8-K

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): November 1, 2018

ABIOMED, Inc.

(Exact name of Registrant as Specified in Its Charter)

Delaware	001-09585	04-2743260
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(IRS Employer Identification No.)

22 Cherry Hill Drive
Danvers, MA 01923

(Address of Principal Executive Offices, including Zip Code)

(978) 646-1400

(Registrant’s 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 (see General Instructions A.2. below):

☐ 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))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

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 November 1, 2018, we issued a press release reporting our financial results for our second quarter ended September 30, 2018.  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 November 1, 2018.

Exhibit Index

Exhibit Number	Description
99.1	Press release dated November 1, 2018.

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/ Todd A. Trapp
		Todd A. Trapp Vice President, Chief Financial Officer (Principal Financial and Accounting Officer)
Date: November 1, 2018

EX-99.1

Exhibit 99.1

ABIOMED ANNOUNCES Q2 FY 2019 RECORD REVENUE OF $182 MILLION, UP 37% OVER PRIOR YEAR

DANVERS, MA. — November 1, 2018 – Abiomed, Inc. (NASDAQ: ABMD), a leading provider of breakthrough heart recovery and support technologies, today reported second quarter fiscal 2019 revenue of $181.8 million, an increase of 37% compared to revenue of $132.8 million for the same period of fiscal 2018. Second quarter fiscal 2019 GAAP net income was $50.1 million or $1.09 per diluted share, up 104% compared to GAAP net income of $24.5 million or $0.54 per diluted share for the prior year period.

Recent financial and operating highlights include:

• Worldwide Impella® heart pump revenue for the quarter totaled $175.3 million, an increase of 38% compared to revenue of $127.4 million during the same period of the prior fiscal year.  

• U.S. Impella heart pump revenue for the quarter totaled $152.2 million, an increase of 34% compared to revenue of $113.6 million during the same period in the prior fiscal year with U.S. patient usage of the Impella heart pumps up 29%.

• Outside the U.S., Impella heart pump revenue for the quarter totaled $23.1 million, an increase of 67% compared to revenue of $13.8 million during the same period in the prior fiscal year.

• Gross margin for the second quarter fiscal 2019 was 83.6% compared to 83.7% during the same period in the prior fiscal year.

• Operating income for the second quarter fiscal 2019 was $50.3 million, or 27.7% operating margin, compared to $31.7 million, or 23.9% operating margin in the prior fiscal year.

• Second quarter fiscal 2019 GAAP net income was $50.1 million, or $1.09 per diluted share, which benefited from $12.9 million, or $0.28 per diluted share, of excess tax benefits related to employee share-based compensation awards. This compared to GAAP net income of $24.5 million or $0.54 per diluted share for the prior fiscal year, which benefited from $4.5 million, or $0.10 per diluted share, of excess tax benefits.

• The Company’s cash and marketable securities balance as of September 30, 2018 was $410.4 million. The Company currently has no debt.

• In September 2018, a data analysis presented at the Transcatheter Cardiovascular Therapeutics (TCT) conference from Abiomed's Impella® Quality (IQ) Database showed that the utilization of best practices, including early placement of Impella, pre-PCI, led to a 24% relative increase in mean survival for acute myocardial infarction (AMI) cardiogenic shock patients since Impella’s cardiogenic shock FDA post-market approval (PMA) in 2016. The percent of Impella hospitals achieving greater than 70% survival now total 39%, up from 25% prior to the FDA approval.

• Separately at TCT, William O’Neill, MD, medical director of the Center for Structural Heart Disease at Henry Ford Hospital in Detroit, presented initial data from the first 104 patients treated with the National Cardiogenic Shock Initiative (NCSI) protocol. After more than 20 years of stagnant shock

survival rates at roughly 50%, NCSI has now demonstrated a survival of 77%, with 99% of survivors discharged home with their native heart. The NCSI protocol includes placing Impella pre-PCI, reducing the use of inotropes, and right heart hemodynamic monitoring. NCSI is an independent, physician-led collaboration to improve outcomes in cardiogenic shock.

• The Company announces the STEMI DTU FDA safety and feasibility study will be presented in the Late-Breaking Clinical Trials at 10:00 a.m. CST on November 11th at the American Heart Association (AHA) Scientific Sessions in Chicago.  More information is available at the following link: http://www.abstractsonline.com/pp8/#!/4682/presentation/59042.  

• Today, the Company announces that it will host a short investor call to discuss the STEMI DTU FDA safety and feasibility study results on Monday, November 12 at 8:00 a.m. EST.

“We have established a strong foundation with our innovation and technology, balance sheet and intellectual property portfolio,” said Michael R. Minogue, Chairman, President and Chief Executive Officer, Abiomed, Inc. “We are executing our plan for sustainable growth while helping to improve patient outcomes focused on native heart recovery.”

FISCAL YEAR 2019 OUTLOOK

The Company is again increasing the low end of its fiscal year 2019 revenue guidance to $765 million to $770 million (up 29% to 30%) over the prior fiscal year. This compares to the post fiscal first quarter guidance of $755 million to $770 million (up 27% to 30%) and the Company's initial forecast of $740 million to $770 million (up 25% to 30%) from the prior year. The Company is maintaining its fiscal year 2019 guidance for GAAP operating margin in the range of 28% to 30%.

EARNINGS CONFERENCE CALL DETAILS

The Company will host a conference call to discuss the results at 8:00 a.m. EST on Thursday, November 1, 2018. The conference call releasing full quarterly results will be hosted by Michael R. Minogue, Chairman, President and Chief Executive Officer and Todd A. Trapp, Vice President and Chief Financial Officer.

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 11:00 a.m. EST November 1, 2018 through 10:00 a.m. EST on November 8, 2018. The replay phone number is (855) 859-2056; the international number is (404) 537-3406. The replay access code is 349 3749.

The ABIOMED logo, ABIOMED, IMPELLA, IMPELLA 2.5, IMPELLA 5.0, IMPELLA LD, IMPELLA CP, IMPELLA RP, IMPELLA BTR, IMPELLA 5.5, and IMPELLA ECP are registered marks or trademarks of ABIOMED, Inc., and are registered in the U.S. and certain foreign countries. AB5000 and cVAD REGISTRY, 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 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.

For further information please contact:  

Ingrid Goldberg

Director, Investor Relations

978-646-1590

ir@abiomed.com

Tom Langford

Director, Communications & Public Relations

978-882-8408

tlangford@abiomed.com

Abiomed, Inc. and Subsidiaries
Consolidated Balance Sheets
(Unaudited)
(in thousands, except share data)
	September 30, 2018			March 31, 2018
ASSETS
Current assets:
Cash and cash equivalents	$	76,382		$	42,975
Short-term marketable securities		334,064			319,274
Accounts receivable, net		74,201			70,010
Inventories		63,656			50,204
Prepaid expenses and other current assets		13,296			11,808
Total current assets		561,599			494,271
Long-term marketable securities		-			37,502
Property and equipment, net		134,065			117,167
Goodwill		33,719			35,808
In-process research and development		15,730			16,705
Long-term deferred tax assets, net		116,248			70,746
Other assets		25,804			14,176
Total assets	$	887,165		$	786,375
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable	$	21,884		$	23,565
Accrued expenses		46,099			46,147
Deferred revenue		13,996			14,970
Total current liabilities		81,979			84,682
Other long-term liabilities		889			776
Contingent consideration		10,493			10,490
Long-term deferred tax liabilities		850			903
Total liabilities		94,211			96,851
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		450			444
Authorized - 100,000,000 shares; Issued - 46,935,424 shares at September 30, 2018 and 46,100,649 shares at March 31, 2018
Outstanding - 45,038,453 shares at September 30, 2018 and 44,375,337 shares at March 31, 2018
Additional paid in capital		660,132			619,905
Retained earnings		280,650			140,457
Treasury stock at cost - 1,896,971 shares at September 30, 2018 and 1,725,312 shares at March 31, 2018		(136,743	)		(67,078	)
Accumulated other comprehensive loss		(11,535	)		(4,204	)
Total stockholders' equity		792,954			689,524
Total liabilities and stockholders' equity	$	887,165		$	786,375

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,
	2018			2017			2018			2017
Revenue	$	181,778		$	132,823		$	361,788		$	265,291
Costs and expenses:
Cost of product revenue		29,846			21,627			60,696			43,489
Research and development		22,717			19,390			43,990			36,321
Selling, general and administrative		78,895			60,080			160,034			120,677
		131,458			101,097			264,720			200,487
Income from operations		50,320			31,726			97,068			64,804
Other income:
Investment income, net		1,671			781			3,222			1,416
Other (expense) income, net		(158	)		(23	)		30			56
		1,513			758			3,252			1,472
Income before income taxes		51,833			32,484			100,320			66,276
Income tax provision (benefit) (1)		1,706			7,981			(39,873	)		4,399
Net income	$	50,127		$	24,503		$	140,193		$	61,877
Basic net income per share	$	1.11		$	0.56		$	3.13		$	1.41
Basic weighted average shares outstanding		44,961			44,141			44,754			44,018
Diluted net income per share (2)	$	1.09		$	0.54		$	3.04		$	1.36
Diluted weighted average shares outstanding		46,153			45,698			46,164			45,655
(1) Income tax benefit includes the effect of the following item:
Excess tax benefits related to stock-based compensation awards	$	12,928		$	4,434		$	66,765		$	21,276
(2) Diluted net income per share includes the effect of the following item:
Excess tax benefits related to stock-based compensation awards	$	0.28		$	0.10		$	1.45		$	0.47