-----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, Kz1cO6mT3QjxHrO+mlXNhxegtnv8zgA2fQ5BgavFRuC4IrxXhfQDJ8tnt20ZYeOM +/NJUXJAGQG2AgLZ3maqOA== 0001193125-10-021564.txt : 20100204 0001193125-10-021564.hdr.sgml : 20100204 20100204074049 ACCESSION NUMBER: 0001193125-10-021564 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20100204 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20100204 DATE AS OF CHANGE: 20100204 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: 10572420 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 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 February 4, 2010 we issued a press release reporting our financial results for our third quarter ended December 31, 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 February 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: February 4, 2010


Exhibit Index

 

Exhibit Number

  

Description

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

Exhibit 99.1

LOGO

ABIOMED REPORTS THIRD QUARTER FISCAL 2010 FINANCIAL RESULTS

 

   

U.S. Commercial Impella Revenue of $14.5 Million, Up 116%

DANVERS, Mass. — February 4, 2010 – Abiomed, Inc. (NASDAQ: ABMD), a leading provider of breakthrough heart support technologies, today reported third quarter fiscal 2010 revenue of $22.8 million, up 32% compared to revenue of $17.3 million for the same period of fiscal 2009.

Financial and operating highlights during the third quarter of fiscal 2010 include:

 

   

U.S. commercial Impella revenue totaled $14.5 million, up 116% compared to revenue of $6.7 million in the third quarter of fiscal 2009. U.S. commercial reorders totaled $8.2 million, up 173% from $3.0 million in the third quarter of fiscal 2009.

 

   

Worldwide Impella revenue totaled $15.9 million, up 81% compared to revenue of $8.8 million for the third quarter of fiscal 2009.

 

   

Approximately 425 U.S. commercial patients were treated with Impella® 2.5, 5.0 or LD, a 166% increase compared to approximately 160 commercial patients in the third quarter of fiscal 2009. A total of approximately 1,625 U.S. commercial patients have been treated with Impella as of the end of the third quarter of fiscal 2010.

 

   

An additional 66 U.S. hospitals purchased Impella 2.5 for commercial use during the quarter, bringing the total to 392 commercial customers.

 

   

Approximately 80% of Impella U.S. customers were upgraded to the new Impella platform, which includes the Quick Setup Kit.

 

   

Twenty four patients were enrolled in the Protect II study, for a total of 314 patients completed, or 48% of the 654 patients required.

 

   

Non-Impella revenue was $6.9 million, up 1% sequentially from the second quarter of fiscal 2010 and 18% lower than the third quarter of fiscal 2009.

 

   

Gross margin for the quarter was 75% compared to 74% in the third quarter of fiscal 2009.

 

   

The GAAP net loss was $4.6 million, or $0.12 per share, compared to a GAAP net loss of $7.7 million, or $0.21 per share for the third quarter of fiscal 2009.

 

   

The non-GAAP net loss, after excluding stock-based compensation expense of $2.2 million and intangibles amortization expense of $0.4 million, was $2.0 million, or $0.05 per share, compared to the non-GAAP net loss of $5.4 million, or $0.15 per share, for the third quarter of fiscal 2009, after excluding stock-based compensation expense of $1.9 million and intangibles amortization expense of $0.4 million.

 

   

Cash burn for the third quarter was $0.6 million, with cash, cash equivalents plus short and long-term marketable securities totaling $51.7 million compared to $52.3 million at the end of the second fiscal quarter of 2010.


LOGO

 

IMPELLA US COMMERCIAL LAUNCH

 

     Q2’09    Q3’09    Q4’09    Q1’10    Q2’10    Q3’10    Growth
Q3’10
vs.
Q3’09
 

# of Patients per Quarter

     100      160      261      341      338      425    166

Avg. # of Patients Supported per Week

     8      12      20      26      26      33    175

# of Hospitals added per Quarter

     108      55      66      47      50      66    20
                                                

Total U.S. Commercial Revenue

   $ 6.2M    $ 6.7M    $ 9.1M    $ 10.5M    $ 12.1M    $ 14.5M    116
                                                

U.S. Reorder Revenue

(Contribution to Total Commercial Revenue)

   $ 2.0M    $ 3.0M    $ 4.9M    $ 6.4M    $ 6.6M    $ 8.2M    173
                                                

Total Worldwide Impella Revenue

(ROW, Commercial & Trial)

   $ 10.5M    $ 8.8M    $ 11.2M    $ 12M    $ 13.2M    $ 15.9M    81
                                                

“We posted a record fiscal third quarter driven by year over year patient utilization growth of 166% and strong operational performance” said Michael R. Minogue, Chairman, President and Chief Executive Officer of Abiomed. “By the end of the quarter, the majority of sites had received our new Impella 2.5 Quick Setup Kit which significantly reduces set up times and positions us well for urgent and emergent patient situations. In addition, we reduced our cash burn to $600k. We continue to execute our Impella strategy of demonstrating clinical utility, ease of use and physician and field training.”

Abiomed today updated revenue guidance for the full fiscal year 2010 to reflect a fiscal fourth quarter focus on existing site Impella utilization and training rather than on new Impella site openings and the legacy business. For the full fiscal year 2010, the Company reaffirms Impella revenue guidance in the range of $55 million to $58 million, reflecting a growth rate for Impella of 50% to 60% but is revising its total revenue guidance from a range of $86 million to $91 million to a range of $84 million to $86 million.

The Company will host a conference call on Thursday, February 4, 2010 at 8 a.m. ET to discuss its third quarter 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 866.202.3109; the international number is 617.213.8844. The access participant code is 44119781. A replay of this conference call will be available beginning at 11 a.m. ET on February 4, 2010 through 11:59 p.m. ET on February 18, 2010. The replay phone number is 888.286.8010; the international number is 617.801.6888. The replay access code is 51319497.


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, as well as cash burn, which we define as the change in cash, cash equivalents, short and long-term marketable securities and restricted securities. 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)

 

     December 31, 2009     March 31, 2009  
     (unaudited)        

ASSETS

    

Current assets:

    

Cash and cash equivalents

   $ 3,236      $ 1,785   

Short-term marketable securities

     48,476        55,394   

Accounts receivable, net

     14,400        15,724   

Inventories

     12,629        14,777   

Prepaid expenses and other current assets

     822        809   
                

Total current assets

     79,563        88,489   

Property and equipment, net

     7,225        7,792   

Intangible assets, net

     3,549        4,359   

Goodwill

     39,595        31,295   

Long-term marketable securities

     —          3,721   

Other assets

     302        302   
                

Total assets

   $ 130,234      $ 135,958   
                

LIABILITIES AND STOCKHOLDERS’ EQUITY

    

Current liabilities:

    

Accounts payable

   $ 4,826      $ 5,550   

Accrued expenses

     10,891        10,818   

Deferred revenue

     1,098        1,211   
                

Total current liabilities

     16,815        17,579   

Long-term deferred tax liability

     2,797        2,086   

Other long-term liabilities

     460        310   
                

Total liabilities

     20,072        19,975   
                

Commitments and contingencies (Note 11)

    

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 - 37,541,415 shares at December 31, 2009 and 36,736,843 shares at March 31, 2009;

    

Outstanding - 37,490,461 shares at December 31, 2009 and 36,685,889 shares at March 31, 2009

    

Additional paid-in-capital

     372,507        362,097   

Accumulated deficit

     (263,990     (243,991

Treasury stock at cost - 50,954 shares

     (827     (827

Accumulated other comprehensive income (loss)

     2,097        (1,663
                

Total stockholders’ equity

     110,162        115,983   
                

Total liabilities and stockholders’ equity

   $ 130,234      $ 135,958   
                


LOGO

 

Abiomed, Inc. and Subsidiaries

Condensed Consolidated Statements of Operations

(Unaudited)

(in thousands, except share and per share data)

 

     Three Months Ended
December 31,
    Nine Months Ended
December 31,
 
     2009     2008     2009     2008  

Revenue:

        

Product

   $ 22,623      $ 17,081      $ 61,937      $ 53,128   

Funded research and development

     176        190        797        499   
                                

Total Revenue

     22,799        17,271        62,734        53,627   
                                

Costs and expenses:

        

Cost of product revenue excluding amortization of intangibles

     5,772        4,519        16,290        14,939   

Research and development

     6,397        5,203        19,166        18,197   

Selling, general and administrative

     15,190        13,227        45,973        40,639   

Amortization of intangible assets

     382        362        1,107        1,199   
                                
     27,741        23,311        82,536        74,974   
                                

Loss from operations

     (4,942     (6,040     (19,802     (21,347
                                

Other income and expense:

        

Investment income (expense), net

     275        (1,709     372        (1,508

Gain on sale of WorldHeart stock

     —          313        —          313   

Other income (expense), net

     62        (81     (141     (1
                                
     337        (1,477     231        (1,196
                                

Loss before provision for income taxes

     (4,605     (7,517     (19,571     (22,543

Income tax (benefit) provision

     (40     182        428        600   
                                

Net loss

   $ (4,565   $ (7,699   $ (19,999   $ (23,143
                                

Basic and diluted net loss per share

   $ (0.12   $ (0.21   $ (0.54   $ (0.67

Weighted average shares outstanding

     37,011        36,051        36,829        34,470   
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-----END PRIVACY-ENHANCED MESSAGE-----