Abiomed, Inc. (NASDAQ: ABMD) today announced financial results for its fourth quarter of fiscal 2007 ended March 31, 2007. Revenue for the fourth quarter of fiscal 2007 was $13.9 million and revenue for the full fiscal year 2007 reached $50.6 million, up approximately 16% over fiscal year 2006. For the full fiscal year 2007, revenue from its AB5000 product platform was up 38%, BVS declined 22%, and Impella was up 87%.
Recent financial and operating highlights include:
- In the fourth quarter of fiscal 2007, Abiomed shipped a record 625 disposable units. Revenues in the fourth quarter of fiscal 2007 as compared to the fourth quarter of fiscal 2006 for AB5000 disposables increased 15%, BVS disposables revenue declined 19%, and Impella disposables revenue grew 140%.
- The Company believes there will be U.S. market demand for Abiomed’s iPulse console (combination driver for the Intra-Aortic Balloon, BVS and AB5000) following FDA supplement approval anticipated later this summer. In December 2006, Abiomed announced the new iPulse Console and 510(k) clearance of its Intra-Aortic Balloon. In the fourth quarter of fiscal 2007, Abiomed began selling Intra-Aortic Balloons. In the fourth quarter of fiscal 2007 compared to the fourth quarter of fiscal 2006, AB5000 console revenue declined 38%, however, total AB5000 console revenue increased 41% for the full fiscal year 2007 compared to fiscal 2006.
- Fourth quarter of fiscal 2007 total revenue of $13.9 million increased approximately 1% compared to the same period of fiscal 2006, as disposables growth was partially offset by lower AB5000 console revenue.
- Gross margin for the fourth quarter of fiscal 2007 was 80%, up 800 basis points compared to the same period of fiscal 2006.
- The fourth quarter of fiscal 2007 was the fifth consecutive record quarter for the number of patients supported by AB5000 Circulatory Support Systems worldwide and a record number of AB5000 Ventricles were shipped during the quarter.
- The fourth quarter of fiscal 2007 GAAP net loss was $6.3 million, or $.22 per share, which included stock option and other stock-based compensation expense of $1.2 million, or $.04 per share. The net loss for the fourth quarter of fiscal 2006 was $3.7 million, or $.14 per share.
- Completed public offering of approximately 5.1 million common shares with net cash proceeds of approximately $65 million.
- Completed patient enrollment of 20 patients in the pilot trial for Impella 2.5. The pilot trial will be completed after Abiomed has concluded all necessary post-enrollment patient monitoring. In addition, Abiomed continues to work with the FDA on its 510(k) submission for the Impella 2.5.
“We are pleased with our momentum during fiscal year 2007 as we increased our global distribution, announced four new products, demonstrated progress with our regulatory approvals and grew revenue by double digits,” said Michael R. Minogue, Chairman, CEO and President of Abiomed. “We are excited about our growth opportunities in fiscal 2008 as we bring Impella, iPulse and other new products to global markets to establish heart recovery as the standard of care for all acute events.”
Abiomed forecasts fiscal 2008 revenue growth to be greater than 20%, with incremental revenue growth based on the timing of U.S. clinical trials and global regulatory approvals of new products (Impella 2.5, Impella 5.0, Impella pediatric, iPulse supplement, AbioCor supplement, and other products to be announced). Abiomed’s forecast for fiscal 2008 does not include the impact of potentially receiving 510(k) clearance of the Impella 2.5. Based on its current strategy to increase its global distribution and invest in research and development to broaden its product portfolio, the Company expects a GAAP net loss in fiscal 2008 of approximately $21 million to $26 million, including the effects of stock option expense of approximately $6 million.
Financial information for the fourth quarter and full year of fiscal 2007 is attached to this press release.
CONFERENCE CALL AND WEBCAST INFORMATION
The Company will host a conference call to discuss the results on May 17, 2007, at 11:00 a.m. ET. Michael R. Minogue, chairman, chief executive officer and president, and Daniel J. Sutherby, 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 800-510-0219; the international number is 617-614-3451. The access code is 91288639. A replay of this conference call will be available beginning at 1 p.m. ET on May 17, 2007 through 11:59 p.m. ET on May 31, 2007. The replay phone number is 888-286-8010; the international number is 617-801-6888. The replay access code is 88212273.
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.
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. 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, 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 its 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, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (in thousands, except share data) | ||||||||
| March 31, | ||||||||
| 2007 | 2006 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 69,646 | $ | 7,832 | ||||
| Short-term marketable securities | 5,479 | 23,003 | ||||||
| Accounts receivable, net | 10,932 | 8,880 | ||||||
| Inventories | 8,567 | 4,868 | ||||||
| Prepaid expenses and other current assets | 1,758 | 1,860 | ||||||
| Total current assets | 96,382 | 46,443 | ||||||
Property and equipment, net | 5,764 | 4,824 | ||||||
| Intangible assets, net | 7,329 | 8,164 | ||||||
| Goodwill | 26,708 | 19,106 | ||||||
| Total Assets | $ | 136,183 | $ | 78,537 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 5,185 | $ | 3,070 | ||||
| Accrued expenses | 7,017 | 5,185 | ||||||
| Deferred revenue | 695 | 484 | ||||||
| Total current liabilities | 12,897 | 8,739 | ||||||
| Long-term deferred tax liability | 1,191 | 310 | ||||||
| Total Liabilities | 14,088 | 9,049 | ||||||
| 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— | ||||||||
| Authorized—100,000,000 shares; Issued—32,254,577 shares at March 31, 2007 and 26,474,270 shares at March 31, 2006 | ||||||||
| Outstanding—32,243,558 shares at March 31, 2007 and 26,468,091 shares at March 31, 2006 | 323 | 265 | ||||||
| Additional paid-in capital | 292,467 | 214,666 | ||||||
| Deferred stock-based compensation | — | (171 | ) | |||||
| Accumulated deficit | (171,189 | ) | (143,308 | ) | ||||
| Treasury stock, at cost | ||||||||
| 11,019 shares at March 31, 2007 and 6,179 shares at March 31, 2006 | (116 | ) | (66 | ) | ||||
| Accumulated other comprehensive (loss) income | 610 | (1,898 | ) | |||||
| Total stockholders’ equity | 122,095 | 69,488 | ||||||
| Total liabilities and stockholders’ equity | $ | 136,183 | $ | 78,537 | ||||
ABIOMED, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) (in thousands, except per share data) | ||||||||||||||||
| Three months ended March 31, | Twelve months ended March 31, | |||||||||||||||
| 2007 | 2006 | 2007 | 2006 | |||||||||||||
| Revenue: | ||||||||||||||||
| Products | $ | 13,710 | $ | 13,717 | $ | 50,408 | $ | 43,322 | ||||||||
| Funded research and development | 141 | 79 | 241 | 348 | ||||||||||||
| 13,851 | 13,796 | 50,649 | 43,670 | |||||||||||||
| Costs and expenses: | ||||||||||||||||
| Cost of product revenue excluding amortization | 2,731 | 3,834 | 12,012 | 11,685 | ||||||||||||
| Research and development | 5,963 | 4,222 | 22,292 | 16,739 | ||||||||||||
| Selling, general and administrative | 11,093 | 9,365 | 42,448 | 30,923 | ||||||||||||
| Expensed in-process research and development | — | — | 800 | 13,306 | ||||||||||||
| Amortization of intangible assets | 365 | 353 | 1,608 | 1,308 | ||||||||||||
| 20,152 | 17,774 | 79,160 | 73,961 | |||||||||||||
| Loss from operations | (6,301 | ) | (3,978 | ) | (28,511 | ) | (30,291 | ) | ||||||||
| Other income: | ||||||||||||||||
| Investment income | 204 | 318 | 1,045 | 1,194 | ||||||||||||
| Foreign exchange gain (loss) | (176 | ) | 52 | (27 | ) | (116 | ) | |||||||||
| Other income, net | 55 | 29 | 87 | 120 | ||||||||||||
| 83 | 399 | 1,105 | 1,198 | |||||||||||||
| Net loss before provision for income taxes | (6,218 | ) | (3,579 | ) | (27,406 | ) | (29,093 | ) | ||||||||
| Provision for income taxes | 131 | 103 | 475 | 356 | ||||||||||||
| Net loss | $ | (6,349 | ) | $ | (3,682 | ) | $ | (27,881 | ) | $ | (29,449 | ) | ||||
| Basic and diluted net loss per share | $ | (0.22 | ) | $ | (0.14 | ) | $ | (1.03 | ) | $ | (1.15 | ) | ||||
| Weighted average shares outstanding | 28,336 | 26,382 | 27,124 | 25,649 | ||||||||||||
