-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, PlpU54UWWwTcMnZmQfQDNpGR8CuqVRRt0gCD2LbZSbDmZxOqJXwKjxmPYPdM42rB e6cae7tpw15jrwgCUnil7A== 0001193125-09-108027.txt : 20090512 0001193125-09-108027.hdr.sgml : 20090512 20090512090945 ACCESSION NUMBER: 0001193125-09-108027 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20090512 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20090512 DATE AS OF CHANGE: 20090512 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ABIOMED INC CENTRAL INDEX KEY: 0000815094 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 042743260 STATE OF INCORPORATION: DE FISCAL YEAR END: 0331 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-09585 FILM NUMBER: 09817190 BUSINESS ADDRESS: STREET 1: 22 CHERRY HILL DR CITY: DANVERS STATE: MA ZIP: 01923 BUSINESS PHONE: 9787775410 MAIL ADDRESS: STREET 1: 22 CHERRY HILL DRIVE CITY: DANVERS STATE: MA ZIP: 01923 8-K 1 d8k.htm FORM 8-K Form 8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934

Date of Report: May 12, 2009

(Date of earliest event reported)

 

 

ABIOMED, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   04-2743260

(State or other Jurisdiction

of Incorporation)

 

(IRS Employer

Identification Number)

0-20584

(Commission File Number)

22 Cherry Hill Drive

Danvers, MA 01923

(Address of Principal Executive Offices, including Zip Code)

(978) 646-1400

(Registrant’s Telephone Number, including Area Code)

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)

 

 

 


Item 2.02 Results of Operations and Financial Condition.

On May 12, 2009 we issued a press release reporting our unaudited financial results for our fourth quarter and fiscal year ended March 31, 2009. A copy of the press release is set forth as exhibit 99.1 and is incorporated herein by reference. The information contained in this report shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Securities Act of 1934, whether made before or after the date hereof and regardless of any general incorporation language in such filing, except as expressly set forth by specific reference in such filing.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit

 

Description

99.1   Press release dated May 12, 2009.


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

Abiomed, Inc.
By:  

/s/ Robert L. Bowen

  Robert L. Bowen
  Vice President and Chief Financial Officer
  (Principal Accounting and Financial Officer)

Date: May 12, 2009


Exhibit Index

 

Exhibit

Number

 

Description

99.1   Press release dated May 12, 2009.
EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

LOGO

ABIOMED ANNOUNCES FISCAL FOURTH QUARTER REVENUE OF $19.6 MILLION

AND RECORD IMPELLA® REVENUE UP 124% TO $11.2 MILLION

 

   

261 U.S. Patients Treated With Impella 2.5 During Fourth Quarter of Fiscal 2009, Up 63% Sequentially, With Over 500 U.S. Patients Treated Since 510(k);

 

   

Full Year Fiscal 2009 Worldwide Impella Revenue of $36.4 Million, Up 196%

DANVERS, Mass. — May 12, 2009 – Abiomed, Inc. (NASDAQ: ABMD), a leading provider of breakthrough heart support technologies, today announced fourth quarter of fiscal 2009 revenue of $19.6 million, up 12% compared to revenue of $17.5 million for the fourth quarter of fiscal 2008, and up 13% sequentially, compared to revenue of $17.3 million for the third quarter of fiscal 2009.

Total revenue for the twelve months ended March 31, 2009, was $73.2 million, up 24% compared to revenue of $58.9 million for the full year fiscal 2008. Full year fiscal 2009 worldwide Impella revenue was $36.4 million, up 196% compared to Impella revenue of $12.3 million for the full year fiscal 2008.

Recent financial and operating highlights during the fourth quarter of fiscal 2009 include:

 

   

Worldwide Impella revenue was $11.2 million, up 124% compared to revenue of $5.0 million for the fourth quarter of fiscal 2008 and up 26% sequentially, compared to revenue of $8.9 million for the third quarter of fiscal 2009.

 

   

Impella U.S. revenue totaled $9.9 million, of which $9.1 million was for sales of Impella 2.5 under 510(k) clearance, up 36% sequentially, compared to revenue of $6.7 million for the third quarter of fiscal 2009.

 

   

Approximately 261 U.S. patients were treated with Impella 2.5 under the 510(k) clearance, up 63% from approximately 160 patients treated in the third quarter and up 161% from approximately 100 patients treated within the first four months after the 510(k) clearance in June 2008. For the full year fiscal 2009, approximately 521 U.S. patients were supported with Impella 2.5 under the 510(k) clearance.

 

   

During the quarter, over 50% of total Impella 2.5 510(k) revenue was from reorders and reorder rates exceeded 80% of patient utilization.

 

   

An additional 66 U.S. hospitals purchased Impella 2.5 for general use, bringing the total to 229 general use customers or 14% of potential 1,700 U.S. hospitals with catheterization labs (cath labs). The average order for new Impella sites was three disposable units.

 

   

A total of 95 hospitals are participating in the Protect II study and 43 patients were enrolled, for a total of 223 patients completed in the Protect II study, or 34% of the 654 patients required.

 

   

Legacy revenue was $8.4 million, 33% lower than the fourth quarter of fiscal 2008. The fourth quarter of fiscal 2008 legacy revenue included $1.3 million in revenues from the initial hospital start-up of the AbioCor.

 

 

 

On March 30, 2009, Abiomed announced it had received U.S. Food and Drug Administration (FDA) approval of its Premarket Approval Application (PMA) supplement for the AB Portable™ Driver. Additionally, on April 22, 2009, Abiomed announced that it had received U.S. Food and Drug Administration (FDA) 510(k) clearance of its Impella® 5.0 and Impella® LD Circulatory Support Devices.


LOGO

 

   

The GAAP net loss was $8.5 million, or a loss of $0.23 per fully diluted share, compared to a GAAP net loss of $15.0 million, or a loss of $0.46 per fully diluted share during the fourth quarter of fiscal 2008. The full year fiscal 2009 GAAP net loss was $31.6 million, or a loss of $0.91 per fully diluted share, compared to a GAAP net loss of $40.9 million, or a loss of $1.26 per fully diluted share for the full year fiscal 2008.

 

   

The non-GAAP net loss for the fourth quarter of fiscal 2008, after excluding stock-based compensation expense of $1.8 million, intangibles amortization expense of $0.4 million, was $6.3 million, or a loss of $0.17 per fully diluted share, compared to the non-GAAP net loss for the fourth quarter of fiscal 2008, after excluding stock-based compensation expense of $1.1 million, intangibles amortization of $0.4 million, and a non-cash charge of $5.6 million for the change in fair value of the Company’s note receivable from World Heart Corporation, which was $7.9 million, or a loss of $0.24 per fully diluted share. The non-GAAP net loss for the full fiscal year 2009, after excluding stock-based compensation expense of $8.8 million and intangibles amortization of $1.6 million, was $21.2 million, or a loss of $0.61 per fully diluted share, compared to the non-GAAP net loss for the full fiscal year 2008, after excluding stock-based compensation expense of $5.4 million, intangibles amortization of $1.6 million, a litigation settlement of $1.2 million, and a non-cash charge of $5.0 million for the change in the fair value of the Company’s note receivable from World Heart Corporation, which was $27.7 million, or a loss of $0.85 per fully diluted share.

 

   

Cash, cash equivalents plus short and long-term marketable securities totaled $60.9 million compared to $63.8 million at December 31, 2008.

“Fiscal 2009 showcased the U.S. market demand for Impella 2.5 minimally invasive heart recovery technology, demonstrated by its rapid adoption and utilization, during a difficult financial time for our customers,” said Michael R. Minogue, Chairman, President and Chief Executive Officer of Abiomed. “We quickly surpassed our fiscal 2009 goal of penetrating 100 hospitals and supporting 100 patients by reaching 229 hospital sites and 521 patients in ten months. In addition, we reduced the cash burn, raised additional funds, and executed on our U.S. regulatory path with four new product introductions over the last 12 months. In fiscal 2010, we are focused on growing shareholder value by further increasing Impella utilization and expanding its clinical utility.”

The Company will host a conference call on Monday, May 18, 2009 at 8 a.m. ET to discuss its fourth quarter of fiscal 2009 results and fiscal 2010 guidance. Michael R. Minogue, Chairman, Chief Executive Officer and President, 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 800.798.2864; the international number is 617.614.6206. The access participant code is 92860386. A replay of this conference call will be available beginning at 11 a.m. ET on May 18, 2009 through 11:59 p.m. ET on June 1, 2009. The replay phone number is 888.286.8010; the international number is 617.801.6888. The replay access code is 89776134.

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 loss and net loss per share, in each case excluding, where appropriate, stock option expense, and intangibles amortization. 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


LOGO

 

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 option and other 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 and above, these 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, 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:

Aimee Maillett

Public Relations Specialist

978-646-1553

ir@abiomed.com

###

Abiomed, Impella, iPulse, BVS5000, AB5000, AbioCor and the Abiomed logo are all trademarks of Abiomed. Other company and product names may be trademarks of their respective owners.


LOGO

Abiomed, Inc. and Subsidiaries

Condensed Consolidated Balance Sheets

(Unaudited)

(in thousands, except share data)

 

     March 31,  
     2009     2008  

ASSETS

    

Current assets:

    

Cash and cash equivalents

   $ 1,785     $ 2,042  

Short-term marketable securities

     55,394       36,257  

Accounts receivable, net

     15,724       14,071  

Inventories

     14,777       17,428  

Prepaid expenses and other current assets

     809       1,705  
                

Total current assets

     88,489       71,503  

Property and equipment, net

     7,792       7,551  

Intangible assets, net

     4,359       6,921  

Goodwill

     31,295       31,563  

Long-term marketable securities

     3,721       —    

Other assets

     302       493  
                

Total assets

   $ 135,958     $ 118,031  
                

LIABILITIES AND STOCKHOLDERS’ EQUITY

    

Current liabilities:

    

Accounts payable

   $ 5,550     $ 9,024  

Accrued expenses

     10,818       9,290  

Deferred revenue

     1,211       1,162  
                

Total current liabilities

     17,579       19,476  

Long-term deferred tax liability

     2,086       4,740  

Other long-term liabilities

     310       221  
                

Total liabilities

     19,975       24,437  
                

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

     367       328  

Authorized - 100,000,000 shares; Issued - 36,736,843 shares at March 31, 2009 and 32,779,404 shares at March 31, 2008;

    

Outstanding - 36,685,889 shares at March 31, 2009 and 32,768,385 shares at March 31, 2008

    

Additional paid-in-capital

     362,125       300,787  

Accumulated deficit

     (243,991 )     (212,394 )

Treasury stock at cost - 50,954 at March 31, 2009 and 11,019 shares at March 31, 2008

     (827 )     (116 )

Accumulated other comprehensive (loss) income

     (1,691 )     4,989  
                

Total stockholders’ equity

     115,983       93,594  
                

Total liabilities and stockholders’ equity

   $ 135,958     $ 118,031  
                


LOGO

Abiomed, Inc. and Subsidiaries

Condensed Consolidated Statements of Operations

(Unaudited)

(in thousands, except per share data)

 

     Three Months Ended
March 31,
    Twelve Months Ended
March 31,
 
     2009     2008     2009     2008  

Revenue:

        

Product

   $ 19,384     $ 17,323     $ 72,512     $ 58,322  

Funded research and development

     199       184       698       619  
                                

Total Revenue

     19,583       17,507       73,210       58,941  
                                

Costs and expenses:

        

Cost of product revenue excluding amortization of intangibles

     5,498       4,883       20,437       15,065  

Research and development

     7,131       6,686       25,328       24,917  

Selling, general and administrative

     14,718       14,419       55,357       52,658  

Arbitration decision

     —         —         —         1,206  

Amortization of intangible assets

     407       413       1,606       1,582  
                                
     27,754       26,401       102,728       95,428  
                                

Loss from operations

     (8,171 )     (8,894 )     (29,518 )     (36,487 )
                                

Other income and expense:

        

Investment (expense) income, net

     104       (695 )     (1,404 )     1,625  

Gain on sale of WorldHeart stock

     0       —         313       —    

Change in fair value of WorldHeart note receivable and warrant

     —         (5,589 )     —         (5,000 )

Other expense, net

     (235 )     276       (236 )     (541 )
                                
     (131 )     (6,008 )     (1,327 )     (3,916 )
                                

Loss before provision for income taxes

     (8,302 )     (14,902 )     (30,845 )     (40,403 )

Provision for income taxes

     152       70       752       527  
                                

Net loss

   $ (8,454 )   $ (14,972 )   $ (31,597 )   $ (40,930 )
                                

Basic and diluted net loss per share

   $ (0.23 )   $ (0.46 )   $ (0.91 )   $ (1.26 )

Weighted average shares outstanding

     36,142       32,612       34,882       32,465  
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-----END PRIVACY-ENHANCED MESSAGE-----