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8-K - 8-K - ABIOMED INCd576527d8k.htm

Exhibit 99.1

 

LOGO

ABIOMED ANNOUNCES FIRST QUARTER FISCAL 2014 REVENUE OF $42.7 MILLION, UP 10% OVER PRIOR YEAR

- Abiomed Receives FDA Approval of PMA Shell for Modular Submission of the Impella 2.5

DANVERS, Mass. — August 1, 2013 Abiomed, Inc. (NASDAQ: ABMD), a leading provider of breakthrough heart support technologies, today reported first quarter fiscal 2014 revenue of $42.7 million, up 10% compared to revenue of $38.8 million in the same period of fiscal 2013, and a first quarter fiscal 2014 GAAP net loss of $1.7 million or a loss of $0.04 per diluted share, compared to GAAP net income of $3.1 million or $0.08 per diluted share in the prior year period.

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

 

   

Fiscal first quarter worldwide Impella® revenue totaled $38.7 million, up 12% compared to revenue of $34.7 million during the same period of the prior year. U.S. Impella revenue grew 7% to $35.4 million from $33.0 million in the prior year with U.S. Impella patient usage up 12%.

 

   

An additional 27 hospitals purchased Impella 2.5 during the quarter, bringing the total to 775 customer sites. As part of Abiomed’s continued Impella CP™ launch, an additional 66 hospitals purchased Impella CP, bringing the total number of Impella CP U.S. sites to 172. 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 first quarter of fiscal 2014 was 79.6% compared to 80.8% in the first quarter of fiscal 2013. There were 191 Impella AIC consoles placed during the quarter compared to 163 in the same period of the prior year.

 

   

Income/(loss) from operations for the first quarter fiscal 2014 was a loss of $1.3 million, compared to a gain of $3.6 million in the prior year period. Compared to the prior year, the loss included $2.6 million of incremental legal expenses related to the Department of Justice subpoena, shareholder lawsuit and derivative action, $1.2 million of higher stock compensation expense and $0.6 million of incremental expense for the medical device tax.

 

   

Cash, cash equivalents, short and long-term marketable securities totaled $88 million as of June 30, 2013, which remained unchanged from March 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 announced in May the publication of the Protect II Cost Effectiveness Study in American Health & Drug Benefits Journal, demonstrating the cost effectiveness of Impella.

 

   

Abiomed also announced that the Netherlands has approved new reimbursement coding and payment for the Impella product. The new coding allows for hospitals to receive funding for the use of the Impella technology in a broad set of clinical indications of heart disease through the process known as Diagnosis Treatment Combinations (Diagnose Behandeling Combinaties; DBCs), similar to the Medicare Diagnosis-Related Group (DRG) system in the United States.


   

Abiomed also announced in June that the U.S. District Court of Massachusetts dismissed the derivative lawsuit that was filed in February 2013.

 

   

There were several Impella-related sessions at the 22nd Annual Meeting of the Japanese Association of CardioVascular Intervention and Therapeutics (CVIT 2013) in Kobe, Japan, which took place July 11-13. Abiomed anticipates Japanese PMDA approval for Impella by the end of the year, with reimbursement to follow within 6 – 12 months.

 

   

In July, the 15,000th U.S. patient was treated with Impella.

 

   

The Company has also received written notification that the U.S. Food and Drug Administration (FDA) has reviewed Abiomed’s proposed premarket approval application (PMA) Shell for modular review of the Impella 2.5 System. The FDA has confirmed that the Agency agrees with Abiomed’s proposed Shell and that the company may begin submitting modules.

“We are on track to achieve our fiscal year revenue guidance and set new records in patient utilization. We are investing for success in our training, regulatory approvals and product portfolio,” said Michael R. Minogue, Chairman, President and Chief Executive Officer of Abiomed. “We are pleased to report today that the FDA has recently approved our PMA Shell for our Impella modular submission.”

The Company is maintaining its fiscal year 2014 revenue guidance in a range of $180 million to $185 million, with worldwide Impella revenue forecasted to increase by approximately 20%. The Company is revising its fiscal year 2014 GAAP operating margin guidance, now expected to be approximately breakeven to 5% (from its prior guidance of operating margin of 7% to 8%) due to legal costs, regulatory submissions, pipeline development, and stock compensation expense.

The Company will host a conference call to discuss the first quarter fiscal year 2014 results on Thursday, August 1, 2013, 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 a.m. ET August 1, 2013 through 11:59 p.m. ET on August 8, 2013. The replay phone number is (855) 859-2056; the international number is (404) 537-3406. The replay access code is 17314885.

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, 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. 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 Genzler

Corporate Communications Manager

978-646-1553

ir@abiomed.com


Abiomed, Inc. and Subsidiaries

Consolidated Balance Sheets

(Unaudited)

(in thousands, except share data)

 

     June 30,
2013
    March 31,
2013
 
     (unaudited)        

ASSETS

    

Current assets:

    

Cash and cash equivalents

   $ 11,727      $ 9,451   

Short-term marketable securities

     55,725        67,256   

Accounts receivable, net

     20,983        22,946   

Inventories

     16,513        14,930   

Prepaid expenses and other current assets

     1,737        2,022   
  

 

 

   

 

 

 

Total current assets

     106,685        116,605   

Long-term marketable securities

     20,588        11,406   

Property and equipment, net

     6,479        6,549   

Goodwill

     35,932        35,410   

Other assets

     779        29   
  

 

 

   

 

 

 

Total assets

   $ 170,463      $ 169,999   
  

 

 

   

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

    

Current liabilities:

    

Accounts payable

   $ 6,270      $ 7,696   

Accrued expenses

     12,829        15,162   

Deferred revenue

     3,993        4,198   
  

 

 

   

 

 

 

Total current liabilities

     23,092        27,056   

Long-term deferred tax liability

     5,781        5,554   

Other long-term liabilities

     285        309   
  

 

 

   

 

 

 

Total liabilities

     29,158        32,919   
  

 

 

   

 

 

 

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

     401        397   

Authorized - 100,000,000 shares; Issued - 40,218,485 shares at June 30, 2013 and 39,788,383 shares at March 31, 2013;

    

Outstanding - 39,012,118 shares at June 30, 2013 and 38,601,384 shares at March 31, 2013

    

Additional paid in capital

     420,674        414,810   

Accumulated deficit

     (259,984     (258,261

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

     (16,554     (16,129

Accumulated other comprehensive loss

     (3,232     (3,737
  

 

 

   

 

 

 

Total stockholders’ equity

     141,305        137,080   
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 170,463      $ 169,999   
  

 

 

   

 

 

 


Abiomed, Inc. and Subsidiaries

Consolidated Statements of Operations

(Unaudited)

(in thousands, except share data)

 

     Three Months Ended
June 30,
 
     2013     2012  

Revenue:

    

Product revenue

   $ 42,609      $ 38,647   

Funded research and development

     61        136   
  

 

 

   

 

 

 
     42,670        38,783   
  

 

 

   

 

 

 

Costs and expenses:

    

Cost of product revenue

     8,723        7,446   

Research and development

     7,287        6,712   

Selling, general and administrative

     27,967        20,953   

Amortization of intangible assets

     —          111   
  

 

 

   

 

 

 
     43,977        35,222   
  

 

 

   

 

 

 

Income (loss) from operations

     (1,307     3,561   
  

 

 

   

 

 

 

Other expense:

    

Investment income (expense), net

     16        (2

Other expense, net

     (21     (4
  

 

 

   

 

 

 
     (5     (6
  

 

 

   

 

 

 

Income (loss) before income tax provision

     (1,312     3,555   

Income tax provision

     411        436   
  

 

 

   

 

 

 

Net income (loss)

   $ (1,723   $ 3,119   
  

 

 

   

 

 

 

Basic net income (loss) per share

   $ (0.04   $ 0.08   

Basic weighted average shares outstanding

     38,678        39,144   

Diluted net income (loss) per share

   $ (0.04   $ 0.08   

Diluted weighted average shares outstanding

     38,678        41,549