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): October 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) |
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On October 26, 2017, we issued a press release reporting our financial results for our second quarter ended September 30, 2017. 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 October 26, 2017. |
Exhibit Index
Exhibit Number |
Description | |
99.1 | Press release dated October 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/ Ian W. McLeod | |
Ian W. McLeod | ||
Vice President and Corporate Controller | ||
(Interim Principal Accounting and Financial Officer) |
Date: October 26, 2017
Exhibit 99.1
ABIOMED ANNOUNCES Q2 FY 2018 REVENUE OF $132.8 MILLION, UP 29% AND RECORD U.S.
PATIENT UTILIZATION, UP 33%
DANVERS, Mass. October 26, 2017 Abiomed, Inc. (NASDAQ: ABMD), a leading provider of breakthrough heart support technologies, today reported second quarter fiscal 2018 revenue of $132.8 million, an increase of 29% compared to revenue of $103.0 million for the same period of fiscal 2017. Second quarter fiscal 2018 GAAP net income was $24.5 million or $0.54 per diluted share, compared to GAAP net income of $8.9 million or $0.20 per diluted share for the prior year period.
Financial and operating highlights during the second quarter of fiscal 2018 include:
| Worldwide revenue from Impella heart pumps totaled $127.4 million, an increase of 30% compared to revenue of $97.9 million during the same period of the prior year. U.S. revenue from Impella pumps grew 27% to $113.6 million and U.S. patient usage grew 33%. |
| Outside the U.S., revenue from Impella heart pumps totaled $13.8 million and was up 61%, predominantly from Germany, which grew 64% in revenue from the prior year with record number of patients. |
| The installed base for Impella 2.5® heart pumps in the U.S. grew by an additional 17 hospitals, which made initial purchases of Impella heart pumps, bringing the installed customer base to 1,171 sites. The installed customer base for Impella CP® heart pumps grew by 31 new U.S. hospitals, bringing the total number of Impella CP sites to 1,093. The installed customer base for Impella 5.0® heart pumps grew by 12 new U.S. hospitals, bringing the total number of Impella 5.0 sites to 484. |
| An additional 44 sites made initial purchases of Impella RP® heart pumps during the quarter, bringing the total number of sites to 186. |
| Gross margin of 84% compared to 83% of the prior year. |
| Operating income was $31.7 million, or 24% operating margin, compared to $14.5 million, or 14% operating margin in the prior year. |
| GAAP net income was $24.5 million or $0.54 per diluted share, which benefited from a new accounting standard that required $4.5 million, or $0.10 per diluted share, of excess tax benefits related to employee share-based compensation awards be recorded as a reduction of income tax expense. This compared to GAAP net income of $8.9 million or $0.20 per diluted share for the prior year, before the new accounting standard. |
| The Company generated $30.1 million in cash, cash equivalents and marketable securities, totaling $319.2 million as of September 30, 2017, compared to $289.1 million at June 30, 2017. The Company currently has no debt. |
| On September 20, 2017, Abiomed received FDA PMA approval for the Impella RP heart pump. With this approval, the Impella RP heart pump is the only percutaneous temporary ventricular support device that is FDA-approved as safe and effective for right heart failure. |
| Today, Abiomed announced in a separate press release the first patient treated with Impella® heart pump in Japan. The Impella 2.5 and Impella 5.0 heart pumps are approved for the treatment of drug-resistant acute heart failure and are the first and only percutaneous temporary ventricular support devices approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. |
This quarter, we set new records for supporting patients in the U.S. and Germany and we continue to observe improved clinical outcomes with our education and training initiatives, said Michael R. Minogue, Chairman, President and Chief Executive Officer, Abiomed. I am proud of the teams ability to consistently adapt and execute as we transform the standard of care and build the Field of Heart Recovery.
FISCAL YEAR 2018 OUTLOOK
The Company is again increasing the lower end of its fiscal year 2018 revenue guidance by $5 million to a new range of $565 million to $575 million, an increase in revenue of 27% to 29% from the prior year. This compares to the Companys initial forecast of $555 million to $575 million and a 25% to 29% increase from the prior year. The Company is also increasing its fiscal year guidance for GAAP operating margin to the range of 23% to 25%, from 22% to 24%.
CONFERENCE CALL
The Company will host a conference call to discuss the results on Thursday, October 26, 2017, at 8:00 a.m. EDT. Michael R. Minogue, Chairman, President and Chief Executive Officer and Robert L. Bowen, former 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 October 26, 2017 through 11:00 a.m. EDT on October 29, 2017. The replay phone number is (855) 859-2056; the international number is (404) 537-3406. The replay access code is 95924236.
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
ir@abiomed.com
Abiomed, Inc. and Subsidiaries
Consolidated Balance Sheets
(Unaudited)
(in thousands, except share data)
September 30, 2017 | March 31, 2017 | |||||||
ASSETS |
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Current assets: |
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Cash and cash equivalents |
$ | 44,536 | $ | 39,040 | ||||
Short-term marketable securities |
218,661 | 190,908 | ||||||
Accounts receivable, net |
57,327 | 54,055 | ||||||
Inventories |
40,632 | 34,931 | ||||||
Prepaid expenses and other current assets |
9,014 | 8,024 | ||||||
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Total current assets |
370,170 | 326,958 | ||||||
Long-term marketable securities |
55,954 | 47,143 | ||||||
Property and equipment, net |
97,697 | 87,777 | ||||||
Goodwill |
34,332 | 31,045 | ||||||
In-process research and development |
16,016 | 14,482 | ||||||
Long-term deferred tax assets, net |
106,798 | 34,723 | ||||||
Other assets |
13,686 | 8,286 | ||||||
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Total assets |
$ | 694,653 | $ | 550,414 | ||||
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable |
$ | 16,667 | $ | 20,620 | ||||
Accrued expenses |
35,256 | 37,703 | ||||||
Deferred revenue |
10,584 | 10,495 | ||||||
Current portion of capital lease obligation |
851 | 799 | ||||||
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Total current liabilities |
63,358 | 69,617 | ||||||
Other long-term liabilities |
598 | 3,251 | ||||||
Contingent consideration |
9,835 | 9,153 | ||||||
Long-term deferred tax liabilities |
866 | 783 | ||||||
Capital lease obligation, net of current portion |
15,110 | 15,539 | ||||||
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Total liabilities |
89,767 | 98,343 | ||||||
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Commitments and contingencies |
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Stockholders equity: |
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Class B Preferred Stock, $.01 par value |
| | ||||||
Authorized1,000,000 shares; Issued and outstandingnone |
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Common stock, $.01 par value |
442 | 437 | ||||||
Authorized100,000,000 shares; Issued45,921,029 shares at September 30, 2017 and 45,249,281 shares at March 31, 2017 |
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Outstanding44,200,784 shares at September 30, 2017 and 43,673,286 shares |
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Additional paid in capital |
592,081 | 565,962 | ||||||
Retained earnings (accumulated deficit) |
90,164 | (46,959 | ) | |||||
Treasury stock at cost1,720,245 shares at September 30, 2017 and 1,575,995 shares at March 31, 2017 |
(65,999 | ) | (46,763 | ) | ||||
Accumulated other comprehensive loss |
(11,802 | ) | (20,606 | ) | ||||
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Total stockholders equity |
604,886 | 452,071 | ||||||
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Total liabilities and stockholders equity |
$ | 694,653 | $ | 550,414 | ||||
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Abiomed, Inc. and Subsidiaries
Consolidated Statements of Operations
(Unaudited)
(in thousands, except per share data)
Three Months Ended September 30, |
Six Months Ended September 30, |
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2017 | 2016 | 2017 | 2016 | |||||||||||||
Revenue: |
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Product revenue |
$ | 132,782 | $ | 102,928 | $ | 265,213 | $ | 205,917 | ||||||||
Funded research and development |
41 | 27 | 78 | 33 | ||||||||||||
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132,823 | 102,955 | 265,291 | 205,950 | |||||||||||||
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Costs and expenses: |
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Cost of product revenue |
21,627 | 17,309 | 43,489 | 32,379 | ||||||||||||
Research and development |
19,390 | 18,052 | 36,321 | 33,712 | ||||||||||||
Selling, general and administrative |
60,080 | 53,086 | 120,677 | 104,118 | ||||||||||||
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101,097 | 88,447 | 200,487 | 170,209 | |||||||||||||
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Income from operations |
31,726 | 14,508 | 64,804 | 35,741 | ||||||||||||
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Other income: |
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Investment income, net |
781 | 342 | 1,416 | 611 | ||||||||||||
Other (expense) income, net |
(23 | ) | (114 | ) | 56 | (191 | ) | |||||||||
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758 | 228 | 1,472 | 420 | |||||||||||||
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Income before income taxes |
32,484 | 14,736 | 66,276 | 36,161 | ||||||||||||
Income tax provision (1) |
7,981 | 5,861 | 4,399 | 14,376 | ||||||||||||
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Net income |
$ | 24,503 | $ | 8,875 | $ | 61,877 | $ | 21,785 | ||||||||
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Basic net income per share |
$ | 0.56 | $ | 0.21 | $ | 1.41 | $ | 0.51 | ||||||||
Basic weighted average shares outstanding |
44,141 | 43,129 | 44,018 | 42,971 | ||||||||||||
Diluted net income per share (2) |
$ | 0.54 | $ | 0.20 | $ | 1.36 | $ | 0.49 | ||||||||
Diluted weighted average shares outstanding |
45,698 | 44,580 | 45,655 | 44,493 | ||||||||||||
(1) Income tax provision includes the effect of the following item: |
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Excess tax benefits related to stock-based compensation awards * |
$ | 4,434 | $ | | $ | 21,276 | $ | | ||||||||
(2) Diluted net income per share includes the effect of the following item: |
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Excess tax benefits related to stock-based compensation awards * |
$ | 0.10 | $ | | $ | 0.47 | $ | |
* | In the first quarter of fiscal 2018, the Company adopted Accounting Standards Update No. 2016-09, Improvements to Employee Share-Based Payment Accounting, which requires that all excess tax benefits and tax deficiencies related share-based compensation arrangements be recognized as income tax benefit or expense, instead of in stockholders equity as previous guidance required. |