UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 5, 2015
(Date of earliest event reported)
ABIOMED, Inc.
(Exact name of registrant as specified in its charter)
Delaware | 04-2743260 | |
(State or other Jurisdiction of Incorporation) |
(IRS Employer Identification Number) |
001-09585
(Commission File Number)
22 Cherry Hill Drive
Danvers, MA 01923
(Address of Principal Executive Offices, including Zip Code)
(978) 646-1400
(Registrants Telephone Number, including Area Code)
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c) |
Item 2.02 | Results of Operations and Financial Condition. |
On May 5, 2015, we issued a press release reporting our financial results for our fourth quarter ended March 31, 2015. A copy of the press release is set forth as Exhibit 99.1 and is incorporated herein by reference. The information contained in this report shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Securities Act of 1934, whether made before or after the date hereof and regardless of any general incorporation language in such filing, except as expressly set forth by specific reference in such filing.
Item 9.01 | Financial Statements and Exhibits. |
(d) | Exhibits. |
Exhibit |
Description | |
99.1 | Press release dated May 5, 2015. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
Abiomed, Inc. | ||
By: | /s/ Robert L. Bowen | |
Robert L. Bowen | ||
Vice President and Chief Financial Officer | ||
(Principal Accounting and Financial Officer) |
Date: May 5, 2015
Exhibit Index
Exhibit |
Description | |
99.1 | Press release dated May 5, 2015. |
Exhibit 99.1
ABIOMED ANNOUNCES RECORD REVENUE OF $67.6 MILLION, UP 34% AND U.S. PATIENT
GROWTH UP 42% IN FISCAL FOURTH QUARTER 2015
| Total Year Revenue of $230.3 Million, Up 25% Over the Prior Year |
DANVERS, Mass. May 5, 2015 Abiomed, Inc. (NASDAQ: ABMD), a leading provider of breakthrough heart support technologies, today reported fiscal fourth quarter 2015 revenue of $67.6 million, up 34% compared to revenue of $50.4 million in the same period of fiscal 2014, and a fiscal fourth quarter 2015 GAAP net income of $98.9 million, or $2.24 per diluted share, compared to $3.6 million, or $0.09 per diluted share, in the prior year period.
Fiscal fourth quarter GAAP income from operations totaled $12.4 million, up 235% compared to $3.7 million in the prior year. GAAP net income included an income tax benefit of $86.5 million largely due to the release of the valuation allowance on most of Abiomeds deferred tax assets. The release of the valuation allowance is a onetime accounting adjustment with the offset recorded on the balance sheet as short and long term deferred tax assets based on the Companys estimates of sustainable profitability.
For fiscal year 2015, total revenue was $230.3 million, up 25% compared to revenue of $183.6 million in fiscal year 2014. GAAP net income was $113.7 million or $2.65 per diluted share compared with $7.4 million or $0.18 per diluted share in fiscal year 2014.
Financial and operating highlights during the fourth quarter and for the full fiscal year include:
| Fiscal fourth quarter worldwide Impella® revenue totaled $63.4 million, an increase of 38% compared to revenue of $46.1 million during the same period of the prior year. Full year worldwide Impella revenue totaled $212.7 million, up 27% compared to $167.0 million for fiscal year 2014. |
| Fiscal fourth quarter U.S. Impella revenue grew 38% to $57.7 million from $41.8 million in the prior year. Full year U.S. Impella revenue totaled $191.5 million, up 26% compared to $152.0 million in the prior year. |
| An additional 27 hospitals made initial purchases of Impella during the quarter, compared to 23 new hospital sites in the prior year period, bringing the installed customer base to 958 sites. As part of Abiomeds continued Impella CP® launch, 57 hospitals purchased Impella CP, bringing the total number of Impella CP U.S. sites to 640, 67% of total Impella sites. |
| Outside the U.S., fiscal fourth quarter Impella revenue was $5.7 million, an increase of 30% over the prior year. |
| Gross margin for fiscal fourth quarter 2015 was 84.0% compared to 79.9% in the fourth quarter of fiscal 2014. For the full fiscal year, gross margin was 82.7% compared to 79.7% in the prior year. There were 529 Impella AIC consoles placed during fiscal year 2015 compared to 675 in fiscal year 2014. |
| Fiscal fourth quarter income from operations was $12.4 million, or operating margin of 18.3% compared to $3.7 million, or operating margin of 7.3% in the prior year period. For the full fiscal year, income from operations was $28.7 million or operating margin of 12.4% compared to $8.4 million or operating margin of 4.6% in the prior year. |
| Cash, cash equivalents, short and long-term marketable securities totaled $146.0 million as of March 31, 2015. The Company has no debt. |
| On March 23, Abiomed and the FDA announced that the Impella 2.5 had received FDA approval for elective and urgent high risk percutaneous coronary intervention (PCI) procedures, making it the only FDA-approved percutaneous hemodynamic support device determined to be safe and effective for the high risk PCI indication. |
This quarter and fiscal year, Abiomed executed and achieved high growth, regulatory approvals, sustainable profitability and is positioned to address a substantial clinical need as Impella becomes the standard of care, said Michael R. Minogue, Chairman, President and Chief Executive Officer, Abiomed.
FISCAL YEAR 2016 OUTLOOK
The Company is increasing its fiscal year 2016 guidance for total revenue to be in the range of $285 million to $295 million, an increase of 24% to 28% from the prior year. This new range compares to the previous estimated range of $260 million to $270 million. The Company is also giving its fiscal year guidance for GAAP operating margin to be in the range of 12% to 16%.
CONFERENCE CALL
The Company will host a conference call to discuss the results on Tuesday, May 5, 2015, at 8:00 a.m. EDT. Michael R. Minogue, Chairman, President and Chief Executive Officer; 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 (855) 212-2361; the international number is (678) 809-1538. A replay of this conference call will be available beginning at 11 a.m. EDT May 5, 2015 through 11:59 p.m. EDT on May 7, 2015. The replay phone number is (855) 859-2056; the international number is (404) 537-3406. The replay access code is 5151339.
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 Abiomeds existing and new products, the Companys progress toward commercial growth, and financial guidance for fiscal year 2016. These forward-looking statements may be accompanied by such words as anticipate, believe, estimate, expect, forecast, intend, may, plan, potential, project, target, will, and other words and terms of similar meaning. These forward-looking statements include all matters that are not historical facts. The Companys 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, commercialization and related regulatory approvals, including the potential for future losses, complex manufacturing, high quality requirements, dependence on limited sources of supply, dependence on Impella products for a significant portion of the Companys revenue, competition, technological change, government regulation, litigation matters, future capital needs and uncertainty of additional financing, and other risks and challenges detailed in the Companys 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 update or revise 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, whether as a result of new information, future events or otherwise, unless otherwise required by law.
For further information please contact:
Ingrid Goldberg,
Director, Investor Relations
978-646-1590
ir@abiomed.com
Aimee Genzler
Director, Corporate Communications
978-646-1553
agenzler@abiomed.com
Abiomed, Inc. and Subsidiaries
Consolidated Balance Sheets
(Unaudited)
(in thousands, except share data)
March 31, 2015 | March 31, 2014 | |||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 22,401 | $ | 20,916 | ||||
Short-term marketable securities |
109,557 | 55,663 | ||||||
Accounts receivable, net |
31,828 | 24,357 | ||||||
Inventories |
16,774 | 13,948 | ||||||
Prepaid expenses and other current assets |
4,479 | 3,082 | ||||||
Deferred tax assets, net |
35,100 | | ||||||
|
|
|
|
|||||
Total current assets |
220,139 | 117,966 | ||||||
Long-term marketable securities |
13,996 | 41,761 | ||||||
Property and equipment, net |
9,127 | 6,889 | ||||||
Goodwill |
31,534 | 37,990 | ||||||
In-process research and development |
14,711 | | ||||||
Long-term deferred tax assets, net |
45,206 | | ||||||
Other assets |
3,654 | 801 | ||||||
|
|
|
|
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Total assets |
$ | 338,367 | $ | 205,407 | ||||
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LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 10,389 | $ | 7,746 | ||||
Accrued expenses |
21,894 | 17,899 | ||||||
Deferred revenue |
7,036 | 4,766 | ||||||
|
|
|
|
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Total current liabilities |
39,319 | 30,411 | ||||||
Other long-term liabilities |
183 | 228 | ||||||
Contingent consideration |
6,510 | | ||||||
Long-term deferred tax liabilities |
795 | 6,415 | ||||||
|
|
|
|
|||||
Total liabilities |
46,807 | 37,054 | ||||||
|
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|
|
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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 |
413 | 411 | ||||||
Authorized - 100,000,000 shares; Issued - 42,618,717 shares at March 31, 2015 and 41,122,695 shares at March 31, 2014; |
||||||||
Outstanding - 41,335,773 shares at March 31, 2015 and 39,916,328 shares at March 31, 2014 |
||||||||
Additional paid in capital |
465,046 | 436,136 | ||||||
Accumulated deficit |
(137,222 | ) | (250,910 | ) | ||||
Treasury stock at cost - 1,282,944 shares at March 31, 2015 and 1,206,367 shares at March 31, 2014 |
(19,347 | ) | (16,554 | ) | ||||
Accumulated other comprehensive loss |
(17,330 | ) | (730 | ) | ||||
|
|
|
|
|||||
Total stockholders equity |
291,560 | 168,353 | ||||||
|
|
|
|
|||||
Total liabilities and stockholders equity |
$ | 338,367 | $ | 205,407 | ||||
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|
|
Abiomed, Inc. and Subsidiaries
Consolidated Statements of Operations
(Unaudited)
(in thousands, except share data)
Three Months Ended March 31, |
Year Ended March 31, |
|||||||||||||||
2015 | 2014 | 2015 | 2014 | |||||||||||||
Revenue: |
||||||||||||||||
Product revenue |
$ | 67,550 | $ | 50,242 | $ | 229,950 | $ | 183,280 | ||||||||
Funded research and development |
7 | 191 | 361 | 363 | ||||||||||||
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|
|
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|
|
|||||||||
67,557 | 50,433 | 230,311 | 183,643 | |||||||||||||
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Costs and expenses: |
||||||||||||||||
Cost of product revenue |
10,806 | 10,114 | 39,945 | 37,322 | ||||||||||||
Research and development |
9,853 | 7,920 | 35,973 | 30,707 | ||||||||||||
Selling, general and administrative |
34,535 | 28,721 | 125,727 | 107,251 | ||||||||||||
|
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|
|
|||||||||
55,194 | 46,755 | 201,645 | 175,280 | |||||||||||||
|
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|
|
|||||||||
Income from operations |
12,363 | 3,678 | 28,666 | 8,363 | ||||||||||||
|
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|
|
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Other income (expense): |
||||||||||||||||
Investment income (expense), net |
68 | 40 | 196 | 118 | ||||||||||||
Other (expense) income, net |
(59 | ) | 44 | (97 | ) | 49 | ||||||||||
|
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|
|||||||||
9 | 84 | 99 | 167 | |||||||||||||
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|
|
|||||||||
Income before provision for income taxes |
12,372 | 3,762 | 28,765 | 8,530 | ||||||||||||
Income tax (benefit) provision |
(86,502 | ) | 140 | (84,923 | ) | 1,179 | ||||||||||
|
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|
|
|
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|||||||||
Net income |
$ | 98,874 | $ | 3,622 | $ | 113,688 | $ | 7,351 | ||||||||
|
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|
|
|
|||||||||
Basic net income per share |
$ | 2.40 | $ | 0.09 | $ | 2.80 | $ | 0.19 | ||||||||
Basic weighted average shares outstanding |
41,168 | 39,810 | 40,632 | 39,334 | ||||||||||||
Diluted net income per share |
$ | 2.24 | $ | 0.09 | $ | 2.65 | $ | 0.18 | ||||||||
Diluted weighted average shares outstanding |
44,049 | 42,125 | 42,858 | 41,606 |
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