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): January 26, 2017
(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 January 26, 2017, we issued a press release reporting our financial results for our third quarter ended December 31, 2016. A copy of the press release is set forth as Exhibit 99.1 and is incorporated herein by reference. Supplemental information in the form of a slide presentation that we will discuss in our earnings conference call is accessible at http://investor.abiomed.com. 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 January 26, 2017. |
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/ Michael J. Tomsicek | |
Michael J. Tomsicek | ||
Vice President and Chief Financial Officer (Principal Accounting and Financial Officer) |
Date: January 26, 2017
Exhibit Index
Exhibit Number |
Description | |
99.1 | Press release dated January 26, 2017. |
Exhibit 99.1
ABIOMED ANNOUNCES Q3 FY 2017 REVENUE OF $114.7 MILLION, UP 34% OVER PRIOR YEAR
- Largest Quarterly Sequential Revenue Increase in Company History
DANVERS, Mass. January 26, 2017 Abiomed, Inc. (NASDAQ: ABMD), a leading provider of breakthrough heart support technologies, today reported third quarter fiscal 2017 revenue of $114.7 million, an increase of 34% compared to revenue of $85.8 million for the same period of fiscal 2016. Third quarter fiscal 2017 GAAP net income was $15.4 million or $0.34 per diluted share, compared to GAAP net income of $10.6 million or $0.23 per diluted share for the prior year period.
Financial and operating highlights during the third quarter of fiscal 2017 include:
| Fiscal third quarter worldwide revenue from Impella heart pumps totaled $109.2 million, an increase of 35% compared to revenue of $81.0 million during the same period of the prior fiscal year. U.S. revenue from Impella pumps grew 34% to $100.3 million and U.S. patient usage grew 32%. |
| Outside the U.S., revenue from Impella heart pumps totaled $8.9 million and was up 47%, predominantly from Germany, which grew 80% in revenue from the prior fiscal year. |
| The installed base for Impella 2.5 heart pumps in the U.S. grew by an additional 20 hospitals, which made initial purchases of Impella heart pumps, bringing the installed customer base to 1,119 sites. The installed customer base for Impella CP® heart pumps grew by 49 new U.S. hospitals, bringing the total number of Impella CP sites to 972. |
| An additional 8 sites made initial purchases of Impella RP® heart pumps during the quarter, bringing the total number of sites to 120. |
| Gross margin for third quarter fiscal 2017 was 83.4% compared to 85.1% in the prior year period. |
| Operating income for the third quarter of fiscal 2017 was $25.4 million, or 22.2% operating margin, compared to $17.5 million, or 20.4% operating margin in the prior year period. |
| The Company generated $22.0 million in cash, cash equivalents and marketable securities, totaling $258.9 million as of December 31, 2016, compared to $236.9 million at September 30, 2016. The Company currently has no debt. |
| On October 31, 2016, Abiomed launched the Impella Quality (IQ) Assurance Program. The mission of the program is to improve real-world outcomes in Protected PCI and cardiogenic shock patients through training, education and utilization of clinical guidelines, protocols and best practices derived from observational quality assurance data (IQ), Institutional Review Board (IRB) approved registry data (cVAD) and Investigational Device Exemption (IDE) approved FDA studies. |
| On December 7, 2016, Abiomed announced that the Impella CP received expanded FDA Approval for High-Risk Percutaneous Coronary Intervention (PCI) Procedures |
These are the best of times for Abiomed, because the high risk patient population has been validated and only now with our regulatory approvals can we educate and train our customers to improve the standard of care through hemodynamic support. We began building this field of heart recovery less than
one year ago and in the medical technology industry history demonstrates the impact of FDA approvals on adoption, said Michael R. Minogue, Chairman, President and Chief Executive Officer, Abiomed. What makes Abiomed unique is Impellas ability to be used effectively in a Hub and Spoke model to achieve Protected PCI and heart muscle recovery in your community.
FISCAL YEAR 2017 OUTLOOK
The Company is increasing the lower end of its fiscal year 2017 revenue guidance with the new range of $440 million to $445 million, an increase in revenue of 34% to 35% from the prior year. This compares to the prior increased forecast of $435 million to $445 million. The Company projects revenue to be around $122 million for the fourth quarter of fiscal 2017 and is maintaining its fiscal year guidance for GAAP operating margin in the range of 18% to 20%.
CONFERENCE CALL
The Company will host a conference call to discuss the results on Thursday, January 26, 2017, at 8:00 a.m. EDT. Michael R. Minogue, Chairman, President and Chief Executive Officer; Michael Tomsicek, 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. EST January 26, 2017 through 11 a.m. EST on January 29, 2017. The replay phone number is (855) 859-2056; the international number is (404) 537-3406. The replay access code is 44227123.
The ABIOMED logo, ABIOMED, Impella, Impella CP, and Impella RP are registered trademarks of Abiomed, Inc. in the U.S. and in certain foreign countries. Impella 2.5, Impella 5.0, and Recovering hearts. Saving lives. are trademarks of Abiomed, Inc.
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 future opportunities and expected regulatory approvals. 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 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 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 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:
Ingrid Goldberg
Director, Investor Relations
978-646-1590
igoldberg@abiomed.com
Adrienne Smith
Senior Director, Public Relations and Corporate Communications
978-646-1553
adsmith@abiomed.com
Abiomed, Inc. and Subsidiaries
Consolidated Balance Sheets
(Unaudited)
(in thousands, except share data)
December 31, 2016 | March 31, 2016 | |||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 61,069 | $ | 48,231 | ||||
Short-term marketable securities |
179,640 | 163,822 | ||||||
Accounts receivable, net |
50,178 | 42,821 | ||||||
Inventories |
32,053 | 26,740 | ||||||
Prepaid expenses and other current assets |
10,479 | 6,778 | ||||||
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|
|
|
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Total current assets |
333,419 | 288,392 | ||||||
Long-term marketable securities |
18,240 | 1,000 | ||||||
Property and equipment, net |
60,909 | 23,184 | ||||||
Goodwill |
30,562 | 33,003 | ||||||
In-process research and development |
14,257 | 15,396 | ||||||
Long-term deferred tax assets, net |
39,007 | 58,534 | ||||||
Other assets |
4,570 | 4,422 | ||||||
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|
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Total assets |
$ | 500,964 | $ | 423,931 | ||||
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current liabilities: |
||||||||
Accounts payable |
$ | 14,558 | $ | 9,381 | ||||
Accrued expenses |
34,539 | 28,382 | ||||||
Deferred revenue |
9,004 | 8,778 | ||||||
Current portion of capital lease obligation |
770 | | ||||||
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|
|
|
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Total current liabilities |
58,871 | 46,541 | ||||||
Other long-term liabilities |
17 | 220 | ||||||
Contingent consideration |
8,175 | 7,563 | ||||||
Long-term deferred tax liabilities |
771 | 832 | ||||||
Capital lease obligation, net of current portion |
15,750 | | ||||||
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|
|
|
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Total liabilities |
83,584 | 55,156 | ||||||
Commitments and contingencies |
||||||||
Stockholders equity: |
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Class B Preferred Stock, $.01 par value |
| | ||||||
Authorized - 1,000,000 shares; Issued and outstanding - none |
||||||||
Common stock, $.01 par value |
435 | 426 | ||||||
Authorized - 100,000,000 shares; Issued - 45,081,996 shares at December 31, 2016 and 43,973,119 shares at March 31, 2016 |
||||||||
Outstanding - 43,507,808 shares at December 31, 2016 and 42,596,228 shares at March 31, 2016 |
||||||||
Additional paid in capital |
546,796 | 508,624 | ||||||
Accumulated deficit |
(61,858 | ) | (99,075 | ) | ||||
Treasury stock at cost - 1,574,188 shares at December 31, 2016 and 1,376,891 shares at March 31, 2016 |
(46,556 | ) | (26,660 | ) | ||||
Accumulated other comprehensive loss |
(21,437 | ) | (14,540 | ) | ||||
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|
|
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Total stockholders equity |
417,380 | 368,775 | ||||||
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|
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Total liabilities and stockholders equity |
$ | 500,964 | $ | 423,931 | ||||
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Abiomed, Inc. and Subsidiaries
Consolidated Statements of Operations
(Unaudited)
(in thousands, except per share data)
For the Three Months Ended December 31, |
For the Nine Months Ended December 31, |
|||||||||||||||
2016 | 2015 | 2016 | 2015 | |||||||||||||
Revenue: |
||||||||||||||||
Product revenue |
$ | 114,624 | $ | 85,789 | $ | 320,541 | $ | 235,569 | ||||||||
Funded research and development |
50 | 6 | 83 | 17 | ||||||||||||
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114,674 | 85,795 | 320,624 | 235,586 | |||||||||||||
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Costs and expenses: |
||||||||||||||||
Cost of product revenue |
18,987 | 12,744 | 51,366 | 35,756 | ||||||||||||
Research and development |
16,349 | 13,755 | 50,061 | 35,534 | ||||||||||||
Selling, general and administrative |
53,935 | 41,853 | 158,053 | 119,005 | ||||||||||||
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89,271 | 68,352 | 259,480 | 190,295 | |||||||||||||
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Income from operations |
25,403 | 17,443 | 61,144 | 45,291 | ||||||||||||
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Other income (expense): |
||||||||||||||||
Investment income, net |
457 | 84 | 1,068 | 209 | ||||||||||||
Other (expense) income, net |
(34 | ) | (29 | ) | (225 | ) | 111 | |||||||||
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423 | 55 | 843 | 320 | |||||||||||||
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Income before income taxes |
25,826 | 17,498 | 61,987 | 45,611 | ||||||||||||
Income tax provision |
10,394 | 6,943 | 24,770 | 18,462 | ||||||||||||
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Net income |
$ | 15,432 | $ | 10,555 | $ | 37,217 | $ | 27,149 | ||||||||
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Basic net income per share |
$ | 0.36 | $ | 0.25 | $ | 0.86 | $ | 0.64 | ||||||||
Basic weighted average shares outstanding |
43,431 | 42,427 | 43,125 | 42,118 | ||||||||||||
Diluted net income per share |
$ | 0.34 | $ | 0.23 | $ | 0.83 | $ | 0.61 | ||||||||
Diluted weighted average shares outstanding |
44,770 | 44,949 | 44,597 | 44,805 |
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