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): January 31, 2019

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 January 31, 2019, we issued a press release reporting our financial results for our third quarter ended December 31, 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 January 31, 2019.

Exhibit Index

Exhibit Number	Description
99.1	Press release dated January 31, 2019.

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: January 31, 2019

EX-99.1

Exhibit 99.1

ABIOMED ANNOUNCES Q3 FY 2019 RECORD REVENUE OF $201 MILLION,
UP 30% OVER PRIOR YEAR

Achieved Record Operating Margin of 31%

DANVERS, Mass. — January 31, 2019 – Abiomed, Inc. (NASDAQ: ABMD), a leading provider of breakthrough heart recovery and support technologies, today reported third quarter fiscal 2019 revenue of $200.6 million, an increase of 30% compared to revenue of $154.0 million for the same period of fiscal 2018. Third quarter fiscal 2019 GAAP net income was $44.9 million or $0.97 per diluted share, up 235% compared to GAAP net income of $13.4 million or $0.29 per diluted share for the same period of fiscal 2018.

Recent financial and operating highlights include:

• Worldwide Impella® heart pump revenue for the quarter totaled $193.3 million, an increase of 31% compared to revenue of $148.0 million during the same period of fiscal 2018.  

• U.S. Impella product revenue for the quarter totaled $165.7 million, an increase of 27% compared to revenue of $130.7 million during the same period of fiscal 2018 with U.S. patient usage of the Impella heart pumps up 24%.

• Outside the U.S., Impella product revenue for the quarter totaled $27.5 million, an increase of 59% compared to revenue of $17.3 million during the same period of fiscal 2018, due to strength in Germany and Japan. In Japan, revenue was $5.4 million, an increase of 391% compared to the same period of the prior year.

• Gross margin for the third quarter fiscal 2019 was 83.0% compared to 83.8% during the same period of fiscal 2018.

• Operating income for the third quarter fiscal 2019 was $62.4 million, or 31.1% operating margin, compared to $44.8 million, or 29.1% operating margin in the same period of fiscal 2018.

• Third quarter fiscal 2019 GAAP net income was $44.9 million or $0.97 per diluted share, an increase of 235% compared to GAAP net income of $13.4 million or $0.29 per diluted share for the same period of fiscal 2018. The prior year included an income tax expense charge of $22.0 million, or $0.48 per diluted share due to the enacted U.S. Tax Cuts and Jobs Act.

• As of December 31, 2018, the company had $458.2 million of cash and marketable securities and no debt.

• The company has supported more than 100,000 patients world-wide with its Impella® heart pumps.

• In November 2018, the company announced that the FDA STEMI DTU safety study found unloading the left ventricle for 30 minutes prior to reperfusion in heart attack patients is safe and feasible in a clinical trial and appeared to reduce infarct size as a percentage of area at risk among patients with a ST sum greater than 6. The company is moving forward with an FDA pivotal randomized controlled trial.

• On January 15, 2019, the company celebrated one year of Impella use in Japan by hosting a seminar for media in Tokyo. The company announced by the end of December 2018, 48 hospitals were using Impella in Japan. Additionally, a leading Japanese surgeon and interventional cardiologist spoke about the benefits of Impella and heart recovery and shared the story of a patient who was treated in Japan.

• In January 2019, the company presented at the 37th Annual J.P. Morgan Healthcare Conference. A webcast of the presentation with automatic slide advance and animations is available on the investor section of our website and at: http://www.abiomed.com/jpmorgan.

“We are proud of our 100,000th patient milestone and we will continue to grow the field of heart recovery and improve patient outcomes by partnering with our customers to use real-world data to identify and validate best practices and protocols,” said Michael R. Minogue, Chairman, President and Chief Executive Officer, Abiomed, Inc. “We remain focused on disciplined execution and sustainable growth so that even more patients around the world can benefit from heart recovery.”

FISCAL YEAR 2019 OUTLOOK

As previously announced, the company increased its 2019 revenue guidance to $780 million, up from a range of $765 million to $770 million, an increase in revenue of approximately 31% from the prior year. The company is now updating its fiscal year 2019 guidance for GAAP operating margin to the range of 29% to 29.5%. This compares to the company’s prior fiscal 2019 guidance 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, January 31, 2019. 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 https://edge.media-server.com/m6/p/kxrqfpvz or dial (855) 212-2361; the international number is (678) 809-1538. A replay of this conference call will be available beginning at 12:00 p.m. EST January 31, 2019 through 12:00 p.m. EST on February 7, 2019. The replay phone number is (855) 859-2056; the international number is (404) 537-3406. The replay access code is 2499899.

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. To learn more about the Impella platform of heart pumps, including their approved indications and important safety and risk information associated with the use of the devices, please visit: www.protectedpci.com.

The ABIOMED logo, ABIOMED, Impella, Impella 2.5, Impella 5.0, Impella LD, Impella CP, Impella RP, Impella Connect, and Recovering hearts. Saving lives. are registered trademarks of ABIOMED, Inc. in the U.S. and in certain foreign countries.

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 unpredictability of future operating results, 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	Tom Langford
Director, Investor Relations	Director, Communications & Public Relations
978-646-1590	978-882-8408
ir@abiomed.com	tlangford@abiomed.com

Abiomed, Inc. and Subsidiaries
Consolidated Balance Sheets
(Unaudited)
(in thousands, except share data)
	December 31, 2018			March 31, 2018
ASSETS
Current assets:
Cash and cash equivalents	$	84,181		$	42,975
Short-term marketable securities		373,975			319,274
Accounts receivable, net		88,215			70,010
Inventories		71,808			50,204
Prepaid expenses and other current assets		10,549			11,808
Total current assets		628,728			494,271
Long-term marketable securities		-			37,502
Property and equipment, net		138,455			117,167
Goodwill		33,260			35,808
In-process research and development		15,516			16,705
Long-term deferred tax assets, net		96,450			70,746
Other assets		44,707			14,176
Total assets	$	957,116		$	786,375
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable	$	26,179		$	23,565
Accrued expenses		51,721			46,147
Deferred revenue		15,080			14,970
Total current liabilities		92,980			84,682
Other long-term liabilities		1,185			776
Contingent consideration		10,583			10,490
Long-term deferred tax liabilities		838			903
Total liabilities		105,586			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		451			444
Authorized - 100,000,000 shares; Issued - 46,959,653 shares at December 31, 2018 and 46,100,649 shares at March 31, 2018
Outstanding - 45,058,049 shares at December 31, 2018 and 44,375,337 shares at March 31, 2018
Additional paid in capital		676,171			619,905
Retained earnings		325,513			140,457
Treasury stock at cost - 1,901,604 shares at December 31, 2018 and 1,725,312 shares at March 31, 2018		(138,289	)		(67,078	)
Accumulated other comprehensive loss		(12,316	)		(4,204	)
Total stockholders' equity		851,530			689,524
Total liabilities and stockholders' equity	$	957,116		$	786,375

Abiomed, Inc. and Subsidiaries
Consolidated Statements of Operations
(Unaudited)
(in thousands, except per share data)
	Three Months Ended December 31,						Nine Months Ended December 31,
	2018			2017			2018			2017
Revenue	$	200,563		$	154,022		$	562,351		$	419,313
Costs and expenses:
Cost of product revenue		34,023			24,994			94,718			68,483
Research and development		23,965			17,706			67,955			54,027
Selling, general and administrative		80,220			66,556			240,254			187,233
		138,208			109,256			402,927			309,743
Income from operations		62,355			44,766			159,424			109,570
Other income:
Investment income, net		2,175			969			5,397			2,385
Other (expense) income, net		(20	)		(81	)		10			(25	)
		2,155			888			5,407			2,360
Income before income taxes		64,510			45,654			164,831			111,930
Income tax provision (benefit) (1)		19,648			32,208			(20,225	)		36,607
Net income	$	44,862		$	13,446		$	185,056		$	75,323
Basic net income per share	$	1.00		$	0.30		$	4.13		$	1.71
Basic weighted average shares outstanding		45,046			44,247			44,852			44,095
Diluted net income per share (2)	$	0.97		$	0.29		$	4.01		$	1.65
Diluted weighted average shares outstanding		46,136			45,869			46,147			45,731
(1) Income tax benefit includes the effect of the following items:
Effect of the Tax Reform Act on net deferred tax assets	$	—		$	21,957		$	—		$	21,957
Excess tax benefits related to stock-based compensation awards		(1,704	)		(3,214	)		(68,469	)		(24,490	)
	$	(1,704	)	$	18,743		$	(68,469	)	$	(2,533	)
(2) Diluted net income per share includes the effect of the following items:
Effect of the Tax Reform Act on net deferred tax assets	$	—		$	0.48		$	—		$	0.48
Excess tax benefits related to stock-based compensation awards		(0.04	)		(0.07	)		(1.48	)		(0.54	)
	$	(0.04	)	$	0.41		$	(1.48	)	$	(0.06	)