-----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, SghRkXCXORUkpIRA0UBH1v4IYy0DwbpcEOc1Yv07nTUT4dDF26O2mAv4RUj9v3dV edi0QtmfTxrnNl/4vtuAkg== 0001193125-09-166345.txt : 20090806 0001193125-09-166345.hdr.sgml : 20090806 20090806073417 ACCESSION NUMBER: 0001193125-09-166345 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20090806 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20090806 DATE AS OF CHANGE: 20090806 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: 09989904 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 6, 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 August 6, 2009 we issued a press release reporting our financial results for our first quarter ended June 30, 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 August 6, 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: August 6, 2009


Exhibit Index

 

Exhibit Number

  

Description

99.1    Press release dated August 6, 2009.
EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

LOGO

ABIOMED ANNOUNCES FISCAL FIRST QUARTER REVENUE OF $19.9 MILLION AND

RECORD IMPELLA® REVENUE UP 107% TO $12 MILLION

 

  - 341 U.S. Patients Treated With Impella During First Quarter of Fiscal 2010, Up 31% Sequentially, With Over 850 U.S. Patients Treated Since 510(k) clearance

DANVERS, Mass. — August 6, 2009 – Abiomed, Inc. (NASDAQ: ABMD), a leading provider of breakthrough heart support technologies, today announced first quarter of fiscal 2010 revenue of $19.9 million, up 21% compared to revenue of $16.4 million for the first quarter of fiscal 2009.

Recent financial and operating highlights during the first quarter of fiscal 2010 include:

 

   

Approximately 341 U.S. patients were treated with Impella® 2.5, 5.0 or LD under the 510(k) clearance, up 31% sequentially from approximately 261 patients treated in the fourth quarter of fiscal 2009.

 

   

Existing customer reorders of Impella 2.5 commercial disposables grew 31% sequentially and represented 68% of total Impella 2.5 commercial revenue, compared to 54% in the prior sequential quarter.

 

   

Worldwide Impella revenue was $12.0 million, up 107% compared to revenue of $5.8 million for the first quarter of fiscal 2009. Impella U.S. revenue totaled $11.0 million, up 144% compared to revenue of $4.5 million in the first quarter of fiscal 2009 (Impella 2.5 510(k) clearance received June 2, 2008) and up 11% sequentially compared to revenue of $9.9 million for the fourth quarter of fiscal 2009.

 

   

An additional 47 U.S. hospitals purchased Impella 2.5 for general use during the quarter, bringing the total to 276 general use customers or 16% of the potential 1,700 U.S. hospitals with catheterization labs (cath labs).

 

   

Approximately 100 hospitals are participating in the Protect II study and 39 patients were enrolled during the quarter, for a total of 262 patients completed in the Protect II study, or 40% of the 654 patients required.

 

   

Legacy revenue, which consists of non-Impella revenue, was $7.9 million, $2.7 million or 25% lower than the first quarter of fiscal 2009, and $0.5 million or 6% lower than the fourth quarter of fiscal 2009.

 

   

Gross margin for the quarter was 75%, up nine points, compared to 66% in the first quarter of fiscal 2009 largely due to fewer no charge console placements and higher Impella disposable revenues.

 

   

The GAAP net loss was $7.8 million, or a loss of $0.21 per share, compared to a GAAP net loss of $9.1 million, or a loss of $0.28 per share for the first quarter of fiscal 2009.

 

   

The non-GAAP net loss, after excluding stock-based compensation expense of $1.7 million and intangibles amortization expense of $0.4 million, was $5.7 million, or a loss of $0.16 per share, compared to the non-GAAP net loss of $7.0 million, or a loss of $0.21 per share, for the first quarter of fiscal 2009, after excluding stock-based compensation expense of $1.7 million and intangibles amortization expense of $0.4 million.


LOGO

 

   

Cash, cash equivalents plus short and long-term marketable securities totaled $54.5 million compared to $60.9 million at March 31, 2009. Cash used during the quarter included a payment of $1.8 million, triggered by the 510(k) clearance of Impella 5.0, related to the cash portion of the final milestone payment in connection with the Company’s acquisition of Impella.

 

   

On June 24, 2009, Abiomed announced the successful implant of its AbioCor® Total Replacement Heart, performed at Robert Wood Johnson University Hospital. This was the first AbioCor implant since the completion of clinical trials and Humanitarian Device Exemption (HDE) approval from the U.S. Food and Drug Administration (FDA) on September 5, 2006.

“During the first quarter of fiscal 2010, we continued to advance the Protect II study, while also focusing on enhancing the product portfolio and ramping up commercial training for our customers and employees,” said Michael R. Minogue, Chairman, President and Chief Executive Officer of Abiomed. “In addition, we reinvigorated our surgery business by successfully executing on our first Impella 5.0 patient, first AB Portable Driver home discharge patient, and first commercial AbioCor patient.”

Abiomed today re-affirmed its previously issued full-year fiscal 2010 revenue guidance in the range of $86 million to $91 million.

The Company will host a conference call on Thursday, August 6, 2009 at 8 a.m. ET to discuss its first quarter of fiscal 2010 results. 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 866.804.6925; the international number is 857.350.1671. The access participant code is 29344115. A replay of this conference call will be available beginning at 11 a.m. ET on August 6, 2009 through 11:59 p.m. ET on August 20, 2009. The replay phone number is 888.286.8010; the international number is 617.801.6888. The replay access code is 69351319.

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-based compensation 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 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.


LOGO

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, regulatory approvals, 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.

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)

 

     June 30, 2009     March 31, 2009  
     (unaudited)        

ASSETS

    

Current assets:

    

Cash and cash equivalents

   $ 1,971      $ 1,785   

Short-term marketable securities

     50,417        55,394   

Accounts receivable, net

     14,476        15,724   

Inventories

     14,724        14,777   

Prepaid expenses and other current assets

     983        809   
                

Total current assets

     82,571        88,489   

Property and equipment, net

     7,679        7,792   

Intangible assets, net

     4,222        4,359   

Goodwill

     38,808        31,295   

Long-term marketable securities

     2,080        3,721   

Other assets

     302        302   
                

Total assets

   $ 135,662      $ 135,958   
                

LIABILITIES AND STOCKHOLDERS’ EQUITY

    

Current liabilities:

    

Accounts payable

   $ 4,916      $ 5,550   

Accrued expenses

     10,112        10,818   

Deferred revenue

     1,206        1,211   
                

Total current liabilities

     16,234        17,579   

Long-term deferred tax liability

     2,312        2,086   

Other long-term liabilities

     361        310   
                

Total liabilities

     18,907        19,975   
                

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

     374        367   

Authorized - 100,000,000 shares; Issued - 37,402,683 shares at June 30, 2009 and 36,736,843 shares at March 31, 2009;

    

Outstanding - 37,351,729 shares at June 30, 2009 and 36,685,889 shares at March 31, 2009

    

Additional paid-in-capital

     367,711        362,097   

Accumulated deficit

     (251,751     (243,991

Treasury stock at cost - 50,954 at June 30, 2009 and March 31, 2009

     (827     (827

Accumulated other comprehensive income (loss)

     1,248        (1,663
                

Total stockholders’ equity

     116,755        115,983   
                

Total liabilities and stockholders’ equity

   $ 135,662      $ 135,958   
                


LOGO

Abiomed, Inc. and Subsidiaries

Condensed Consolidated Statements of Operations

(Unaudited)

(in thousands, except share data)

 

     Three Months Ended
June 30,
 
     2009     2008  

Revenue:

    

Products

   $ 19,588      $ 16,270   

Funded research and development

     325        87   
                
     19,913        16,357   
                

Costs and expenses:

    

Cost of product revenue excluding amortization of intangibles

     5,072        5,627   

Research and development

     5,983        6,144   

Selling, general and administrative

     15,967        13,514   

Amortization of intangible assets

     354        426   
                
     27,376        25,711   
                

Loss from operations

     (7,463     (9,354
                

Other income:

    

Investment income, net

     44        244   

Other (expense) income, net

     (115     141   
                
     (71     385   
                

Loss before provision for income taxes

     (7,534     (8,969

Provision for income taxes

     226        145   
                

Net loss

   $ (7,760   $ (9,114
                

Basic and diluted net loss per share

   $ (0.21   $ (0.28

Weighted average shares outstanding

     36,549        32,845   
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-----END PRIVACY-ENHANCED MESSAGE-----