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Record Patient Utilization and 200% Growth in Impella CP Patients
- Abiomed Completes Impella 2.5 Submission for Pre-Market Approval (PMA)
DANVERS, Mass., May 1, 2014 (GLOBE NEWSWIRE) -- Abiomed, Inc. (Nasdaq:ABMD), a leading provider of breakthrough heart support technologies, today reported fourth quarter fiscal 2014 revenue of $50.4 million, up 15% compared to revenue of $43.7 million for the same period of fiscal 2013, and a fourth quarter fiscal 2014 GAAP net income of $3.6 million, or $0.09 per diluted share. For the full fiscal year 2014, total revenue was $183.6 million, up 16%, and GAAP net income was $7.4 million or $0.18 per diluted share.
Financial and operating highlights for the fourth quarter of fiscal 2014 and fiscal year to date include:
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Fiscal fourth quarter worldwide Impella® revenue totaled $46.1 million, an increase of 17%, compared to revenue of $39.3 million in the prior year. Full year worldwide Impella revenue totaled $167.0 million, up 19% compared to $140.3 million for fiscal year 2013.
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Fiscal fourth quarter U.S. Impella revenue grew 15% to $41.8 million from $36.5 million in the prior year. Full year U.S. Impella revenue grew 16% to $152.0 million from $131.3 million in the prior year.
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An additional 23 hospitals purchased Impella 2.5 during the quarter, compared to 30 hospitals in the same period of the prior year, bringing the total number of customer sites to 859. As part of Abiomed's continued Impella CP® launch, an additional 77 hospitals purchased Impella CP during the fiscal fourth quarter, compared to 60 hospitals in the prior year, bringing the total number of Impella CP U.S. sites to 389.
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Gross margin for the fourth quarter of fiscal 2014 was 79.9% compared to 79.8% for the fourth quarter of fiscal 2013. For the full fiscal year 2014, gross margin was 79.7% compared to 80.0% in the prior year. There were 675 Impella AIC consoles placed during fiscal year 2014 compared to 640 in the prior year.
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Income from operations for the fourth quarter fiscal 2014 was $3.7 million, or 7.3% of revenue. For the full fiscal year period, income from operations was $8.4 million or 4.6% of revenue.
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Cash, cash equivalents, short- and long-term marketable securities totaled $118.3 million, as of March 31, 2014. The Company continues to have no debt, and its U.S. federal net operating loss carry-forward was approximately $194 million, as of March 31, 2014.
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In March, Abiomed announced, with the enrollment of the 30th patient, the completion of the Impella® RP RECOVER RIGHT trial. Additionally, the Impella RP received CE Marking approval in the European Union in April 2014, which will allow the Company to market the Impella RP device in Europe.
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Additionally during the quarter, Abiomed announced that the Centers for Medicare & Medicaid Services (CMS) released an updated version of ICD-10 Diagnosis Related Groups (MS-DRGs) (version 31R) and Impella maintained its assignment to MS-DRGs 216-221 for the category of devices that includes Impella pumps.
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In April, Abiomed announced the acquisition of an exclusive license for Opsens' optical sensor technologies for the integration of miniature optical pressure sensors into Impella heart pump catheters.
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On April 10, 2014, the U.S. District Court for the District of Massachusetts granted Abiomed's motion to dismiss the consolidated shareholder's lawsuit.
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On April 25, 2014, Abiomed received a subpoena from the Boston regional office of the United States Department of Health and Human Services, Office of Inspector General requesting materials relevant to the Company's reimbursement of expenses and remuneration to healthcare providers during the period of July 2012 – December 2012. The Office of Inspector General has informed the Company that the subpoena currently relates to a civil investigation. The Company intends to comply fully and promptly with this request.
- Today, Abiomed announces it has submitted the final module to the Food & Drug Administration (FDA) submission for Pre-Market Approval (PMA), as planned last quarter. The PMA submission for Impella 2.5 contains clinical data from 215 publications, references 1,638 Impella 2.5 patients, including three FDA studies: PROTECT I, PROTECT II, and RECOVER I, as well as 791 new high risk Impella patients from the U.S. Impella registry.
"Abiomed delivered another strong quarter, driven by record patient utilization and 200% growth in Impella CP patients," said Michael R. Minogue, Chairman, President and Chief Executive Officer, Abiomed. "For the full fiscal year, Abiomed had solid Impella growth of 19% with overall revenue of $183.6M, and set new records for patients supported and quantity of clinical publications. On the regulatory side, we completed our Impella 2.5 PMA submission and our Impella RP FDA trial."
FISCAL YEAR 2015 OUTLOOK
The Company is giving its fiscal year 2015 guidance for total revenues to be in the range of $205 million to $212 million. The Company is also giving its fiscal year 2015 guidance for GAAP operating margin to be in the range of 5% - 7%.
CONFERENCE CALL
The Company will host a conference call to discuss the results on Thursday, May 1, 2014, 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 (877) 638-9567; the international number is (253) 237-1032. A replay of this conference call will be available beginning at 11 a.m. ET May 1, 2014 through 11:59 p.m. ET on May 8, 2014. The replay phone number is (855) 859-2056; the international number is (404) 537-3406. The replay access code is 22380865.
ABOUT ABIOMED
Based in Danvers, Massachusetts, Abiomed, Inc. is a leading provider of medical devices that provide circulatory support. Our products are designed to enable the heart to rest 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 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 the potential for future losses, complex manufacturing, high quality requirements, dependence on limited sources of supply, competition, technological change, government regulation, litigation matters, 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 most recently filed Annual Report on Form 10-K and 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 | ||
| Consolidated Balance Sheets | ||
| (Unaudited) | ||
| (in thousands, except share data) | ||
| March 31, | ||
| 2014 | 2013 | |
| ASSETS | ||
| Current assets: | ||
| Cash and cash equivalents | $ 20,916 | $ 9,451 |
| Short-term marketable securities | 55,663 | 67,256 |
| Accounts receivable, net | 24,357 | 22,946 |
| Inventories | 13,948 | 14,930 |
| Prepaid expenses and other current assets | 3,082 | 2,022 |
| Total current assets | 117,966 | 116,605 |
| Long-term marketable securities | 41,761 | 11,406 |
| Property and equipment, net | 6,889 | 6,549 |
| Goodwill | 37,990 | 35,410 |
| Other | 801 | 29 |
| Total assets | $ 205,407 | $ 169,999 |
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||
| Current liabilities: | ||
| Accounts payable | $ 7,746 | $ 7,696 |
| Accrued expenses | 17,899 | 15,162 |
| Deferred revenue | 4,766 | 4,198 |
| Total current liabilities | 30,411 | 27,056 |
| Long-term deferred tax liability | 6,415 | 5,554 |
| Other long-term liabilities | 228 | 309 |
| Total liabilities | 37,054 | 32,919 |
| 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 | 411 | 397 |
| Authorized - 100,000,000 shares; Issued - 41,122,695 shares at March 31, 2014 and 39,788,383 shares at March 31, 2013; | ||
| Outstanding - 39,916,328 shares at March 31, 2014 and 38,601,384 shares at March 31, 2013 | ||
| Additional paid in capital | 436,136 | 414,810 |
| Accumulated deficit | (250,910) | (258,261) |
| Treasury stock at cost - 1,206,367 shares at March 31, 2014 and 1,186,999 shares at March 31, 2013 | (16,554) | (16,129) |
| Accumulated other comprehensive loss | (730) | (3,737) |
| Total stockholders' equity | 168,353 | 137,080 |
| Total liabilities and stockholders' equity | $ 205,407 | $ 169,999 |
| Abiomed, Inc. and Subsidiaries | ||||
| Consolidated Statements of Operations | ||||
| (Unaudited) | ||||
| (in thousands, except share data) | ||||
| Three Months Ended | Year Ended | |||
| March 31, | March 31, | |||
| 2014 | 2013 | 2014 | 2013 | |
| Revenue: | ||||
| Product revenue | $ 50,242 | $ 43,536 | $ 183,280 | $ 157,614 |
| Funded research and development | 191 | 138 | 363 | 510 |
| 50,433 | 43,674 | 183,643 | 158,124 | |
| Costs and expenses: | ||||
| Cost of product revenue | 10,114 | 8,826 | 37,322 | 31,596 |
| Research and development | 7,920 | 6,822 | 30,707 | 25,647 |
| Selling, general and administrative | 28,721 | 23,894 | 107,251 | 84,227 |
| Amortization of intangible assets | -- | -- | -- | 111 |
| 46,755 | 39,542 | 175,280 | 141,581 | |
| Income from operations | 3,678 | 4,132 | 8,363 | 16,543 |
| Other income (expense): | ||||
| Investment income (expense), net | 40 | (7) | 118 | (7) |
| Other income (expense), net | 44 | 15 | 49 | 326 |
| 84 | 8 | 167 | 319 | |
| Income before provision for income taxes | 3,762 | 4,140 | 8,530 | 16,862 |
| Income tax provision | 140 | 398 | 1,179 | 1,848 |
| Net income | $ 3,622 | $ 3,742 | $ 7,351 | $ 15,014 |
| Basic net income per share | $ 0.09 | $ 0.10 | $ 0.19 | $ 0.38 |
| Basic weighted average shares outstanding | 39,810 | 38,445 | 39,334 | 39,113 |
| Diluted net income per share | $ 0.09 | $ 0.09 | $ 0.18 | $ 0.37 |
| Diluted weighted average shares outstanding | 42,125 | 39,824 | 41,606 | 41,052 |