-----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, R9JsPwZBXyMbcz3y59oBdjKEOi6NiLYl6yKsHgG4jSsCQBk71DkLVFqM2i71YldD Q/fQlBaoUla3wikoqsT8kQ== 0001193125-10-247176.txt : 20101104 0001193125-10-247176.hdr.sgml : 20101104 20101104075525 ACCESSION NUMBER: 0001193125-10-247176 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20101104 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20101104 DATE AS OF CHANGE: 20101104 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: 101163213 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 4, 2010

(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 4, 2010 we issued a press release reporting our financial results for our second quarter ended September 30, 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 November 4, 2010.


 

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 4, 2010


 

Exhibit Index

 

Exhibit Number

  

Description

99.1    Press release dated November 4, 2010.
EX-99.1 2 dex991.htm PRESS RELEASE Press Release

 

Exhibit 99.1

LOGO

FINAL

ABIOMED REPORTS RECORD REVENUES OF $23.4 MILLION, UP 17%

FOR SECOND QUARTER OF FISCAL 2011

 

   

Record Worldwide Impella Revenue of $17.6 Million, Up 33%

 

   

U.S. Commercial Impella Reorders of $13.7 Million, Up 108%

DANVERS, Mass. — November 4, 2010 – Abiomed, Inc. (NASDAQ: ABMD), a leading provider of breakthrough heart support technologies, today reported second quarter fiscal 2011 revenue of $23.4 million, up 17% compared to the same period of fiscal 2010. Revenues for the first half of fiscal 2011 were $45.4 million, up 14% from $39.9 million in the first half of fiscal 2010.

Total commercial U.S. Impella® revenue, including initial site stocking orders and reorders, totaled $16.1 million, a 33% increase compared to $12.1 million in the second quarter of fiscal 2010. Commercial U.S. Impella reorders of $13.7 million were up 108% from $6.6 million in the second quarter of fiscal 2010 and represented 85% of commercial U.S. Impella revenue.

Worldwide Impella revenue totaled $17.6 million, up 33% compared to revenue of $13.2 million during the same period of the prior year.

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

 

   

A reported 597 U.S. commercial patients were treated with Impella 2.5, 5.0 or LD, a 77% increase compared to a reported 338 commercial patients in the second quarter of fiscal 2010. As of September 30, 2010, a reported 3,362 U.S. patients have been treated with Impella since the Impella 2.5 510(k) clearance in June 2008.

 

   

An additional 27 U.S. hospitals purchased Impella 2.5 for commercial use during the quarter, bringing the total to 464 commercial customers, as compared to 50 hospitals added in the second quarter of fiscal 2010, aligning with the Company’s strategy to open fewer sites and drive deeper utilization at existing customer sites.

 

   

Gross margin rate for the second quarter of fiscal 2011 was 77%, compared to 73% in the second quarter of fiscal 2010.

 

   

39 patients were enrolled in the Protect II study, for a total of 429 patients completed, or 66% of the 654 patients required.

 

   

Non-Impella revenue was $5.8 million for the second quarter of fiscal 2011, 15% lower than $6.8 million in the second quarter of fiscal 2010 and up 7% from $5.4 million in the first quarter of fiscal 2011.

 

   

GAAP net loss for the second quarter of fiscal 2011 was $3.2 million, or $0.09 per share, compared to a GAAP net loss of $7.7 million, or $0.21 per share for the second quarter of fiscal 2010. GAAP net loss for the first half of fiscal 2011 was $9.2 million, or $0.25 per share, compared to a GAAP net loss of $15.4 million, or $0.42 per share for the first half of fiscal 2010.

 

   

Non-GAAP net loss, which is described later in this press release for the second quarter of fiscal 2011 was $1.7 million, or $0.05 per share versus non-GAAP net loss of $5.3 million or $0.14 per share, in the second quarter of fiscal 2010. Non-GAAP net loss for the first half of fiscal 2011 was $5.4 million, or $0.14 per share versus non-GAAP net loss of $11.0 million or $0.30 per share, in the first half of fiscal 2010.


 

LOGO

 

   

Cash, cash equivalents and short-term marketable securities totaled $54.1 million at September 30, 2010 compared to $54.9 million at June 30, 2010.

 

   

At TCT 2010 in September, Abiomed announced the latest results from USpella, a U.S. multicenter, observational registry of 352 Impella 2.5 patients. Impella was also used in three live cases broadcasted during the conference.

 

   

On September 30, 2010, Abiomed announced the launch of a specialized partner program that enables select top healthcare institutions to provide advanced training in hemodynamic support and complex patient management to better facilitate heart muscle recovery. PinnacleHealth is the first healthcare institution to join the program.

“The second quarter of fiscal 2011 was outstanding. It was highlighted by the release of the USpella results at TCT in September, record revenues and number of patients supported and positive operational performance,” said Michael R. Minogue, Chairman, President and Chief Executive Officer of Abiomed. “Despite the industry summer slowdown, the second quarter of fiscal 2011 demonstrated that our momentum is growing both year over year and sequentially on revenue, patients, and clinical evidence. In summary, the company executed and had the best quarter in our 29 year history.”

Based on second quarter fiscal 2011 results and a positive Impella outlook, the Company is raising full year worldwide revenue guidance to the range of $93 million to $97 million.

The Company will host a conference call to discuss the results on Thursday, November 4, 2010, 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 800.659.1942; the international number is 617.614.2710. The access participant code is 82092317. A replay of this conference call will be available beginning at 11 a.m. ET on November 4, 2010 through 11:59 p.m. ET on November 18, 2010. The replay phone number is 888.286.8010; the international number is 617.801.6888. The replay access code is 72509166.

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, 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


 

LOGO

 

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, 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 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     Six Months Ended  
     September 30, 2010     September 30, 2009     September 30, 2010     September 30, 2009  

Net loss on a GAAP basis

   $ (3,201   $ (7,674   $ (9,181   $ (15,434

Share-based compensation expense:

        

- Cost of product revenue

     50        138        112        255   

- Research & development

     226        389        536        518   

- Selling, general and administrative

     1,099        1,471        2,098        2,925   

Athlone lease exit charge

        

- Selling, general and administrative

     —          —          791        —     

Amortization of intangible assets

     372        371        739        725   

Sale of World Heart Stock

        

- Other income/(expense)

     (217     —          (456     —     

Income tax effect of non-GAAP adjustments

     —          —          —          —     

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

   $ (1,671   $ (5,305   $ (5,361   $ (11,011

Net income/(loss) per share reconciliation

(in thousands, except for per share data)

 

     Three Months Ended     Six Months Ended  
     September 30, 2010     September 30, 2009     September 30, 2010     September 30, 2009  

Net loss per share on a GAAP basis

   ($ 0.09   ($ 0.21   ($ 0.25   ($ 0.42

Share-based compensation expense:

        

- Cost of product revenue

     0.00        0.01        0.01        0.01   

- Research & development

     0.01        0.01        0.01        0.01   

- Selling, general and administrative

     0.03        0.04        0.06        0.08   

Athlone fair value charge

        

- Selling, general and administrative

     —          —          0.02        —     

Amortization of intangible assets

     0.01        0.01        0.02        0.02   

Sale of World Heart Stock

        

- Other income/(expense)

     (0.01     —          (0.01     —     

Income tax effect of non-GAAP adjustments

     —          —          —          —     

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

   ($ 0.05   ($ 0.14   ($ 0.14   ($ 0.30

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

     37,156        36,924        37,121        36,736   


 

LOGO

 

Abiomed, Inc. and Subsidiaries

Condensed Consolidated Balance Sheets

(in thousands, except share data)

 

     September 30, 2010     March 31, 2010  
     (unaudited)        

ASSETS

    

Current assets:

    

Cash and cash equivalents

   $ 4,151      $ 4,788   

Short-term marketable securities

     49,979        53,477   

Accounts receivable, net

     14,986        13,516   

Inventories

     7,031        9,211   

Prepaid expenses and other current assets

     1,215        1,676   
                

Total current assets

     77,362        82,668   

Property and equipment, net

     6,171        6,753   

Intangible assets, net

     2,295        2,979   

Goodwill

     37,603        37,170   
                

Total assets

   $ 123,431      $ 129,570   
                

LIABILITIES AND STOCKHOLDERS’ EQUITY

    

Current liabilities:

    

Accounts payable

   $ 3,706      $ 3,764   

Accrued expenses

     11,938        13,011   

Deferred revenue

     1,529        1,289   
                

Total current liabilities

     17,173        18,064   

Long-term deferred tax liability

     3,525        3,040   

Other long-term liabilities

     538        510   
                

Total liabilities

     21,236        21,614   
                

Stockholders’ equity:

    

Class B Preferred Stock, $.01 par value

     —          —     

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

    

Common stock, $.01 par value

     378        375   

Authorized - 100,000,000 shares; Issued - 37,893,294 shares at September 30, 2010 and 37,484,018 shares at March 31, 2010;

    

Outstanding - 37,842,640 shares at September 30, 2010 and 37,433,064 shares at March 31, 2010

    

Additional paid-in-capital

     375,663        372,425   

Accumulated deficit

     (272,196     (263,015

Treasury stock at cost - 50,954 at September 30, 2010 and March 31, 2010

     (827     (827

Accumulated other comprehensive loss

     (823     (1,002
                

Total stockholders’ equity

     102,195        107,956   
                

Total liabilities and stockholders’ equity

   $ 123,431      $ 129,570   
                


 

LOGO

 

Abiomed, Inc. and Subsidiaries

Condensed Consolidated Statements of Operations

(Unaudited)

(in thousands, except share data)

 

     Three Months Ended
September 30,
    Six Months Ended
September 30,
 
     2010     2009     2010     2009  

Revenue:

        

Product

   $ 23,058      $ 19,725      $ 44,819      $ 39,314   

Funded research and development

     318        297        559        621   
                                

Total Revenue

     23,376        20,022        45,378        39,935   
                                

Costs and expenses:

        

Cost of product revenue excluding amortization of intangibles

     5,408        5,446        10,692        10,518   

Research and development

     6,589        6,786        13,242        12,769   

Selling, general and administrative

     14,054        14,816        29,807        30,783   

Amortization of intangible assets

     372        371        739        725   
                                
     26,423        27,419        54,480        54,795   
                                

Loss from operations

     (3,047     (7,397     (9,102     (14,860
                                

Other income and expense:

        

Investment (expense) income, net

     (1     53        (3     97   

Gain on sale of WorldHeart stock

     217        —          456        —     

Other expense, net

     (128     (88     (47     (203
                                
     88        (35     406        (106
                                

Loss before provision for income taxes

     (2,959     (7,432     (8,696     (14,966

Provision for income taxes

     242        242        485        468   
                                

Net loss

   $ (3,201   $ (7,674   $ (9,181   $ (15,434
                                

Basic and diluted net loss per share

   $ (0.09   $ (0.21   $ (0.25   $ (0.42

Weighted average shares outstanding

     37,156        36,924        37,121        36,736   
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-----END PRIVACY-ENHANCED MESSAGE-----