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 28, 2021

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, Massachusetts 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)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading symbol	Name of each exchange on which registered
Common Stock, $0.01 par value	ABMD	The NASDAQ Stock Market LLC

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 28, 2021, ABIOMED, Inc. (the “Company,” “we” or “us”) issued a press release reporting our financial results for our third quarter ended December 31, 2020. 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.

Caution Concerning Forward-Looking Statements

This Form 8-K contains information that includes or is based on forward-looking statements within the meaning of the federal securities laws that are subject to various risks and uncertainties that could cause our actual results to differ materially from those expressed or implied in such statements. Such statements include, but are not limited to, those regarding our financial performance and the impact of the COVID-19 pandemic on our operations and financial results and are subject to, among other risks, the COVID-19 pandemic and any related policies and actions by governments or other third parties. Additional information concerning these and other factors is contained in our filings with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q that we have filed or will file hereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statement to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that affect the likelihood that actual results will differ from those contained in the forward-looking statements.

Item 9.01   Financial Statements and Exhibits.

(d) Exhibits.

Exhibit	Description
99.1	Press release dated January 28, 2021

Exhibit Index

Exhibit	Description
99.1	Press release dated January 28, 2021
104	Cover Page Interactive Data File (embedded with the Inline XBRL document)

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 and Chief Financial Officer (Authorized Signatory)
Date: January 28, 2021

EX-99.1

Exhibit 99.1

ABIOMED ANNOUNCES Q3 FY 2021 RECORD REVENUE OF $232 MILLION, UP 5% YEAR OVER YEAR, WITH 31% OPERATING MARGIN

DANVERS, Mass. — January 28, 2021 – Abiomed, Inc. (NASDAQ: ABMD), a leading provider of breakthrough heart support technologies today reported record revenue in the third quarter fiscal 2021 of $231.7 million, a year over year increase of 5% compared to Q3 fiscal year 2020 despite the negative impact of COVID-19. Operating income was $71.4 million up 2%, compared to $70.3 million in the same period of fiscal 2020.

Recent financial and operating highlights include:

• Worldwide Impella® product revenue for the quarter totaled $220.8 million, an increase of 4% compared to revenue of $212.6 million during Q3 fiscal year 2020.

• U.S. Impella product revenue for the quarter totaled $179.6 million, an increase of 1% compared to revenue of $177.4 million during Q3 fiscal year 2020 with U.S. patient usage of the Impella heart pumps down 2% over prior fiscal year.

• Outside the U.S., Impella product revenue for the quarter totaled $41.2 million, an increase of 17% compared to revenue of $35.2 million during Q3 fiscal year 2020. European Impella product revenue increased 11% compared to the prior fiscal year. Japan Impella product revenue and service increased 38% compared to the prior fiscal year.

• Gross margin for the third quarter fiscal 2021 was 82.3% compared to 82.0% during the same period of fiscal 2020.

• Operating income for the third quarter fiscal 2021 was $71.4 million, or 30.8% operating margin, compared to $70.3 million, or 31.7% operating margin in the same period of fiscal 2020.

• Third quarter fiscal 2021 GAAP net income was $61.9 million, or $1.35 per diluted share, which includes a $6.2 million, or $0.14 per diluted share, gain on our investment in Shockwave and a $1.9 million, or $0.04 per diluted share, of excess tax benefits related to employee share-based compensation awards. This compared to GAAP net income of $69.2 million or $1.51 per diluted share for the prior fiscal year.

• The company generated operating cash flow of $79.1 million in the third quarter. As of December 31, 2020, the company had $787.8 million of cash and marketable securities and no debt.

• On November 5, the company announced that 1,000 patients have been treated with the Impella 5.5 with SmartAssist heart pump in the first year after the U.S. Food and Drug Administration (FDA) granted Impella 5.5 with SmartAssist its highest level of approval for safety and efficacy. The first 1,000 patients were treated primarily for cardiogenic shock from cardiomyopathy, Acute Myocardial Infarction (AMI), and post-cardiotomy, with an average duration of support of 14 days.

• On December 15, the company announced the achievement of two milestones in the development of small bore access for the Impella heart pump. The Impella ECP heart pump has completed the first stage in its FDA early feasibility study (EFS). The FDA also granted 510(k) clearance for the Expandable and Recoilable (XR) Sheath for the Impella 2.5.

• On December 21, the company announced the first two patients in the world have been treated with the Abiomed Breethe OXY-1 System, a compact cardiopulmonary bypass system. The advanced ECMO technology pumps, oxygenates, and removes carbon dioxide from blood for patients whose lungs can no longer provide sufficient end organ oxygenation.

• On January 7, the company announced it has surpassed more than 1,000 patents worldwide, with more than 850 additional patents pending. Abiomed’s robust intellectual property portfolio protects its current and future pump and catheter designs, along with other product components such as motors, cannulas, sensors, software, and access devices. The portfolio also protects manufacturing processes and future artificial intelligence algorithms.

• On January 12, the company presented at the 39th Annual J.P. Morgan Healthcare Conference. A replay of the presentation is available on the investor section of our website.

• On January 27, the company received approval from the FDA to expand the early feasibility study for the Impella ECP based on their review of the results from the first 5 patients.

“Abiomed delivered a record revenue quarter as we continue to remain both focused and committed to our mission of recovering hearts and saving lives despite the challenging COVID environment” said Michael R. Minogue, Abiomed’s Chairman, President and Chief Executive Officer. “We are excited to close Q4 as Abiomed 2.0 and enter Fiscal Year 2022 with our best ever clinical outcomes from existing products, existing indications and existing countries.”

FOURTH QUARTER 2021 REVENUE OUTLOOK

The company anticipates fourth quarter fiscal year 2021 global revenue to be in the range of $225 million to $235 million, representing 9% to 14% growth compared to fourth quarter fiscal year 2020.

EARNINGS CONFERENCE CALL DETAILS

The company will host a conference call to discuss the quarterly results at 8:00 a.m. ET on Thursday, January 28. The conference call 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/mmc/p/or57h3yj 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. ET January 28, 2021 through 10:00 a.m. ET on February 4, 2021. The replay phone number is (855) 859-2056; the international number is (404) 537-3406. The replay access code is 8012819.

ABOUT ABIOMED

Based in Danvers, Massachusetts, USA, 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. Abiomed, Impella, Impella 2.5, Impella 5.0, Impella LD, Impella CP, Impella RP, Impella 5.5, Impella Connect, and SmartAssist are registered trademarks of Abiomed, Inc., and are registered in the U.S. and certain foreign countries. Impella ECP, Impella XR Sheath, Impella BTR, CVAD, STEMI DTU, Automated Impella Controller and Abiomed Breethe OXY-1 System are pending trademarks of Abiomed, Inc.

FORWARD-LOOKING STATEMENTS

This release contains forward-looking statements, including, without limitation, statements regarding development of Abiomed's existing and new products, the company's progress toward commercial growth, and future opportunities and expected regulatory approvals. All statements, other than statements of historical facts, may be forward-looking statements. These forward-looking statements may be accompanied by such words as “anticipate,” “believe,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “potential,” “project,” “target,” “should,” “likely,”  “will” and other words and terms of similar meaning. The company's actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including, without limitation: the scope, scale and duration of the impact of the COVID-19 pandemic, the company’s dependence on Impella® products for all of its revenues; the company’s ability to successfully compete against its existing or potential competitors; the acceptance of the company’s products by cardiac surgeons and interventional cardiologists; long sales and training cycles associated with expansion into new hospital cardiac centers; reduced market acceptance of the company’s products due to lengthy clinician training process; the company’s ability to effectively manage its growth; the company’s ability to successfully commercialize its products; the company’s ability to obtain regulatory approvals and market and sell its products in certain jurisdictions; enforcement actions and product liability suits relating to off-label uses of the company’s products; unsuccessful clinical trials or procedures relating to products under development; the company’s ability to maintain compliance with regulatory requirements; the failure of third-party payers to provide reimbursement of the company’s products; the company’s ability to increase manufacturing capacity to support continued demand for its products; the company or its vendors’ failure to achieve and maintain high manufacturing standards; the failure of the company’s suppliers to provide the components the company requires; the company’s ability to expand its direct sales activities into international markets; the outcome of ongoing securities class action litigation relating to our public disclosures, the company’s ability to integrate acquired companies into its operations and other risks and challenges detailed in the company's filings with the Securities and Exchange Commission (the “SEC”), including the most recently filed Annual Report on Form 10-K and the filings subsequently filed with or furnished to the SEC. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. Unless otherwise required by law, 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:  

Todd Trapp	Sarah Karr
Vice President and Chief Financial Officer	Communications Manager
978-646-1680	978-882-8211
ttrapp@abiomed.com	skarr@abiomed.com

Abiomed, Inc. and Subsidiaries
Consolidated Balance Sheets
(Unaudited)
(in thousands, except share data)
	December 31, 2020			March 31, 2020
ASSETS
Current assets:
Cash and cash equivalents	$	181,018		$	192,341
Short-term marketable securities		305,434			250,775
Accounts receivable, net		92,990			84,650
Inventories		82,448			90,088
Prepaid expenses and other current assets		31,801			18,009
Total current assets		693,691			635,863
Long-term marketable securities		301,315			207,795
Property and equipment, net		179,364			164,931
Goodwill		79,691			31,969
Other intangibles, net		43,327			14,913
Deferred tax assets		21,233			43,336
Other assets		109,813			117,655
Total assets	$	1,428,434		$	1,216,462
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable	$	23,594		$	32,774
Accrued expenses		71,661			75,107
Deferred revenues		21,291			19,147
Other current liabilities		3,854			4,857
Total current liabilities		120,400			131,885
Contingent consideration		25,316			9,000
Deferred tax liabilities		4,303			806
Other long-term liabilities		16,974			9,305
Total liabilities		166,993			150,996
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		452			451
Authorized - 100,000,000 shares; Issued 47,882,615 shares at December 31, 2020 and 47,542,061 shares at March 31, 2020
Outstanding 45,224,596 shares at December 31, 2020 and 45,008,687 shares at March 31, 2020
Additional paid in capital		781,903			739,133
Retained earnings		771,151			602,482
Treasury stock at cost 2,658,019 shares at December 31, 2020 and 2,533,374 shares at March 31, 2020		(287,896	)		(265,411	)
Accumulated other comprehensive loss		(4,169	)		(11,189	)
Total stockholders' equity		1,261,441			1,065,466
Total liabilities and stockholders' equity	$	1,428,434		$	1,216,462

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,
	2020			2019			2020			2019
Revenue	$	231,663		$	221,584		$	606,277		$	634,225
Costs and expenses:
Cost of revenue		41,110			39,996			115,829			111,937
Research and development		33,004			25,655			89,886			73,413
Selling, general and administrative		86,198			85,674			233,809			257,708
		160,312			151,325			439,524			443,058
Income from operations		71,351			70,259			166,753			191,167
Other income:
Investment income, net		1,449			3,086			5,668			9,066
Other income, net		7,935			23,671			42,305			17,279
		9,384			26,757			47,973			26,345
Income before income taxes		80,735			97,016			214,726			217,512
Income tax provision		18,867			27,799			46,057			46,301
Net income (A)	$	61,868		$	69,217		$	168,669		$	171,211
Basic net income per share	$	1.37		$	1.53		$	3.74		$	3.79
Basic weighted average shares outstanding		45,201			45,140			45,105			45,225
Diluted net income per share (B)	$	1.35		$	1.51		$	3.69		$	3.73
Diluted weighted average shares outstanding		45,706			45,695			45,653			45,935
(A) Net income includes the following items:
Excess tax benefits on stock-based compensation awards	$	(1,909	)	$	(485	)	$	(10,363	)	$	(13,775	)
Gain on investment in Shockwave Medical		(6,237	)		(17,775	)		(32,338	)		(13,272	)
	$	(8,146	)	$	(18,260	)	$	(42,701	)	$	(27,047	)
(B) Diluted net income per share includes the following items:
Excess tax benefits on stock-based compensation awards	$	(0.04	)	$	(0.01	)	$	(0.23	)	$	(0.30	)
Gain on investment in Shockwave Medical		(0.14	)		(0.39	)		(0.71	)		(0.29	)
	$	(0.18	)	$	(0.40	)	$	(0.94	)	$	(0.59	)

XML

Document and Entity Information	Jan. 28, 2021
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Jan. 28, 2021
Entity Registrant Name	ABIOMED, Inc.
Entity Central Index Key	0000815094
Entity Emerging Growth Company	false
Entity File Number	001-09585
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	04-2743260
Entity Address, Address Line One	22 Cherry Hill Drive
Entity Address, City or Town	Danvers
Entity Address, State or Province	MA
Entity Address, Postal Zip Code	01923
City Area Code	(978)
Local Phone Number	646-1400
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of each class	Common Stock, $0.01 par value
Trading Symbol	ABMD
Name of each exchange on which registered	NASDAQ