ABIOMED INC - Quarter Report: 2022 September (Form 10-Q)

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)


☒	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2022


☐	TRANSITION REPORT PURSUANT TO SECTION 13 or 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission file number: 001-09585

ABIOMED, INC.

(Exact name of registrant as specified in its charter)


Delaware		04-2743260
(State or other jurisdiction of incorporation or organization)		(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)

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

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically, every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 229.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.


Large accelerated filer	☒	Accelerated filer	☐
Non-accelerated filer	☐	Smaller reporting company	☐
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. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of October 28, 2022, 45,091,184 shares of the registrant’s common stock, $.01 par value, were outstanding.

TABLE OF CONTENTS


PART I - FINANCIAL INFORMATION:			Page

Item 1.	Condensed Consolidated Financial Statements (unaudited)	4

	Condensed Consolidated Balance Sheets as of September 30, 2022 and March 31, 2022	4

	Condensed Consolidated Statements of Operations for the three and six months ended September 30, 2022 and 2021	5

	Condensed Consolidated Statements of Comprehensive Income for the three and six months ended September 30, 2022 and 2021	6

	Condensed Consolidated Statements of Stockholders’ Equity for the three and six months ended September 30, 2022 and 2021	7

	Condensed Consolidated Statements of Cash Flows for the six months ended September 30, 2022 and 2021	8

	Notes to Condensed Consolidated Financial Statements (unaudited)	9

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	27

Item 3.	Quantitative and Qualitative Disclosures About Market Risk	38

Item 4.	Controls and Procedures	38

PART II - OTHER INFORMATION:

Item 1.	Legal Proceedings	39

Item 1A.	Risk Factors	39

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	41

Item 3.	Defaults Upon Senior Securities	42

Item 4.	Mine Safety Disclosures	42

Item 5.	Other Information	42

Item 6.	Exhibits	43

Signatures		45

EXPLANATORY NOTES

Pending Trademarks and Registered Marks

Throughout this quarterly report on Form 10-Q (“this Report”), we refer to various trademarks, service marks and trade names that we use in our business. 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 BTR, STEMI DTU, Automated Impella Controller, Abiomed Breethe OXY-1 System and preCARDIA are pending trademarks of ABIOMED, Inc. Other trademarks and service marks appearing in this Report are the property of their respective holders.

Company References

Throughout this Report, unless the context otherwise requires, “ABIOMED, Inc.,” the “Company,” “we,” “us” and “our” refer to ABIOMED, Inc. and its consolidated subsidiaries.

Where You Can Find More Information

We make available, free of charge on our website located at www.abiomed.com, our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and any amendments to those reports, as soon as reasonably practicable after filing such reports with or furnishing such reports to the U.S. Securities and Exchange Commission (“SEC”). We also use our website for the distribution of Company information. The information we post on our website may be deemed to be material information. Accordingly, investors should monitor our website, in addition to following our press releases, SEC reports and other filings and public conference calls and webcasts. The contents of our website are not incorporated by reference into this Report.

PART I. FINANCIAL INFORMATION

ITEM 1: Condensed Consolidated Financial Statements

ABIOMED, INC. AND SUBSIDIARIES

Condensed Consolidated Balance Sheets (Unaudited)

(in thousands)


	September 30, 2022			March 31, 2022
ASSETS
Current assets:
Cash and cash equivalents	$	182,335		$	132,818
Short-term marketable securities		638,037			625,789
Accounts receivable, net		94,475			90,608
Inventories, net		102,237			93,981
Prepaid expenses and other current assets		45,714			33,277
Total current assets		1,062,798			976,473
Long-term marketable securities		116,871			220,089
Property and equipment, net		195,157			202,490
Goodwill		72,960			76,786
Other intangibles, net		36,833			39,518
Deferred tax assets		18,881			10,552
Other assets		193,044			147,485
Total assets	$	1,696,544		$	1,673,393
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable	$	35,070		$	35,346
Accrued expenses		69,434			72,629
Deferred revenue		25,962			26,362
Other current liabilities		3,594			4,120
Total current liabilities		134,060			138,457
Other long-term liabilities		7,013			9,319
Contingent consideration		14,995			21,510
Deferred tax liabilities		689			781
Total liabilities		156,757			170,067
Commitments and contingencies (Note 15)
Stockholders' equity:
Class B Preferred Stock, $.01 par value		—			—
1,000 shares authorized; issued and outstanding - none
Common stock, $.01 par value		452			455
100,000 shares authorized; 48,418 and 48,258 shares issued as of September 30, 2022 and March 31, 2022, respectively
45,172 and 45,545 shares outstanding as of September 30, 2022 and March 31, 2022, respectively
Additional paid in capital		904,755			870,074
Retained earnings		1,125,199			964,512
Treasury stock at cost - 3,246 and 2,713 shares as of September 30, 2022 and March 31, 2022, respectively		(443,974	)		(304,555	)
Accumulated other comprehensive loss		(46,645	)		(27,160	)
Total stockholders' equity		1,539,787			1,503,326
Total liabilities and stockholders' equity	$	1,696,544		$	1,673,393

The accompanying notes are an integral part of the condensed consolidated financial statements (unaudited)

ABIOMED, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Operations (Unaudited)

(in thousands, except per share data)


	For the Three Months Ended September 30,				For the Six Months Ended September 30,
	2022		2021		2022		2021
Revenue	$	265,921	$	248,142	$	543,070	$	500,727
Cost of revenue and operating expenses:
Cost of revenue		48,880		43,886		101,506		89,074
Research and development		42,089		41,041		82,566		78,749
Selling, general and administrative		116,958		102,779		234,954		206,263
Acquired in-process research and development		—		—		—		115,490
		207,927		187,706		419,026		489,576
Income from operations		57,994		60,436		124,044		11,151
Interest and other income, net		80,709		6,835		84,481		46,770
Income before income taxes		138,703		67,271		208,525		57,921
Income tax provision		32,570		10,318		47,838		27,493
Net income	$	106,133	$	56,953	$	160,687	$	30,428

Net income per share - basic	$	2.34	$	1.25	$	3.53	$	0.67
Weighted average shares outstanding - basic		45,372		45,437		45,475		45,374

Net income per share - diluted	$	2.32	$	1.24	$	3.51	$	0.66
Weighted average shares outstanding - diluted		45,711		45,893		45,812		45,857

The accompanying notes are an integral part of the condensed consolidated financial statements (unaudited)

ABIOMED, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Comprehensive Income (Unaudited)

(in thousands)


	For the Three Months Ended September 30,						For the Six Months Ended September 30,
	2022			2021			2022			2021
Net income	$	106,133		$	56,953		$	160,687		$	30,428
Other comprehensive loss:
Foreign currency translation losses		(8,029	)		(2,693	)		(16,758	)		(2,610	)
Unrealized gains (losses) on derivative instrument		78			545			(306	)		328
Net unrealized losses on marketable securities, net of tax		(423	)		(197	)		(2,421	)		(829	)
Other comprehensive loss		(8,374	)		(2,345	)		(19,485	)		(3,111	)

Comprehensive income	$	97,759		$	54,608		$	141,202		$	27,317

The accompanying notes are an integral part of the condensed consolidated financial statements (unaudited)

ABIOMED, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Stockholders’ Equity (Unaudited)

(in thousands, except share data)


	Common Stock						Treasury Stock					Additional Paid			Retained		Accumulated Other			Total Stockholders'
	Shares			Par value			Shares		Amount			in Capital			Earnings		Comprehensive Loss			Equity
Balance, March 31, 2022		45,545,438		$	455			2,713,125	$	(304,555	)	$	870,074		$	964,512	$	(27,160	)	$	1,503,326
Restricted stock units issued		105,701			2			—		—			(1	)		—		—			1
Stock options exercised		18,136			1			—		—			1,530			—		—			1,531
Return of common stock to pay withholding taxes on restricted stock units		(42,046	)		(1	)		42,046		(10,949	)		—			—		—			(10,950	)
Stock-based compensation expense		—			—			—		—			13,362			—		—			13,362
Stock repurchase program		(60,282	)		(1	)		60,282		(14,516	)		—			—		—			(14,517	)
Other comprehensive loss		—			—			—		—			—			—		(11,111	)		(11,111	)
Net income		—			—			—		—			—			54,554		—			54,554
Balance, June 30, 2022		45,566,947		$	456			2,815,453	$	(330,020	)	$	884,965		$	1,019,066	$	(38,271	)	$	1,536,196
Restricted stock units issued		16,809			—			—		—			—			—		—			—
Stock options exercised		3,337			—			—		—			468			—		—			468
Return of common stock to pay withholding taxes on restricted stock		(6,332	)		—			6,332		(1,852	)		—			—		—			(1,852	)
Stock issued under employee stock purchase plan		15,841			—			—		—			3,308			—		—			3,308
Stock-based compensation expense		—			—			—		—			16,014			—		—			16,014
Stock repurchase program		(424,452	)		(4	)		424,452		(112,102	)		—			—		—			(112,106	)
Other comprehensive loss		—			—			—		—			—			—		(8,374	)		(8,374	)
Net income		—			—			—		—			—			106,133		—			106,133
Balance, September 30, 2022		45,172,150		$	452			3,246,237	$	(443,974	)	$	904,755		$	1,125,199	$	(46,645	)	$	1,539,787


	Common Stock						Treasury Stock					Additional Paid			Retained			Accumulated Other			Total Stockholders'
	Shares			Par value			Shares		Amount			in Capital			Earnings			Comprehensive Loss			Equity
Balance, March 31, 2021		45,270,948		$	453			2,658,454	$	(288,030	)	$	800,690		$	828,007		$	(11,445	)	$	1,329,675
Restricted stock units issued		85,284			1			—		—			(1	)		—			—			—
Stock options exercised		55,757			1			—		—			2,119			—			—			2,120
Return of common stock to pay withholding taxes on restricted stock units		(34,274	)		(1	)		34,274		(9,589	)		—			—			—			(9,590	)
Stock-based compensation expense		—			—			—		—			12,608			—			—			12,608
Other comprehensive loss		—			—			—		—			—			—			(766	)		(766	)
Net loss		—			—			—		—			—			(26,525	)		—			(26,525	)
Balance, June 30, 2021		45,377,715		$	454			2,692,728	$	(297,619	)	$	815,416		$	801,482		$	(12,211	)	$	1,307,522
Restricted stock units issued		19,638			—			—		—			—			—			—			—
Stock options exercised		95,916			1			—		—			6,261			—			—			6,262
Return of common stock to pay withholding taxes on restricted stock		(7,753	)		—			7,753		(2,539	)		—			—			—			(2,539	)
Stock issued under employee stock purchase plan		11,047			—			—		—			2,961			—			—			2,961
Stock-based compensation expense		—			—			—		—			15,749			—			—			15,749
Other comprehensive loss		—			—			—		—			—			—			(2,345	)		(2,345	)
Net income		—			—			—		—			—			56,953			—			56,953
Balance, September 30, 2021		45,496,563		$	455			2,700,481	$	(300,158	)	$	840,387		$	858,435		$	(14,556	)	$	1,384,563

The accompanying notes are an integral part of the condensed consolidated financial statements (unaudited)

ABIOMED, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Cash Flows (Unaudited)

(in thousands)


	For the Six Months Ended September 30,
	2022			2021
Operating activities:
Net income	$	160,687		$	30,428
Adjustments to reconcile net income to net cash provided by operating activities:
Depreciation and amortization		13,344			13,873
Acquired in-process research & development		—			115,490
Bad debt expense (recoveries)		85			(27	)
Stock-based compensation		29,376			28,357
Write-down of inventory and other		7,110			6,195
Accretion on marketable securities		319			1,768
Change in fair value of other investments		(77,373	)		(22,440	)
Gain on previously held interest in preCARDIA		—			(20,980	)
Deferred tax provision		(7,416	)		8,193
Change in fair value of contingent consideration		(6,515	)		108
Other non-cash operating activities		1,556			1,553
Changes in assets and liabilities:
Accounts receivable		(6,402	)		7,444
Inventories		(18,346	)		(11,673	)
Prepaid expenses and other assets		(13,149	)		(20,300	)
Accounts payable		1,570			(6,266	)
Accrued expenses and other liabilities		(3,408	)		(15,590	)
Deferred revenue		86			(202	)
Net cash provided by operating activities		81,524			115,931
Investing activities:
Purchases of marketable securities		(272,618	)		(333,832	)
Proceeds from the sale and maturity of marketable securities and other		359,671			326,518
Purchases of other investments		(4,975	)		(3,866	)
Acquisition of preCARDIA, net of cash acquired		—			(82,821	)
Proceeds from sales of Shockwave Medical securities		39,995			—
Purchases of property and equipment		(12,392	)		(14,394	)
Net cash provided by (used for) investing activities		109,681			(108,395	)
Financing activities:
Proceeds from the exercise of stock options		1,999			8,382
Taxes paid related to net share settlement upon vesting of stock awards		(12,802	)		(12,129	)
Repurchase of common stock		(126,623	)		—
Proceeds from the issuance of stock under employee stock purchase plan		3,308			2,961
Net cash used for financing activities		(134,118	)		(786	)
Effect of exchange rate changes on cash and cash equivalents		(7,570	)		2,422
Net increase in cash and cash equivalents		49,517			9,172
Cash and cash equivalents at beginning of period		132,818			232,710
Cash and cash equivalents at end of period	$	182,335		$	241,882

Supplemental disclosure of cash flow information:
Cash paid for income taxes, net of refunds	$	68,615		$	35,642
Supplemental disclosure of non-cash activities:
Property and equipment in accounts payable and accrued expenses		1,427			578
Right-of-use assets obtained in exchange for lease liabilities		356			569

The accompanying notes are an integral part of the condensed consolidated financial statements (unaudited)

ABIOMED, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)

(In thousands, except share data)

Note 1. Nature of Operations

ABIOMED, Inc. (the “Company” or “ABIOMED”) is a leading provider of medical technology that provides circulatory support and oxygenation. The Company's products are designed to enable the heart to rest by improving blood flow and/or performing the pumping of the heart. The Company’s products are used in the cardiac catheterization lab, or cath lab, by interventional cardiologists and in the heart surgery suite by cardiac surgeons for patients who are in need of hemodynamic support prophylactically or emergently before, during or after angioplasty or heart surgery procedures.

Note 2. Basis of Presentation and Summary of Significant Accounting Policies

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles, or GAAP, for interim financial reporting as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”) and in accordance with Article 10 of Regulation S-X. Accordingly, they do not include all of the information and note disclosures required by GAAP for complete financial statements. These statements should be read in conjunction with the consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended March 31, 2022 that has been filed with the SEC.

In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all normal and recurring adjustments that are necessary for a fair presentation of results for the interim periods presented. The results of operations for any interim period may not be indicative of results for the full fiscal year or any other subsequent period. The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements. Actual results may differ from these estimates.

There have been no changes in the Company’s significant accounting policies for the three and six months ended September 30, 2022 as compared to the significant accounting policies described in the Company’s Annual Report on Form 10-K for the fiscal year ended March 31, 2022 that has been filed with the SEC.

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements. Actual results may differ from these estimates.

COVID-19 Pandemic

The Company is subject to additional risks and uncertainties as a result of the ongoing novel coronavirus (“COVID-19”) pandemic. Since March 2020, the ongoing COVID-19 pandemic has adversely impacted and is likely to further adversely impact the Company’s business and markets, including the Company’s workforce and the operations of its customers, suppliers, and business partners. While the COVID-19 (including new variants of COVID-19) pandemic remains fluid and continues to evolve differently across various geographies, the Company believes it is likely to continue to experience variable impacts on its business.

To ensure the health and safety of its global employees, the Company continues to offer onsite COVID-19 testing and vaccinations in order to maintain a safe working environment. The Company’s proactive testing and vaccination programs have reduced exposure with early detection and enabled its manufacturing facilities to operate at full capacity.

The depth and extent to which the COVID-19 pandemic may directly or indirectly impact the Company’s business, results of operations, financial condition and individual markets is dependent upon various factors, including the spread of additional variants; the availability of vaccinations, personal protective equipment, intensive care unit (“ICU”) and operating room capacity, and medical staff; and government interventions to reduce the spread of the virus. When COVID-19 infection rates spike in a particular region, the Company’s patient utilization volumes have generally been negatively impacted as hospitals face capacity limitations, staffing shortages and some in-patient treatments have been deferred.

While patient utilization increased in the second quarter of fiscal year 2023, sales were impacted by extended vacations from physicians and medical employees, in addition to the ongoing impact of hospital labor shortages. The Company continues to closely monitor the impact of COVID-19 on all aspects of its business, including customers, employees, suppliers, vendors, business partners and distribution channels, as well as on procedures and the demand for its products by keeping apprised of local, regional, and global COVID-19 surges (including new variants of the virus).

While the Company cannot reliably estimate the extent to which the COVID-19 pandemic may impact patient utilization and revenues of its products, the Company's focus is to increase patient utilization of its Impella devices. As of the date of issuance of
these financial statements, the extent to which the COVID-19 pandemic may materially adversely affect the Company’s financial condition, liquidity or results of operations is uncertain.

Recently Adopted Accounting Pronouncements

In November 2021, the FASB issued ASU 2021-10, “Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance” an amendment focused on increasing transparency of government assistance including the disclosure of (1) the types of assistance, (2) an entity’s accounting for the assistance, and (3) the effect of the assistance on an entity’s financial statements. The Company adopted ASU 2021-10 as of April 1, 2022, on a prospective basis, and the adoption did not have a material impact on the Company’s condensed consolidated financial statements.

Recently Issued Accounting Pronouncements Not Yet Effective

No new accounting pronouncements issued or effective during the period had, or are expected to have, a material impact on the consolidated financial statements.

Note 3. Acquisitions

Acquisition of preCARDIA, Inc.

The Company acquired 100% interest in preCARDIA , Inc. (“preCARDIA”) on May 28, 2021. preCARDIA is a developer of a proprietary catheter and controller that is expected to complement the Company’s product portfolio to expand options for patients with acute decompensated heart failure (“ADHF”). The preCARDIA system is uniquely designed to rapidly treat ADHF-related volume overload by effectively reducing cardiac filling pressures and promoting decongestion to improve overall cardiac and renal function. The Company determined that substantially all of the fair value was concentrated in the acquired in-process research and development asset in accordance with ASC 805 Business Combinations. As such, the acquisition was accounted for as an asset acquisition.

The Company acquired preCARDIA for a purchase price of $115.2 million. The purchase price included cash consideration of $82.8 million for the remaining interest in preCARDIA, paid to the selling shareholders and for transaction costs associated with the acquisition, and $32.4 million representing the Company’s previously owned minority interest in preCARDIA. The Company recognized a gain of $21.0 million related to its previously owned minority interest in preCARDIA within the condensed consolidated statement of operations for the six months ended September 30, 2021.

In connection with the acquisition, the Company acquired net assets of $115.2 million, which included $115.5 million related to the fair value of the in-process research and development asset and $0.3 million for net liabilities assumed. Since the acquired technology platform is pre-commercial and has not reached technical feasibility, the cost of the in-process research and development asset was expensed, resulting in a charge of $115.5 million to the condensed consolidated statement of operations for the six months ended September 30, 2021. In connection with the acquisition, the Company acquired a license agreement, under which there is a potential payout of $5 million based on the achievement of a commercial milestone.

Note 4. Net Income Per Share

Basic net income per share is computed by dividing net income by the weighted average number of common shares outstanding during the period. Diluted net income per share is computed using the treasury stock method by dividing net income by the weighted average number of dilutive common shares outstanding during the period. Diluted shares outstanding is calculated by adding to the weighted average shares outstanding any potential dilutive securities outstanding for the period. Potential dilutive securities include stock options, restricted stock units, performance-based stock awards and shares to be purchased under the Company’s employee stock purchase plan.

For purposes of the diluted net income per share calculation, potential dilutive securities are excluded from the calculation if their effect would be anti-dilutive. As such, basic and diluted net loss per share are the same for periods with a net loss.

The Company’s basic and diluted net income per share were as follows:


	For the Three Months Ended September 30,				For the Six Months Ended September 30,
	2022		2021		2022		2021
Net income per share – basic	(in thousands, except per share data)
Net income	$	106,133	$	56,953	$	160,687	$	30,428

Weighted average shares – basic		45,372		45,437		45,475		45,374

Net income per share – basic	$	2.34	$	1.25	$	3.53	$	0.67


	For the Three Months Ended September 30,				For the Six Months Ended September 30,
	2022		2021		2022		2021
Net income per share – diluted	(in thousands, except per share data)
Net income	$	106,133	$	56,953	$	160,687	$	30,428

Weighted average shares – basic		45,372		45,437		45,475		45,374
Effect of dilutive securities		339		456		337		483
Weighted average shares – diluted		45,711		45,893		45,812		45,857

Net income per share – diluted	$	2.32	$	1.24	$	3.51	$	0.66

For each of the three and six months ended September 30, 2022 and 2021, approximately 0.2 million shares of common stock underlying outstanding securities related to out-of-the-money stock options and performance-based awards where milestones were not met were not included in the computation of diluted earnings per share because their inclusion would be anti-dilutive or such shares are contingently issuable upon meeting performance criteria in the periods presented.

Note 5. Revenue Recognition

Revenue is recognized when, or as, obligations under the terms of a contract are satisfied, which occurs when control of the promised products or services is transferred to customers. Revenue is measured as the amount of consideration the Company expects to receive in exchange for transferring products or services to a customer.

Product revenue is generally recognized when the customer obtains control of the Company’s product, which occurs at a point in time, and may be upon shipment or upon delivery based on the contractual shipping terms of a contract.

Service revenue is generally recognized over time as the services are rendered to the customer based on the extent of progress towards completion of the performance obligation. The Company recognizes service revenue over the term of the service contract. Services are expected to be transferred to the customer throughout the term of the contract and the Company believes recognizing revenue ratably over the term of the contract best depicts the transfer of value to the customer. Revenue generated from preventative maintenance calls is recognized at a point in time when the services are provided to the customer.

Revenue from the sale of products and services are evidenced by either a contract with the customer or a valid purchase order and an invoice which includes all relevant terms of sale and shipment of product or service provided has been incurred. The Company performs a review of each specific customer's credit worthiness and ability to pay prior to acceptance as a customer. Further, the Company performs periodic reviews of its customers' creditworthiness prospectively.

Disaggregation of Revenue

Revenue is disaggregated from contracts between product revenue and service and other revenue and by geography, which the Company believes best depicts how the nature, amount, timing, and uncertainty of revenues and cash flows are affected by economic factors. The Company generally sells its products and services through a direct sales force in the U.S. and Germany and through direct sales and distribution agreements in other international markets outside the U.S. (e.g., Japan, Europe, Canada, Latin America, Asia-Pacific, Middle East).

The following table disaggregates the Company’s revenue by products and services and other:


	For the Three Months Ended September 30,				For the Six Months Ended September 30,
	2022		2021		2022		2021
	(in thousands)				(in thousands)
Product revenue	$	253,246	$	235,785	$	517,717	$	477,259
Service and other revenue		12,675		12,357		25,353		23,468
Total revenue	$	265,921	$	248,142	$	543,070	$	500,727

The following table disaggregates the Company’s revenue by geographic location:


	For the Three Months Ended September 30,				For the Six Months Ended September 30,
	2022		2021		2022		2021
	(in thousands)				(in thousands)
United States	$	218,943	$	200,485	$	445,462	$	407,627
Europe		30,269		32,527		64,105		64,764
Japan		12,467		12,267		25,702		23,552
Rest of world		4,242		2,863		7,801		4,784
Outside the U.S.		46,978		47,657		97,608		93,100
Total revenue	$	265,921	$	248,142	$	543,070	$	500,727

Variable Consideration

Returns Reserve

The Company estimates an allowance for future sales returns based on historical return experience, which requires judgment. The Company estimates the amount of its product sales that may be returned by its customers and records this estimate as a reduction of revenue in the period the related product revenue is recognized. The Company estimates product return liabilities using the expected value method based on its historical sales information and other factors that it believes could significantly impact its expected returns. The Company’s returns reserve was not material as of September 30, 2022 and March 31, 2022.

Rebates and Discounts

The Company provides certain customers with rebates and discounts that are defined in the Company’s contractual arrangements with customers and are recorded as a reduction of revenue in the period the related revenue is recognized with a corresponding liability recorded and included in accrued expenses in the accompanying condensed consolidated balance sheets. Rebates normally result from performance-based offers that are primarily based on attaining contractually specified sales volumes as well as product usage. Discounts are normally from early payment incentives. The Company estimates the amount of rebates and discounts based on an estimate of the third-party’s sales and the respective rebate or discount defined in the customer contractual arrangement.

Contract Balances

Contract balances represent amounts presented in the condensed consolidated balance sheets when either the Company has transferred goods or services to the customer, or the customer has paid consideration to the Company under the contract. These contract balances include trade accounts receivable and deferred revenue.

Deferred Revenue

The Company’s deferred revenue balance was $26.0 million and $26.4 million as of September 30, 2022 and March 31, 2022, respectively. The deferred revenue balance is comprised of product shipments in which the Company recognizes revenue when the customer obtains control of the product, and preventative maintenance service contracts in which revenue is recognized ratably over the term of the service contract. During the three and six months ended September 30, 2022, the Company recognized $6.4 million and $20.1 million of revenue, respectively, that was included in the deferred revenue balance as of March 31, 2022. During the three and six months ended September 30, 2021, the Company recognized $9.9 million and $21.0 million of revenue, respectively, that was included in the deferred revenue balance as of March 31, 2021.

Costs to Obtain or Fulfill a Customer Contract

The Company has certain costs to obtain and fulfill a customer contract, such as commissions and shipping costs. The Company recognizes the incremental costs of obtaining contracts as an expense when incurred if the amortization period of the assets that the Company otherwise would have recognized is one year or less. The Company accounts for shipping and handling activities related to contracts with customers as costs to fulfill the promise to transfer the associated products. These costs are included in selling, general, and administrative expenses.

Note 6. Financial Instruments

Cash Equivalents and Marketable Securities

The Company’s cash equivalents and marketable securities at September 30, 2022 and March 31, 2022 are invested in the following:


	Amortized		Gross Unrealized		Gross Unrealized			Fair Market
	Cost		Gains		Losses			Value
September 30, 2022	(in thousands)
Money market funds	$	86,806	$	—	$	—		$	86,806
U.S. Treasury mutual fund securities		17,939		—		(3	)		17,936
Total cash equivalents		104,745		—		(3	)		104,742
Short-term U.S. Treasury mutual fund securities		335,024		6		(3,218	)		331,812
Short-term government-backed securities		146,747		—		(2,550	)		144,197
Short-term corporate debt securities		40,681		—		(519	)		40,162
Short-term commercial paper		122,353		—		(487	)		121,866
Total short-term marketable securities		644,805		6		(6,774	)		638,037
Long-term U.S. Treasury mutual fund securities		28,595		—		(1,229	)		27,366
Long-term government-backed securities		93,235		14		(3,744	)		89,505
Total long-term marketable securities		121,830		14		(4,973	)		116,871
Total cash equivalents and marketable securities	$	871,380	$	20	$	(11,750	)	$	859,650


	Amortized		Gross Unrealized		Gross Unrealized			Fair Market
	Cost		Gains		Losses			Value
March 31, 2022:	(in thousands)
Money market funds	$	32,955	$	—	$	—		$	32,955
Commercial paper		28,961		—		(3	)		28,958
Total cash equivalents		61,916		—		(3	)		61,913
Short-term U.S. Treasury mutual fund securities		287,010		—		(1,384	)		285,626
Short-term government-backed securities		131,954		1		(554	)		131,401
Short-term corporate debt securities		61,108		36		(113	)		61,031
Short-term commercial paper		148,128		—		(397	)		147,731
Total short-term marketable securities		628,200		37		(2,448	)		625,789
Long-term U.S. Treasury mutual fund securities		89,168		—		(1,796	)		87,372
Long-term government-backed securities		126,150		—		(3,378	)		122,772
Long-term corporate debt securities		10,226		—		(281	)		9,945
Total long-term marketable securities		225,544		—		(5,455	)		220,089
Total cash equivalents and marketable securities	$	915,660	$	37	$	(7,906	)	$	907,791

Gross realized gains and losses on sales of marketable securities were not material for the three and six months ended September 30, 2022 and 2021.

The securities that the Company invests in are generally deemed to be low risk based on their credit ratings from the major rating agencies. The longer the duration of these securities, the more susceptible they are to changes in market interest rates and bond yields. As interest rates increase, those securities purchased at a lower yield show a mark-to-market unrealized loss. Unrealized losses as of September 30, 2022 are primarily due to changes in interest rates and credit spreads. Accordingly, the Company has not recorded an allowance for credit losses. No marketable securities have been in a continuous material unrealized loss position for greater than twelve months as of September 30, 2022.

Derivative Instruments

In October 2019, the Company entered into an intercompany agreement in which it loaned 85.0 million Euro to Abiomed Europe GmbH, its German subsidiary. In conjunction with this intercompany loan agreement, the Company entered into a cross-currency swap agreement to convert the notional amount of the intercompany loan of 85.0 million Euro to its U.S. dollar equivalent, or $93.5 million. The objective of this cross-currency swap is to hedge the variability of cash flows related to the forecasted interest and principal payments on the Euro denominated fixed rate intercompany loan against changes in the exchange rate between the U.S. dollar and the Euro and has been designated as a cash flow hedge. The Company will make interest payments in Euro and receive interest in U.S. dollars from the counterparty. Upon maturity, the Company will pay the principal amount of the intercompany loan in Euro and receive the U.S. dollar equivalent from the counterparty. The cross-currency swap is carried on the consolidated balance sheets at fair value, and changes to the derivative instrument are recorded as unrealized gains or losses in accumulated other comprehensive income (loss). These amounts are reclassified into the consolidated statements of operations in the same period in which the related hedged item (intercompany loan agreement) affects earnings. The Company does not enter into derivative instruments for any purpose other than cash flow hedging.

In September 2022, Abiomed Europe GmbH made a one-time payment of 20.0 million Euro, reducing the outstanding principal balance on the intercompany loan to 65.0 million Euro. Concurrently, the Company partially terminated the cross-currency swap to adjust the notional amount to 65.0 million Euro. Accordingly, the terminated portion of the cross-currency swap of 20.0 million Euro was no longer effective, and therefore, the related net gains and losses recorded to accumulated other comprehensive income (loss) of $0.1 million were reclassified to earnings.

The following table summarizes the terms of the cross-currency swap as of September 30, 2022 (amounts in thousands):



	Effective Date	Maturity	Fixed Rate	Aggregate Notional Amount
Pay EUR	October 15, 2019	October 15, 2024	2.75%		EUR 65,000
Receive U.S.$			4.64%		USD 71,468

The following table summarizes the terms of the cross-currency swap as of March 31, 2022 (amounts in thousands):


	Effective Date	Maturity	Fixed Rate	Aggregate Notional Amount
Pay EUR	October 15, 2019	October 15, 2024	2.75%		EUR 85,000
Receive U.S.$			4.64%		USD 93,457

The following table presents the fair value of the cross-currency swap (amounts in thousands):


Derivatives designated as hedging instruments under ASC 815	Balance Sheet classification	September 30, 2022		March 31, 2022
Cross-currency swap	Other assets (other long-term liabilities)	$	8,215	$	(489	)

The change in fair value of the cross-currency swap during the three and six months ended September 30, 2022 was mainly due to fluctuations in the Euro to the U.S. dollar exchange rates.

For the three and six months ended September 30, 2022, the Company recorded income related to the interest rate differential of the cross-currency swap of $0.5 million and $1.0 million, respectively in interest and other income, net, within the condensed consolidated statements of operations. For the three and six months ended September 30, 2021, the Company recorded income related to the interest rate differential of the cross-currency swap of $0.4 million and $0.8 million, respectively, in interest and other income, net within the condensed consolidated statements of operations.

Fair Value Hierarchy

Fair value is defined as the price that would be received upon the sale of an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three categories:

Level 1 primarily consists of financial instruments whose values are based on quoted market prices such as exchange-traded instruments and listed equities.

Level 2 includes financial instruments that are valued using models or other valuation methodologies. These models are primarily industry-standard models that consider various assumptions, including time value, yield curve, volatility factors, prepayment speeds, default rates, loss severity, current market and contractual prices for the underlying financial instruments, as well as other relevant economic measures. Substantially all of these assumptions are observable in the marketplace, can be derived from observable data or are supported by observable levels at which transactions are executed in the marketplace.

Level 3 is comprised of unobservable inputs that are supported by little or no market activity. Financial assets are considered Level 3 when their fair values are determined using pricing models, discounted cash flows or similar techniques and at least one significant model assumption or input is unobservable.

The following tables present the Company’s assets and liabilities measured at fair value on a recurring basis:


	Level 1		Level 2		Level 3		Total
September 30, 2022:	(in thousands)
Assets
Money market funds	$	86,806	$	—	$	—	$	86,806
U.S. Treasury mutual fund securities		—		17,936		—		17,936
Short-term U.S. Treasury mutual fund securities		—		331,812		—		331,812
Short-term government-backed securities		—		144,197		—		144,197
Short-term corporate debt securities		—		40,162		—		40,162
Short-term commercial paper		—		121,866		—		121,866
Long-term U.S. Treasury mutual fund securities		—		27,366		—		27,366
Long-term government-backed securities		—		89,505		—		89,505
Investment in Shockwave Medical		46,385		—		—		46,385
Cross-currency swap agreement		—		8,215		—		8,215
Liabilities
Contingent consideration		—		—		14,995		14,995


	Level 1		Level 2		Level 3		Total
March 31, 2022:	(in thousands)
Assets
Money market funds	$	32,955	$	—	$	—	$	32,955
Commercial paper		—		28,958		—		28,958
Short-term U.S. Treasury mutual fund securities		—		285,626		—		285,626
Short-term government-backed securities		—		131,401		—		131,401
Short-term corporate debt securities		—		61,031		—		61,031
Short-term commercial paper		—		147,731		—		147,731
Long-term U.S. Treasury mutual fund securities		—		87,372		—		87,372
Long-term government-backed securities		—		122,772		—		122,772
Long-term corporate debt securities		—		9,945		—		9,945
Investment in Shockwave Medical		61,535		—		—		61,535
Liabilities
Cross-currency swap agreement		—		489		—		489
Contingent consideration		—		—		21,510		21,510

The Company has determined that the estimated fair value of its money market funds and its investment in Shockwave Medical, a publicly traded medical device company, are reported as Level 1 financial assets as they are valued at quoted market prices in active markets. The investment in Shockwave Medical is classified within other assets in the condensed consolidated balance sheets.

The Company has determined that the estimated fair value of its commercial paper, U.S. Treasury mutual fund securities, government-backed securities, corporate debt securities and cross-currency swap agreement are reported as Level 2 financial assets and liabilities as they are based on model-driven valuations in which all significant inputs are observable, or can be derived from or corroborated by observable market data for substantially the full term of the asset or liability.

The Company evaluates transfers between fair value levels at the end of each reporting period. There were no transfers of assets or liabilities between fair value levels during the six months ended September 30, 2022.

Level 3 Assets and Liabilities

Other Investments

The Company periodically makes investments in medical device companies that focus on heart failure and heart pumps and other medical device technologies. The Company measures these equity investments at cost minus impairment, if any, plus or minus changes resulting from observable price changes in orderly transactions for an identical or similar investment. The Company monitors any events or changes in circumstances that may have a significant effect on the fair value of investments, either due to impairment or based on observable price changes and records adjustments as needed.

The Company’s other investments are classified as a Level 3 assets and are not included in the fair value table above.

The carrying value of the Company’s portfolio of other investments and the change in the balance for the six months ended September 30, 2022 are as follows:


	(in thousands)
Balance, March 31, 2022	$	70,314
Additions		4,975
Impairments		(1,816	)
Change in fair value, net		52,334
Balance, September 30, 2022	$	125,807

Change in fair value, net represents upward and downward adjustments due to observable price changes and related foreign currency fluctuations, which are reflected within interest and other income, net in the Company's condensed consolidated statements of operations for the three and six months ended September 30, 2022.

Contingent Consideration

Contingent consideration represents potential milestones that the Company may pay as additional consideration related to the acquisition of ECP Entwicklungsgesellschaft mbH (“ECP”) in July 2014 and the acquisition of Breethe in April 2020. Changes in fair value of contingent consideration are reflected within research and development expenses in the Company’s condensed consolidated statements of operations. There is no assurance that any of the conditions for the milestone payments will be met.

The components of contingent consideration are as follows:


	September 30, 2022		March 31, 2022
	(in thousands)
ECP	$	11,495	$	12,010
Breethe		3,500		9,500
Total contingent consideration	$	14,995	$	21,510

ECP

In July 2014, the Company acquired ECP and AIS GmbH Aachen Innovative Solutions (“AIS”) for $13.0 million in cash, with additional potential payouts totaling $15.0 million based on the achievement of CE Mark approval in the European Union and a revenue-based milestone related to the development of the future Impella ECPTM expandable catheter pump technology. These potential milestone payments may be made, at the Company’s option, by a combination of cash or ABIOMED common stock.

The Company uses a combination of an income approach, based on various revenue and cost assumptions and the application of a probability to each outcome, and a Monte-Carlo valuation model, both of which consider significant unobservable inputs. As it relates to the CE Mark approval milestone, probabilities were applied to each potential scenario and the resulting values were discounted using a rate that considers weighted average cost of capital as well as a specific risk premium associated with the riskiness of the earn out itself, the related projections, and the overall business. The revenue-based milestone is valued using a Monte-Carlo valuation model, which simulates estimated future revenues during the earn out-period using management’s best estimates.

Key unobservable inputs include the discount rate used to present value the projected revenues and cash flows (ranging from 5.9% to 17.5%), the probability of achieving the various technical, regulatory and commercial milestones (estimated to range from 10% to 45%) and projected revenues based on a Monte-Carlo valuation (96%) which are based on the Company’s most recent internal operational budgets and long-range strategic plans.

Breethe

In April 2020, the Company acquired Breethe for $55.0 million in cash, with additional potential payouts up to a maximum of $55.0 million payable based on the achievement of certain technical, regulatory and commercial milestones.

The Company uses a combination of an income approach, based on various revenue and cost assumptions and the application of a probability to each outcome, and a Monte-Carlo valuation model, both of which consider significant unobservable inputs. As it relates to the regulatory milestones, probabilities were applied to each potential scenario and the resulting values were discounted using a rate that considers weighted average cost of capital as well as a specific risk premium associated with the riskiness of the earn out itself, the related projections, and the overall business. The commercial milestones are valued using a Monte-Carlo valuation model, which simulates estimated future revenues during the earn out-period using management’s best estimates.

Key unobservable inputs include the discount rates used to present value the projected revenues and cash flows (ranging from 5.9% to 15.5%), the probability of achieving the various technical, regulatory and commercial milestones (estimated to range from 10% to 25%) and projected revenues based on a Monte-Carlo valuation (4%) which are based on the Company’s operational forecasts and long-range strategic plans.

Contingent consideration is classified as a Level 3 liability as the estimated fair value of the contingent consideration related to the acquisitions of ECP and Breethe require significant management judgment or estimation.

The following table summarizes the change in fair value, as determined by Level 3 inputs of the contingent consideration for the six months ended September 30, 2022:



	(in thousands)
Balance, March 31, 2022	$	21,510
Change in fair value		(6,515	)
Balance, September 30, 2022	$	14,995

The change in fair value of the contingent consideration was primarily due to estimates related to development timelines and the passage of time on the fair value measurement of milestones.

The significant unobservable inputs used in the fair value of the Company’s contingent consideration are the discount rate and forecasted financial information, including the probability of achievement. Significant increases (decreases) in the discount rate would have resulted in a significantly lower (higher) fair value measurement. Significant increases (decreases) in the forecasted financial information would have resulted in a significantly higher (lower) fair value measurement. As of September 30, 2022 and March 31, 2022, the present value of expected payments related to the Company’s contingent consideration was $15.0 million and $21.5 million, respectively. The undiscounted value of the payments, assuming that all contingencies are met, would be $67.5 million as of both September 30, 2022 and March 31, 2022.

Note 7. Inventories, net

The components of inventories, net are as follows:


	September 30, 2022		March 31, 2022
	(in thousands)
Raw materials and supplies	$	34,447	$	28,326
Work-in-progress		51,443		34,788
Finished goods		16,347		30,867
Inventories, net	$	102,237	$	93,981

The Company’s inventories relate to its Impella® and Abiomed Breethe OXY-1 System™ (“Breethe OXY-1”) product platforms. Finished goods and work-in-process inventories consist of direct material, labor and overhead.

Note 8. Property and Equipment, net

The components of property and equipment, net are as follows:


	September 30, 2022			March 31, 2022
	(in thousands)
Land	$	10,144		$	10,643
Building and building improvements		157,507			152,374
Leasehold improvements		1,897			1,810
Machinery, equipment and computer software		106,235			104,407
Furniture and fixtures		15,391			15,420
Construction in progress		13,407			19,898
Total cost		304,581			304,552
Less accumulated depreciation		(109,424	)		(102,062	)
Property and equipment, net	$	195,157		$	202,490

Depreciation expense related to property and equipment was $6.3 million and $6.6 million for the three months ended September 30, 2022 and 2021, respectively. Depreciation expense related to property and equipment was $12.4 million and $13.0 million for the six months ended September 30, 2022 and 2021, respectively.

Note 9. Goodwill and Other Intangible Assets, net

Goodwill

The carrying amount of goodwill as of September 30, 2022 and March 31, 2022 was $73.0 million and $76.8 million, respectively, and has been recorded in connection with the Company’s acquisition of Impella Cardiosystems AG, in May 2005, ECP in July 2014 and Breethe in April 2020. The carrying value of goodwill and the change in the balance for the six months ended September 30, 2022 are as follows:


	(in thousands)
Balance, March 31, 2022	$	76,786
Foreign currency translation		(3,826	)
Balance, September 30, 2022	$	72,960

The Company evaluates goodwill at least annually on October 31, as well as whenever events or changes in circumstances suggest that the carrying amount may not be recoverable. The Company has no accumulated impairment losses on goodwill.

Other Intangible Assets, net

Other intangible assets, net consists of the following:


	September 30, 2022
	Weighted Average Amortization Period (in years)	Cost		Accumulated Amortization			Net Carrying Value
		(in thousands)
Finite-lived intangible assets
Developed technology	13.1	$	27,000	$	(3,450	)	$	23,550

Indefinite-lived intangible assets
In-process research and development			13,283		—			13,283
Total		$	40,283	$	(3,450	)	$	36,833


	March 31, 2022
	Weighted Average Amortization Period (in years)	Cost		Accumulated Amortization			Net Carrying Value
		(in thousands)
Finite-lived intangible assets
Developed technology	13.6	$	27,000	$	(2,550	)	$	24,450

Indefinite-lived intangible assets
In-process research and development			15,068		—			15,068
Total		$	42,068	$	(2,550	)	$	39,518

The Company’s finite-lived intangible asset represents developed technology associated with the estimated fair value of the Breethe OXY-1 System. During the year ended March 31, 2021, the Company reclassified the in-process research and development (“IPR&D”) asset to developed technology upon receiving U.S. Food and Drug Administration or FDA 510(k) clearance of the Breethe OXY-1 System and began amortizing the intangible asset on a straight-line basis over an estimated useful life of 15 years.

The Company’s IPR&D asset represents the estimated fair value of the Impella ECPTM related to the acquisition of ECP and AIS, in July 2014. The estimated fair value of the IPR&D asset at the acquisition date was determined using a probability-weighted income approach, which discounts expected future cash flows to present value. The projected cash flow estimates for the future Impella ECPTM expandable catheter pump were based on certain key assumptions, including estimates of future revenue and expenses, taking into account the stage of development of the technology at the acquisition date and the time and resources needed to complete development.

The Company evaluates the other intangible assets at least annually on October 31, as well as whenever events or changes in circumstances suggest that the carrying amount may not be recoverable. The Company has no accumulated impairment losses on other intangible assets. The change in the IPR&D balance for the six months ended September 30, 2022, relates to the impact of foreign currency translation.

Note 10. Other Assets

The components of other assets are as follows:


	September 30, 2022		March 31, 2022
	(in thousands)
Investment in Shockwave Medical	$	46,385	$	61,535
Other investments (Note 6)		125,807		70,314
Operating lease right of use assets		7,550		9,518
Other intangible assets and other assets		13,302		6,118
Total other assets	$	193,044	$	147,485

Investment in Shockwave Medical

The fair value of the Company’s investment in Shockwave Medical, a publicly-traded medical device company, was $46.4 million and $61.5 million as of September 30, 2022 and March 31, 2022, respectively. During the three months ended September 30, 2022 and 2021, the Company recorded an unrealized gain of $14.5 million and $4.8 million, respectively, in interest and other income, net within the condensed consolidated statements of operations. During the six months ended September 30, 2022 and 2021, the Company recorded an unrealized gain of $9.7 million and $22.4 million, respectively, in interest and other income, net within the condensed consolidated statements of operations.

In August 2022, the Company sold approximately 0.1 million of its shares of Shockwave Medical stock for cash proceeds of approximately $40.0 million and realized a net gain of $15.2 million in interest and other income, net within the condensed consolidated statement of operations.

Operating Lease Right of Use Assets

The Company has lease agreements for real estate including corporate offices and warehouse space, vehicles and certain equipment. The balance of operating lease right-of-use assets included in other assets was $7.6 million and $9.5 million as of September 30, 2022 and March 31, 2022, respectively

Other Long-Term Assets

The Company’s other long-term assets is comprised primarily of license manufacturing rights to certain technology from third parties and prepayments related to the Company’s clinical trial activities.

Note 11. Accrued Expenses

Accrued expenses consist of the following:


	September 30, 2022		March 31, 2022
	(in thousands)
Employee compensation	$	42,365	$	50,649
Research and development		10,276		7,337
Sales and income taxes		2,859		1,931
Marketing		2,259		2,289
Professional, legal and accounting fees		1,739		1,479
Warranty		1,674		1,935
Other		8,262		7,009
	$	69,434	$	72,629

Employee compensation consists primarily of accrued bonuses, accrued commissions and accrued employee benefits. Other includes returns reserve, allowance for rebates and discounts and other miscellaneous accrued expenses.

Note 12. Stockholders’ Equity

Class B Preferred Stock

The Company has authorized 1,000,000 shares of Class B Preferred Stock, $.01 par value, of which the board of directors can set the designation, rights and privileges. No shares of Class B Preferred Stock have been issued or are outstanding.

Stock Repurchase Program

In August 2019, the Company’s Board of Directors authorized a stock repurchase program for up to $200.0 million of shares of its common stock (the "2019 Share Repurchase Program"). In August 2022, the Company’s Board of Directors authorized an additional stock repurchase program for up to $200.0 million of shares of its common stock (the “2022 Share Repurchase Program”). Under these stock repurchase programs, the Company is authorized to repurchase shares through open market purchases, privately negotiated transactions or otherwise in accordance with applicable federal securities laws, including through Rule 10b5-1 trading plans and under Rule 10b-18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). The stock repurchase programs have no time limit and may be suspended for periods or discontinued at any time. The Company is funding the stock repurchase programs with its available cash and marketable securities. The remaining authorization under the stock repurchase programs was $177.2 million as of September 30, 2022.

The following table provides stock repurchase activities during the three and six months ended September 30, 2022 and 2021:


	For the Three Months Ended September 30,				For the Six Months Ended September 30,
	2022		2021		2022		2021
Shares repurchased		424,452		—		484,734		—
Average price per share	$	264.10		—	$	261.20		—
Value of shares repurchased (in millions)	$	112.1		—	$	126.6		—

Accumulated Other Comprehensive Loss

The components of accumulated other comprehensive loss are as follows (in thousands):


	Three and Six Months Ended September 30, 2022
	Foreign Currency Translation Losses			Unrealized Gains (Losses) on Derivative Instrument			Net Unrealized Losses on Marketable Securities, net of tax			Total
Balance, March 31, 2022	$	(20,562	)	$	125		$	(6,723	)	$	(27,160	)
Other comprehensive loss		(8,729	)		(384	)		(1,998	)		(11,111	)
Balance, June 30, 2022		(29,291	)		(259	)		(8,721	)		(38,271	)
Other comprehensive (loss) income		(8,029	)		78			(423	)		(8,374	)
Balance, September 30, 2022	$	(37,320	)	$	(181	)	$	(9,144	)	$	(46,645	)


	Three and Six Months Ended September 30, 2021
	Foreign Currency Translation (Losses) Gains			Unrealized Gains (Losses) on Derivative Instrument			Net Unrealized Gains (Losses) on Marketable Securities, net of tax			Total
Balance, March 31, 2021	$	(14,718	)	$	1,904		$	1,369		$	(11,445	)
Other comprehensive income (loss)		83			(217	)		(632	)		(766	)
Balance, June 30, 2021		(14,635	)		1,687			737			(12,211	)
Other comprehensive (loss) income		(2,693	)		545			(197	)		(2,345	)
Balance, September 30, 2021	$	(17,328	)	$	2,232		$	540		$	(14,556	)

Note 13. Stock-Based Compensation

The following table summarizes stock-based compensation expense by financial statement line item in the Company’s condensed consolidated statements of operations for each of the three and six months ended September 30, 2022 and 2021:


	For the Three Months Ended September 30,				For the Six Months Ended September 30,
	2022		2021		2022		2021
	(in thousands)
Cost of revenue	$	1,358	$	1,300	$	2,754	$	2,330
Research and development		2,976		2,294		5,774		4,403
Selling, general and administrative		11,680		12,155		20,848		21,624
	$	16,014	$	15,749	$	29,376	$	28,357

Stock Options

The following table summarizes the stock option activity for the six months ended September 30, 2022:



						Weighted
				Weighted		Average		Aggregate
				Average		Remaining		Intrinsic
	Options			Exercise		Contractual		Value
	(in thousands)			Price		Term (years)		(in thousands)
Outstanding at beginning of period		595		$	178.54		5.55
Granted		5			267.96
Exercised		(21	)		93.07
Cancelled and expired		(3	)		285.00
Outstanding at end of period		576		$	182.01		5.14	$	49,789
Exercisable at end of period		500		$	169.15		4.64	$	49,167
Options vested and expected to vest at end of period		576		$	182.01		5.14	$	49,789

Stock options generally vest and become exercisable annually over three years. The remaining unrecognized stock-based compensation expense for unvested stock option awards as of September 30, 2022, was approximately $5.7 million and the weighted-average period over which this cost is expected to be recognized is 1.6 years.

The aggregate intrinsic value of stock options exercised was $4.1 million for the six months ended September 30, 2022. The total cash received as a result of employee stock option exercises for the six months ended September 30, 2022, was approximately $2.0 million.

The Company estimates the fair value of each stock option granted at the grant date using the Black-Scholes option valuation model. The weighted average grant-date fair values and weighted average assumptions used in the calculation of fair value of options granted were as follows:


	For the Three Months Ended September 30,						For the Six Months Ended September 30,
	2022			2021			2022			2021
Weighted average grant-date fair value	$	118.40		$	115.99		$	119.74		$	103.48

Valuation assumptions:
Risk-free interest rate		3.32	%		0.77	%		3.20	%		0.79	%
Expected option life (years)		5.60			4.14			5.58			4.20
Expected volatility		43.49	%		44.72	%		43.50	%		44.30	%

Restricted Stock Units

The following table summarizes activity of restricted stock units for the six months ended September 30, 2022:


				Weighted
				Average
	Number of			Grant Date
	Shares			Fair Value
	(in thousands)			(per share)
Restricted stock units at beginning of period		307		$	274.32
Granted (1)		267			266.68
Vested		(122	)		284.98
Forfeited		(7	)		275.21
Restricted stock units at end of period		445		$	266.72

(1) Includes 19,000 performance-based awards granted due to greater than 100% target vesting.

The weighted average grant-date fair value for restricted stock units granted during the six months ended September 30, 2022 was $266.7. The total fair value of restricted stock units vested during the six months ended September 30, 2022 was $34.7 million.

Restricted stock units generally vest annually, over three years. The remaining unrecognized compensation expense for outstanding restricted stock units, including performance-based and market-based awards, as of September 30, 2022 was $87.1 million and the estimated weighted-average period over which this cost is expected to be recognized is 2.2 years.

As of September 30, 2022, the Company recognized compensation expense based on the probable outcomes related to the prescribed performance targets on the outstanding awards. The remaining unrecognized compensation expense for outstanding performance-based and market-based restricted stock units as of September 30, 2022 was $28.7 million and the weighted-average period over which this cost is expected to be recognized is 2.1 years.

Performance-Based Awards

The Company grants performance-based restricted stock units to certain executive officers and employees, which vest upon achievement of prescribed service-based milestones by the award recipients and the achievement of prescribed performance milestones by the Company, as defined in the respective agreements.

Market-Based Awards

The Company grants market-based restricted stock units to certain executive officers and employees. These restricted stock units vest upon achievement of prescribed service-based milestones, relative total shareholder return (“TSR”) goals by the Company and the achievement of prescribed performance milestones by the Company, as defined in the respective agreements.

The Company used a Monte-Carlo simulation model to estimate the grant-date fair value of the TSR restricted stock units. The fair value related to these awards is recorded as compensation expense over the vesting term, regardless of the actual TSR outcome reached.

The table below sets forth the assumptions used to value the outstanding market-based restricted stock units and the estimated grant-date fair value:


	May 2021			May 2020
Risk-free interest rate		0.3	%		0.2	%
Expected volatility		44.8	%		35.5	%
Dividend yield		—			—
Remaining performance period (years)	2.8				2.9
Estimated fair value per share	$	292.40		$	349.28
Target performance (number of shares)		25,172			15,425

Note 14. Income Taxes

The Company’s income tax provision was $32.6 million and $10.3 million for the three months ended September 30, 2022 and 2021, respectively. The Company’s income tax provision was $47.8 million and $27.5 million for the six months ended September 30, 2022 and 2021, respectively. The Company’s effective income tax rate was 23.5% and 15.3% for the three months ended September 30, 2022 and 2021, respectively. The Company’s effective income tax rate was 22.9% and 47.5% for the six months ended September 30, 2022 and 2021, respectively. The effective income tax rate differs from the statutory federal income tax rate of 21.0% for the three months ended September 30, 2022 primarily due to state and foreign income taxes and permanent differences, offset by credits. The effective income tax rate differs from the statutory federal income tax rate of 21.0% for the three months ended September 30, 2021 primarily due to state and foreign income taxes and permanent differences, offset by credits and excess tax benefits. The effective income tax rate differs from the statutory federal income tax rate of 21.0% for the six months ended September 30, 2022 and 2021 primarily due to state and foreign income taxes and permanent differences offset by credits and excess tax benefits and the non-deductible charge for in-process research and development related to the preCARDIA acquisition for the six months ended September 30, 2021. The Company recognized shortfall expenses associated with stock-based awards of less than $0.1 million and excess tax benefits associated with stock-based awards of $6.2 million for the three months ended September 30, 2022 and 2021, respectively. The Company recognized excess tax benefits associated with stock-based awards of $0.9 million and $9.8 million for the six months ended September 30, 2022 and 2021, respectively.

The Company is subject to the examination of its income tax returns by the Internal Revenue Service and other tax authorities. The outcome of these audits cannot be predicted with certainty. The Company’s most recent completed income tax audits were in the U.S., relating to fiscal year 2016 and in Germany, which covered fiscal years 2016 through 2019. These tax audits did not materially impact the Company’s financial statements. All other tax years remain subject to examination by the IRS, state and foreign tax authorities.

On August 16, 2022, the Inflation Reduction Act (“IRA”) was signed into law, effective as of January 1, 2023. The IRA includes a new alternative minimum tax based upon financial statement income (book minimum tax), an excise tax on stock buybacks and tax incentives for energy and climate initiatives, among other provisions. We do not currently expect the legislation will have a material effect on our results of operations, financial condition or liquidity.

Note 15. Commitments and Contingencies

From time to time, the Company is involved in legal and administrative proceedings and claims of various types. In some actions, the claimants seek damages, as well as other relief, which, if granted, would require significant expenditures. The Company records a liability in its consolidated financial statements for these matters when a loss is known or considered probable and the amount can be reasonably estimated. The Company reviews these estimates each accounting period as additional information is known and adjusts the loss provision when appropriate. If a matter is both probable to result in liability to the Company and the amount of loss can be reasonably estimated, the Company estimates and discloses the possible loss or range of loss. If the loss is not probable or cannot be reasonably estimated, a liability is not recorded in its consolidated financial statements.

Maquet Matters

The Company has been litigating certain patents owned by Maquet Cardiovascular LLC (“Maquet”) in two separate cases pending in the U.S. District Court for the District of Massachusetts (“D. Mass” or “the Court”) since 2016.

In May 2016, the Company filed a declaratory judgment action (the “2016 Action”) alleging that it does not infringe Maquet’s patent. Following the claim construction (“Markman”) order issued in November 2018, and prior to the close of discovery, both parties filed series of motions. On September 30, 2021, the Court granted the Company’s Motion for Summary Judgement (“MSJ”) for non-infringement of the two claims remaining in this case. Maquet moved for reconsideration of the MSJ order, which the Court denied on November 30, 2021. The Court has not entered a final judgement; therefore, the case is not yet appealable to the Federal Circuit.

In November 2017, Maquet filed a new action in D. Mass alleging that the Company’s Impella 2.5®, Impella CP®, and Impella 5.0® heart pumps infringe certain claims of another patent in the same family (the seventh patent overall between both cases). The Parties submitted Markman briefs and argued their respective positions in November 2019. The Court issued the Markman order on September 12, 2022; discovery and dispositive motions are to be completed and filed prior to the pretrial conference scheduled for May 26, 2023.

The asserted patents in both cases expired on September 1, 2020.

The Company is unable to estimate the potential liability with respect to the legal matters noted above. There are numerous factors that make it difficult to meaningfully estimate possible loss or range of loss at this stage of the legal proceedings, including the significant number of legal and factual issues still to be resolved in the Maquet patent disputes.

Note 16. Segment and Geographic Information

Segment Information

Operating segments are components of an enterprise for which separate financial information is available and is evaluated regularly by the Company’s chief operating decision-maker (“CODM”) in deciding how to allocate resources and in assessing performance. The Company’s CODM (determined to be the Chief Executive Officer) reviews the business, makes investment and resource allocation decisions, and assesses operating performance based on the Company’s consolidated operating results. The Company operates as one reportable segment.

Geographic Information

Sales outside the U.S. accounted for 18% and 19% of total revenue for each of the three months ended September 30, 2022 and 2021, respectively. Sales outside the U.S. accounted for 18% and 19% of total revenue for each of the six months ended September 30, 2022 and 2021, respectively.

Geographic information about long-lived assets, net excluding goodwill and other intangible assets is as follows:


	September 30, 2022		March 31, 2022
	(in thousands)
United States	$	145,610	$	147,403
Europe		53,133		59,368
Japan		3,964		5,237
Total	$	202,707	$	212,008

Note 17. Employee Benefit Plans

The Company sponsors voluntary 401(k) retirement savings plans for eligible employees in the U.S. and Japan. The Company matches the contributions of participating employees on the basis of percentages specified in each plan. Total expense related to the Company's matching contributions to the plans was $1.4 million and $1.1 million for the three months ended September 30, 2022 and 2021, respectively. Total expense related to the Company's matching contributions to the plans was $2.7 million and $2.2 million for the six months ended September 30, 2022 and 2021, respectively.

Note 18. Subsequent Events

On October 31, 2022, the Company, Johnson & Johnson (“J&J”), and Athos Merger Sub, Inc., a wholly owned subsidiary of J&J (“Merger Sub”), entered into an Agreement and Plan of Merger (the “J&J Merger Agreement”), pursuant to which, on the terms and subject to the conditions set forth in the J&J Merger Agreement, (i) Merger Sub will commence a tender offer (the “J&J Offer”) to acquire all outstanding shares of common stock of the Company (“Company Shares”) for $380.00 per share in cash, without interest and less any applicable withholding tax, and one non-tradeable contingent value right per Company Share (each, a “CVR”) which represents the right to receive contingent payments of up to $35.00 per Company Share, in cash, without interest and less any applicable withholding tax, upon achievement of certain specified milestones and (ii) following consummation of the J&J Offer, Merger Sub will merge with and into the Company (the “J&J Merger” and together with the J&J Offer and the other transactions contemplated by the J&J Merger Agreement and the CVR Agreement (as defined below), the “J&J Transaction”)), with the Company surviving the J&J Merger as a wholly owned subsidiary of J&J.

On the terms and subject to the conditions set forth in a contingent value right agreement (the “CVR Agreement”) to be entered into by J&J and a rights agent mutually agreed between J&J and the Company, each CVR will represent the right to receive the following cash payments if the following milestones are achieved: (i) $10.00 per CVR if the results from the STEMI DTU study, the PROTECT IV study or the RECOVER IV study contribute to the publication of a Class I recommendation in the clinical practice guideline recommending the use of any device in the Impella product family in high risk PCI or STEMI patients with or without cardiogenic shock within four years from their respective clinical endpoint publication dates, but in all cases no later than December 31, 2029; (ii) $7.50 per CVR if, prior to January 1, 2028, the U.S. Food and Drug Administration approves a premarket approval application or premarket approval application supplement for the use of any device in the Impella product family in patients with STEMI, or Anterior STEMI, without cardiogenic shock; and (iii) either (x) $17.50 per CVR if J&J achieves $3.7 billion aggregate worldwide net sales with respect to certain of the Company’s products during the period from the first day of J&J’s second fiscal quarter of 2027 through the last day of J&J’s first fiscal quarter of 2028 or (y) $8.75 per CVR if J&J achieves $3.7 billion aggregate worldwide net sales with respect to certain of the Company’s products in any four consecutive fiscal quarters during the period from the first day of J&J’s third fiscal quarter of 2027 through the last day of J&J’s first fiscal quarter of 2029.

The boards of directors of both the Company and J&J have unanimously approved the J&J Merger and the board of directors of the Company unanimously recommends that the Company’s stockholders tender their Company Shares in the J&J Offer. The closing of the J&J Transaction is subject to the tender of more than 50% of the Company Shares, the expiration or termination of any waiting period (and extensions thereof) under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and the receipt of certain other non-U.S. regulatory approvals, and other customary closing conditions. The companies expect the J&J Transaction to close prior to the end of the first calendar quarter of 2023.

Additional information about the J&J Merger Agreement, the J&J Offer and the J&J Merger will be set forth in the Company’s Solicitation/Recommendation Statement on Schedule 14D-9 that will be filed with the SEC.

ITEM 2: MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Forward Looking Statements

This Report, including the documents incorporated by reference in this Report, includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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 following discussion and analysis of our financial condition and results of operations should be read in conjunction with our condensed consolidated financial statements and the accompanying notes included in this Report. The following discussion may contain forward-looking statements that reflect our plans, estimates and beliefs, which are subject to risks, uncertainties and assumptions. Our actual results could differ materially from those expressed or implied by such statements. The forward-looking statements in this Report are based on certain risks and uncertainties, including, but not limited to, the risk factors described in “Part I, Item 1A. Risk Factors” of our annual report on Form 10-K for the year ended March 31, 2022 and the following: the impact of public health threats and epidemics, including the COVID-19 pandemic; the impact of prolonged economic downturns on our operations and financial conditions; fluctuations in foreign currency exchange rates and inflation; climate change; corporate social responsibility and sustainability matters; our dependence on Impella® products for most of our revenues; our ability to successfully compete against our existing or potential competitors; the acceptance of our products by cardiac surgeons and interventional cardiologists, especially those with significant influence over medical device selection and purchasing decisions; the effect of long sales and training cycles associated with expansion into new hospital cardiac centers; the potential for reduced market acceptance of our products and reduced revenue due to lengthy clinician training process; our ability to effectively manage our growth; our ability to anticipate demand for, and successfully commercialize, our products; the impact of unsuccessful clinical trials or procedures relating to products under development; our ability to develop new circulatory assist products and our development efforts; our ability to develop additional and high-quality manufacturing capacity to support continued demand for our products; our dependence on third-party payers to provide reimbursement to our customers of our products; our suppliers’ failure to provide the components we require; our reliance on distributors to sell our products in international markets; our success in expanding our direct sales activities into international markets; our ability to sustain profitability at levels achieved in recent years; the unpredictability of fluctuations in our operating results; our ability to develop and commercialize new products or acquire desirable companies, products or technologies; inventory write-downs and other costs due to product quality issues; risks and liabilities associated with acquisitions of other companies or businesses, including our ability to integrate acquired businesses into our operations; the impact of consolidation in the healthcare industry on our prices; our ability to attract and retain key personnel; our ability to obtain and maintain governmental and other regulatory approvals and market and sell our products in certain jurisdictions; regulatory or enforcement actions and product liability suits relating to off-label uses of our products; the increased risk of material product liability claims and impact on our reputation and financial results; our ability to maintain compliance with regulatory requirements and continuing regulatory review; the impact of mandatory or voluntary product recalls; changes in healthcare policy and reimbursement systems in the U.S. and abroad; our ability to comply with healthcare “fraud and abuse” laws and any related penalties for non-compliance; our failure to comply with the U.S. Foreign Corrupt Practices Act and other anti-corruption laws, export control laws, import and customs laws, trade and economic sanctions laws and other laws governing our operations; our or our vendors’ ability to achieve and maintain high manufacturing standards; the economic effects of “Brexit” and related impacts to relationships with our existing and future customers; our potential “ownership change” for U.S. federal income tax purposes and our limited utilization of net operating losses and income tax credit carryforwards from prior tax years; our ability to maintain compliance with, and the impact on us of changes in, tax laws; our ability to comply with, and the impact of any related costs or regulatory actions with respect to, environmental, health and safety requirements; our failure to protect our intellectual property, both domestically and internationally, or develop or acquire additional intellectual property; claims that our current or future products infringe or misappropriate the proprietary rights of others; compliance with laws protecting the confidentiality of patient health information; disruptions of critical information systems or material breaches in the security of our systems; risks relating to our shares of common stock, including market price volatility; the potential for dilution to our stockholders’ ownership interests through the sale of additional securities; the failure to satisfy or waive the conditions to consummation of the J&J Transaction, many of which are largely outside of the parties’ control; the impact failure to complete the J&J Transaction could have on stock price and future business; business uncertainties and certain contractual restrictions the Company is subject to while the J&J Transaction is pending; the risk of incurring substantial transaction fees and costs in connection with the J&J Transaction; the termination fee and restrictions on solicitation contained in the J&J Merger Agreement; litigation against the Company, J&J, or the members of their respective boards; the impact that uncertainty about the J&J Transaction may have on the relationships between the Company and its customers, vendors and employees; the risk that the Company or J&J may terminate the J&J Merger Agreement if the J&J Merger is not consummated by July 1, 2023 (or September 1, 2023 in certain circumstances); and the risk that our stockholders potentially may not receive any payment on the contingent value rights and the contingent value rights may otherwise expire valueless.

Overview

We are a provider of medical devices that provide circulatory support and oxygenation. We develop, manufacture and market proprietary products that are designed to enable the heart to rest and recover by improving blood flow and/or performing the pumping function of the heart and provide sufficient oxygenation to those in respiratory failure. Our products are used in the cardiac catheterization lab, or cath lab, by interventional cardiologists and in the heart surgery suite by cardiac surgeons for patients who are in need of hemodynamic support prophylactically or emergently before, during or after angioplasty or heart surgery procedures. We believe that heart recovery is the optimal clinical outcome for a patient experiencing heart failure because it enhances the potential for the patient to go home with their own heart, facilitating the restoration of quality of life. In addition, we believe that, for the care of such patients, heart recovery is often the most cost-effective solution for the healthcare system.

COVID-19 Pandemic

We are subject to additional risks and uncertainties as a result of the ongoing novel coronavirus (“COVID-19”) pandemic. Since March 2020, the ongoing COVID-19 pandemic has adversely impacted and is likely to further adversely impact our business and markets, including our workforce and the operations of our customers, suppliers, and business partners. While the COVID-19 (including new variants of COVID-19) pandemic remains fluid and continues to evolve differently across various geographies, we believe we are likely to continue to experience variable impacts on our business. To ensure the health and safety of our global employees, we continue to offer onsite COVID-19 testing and vaccinations in order to maintain a safe working environment. Our proactive testing and vaccination programs have reduced exposure with early detection and enabled our manufacturing facilities to operate at full capacity.

The depth and extent to which the COVID-19 pandemic may directly or indirectly impact our business, results of operations, financial condition and individual markets is dependent upon various factors, including the spread of additional variants; the availability of vaccinations, personal protective equipment, intensive care unit (“ICU”) and operating room capacity, and medical staff; and government interventions to reduce the spread of the virus. When COVID-19 infection rates spike in a particular region, our patient utilization volumes have generally been negatively impacted as hospitals face capacity limitations, staffing shortages and some in-patient treatments have been deferred.

While patient utilization increased in the second quarter of fiscal year 2023, sales were impacted by extended vacations from physicians and medical employees, in addition to the ongoing impact of hospital staffing shortages. We continue to closely monitor the impact of COVID-19 on all aspects of our business, including customers, employees, suppliers, vendors, business partners and distribution channels, as well as on procedures and the demand for our products by keeping apprised of local, regional, and global COVID-19 surges (including new variants of the virus).

While we cannot reliably estimate the extent to which the COVID-19 pandemic may impact patient utilization and revenues of our products, our focus is to continue increasing patient utilization of our Impella devices in the U.S. and growing our business internationally, with a continued focus on Europe and Japan. As of the date of issuance of these financial statements, the extent to which the COVID-19 pandemic may materially adversely affect our financial condition, liquidity or results of operations is uncertain.

Macroeconomic Conditions

Our revenues and results of operations may be susceptible to fluctuations in macroeconomic conditions, including inflation and slowing economic growth and contractions, fluctuations in the rate of exchange between the U.S. dollar and foreign currencies, changes in customer and consumer sentiment and demand, increasing prices for raw materials, transportation and labor costs, disruptions in the manufacturing, supply and distribution operations of us and our suppliers. The nature and extent of the impact of these factors among others varies by region and remains uncertain and unpredictable.

Acquisition of preCARDIA

We acquired 100% interest in preCARDIA on May 28, 2021. preCARDIA is a developer of a proprietary catheter and controller that will complement Abiomed’s product portfolio to expand options for patients with acute decompensated heart failure (“ADHF”). The preCARDIA system is uniquely designed to rapidly treat ADHF-related volume overload by effectively reducing cardiac filling pressures and promoting decongestion to improve overall cardiac and renal function. We acquired preCARDIA for a purchase price of $115.2 million. The acquisition was accounted for as an asset acquisition as substantially all of the fair value of the acquisition related to the acquired in-process research and development asset. Since the acquired technology platform is pre-commercial and has not reached technical feasibility, the cost of the in-process research and development asset was expensed, resulting in a charge of $115.5 million to the condensed consolidated statements of operations for the six months ended September 30, 2021. In addition, we recognized a gain of $21.0 million related to our previously owned minority interest within the condensed consolidated statements of operations for the six months ended September 30, 2021. In connection with the acquisition, we acquired a license agreement, under which there is a potential payout of $5 million based on the achievement of a commercial milestone.

The J&J Transaction

Our Existing Products

Our strategic focus and the primary driver of our revenue growth is the market penetration of our family of Impella® heart pumps. The Impella device portfolio, which includes the Impella 2.5®, Impella CP®, Impella 5.0®, Impella LD®, Impella 5.5® and Impella RP® devices, has supported thousands of patients worldwide.

As we continue to innovate our product portfolio, we expect to continue to transition our sales focus to newer generations of Impella devices over time. In the catheterization lab, we expect to continue shifting sales focus from the Impella 2.5 device to the Impella CP device and in the surgical suite, from the Impella 5.0 device to the Impella 5.5 device. Accordingly, we expect that a greater concentration of our product revenues will be from Impella CP and Impella 5.5 devices in the future.

Below is a summary of our existing products and the countries where they have received regulatory approval. We expect to continue to make additional regulatory submissions for our products for additional indications and in additional countries.

Impella 2.5®

The Impella 2.5 device is a percutaneous heart pump with an integrated motor and sensors. The technology is designed primarily for use by interventional cardiologists to support patients in the cath lab who may require assistance to maintain circulation. The Impella 2.5 heart pump can be quickly inserted via the femoral artery to reach the left ventricle of the heart, where it is directly deployed to draw blood out of the ventricle and deliver it to the circulatory system. This function is intended to reduce ventricular work and provide blood flow to vital organs. The Impella 2.5 heart pump is introduced with normal interventional cardiology procedures and can pump up to 2.5 liters of blood per minute.

Our Impella 2.5 device has received FDA and PMDA approvals which allows us to market it in the U.S. and Japan, respectively. The technology is also approved for use in multiple other countries.

Impella CP®

The Impella CP device provides blood flow of up to 4.3 liters of blood per minute and is primarily used by either interventional cardiologists to support patients in the cath lab or by cardiac surgeons in the heart surgery suite.

Our Impella CP device has received FDA, CE Mark, PMDA approvals which allows us to market it in the U.S., European Union and Japan, respectively. The technology is also approved for use in multiple other countries.

Impella 5.0® and Impella LD®

The Impella 5.0 and Impella LD devices are percutaneous heart pumps with integrated motors and sensors for use primarily in the heart surgery suite. These devices are designed to support patients who require higher levels of circulatory support as compared to the Impella 2.5 and Impella CP devices.

Our Impella 5.0 and Impella LD devices have received FDA, CE Mark, PMDA approvals which allow us to market them in the U.S., European Union and Japan, respectively. The technology is also approved for use in multiple other countries.

Impella 5.5®

The Impella 5.5 device is designed to be a percutaneous heart pump with integrated motors and sensors. The Impella 5.5 device delivers peak flows of greater than six liters per minute. The Impella 5.5 device has a motor housing that is thinner and 45% shorter than the Impella 5.0 device and it improves ease of pump insertion through the vasculature.

In September 2019, the Impella 5.5 device received PMA approval from the FDA for safety and efficacy in the therapy of cardiogenic shock for up to 14 days in the U.S. The Impella 5.5 device was introduced in the U.S. through a controlled rollout at hospitals with established heart recovery protocols beginning in fiscal year 2020. In April 2018, the Impella 5.5 device received CE Mark approval in Europe and was introduced in Europe through a controlled rollout, similar to the U.S. In November 2021, the Impella 5.5 device received PMDA approval and we began a controlled rollout in Japan in fiscal year 2022, similar to the U.S. and Europe.

Impella RP®

The Impella RP device is a percutaneous catheter-based axial flow pump that is designed to allow for greater than four liters of blood flow per minute and is intended to provide the flow and pressure needed to compensate for right side heart failure. Our Impella RP device has received FDA and CE Mark approval which allows us to market this technology in the U.S. and European Union. The Impella RP device is the first percutaneous heart pump designed for right heart support to receive FDA approval. The Impella RP device is approved to provide support of the right heart during times of acute failure for certain patients who have received a left ventricle assist device or have suffered heart failure due to AMI, a failed heart transplant, or following open heart surgery. Additionally, we have adapted the design of the Impella RP device to be implanted through the internal jugular vein in the neck; we believe this approach is the preferred method for heart surgeons as it allows for increased patient mobility. We anticipate making a regulatory submission for this technology in fiscal year 2023.

Impella SmartAssist®

The Impella SmartAssist platform includes optical sensor technology for improved pump positioning and the use of algorithms that enable improved native heart assessment during the weaning process. The Impella SmartAssist platform is currently available for our Impella CP, Impella 5.5 and Impella RP heart pumps. The Impella SmartAssist platform received FDA, CE Mark and PMDA approvals which allows us to market it in the U.S., European Union and Japan, respectively. The technology is also approved for use in multiple other countries.

Impella Connect®

Impella Connect is a cloud-based technology that enables secure, remote viewing of the Automated Impella Controller, or AIC, for physicians and hospital staff. We began a controlled rollout of Impella Connect at certain hospital sites during fiscal year 2020 and have transitioned most of our customers to this technology. We continue to introduce this technology to hospitals outside the U.S.

Abiomed Breethe OXY-1 System™

The Breethe OXY-1 System is a portable external respiratory assistance device that we acquired as part of our acquisition of Breethe, in April 2020 in connections with our efforts to expand our product portfolio to support the needs of patients, such as those suffering from cardiogenic shock or respiratory failure, whose lungs can no longer provide sufficient oxygenation. The Breethe OXY-1 System takes venous blood from the patient, removes carbon dioxide and adds oxygen much like a human lung, and returns the oxygenated blood safely back to the patient. In October 2020, the Breethe OXY-1 System received 510(k) clearance from the FDA for an all-in-one, compact cardiopulmonary bypass system. We have conducted a controlled launch of the Breethe OXY-1 System at a limited number of hospitals in the U.S. and have seen positive results regarding survival, blood compatibility, durability of the Pump Lung Unit (“PLU”), hemodynamic flow rates and ease of patient ambulation. Based on our early patient study, we identified areas of improvement around the electronics of the console and implemented a voluntary recall at the seven hospitals where the Breethe OXY-1 Systems were placed in fiscal year 2022. Until the corrective action is completed, we are not expanding the number of patients or centers under the controlled launch. The console upgrades require 510(k) clearance from the FDA. We expect to resume commercialization of the Breethe OXY-1 System under a controlled rollout in the fourth quarter of fiscal year 2023.

Our Product Pipeline

Impella ECP™

The Impella ECP device is designed for blood flow of greater than three and a half liters per minute. It is intended to be delivered on a standard sized (9 French) catheter and will include an expandable inflow in the left ventricle. The Impella ECP device has achieved initial FDA safety milestones, including completion of the first stage in its FDA early feasibility study (“EFS”). The prospective, multi-center, single arm EFS is designed to allow us, study investigators, and the FDA to make qualitative assessments about the safety and feasibility of the use of the Impella ECP device in high-risk percutaneous coronary intervention (“PCI”) patients. In fiscal year 2021, we received approval from the FDA to expand the EFS for the Impella ECP device and we continue to enroll patients in this study. In August 2021, we received Breakthrough Device designation by the FDA for the Impella ECP device, which is provided pursuant to the FDA’s Breakthrough Device Program, a program intended to help patients receive more timely access to certain medical technologies by providing a speedier development, assessment and review process for such technologies. The protocol of a single arm pivotal high-risk PCI study for the Impella ECP device, as part of an investigational device exemption (“IDE”), has been approved by the FDA. We have supported over 25 patients in our early feasibility study and began patient enrollment under a pivotal-like protocol in March 2022. We expect to transition to a pivotal trial in fiscal year 2023. The Impella ECP device is still in development and has not been approved for commercial use or sale.

Impella BTR™

The Impella BTR device is designed to be a percutaneous, weanable, smart heart pump with integrated motors and sensors. The Impella BTR device is designed to allow for greater than six liters of blood flow per minute, provide up to one year of hemodynamic support and include a wearable driver designed for hospital discharge. The Impella BTR device is expected to and intended to allow for heart recovery with adjunctive therapies for advanced heart-failure patients. In December 2021, we received conditional approval for an IDE early feasibility study for the Impella BTR device and began enrollment in early fiscal year 2023. The Impella BTR device is still in development and has not been approved for commercial use or sale.

preCARDIA™

The preCARDIA system is a minimally invasive, catheter-mounted superior vena cava therapy system designed to rapidly treat acutely decompensated heart failure (“ADHF”) related volume overload by effectively reducing cardiac filling pressures and promoting decongestion to improve overall cardiac and renal function. The preCARDIA system allows for straightforward placement in the ICU by physicians and hemodynamic monitoring by medical staff. Prior to the acquisition of preCARDIA, the preCARDIA system received Breakthrough Device Designation by the FDA. In January 2022, we announced results of the first-in-human early feasibility study of the preCARDIA system. The multicenter, prospective, single-arm VENUS-HF early feasibility study examined 30 patients with ADHF who were assigned preCARDIA therapy for 12 or 24 hours. The primary endpoint was a composite of major adverse events through 30 days. The results support additional study of the preCARDIA system. In the second quarter of fiscal year 2023, the FDA authorized the preCARDIA early feasibility study to be expanded to up to 160 patients. The preCARDIA system is still in development and has not been approved for commercial use or sale.

Critical Accounting Policies and Estimates

Other than the accounting policy changes discussed in “Note 2. Basis of Presentation and Summary of Significant Accounting Policies” to our condensed consolidated financial statements, which is incorporated herein by reference, there have been no significant changes in our critical accounting policies during the three and six months ended September 30, 2022, as compared to the critical accounting policies disclosed in Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form 10-K for the fiscal year ended March 31, 2022.

Results of Operations for the Three and Six Months Ended September 30, 2022 compared with the Three and Six Months Ended September 30, 2021

Revenue

The following tables disaggregate our revenue by products and services:


	For the Three Months Ended September 30,
	2022					2021					Change
	Amount (in thousands)		% of Total revenue			Amount (in thousands)		% of Total revenue			Amount (in thousands)		%
Product revenue	$	253,246		95	%	$	235,785		95	%	$	17,461		7	%
Service and other revenue		12,675		5	%		12,357		5	%		318		3	%
Total revenue	$	265,921		100	%	$	248,142		100	%	$	17,779		7	%


	For the Six Months Ended September 30,
	2022					2021					Change
	Amount (in thousands)		% of Total revenue			Amount (in thousands)		% of Total revenue			Amount (in thousands)		%
Product revenue	$	517,717		95	%	$	477,259		95	%	$	40,458		8	%
Service and other revenue		25,353		5	%		23,468		5	%		1,885		8	%
Total revenue	$	543,070		100	%	$	500,727		100	%	$	42,343		8	%

The following tables disaggregate our revenue by geographic location:


	For the Three Months Ended September 30,
	2022					2021					Change
	Amount (in thousands)		% of Total revenue			Amount (in thousands)		% of Total revenue			Amount (in thousands)			%
United States	$	218,943		82	%	$	200,485		81	%	$	18,458			9	%
Europe		30,269		11	%		32,527		13	%		(2,258	)		(7	)%
Japan		12,467		5	%		12,267		5	%		200			2	%
Rest of world		4,242		2	%		2,863		1	%		1,379			48	%
Outside the U.S.		46,978		18	%		47,657		19	%		(679	)		(1	)%
Total revenue	$	265,921		100	%	$	248,142		100	%	$	17,779			7	%


	For the Six Months Ended September 30,
	2022					2021					Change
	Amount (in thousands)		% of Total revenue			Amount (in thousands)		% of Total revenue			Amount (in thousands)			%
United States	$	445,462		82	%	$	407,627		81	%	$	37,835			9	%
Europe		64,105		12	%		64,764		13	%		(659	)		(1	)%
Japan		25,702		5	%		23,552		5	%		2,150			9	%
Rest of world		7,801		1	%		4,784		1	%		3,017			63	%
Outside the U.S.		97,608		18	%		93,100		19	%		4,508			5	%
Total revenue	$	543,070		100	%	$	500,727		100	%	$	42,343			8	%

The following tables disaggregate our product revenue by geographic location:


	For the Three Months Ended September 30,
	2022					2021					Change
	Amount (in thousands)		% of Total revenue			Amount (in thousands)		% of Total revenue			Amount (in thousands)			%
United States	$	207,948		78	%	$	189,761		76	%	$	18,187			10	%
Europe		29,042		11	%		31,328		13	%		(2,286	)		(7	)%
Japan		12,014		5	%		11,833		5	%		181			2	%
Rest of world		4,242		2	%		2,863		1	%		1,379			48	%
Outside the U.S.		45,298		17	%		46,024		19	%		(726	)		(2	)%
Total product revenue	$	253,246		95	%	$	235,785		95	%	$	17,461			7	%


	For the Six Months Ended September 30,
	2022					2021					Change
	Amount (in thousands)		% of Total revenue			Amount (in thousands)		% of Total revenue			Amount (in thousands)			%
United States	$	423,514		78	%	$	387,220		77	%	$	36,294			9	%
Europe		61,611		11	%		62,557		12	%		(946	)		(2	)%
Japan		24,792		5	%		22,698		5	%		2,094			9	%
Rest of world		7,800		1	%		4,784		1	%		3,016			63	%
Outside the U.S.		94,203		17	%		90,039		18	%		4,164			5	%
Total product revenue	$	517,717		95	%	$	477,259		95	%	$	40,458			8	%

Product revenue encompasses Impella 2.5, Impella CP, Impella 5.0, Impella LD, Impella 5.5, Impella RP and Impella AIC product sales and related accessories. Service and other revenue represents revenue earned on service maintenance contracts and preventative maintenance calls. The following is a discussion of our revenues for the three and six months ended September 30, 2022.

Total Revenue

Total revenue increased by $17.8 million, or 7%, from the three months ended September 30, 2021 to the three months ended September 30, 2022. Total revenue increased by $42.3 million, or 8%, from the six months ended September 30, 2021 to the six months ended September 30, 2022. The increase in total revenue from the three and six months ended September 30, 2021 to the three and six months ended September 30, 2022 was driven by an increase in both product revenue and service and other revenue, as further described below.

Product Revenue

Product revenue increased by $17.5 million, or 7%, from the three months ended September 30, 2021 to the three months ended September 30, 2022. Product revenue increased by $40.5 million, or 8%, from the six months ended September 30, 2021 to the six months ended September 30, 2022. U.S. product revenue increased by $18.2 million, or 10%, from the three months ended September 30, 2021 to the three months ended September 30, 2022. U.S. product revenue increased by $36.3 million, or 9%, from the six months ended September 30, 2021 to the six months ended September 30, 2022. Outside the U.S., product revenue decreased by $0.7 million, or 2%, from the three months ended September 30, 2021 to the three months ended September 30, 2022. Outside the U.S., product revenue increased by $4.2 million, or 5%, from the six months ended September 30, 2021 to the six months ended September 30, 2022.

Product revenue increased in the three and six months ended September 30, 2022, primarily due to higher patient utilization and sales mix in the U.S., Europe and Japan as compared to the three and six months ended September 30, 2021, partially offset by the unfavorable impact of foreign exchange fluctuations due to the strengthening of the U.S dollar during the six months ended September 30, 2022, extended vacations from physicians and medical employees and the ongoing impact of hospital staffing shortages.

Service and other revenue

Service and other revenue increased by $0.3 million, or 3%, from the three months ended September 30, 2021 to the three months ended September 30, 2022. Service and other revenue increased by $1.9 million, or 8%, from the six months ended September 30, 2021 to the six months ended September 30, 2022. The increase in service revenue was primarily due to an increase in service contracts sold. We have expanded the number of Impella AIC consoles at many of our existing higher volume customer sites and continue to sell additional consoles to new customer sites. We expect revenue growth for service revenue to be consistent with recent history as most customer sites in the U.S. have service contracts which typically have three-year terms.

Cost of revenue


	For the Three Months Ended September 30,
	2022					2021					Change
	Amount (in thousands)		% of Total revenue			Amount (in thousands)		% of Total revenue			Amount (in thousands)		%
Cost of revenue	$	48,880		18	%	$	43,886		18	%	$	4,994		11	%


	For the Six Months Ended September 30,
	2022					2021					Change
	Amount (in thousands)		% of Total revenue			Amount (in thousands)		% of Total revenue			Amount (in thousands)		%
Cost of revenue	$	101,506		19	%	$	89,074		18	%	$	12,432		14	%

Cost of revenue increased by $5.0 million, or 11%, from the three months ended September 30, 2021 to the three months ended September 30, 2022. Cost of revenue increased by $12.4 million, or 14%, from the six months ended September 30, 2021 to the six months ended September 30, 2022. Gross margin was 81.6% for the three months ended September 30, 2022 and 82.3% for the three months ended September 30, 2021. Gross margin was 81.3% for the six months ended September 30, 2022 and 82.2% for the six months ended September 30, 2021.

Cost of product revenue increased due to our investment in direct labor and overhead as we continue to expand the manufacturing capacity of our facilities in the U.S. and Germany, resulting in a corresponding decrease to gross margin.

Operating expenses


	For the Three Months Ended September 30,
	2022					2021					Change
	Amount (in thousands)		% of Total revenue			Amount (in thousands)		% of Total revenue			Amount (in thousands)		%
Research and development	$	42,089		16	%	$	41,041		17	%	$	1,048		3	%
Selling, general and administrative		116,958		44	%		102,779		41	%		14,179		14	%
Total operating expenses	$	159,047		60	%	$	143,820		58	%	$	15,227		11	%


	For the Six Months Ended September 30,
	2022					2021					Change
	Amount (in thousands)		% of Total revenue			Amount (in thousands)		% of Total revenue			Amount (in thousands)			%
Research and development	$	82,566		15	%	$	78,749		16	%	$	3,817			5	%
Selling, general and administrative		234,954		43	%		206,263		41	%		28,691			14	%
Acquired in-process research and development		-		0	%		115,490		23	%		(115,490	)		(100	)%
Total operating expenses	$	317,520		58	%	$	400,502		80	%	$	(82,982	)		(21	)%

Research and Development Expenses

Research and development expenses increased by $1.0 million, or 3%, from the three months ended September 30, 2021 to the three months ended September 30, 2022. Research and development expenses increased by $3.8 million, or 5%, from the six months ended September 30, 2021 to the six months ended September 30, 2022. The increase in research and development expenses was primarily due to ongoing product development initiatives relating to our existing and pipeline products, including the development of the Impella ECP™, preCARDIA and Impella BTR™ devices and continued investment in our clinical trials, most notably the STEMI DTU and PROTECT IV studies. The increase in research and development expenses was partially offset by a $3.1 million and a $6.5 million reduction to the fair value of our contingent consideration for the three months ended September 30, 2022 and the six months ended September 30, 2022, respectively.

We expect research and development expenses to continue to increase as we continue to increase engineering, product development and clinical spending related to our initiatives to improve our existing products, develop new technologies and conduct clinical studies.

Selling, General and Administrative Expenses

Selling, general and administrative expenses increased by $14.2 million, or 14%, from the three months ended September 30, 2021 to the three months ended September 30, 2022. Selling, general and administrative expenses increased by $28.7 million, or 14%, from the six months ended September 30, 2021 to the six months ended September 30, 2022. The increase in selling, general and administrative expenses was primarily due to increases in commercial hiring, marketing, travel and clinical training and education initiatives.

We aim to continue to invest strategically in hiring and sales and marketing activities, with a particular focus on training and education to drive utilization of our Impella devices and recovery awareness for acute heart failure patients.

Acquired In-Process Research and Development Expenses

We acquired 100% interest in preCARDIA on May 28, 2021, for a purchase price of $115.2 million. In connection with the acquisition, we acquired net assets of $115.2 million, which included $115.5 million related to the fair value of the in-process research and development asset and $0.3 million for net liabilities assumed. The acquisition was accounted for as an asset acquisition as substantially all of the fair value of the acquisition related to the acquired in-process research and development asset. Since the acquired technology platform is pre-commercial and has not reached technical feasibility, the cost of the in-process research and development asset was expensed, resulting in a charge of $115.5 million to the condensed consolidated statements of operations for the six months ended September 30, 2021.

Interest and other income, net


	For the Three Months Ended September 30,
	2022		2021			Change
	Amount (in thousands)		Amount (in thousands)			Amount (in thousands)		%
Interest and other income, net	$	80,709	$	6,835	$		73,874		1,081	%


	For the Six Months Ended September 30,
	2022		2021			Change
	Amount (in thousands)		Amount (in thousands)			Amount (in thousands)		%
Interest and other income, net	$	84,481	$	46,770	$		37,711		81	%

Interest and other income, net increased by $73.9 million, or 1,081%, from the three months ended September 30, 2021 to the three months ended September 30, 2022. For the three months ended September 30, 2022 interest and other income, net was primarily comprised of a $47.4 million unrealized gain on other investments related to an upward adjustment due to observable price changes, a $15.2 million net realized gain from the sale of Shockwave Medical securities and a $14.5 million unrealized gain from our investment in Shockwave Medical, offset by impairment charges of $1.8 million related to our other investments. For the three months ended September 30, 2021 interest and other income, net was primarily comprised of a $4.8 million unrealized gain from our investment in Shockwave Medical.

Interest and other income, net increased by $37.7 million, or 81%, from the six months ended September 30, 2021 to the six months ended September 30, 2022. For the six months ended September 30, 2022 interest and other income, net was primarily comprised of $52.3 million unrealized gains on other investments related to upward adjustments due to observable price changes, a $15.2 million net realized gain from the sale of Shockwave Medical securities and a $9.7 million unrealized gain from our investment in Shockwave Medical, offset by impairment charges of $1.8 million related to our other investments. For the six months ended September 30, 2021 interest and other income, net was primarily comprised of a $22.4 million unrealized gain from our investment in Shockwave Medical and a $21.0 million gain related to our previously owned minority interest in preCARDIA.

Income tax provision


	For the Three Months Ended September 30,
	2022		2021			Change
	Amount (in thousands)		Amount (in thousands)			Amount (in thousands)		%
Income tax provision	$	32,570	$	10,318	$		22,252		216	%


	For the Six Months Ended September 30,
	2022		2021			Change
	Amount (in thousands)		Amount (in thousands)			Amount (in thousands)		%
Income tax provision	$	47,838	$	27,493	$		20,345		74	%

The income tax provision increased by $22.3 million, or 216%, from the three months ended September 30, 2021 to the three months ended September 30, 2022 primarily due to the change in fair value of other investments. Our effective income tax rate was 23.5% and 15.3% for the three months ended September 30, 2022 and 2021, respectively. The income tax provision increased by $20.3 million, or 74%, from the six months ended September 30, 2021 to the six months ended September 30, 2022 primarily due to the change in fair value of other investments. Our effective income tax rate was 22.9% and 47.5% for the six months ended September 30, 2022 and 2021, respectively. The decrease in the effective income tax rate for the six months ended September 30, 2022 is primarily due to a non-deductible charge for in-process research and development related to the preCARDIA acquisition that occurred during the six months ended September 30, 2021.

Liquidity and Capital Resources

As of September 30, 2022, our total cash, cash equivalents and short and long-term marketable securities totaled $937.2 million, an increase of $41.5 million compared to $978.7 million at March 31, 2022. The change in our total cash, cash equivalents and short and long-term marketable securities was primarily due to positive cash flows from operations, cash provided by investing activities, net of cash used for purchases of property, equipment and other investments, and net cash used for financing activities related to equity activity.

A summary of our cash flow activities is as follows:


	For the Six Months Ended September 30,
	2022			2021
Net cash provided by operating activities	$	81,524		$	115,931
Net cash provided by (used for) investing activities		109,681			(108,395	)
Net cash used for financing activities		(134,118	)		(786	)
Effect of exchange rate changes on cash and cash equivalents		(7,570	)		2,422
Net increase in cash and cash equivalents	$	49,517		$	9,172

Cash Provided by Operating Activities

For the six months ended September 30, 2022, net cash provided by operating activities consisted of net income of $160.7 million, less non-cash items of $39.5 million and cash used for working capital of $39.6 million. As discussed above, the change in net income was primarily due to an increase in operating expenses and income tax expense, partially offset by an increase in revenue for the six months ended September 30, 2022 compared to the six months ended September 30, 2021. Adjustments for non-cash items consisted primarily of a $77.4 million net change in fair value of our investments in Shockwave Medical and other private medical technology companies, $29.4 million of stock-based compensation expense, $13.3 million of depreciation and amortization expense, $7.4 million in deferred tax provision, $7.1 million in inventory and other write-downs, a change in fair value of contingent consideration of $6.5 million and $0.3 million in accretion on marketable securities. The decrease in cash from changes in working capital is primarily due to a $18.3 million increase in inventory to support growing sales volume, a $13.1 million increase in prepaid expenses and other assets due to timing of tax payments, a $6.4 million increase in accounts receivable due to timing of collections, a $1.8 million decrease in accounts payable, accrued expenses and other liabilities, partially offset by a $0.1 million increase in deferred revenue.

For the six months ended September 30, 2021, cash provided by operating activities consisted of net income of $30.4 million, plus non-cash items of $132.1 million offset by cash used in working capital of $46.6 million. Adjustments for non-cash items consisted primarily of $115.5 million for acquired preCARDIA in-process research and development, a $21.0 million gain related to our previously owned minority interest in preCARDIA recognized upon the acquisition of preCARDIA in May 2021, a $22.4 million net change in fair value of our investments in Shockwave Medical and other private medical technology companies, $28.4 million of stock-based compensation expense, $13.9 million of depreciation and amortization expense, $8.2 million in deferred tax provision, $6.2 million in inventory and other write-downs and $1.8 million in accretion on marketable securities. The decrease in cash from changes in working capital included a $7.4 million decrease in accounts receivable due to timing of collections, a $21.9 million decrease in accounts payable, accrued expenses and other liabilities offset by a $20.3 million increase in prepaid expenses and other assets and a $11.7 million increase in inventory due to the mix of customer demand and production.

Cash Provided by (Used for) Investing Activities

For the six months ended September 30, 2022, net cash provided by investing activities included $87.1 million in sales and maturities (net of purchases) of marketable securities and $40.0 million in proceeds from sales of Shockwave Medical securities. These amounts were offset by $12.4 million used for the purchase of property and equipment primarily related to continued expansion of manufacturing capacity, office space and research development facilities in Danvers and Aachen, Germany and $5.0 million for our investment in private medical technology companies.

For the six months ended September 30, 2021, net cash used for investing activities included $82.8 million for our acquisition of preCARDIA, $3.9 million for our investment in private medical technology companies, $7.3 million in purchases of marketable securities (net of sales), and $14.4 million for the purchase of property and equipment primarily related to continued expansion of manufacturing capacity, office space and research development facilities in Danvers and Aachen, Germany.

Capital expenditures for fiscal year 2023 are estimated to range from $40 million to $50 million, including, as part of the long-term development of our business, additional capital expenditures for manufacturing capacity and building expansions in our Danvers and Aachen facilities and information systems development projects.

Cash Used for Financing Activities

For the six months ended September 30, 2022, net cash used for financing activities included $126.6 million for repurchases of our common stock and $12.8 million in payments in lieu of issuance of common stock for payroll withholding taxes upon vesting of certain equity awards. These amounts were offset by $3.3 million in proceeds from the issuance of stock under the employee stock purchase plan and $2.0 million in proceeds from the exercise of stock options.

For the six months ended September 30, 2021, net cash used for financing activities included $12.1 million in payments in lieu of issuance of common stock for payroll withholding taxes upon vesting of certain equity awards. These amounts were offset by $8.4 million in proceeds from the exercise of stock options and $3.0 million in proceeds from the issuance of stock under the employee stock purchase plan.

Operating Capital and Liquidity Requirements

Our sources of cash liquidity are primarily from existing cash and cash equivalents, marketable securities and cash flows from operations. As of September 30, 2022, our cash, cash equivalents, and short and long-term marketable securities totaled $937.2 million, an increase of $41.5 million compared to $978.7 million as of March 31, 2022. Marketable securities as of September 30, 2022 consisted of $754.9 million held in funds that invest in U.S. Treasury securities, government-backed securities, corporate debt securities and commercial paper. We generated operating cash flows of $81.5 million and $115.9 million for the six months ended September 30, 2022 and 2021, respectively. At September 30, 2022, we had no debt outstanding. We believe that our sources of liquidity are sufficient to fund the current requirements of working capital, capital expenditures, and other financial commitments for at least the next twelve months.

We primarily fund our operations from product sales. Our primary liquidity requirements are to fund the following: expansion of our commercial and operational infrastructures; expansion of our manufacturing capacity and office space; the procurement and production of inventory to meet customer demand for our Impella devices; funding of new product and business development initiatives, such as the recent acquisitions of preCARDIA and Breethe; ongoing commercial launch in Japan and expansion into potential new markets; increased clinical spending; legal expenses related to ongoing patent litigation and other legal matters; purchases of our common stock through our share repurchase programs; payments in lieu of issuance of common stock for payroll withholding taxes upon vesting of certain equity awards and provide for general working capital needs.

We believe that our sources of liquidity are sufficient to fund the current requirements of working capital, capital expenditures, and other financial commitments for at least the next twelve months. Our liquidity is influenced by our ability to sell our products in a competitive industry and our customers’ ability to pay for our products. Factors that may affect liquidity primarily include our ability to penetrate the market for our products, our ability to maintain or reduce the length of the selling cycle for our products, our capital expenditures, and our ability to collect cash from customers after our products are sold. We continue to review our short-term and long-term cash needs on a regular basis.

ITEM 3: QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK

There have been no material changes to our quantitative and qualitative disclosures about market risk as compared to the quantitative and qualitative disclosures about market risk described in our Annual Report on Form 10-K for the fiscal year ended March 31, 2022.

ITEM 4. CONTROLS AND PROCEDURES

Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our principal executive officer and principal financial officer, has evaluated the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) and Rule 15d-15(e) under the Exchange Act, as of September 30, 2022. Based on this evaluation, our principal executive officer and principal financial officer concluded that, as of September 30, 2022, these disclosure controls and procedures were effective to provide reasonable assurance that material information required to be disclosed by us, including our consolidated subsidiaries, in reports that we file or submit under the Exchange Act, is recorded, processed, summarized and reported, within the time periods specified in SEC rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure.

Changes in Internal Control over Financial Reporting

During the second quarter of our fiscal year ending March 31, 2023, there were no changes in our internal control over financial reporting (as defined in Rule 13a-15(f) and Rule 15d-15(f) under the Exchange Act), that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

PART II — OTHER INFORMATION

ITEM 1. LEGAL PROCEEDINGS

We are from time to time involved in various legal actions, the outcomes of which are not within our complete control and may not be known for prolonged periods of time. In some actions, the claimants seek damages, as well as other relief, which, if granted, would require significant expenditures and could impair our business and results of operations. Material legal proceedings are discussed in “Note 15. Commitments and Contingencies” to our condensed consolidated financial statements and such information is incorporated herein by reference.

ITEM 1A. RISK FACTORS

Investing in our common stock involves a high degree of risk. In addition to the other information set forth in this Report, you should carefully consider the factors discussed in “Part I, Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended March 31, 2022, which could materially affect our business, financial condition or future results. Except for the risk factors set forth below, as of the date of this Report there has been no material change in any of the risk factors described in our Annual Report on Form 10-K for the fiscal year ended March 31, 2022.

The consummation of the J&J Transaction is subject to a number of conditions, many of which are largely outside of the parties’ control, and, if these conditions are not satisfied or waived on a timely basis, the J&J Merger Agreement may be terminated and the J&J Transaction may not be completed.

The J&J Transaction is subject to certain customary closing conditions, including as of immediately prior to the expiration time of the J&J Offer:

(i) more than 50% of the then-outstanding Company Shares are validly tendered and not withdrawn, and received by the depositary; (ii) the accuracy of the representations and warranties of the Company contained in the J&J Merger Agreement (subject to certain materiality exceptions); (iii) the Company’s compliance or performance in all material respects with its covenants and agreements contained in the J&J Merger Agreement prior to the expiration time of the J&J Offer; (iv) the expiration, termination or receipt of any approval or clearances applicable to the consummation of the transactions contemplated by the J&J Merger Agreement under applicable antitrust laws, including the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and the receipt of certain other non-U.S. regulatory approvals; (v) the absence of any law or order making illegal, prohibit or otherwise prevent the consummation of the J&J Offer, the acquisition of Company Shares by J&J or Merger Sub, or the J&J Merger; (vi) the absence of certain legal proceedings under antitrust laws by governmental authorities challenging or seeking to make illegal, prohibit or otherwise prevent the consummation of the J&J Offer, the acquisition of Company Shares by J&J or Merger Sub, or the J&J Merger; and (vii) other customary conditions.

The failure to satisfy all of the required conditions could delay the completion of the J&J Transaction by a significant period of time or prevent it from occurring. Any delay in completing the J&J Transaction could cause the parties to not realize some or all of the benefits that are expected to be achieved if the J&J Transaction is successfully completed within the expected timeframe. There can be no assurance that the conditions to closing of the J&J Transaction will be satisfied or waived or that the J&J Transaction will be completed within the expected timeframe or at all.

Failure to complete the J&J Transaction could adversely affect the stock price and future business and financial results of the Company.

There can be no assurance that the conditions to the closing of the J&J Transaction will be satisfied or waived or that the J&J Transaction will be completed. If the J&J Transaction is not completed within the expected timeframe or at all, the ongoing business of the Company could be adversely affected and the Company will be subject to a variety of risks and possible consequences associated with the failure to complete the J&J Transaction, including the following: (i) upon termination of the J&J Merger Agreement under specified circumstances, the Company is required to pay J&J a termination fee of $550,000,000; (ii) the Company will incur certain transaction costs, including legal, accounting, financial advisor, filing, printing and mailing fees, regardless of whether the J&J Transaction closes; (iii) under the J&J Merger Agreement, the Company is subject to certain restrictions on the conduct of its business prior to the closing of the J&J Transaction, which may adversely affect its ability to execute certain of its business strategies; and (iv) the proposed J&J Transaction, whether or not it closes, will divert the attention of certain management and other key employees of the Company from ongoing business activities, including the pursuit of other opportunities that could be beneficial to the Company as an independent company.

If the J&J Transaction is not completed, these risks could materially affect the business and financial results of the Company and its stock price, including to the extent that the current market price of the Company Shares is positively affected by a market assumption that the J&J Transaction will be completed.

While the J&J Transaction is pending, the Company will be subject to business uncertainties and certain contractual restrictions that could adversely affect the business and operations of the Company.

In connection with the pending J&J Transaction, some customers, vendors or other third parties of the Company may react unfavorably, including by delaying or deferring decisions concerning their business relationships or transactions with the Company, which could adversely affect the revenues, earnings, funds from operations, cash flows and expenses of the Company, regardless of whether the J&J Transaction is completed. In addition, due to certain restrictions in the J&J Merger Agreement on the conduct of business prior to completing the J&J Transaction, the Company may be unable (without J&J’s prior written consent), during the pendency of the J&J Transaction, to pursue strategic transactions, undertake significant capital projects, undertake certain significant financing transactions and otherwise pursue other actions, even if such actions would prove beneficial and may cause the Company to forego certain opportunities it might otherwise pursue. In addition, the pendency of the J&J Transaction may make it more difficult for the Company to effectively retain and incentivize key personnel and may cause distractions from the Company’s strategy and day-to-day operations for its current employees and management.

The Company will incur substantial transaction fees and costs in connection with the J&J Transaction that could adversely affect the business and operations of the Company if the J&J Transaction is not completed.

The Company expects to incur non-recurring transaction fees, which include legal and advisory fees and substantial costs associated with completing the J&J Transaction, and which could adversely affect the business operations of the Company if the J&J Transaction is not completed.

The termination fee and restrictions on solicitation contained in the J&J Merger Agreement may discourage other companies from trying to acquire the Company.

The J&J Merger Agreement prohibits the Company from soliciting, initiating, knowingly encouraging or knowingly facilitating any competing acquisition proposals, subject to certain limited exceptions. The J&J Merger Agreement also contains certain termination rights, including, but not limited to, the Company’s right to terminate the J&J Merger Agreement to accept a Superior Proposal (as defined in the J&J Merger Agreement), subject to and in accordance with the terms and conditions of the J&J Merger Agreement. The J&J Merger Agreement further provides that, upon termination of the J&J Merger Agreement by the Company to enter into an alternative acquisition agreement with respect to a Superior Proposal, the Company will be required to pay J&J a termination fee of $550,000,000 in cash. The termination fees and restrictions could discourage other companies from trying to acquire the Company even though those other companies might be willing to offer greater value to the Company’s stockholders than the J&J Transaction.

Litigation against the Company, J&J, or the members of their respective boards, could prevent or delay the completion of the J&J Transaction or result in the payment of damages following completion of the J&J Transaction.

It is possible that lawsuits may be filed by the Company’s stockholders challenging the J&J Transaction. The outcome of such lawsuits cannot be assured, including the amount of costs associated with defending these claims or any other liabilities that may be incurred in connection with the litigation of these claims. If plaintiffs are successful in obtaining an injunction prohibiting the parties from completing the J&J Transaction, such injunction may delay the consummation of the J&J Transaction in the expected timeframe, or may prevent the J&J Transaction from being consummated at all. Whether or not any plaintiff’s claim is successful, this type of litigation can result in significant costs and divert management’s attention and resources from the closing of the J&J Transaction and ongoing business activities, which could adversely affect the operations of the Company.

Uncertainty about the J&J Transaction may adversely affect the relationships between the Company and its customers, vendors and employees, whether or not the J&J Transaction is completed.

In response to the announcement of the J&J Transaction, existing or prospective customers, vendors and other third party relationships of the Company may delay, defer or cease providing goods or services, delay or defer other decisions concerning the Company, refuse to extend credit to the Company, or otherwise seek to change the terms on which they do business with the Company. Any such delays or changes to terms could materially harm the Company’s business.

In addition, as a result of the J&J Transaction, current and prospective employees could experience uncertainty about their future with the Company. These uncertainties may impair the Company’s ability to retain, recruit or motivate key management and technical, manufacturing, and other personnel.

If the J&J Merger is not consummated by July 1, 2023 (or September 1, 2023 in certain circumstances), either the Company or J&J may terminate the J&J Merger Agreement, subject to certain exceptions.

Either the Company or J&J may terminate the J&J Merger Agreement if the J&J Merger has not been consummated by July 1, 2023 (or September 1, 2023 if certain regulatory approvals have not been received). However, this termination right will not be available to any party whose material breach of its obligations under the J&J Merger Agreement was the principal cause of or resulted in the failure of the J&J Transaction to occur as of such time. In the event the J&J Merger Agreement is terminated by either party due to the failure of the J&J Transaction to close by July 1, 2023 (or September 1, 2023 if certain regulatory approvals have not been received), the Company will have incurred significant costs and will have diverted significant management focus and resources from other strategic opportunities and ongoing business activities without realizing the anticipated benefits of the J&J Transaction.

Our stockholders potentially may not receive any payment on the contingent value rights and the contingent value rights may otherwise expire valueless.

The J&J Merger Agreement contemplates that J&J will enter into a Contingent Value Rights Agreement (the “CVR Agreement”) with a rights agent pursuant to which each stockholder who tenders its Company Shares will receive one contingent value right (each, a “CVR”), for each outstanding Company Share held by such stockholder on such date. Each CVR will represent the right to receive the following cash payments if the following milestones are achieved: (i) $10.00 per CVR if the results from the STEMI DTU study, the PROTECT IV study or the RECOVER IV study contribute to the publication of a Class I recommendation in the clinical practice guideline recommending the use of any device in the Impella product family in high risk PCI or STEMI patients with or without cardiogenic shock within four years from their respective clinical endpoint publication dates, but in all cases no later than December 31, 2029; (ii) $7.50 per CVR if, prior to January 1, 2028, the U.S. Food and Drug Administration approves a premarket approval application or premarket approval application supplement for the use of any device in the Impella product family in patients with STEMI, or Anterior STEMI, without cardiogenic shock; and (iii) either (x) $17.50 per CVR if J&J achieves $3.7 billion aggregate worldwide Net Sales (as defined in the CVR Agreement) during the period from the first day of J&J’s second fiscal quarter of 2027 through the last day of J&J’s first fiscal quarter of 2028 or (y) $8.75 per CVR if J&J achieves $3.7 billion aggregate worldwide Net Sales in any four consecutive fiscal quarters during the period from the first day of J&J’s third fiscal quarter of 2027 through the last day of J&J’s first fiscal quarter of 2029. The right of our stockholders to derive any value from the CVRs will be contingent solely upon the achievement of these milestones.

We may not be able to achieve the milestones as described above. If these are not achieved for any reason within the time periods specified in the CVR Agreement, the corresponding payments will not be made under the CVRs, and if none of the milestones are achieved, then the CVRs will expire valueless.

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

(a)

Not applicable

(b)

Not applicable

(c)

The following table provides information about our repurchases of shares of our common stock during the three months ended September 30, 2022. During that period, we did not act in concert with any affiliate or any other person to acquire any of our common stock and, accordingly, we do not believe that purchases by any such affiliate or other person (if any) are reportable in the following table.


Period	Total Number of Shares Repurchased (1)		Average Price Paid per Share (1)		Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs (2)		Approximate Dollar Value Maximum of Shares that May Yet Be Purchased Under the Plans or Programs (in $000's) (2)
July 1-31, 2022		107,332		262.40		107,332	$	61,129
August 1-31, 2022		181,579		269.49		181,579		212,190
September 1-30, 2022		135,541		258.22		135,541		177,189
Total		424,452	$	264.10		424,452	$	177,189

(1) The Company’s policy is to consider shares to have been repurchased upon the settlement date of the transaction, which is typically two days subsequent to the trading date.

(2) In August 2019, the Company’s Board of Directors authorized a stock repurchase program for up to $200.0 million of shares of its common stock (the "2019 Share Repurchase Program"). On August 3, 2022, the Company’s Board of Directors authorized an additional stock repurchase program for up to $200 million of shares of its common stock (the "2022 Share Repurchase Program"). The amount reflected under the column captioned “Approximate Dollar Value Maximum of Shares that May Yet Be Purchased Under the Plans or Programs (in $000's)” reflects the approximate dollar value maximum at the end of the applicable month for the 2019 Share Repurchase Program and the 2022 Share Repurchase Program, as applicable. The remaining authorization under these programs was $177.2 million as of September 30, 2022. The 2019 Share Repurchase Program and 2022 Share Repurchase Program have no time limit and may be suspended for periods or discontinued at any time.

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

None.

ITEM 4. MINE SAFETY DISCLOSURES

None.

ITEM 5. OTHER INFORMATION

None.

ITEM 6. EXHIBITS

Exhibit No.

Description

Filed with

This Form 10-Q

Incorporated by Reference

Form

Filing Date

Exhibit No.

2.1

Agreement and Plan of Merger, dated as of October 31, 2022, by and among ABIOMED, Inc., Johnson & Johnson, and Athos Merger Sub, Inc.

8-K

November 1, 2022

2.1

2.2

Form of Contingent Value Rights Agreement, by and among Johnson & Johnson and a rights agent mutually acceptable to Johnson & Johnson and ABIOMED, Inc.

8-K

November 1, 2022

2.2

3.1

Restated Certificate of Incorporation

S-3

September 29, 1997

3.1

3.2

Amended & Restated By-Laws, as Amended and Restated May 26, 2022, as further amended on October 31, 2022

8-K

November 1, 2022

3.1

3.3

Amendment to the Company’s Restated Certificate of Incorporation to increase the authorized shares of common stock from 25,000,000 to 100,000,000

8-K

March 21, 2007
(File No. 001-09585)

3.4

31.1

Rule 13a—14(a)/15d—14(a) certification of principal executive officer

31.2

Rule 13a—14(a)/15d—14(a) certification of principal accounting officer

32.1

Section 1350 certification

101

The following financial information from the ABIOMED, Inc. Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, formatted in inline Extensible Business Reporting Language (XBRL): (i) Condensed Consolidated Balance Sheets (Unaudited) as of September 30, 2022 and March 31, 2022; (ii) Condensed Consolidated Statements of Operations (Unaudited) for the three and six months ended September 30, 2022 and 2021; (iii) Condensed Consolidated Statements of Comprehensive Income (Unaudited) for the three and six months ended September 30, 2022 and 2021; (iv) Condensed Consolidated Statements of Stockholders’ Equity (Unaudited) for the three and six months ended September 30, 2022 and 2021 (v) Condensed Consolidated Statements of Cash Flows (Unaudited) for the six months ended September 30, 2022 and 2021; and (vi) Notes to Condensed Consolidated Financial Statements (Unaudited).

104

Cover page from the ABIOMED, Inc. Quarterly Report on Form 10-Q for the quarter ended September 30, 2022 formatted in iXBRL and contained in Exhibit 101

* Management contract or compensatory plan, contract or arrangement.

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.

Date: November 3, 2022		/s/ TODD A. TRAPP
		Todd A. Trapp
		Executive Vice President and Chief Financial Officer
		(Authorized Signatory)