-----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, HaBiXHKAP6MzIhvIynBz461UA/RybK69zvhBd4wI3FZ347UoxStJEfa1Dfhxao36 ZU3dpe7e4FdLdGsL0za0Fw== 0001193125-11-022563.txt : 20110203 0001193125-11-022563.hdr.sgml : 20110203 20110203075534 ACCESSION NUMBER: 0001193125-11-022563 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20110203 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20110203 DATE AS OF CHANGE: 20110203 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: 11568483 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 3, 2011

(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 3, 2011 we issued a press release reporting our financial results for our third quarter ended December 31, 2010. 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 3, 2011.


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 3, 2011


Exhibit Index

 

Exhibit Number

  

Description

99.1    Press release dated February 3, 2011.
EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

LOGO

ABIOMED INCREASES REVENUES BY 19% TO $27.2 MILLION

AND ACHIEVES NON-GAAP PROFITABILITY WHILE GENERATING $5 MILLION IN

CASH FOR THIRD QUARTER OF FISCAL 2011

 

  - Record U.S. Commercial Utilization of 752 Patients, Up 77% Over Prior Year

DANVERS, Mass. — February 3, 2011 – Abiomed, Inc. (NASDAQ: ABMD), a leading provider of breakthrough heart support technologies, today reported third quarter fiscal 2011 revenue of $27.2 million, up 19% compared to the same period of fiscal 2010.

Worldwide Impella revenue totaled $21.1 million, up 33% compared to revenue of $15.9 million during the same period of the prior year.

Financial and operating highlights during the third quarter of fiscal 2011 include:

 

   

A reported 752 U.S. commercial patients were treated with Impella 2.5, 5.0 or LD, a 77% increase compared to a reported 425 patients in the third quarter of fiscal 2010. As of December 31, 2010, over 4,000 U.S. patients have been treated with Impella since the Impella 2.5 510(k) clearance in June 2008.

 

   

U.S. Impella reorders of $16.9 million were up 106% from $8.2 million in the third quarter of fiscal 2010 and represented 87% of U.S. Impella revenue.

 

   

In alignment with the Company’s strategy to open fewer sites and drive deeper utilization at existing customer sites, an additional 29 U.S. hospitals purchased Impella 2.5 during the quarter, bringing the total to 493 customers. This compares to 66 hospitals added in the third quarter of fiscal 2010.

 

   

Gross margin rate for the third quarter of fiscal 2011 was 80%, compared to 75% in the third quarter of fiscal 2010.

 

   

Non-Impella revenue was $6.1 million for the third quarter of fiscal 2011, 12% lower than $6.9 million in the third quarter of fiscal 2010 and up 5% from $5.8 million in the second quarter of fiscal 2011.

 

   

GAAP net loss for the third quarter of fiscal 2011 was $0.8 million, or $0.02 per share, compared to a GAAP net loss of $4.6 million, or $0.12 per share for the third quarter of fiscal 2010.

 

   

Non-GAAP net income, which is described later in this press release for the third quarter of fiscal 2011, was $0.8 million, or $0.02 per share versus a non-GAAP net loss of $1.3 million or $0.03 per share, in the third quarter of fiscal 2010.

 

   

Cash, cash equivalents and short-term marketable securities totaled $59.2 million at December 31, 2010 compared to $54.1 million at September 30, 2010, representing an increase of $5.1 million.

 

   

Abiomed is today announcing the new Automated Impella Controller console, offering a new level of automation that enables clinicians the ability to easily monitor the use of the Impella device, providing a single source for critical decision making for the Impella family of catheters. The controller, which received FDA 510(k) clearance, incorporates a bi-ventricular Impella platform, which will include the Impella RP (right-side support).


LOGO

 

   

On December 2, 2010, Abiomed announced it received conditional FDA approval to begin MINI-AMI, a prospective, randomized, controlled multi-site trial to assess the potential role of the Impella 2.5 in reducing infarct size in patients with ST-elevation myocardial infarction (STEMI).

 

   

On December 6, 2010, Abiomed announced that it ended the PROTECT II study and reported a first look at the interim results. More detailed results will be reported at the American College of Cardiology (ACC) show from April 2 – 5, 2011.

Based on third quarter fiscal 2011 results and a positive Impella outlook, the Company is raising prior full year worldwide revenue guidance of $93 million to $97 million to the range of $99 million to $101 million, representing a 16% to 18% increase over the prior fiscal year.

“Abiomed’s momentum continues to grow with best ever results for: revenue, gross margin, operating cash flow, and number of patients supported,” said Michael R. Minogue, Chairman, President and Chief Executive Officer of Abiomed. “Today, Abiomed is proud to report to the shareholders that our innovative company is now generating cash flow. This is an exciting time as the benefits of Impella are translating over to success in both patient outcomes and the Company’s financial performance.”

The Company will host a conference call to discuss the results on Thursday, February 3, 2011, at 8:00 a.m. ET. Michael R. Minogue, Chairman, President and Chief Executive Officer 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 800.299.9086; the international number is 617.786.2903. The access participant code is 47464625. A replay of this conference call will be available beginning at 11 a.m. ET on February 3, 2011 through 11:59 p.m. ET on February 17, 2011. The replay phone number is 888-286-8010; the international number is 617-801-6888. The replay access code is 85462899.

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 income, net income per share, net loss and net loss per share, in each case excluding, where appropriate, stock-based compensation, intangibles amortization and other costs, expenses or income, all as further detailed in the financial tables accompanying this earnings announcement, which management believes are useful supplemental information to management and investors regarding the performance of the company’s business operations, provide a greater transparency with respect to key metrics used by management in its decision making, facilitate comparisons of results for current periods and assist in analyzing future trends. 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


LOGO

 

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, 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, the Company’s projected revenues, 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 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

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

Reconciliation of GAAP to Non-GAAP Net Income/(Loss)

(in thousands, except for per share data)

 

     Three Months Ended     Nine Months Ended  
     December 31, 2010     December 31, 2009     December 31, 2010     December 31, 2009  

Net loss on a GAAP basis

   $ (802   $ (4,565   $ (9,983   $ (19,999

Share-based compensation expense:

        

–   Cost of product revenue

     51        139        163        393   

–   Research & development

     214        374        750        892   

–   Selling, general and administrative

     1,007        1,653        3,105        4,579   

Legacy product inventory reserve for excess or obsolete

        

–   Cost of product revenue

     —          731        —          979   

Athlone lease exit charge

        

–   Selling, general and administrative

     —          —          791        —     

Amortization of intangible assets

     295        382        1,034        1,107   

Sale of World Heart Stock

        

–   Other income/(expense)

     —          —          (456     —     

Income tax effect of non-GAAP adjustments

     —          —          —          —     

Net income/(loss) on a non-GAAP basis

   $ 765      $ (1,286   $ (4,596   $ (12,049

Net income/(loss) per share reconciliation

(in thousands, except for per share data)

 

     Three Months Ended     Nine Months Ended  
     December 31, 2010     December 31, 2009     December 31, 2010     December 31, 2009  

Net loss per share on a GAAP basis

   $ (0.02   $ (0.12   $ (0.27   $ (0.54

Share-based compensation expense:

        

–   Cost of product revenue

     —          0.01        0.01        0.01   

–   Research & development

     —          0.01        0.02        0.03   

–   Selling, general and administrative

     0.03        0.04        0.08        0.12   

Legacy product inventory reserve for excess or obsolete

        

–   Cost of product revenue

     —          0.02        —          0.02   

Athlone fair value charge

        

–   Selling, general and administrative

     —          —          0.02        —     

Amortization of intangible assets

     0.01        0.01        0.03        0.03   

Sale of World Heart Stock

        

–   Other income/(expense)

     —          —          (0.01     —     

Income tax effect of non-GAAP adjustments

     —          —          —          —     

Net income/(loss) per share on a non-GAAP basis

   $ 0.02      $ (0.03   $ (0.12   $ (0.33

Shares used in calculation of net income/(loss) per share on a non-GAAP basis

     38,287        37,011        37,146        36,829   


LOGO

 

Abiomed, Inc. and Subsidiaries

Consolidated Balance Sheets

(in thousands, except share data)

 

     December 31, 2010     March 31, 2010  
     (unaudited)        

ASSETS

    

Current assets:

    

Cash and cash equivalents

   $ 4,193      $ 4,788   

Short-term marketable securities

     54,980        53,477   

Accounts receivable, net

     12,872        13,516   

Inventories

     6,878        9,211   

Prepaid expenses and other current assets

     881        1,676   
                

Total current assets

     79,804        82,668   

Property and equipment, net

     6,060        6,753   

Intangible assets, net

     1,887        2,979   

Goodwill

     36,611        37,170   
                

Total assets

   $ 124,362      $ 129,570   
                

LIABILITIES AND STOCKHOLDERS’ EQUITY

    

Current liabilities:

    

Accounts payable

   $ 3,556      $ 3,764   

Accrued expenses

     13,351        13,011   

Deferred revenue

     1,993        1,289   
                

Total current liabilities

     18,900        18,064   

Long-term deferred tax liability

     3,768        3,040   

Other long-term liabilities

     515        510   
                

Total liabilities

     23,183        21,614   
                

Commitments and contingencies (Note 10)

    

Stockholders’ equity:

    

Class B Preferred Stock, $.01 par value

     —          —     

Authorized - 1,000,000 shares; Issued and outstanding - none

    

Common stock, $.01 par value

     379        375   

Authorized - 100,000,000 shares; Issued - 37,904,179 shares at December 31, 2010 and 37,484,018 shares at March 31, 2010;

    

Outstanding - 37,853,225 shares at December 31, 2010 and 37,433,064 shares at March 31, 2010

    

Additional paid-in-capital

     377,007        372,425   

Accumulated deficit

     (272,998     (263,015

Treasury stock at cost - 50,954 at December 31, 2010 and March 31, 2010

     (827     (827

Accumulated other comprehensive loss

     (2,382     (1,002
                

Total stockholders’ equity

     101,179        107,956   
                

Total liabilities and stockholders’ equity

   $ 124,362      $ 129,570   
                


LOGO

 

Abiomed, Inc. and Subsidiaries

Consolidated Statements of Operations

(Unaudited)

(in thousands, except share data)

 

     Three Months Ended     Nine Months Ended  
     December 31,     December 31,  
     2010     2009     2010     2009  

Revenue:

        

Product

   $ 26,915      $ 22,623      $ 71,734      $ 61,937   

Funded research and development

     329        176        888        797   
                                

Total Revenue

     27,244        22,799        72,622        62,734   
                                

Costs and expenses:

        

Cost of product revenue excluding amortization of intangibles

     5,437        5,772        16,129        16,290   

Research and development

     6,592        6,397        19,834        19,166   

Selling, general and administrative

     15,592        15,190        45,399        45,973   

Amortization of intangible assets

     295        382        1,034        1,107   
                                
     27,916        27,741        82,396        82,536   
                                

Loss from operations

     (672     (4,942     (9,774     (19,802
                                

Other income and expense:

        

Investment income, net

     4        275        1        372   

Gain on sale of WorldHeart stock

     —          —          456        —     

Other income (expense), net

     30        62        (17     (141
                                
     34        337        440        231   
                                

Loss before provision for income taxes

     (638     (4,605     (9,334     (19,571

Income tax provision (benefit)

     164        (40     649        428   
                                

Net loss

   $ (802   $ (4,565   $ (9,983   $ (19,999
                                

Basic net loss per share

   $ (0.02   $ (0.12   $ (0.27   $ (0.54

Weighted average shares outstanding

     37,195        37,011        37,146        36,829   
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-----END PRIVACY-ENHANCED MESSAGE-----