-----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, Uq9D62ERr7j8oA79NH3x4f8rgQ2wCWhytDSDu4Rmozrln7n+rjFaP7vYJGBgilzk Q7aMd+Fhqq9X83RJXnG+jw== 0001193125-09-224669.txt : 20091105 0001193125-09-224669.hdr.sgml : 20091105 20091105073904 ACCESSION NUMBER: 0001193125-09-224669 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20091105 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20091105 DATE AS OF CHANGE: 20091105 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: 091159451 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: November 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 November 5, 2009 we issued a press release reporting our financial results for our second quarter ended September 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 November 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: November 5, 2009


Exhibit Index

 

Exhibit
Number

  

Description

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

Exhibit 99.1

LOGO

ABIOMED ANNOUNCES RECORD REVENUE OF $20 MILLION FOR SECOND QUARTER OF FISCAL 2010

 

   

U.S. Commercial Impella Revenue at $12.1 Million, Up 95% From Prior Year

DANVERS, Mass. — November 5, 2009 – Abiomed, Inc. (NASDAQ: ABMD), a leading provider of breakthrough heart support technologies, today announced second quarter fiscal 2010 revenue of $20 million.

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

 

   

U.S. commercial Impella revenue totaled $12.1 million, up 95% compared to revenue of $6.2 million in the second quarter of fiscal 2009. U.S. commercial reorders totaled $6.6 million, up 230% from $2.0 million in the second quarter of fiscal 2009.

 

   

Worldwide Impella revenue was $13.2 million, up 26% compared to revenue of $10.5 million for the second quarter of fiscal 2009.

 

   

Approximately 338 U.S. commercial patients were treated with Impella® 2.5, 5.0 or LD, a 238% increase compared to approximately 100 commercial patients in the second quarter of fiscal 2009. A total of over 1,200 U.S. commercial patients have been treated with Impella as of the end of the second quarter of fiscal 2010.

 

   

An additional 50 U.S. hospitals purchased Impella 2.5 for commercial use during the quarter, bringing the total to 326 commercial customers.

 

   

During the second quarter of fiscal 2010, there were 28 patients enrolled in the Protect II study, for a total of 290 patients completed, or 44% of the 654 patients required.

 

   

Legacy revenue, which consists of non-Impella revenue, was $6.8 million or 28% lower than the second quarter of fiscal 2009.

 

   

Gross margin for the quarter was 73% compared to 76% in the second quarter of fiscal 2009.

 

   

The GAAP net loss was $7.7 million, or a loss of $0.21 per share, compared to a GAAP net loss of $6.3 million, or a loss of $0.18 per share for the second quarter of fiscal 2009.

 

   

The non-GAAP net loss, after excluding stock-based compensation expense of $2.0 million and intangibles amortization expense of $0.4 million, was $5.3 million, or a loss of $0.14 per share, compared to the non-GAAP net loss of $2.5 million, or a loss of $0.08 per share, for the second quarter of fiscal 2009, after excluding stock-based compensation expense of $3.4 million and intangibles amortization expense of $0.4 million.

 

   

Cash, cash equivalents plus short and long-term marketable securities totaled $52.3 million compared to $54.5 million at the end of the first quarter fiscal 2010, reflecting a cash burn for the second quarter of fiscal 2010 of $2.2 million, a decrease of 46% compared to $4.1 million during the second quarter of fiscal 2009, excluding proceeds of $42.0 million from a stock offering.


LOGO

 

   

At TCT in September 2009, Abiomed announced the clinical data from USpella, the first U.S. multicenter registry of 181 Impella 2.5 patients, demonstrating that Impella 2.5 is able to treat patients in the cath lab who were turned down by surgery and decrease their SYNTAX score. High-risk PCI and AMI patients treated with Impella 2.5 showed an improvement in ejection fraction.

 

   

Also at TCT 2009, data released from the Academic Medical Center’s MACH II three-year follow-up results revealed that patients in the Impella 2.5 arm of the trial showed improved left ventricular function, cardiac output and quality of life.

IMPELLA US COMMERCIAL LAUNCH

 

     Q2’09    Q3’09    Q4’09    Q1’10    Q2’10    V%
Growth
Q2’10
vs.
Q2’09
 
# of Patients per Quarter      100      160      261      341      338    238
Avg. # of Patients Supported per Week      8      12      20      26      26    225
# of Hospitals added per Quarter      108      55      66      47      50    (-54 %) 
Total Commercial Revenue    $ 6.2M    $ 6.7M    $ 9.1M    $ 10.5M    $ 12.1M    95

Reorder Revenue

(Contribution to Total Commercial Revenue)

   $ 2.0M    $ 3.0M    $ 4.9M    $ 6.4M    $ 6.6M    230

Total Worldwide Impella Revenue

(ROW, Commercial & Trial)

   $ 10.5M    $ 8.8M    $ 11.2M    $ 12M    $ 13.2M    26

“In summary, in the U.S. since last fiscal second quarter, as compared to this quarter, Abiomed has doubled the commercial U.S. Impella revenue, tripled the number of patients in the quarter and tripled the reorder revenue number,” said Michael R. Minogue, Chairman, President and Chief Executive Officer of Abiomed. “We have also cut our cash burn in half while ramping up our expanded U.S. field team, releasing new product enhancements and unveiling our most robust clinical data to date at the premier customer TCT meeting. We like our position and strategy and are confident in our people, technology and execution.”

Abiomed today reaffirmed its previously issued full-year fiscal 2010 revenue guidance of growth in the range of 17% to 24% or revenues of $86 million to $91 million.

The Company will host a conference call on Thursday, November 5, 2009 at 8 a.m. ET to discuss its second 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 800.638.4930; the international number is 617.614.3944. The access participant code is 10095872. A replay of this conference call will be available beginning at 11 a.m. ET on November 5, 2009 through 11:59 p.m. ET on November 19, 2009. The replay phone number is 888.286.8010; the international number is 617.801.6888. The replay access code is 72639080.


LOGO

 

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.

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 and the 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)

 

      September 30, 2009     March 31, 2009  
     (unaudited)        

ASSETS

    

Current assets:

    

Cash and cash equivalents

   $ 2,782      $ 1,785   

Short-term marketable securities

     49,548        55,394   

Accounts receivable, net

     13,403        15,724   

Inventories

     14,111        14,777   

Prepaid expenses and other current assets

     992        809   
                

Total current assets

     80,836        88,489   

Property and equipment, net

     7,540        7,792   

Intangible assets, net

     3,996        4,359   

Goodwill

     40,310        31,295   

Long-term marketable securities

            3,721   

Other assets

     302        302   
                

Total assets

   $ 132,984      $ 135,958   
                

LIABILITIES AND STOCKHOLDERS’ EQUITY

    

Current liabilities:

    

Accounts payable

   $ 5,239      $ 5,550   

Accrued expenses

     9,654        10,818   

Deferred revenue

     1,237        1,211   
                

Total current liabilities

     16,130        17,579   

Long-term deferred tax liability

     2,554        2,086   

Other long-term liabilities

     410        310   
                

Total liabilities

     19,094        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

     375        367   

Authorized - 100,000,000 shares; Issued - 37,520,065 shares at September 30, 2009 and 36,736,843 shares at March 31, 2009;

    

Outstanding - 37,469,111 shares at September 30, 2009 and 36,685,889 shares at March 31, 2009

    

Additional paid-in-capital

     370,169        362,097   

Accumulated deficit

     (259,425     (243,991

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

     (827     (827

Accumulated other comprehensive income (loss)

     3,598        (1,663
                

Total stockholders’ equity

     113,890        115,983   
                

Total liabilities and stockholders’ equity

   $ 132,984      $ 135,958   
                


LOGO

 

Abiomed, Inc. and Subsidiaries

Condensed Consolidated Statements of Operations

(Unaudited)

(in thousands, except share and per share data)

 

     Three Months Ended
September 30,
    Six Months Ended
September 30,
 
     2009     2008     2009     2008  

Revenue:

        

Product

   $ 19,725      $ 19,777      $ 39,314      $ 36,047   

Funded research and development

     297        222        621        309   
                                

Total Revenue

     20,022        19,999        39,935        36,356   
                                

Costs and expenses:

        

Cost of product revenue excluding amortization of intangibles

     5,446        4,793        10,518        10,420   

Research and development

     6,786        6,850        12,769        12,994   

Selling, general and administrative

     14,816        13,898        30,783        27,412   

Amortization of intangible assets

     371        411        725        837   
                                
     27,419        25,952        54,795        51,663   
                                

Loss from operations

     (7,397     (5,953     (14,860     (15,307
                                

Other income and expense:

        

Investment income (expense), net

     53        (43     97        201   

Other (expense) income, net

     (88     (61     (203     80   
                                
     (35     (104     (106     281   
                                

Loss before provision for income taxes

     (7,432     (6,057     (14,966     (15,026

Provision for income taxes

     242        273        468        418   
                                

Net loss

   $ (7,674   $ (6,330   $ (15,434   $ (15,444
                                

Basic and diluted net loss per share

   $ (0.21   $ (0.18   $ (0.42   $ (0.46

Weighted average shares outstanding

     36,924        34,475        36,736        33,393   
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-----END PRIVACY-ENHANCED MESSAGE-----