-----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, KhbhQDbl42SvGeMaR+eqT+d5v/SvLhMMs/c03tr4ozjRVFvRnk2192/a/2NHTRCG 9LO0gpjC/gZlVorst32WsA== 0001193125-09-019410.txt : 20090205 0001193125-09-019410.hdr.sgml : 20090205 20090205073452 ACCESSION NUMBER: 0001193125-09-019410 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20090205 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20090205 DATE AS OF CHANGE: 20090205 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: 09569977 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: February 5, 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 February 5, 2009 we issued a press release reporting our financial results for our third quarter ended December 31, 2008. 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 February 5, 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: February 5, 2009


Exhibit Index

 

Exhibit
Number

 

Description

99.1   Press release dated February 5, 2009.
EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

LOGO

ABIOMED ANNOUNCES REVENUE OF $17.3 MILLION, REPRESENTING 8%

GROWTH FOR THIRD QUARTER OF FISCAL 2009

 

   

Impella Revenue of $8.9 Million, Increased by 112%, Legacy Business Decreased by 29%

 

   

Net Cash Used for Operating Activities of $2.5M

DANVERS, Mass.— February 5, 2009 — Abiomed, Inc. (NASDAQ: ABMD), a leading provider of heart recovery products providing circulatory support to acute heart failure patients, today announced third quarter of fiscal 2009 revenue of $17.3 million, up 8% compared to revenue of $16.0 million for the same period of fiscal 2008. Revenue for the nine months ended December 31, 2008 was $53.6 million, up 29% compared to revenue of $41.4 million in the first nine months of fiscal 2008.

 

   

As of December 31, 2008, 163 U.S. hospitals had purchased Impella 2.5 for commercial 510(k) use, as compared to 108 hospitals that had purchased Impella 2.5 by the end of the prior quarter, a 51% increase.

 

   

Total Impella revenue was $8.9 million, up 112% for the third fiscal quarter of 2009 compared to the same period of fiscal 2008.

 

   

Impella revenue recorded during the third fiscal quarter of 2009 included $7.3 million in U.S. sales, of which $6.7 million was for sales of Impella 2.5 sold under 510(k) clearance as compared to $6.2 million from the second quarter of fiscal 2009, representing an 8% sequential growth. Fiscal third quarter revenues of $0.6 million sold under the Protect II and Recover II trials compared to $2.6 million in the second quarter of fiscal 2009.

 

   

As of December 31, 2008, 85 U.S. hospitals are enrolling patients in the Protect II study for high-risk percutaneous coronary intervention (PCI) and 18 hospitals had submitted to the IRB or submission was pending. Overall, 180 patients from 49 hospitals were completed or 28% of the 654 patients required.

 

   

The assumptions for the Protect II major adverse event rate (MAE) are 20 and 30% for Impella and IABP respectively. At the Transcatheter Cardiovascular Therapeutics (TCT) Conference in October 2008, the Protect II Primary Investigator, William W. O’Neill, M.D., University of Miami Health System, stated that the initial aggregate adverse event rates for the trial are tracking in line with the 25% expected rate at 20% completion of the study.

 

   

As of December 31, 2008, one patient has been enrolled out of the seven U.S. hospitals that were enrolling patients in the Impella 2.5 Recover II study for acute myocardial infarction (AMI), 10 sites have IRB approval and not yet ready to enroll, and 24 sites have submitted for IRB approval.

 

 

 

Total non-Impella business revenue (BVS® 5000, AB5000®, iPulseTM, intra-aortic balloon or IAB, AbioCor®, service and other) was $8.4 million for the third fiscal quarter of 2009 and decreased $3.4 million or approximately 29% compared to the same period of fiscal 2008.

 

   

A total of 771 pumps were shipped during the quarter (excluding IAB disposables) as compared to 676 in the third quarter of fiscal 2008, representing a 14% increase in the number of units shipped. Total disposables, service and other revenue (non-console revenue) comprised approximately 93% of total revenue for third quarter of fiscal 2009.


LOGO

 

   

Gross margin for the third quarter of fiscal 2009 was 74% compared to 76% for the same period of fiscal 2008.

 

   

The third quarter of fiscal 2009 GAAP net loss was $7.7 million or $0.21 per share, down from a GAAP net loss of $8.3 million or $0.26 per share during the third quarter of fiscal 2008. Third quarter fiscal 2009 GAAP net loss included stock-based compensation expense of $1.9 million and intangibles amortization of $0.4 million. Fiscal 2008 GAAP net loss included stock-based compensation expense of $1.4 million and intangibles amortization of $0.4 million.

 

   

The non-GAAP net loss, excluding stock-based compensation and intangibles amortization expense, for the third quarter of fiscal 2009 was approximately $5.4 million, or $0.15 per share, a decrease compared to the non-GAAP net loss for the third quarter of fiscal 2008 which was $6.5 million, or $0.20 per share.

 

   

The net cash used for operating activities for the third quarter of fiscal 2009 was $2.5 million, which included a $1.9 million loss on the Columbia Fund Investment. At December 31, 2008, the Company had cash and short-term marketable securities of $63.8 million.

“Impella 2.5 is now at 76% of the top 50 heart hospitals listed in the US World & News Report, after six months of 510(k) clearance, “ said Michael R. Minogue, Chairman, President and Chief Executive Officer, Abiomed. “In addition to our ongoing Impella momentum and customer adoption, we have significantly reduced our cash burn this quarter.”

For the fiscal year 2009, the Company believes worldwide revenues will be at the lower end of the previously guided range of $75-80 million.

The Company will host a conference call today at 8 a.m. ET to discuss its third quarter of fiscal 2009 results and provide an update on the Impella launch and trials. 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 866.356.4279; the international number is 617.597.5394. The access participant code is 37762794. A replay of this conference call will be available beginning at 10 a.m. ET on February 5, 2009 through 11:59 p.m. ET on February 19, 2009. The replay phone number is 888.286.8010; the international number is 617.801.6888. The replay access code is 72392957.

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 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


LOGO

 

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

(in thousands, except share data)

 

     December 31, 2008     March 31, 2008  
     (Unaudited)        

ASSETS

    

Current assets:

    

Cash and cash equivalents

   $ 2,734     $ 2,042  

Short-term marketable securities

     61,046       36,257  

Accounts receivable, net

     14,170       14,071  

Inventories

     17,776       17,428  

Prepaid expenses and other current assets

     666       1,705  
                

Total current assets

     96,392       71,503  

Property and equipment, net

     7,649       7,551  

Intangible assets, net

     4,982       6,921  

Goodwill

     32,731       31,563  

Other assets

     357       493  
                

Total assets

   $ 142,111     $ 118,031  
                

LIABILITIES AND STOCKHOLDERS’ EQUITY

    

Current liabilities:

    

Accounts payable

   $ 3,947     $ 9,024  

Accrued expenses

     8,456       9,290  

Deferred revenue

     1,210       1,162  
                

Total current liabilities

     13,613       19,476  

Long-term deferred tax liability

     1,894       4,740  

Other long-term liabilities

     260       221  
                

Total liabilities

     15,767       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

     368       328  

Authorized - 100,000,000 shares;

    

Issued - 36,737,462 shares at December 31, 2008 and 32,779,404 shares at March 31, 2008;

    

Outstanding - 36,686,508 shares at December 31, 2008 and 32,768,385 shares at March 31, 2008

    

Additional paid-in-capital

     360,120       300,787  

Accumulated deficit

     (235,537 )     (212,394 )

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

     (827 )     (116 )

Accumulated other comprehensive income

     2,220       4,989  
                

Total stockholders’ equity

     126,344       93,594  
                

Total liabilities and stockholders’ equity

   $ 142,111     $ 118,031  
                


LOGO

 

ABIOMED, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except per share data)

 

     Three Months Ended
December 31,
    Nine Months Ended
December 31,
 
     2008     2007     2008     2007  

Revenue:

        

Product

   $ 17,081     $ 15,826     $ 53,128     $ 40,999  

Funded research and development

     190       189       499       435  
                                

Total Revenue

     17,271       16,015       53,627       41,434  
                                

Costs and expenses:

        

Cost of product revenue excluding amortization of intangibles

     4,519       3,773       14,939       10,182  

Research and development

     5,203       6,883       18,197       18,231  

Selling, general and administrative

     13,227       13,540       40,639       38,239  

Arbitration decision

     —         —         —         1,206  

Amortization of intangible assets

     362       403       1,199       1,169  
                                
     23,311       24,599       74,974       69,027  
                                

Loss from operations

     (6,040 )     (8,584 )     (21,347 )     (27,593 )
                                

Other income and expense:

        

Investment (expense) income, net

     (1,709 )     611       (1,508 )     2,320  

Gain on sale of WorldHeart stock

     313       —         313       —    

Change in fair value of WorldHeart note receivable and warrant

     —         589       —         589  

Other expense, net

     (81 )     (750 )     (1 )     (817 )
                                
     (1,477 )     450       (1,196 )     2,092  
                                

Loss before provision for income taxes

     (7,517 )     (8,134 )     (22,543 )     (25,501 )

Provision for income taxes

     182       167       600       457  
                                

Net loss

   $ (7,699 )   $ (8,301 )   $ (23,143 )   $ (25,958 )
                                

Basic and diluted net loss per share

   $ (0.21 )   $ (0.26 )   $ (0.67 )   $ (0.80 )

Weighted average shares outstanding

     36,051       32,488       34,470       32,415  
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-----END PRIVACY-ENHANCED MESSAGE-----