Abiomed Reports Third Quarter Fiscal 2010 Financial Results

Thu Feb 4, 7:08 AM

DANVERS, Mass.--(BUSINESS WIRE)--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.
 

IMPELLA US COMMERCIAL LAUNCH

 
                                          Growth
Q2‘09 Q3’09 Q4’09 Q1’10 Q2’10 Q3’10

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.

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.

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, 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 - 37,409,461 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  
 

 
Abiomed, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations
(Unaudited)
(in thousands, except share and per share data)
         
Three Months Ended Nine Months Ended
December 31, 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

Abiomed, Inc.
Paula Carpinella, 978-646-1816
ir@abiomed.com