-----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, NKbzOAXFiEToUNOi3tbIs+gGLTDvRw2RZnNbGIvbcnHO5SsqgypSuJSzrN6IHzO0 l9bdMQpgx9WDJh2uU58jkw== 0001193125-08-169159.txt : 20080807 0001193125-08-169159.hdr.sgml : 20080807 20080807073028 ACCESSION NUMBER: 0001193125-08-169159 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20080807 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080807 DATE AS OF CHANGE: 20080807 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: 08996511 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: August 7, 2008

(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 August 7, 2008, we issued a press release reporting our financial results for our first quarter ended June 30, 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 August 7, 2008.


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/ Daniel J. Sutherby

  Daniel J. Sutherby
  Chief Financial Officer

Date: August 7, 2008

EX-99.1 2 dex991.htm PRESS RELEASE Press Release

EXHIBIT 99.1

(BW)(MA-ABIOMED)(ABMD) Abiomed Announces 16% Revenue Growth to $16.4 Million for First Quarter of Fiscal 2009

 

   

Impella Disposable Revenue Increased 323%

 

   

86 U.S. Hospitals to Date Have Purchased Impella 2.5

 

   

107 Patients Enrolled to Date in Impella 2.5 Protect II Study

Business Editors/Health Editors

DANVERS, Mass.—(BUSINESS WIRE)—xx—Abiomed, Inc. (NASDAQ: ABMD) today announced first quarter of fiscal 2009 revenue of $16.4 million, up 16% compared to revenue of $14.1 million for the same period of fiscal 2008.

Recent financial and operating highlights include:

 

   

On June 2, 2008, Abiomed announced that it had received U.S. Food and Drug Administration (FDA) 510(k) clearance of its Impella(R) 2.5 Cardiac Assist Device. Through August 6, 2008, 56 of the approximately 1,700 U.S. hospitals with catheterization labs have acquired Abiomed’s Impella 2.5 device under the 510(k) clearance and 86 U.S. hospitals have purchased the Impella 2.5 device overall.

 

   

Total Impella revenue was $5.9 million, up 228%, and Impella disposable revenue was $5.5 million, up 323%, for the first fiscal quarter of 2009 compared to the same period of fiscal 2008.

 

   

Total legacy business revenue (BVS(R) 5000, AB5000(R), iPulse(TM), intra-aortic balloon or IAB, AbioCor(R), service and other) was $10.5 million for the first fiscal quarter of 2009 and decreased approximately 15% compared to the same period of fiscal 2008. AB5000 patient utilization during the first quarter of fiscal 2009 was approximately flat with the fourth quarter of fiscal 2008.

 

   

Total disposables, service and other revenue (non-console revenue) comprised approximately 90% of total revenue for first quarter of fiscal 2009. A total of 709 disposable units were shipped during the quarter (excluding IAB disposables).

 

   

Abiomed currently conducting an Impella 2.5 study for high risk percutaneous coronary intervention (PCI) at up to 150 U.S. hospitals (Protect II study). As of August 6, 2008, 187 U.S. hospitals are pursuing the study, with 55 hospitals ready for enrollment of patients, 36 with Investigational Review Board (IRB) approval but not yet enrolling, and 96 hospitals having submitted to the IRB or submission is pending. We have completed 107 patients from 28 hospitals or 16% of the 654 patients required.

 

   

Abiomed’s pivotal study with Impella 2.5 for acute myocardial infarction (AMI) was approved by the FDA for up to 150


 

hospitals (Recover II study). As of August 6, 2008, 53 U.S. hospitals are pursuing the study. No hospitals are enrolling patients yet, however, 4 hospitals have IRB approval, and 49 have submitted to the IRB or submission is pending.

 

   

Based on the recent Centers for Medicare and Medicaid services (CMS) update on August 1, 2008, the BVS 5000 and AB5000 are the only ventricular assist devices (VADs) eligible for diagnostic related group 1 (DRG 1) for heart recovery. Additionally, the AbioCor total replacement heart has been re-assigned to DRG 1.

 

   

Gross margin for the first quarter of fiscal 2009 was 66%. The Company implemented certain Impella console placement programs during the quarter to generate future disposable revenue. For the U.S. pivotal studies, thirty-eight consoles were placed on consignment with the expectation that the respective hospitals will purchase a minimum amount of future disposables and participate in the pivotal studies. Eight consoles for Impella 2.5 commercial were placed on consignment with the expectation that the respective hospitals will purchase a minimum amount of disposables within a given period of time. If these expectations for future disposable orders are not met within the given timeframe, the Company has the right to take back the Impella consoles. Eight AB5000 and twelve iPulse consoles transferred title based on completion of the deployment utilization agreements with the hospitals. Four AB5000 consoles were consigned with the expectations for future disposable revenue. The total effect of these console placement programs negatively impacted gross margin for the first quarter of fiscal 2009 by approximately eight gross margin points.

 

   

The first quarter of fiscal 2009 GAAP net loss was approximately $9.1 million, or $.28 per share, which included stock option and other stock-based compensation expense of $1.7 million and intangibles amortization of $0.4 million. Excluding these charges the non-GAAP net loss for the first quarter of fiscal 2009 was approximately $7.0 million, or $.21 per share. The GAAP net loss for the first quarter of fiscal 2008 was $8.3 million, or $.26 per share and included stock option and other stock-based compensation expense of $1.7 million and $0.4 million of intangibles amortization.

“Our top Fiscal Year 2009 goal is launching our Impella 2.5 platform including successful clinical trial execution. During this first fiscal quarter of 2009, we were pleased with our revenue growth from Impella and the continued momentum in our two U.S. pivotal studies for the Impella 2.5,” said Michael R. Minogue, Chairman, CEO and President of Abiomed.

Abiomed today announced it is reaffirming its full-year fiscal 2009 revenue estimate of approximately $75 million to $80 million.

The Company will host a conference call today at 8:00 a.m. ET to discuss its first quarter of fiscal 2009 results. Michael R. Minogue, Chairman, Chief Executive Officer and President, and Daniel J. Sutherby, 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 866.362.4829; the international number is 617.597.5346. The access code is 21674892. A replay of this conference call will be available beginning at 10 a.m. ET on August 7, 2008 through 11:59 p.m. ET on August 21, 2008. The replay phone number is 888.286.8010; the international number is 617.801.6888. The replay access code is 25571704.

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 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 option 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 option 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. 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.

Abiomed, Inc. and Subsidiaries

Condensed Consolidated Balance Sheets

(in thousands, except share data)

 

     June 30,
2008
    March 31,
2008
 
     (Unaudited)        

ASSETS

    

Current assets:

    

Cash and cash equivalents

   $ 1,627     $ 2,042  

Restricted securities

     22,739       —    

Short-term marketable securities

     4,062       36,257  

Accounts receivable, net

     13,883       14,071  

Inventories

     19,514       17,428  

Prepaid expenses and other current assets

     1,506       1,705  
                

Total current assets

     63,331       71,503  

Property and equipment, net

     7,232       7,551  

Intangible assets, net

     6,466       6,921  

Goodwill

     37,033       31,563  

Other assets

     565       493  
                

Total assets

   $ 114,627     $ 118,031  
                

LIABILITIES AND STOCKHOLDERS’ EQUITY

    

Current liabilities:

    

Accounts payable

   $ 6,790     $ 9,024  

Accrued expenses

     7,821       9,290  

Deferred revenue

     1,072       1,162  
                

Total current liabilities

     15,683       19,476  

Long-term deferred tax liability

     4,799       4,740  

Other long-term liabilities

     73       221  
                

Total liabilities

     20,555       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

     337       328  

Authorized—100,000,000 shares;

    

Issued—33,693,217 shares at June 30, 2008 and 32,779,404 shares at March 31, 2008;

    

Outstanding—33,682,198 shares at June 30, 2008 and 32,768,385 shares at March 31, 2008

    

Additional paid-in-capital

     310,503       300,787  

Accumulated deficit

     (221,508 )     (212,394 )

Treasury stock at cost—11,019 shares at June 30, 2008 and at March 31, 2008

     (116 )     (116 )

Accumulated other comprehensive income

     4,856       4,989  
                

Total stockholders’ equity

     94,072       93,594  
                

Total liabilities and stockholders’ equity

   $ 114,627     $ 118,031  
                


Abiomed, Inc. and Subsidiaries

Condensed Consolidated Statements of Operations

(Unaudited)

(in thousands, except share data)

 

     Three Months Ended
June 30,
 
     2008     2007  

Revenue:

    

Products

   $ 16,270     $ 13,901  

Funded research and development

     87       162  
                
     16,357       14,063  
                

Costs and expenses:

    

Cost of product revenue excluding amortization of intangibles

     5,627       3,532  

Research and development

     6,144       5,516  

Selling, general and administrative

     13,514       12,441  

Arbitration decision

     —         1,232  

Amortization of intangible assets

     426       380  
                
     25,711       23,101  
                

Loss from operations

     (9,354 )     (9,038 )
                

Other income:

    

Investment income, net

     244       907  

Other income, net

     141       1  
                
     385       908  
                

Loss before provision for income taxes

     (8,969 )     (8,130 )

Provision for income taxes

     145       145  
                

Net loss

   $ (9,114 )   $ (8,275 )
                

Basic and diluted net loss per share

   $ (0.28 )   $ (0.26 )

Weighted average shares outstanding

     32,845       32,338  


—30—

 

CONTACT:    Abiomed, Inc.
   Daniel J. Sutherby, 978-777-5410
   Chief Financial Officer
   ir@abiomed.com
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