News Column

Abiomed Announces Fourth Quarter Fiscal 2014 Revenue of $50.4 Million, Up 15%

May 1, 2014

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:

• 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.

 • 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.

 • 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.

 • 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.

 • 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.

 • 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.

 • 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.

 • 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.

 • 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.

 • 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. 

 • 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. ETMay 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,
 20142013
     
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 EndedYear Ended
 March 31,March 31,
 2014201320142013
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

CONTACT: For further information please contact: Aimee Genzler Corporate Communications Manager 978-646-1553 ir@abiomed.com



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