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8-K - FORM 8-K - ABIOMED INCd462649d8k.htm

Exhibit 99.1

 

LOGO

ABIOMED ANNOUNCES Q2 FY 2018 REVENUE OF $132.8 MILLION, UP 29% AND RECORD U.S.

PATIENT UTILIZATION, UP 33%

DANVERS, Mass. — October 26, 2017Abiomed, Inc. (NASDAQ: ABMD), a leading provider of breakthrough heart support technologies, today reported second quarter fiscal 2018 revenue of $132.8 million, an increase of 29% compared to revenue of $103.0 million for the same period of fiscal 2017. Second quarter fiscal 2018 GAAP net income was $24.5 million or $0.54 per diluted share, compared to GAAP net income of $8.9 million or $0.20 per diluted share for the prior year period.

Financial and operating highlights during the second quarter of fiscal 2018 include:

 

    Worldwide revenue from Impella heart pumps totaled $127.4 million, an increase of 30% compared to revenue of $97.9 million during the same period of the prior year. U.S. revenue from Impella pumps grew 27% to $113.6 million and U.S. patient usage grew 33%.

 

    Outside the U.S., revenue from Impella heart pumps totaled $13.8 million and was up 61%, predominantly from Germany, which grew 64% in revenue from the prior year with record number of patients.

 

    The installed base for Impella 2.5® heart pumps in the U.S. grew by an additional 17 hospitals, which made initial purchases of Impella heart pumps, bringing the installed customer base to 1,171 sites. The installed customer base for Impella CP® heart pumps grew by 31 new U.S. hospitals, bringing the total number of Impella CP sites to 1,093. The installed customer base for Impella 5.0® heart pumps grew by 12 new U.S. hospitals, bringing the total number of Impella 5.0 sites to 484.

 

    An additional 44 sites made initial purchases of Impella RP® heart pumps during the quarter, bringing the total number of sites to 186.

 

    Gross margin of 84% compared to 83% of the prior year.

 

    Operating income was $31.7 million, or 24% operating margin, compared to $14.5 million, or 14% operating margin in the prior year.

 

    GAAP net income was $24.5 million or $0.54 per diluted share, which benefited from a new accounting standard that required $4.5 million, or $0.10 per diluted share, of excess tax benefits related to employee share-based compensation awards be recorded as a reduction of income tax expense. This compared to GAAP net income of $8.9 million or $0.20 per diluted share for the prior year, before the new accounting standard.

 

    The Company generated $30.1 million in cash, cash equivalents and marketable securities, totaling $319.2 million as of September 30, 2017, compared to $289.1 million at June 30, 2017. The Company currently has no debt.

 

    On September 20, 2017, Abiomed received FDA PMA approval for the Impella RP heart pump. With this approval, the Impella RP heart pump is the only percutaneous temporary ventricular support device that is FDA-approved as safe and effective for right heart failure.


    Today, Abiomed announced in a separate press release the first patient treated with Impella® heart pump in Japan. The Impella 2.5 and Impella 5.0 heart pumps are approved for the treatment of drug-resistant acute heart failure and are the first and only percutaneous temporary ventricular support devices approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan.

“This quarter, we set new records for supporting patients in the U.S. and Germany and we continue to observe improved clinical outcomes with our education and training initiatives,” said Michael R. Minogue, Chairman, President and Chief Executive Officer, Abiomed. “I am proud of the team’s ability to consistently adapt and execute as we transform the standard of care and build the Field of Heart Recovery.”

FISCAL YEAR 2018 OUTLOOK

The Company is again increasing the lower end of its fiscal year 2018 revenue guidance by $5 million to a new range of $565 million to $575 million, an increase in revenue of 27% to 29% from the prior year. This compares to the Company’s initial forecast of $555 million to $575 million and a 25% to 29% increase from the prior year. The Company is also increasing its fiscal year guidance for GAAP operating margin to the range of 23% to 25%, from 22% to 24%.

CONFERENCE CALL

The Company will host a conference call to discuss the results on Thursday, October 26, 2017, at 8:00 a.m. EDT. Michael R. Minogue, Chairman, President and Chief Executive Officer and Robert L. Bowen, former 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 October 26, 2017 through 11:00 a.m. EDT on October 29, 2017. The replay phone number is (855) 859-2056; the international number is (404) 537-3406. The replay access code is 95924236.

The ABIOMED logo, ABIOMED, Impella, Impella CP, and Impella RP are registered trademarks of Abiomed, Inc. in the U.S. and in certain foreign countries. Impella 2.5, Impella 5.0, and Recovering hearts. Saving lives. are trademarks of Abiomed, Inc.

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.


For further information please contact:

Ingrid Goldberg,

Director, Investor Relations

978-646-1590

ir@abiomed.com


Abiomed, Inc. and Subsidiaries

Consolidated Balance Sheets

(Unaudited)

(in thousands, except share data)

 

     September 30, 2017     March 31, 2017  

ASSETS

    

Current assets:

    

Cash and cash equivalents

   $ 44,536     $ 39,040  

Short-term marketable securities

     218,661       190,908  

Accounts receivable, net

     57,327       54,055  

Inventories

     40,632       34,931  

Prepaid expenses and other current assets

     9,014       8,024  
  

 

 

   

 

 

 

Total current assets

     370,170       326,958  

Long-term marketable securities

     55,954       47,143  

Property and equipment, net

     97,697       87,777  

Goodwill

     34,332       31,045  

In-process research and development

     16,016       14,482  

Long-term deferred tax assets, net

     106,798       34,723  

Other assets

     13,686       8,286  
  

 

 

   

 

 

 

Total assets

   $ 694,653     $ 550,414  
  

 

 

   

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

    

Current liabilities:

    

Accounts payable

   $ 16,667     $ 20,620  

Accrued expenses

     35,256       37,703  

Deferred revenue

     10,584       10,495  

Current portion of capital lease obligation

     851       799  
  

 

 

   

 

 

 

Total current liabilities

     63,358       69,617  

Other long-term liabilities

     598       3,251  

Contingent consideration

     9,835       9,153  

Long-term deferred tax liabilities

     866       783  

Capital lease obligation, net of current portion

     15,110       15,539  
  

 

 

   

 

 

 

Total liabilities

     89,767       98,343  
  

 

 

   

 

 

 

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

     442       437  

Authorized—100,000,000 shares; Issued—45,921,029 shares at September 30, 2017 and 45,249,281 shares at March 31, 2017

    

Outstanding—44,200,784 shares at September 30, 2017 and 43,673,286 shares
at March 31, 2017

    

Additional paid in capital

     592,081       565,962  

Retained earnings (accumulated deficit)

     90,164       (46,959

Treasury stock at cost—1,720,245 shares at September 30, 2017 and 1,575,995 shares at March 31, 2017

     (65,999     (46,763

Accumulated other comprehensive loss

     (11,802     (20,606
  

 

 

   

 

 

 

Total stockholders’ equity

     604,886       452,071  
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 694,653     $ 550,414  
  

 

 

   

 

 

 


Abiomed, Inc. and Subsidiaries

Consolidated Statements of Operations

(Unaudited)

(in thousands, except per share data)

 

     Three Months Ended
September 30,
    Six Months Ended
September 30,
 
     2017     2016     2017      2016  

Revenue:

         

Product revenue

   $ 132,782     $ 102,928     $ 265,213      $ 205,917  

Funded research and development

     41       27       78        33  
  

 

 

   

 

 

   

 

 

    

 

 

 
     132,823       102,955       265,291        205,950  
  

 

 

   

 

 

   

 

 

    

 

 

 

Costs and expenses:

         

Cost of product revenue

     21,627       17,309       43,489        32,379  

Research and development

     19,390       18,052       36,321        33,712  

Selling, general and administrative

     60,080       53,086       120,677        104,118  
  

 

 

   

 

 

   

 

 

    

 

 

 
     101,097       88,447       200,487        170,209  
  

 

 

   

 

 

   

 

 

    

 

 

 

Income from operations

     31,726       14,508       64,804        35,741  
  

 

 

   

 

 

   

 

 

    

 

 

 

Other income:

         

Investment income, net

     781       342       1,416        611  

Other (expense) income, net

     (23     (114     56        (191
  

 

 

   

 

 

   

 

 

    

 

 

 
     758       228       1,472        420  
  

 

 

   

 

 

   

 

 

    

 

 

 

Income before income taxes

     32,484       14,736       66,276        36,161  

Income tax provision (1)

     7,981       5,861       4,399        14,376  
  

 

 

   

 

 

   

 

 

    

 

 

 

Net income

   $ 24,503     $ 8,875     $ 61,877      $ 21,785  
  

 

 

   

 

 

   

 

 

    

 

 

 

Basic net income per share

   $ 0.56     $ 0.21     $ 1.41      $ 0.51  

Basic weighted average shares outstanding

     44,141       43,129       44,018        42,971  

Diluted net income per share (2)

   $ 0.54     $ 0.20     $ 1.36      $ 0.49  

Diluted weighted average shares outstanding

     45,698       44,580       45,655        44,493  

(1) Income tax provision includes the effect of the following item:

         

Excess tax benefits related to stock-based compensation awards *

   $ 4,434     $ —       $ 21,276      $ —    

(2) Diluted net income per share includes the effect of the following item:

         

Excess tax benefits related to stock-based compensation awards *

   $ 0.10     $ —       $ 0.47      $ —    

 

* In the first quarter of fiscal 2018, the Company adopted Accounting Standards Update No. 2016-09, Improvements to Employee Share-Based Payment Accounting, which requires that all excess tax benefits and tax deficiencies related share-based compensation arrangements be recognized as income tax benefit or expense, instead of in stockholders’ equity as previous guidance required.