<< Back
Abiomed Announces Revenue of $17.3 Million, Representing 8% Growth for Third Quarter of Fiscal 2009

DANVERS, Mass.--(BUSINESS WIRE)-- Abiomed, Inc. (NASDAQ: ABMD)

  • Impella Revenue of $8.9 Million, Increased by 112%, Legacy Business Decreased by 29%
  • Net Cash Used for Operating Activities of $2.5M

Abiomed, Inc. (NASDAQ: ABMD), a leading provider of heart recovery products providing circulatory support to acute heart failure patients, today announced third quarter of fiscal 2009 revenue of $17.3 million, up 8% compared to revenue of $16.0 million for the same period of fiscal 2008. Revenue for the nine months ended December 31, 2008 was $53.6 million, up 29% compared to revenue of $41.4 million in the first nine months of fiscal 2008.

  • As of December 31, 2008, 163 U.S. hospitals had purchased Impella 2.5 for commercial 510(k) use, as compared to 108 hospitals that had purchased Impella 2.5 by the end of the prior quarter, a 51% increase.
  • Total Impella revenue was $8.9 million, up 112% for the third fiscal quarter of 2009 compared to the same period of fiscal 2008.
  • Impella revenue recorded during the third fiscal quarter of 2009 included $7.3 million in U.S. sales, of which $6.7 million was for sales of Impella 2.5 sold under 510(k) clearance as compared to $6.2 million from the second quarter of fiscal 2009, representing an 8% sequential growth. Fiscal third quarter revenues of $0.6 million sold under the Protect II and Recover II trials compared to $2.6 million in the second quarter of fiscal 2009.
  • As of December 31, 2008, 85 U.S. hospitals are enrolling patients in the Protect II study for high-risk percutaneous coronary intervention (PCI) and 18 hospitals had submitted to the IRB or submission was pending. Overall, 180 patients from 49 hospitals were completed or 28% of the 654 patients required.
  • The assumptions for the Protect II major adverse event rate (MAE) are 20 and 30% for Impella and IABP respectively. At the Transcatheter Cardiovascular Therapeutics (TCT) Conference in October 2008, the Protect II Primary Investigator, William W. O’Neill, M.D., University of Miami Health System, stated that the initial aggregate adverse event rates for the trial are tracking in line with the 25% expected rate at 20% completion of the study.
  • As of December 31, 2008, one patient has been enrolled out of the seven U.S. hospitals that were enrolling patients in the Impella 2.5 Recover II study for acute myocardial infarction (AMI), 10 sites have IRB approval and not yet ready to enroll, and 24 sites have submitted for IRB approval.
  • Total non-Impella business revenue (BVS® 5000, AB5000®, iPulseTM, intra-aortic balloon or IAB, AbioCor®, service and other) was $8.4 million for the third fiscal quarter of 2009 and decreased $3.4 million or approximately 29% compared to the same period of fiscal 2008.
  • A total of 771 pumps were shipped during the quarter (excluding IAB disposables) as compared to 676 in the third quarter of fiscal 2008, representing a 14% increase in the number of units shipped. Total disposables, service and other revenue (non-console revenue) comprised approximately 93% of total revenue for third quarter of fiscal 2009.
  • Gross margin for the third quarter of fiscal 2009 was 74% compared to 76% for the same period of fiscal 2008.
  • The third quarter of fiscal 2009 GAAP net loss was $7.7 million or $0.21 per share, down from a GAAP net loss of $8.3 million or $0.26 per share during the third quarter of fiscal 2008. Third quarter fiscal 2009 GAAP net loss included stock-based compensation expense of $1.9 million and intangibles amortization of $0.4 million. Fiscal 2008 GAAP net loss included stock-based compensation expense of $1.4 million and intangibles amortization of $0.4 million.
  • The non-GAAP net loss, excluding stock-based compensation and intangibles amortization expense, for the third quarter of fiscal 2009 was approximately $5.4 million, or $0.15 per share, a decrease compared to the non-GAAP net loss for the third quarter of fiscal 2008 which was $6.5 million, or $0.20 per share.
  • The net cash used for operating activities for the third quarter of fiscal 2009 was $2.5 million, which included a $1.9 million write down of the Columbia Fund Investments. At December 31, 2008, the Company had cash and short-term marketable securities of $63.8 million.

“Impella 2.5 is now at 76% of the top 50 heart hospitals listed in the US World & News Report, after six months of 510(k) clearance, " said Michael R. Minogue, Chairman, President and Chief Executive Officer, Abiomed. “In addition to our ongoing Impella momentum and customer adoption, we have significantly reduced our cash burn this quarter.”

For the fiscal year 2009, the Company believes worldwide revenues will be at the lower end of the previously guided range of $75-80 million.

The Company will host a conference call today at 8 a.m. ET to discuss its third quarter of fiscal 2009 results and provide an update on the Impella launch and trials. 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 866.356.4279; the international number is 617.597.5394. The access participant code is 37762794. A replay of this conference call will be available beginning at 10 a.m. ET on February 5, 2009 through 11:59 p.m. ET on February 19, 2009. The replay phone number is 888.286.8010; the international number is 617.801.6888. The replay access code is 72392957.

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 option expense, 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 option and other 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 and related regulatory approvals, including 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 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.

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.

ABIOMED, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share data)
   
December 31, 2008 March 31, 2008
(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents $ 2,734 $ 2,042
Short-term marketable securities 61,046 36,257
Accounts receivable, net 14,170 14,071
Inventories 17,776 17,428
Prepaid expenses and other current assets   666     1,705  
Total current assets 96,392 71,503
Property and equipment, net 7,649 7,551
Intangible assets, net 4,982 6,921
Goodwill 32,731 31,563
Other assets   357     493  
Total assets $ 142,111   $ 118,031  
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 3,947 $ 9,024
Accrued expenses 8,456 9,290
Deferred revenue   1,210     1,162  
Total current liabilities 13,613 19,476
Long-term deferred tax liability 1,894 4,740
Other long-term liabilities   260     221  
Total liabilities   15,767     24,437  
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 368 328
Authorized - 100,000,000 shares;
Issued - 36,737,462 shares at December 31, 2008 and 32,779,404 shares at March 31, 2008;
Outstanding - 36,686,508 shares at December 31, 2008 and 32,768,385 shares at March 31, 2008
Additional paid-in-capital 360,120 300,787
Accumulated deficit (235,537 ) (212,394 )
Treasury stock at cost - 50,954 shares at December 31, 2008 and 11,019 at March 31, 2008 (827 ) (116 )
Accumulated other comprehensive income   2,220     4,989  
Total stockholders' equity   126,344     93,594  
Total liabilities and stockholders' equity $ 142,111   $ 118,031  
ABIOMED, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
       
Three Months Ended Nine Months Ended
December 31, December 31,
2008   2007 2008   2007
Revenue:
Product $ 17,081 $ 15,826 $ 53,128 $ 40,999
Funded research and development   190     189     499     435  
Total Revenue   17,271     16,015     53,627     41,434  
 
Costs and expenses:
Cost of product revenue excluding amortization of intangibles 4,519 3,773 14,939 10,182
Research and development 5,203 6,883 18,197 18,231
Selling, general and administrative 13,227 13,540 40,639 38,239
Arbitration decision - - - 1,206
Amortization of intangible assets   362     403     1,199     1,169  
  23,311     24,599     74,974     69,027  
Loss from operations   (6,040 )   (8,584 )   (21,347 )   (27,593 )
Other income and expense:
Investment (expense) income, net (1,709 ) 611 (1,508 ) 2,320
Gain on sale of WorldHeart stock 313 - 313 -
Change in fair value of WorldHeart note receivable and warrant - 589 - 589
Other expense, net   (81 )   (750 )   (1 )   (817 )
  (1,477 )   450     (1,196 )   2,092  
Loss before provision for income taxes (7,517 ) (8,134 ) (22,543 ) (25,501 )
Provision for income taxes   182     167     600     457  
Net loss $ (7,699 ) $ (8,301 ) $ (23,143 ) $ (25,958 )
 
Basic and diluted net loss per share $ (0.21 ) $ (0.26 ) $ (0.67 ) $ (0.80 )
Weighted average shares outstanding 36,051 32,488 34,470 32,415

Source: Abiomed, Inc.

Abiomed, Inc.
Aimee Maillett, 978-646-1553
Public Relations Specialist
ir@abiomed.com

Could not find file '\\aws.nasdaqomx.com\irwebpro\content3\IRXMLDATA\95\95629\Disclaimers.xml'.