Attached files
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| 8-K - FORM 8-K - ABIOMED INC | d8k.htm |
Exhibit 99.1
ABIOMED REPORTS RECORD FISCAL FOURTH QUARTER REVENUE OF $28.5
MILLION, UP 24% OVER PRIOR YEAR
- $101.2 Million in Total Revenue With Gross Margins of 78% for Full Fiscal Year
DANVERS, Mass. — May 18, 2011 – Abiomed, Inc. (NASDAQ: ABMD), a leading provider of breakthrough heart support technologies, today reported fourth quarter fiscal 2011 revenue of $28.5 million, up 24% compared to revenue of $23.0 million in the same period of fiscal 2010. Total revenue for the full fiscal year was $101.2 million, up 18% compared to revenue of $85.7 million in the prior fiscal year.
Fiscal fourth quarter worldwide Impella revenue totaled $22.4 million, up 34% compared to revenue of $16.7 million during the same period of the prior year. Full fiscal year worldwide Impella revenue totaled $77.8 million, up 35% compared to revenue of $57.8 million in the prior fiscal year.
Financial and operating highlights during the fourth quarter of fiscal 2011 include:
| • | A reported 769 U.S. commercial patients were treated with Impella 2.5, 5.0 or LD, a 41% increase compared to a reported 545 patients in the fourth quarter of fiscal 2010. As of March 31, 2011, almost 5,000 U.S. patients had been treated with Impella since the 510(k) clearance of Impella 2.5 in June 2008. |
| • | U.S. Impella reorders of $18.1 million were up 39% from $13.0 million in the fourth quarter of fiscal 2010 and represented 88% of U.S. Impella revenue. For fiscal year 2011, U.S. Impella reorder revenue grew 82% to $62.5 million from $34.4 million. |
| • | In alignment with the Company’s strategy to open fewer sites and drive deeper utilization at existing customer sites, an additional 28 U.S. hospitals purchased Impella 2.5 during the quarter, bringing the total to 521 customer sites. |
| • | Gross margin rate for the fourth quarter of fiscal 2011 was 80%, compared to 73% in the fourth quarter of fiscal 2010. |
| • | Non-Impella revenue was $6.1 million for the fourth quarter of fiscal 2011, 2% lower than $6.2 million in the fourth quarter of fiscal 2010. |
| • | Non-GAAP net income, which is described later in this press release for the fourth quarter of fiscal 2011, was $0.6 million, or $0.01 per diluted share versus a non-GAAP net loss of $4.1 million or $0.11 per basic and diluted share, in the fourth quarter of fiscal 2010. The full 2011 fiscal year non-GAAP net loss was $2.1 million or $0.06 per share compared to a non-GAAP net loss of $13.5 million or $0.37 per share for fiscal 2010. |
| • | GAAP net loss for the fourth quarter of fiscal 2011 was $1.8 million, or $0.05 per basic and diluted share, compared to GAAP net income of $1.0 million, or $0.03 per basic and diluted share for the fourth quarter of fiscal 2010. In the fourth quarter of fiscal 2010, the Company recorded a gain of $6.4 million from the sale of World Heart stock. The full 2011 fiscal year GAAP net loss was $11.8 million or $0.32 per share compared to full 2010 fiscal GAAP net loss of $19.0 million or $0.52 per share. |
| • | Cash, cash equivalents and short-term marketable securities increased by $2.0 million to $60.3 million at March 31, 2011 compared to $58.3 million at March 31, 2010. |
| • | The PROTECT II analysis was completed in the fourth quarter of fiscal 2011 for the entire patient population at 90 days. This analysis was presented at the American College of Cardiology 2011 Scientific Session in New Orleans on April 3, 2011 and Society for Cardiovascular Angiography Interventions (SCAI) 2011 Scientific Sessions in Baltimore on May 6, 2011, and will be presented at EuroPCR in Paris on May 20. These data from PROTECT II demonstrate that Impella had 21% lower major adverse events (MAE) than the intra-aortic balloon pump (IABP) at 90 days (p=0.029) per-protocol. |
Based on current expectations, the Company anticipates fiscal year 2012 revenues to increase by 20% to 24%, in the range of $120 million to $125 million. Impella revenues are forecasted to grow by approximately 30% to 35% and non-Impella revenues to decline by approximately 25%.
“Our momentum continues to grow with multiple best ever quarterly results and customer comprehension of the positive PROTECT II outcomes at 90 days,” said Michael R. Minogue, Chairman, President and Chief Executive Officer of Abiomed. “The Company executed this year by growing U.S. Impella reorder revenue by 82% and generating $1.6 million in cash from operating activities. We are proud of our results in fiscal year 2011 and grateful to our customers and investors for their ongoing support.”
The Company will host a conference call to discuss the results on Wednesday, May 18, 2011, 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 866.730.5768; the international number is 857.350.1592. The access participant code is 85107095. A replay of this conference call will be available beginning at 11 a.m. ET on May 18, 2011 through 11:59 p.m. ET on June 1, 2011. The replay phone number is 888.286.8010; the international number is 617.801.6888. The replay access code is 17914418.
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 income, net income per share, 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 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, the Company’s projected revenues, 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
Corporate Communications Manager
978-646-1553
ir@abiomed.com
###
Abiomed, Inc. and Subsidiaries
Consolidated Balance Sheets
(in thousands, except share data)
| March 31, | ||||||||
| 2011 | 2010 | |||||||
| ASSETS |
||||||||
| Current assets: |
||||||||
| Cash and cash equivalents |
$ | 5,831 | $ | 4,788 | ||||
| Short-term marketable securities |
54,481 | 53,477 | ||||||
| Accounts receivable, net |
15,376 | 13,516 | ||||||
| Inventories |
7,505 | 9,211 | ||||||
| Prepaid expenses and other current assets |
1,544 | 1,676 | ||||||
| Total current assets |
84,737 | 82,668 | ||||||
| Property and equipment, net |
6,273 | 6,753 | ||||||
| Intangible assets, net |
1,632 | 2,979 | ||||||
| Goodwill |
38,946 | 37,170 | ||||||
| Total assets |
$ | 131,588 | $ | 129,570 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY |
||||||||
| Current liabilities: |
||||||||
| Accounts payable |
$ | 6,283 | $ | 3,764 | ||||
| Accrued expenses |
14,078 | 13,011 | ||||||
| Deferred revenue |
1,982 | 1,289 | ||||||
| Total current liabilities |
22,343 | 18,064 | ||||||
| Long-term deferred tax liability |
4,010 | 3,040 | ||||||
| Other long-term liabilities |
492 | 510 | ||||||
| Total liabilities |
26,845 | 21,614 | ||||||
| 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 |
377 | 375 | ||||||
| Authorized - 100,000,000 shares; Issued - 37,756,719 shares at March 31, 2011 and 37,484,018 shares at March 31, 2010; |
||||||||
| Outstanding - 37,705,765 shares at March 31, 2011 and 37,433,064 shares at March 31, 2010 |
||||||||
| Additional paid-in-capital |
379,218 | 372,425 | ||||||
| Accumulated deficit |
(274,770 | ) | (263,015 | ) | ||||
| Treasury stock at cost - 50,954 at March 31, 2011 and March 31, 2010 |
(827 | ) | (827 | ) | ||||
| Accumulated other comprehensive loss |
745 | (1,002 | ) | |||||
| Total stockholders’ equity |
104,743 | 107,956 | ||||||
| Total liabilities and stockholders’ equity |
$ | 131,588 | $ | 129,570 | ||||
Abiomed, Inc. and Subsidiaries
Consolidated Statements of Operations
(Unaudited)
(in thousands, except share data)
| Three Months
Ended March 31, |
Year
Ended March 31, |
|||||||||||||||
| 2011 | 2010 | 2011 | 2010 | |||||||||||||
| Revenue: |
||||||||||||||||
| Product |
$ | 28,103 | $ | 22,828 | $ | 99,837 | $ | 84,765 | ||||||||
| Funded research and development |
426 | 151 | 1,314 | 948 | ||||||||||||
| Total Revenue |
28,529 | 22,979 | 101,151 | 85,713 | ||||||||||||
| Costs and expenses: |
||||||||||||||||
| Cost of product revenue excluding amortization of intangibles |
5,848 | 6,239 | 21,977 | 22,529 | ||||||||||||
| Research and development |
6,843 | 6,788 | 26,677 | 25,954 | ||||||||||||
| Selling, general and administrative |
16,888 | 14,864 | 62,287 | 60,837 | ||||||||||||
| Amortization of intangible assets |
361 | 362 | 1,395 | 1,469 | ||||||||||||
| 29,940 | 28,253 | 112,336 | 110,789 | |||||||||||||
| Loss from operations |
(1,411 | ) | (5,274 | ) | (11,185 | ) | (25,076 | ) | ||||||||
| Other income and expense: |
||||||||||||||||
| Investment income, net |
8 | 1 | 9 | 373 | ||||||||||||
| Gain on sale of WorldHeart stock |
— | 6,389 | 456 | 6,389 | ||||||||||||
| Other income (expense), net |
(126 | ) | 102 | (143 | ) | (39 | ) | |||||||||
| (118 | ) | 6,492 | 322 | 6,723 | ||||||||||||
| Loss before provision for income taxes |
(1,529 | ) | 1,218 | (10,863 | ) | (18,353 | ) | |||||||||
| Income tax provision |
243 | 243 | 892 | 671 | ||||||||||||
| Net (loss) income |
$ | (1,772 | ) | $ | 975 | $ | (11,755 | ) | $ | (19,024 | ) | |||||
| Basic and diluted net (loss) income per share |
$ | (0.05 | ) | $ | 0.03 | $ | (0.32 | ) | $ | (0.52 | ) | |||||
| Weighted average shares outstanding |
37,231 | 37,017 | 37,167 | 36,875 | ||||||||||||
Abiomed Inc
Reconciliation of GAAP to Non-GAAP Net Income/(Loss)
(in thousands, except for per share data)
| Three Months Ended | Year Ended | |||||||||||||||
| March 31, 2011 | March 31, 2010 | March 31, 2011 | March 31, 2010 | |||||||||||||
| Net (loss) income on a GAAP basis |
$ | (1,772 | ) | $ | 975 | $ | (11,755 | ) | $ | (19,024 | ) | |||||
| Share-based compensation expense: |
||||||||||||||||
| - Cost of product revenue |
51 | 59 | 214 | 452 | ||||||||||||
| - Research & development |
252 | (148 | ) | 1,001 | 744 | |||||||||||
| - Selling, general and administrative |
1,100 | (410 | ) | 4,206 | 4,169 | |||||||||||
| Legacy product inventory reserve for excess or obsolete |
||||||||||||||||
| - Cost of product revenue |
— | 711 | — | 1,690 | ||||||||||||
| Athlone lease exit charge |
||||||||||||||||
| - Selling, general and administrative |
— | — | 791 | — | ||||||||||||
| Amortization of intangible assets |
361 | 362 | 1,395 | 1,469 | ||||||||||||
| Depreciation |
579 | 768 | 2,553 | 3,429 | ||||||||||||
| Sale of World Heart Stock |
— | (6,389 | ) | (456 | ) | (6,389 | ) | |||||||||
| Income tax effect of non-GAAP adjustments |
— | — | — | — | ||||||||||||
| Net income/(loss) on a non-GAAP basis |
$ | 571 | $ | (4,072 | ) | $ | (2,051 | ) | $ | (13,460 | ) | |||||
Net income/(loss) per share reconciliation
(in thousands, except for per share data)
| Three Months Ended | Year Ended | |||||||||||||||
| March 31, 2011 | March 31, 2010 | March 31, 2011 | March 31, 2010 | |||||||||||||
| Basic and diluted net loss per share on a GAAP basis |
($ | 0.05 | ) | $ | 0.03 | ($ | 0.32 | ) | ($ | 0.52 | ) | |||||
| Share-based compensation expense: |
||||||||||||||||
| - Cost of product revenue |
— | — | 0.01 | 0.01 | ||||||||||||
| - Research & development |
0.01 | (0.01 | ) | 0.03 | 0.02 | |||||||||||
| - Selling, general and administrative |
0.03 | (0.01 | ) | 0.11 | 0.11 | |||||||||||
| Legacy product inventory reserve for excess or obsolete |
||||||||||||||||
| - Cost of product revenue |
— | 0.02 | — | 0.05 | ||||||||||||
| Athlone fair value charge |
||||||||||||||||
| - Selling, general and administrative |
— | — | 0.02 | — | ||||||||||||
| Amortization of intangible assets |
0.01 | 0.01 | 0.04 | 0.04 | ||||||||||||
| Depreciation |
0.02 | 0.02 | 0.06 | 0.09 | ||||||||||||
| Sale of World Heart Stock |
— | (0.17 | ) | (0.01 | ) | (0.17 | ) | |||||||||
| Income tax effect of non-GAAP adjustments |
— | — | — | — | ||||||||||||
| Basic net income/(loss) per share on a non-GAAP basis |
0.02 | (0.11 | ) | (0.06 | ) | (0.37 | ) | |||||||||
| Dilution Impact |
(0.01 | ) | — | — | — | |||||||||||
| Diluted net income/(loss) per share on a non-GAAP basis |
0.01 | (0.11 | ) | (0.06 | ) | (0.37 | ) | |||||||||