(Source: Business Wire)

Abiomed, Inc. (NASDAQ: ABMD), a leading provider of breakthrough heart support technologies, today announced fourth quarter of fiscal 2009 revenue of $19.6 million, up 12% compared to revenue of $17.5 million for the fourth quarter of fiscal 2008, and up 13% sequentially, compared to revenue of $17.3 million for the third quarter of fiscal 2009.
Total revenue for the twelve months ended March 31, 2009, was $73.2 million, up 24% compared to revenue of $58.9 million for the full year fiscal 2008. Full year fiscal 2009 worldwide Impella revenue was $36.4 million, up 196% compared to Impella revenue of $12.3 million for the full year fiscal 2008.
Recent financial and operating highlights during the fourth quarter of fiscal 2009 include:
Worldwide Impella revenue was $11.2 million, up 124% compared to revenue of $5.0 million for the fourth quarter of fiscal 2008 and up 26% sequentially, compared to revenue of $8.9 million for the third quarter of fiscal 2009.
Impella U.S. revenue totaled $9.9 million, of which $9.1 million was for sales of Impella 2.5 under 510(k) clearance, up 36% sequentially, compared to revenue of $6.7 million for the third quarter of fiscal 2009.
Approximately 261 U.S. patients were treated with Impella 2.5 under the 510(k) clearance, up 63% from approximately 160 patients treated in the third quarter and up 161% from approximately 100 patients treated within the first four months after the 510(k) clearance in June 2008. For the full year fiscal 2009, approximately 521 U.S. patients were supported with Impella 2.5 under the 510(k) clearance.
During the quarter, over 50% of total Impella 2.5 510(k) revenue was from reorders and reorder rates exceeded 80% of patient utilization.
An additional 66 U.S. hospitals purchased Impella 2.5 for general use, bringing the total to 229 general use customers or 14% of potential 1,700 U.S. hospitals with catheterization labs (cath labs). The average order for new Impella sites was three disposable units.
A total of 95 hospitals are participating in the Protect II study and 43 patients were enrolled, for a total of 223 patients completed in the Protect II study, or 34% of the 654 patients required.
Legacy revenue was $8.4 million, 33% lower than the fourth quarter of fiscal 2008. The fourth quarter of fiscal 2008 legacy revenue included $1.3 million in revenues from the initial hospital start-up of the AbioCor.
On March 30, 2009, Abiomed announced it had received U.S. Food and Drug Administration (FDA) approval of its Premarket Approval Application (PMA) supplement for the AB Portable Driver. Additionally, on April 22, 2009, Abiomed announced that it had received U.S. Food and Drug Administration (FDA) 510(k) clearance of its Impella® 5.0 and Impella® LD Circulatory Support Devices.
The GAAP net loss was $8.5 million, or a loss of $0.23 per fully diluted share, compared to a GAAP net loss of $15.0 million, or a loss of $0.46 per fully diluted share during the fourth quarter of fiscal 2008. The full year fiscal 2009 GAAP net loss was $31.6 million, or a loss of $0.91 per fully diluted share, compared to a GAAP net loss of $40.9 million, or a loss of $1.26 per fully diluted share for the full year fiscal 2008.
The non-GAAP net loss for the fourth quarter of fiscal 2008, after excluding stock-based compensation expense of $1.8 million, intangibles amortization expense of $0.4 million, was $6.3 million, or a loss of $0.17 per fully diluted share, compared to the non-GAAP net loss for the fourth quarter of fiscal 2008, after excluding stock-based compensation expense of $1.1 million, intangibles amortization of $0.4 million, and a non-cash charge of $5.6 million for the change in fair value of the Company's note receivable from World Heart Corporation, which was $7.9 million, or a loss of $0.24 per fully diluted share. The non-GAAP net loss for the full fiscal year 2009, after excluding stock-based compensation expense of $8.8 million and intangibles amortization of $1.6 million, was $21.2 million, or a loss of $0.61 per fully diluted share, compared to the non-GAAP net loss for the full fiscal year 2008, after excluding stock-based compensation expense of $5.4 million, intangibles amortization of $1.6 million, a litigation settlement of $1.2 million, and a non-cash charge of $5.0 million for the change in the fair value of the Company's note receivable from World Heart Corporation, which was $27.7 million, or a loss of $0.85 per fully diluted share.
Cash, cash equivalents plus short and long-term marketable securities totaled $60.9 million compared to $63.8 million at December 31, 2008.
"Fiscal 2009 showcased the U.S. market demand for Impella 2.5 minimally invasive heart recovery technology, demonstrated by its rapid adoption and utilization, during a difficult financial time for our customers," said Michael R. Minogue, Chairman, President and Chief Executive Officer of Abiomed. "We quickly surpassed our fiscal 2009 goal of penetrating 100 hospitals and supporting 100 patients by reaching 229 hospital sites and 521 patients in ten months. In addition, we reduced the cash burn, raised additional funds, and executed on our U.S. regulatory path with four new product introductions over the last 12 months. In fiscal 2010, we are focused on growing shareholder value by further increasing Impella utilization and expanding its clinical utility."
The Company will host a conference call on Monday, May 18, 2009 at 8 a.m. ET to discuss its fourth quarter of fiscal 2009 results and fiscal 2010 guidance. 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 800.798.2864; the international number is 617.614.6206. The access participant code is 92860386. A replay of this conference call will be available beginning at 11 a.m. ET on May 18, 2009 through 11:59 p.m. ET on June 1, 2009. The replay phone number is 888.286.8010; the international number is 617.801.6888. The replay access code is 89776134.
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 (Unaudited) (in thousands, except share data) March 31, 2009 2008 ASSETS Current assets: Cash and cash equivalents $ 1,785 $ 2,042 Short-term marketable securities 55,394 36,257 Accounts receivable, net 15,724 14,071 Inventories 14,777 17,428 Prepaid expenses and other current assets 809 1,705 Total current assets 88,489 71,503 Property and equipment, net 7,792 7,551 Intangible assets, net 4,359 6,921 Goodwill 31,295 31,563 Long-term marketable securities 3,721 - Other assets 302 493 Total assets $ 135,958 $ 118,031 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 5,550 $ 9,024 Accrued expenses 10,818 9,290 Deferred revenue 1,211 1,162 Total current liabilities 17,579 19,476 Long-term deferred tax liability 2,086 4,740 Other long-term liabilities 310 221 Total liabilities 19,975 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 367 328 Authorized - 100,000,000 shares; Issued - 36,736,843 sharesat March 31, 2009 and 32,779,404 shares at March 31, 2008; Outstanding - 36,685,889 shares at March 31, 2009and 32,768,385 shares at March 31, 2008 Additional paid-in-capital 362,125 300,787 Accumulated deficit (243,991 ) (212,394 ) Treasury stock at cost - 50,954 at March 31, 2009 and 11,019 shares at March 31, 2008 (827 ) (116 ) Accumulated other comprehensive (loss) income (1,691 ) 4,989 Total stockholders' equity 115,983 93,594 Total liabilities and stockholders' equity $ 135,958 $ 118,031 -------------------------------------------------------------------------------
Abiomed, Inc. and Subsidiaries Condensed Consolidated Statements of Operations (Unaudited) (in thousands, except per share data) Three Months Ended Twelve Months Ended March 31, March 31, 2009 2008 2009 2008 Revenue: Product $ 19,384 $ 17,323 $ 72,512 $ 58,322 Funded research and development 199 184 698 619 Total Revenue 19,583 17,507 73,210 58,941 Costs and expenses: Cost of product revenue excluding amortization of intangibles 5,498 4,883 20,437 15,065 Research and development 7,131 6,686 25,328 24,917 Selling, general and administrative 14,718 14,419 55,357 52,658 Arbitration decision - - - 1,206 Amortization of intangible assets 407 413 1,606 1,582 27,754 26,401 102,728 95,428 Loss from operations (8,171 ) (8,894 ) (29,518 ) (36,487 ) Other income and expense: Investment (expense) income, net 104 (695 ) (1,404 ) 1,625 Gain on sale of WorldHeart stock 0 - 313 - Change in fair value of WorldHeart note receivable and warrant - (5,589 ) - (5,000 ) Other expense, net (235 ) 276 (236 ) (541 ) (131 ) (6,008 ) (1,327 ) (3,916 ) Loss before provision for income taxes (8,302 ) (14,902 ) (30,845 ) (40,403 ) Provision for income taxes 152 70 752 527 Net loss $ (8,454 ) $ (14,972 ) $ (31,597 ) $ (40,930 ) Basic and diluted net loss per share $ (0.23 ) $ (0.46 ) $ (0.91 ) $ (1.26 ) Weighted average shares outstanding 36,142 32,612 34,882 32,465 -------------------------------------------------------------------------------
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