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8-K - 8-K - ABIOMED INCd913701d8k.htm

Exhibit 99.1

 

 

LOGO

ABIOMED ANNOUNCES RECORD REVENUE OF $67.6 MILLION, UP 34% AND U.S. PATIENT

GROWTH UP 42% IN FISCAL FOURTH QUARTER 2015

 

    Total Year Revenue of $230.3 Million, Up 25% Over the Prior Year

DANVERS, Mass. — May 5, 2015 Abiomed, Inc. (NASDAQ: ABMD), a leading provider of breakthrough heart support technologies, today reported fiscal fourth quarter 2015 revenue of $67.6 million, up 34% compared to revenue of $50.4 million in the same period of fiscal 2014, and a fiscal fourth quarter 2015 GAAP net income of $98.9 million, or $2.24 per diluted share, compared to $3.6 million, or $0.09 per diluted share, in the prior year period.

Fiscal fourth quarter GAAP income from operations totaled $12.4 million, up 235% compared to $3.7 million in the prior year. GAAP net income included an income tax benefit of $86.5 million largely due to the release of the valuation allowance on most of Abiomed’s deferred tax assets. The release of the valuation allowance is a onetime accounting adjustment with the offset recorded on the balance sheet as short and long term deferred tax assets based on the Company’s estimates of sustainable profitability.

For fiscal year 2015, total revenue was $230.3 million, up 25% compared to revenue of $183.6 million in fiscal year 2014. GAAP net income was $113.7 million or $2.65 per diluted share compared with $7.4 million or $0.18 per diluted share in fiscal year 2014.

Financial and operating highlights during the fourth quarter and for the full fiscal year include:

 

    Fiscal fourth quarter worldwide Impella® revenue totaled $63.4 million, an increase of 38% compared to revenue of $46.1 million during the same period of the prior year. Full year worldwide Impella revenue totaled $212.7 million, up 27% compared to $167.0 million for fiscal year 2014.

 

    Fiscal fourth quarter U.S. Impella revenue grew 38% to $57.7 million from $41.8 million in the prior year. Full year U.S. Impella revenue totaled $191.5 million, up 26% compared to $152.0 million in the prior year.

 

    An additional 27 hospitals made initial purchases of Impella during the quarter, compared to 23 new hospital sites in the prior year period, bringing the installed customer base to 958 sites. As part of Abiomed’s continued Impella CP® launch, 57 hospitals purchased Impella CP, bringing the total number of Impella CP U.S. sites to 640, 67% of total Impella sites.

 

    Outside the U.S., fiscal fourth quarter Impella revenue was $5.7 million, an increase of 30% over the prior year.

 

    Gross margin for fiscal fourth quarter 2015 was 84.0% compared to 79.9% in the fourth quarter of fiscal 2014. For the full fiscal year, gross margin was 82.7% compared to 79.7% in the prior year. There were 529 Impella AIC consoles placed during fiscal year 2015 compared to 675 in fiscal year 2014.

 

    Fiscal fourth quarter income from operations was $12.4 million, or operating margin of 18.3% compared to $3.7 million, or operating margin of 7.3% in the prior year period. For the full fiscal year, income from operations was $28.7 million or operating margin of 12.4% compared to $8.4 million or operating margin of 4.6% in the prior year.

 

    Cash, cash equivalents, short and long-term marketable securities totaled $146.0 million as of March 31, 2015. The Company has no debt.

 

    On March 23, Abiomed and the FDA announced that the Impella 2.5 had received FDA approval for elective and urgent high risk percutaneous coronary intervention (PCI) procedures, making it the only FDA-approved percutaneous hemodynamic support device determined to be safe and effective for the high risk PCI indication.


“This quarter and fiscal year, Abiomed executed and achieved high growth, regulatory approvals, sustainable profitability and is positioned to address a substantial clinical need as Impella becomes the standard of care,” said Michael R. Minogue, Chairman, President and Chief Executive Officer, Abiomed.

FISCAL YEAR 2016 OUTLOOK

The Company is increasing its fiscal year 2016 guidance for total revenue to be in the range of $285 million to $295 million, an increase of 24% to 28% from the prior year. This new range compares to the previous estimated range of $260 million to $270 million. The Company is also giving its fiscal year guidance for GAAP operating margin to be in the range of 12% to 16%.

CONFERENCE CALL

The Company will host a conference call to discuss the results on Tuesday, May 5, 2015, at 8:00 a.m. EDT. Michael R. Minogue, Chairman, President and Chief Executive Officer; 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 (855) 212-2361; the international number is (678) 809-1538. A replay of this conference call will be available beginning at 11 a.m. EDT May 5, 2015 through 11:59 p.m. EDT on May 7, 2015. The replay phone number is (855) 859-2056; the international number is (404) 537-3406. The replay access code is 5151339.

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 financial guidance for fiscal year 2016. These forward-looking statements may be accompanied by such words as “anticipate,” “believe,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “potential,” “project,” “target,” “will,” and other words and terms of similar meaning. These forward-looking statements include all matters that are not historical facts. 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, commercialization and related regulatory approvals, including the potential for future losses, complex manufacturing, high quality requirements, dependence on limited sources of supply, dependence on Impella products for a significant portion of the Company’s revenue, 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 update or revise 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, whether as a result of new information, future events or otherwise, unless otherwise required by law.


For further information please contact:

Ingrid Goldberg,

Director, Investor Relations

978-646-1590

ir@abiomed.com

Aimee Genzler

Director, Corporate Communications

978-646-1553

agenzler@abiomed.com


Abiomed, Inc. and Subsidiaries

Consolidated Balance Sheets

(Unaudited)

(in thousands, except share data)

 

     March 31, 2015     March 31, 2014  

ASSETS

    

Current assets:

    

Cash and cash equivalents

   $ 22,401     $ 20,916   

Short-term marketable securities

     109,557       55,663   

Accounts receivable, net

     31,828       24,357   

Inventories

     16,774       13,948   

Prepaid expenses and other current assets

     4,479       3,082   

Deferred tax assets, net

     35,100       —     
  

 

 

   

 

 

 

Total current assets

  220,139     117,966   

Long-term marketable securities

  13,996     41,761   

Property and equipment, net

  9,127     6,889   

Goodwill

  31,534     37,990   

In-process research and development

  14,711     —     

Long-term deferred tax assets, net

  45,206     —     

Other assets

  3,654     801   
  

 

 

   

 

 

 

Total assets

$ 338,367   $ 205,407   
  

 

 

   

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

Current liabilities:

Accounts payable

$ 10,389   $ 7,746   

Accrued expenses

  21,894     17,899   

Deferred revenue

  7,036     4,766   
  

 

 

   

 

 

 

Total current liabilities

  39,319     30,411   

Other long-term liabilities

  183     228   

Contingent consideration

  6,510     —     

Long-term deferred tax liabilities

  795     6,415   
  

 

 

   

 

 

 

Total liabilities

  46,807     37,054   
  

 

 

   

 

 

 

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

  413     411   

Authorized - 100,000,000 shares; Issued - 42,618,717 shares at March 31, 2015 and 41,122,695 shares at March 31, 2014;

Outstanding - 41,335,773 shares at March 31, 2015 and 39,916,328 shares at March 31, 2014

Additional paid in capital

  465,046     436,136   

Accumulated deficit

  (137,222 )   (250,910

Treasury stock at cost - 1,282,944 shares at March 31, 2015 and 1,206,367 shares at March 31, 2014

  (19,347 )   (16,554

Accumulated other comprehensive loss

  (17,330 )   (730
  

 

 

   

 

 

 

Total stockholders’ equity

  291,560     168,353   
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

$ 338,367   $ 205,407   
  

 

 

   

 

 

 


Abiomed, Inc. and Subsidiaries

Consolidated Statements of Operations

(Unaudited)

(in thousands, except share data)

 

     Three Months Ended
March 31,
     Year Ended
March 31,
 
     2015     2014      2015     2014  

Revenue:

         

Product revenue

   $ 67,550     $ 50,242       $ 229,950     $ 183,280   

Funded research and development

     7       191         361       363   
  

 

 

   

 

 

    

 

 

   

 

 

 
  67,557     50,433      230,311     183,643   
  

 

 

   

 

 

    

 

 

   

 

 

 

Costs and expenses:

Cost of product revenue

  10,806     10,114      39,945     37,322   

Research and development

  9,853     7,920      35,973     30,707   

Selling, general and administrative

  34,535     28,721      125,727     107,251   
  

 

 

   

 

 

    

 

 

   

 

 

 
  55,194     46,755      201,645     175,280   
  

 

 

   

 

 

    

 

 

   

 

 

 

Income from operations

  12,363     3,678      28,666     8,363   
  

 

 

   

 

 

    

 

 

   

 

 

 

Other income (expense):

Investment income (expense), net

  68     40      196     118   

Other (expense) income, net

  (59 )   44      (97 )   49   
  

 

 

   

 

 

    

 

 

   

 

 

 
  9     84      99     167   
  

 

 

   

 

 

    

 

 

   

 

 

 

Income before provision for income taxes

  12,372     3,762      28,765     8,530   

Income tax (benefit) provision

  (86,502 )   140      (84,923 )   1,179   
  

 

 

   

 

 

    

 

 

   

 

 

 

Net income

$ 98,874   $ 3,622    $ 113,688   $ 7,351   
  

 

 

   

 

 

    

 

 

   

 

 

 

Basic net income per share

$ 2.40   $ 0.09    $ 2.80   $ 0.19   

Basic weighted average shares outstanding

  41,168     39,810      40,632     39,334   

Diluted net income per share

$ 2.24   $ 0.09    $ 2.65   $ 0.18   

Diluted weighted average shares outstanding

  44,049     42,125      42,858     41,606