 4,964      $ 6,283   

Accrued expenses

     8,700        14,078   

Deferred revenue

     1,715        1,982   
  

 

 

   

 

 

 

Total current liabilities

     15,379        22,343   

Long-term deferred tax liability

     4,106        4,010   

Other long-term liabilities

     469        492   
  

 

 

   

 

 

 

Total liabilities

     19,954        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 Authorized - 100,000,000 shares; Issued - 38,560,747 shares at June 30, 2011 and 37,756,719 shares at March 31, 2011; Outstanding - 38,509,793 shares at June 30, 2011 and 37,705,765 shares at March 31, 2011

     385        377   

Additional paid-in-capital

     389,217        379,218   

Accumulated deficit

     (279,364     (274,770

Treasury stock at cost - 50,954 shares

     (827     (827

Accumulated other comprehensive income

     1,772        745   
  

 

 

   

 

 

 

Total stockholders’ equity

     111,183        104,743   
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 131,137      $ 131,588   
  

 

 

   

 

 

 


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Abiomed, Inc. and Subsidiaries

Consolidated Statements of Operations

(Unaudited)

(in thousands, except share data)

 

     Three Months Ended
June 30,
 
     2011     2010  

Revenue:

    

Products

   $ 27,166      $ 21,761   

Funded research and development

     189        241   
  

 

 

   

 

 

 
     27,355        22,002   
  

 

 

   

 

 

 

Costs and expenses:

    

Cost of product revenue excluding amortization of intangibles

     5,891        5,284   

Research and development

     7,324        6,653   

Selling, general and administrative

     18,176        15,753   

Amortization of intangible assets

     385        367   
  

 

 

   

 

 

 
     31,776        28,057   
  

 

 

   

 

 

 

Loss from operations

     (4,421     (6,055
  

 

 

   

 

 

 

Other (expense) income

    

Investment income (expense), net

     4        (2

Gain on sale of WorldHeart stock

     —          239   

Other (expense) income, net

     (81     81   
  

 

 

   

 

 

 
     (77     318   
  

 

 

   

 

 

 

Loss before provision for income taxes

     (4,498     (5,737

Provision for income taxes

     96        243   
  

 

 

   

 

 

 

Net loss

   $ (4,594   $ (5,980
  

 

 

   

 

 

 

Basic and diluted net loss per share

   $ (0.12   $ (0.16

Weighted average shares outstanding

     38,268        37,086   


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Abiomed Inc

Reconciliation of GAAP to Non-GAAP Net Loss

(in thousands, except for per share data)

 

     Three Months Ended  
     June 30, 2011     June 30, 2010  

Net loss on a GAAP basis

   $ (4,594   $ (5,980

Share-based compensation expense:

    

- Cost of product revenue

     76        62   

- Research & development

     500        310   

- Selling, general and administrative

     1,756        999   

Athlone lease exit charge

    

- Selling, general and administrative

     —          791   

Amortization of intangible assets

     385        367   

Depreciation

     661        592   

Sale of World Heart Stock

     —          (239

Income tax effect of non-GAAP adjustments

     —          —     

Net loss on a non-GAAP basis

   $ (1,216   $ (3,098

Net loss per share reconciliation

(in thousands, except for per share data)

 

     Three Months Ended  
     June 30, 2011     June 30, 2010  

Basic and diluted net loss per share on a GAAP basis

   $ (0.12   $ (0.16

Share-based compensation expense:

    

- Cost of product revenue

     —          —     

- Research & development

     0.01        0.01   

- Selling, general and administrative

     0.05        0.03   

Athlone fair value charge

    

- Selling, general and administrative

     —          0.02   

Amortization of intangible assets

     0.01        0.01   

Depreciation

     0.02        0.02   

Sale of World Heart Stock

     —          (0.01

Income tax effect of non-GAAP adjustments

     —          —     

Basic net loss per share on a non-GAAP basis

   $ (0.03   $ (0.08

Basic Shares used in calculation of net income/(loss) per share on a non-GAAP basis

     38,268        37,086