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 SeptemberJune 30, 20212022
OR
☐ | 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) (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 21, 2021, 45,497,490July 29, 2022, 45,460,884 shares of the registrant’s common stock, $.01 par value, were outstanding.
TABLE OF CONTENTS
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Item 1. | 3 | ||
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| Condensed Consolidated Balance Sheets as of | 3 | |
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| Notes to Condensed Consolidated Financial Statements (unaudited) | 8 | |
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Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations |
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Item 3. |
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Item 4. |
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Item 1. |
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Item 1A. |
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Item 2. |
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Item 3. |
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Item 4. |
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Item 5. |
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Item 6. |
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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 XR Sheath, Impella BTR, CVAD STUDY, STEMI DTU, Automated Impella Controller, and 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.
2
PART I. FINANCIAL INFORMATION
ITEM 1: Condensed Consolidated Financial Statements
ABIOMED, INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets (Unaudited)(Unaudited)
(in thousands, except share data)thousands)
|
| September 30, 2021 |
|
| March 31, 2021 |
|
| June 30, 2022 |
|
| March 31, 2022 |
| ||||
ASSETS |
|
|
|
|
|
|
|
|
|
|
|
|
| |||
Current assets: |
|
|
|
|
|
|
|
|
|
|
|
|
| |||
Cash and cash equivalents |
| $ | 241,882 |
|
| $ | 232,710 |
|
| $ | 180,492 |
|
| $ | 132,818 |
|
Short-term marketable securities |
|
| 408,677 |
|
|
| 350,985 |
|
|
| 663,829 |
|
|
| 625,789 |
|
Accounts receivable, net |
|
| 89,568 |
|
|
| 97,179 |
|
|
| 91,102 |
|
|
| 90,608 |
|
Inventories, net |
|
| 85,986 |
|
|
| 81,059 |
|
|
| 95,373 |
|
|
| 93,981 |
|
Prepaid expenses and other current assets |
|
| 45,374 |
|
|
| 26,032 |
|
|
| 29,563 |
|
|
| 33,277 |
|
Total current assets |
|
| 871,487 |
|
|
| 787,965 |
|
|
| 1,060,359 |
|
|
| 976,473 |
|
Long-term marketable securities |
|
| 210,979 |
|
|
| 264,085 |
|
|
| 159,876 |
|
|
| 220,089 |
|
Property and equipment, net |
|
| 197,184 |
|
|
| 197,129 |
|
|
| 198,478 |
|
|
| 202,490 |
|
Goodwill |
|
| 78,166 |
|
|
| 78,568 |
|
|
| 74,855 |
|
|
| 76,786 |
|
Other intangibles, net |
|
| 41,062 |
|
|
| 42,150 |
|
|
| 38,168 |
|
|
| 39,518 |
|
Deferred tax assets |
|
| 2,975 |
|
|
| 11,380 |
|
|
| 17,096 |
|
|
| 10,552 |
|
Other assets |
|
| 128,181 |
|
|
| 113,082 |
|
|
| 154,804 |
|
|
| 147,485 |
|
Total assets |
| $ | 1,530,034 |
|
| $ | 1,494,359 |
|
| $ | 1,703,636 |
|
| $ | 1,673,393 |
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
|
|
|
|
|
|
|
|
| |||
Current liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
| |||
Accounts payable |
| $ | 27,621 |
|
| $ | 34,842 |
|
| $ | 34,797 |
|
| $ | 35,346 |
|
Accrued expenses |
|
| 56,744 |
|
|
| 66,046 |
|
|
| 79,011 |
|
|
| 72,629 |
|
Deferred revenue |
|
| 24,078 |
|
|
| 24,322 |
|
|
| 23,624 |
|
|
| 26,362 |
|
Other current liabilities |
|
| 5,579 |
|
|
| 3,759 |
|
|
| 3,330 |
|
|
| 4,120 |
|
Total current liabilities |
|
| 114,022 |
|
|
| 128,969 |
|
|
| 140,762 |
|
|
| 138,457 |
|
Other long-term liabilities |
|
| 8,303 |
|
|
| 10,162 |
|
|
| 7,792 |
|
|
| 9,319 |
|
Contingent consideration |
|
| 22,314 |
|
|
| 24,706 |
|
|
| 18,151 |
|
|
| 21,510 |
|
Deferred tax liabilities |
|
| 832 |
|
|
| 847 |
|
|
| 735 |
|
|
| 781 |
|
Total liabilities |
|
| 145,471 |
|
|
| 164,684 |
|
|
| 167,440 |
|
|
| 170,067 |
|
Commitments and contingencies (Note 16) |
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| ||||||||
Commitments and contingencies (Note 15) |
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|
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Stockholders' equity: |
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|
|
| |||
Class B Preferred Stock, $.01 par value |
|
| — |
|
|
| — |
| ||||||||
Authorized - 1,000,000 shares; Issued and outstanding - NaN |
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|
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|
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| ||||||||
Common stock, $.01 par value |
|
| 455 |
|
|
| 453 |
| ||||||||
Authorized - 100,000,000 shares; Issued 48,197,044 shares as of September 30, 2021 and 47,929,402 shares as of March 31, 2021 |
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Outstanding 45,496,563 shares as of September 30, 2021 and 45,270,948 shares as of March 31, 2021 |
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Class B Preferred Stock, $.01 par value |
|
| — |
|
|
| — |
| ||||||||
1,000 shares authorized; issued and outstanding - 0ne |
|
|
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Common stock, $.01 par value |
|
| 456 |
|
|
| 455 |
| ||||||||
100,000 shares authorized; 48,382 and 48,258 shares issued as of June 30, 2022 and March 31, 2022, respectively |
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|
|
|
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45,567 and 45,545 shares outstanding as of June 30, 2022 and March 31, 2022, respectively |
|
|
|
|
| |||||||||||
Additional paid in capital |
|
| 840,387 |
|
|
| 800,690 |
|
|
| 884,965 |
|
|
| 870,074 |
|
Retained earnings |
|
| 858,435 |
|
|
| 828,007 |
|
|
| 1,019,066 |
|
|
| 964,512 |
|
Treasury stock at cost 2,700,481 shares as of September 30, 2021 and 2,658,454 shares as of March 31, 2021 |
|
| (300,158 | ) |
|
| (288,030 | ) | ||||||||
Treasury stock at cost - 2,815 and 2,713 shares as of June 30, 2022 and March 31, 2022, respectively |
|
| (330,020 | ) |
|
| (304,555 | ) | ||||||||
Accumulated other comprehensive loss |
|
| (14,556 | ) |
|
| (11,445 | ) |
|
| (38,271 | ) |
|
| (27,160 | ) |
Total stockholders' equity |
|
| 1,384,563 |
|
|
| 1,329,675 |
|
|
| 1,536,196 |
|
|
| 1,503,326 |
|
Total liabilities and stockholders' equity |
| $ | 1,530,034 |
|
| $ | 1,494,359 |
|
| $ | 1,703,636 |
|
| $ | 1,673,393 |
|
The accompanying notes are an integral part of the condensed consolidated financial statements (unaudited)
3
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, |
|
| ||||||||||
|
| 2021 |
|
| 2020 |
|
| 2021 |
|
| 2020 |
|
| ||||
Revenue |
| $ | 248,142 |
|
| $ | 209,764 |
|
| $ | 500,727 |
|
| $ | 374,614 |
|
|
Costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenue |
|
| 43,886 |
|
|
| 38,736 |
|
|
| 89,074 |
|
|
| 74,719 |
|
|
Research and development |
|
| 41,041 |
|
|
| 30,525 |
|
|
| 78,749 |
|
|
| 56,882 |
|
|
Selling, general and administrative |
|
| 102,779 |
|
|
| 79,167 |
|
|
| 206,263 |
|
|
| 147,611 |
|
|
Acquired in-process research and development |
|
| — |
|
|
| — |
|
|
| 115,490 |
|
|
| — |
|
|
|
|
| 187,706 |
|
|
| 148,428 |
|
|
| 489,576 |
|
|
| 279,212 |
|
|
Operating income |
|
| 60,436 |
|
|
| 61,336 |
|
|
| 11,151 |
|
|
| 95,402 |
|
|
Other income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investment income, net |
|
| 977 |
|
|
| 1,822 |
|
|
| 2,027 |
|
|
| 4,219 |
|
|
Other income, net |
|
| 5,858 |
|
|
| 9,757 |
|
|
| 44,743 |
|
|
| 34,370 |
|
|
|
|
| 6,835 |
|
|
| 11,579 |
|
|
| 46,770 |
|
|
| 38,589 |
|
|
Income before income taxes |
|
| 67,271 |
|
|
| 72,915 |
|
|
| 57,921 |
|
|
| 133,991 |
|
|
Income tax provision |
|
| 10,318 |
|
|
| 10,702 |
|
|
| 27,493 |
|
|
| 27,190 |
|
|
Net income |
| $ | 56,953 |
|
| $ | 62,213 |
|
| $ | 30,428 |
|
| $ | 106,801 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income per share - basic |
| $ | 1.25 |
|
| $ | 1.38 |
|
| $ | 0.67 |
|
| $ | 2.37 |
|
|
Weighted average shares outstanding - basic |
|
| 45,437 |
|
|
| 45,104 |
|
|
| 45,374 |
|
|
| 45,057 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income per share - diluted |
| $ | 1.24 |
|
| $ | 1.36 |
|
| $ | 0.66 |
|
| $ | 2.34 |
|
|
Weighted average shares outstanding - diluted |
|
| 45,893 |
|
|
| 45,661 |
|
|
| 45,857 |
|
|
| 45,609 |
|
|
|
| For the Three Months Ended June 30, |
| |||||
|
| 2022 |
|
| 2021 |
| ||
Revenue |
| $ | 277,149 |
|
| $ | 252,585 |
|
Cost of revenue and operating expenses: |
|
|
|
|
|
| ||
Cost of revenue |
|
| 52,626 |
|
|
| 45,188 |
|
Research and development |
|
| 40,477 |
|
|
| 37,708 |
|
Selling, general and administrative |
|
| 117,996 |
|
|
| 103,484 |
|
Acquired in-process research and development |
|
| 0 |
|
|
| 115,490 |
|
|
|
| 211,099 |
|
|
| 301,870 |
|
Income (loss) from operations |
|
| 66,050 |
|
|
| (49,285 | ) |
Interest and other income, net |
|
| 3,772 |
|
|
| 39,935 |
|
Income (loss) before income taxes |
|
| 69,822 |
|
|
| (9,350 | ) |
Income tax provision |
|
| 15,268 |
|
|
| 17,175 |
|
Net income (loss) |
| $ | 54,554 |
|
| $ | (26,525 | ) |
|
|
|
|
|
|
| ||
Net income (loss) per share - basic |
| $ | 1.20 |
|
| $ | (0.59 | ) |
Weighted average shares outstanding - basic |
|
| 45,575 |
|
|
| 45,311 |
|
|
|
|
|
|
|
| ||
Net income (loss) per share - diluted |
| $ | 1.19 |
|
| $ | (0.59 | ) |
Weighted average shares outstanding - diluted |
|
| 45,922 |
|
|
| 45,311 |
|
The accompanying notes are an integral part of the condensed consolidated financial statements (unaudited)
4
ABIOMED, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Comprehensive Income (Loss) (Unaudited)(Unaudited)
(in thousands)
|
| For the Three Months Ended September 30, |
|
| For the Six Months Ended September 30, |
| ||||||||||
|
| 2021 |
|
| 2020 |
|
| 2021 |
|
| 2020 |
| ||||
Net income |
| $ | 56,953 |
|
| $ | 62,213 |
|
| $ | 30,428 |
|
| $ | 106,801 |
|
Other comprehensive (loss) income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation (losses) gains |
|
| (2,693 | ) |
|
| 2,416 |
|
|
| (2,610 | ) |
|
| 3,776 |
|
Unrealized gains (losses) on derivative instrument |
|
| 545 |
|
|
| (266 | ) |
|
| 328 |
|
|
| (726 | ) |
Net unrealized (losses) gains on marketable securities |
|
| (197 | ) |
|
| (814 | ) |
|
| (829 | ) |
|
| 940 |
|
Other comprehensive (loss) income |
|
| (2,345 | ) |
|
| 1,336 |
|
|
| (3,111 | ) |
|
| 3,990 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income |
| $ | 54,608 |
|
| $ | 63,549 |
|
| $ | 27,317 |
|
| $ | 110,791 |
|
|
| For the Three Months Ended June 30, |
| |||||
|
| 2022 |
|
| 2021 |
| ||
Net income (loss) |
| $ | 54,554 |
|
| $ | (26,525 | ) |
Other comprehensive loss: |
|
|
|
|
|
| ||
Foreign currency translation (losses) gains |
|
| (8,729 | ) |
|
| 83 |
|
Unrealized losses on derivative instrument |
|
| (384 | ) |
|
| (217 | ) |
Net unrealized losses on marketable securities, net of tax |
|
| (1,998 | ) |
|
| (632 | ) |
Other comprehensive loss |
|
| (11,111 | ) |
|
| (766 | ) |
|
|
|
|
|
|
| ||
Comprehensive income (loss) |
| $ | 43,443 |
|
| $ | (27,291 | ) |
The accompanying notes are an integral part of the condensed consolidated financial statements (unaudited)
5
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, 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 |
|
| (34,274 | ) |
|
| (1 | ) |
|
| 34,274 |
|
|
| (9,589 | ) |
|
| — |
|
|
| — |
|
|
| — |
|
|
| (9,590 | ) |
Stock 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 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 |
|
|
| 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 |
|
|
| 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, 2020 |
|
| 45,008,687 |
|
| $ | 450 |
|
|
| 2,533,374 |
|
| $ | (265,411 | ) |
| $ | 739,133 |
|
| $ | 602,482 |
|
| $ | (11,189 | ) |
| $ | 1,065,466 |
|
Restricted stock units issued |
|
| 124,749 |
|
|
| 1 |
|
|
| — |
|
|
| — |
|
|
| (1 | ) |
|
| — |
|
|
| — |
|
|
| — |
|
Stock options exercised |
|
| 31,488 |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| 1,010 |
|
|
| — |
|
|
| — |
|
|
| 1,010 |
|
Return of common stock to pay withholding taxes on restricted stock |
|
| (52,515 | ) |
|
| — |
|
|
| 52,515 |
|
|
| (9,857 | ) |
|
| — |
|
|
| — |
|
|
| — |
|
|
| (9,857 | ) |
Stock compensation expense |
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| 9,298 |
|
|
| — |
|
|
| — |
|
|
| 9,298 |
|
Stock repurchase program |
|
| (67,649 | ) |
|
| (1 | ) |
|
| 67,649 |
|
|
| (11,309 | ) |
|
| — |
|
|
| — |
|
|
| — |
|
|
| (11,310 | ) |
Other comprehensive income |
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| 2,654 |
|
|
| 2,654 |
|
Net income |
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| 44,588 |
|
|
| — |
|
|
| 44,588 |
|
Balance, June 30, 2020 |
|
| 45,044,760 |
|
| $ | 450 |
|
|
| 2,653,538 |
|
| $ | (286,577 | ) |
| $ | 749,440 |
|
| $ | 647,070 |
|
| $ | (8,535 | ) |
| $ | 1,101,848 |
|
Restricted stock units issued |
|
| 11,554 |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
Stock options exercised |
|
| 121,066 |
|
|
| 1 |
|
|
| — |
|
|
| — |
|
|
| 4,544 |
|
|
| — |
|
|
| — |
|
|
| 4,545 |
|
Return of common stock to pay withholding taxes on restricted stock |
|
| (3,602 | ) |
|
| — |
|
|
| 3,602 |
|
|
| (1,077 | ) |
|
| — |
|
|
| — |
|
|
| — |
|
|
| (1,077 | ) |
Stock issued under employee stock purchase plan |
|
| 16,105 |
|
|
| 1 |
|
|
| — |
|
|
| — |
|
|
| 1,978 |
|
|
| — |
|
|
| — |
|
|
| 1,979 |
|
Stock compensation expense |
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| 11,565 |
|
|
| — |
|
|
| — |
|
|
| 11,565 |
|
Other comprehensive income |
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| 1,336 |
|
|
| 1,336 |
|
Net income |
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
|
| 62,213 |
|
|
| — |
|
|
| 62,213 |
|
Balance, September 30, 2020 |
|
| 45,189,883 |
|
| $ | 452 |
|
|
| 2,657,140 |
|
| $ | (287,654 | ) |
| $ | 767,527 |
|
| $ | 709,283 |
|
| $ | (7,199 | ) |
| $ | 1,182,409 |
|
|
| 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 |
|
The accompanying notes are an integral part of the condensed consolidated financial statements (unaudited)
6
ABIOMED, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Cash Flows (Unaudited)
(in thousands)
|
| For the Six Months Ended September 30, |
|
| For the Three Months Ended June 30, |
| ||||||||||
|
| 2021 |
|
| 2020 |
|
| 2022 |
|
| 2021 |
| ||||
Operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
| |||
Net income |
| $ | 30,428 |
|
| $ | 106,801 |
| ||||||||
Adjustments to reconcile net income to net cash provided by operating activities: |
|
|
|
|
|
|
|
| ||||||||
Net income (loss) |
| $ | 54,554 |
|
| $ | (26,525 | ) | ||||||||
Adjustments to reconcile net income (loss) to net cash provided by operating activities: |
|
|
|
|
| |||||||||||
Depreciation and amortization |
|
| 13,873 |
|
|
| 11,137 |
|
|
| 6,620 |
|
|
| 6,907 |
|
Acquired in-process research & development |
|
| 115,490 |
|
|
| — |
|
|
| 0 |
|
|
| 115,490 |
|
Bad debt recoveries |
|
| (27 | ) |
|
| (373 | ) | ||||||||
Bad debt expense (recoveries) |
|
| 11 |
|
|
| (59 | ) | ||||||||
Stock-based compensation |
|
| 28,357 |
|
|
| 20,863 |
|
|
| 13,362 |
|
|
| 12,608 |
|
Write-down of inventory and other |
|
| 6,195 |
|
|
| 3,122 |
|
|
| 2,570 |
|
|
| 3,508 |
|
Accretion on marketable securities |
|
| 1,768 |
|
|
| 473 |
|
|
| 587 |
|
|
| 918 |
|
Change in fair value of other investments |
|
| (22,440 | ) |
|
| (33,872 | ) |
|
| (278 | ) |
|
| (17,648 | ) |
Gain on previously held interest in preCARDIA |
|
| (20,980 | ) |
|
| — |
|
|
| 0 |
|
|
| (20,980 | ) |
Deferred tax provision |
|
| 8,193 |
|
|
| 14,187 |
|
|
| (6,373 | ) |
|
| 6,299 |
|
Change in fair value of contingent consideration |
|
| 108 |
|
|
| 2,117 |
|
|
| (3,359 | ) |
|
| 871 |
|
Other non-cash operating activities |
|
| 1,553 |
|
|
| 2,008 |
|
|
| 1,080 |
|
|
| 751 |
|
Changes in assets and liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
| |||
Accounts receivable |
|
| 7,444 |
|
|
| 4,767 |
|
|
| (1,881 | ) |
|
| 8,763 |
|
Inventories |
|
| (11,673 | ) |
|
| 6,071 |
|
|
| (6,510 | ) |
|
| (5,770 | ) |
Prepaid expenses and other assets |
|
| (20,300 | ) |
|
| 1,744 |
|
|
| 3,117 |
|
|
| (8,697 | ) |
Accounts payable |
|
| (6,266 | ) |
|
| (10,128 | ) |
|
| 1,438 |
|
|
| (4,762 | ) |
Accrued expenses and other liabilities |
|
| (15,590 | ) |
|
| (21,988 | ) |
|
| 5,583 |
|
|
| (16,037 | ) |
Deferred revenue |
|
| (202 | ) |
|
| 2,039 |
|
|
| (2,418 | ) |
|
| (278 | ) |
Net cash provided by operating activities |
|
| 115,931 |
|
|
| 108,968 |
|
|
| 68,103 |
|
|
| 55,359 |
|
Investing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
| |||
Purchases of marketable securities |
|
| (333,832 | ) |
|
| (294,558 | ) |
|
| (121,897 | ) |
|
| (139,021 | ) |
Proceeds from the sale and maturity of marketable securities and other |
|
| 326,518 |
|
|
| 220,197 |
|
|
| 141,385 |
|
|
| 123,823 |
|
Purchases of other investments and intangible assets |
|
| (3,866 | ) |
|
| (3,100 | ) | ||||||||
Purchases of other investments |
|
| (4,591 | ) |
|
| (3,866 | ) | ||||||||
Acquisition of preCARDIA, net of cash acquired |
|
| (82,821 | ) |
|
| — |
|
|
| 0 |
|
|
| (82,821 | ) |
Acquisition of Breethe, net of cash acquired |
|
| — |
|
|
| (52,183 | ) | ||||||||
Proceeds from sales of Shockwave Medical securities |
|
| — |
|
|
| 67,882 |
| ||||||||
Purchases of property and equipment |
|
| (14,394 | ) |
|
| (19,552 | ) |
|
| (6,783 | ) |
|
| (7,170 | ) |
Net cash used for investing activities |
|
| (108,395 | ) |
|
| (81,314 | ) | ||||||||
Net cash provided by (used for) investing activities |
|
| 8,114 |
|
|
| (109,055 | ) | ||||||||
Financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
| |||
Proceeds from the exercise of stock options |
|
| 8,382 |
|
|
| 5,555 |
|
|
| 1,531 |
|
|
| 2,120 |
|
Taxes paid related to net share settlement upon vesting of stock awards |
|
| (12,129 | ) |
|
| (10,934 | ) |
|
| (10,950 | ) |
|
| (9,590 | ) |
Repurchase of common stock |
|
| — |
|
|
| (11,310 | ) |
|
| (14,517 | ) |
|
| 0 |
|
Proceeds from the issuance of stock under employee stock purchase plan |
|
| 2,961 |
|
|
| 1,978 |
| ||||||||
Net cash used for financing activities |
|
| (786 | ) |
|
| (14,711 | ) |
|
| (23,936 | ) |
|
| (7,470 | ) |
Effect of exchange rate changes on cash and cash equivalents |
|
| 2,422 |
|
|
| (3,043 | ) |
|
| (4,607 | ) |
|
| 3,910 |
|
Net increase in cash and cash equivalents |
|
| 9,172 |
|
|
| 9,900 |
| ||||||||
Net increase (decrease) in cash and cash equivalents |
|
| 47,674 |
|
|
| (57,256 | ) | ||||||||
Cash and cash equivalents at beginning of period |
|
| 232,710 |
|
|
| 192,341 |
|
|
| 132,818 |
|
|
| 232,710 |
|
Cash and cash equivalents at end of period |
| $ | 241,882 |
|
| $ | 202,241 |
|
| $ | 180,492 |
|
| $ | 175,454 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||
Supplemental disclosure of cash flow information: |
|
|
|
|
|
|
|
|
|
|
|
|
| |||
Cash paid for income taxes |
| $ | 35,642 |
|
| $ | 25,254 |
| ||||||||
Cash paid for income taxes, net of refunds |
| $ | 3,542 |
|
| $ | 14,998 |
| ||||||||
Supplemental disclosure of non-cash activities: |
|
|
|
|
|
|
|
|
|
|
|
|
| |||
Contingent consideration related to the acquisition of Breethe |
|
| — |
|
|
| 13,300 |
| ||||||||
Property and equipment in accounts payable and accrued expenses |
|
| 578 |
|
|
| 1,244 |
|
|
| 564 |
|
|
| 1,014 |
|
Right-of-use assets obtained in exchange for lease liabilities |
|
| 569 |
|
|
| 193 |
|
|
| 188 |
|
|
| 283 |
|
The accompanying notes are an integral part of the condensed consolidated financial statements (unaudited)
7
ABIOMED, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)
(In thousands, except share data)
Note 1. Nature of BusinessOperations
ABIOMED, Inc. (the “Company” or “ABIOMED”) is a leading provider of medical devicestechnology that provideprovides circulatory support and oxygenation. OurThe Company's products are designed to enable the heart to rest by improving blood flow and/or provide sufficient oxygenation to those in respiratory failure. The Company develops, manufactures and markets proprietary products that are designed to enable the heart to rest, heal and recover by improving blood flow and/or performing the pumping function 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 PreparationPresentation and SummarySummary 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 asas 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, 20212022 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 SeptemberJune 30, 20212022 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, 20212022 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.
Certain prior period amounts within the notes to the condensed consolidated financial statements have been reclassified to conform to the current period presentation.
COVID-19 Pandemic
The Company is subject to additional risks and uncertainties as a result of the ongoing novel coronavirus (“COVID-19”) pandemic. TheSince 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, including, for example: supply shortages, particularlybusiness.
To ensure the health and safety of its product components; supply chain disruptions, which may limitglobal 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 abilitymanufacturing facilities to manufacture or distribute its products.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. During the second quarter of fiscal year 2022, the Company has experienced varying levels of recovery across its product lines and geographic locations from the challenges caused by the pandemic. Despite these improvements, the impact of COVID-19 on the Company’s patient utilization volumes is likely to vary widely by country, region, and type. In particular, Impella product revenue increased in the three and six months ended September 30, 2021 as a result of sales mix and higher patient utilization in the U.S., Germany and Japan as compared to the three and six months ended September 30, 2020, however, in the second quarter of fiscal year 2022, patient utilization of Impella heart pump devices was negatively impacted by an increase in COVID-19 hospitalizations and ongoing shortage of hospital workers that limited ICU capacity which contributed to some deferral of elective procedures. 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 the Company believes there may be a backlog of patients in need
of medical attention that requires the use of the Company’s products, it is difficult to predict when or if those patients may ultimately seek treatment, and therefore, the extent to which COVID-19 may impactWhile patient utilization and, consequently, product revenue.
To ensureincreased in the health and safetyfirst quarter of its global employees, the Company continues to offer onsite COVID-19 testing and vaccinationsfiscal year 2023, sales were impacted by slower than expected improvements 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.
hospital staffing shortages. The Company continues to closely monitor the impact of COVID-19 on all aspects of its business and geographies, including any impact on the Company’s customers, including the ongoing hospital labor shortages, 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 lead materially adversely affect the Company’s financial condition, liquidity or results of operations is uncertain.
8
Recently Adopted Accounting Pronouncements
In December 2019,November 2021, the Financial Accounting Standards Board (“FASB”)FASB issued ASU 2019-12, Simplifying2021-10, “Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance” an amendment focused on increasing transparency of government assistance including the Accountingdisclosure of (1) the types of assistance, (2) an entity’s accounting for Income Taxes (ASC 740). The ASU enhancesthe assistance, and simplifies various aspects(3) the effect of the income tax accounting guidance in ASC 740, including requirements related to hybrid tax regimes, the tax basis step-up in goodwill obtained in a transaction that is not a business combination, separateassistance on an entity’s financial statements of entities not subject to tax, the intra-period tax allocation exception to the incremental approach, ownership changes in investments, changes from a subsidiary to an equity method investment, interim-period accounting for enacted changes in tax law, and the year-to-date loss limitation in interim-period tax accounting. This guidance is effective for the Company for annual and interim periods beginning after December 31, 2020; however, early adoption is permitted.statements. The Company adopted this standardASU 2021-10 as of April 1, 20212022, on a prospective basis. The adoption did not have a material impact on the Company’s condensed consolidated financial statements.
In January 2020, the FASB issued ASU 2020-01, “Investments—Equity Securities (Topic 321), Investments—Equity Method and Joint Ventures (Topic 323), and Derivatives and Hedging (Topic 815),” an amendment clarifying the interaction between accounting standards related to equity securities, equity method investments, and certain derivative instruments. The guidance is effective for fiscal years beginning after December 15, 2020. The Company adopted this standard as of April 1, 2021basis, 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 other new accounting pronouncements issued or effective during the period had, or are expected to have, a material impact on the condensed consolidated financial statements.
Note 3. Acquisitions
Acquisition of preCARDIA, Inc.
The Company acquired 100%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, with a potential payout of $5 million payable based on achievement of a commercial milestone.$115.2 million. The purchase price included cash consideration of $82.8$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$32.4 million representing the Company’s previously owned minority interest in preCARDIA. The Company recognized a gain of $21.0$21.0 million related to its previously owned minority interest in preCARDIA within the condensed consolidated statement of operations for the sixthree months ended SeptemberJune 30, 2021.
In connection with the acquisition, the Company acquired net assets of $115.2$115.2 million, which included $115.5$115.5 million related to the fair value of the in-process research and development asset and $0.3$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$115.5 million to the condensed consolidated statement of operations for the sixthree months ended SeptemberJune 30, 2021.
Acquisition of Breethe, Inc.
The In connection with the acquisition, the Company acquired Breethe, Inc. (“Breethe”), a Maryland corporation, on April 24, 2020. Breethelicense agreement, under which there is engaged in research and developmenta potential payout of a novel extracorporeal membrane oxygenation (“ECMO”) system that will complement and expand its product portfolio to more comprehensively serve the needs of patients whose lungs can no longer provide sufficient oxygenation, including patients suffering from cardiogenic shock, or respiratory failure, such as ARDS, H1N1, or COVID-19. $The Company acquired Breethe for $55.05 million in cash, with additional potential payouts up to a maximum of $55.0 million payable based on the achievement of certain technical, regulatory anda commercial milestones.milestone.
Purchase Price Allocation
The acquisition was accounted for as a business combination. The purchase price for the acquisition has been allocated to the assets acquired and liabilities assumed based on their estimated fair values and was finalized in the year ended March 31, 2021.
The acquisition-date fair value of the consideration transferred is as follows:
| Total Acquisition Date Fair Value (in thousands) |
| |
Cash and other considerations | $ | 57,850 |
|
Contingent consideration |
| 13,300 |
|
Total consideration transferred | $ | 71,150 |
|
The following table summarizes the estimated fair values of the assets acquired and liabilities assumed on the date of acquisition (in thousands):
Acquired assets: |
|
|
|
Cash and cash equivalents | $ | 3,404 |
|
Property and equipment |
| 744 |
|
Goodwill |
| 44,485 |
|
In-process research and development |
| 27,000 |
|
Other assets acquired |
| 895 |
|
Total assets acquired |
| 76,528 |
|
Liabilities assumed: |
|
|
|
Accounts payable and other liabilities |
| 1,562 |
|
Deferred tax liabilities |
| 3,816 |
|
Net assets acquired | $ | 71,150 |
|
Goodwill is calculated as the difference between the acquisition-date fair value of the consideration transferred and the fair values of the assets acquired and liabilities assumed. The goodwill is not expected to be deductible for income tax purposes.
Note 4. Net Income (Loss) Per Share
Basic net income (loss) per share is computed by dividing net income by the weighted average number of common shares outstanding during the period. Diluted net income (loss) 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 areis 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 (loss) 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 following tables illustrate the determination ofCompany’s basic and diluted net income (loss) per share for each period presented (in thousands, except per share data):were as follows:
|
| For the Three Months Ended September 30, |
|
| For the Six Months Ended September 30, |
| ||||||||||
|
|
| 2021 |
|
|
| 2020 |
|
|
| 2021 |
|
|
| 2020 |
|
Net income |
| $ | 56,953 |
|
| $ | 62,213 |
|
| $ | 30,428 |
|
| $ | 106,801 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares – basic |
|
| 45,437 |
|
|
| 45,104 |
|
|
| 45,374 |
|
|
| 45,057 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income per share – basic |
| $ | 1.25 |
|
| $ | 1.38 |
|
| $ | 0.67 |
|
| $ | 2.37 |
|
|
| For the Three Months Ended June 30, |
| |||||
|
| 2022 |
|
| 2021 |
| ||
Net income (loss) per share – basic |
| (in thousands, except per share data) |
| |||||
Net income (loss) |
| $ | 54,554 |
|
| $ | (26,525 | ) |
|
|
|
|
|
|
| ||
Weighted average shares – basic |
|
| 45,575 |
|
|
| 45,311 |
|
|
|
|
|
|
|
| ||
Net income (loss) per share – basic |
| $ | 1.20 |
|
| $ | (0.59 | ) |
9
|
| For the Three Months Ended June 30, |
| |||||
|
| 2022 |
|
| 2021 |
| ||
Net income (loss) per share – diluted |
| (in thousands, except per share data) |
| |||||
Net income (loss) |
| $ | 54,554 |
|
|
| (26,525 | ) |
|
|
|
|
|
|
| ||
Weighted average shares – basic |
|
| 45,575 |
|
|
| 45,311 |
|
Effect of dilutive securities |
|
| 347 |
|
|
| — |
|
Weighted average shares – diluted |
|
| 45,922 |
|
|
| 45,311 |
|
|
|
|
|
|
|
| ||
Net income (loss) per share – diluted |
| $ | 1.19 |
|
| $ | (0.59 | ) |
|
| For the Three Months Ended September 30, |
|
| For the Six Months Ended September 30, |
| ||||||||||
|
|
| 2021 |
|
|
| 2020 |
|
|
| 2021 |
|
|
| 2020 |
|
Net income |
| $ | 56,953 |
|
|
| 62,213 |
|
|
| 30,428 |
|
|
| 106,801 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares – basic |
|
| 45,437 |
|
|
| 45,104 |
|
|
| 45,374 |
|
|
| 45,057 |
|
Effect of dilutive securities |
|
| 456 |
|
|
| 557 |
|
|
| 483 |
|
|
| 552 |
|
Weighted average shares – diluted |
|
| 45,893 |
|
|
| 45,661 |
|
|
| 45,857 |
|
|
| 45,609 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income per share – diluted |
| $ | 1.24 |
|
| $ | 1.36 |
|
| $ | 0.66 |
|
| $ | 2.34 |
|
Share-based compensation awards of approximately 0.2 million and 0.1 million shares forFor the three months ended SeptemberJune 30, 2022 and 2021, and 2020, respectively, and approximately 0.2 million and 0.21.1 million for the six months ended September 30, 2021shares of common stock underlying outstanding securities related to out-of-the-money stock options and 2020, respectively,performance-based awards where milestones were outstanding butnot met were not included in the computation of diluted net incomeearnings per share because the effect of including such sharestheir inclusion would have beenbe 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 isare 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’scustomer's credit worthiness and ability to pay prior to acceptance as a customer. Further, the Company performs periodic reviews of its customers’customers' creditworthiness prospectively.
If a contract contains a single performance obligation, the entire transaction price is allocated to the single performance obligation. Contracts that contain multiple performance obligations require an allocation of the transaction price based on the estimated relative standalone selling prices of the promised products or services underlying each performance obligation. The Company determines standalone selling prices based on the price at which the performance obligation is sold separately.
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:
|
| For the Three Months Ended September 30, |
|
| For the Six Months Ended September 30, |
|
| For the Three Months Ended June 30, |
| |||||||||||||||
|
|
| 2021 |
|
|
| 2020 |
|
|
| 2021 |
|
|
| 2020 |
|
| 2022 |
|
| 2021 |
| ||
|
| (in thousands) |
|
| (in thousands) |
|
| (in thousands) |
| |||||||||||||||
Product revenue |
| $ | 235,785 |
|
| $ | 199,676 |
|
| $ | 477,259 |
|
| $ | 355,093 |
|
| $ | 264,472 |
|
| $ | 241,474 |
|
Service and other revenue |
|
| 12,357 |
|
|
| 10,088 |
|
|
| 23,468 |
|
|
| 19,521 |
|
|
| 12,677 |
|
|
| 11,111 |
|
Total revenue |
| $ | 248,142 |
|
| $ | 209,764 |
|
| $ | 500,727 |
|
| $ | 374,614 |
|
| $ | 277,149 |
|
| $ | 252,585 |
|
10
The following table disaggregates the Company’s revenue by geographicalgeographic location:
|
| For the Three Months Ended September 30, |
|
| For the Six Months Ended September 30, |
| ||||||||||||||||||
|
|
| 2021 |
|
|
| 2020 |
|
|
| 2021 |
|
|
| 2020 |
|
| For the Three Months Ended June 30, |
| |||||
|
| (in thousands) |
|
| (in thousands) |
|
| 2022 |
|
| 2021 |
| ||||||||||||
U.S. |
| $ | 200,485 |
|
| $ | 172,147 |
|
| $ | 407,628 |
|
| $ | 306,872 |
| ||||||||
|
| (in thousands) |
| |||||||||||||||||||||
United States |
| $ | 226,520 |
|
| $ | 207,143 |
| ||||||||||||||||
Europe |
|
| 32,527 |
|
|
| 25,350 |
|
|
| 64,764 |
|
|
| 45,008 |
|
|
| 33,836 |
|
|
| 32,237 |
|
Japan |
|
| 12,267 |
|
|
| 10,311 |
|
|
| 23,551 |
|
|
| 19,296 |
|
|
| 13,235 |
|
|
| 11,284 |
|
Rest of world |
|
| 2,863 |
|
|
| 1,956 |
|
|
| 4,784 |
|
|
| 3,438 |
|
|
| 3,558 |
|
|
| 1,921 |
|
Outside the U.S. |
|
| 50,629 |
|
|
| 45,442 |
| ||||||||||||||||
Total revenue |
| $ | 248,142 |
|
| $ | 209,764 |
|
| $ | 500,727 |
|
| $ | 374,614 |
|
| $ | 277,149 |
|
| $ | 252,585 |
|
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, including product discontinuations, product recalls and expirations, of which it becomes aware. The Company’s cost of replacing defective products has not been material and is accounted for at the time of replacement.returns. The Company’s returns reserve was not material as of SeptemberJune 30, 20212022 and March 31, 2021, was 0t material.2022.
Rebates and Discounts
The Company provides certain customers with rebates and discounts that are defined in the Company’s contractcontractual arrangements with customers and are recorded as a reduction of revenue in the period the related revenue is recognized resulting inwith a reduction to revenuecorresponding liability recorded and the establishment of a liability, which are all included in accrued expenses in the accompanying condensed consolidated balance sheet.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. Revenue adjustments that relate to performance obligations satisfied in prior periods during the three and six months ended September 30, 2021 and 2020, were not material.
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 $24.1$23.6 million and $24.3$26.4 million as of SeptemberJune 30, 20212022 and March 31, 20212022, respectively. The deferred revenue balance is due to the timingcomprised of product shipment and completion of recognizingshipments in which the Company recognizes revenue when the customer obtains control of the product, and additional preventative maintenance service contracts and the subsequent recognition of
the contractin which revenue is recognized ratably over the term of the service contract. TheDuring the three months ended June 30, 2022, the Company recognized $9.9 million and $2113.7 million of revenue during the three and six months ended September 30, 2021, that was included in the deferred revenue balance as of March 31, 2021. The2022. During the three months ended June 30, 2021, the Company recognized $5.4 million and $14.6$9.2 million of revenue during the three and six months ended September 30, 2020,that was included in the deferred revenue balance as of March 31, 2020.2022.
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.
11
Note 6. Financial Instruments
Cash Equivalents and Marketable Securities
The Company’s cash equivalents and marketable securities at SeptemberJune 30, 20212022 and March 31, 20212022 are invested in the following:
|
| Amortized |
|
| Gross |
|
| Gross |
|
| Fair Market |
| ||||
|
| Cost |
|
| Gains |
|
| Losses |
|
| Value |
| ||||
June 30, 2022 |
| (in thousands) |
| |||||||||||||
Money market funds |
| $ | 59,296 |
|
| $ | 0 |
|
| $ | 0 |
|
| $ | 59,296 |
|
Commercial paper |
|
| 5,997 |
|
|
| 0 |
|
|
| (2 | ) |
|
| 5,995 |
|
Total cash equivalents |
|
| 65,293 |
|
|
| 0 |
|
|
| (2 | ) |
|
| 65,291 |
|
Short-term U.S. Treasury mutual fund securities |
|
| 359,213 |
|
|
| 0 |
|
|
| (3,010 | ) |
|
| 356,203 |
|
Short-term government-backed securities |
|
| 160,288 |
|
|
| 1 |
|
|
| (1,875 | ) |
|
| 158,414 |
|
Short-term corporate debt securities |
|
| 33,110 |
|
|
| 0 |
|
|
| (179 | ) |
|
| 32,931 |
|
Short-term commercial paper |
|
| 116,738 |
|
|
| 0 |
|
|
| (457 | ) |
|
| 116,281 |
|
Total short-term marketable securities |
|
| 669,349 |
|
|
| 1 |
|
|
| (5,521 | ) |
|
| 663,829 |
|
Long-term U.S. Treasury mutual fund securities |
|
| 48,631 |
|
|
| 0 |
|
|
| (1,428 | ) |
|
| 47,203 |
|
Long-term government-backed securities |
|
| 105,838 |
|
|
| 0 |
|
|
| (3,026 | ) |
|
| 102,812 |
|
Long-term corporate debt securities |
|
| 10,185 |
|
|
| 0 |
|
|
| (324 | ) |
|
| 9,861 |
|
Total long-term marketable securities |
|
| 164,654 |
|
|
| 0 |
|
|
| (4,778 | ) |
|
| 159,876 |
|
Total cash equivalents and marketable securities |
| $ | 899,296 |
|
| $ | 1 |
|
| $ | (10,301 | ) |
| $ | 888,996 |
|
|
| Amortized |
|
| Gross Unrealized |
|
| Gross Unrealized |
|
| Fair Market |
| ||||||||||||||||||||
|
| Cost |
|
| Gains |
|
| Losses |
|
| Value |
|
| Amortized |
|
| Gross |
|
| Gross |
|
| Fair Market |
| ||||||||
September 30, 2021 |
| (in thousands) |
| |||||||||||||||||||||||||||||
|
| Cost |
|
| Gains |
|
| Losses |
|
| Value |
| ||||||||||||||||||||
March 31, 2022: |
| (in thousands) |
| |||||||||||||||||||||||||||||
Money market funds |
| $ | 92,012 |
|
| $ | — |
|
| $ | — |
|
| $ | 92,012 |
|
| $ | 32,955 |
|
| $ | 0 |
|
| $ | 0 |
|
| $ | 32,955 |
|
Repurchase agreements |
|
| 75,998 |
|
|
| — |
|
|
| — |
|
|
| 75,998 |
| ||||||||||||||||
Commercial paper |
|
| 28,961 |
|
|
| 0 |
|
|
| (3 | ) |
|
| 28,958 |
| ||||||||||||||||
Total cash equivalents |
|
| 168,010 |
|
|
| — |
|
|
| — |
|
|
| 168,010 |
|
|
| 61,916 |
|
|
| 0 |
|
|
| (3 | ) |
|
| 61,913 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||||||||||||
Short-term U.S. Treasury mutual fund securities |
|
| 73,893 |
|
|
| 5 |
|
|
| (2 | ) |
|
| 73,896 |
|
|
| 287,010 |
|
|
| 0 |
|
|
| (1,384 | ) |
|
| 285,626 |
|
Short-term government-backed securities |
|
| 73,672 |
|
|
| 49 |
|
|
| (3 | ) |
|
| 73,718 |
|
|
| 131,954 |
|
|
| 1 |
|
|
| (554 | ) |
|
| 131,401 |
|
Short-term corporate debt securities |
|
| 65,596 |
|
|
| 126 |
|
|
| (6 | ) |
|
| 65,716 |
|
|
| 61,108 |
|
|
| 36 |
|
|
| (113 | ) |
|
| 61,031 |
|
Short-term commercial paper |
|
| 195,339 |
|
|
| 13 |
|
|
| (5 | ) |
|
| 195,347 |
|
|
| 148,128 |
|
|
| 0 |
|
|
| (397 | ) |
|
| 147,731 |
|
Total short-term marketable securities |
|
| 408,500 |
|
|
| 193 |
|
|
| (16 | ) |
|
| 408,677 |
|
|
| 628,200 |
|
|
| 37 |
|
|
| (2,448 | ) |
|
| 625,789 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||||||||||||
Long-term U.S. Treasury mutual fund securities |
|
| 19,349 |
|
|
| — |
|
|
| (6 | ) |
|
| 19,343 |
|
|
| 89,168 |
|
|
| 0 |
|
|
| (1,796 | ) |
|
| 87,372 |
|
Long-term government-backed securities |
|
| 152,698 |
|
|
| 91 |
|
|
| (63 | ) |
|
| 152,726 |
|
|
| 126,150 |
|
|
| 0 |
|
|
| (3,378 | ) |
|
| 122,772 |
|
Long-term corporate debt securities |
|
| 38,569 |
|
|
| 363 |
|
|
| (22 | ) |
|
| 38,910 |
|
|
| 10,226 |
|
|
| 0 |
|
|
| (281 | ) |
|
| 9,945 |
|
Total long-term marketable securities |
|
| 210,616 |
|
|
| 454 |
|
|
| (91 | ) |
|
| 210,979 |
|
|
| 225,544 |
|
|
| 0 |
|
|
| (5,455 | ) |
|
| 220,089 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||||||||||||
Total cash equivalents and marketable securities |
| $ | 787,126 |
|
| $ | 647 |
|
| $ | (107 | ) |
| $ | 787,666 |
|
| $ | 915,660 |
|
| $ | 37 |
|
| $ | (7,906 | ) |
| $ | 907,791 |
|
|
| Amortized |
|
| Gross Unrealized |
|
| Gross Unrealized |
|
| Fair Market |
| ||||
|
| Cost |
|
| Gains |
|
| Losses |
|
| Value |
| ||||
March 31, 2021: |
| (in thousands) |
| |||||||||||||
Money market funds |
| $ | 124,297 |
|
| $ | — |
|
| $ | — |
|
| $ | 124,297 |
|
Repurchase agreements |
|
| 33,000 |
|
|
| — |
|
|
| — |
|
|
| 33,000 |
|
Total cash equivalents |
|
| 157,297 |
|
|
| — |
|
|
| — |
|
|
| 157,297 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-term U.S. Treasury mutual fund securities |
|
| 72,221 |
|
|
| 28 |
|
|
| — |
|
|
| 72,249 |
|
Short-term government-backed securities |
|
| 128,668 |
|
|
| 13 |
|
|
| (12 | ) |
|
| 128,669 |
|
Short-term corporate debt securities |
|
| 104,253 |
|
|
| 581 |
|
|
| (2 | ) |
|
| 104,832 |
|
Short-term commercial paper |
|
| 45,237 |
|
|
| 1 |
|
|
| (3 | ) |
|
| 45,235 |
|
Total short-term marketable securities |
|
| 350,379 |
|
|
| 623 |
|
|
| (17 | ) |
|
| 350,985 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term government-backed securities |
|
| 225,231 |
|
|
| 190 |
|
|
| (37 | ) |
|
| 225,384 |
|
Long-term corporate debt securities |
|
| 38,091 |
|
|
| 630 |
|
|
| (20 | ) |
|
| 38,701 |
|
Total long-term marketable securities |
|
| 263,322 |
|
|
| 820 |
|
|
| (57 | ) |
|
| 264,085 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total cash equivalents and marketable securities |
|
| 770,998 |
|
|
| 1,443 |
|
|
| (74 | ) |
|
| 772,367 |
|
Gross realized gains and losses on sales of marketable securities were not material for the three and six months ended SeptemberJune 30, 20212022 and 2020.2021.
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 June 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 June 30, 2022.
12
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 athe notional amount of the intercompany loan of 85.0 million Euro to its U.S. dollar equivalent, to $93.5 million denominated intercompany loan into U.S. dollars.or $93.5 million. The objective of this cross-currency swap is to hedge the variability of cash flows related to the forecasted interest and principal payments on the Euro denominated fixed rate intercompany loan against changes in the exchange rate between the U.S. dollar and the Euro. Under the terms of this cross-currency swap contract, whichEuro and has been designated as a cash flow hedge, thehedge. The Company will make interest payments in Euro and receive interest in U.S. dollars.dollars from the counterparty. Upon the maturity, of this contract, the Company will pay the principal amount of the intercompany loan in Euro and receive the U.S. dollarsdollar equivalent from the counterparty. The cross-currency swap is carried on the consolidated balance sheetsheets at fair value, and changes into the fair valuesderivative instrument are recorded as unrealized gains or losses in accumulated other comprehensive income (loss) income.
. These amounts are reclassified into the consolidated statements of operations in the same period in which the related hedged item (intercompany loan agreement) affects earnings. The Company does not enter into derivative instruments for any purpose other than cash flow hedging.
The following table summarizes the terms of the cross-currency swap agreement as of SeptemberJune 30, 2021:2022 (amounts in thousands):
Effective Date | Maturity | Fixed Rate | Aggregate Notional Amount | ||||||
Pay EUR | October 15, 2019 | October 15, 2024 | 2.75% | EUR 85,000 | |||||
Receive U.S.$ | 4.64% | USD 93,457 |
|
|
|
|
|
|
|
|
|
|
|
|
| Effective Date |
| Maturity |
| Fixed Rate |
|
| Aggregate Notional Amount (in thousands) |
| ||
Pay EUR | October 15, |
| October 15, |
| 2.75% |
|
|
| EUR 85,000 |
| |
Receive U.S.$ | 2019 |
| 2024 |
| 4.64% |
|
|
| USD 93,457 |
|
The following table presents the fair value of the Company’s derivative instrument:cross-currency swap (amounts in thousands):
Derivatives designated as hedging instruments under ASC 815 |
| Balance Sheet classification |
| September 30, 2021 |
|
| March 31, 2021 |
|
| Balance Sheet classification |
| June 30, 2022 |
|
| March 31, 2022 |
| ||||
Cross-currency swap |
| Other long-term liabilities |
| $ | 2,767 |
|
| $ | 4,298 |
|
| Other assets (other long-term liabilities) |
| $ | 4,508 |
|
| $ | (489 | ) |
The Company has structured its cross-currency swap agreement to be 100% effective and, as a result, there was no net impact to earnings resulting from hedge ineffectiveness. Changes in the fair value of the cross-currency swap are designated as a hedging instrument that effectively offsets the variability of cash flows and are reported in accumulated other comprehensive (loss) income. These amounts subsequently are reclassified into the consolidated statements of operations in the same period in which the related hedged item affects earnings. The change in fair value of the cross-currency swap during the three and six months ended SeptemberJune 30, 20212022 was mainly due to fluctuations in the Euro to the U.S. dollar exchange rates.
For the three and six months ended SeptemberJune 30, 2022 and 2021, the Company recorded income related to the interest rate differential of the cross-currency swap of $0.4$0.5 million and $0.8$0.4 million, respectively in interest and other income, net, within the condensed consolidated statements of operations. For both the three and six months ended September 30, 2020, the Company recorded income related to the interest rate differential of the cross-currency swap of $0.7 million in 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.
13
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, 2021 |
| (in thousands) |
| |||||||||||||||||||||||||||||
|
| Level 1 |
|
| Level 2 |
|
| Level 3 |
|
| Total |
| ||||||||||||||||||||
June 30, 2022: |
| (in thousands) |
| |||||||||||||||||||||||||||||
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||||
Money market funds |
| $ | 92,012 |
|
| $ | — |
|
| $ | — |
|
| $ | 92,012 |
|
| $ | 59,296 |
|
| $ | — |
|
| $ | — |
|
| $ | 59,296 |
|
Repurchase agreements |
|
| — |
|
|
| 75,998 |
|
|
| — |
|
|
| 75,998 |
| ||||||||||||||||
Commercial paper |
|
| — |
|
|
| 5,995 |
|
|
| — |
|
|
| 5,995 |
| ||||||||||||||||
Short-term U.S. Treasury mutual fund securities |
|
| — |
|
|
| 73,896 |
|
|
| — |
|
|
| 73,896 |
|
|
| — |
|
|
| 356,203 |
|
|
| — |
|
|
| 356,203 |
|
Short-term government-backed securities |
|
| — |
|
|
| 73,718 |
|
|
| — |
|
|
| 73,718 |
|
|
| — |
|
|
| 158,414 |
|
|
| — |
|
|
| 158,414 |
|
Short-term corporate debt securities |
|
| — |
|
|
| 65,716 |
|
|
| — |
|
|
| 65,716 |
|
|
| — |
|
|
| 32,931 |
|
|
| — |
|
|
| 32,931 |
|
Short-term commercial paper |
|
| — |
|
|
| 195,347 |
|
|
| — |
|
|
| 195,347 |
|
|
| — |
|
|
| 116,281 |
|
|
| — |
|
|
| 116,281 |
|
Long-term U.S. Treasury mutual fund securities |
|
| — |
|
|
| 19,343 |
|
|
| — |
|
|
| 19,343 |
|
|
| — |
|
|
| 47,203 |
|
|
| — |
|
|
| 47,203 |
|
Long-term government-backed securities |
|
| — |
|
|
| 152,726 |
|
|
| — |
|
|
| 152,726 |
|
|
| — |
|
|
| 102,812 |
|
|
| — |
|
|
| 102,812 |
|
Long-term corporate debt securities |
|
| — |
|
|
| 38,910 |
|
|
| — |
|
|
| 38,910 |
|
|
| — |
|
|
| 9,861 |
|
|
| — |
|
|
| 9,861 |
|
Investment in Shockwave Medical |
|
| 61,096 |
|
|
| — |
|
|
| — |
|
|
| 61,096 |
|
|
| 56,730 |
|
|
| — |
|
|
| — |
|
|
| 56,730 |
|
Cross-currency swap agreement |
|
| — |
|
|
| 4,508 |
|
|
| — |
|
|
| 4,508 |
| ||||||||||||||||
Liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||||
Contingent consideration |
|
| — |
|
|
| — |
|
|
| 24,814 |
|
|
| 24,814 |
|
|
| — |
|
|
| — |
|
|
| 18,151 |
|
|
| 18,151 |
|
Cross-currency swap agreement |
|
| — |
|
|
| 2,767 |
|
|
| — |
|
|
| 2,767 |
|
|
| 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 |
|
|
| Level 1 |
|
| Level 2 |
|
| Level 3 |
|
| Total |
| ||||
March 31, 2021 |
| (in thousands) |
| |||||||||||||
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
| $ | 124,297 |
|
| $ | — |
|
| $ | — |
|
| $ | 124,297 |
|
Repurchase agreements |
|
| — |
|
|
| 33,000 |
|
|
| — |
|
|
| 33,000 |
|
Short-term U.S. Treasury mutual fund securities |
|
| — |
|
|
| 72,249 |
|
|
| — |
|
|
| 72,249 |
|
Short-term government-backed securities |
|
| — |
|
|
| 128,669 |
|
|
| — |
|
|
| 128,669 |
|
Short-term corporate debt securities |
|
| — |
|
|
| 104,832 |
|
|
| — |
|
|
| 104,832 |
|
Short-term commercial paper |
|
| — |
|
|
| 45,235 |
|
|
| — |
|
|
| 45,235 |
|
Long-term government-backed securities |
|
| — |
|
|
| 225,384 |
|
|
| — |
|
|
| 225,384 |
|
Long-term corporate debt securities |
|
| — |
|
|
| 38,701 |
|
|
| — |
|
|
| 38,701 |
|
Investment in Shockwave Medical |
|
| 38,655 |
|
|
| — |
|
|
| — |
|
|
| 38,655 |
|
Liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cross currency swap agreement |
|
| — |
|
|
| 4,298 |
|
|
| — |
|
|
| 4,298 |
|
Contingent consideration |
|
| — |
|
|
| — |
|
|
| 24,706 |
|
|
| 24,706 |
|
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 repurchase agreements,commercial paper, U.S. Treasury mutual fund securities, government-backed securities, corporate debt securities and commercial paper 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 sixthree months ended SeptemberJune 30, 2021.2022.
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 makes any necessary adjustments.records adjustments as needed.
14
The Company’s other investments balance isare classified as a Level 3 assetassets and isare 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 sixthree months ended SeptemberJune 30, 20212022 are as follows:
|
|
|
| |
|
| (in thousands) |
| |
Balance, March 31, 2022 |
| $ | 70,314 |
|
Additions |
|
| 4,591 |
|
Change in fair value, net |
|
| 4,731 |
|
Balance, June 30, 2022 |
| $ | 79,636 |
|
|
|
|
|
|
|
| (in thousands) |
| |
Balance, March 31, 2021 |
| $ | 62,995 |
|
Additions |
|
| 3,866 |
|
Change in investment upon acquisition (Note 3) |
|
| (11,443 | ) |
Balance, September 30, 2021 |
| $ | 55,418 |
|
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.
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, 2021 |
|
| March 31, 2021 |
|
| June 30, 2022 |
|
| March 31, 2022 |
| ||||
|
| (in thousands) |
|
| (in thousands) |
| ||||||||||
ECP |
| $ | 10,814 |
|
| $ | 10,306 |
|
| $ | 11,651 |
|
| $ | 12,010 |
|
Breethe |
|
| 14,000 |
|
|
| 14,400 |
|
|
| 6,500 |
|
|
| 9,500 |
|
Total contingent consideration |
| $ | 24,814 |
|
| $ | 24,706 |
|
| $ | 18,151 |
|
| $ | 21,510 |
|
The following table presents supplemental balance sheet information related to contingent consideration:ECP
|
| September 30, 2021 |
|
| March 31, 2021 |
| ||
|
| (in thousands) |
| |||||
Contingent consideration in other current liabilities |
| $ | 2,500 |
|
| $ | — |
|
Contingent consideration |
|
| 22,314 |
|
|
| 24,706 |
|
Total contingent consideration |
| $ | 24,814 |
|
| $ | 24,706 |
|
ECP
In July 2014, the Company acquired ECP and AIS GmbH Aachen Innovative Solutions (“AIS”) for $13.0$13.0 million in cash, with additional potential payouts totaling $15.0$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 appliesthe application of a probability to each outcome, and a Monte-Carlo valuation model, both of which consider significant unobservable inputs. Probabilities areAs it relates to the CE Mark approval milestone, probabilities were applied to the clinical and regulatory milestones, for each potential scenario and the resulting values arewere 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 1%4.7% to 2%16.5%), the probability of achieving the various technical, regulatory and commercial milestones (estimated to range from 15% be 74%10% to 55%) and projected revenues based on a Monte-Carlo valuation (94%) 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$55.0 million in cash, with additional potential payouts up to a maximum of $55.0$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 appliesthe application of a probability to each outcome, and a Monte-Carlo valuation model, both of which consider significant unobservable inputs. ForAs it relates to the regulatory milestones, probabilities arewere applied to each potential scenario and the resulting values arewere 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.
15
Key unobservable inputs include the discount rates used to present value the projected revenues and cash flows (ranging from 1%4.7% to 2%12.6%), the probability of achieving the various technical, regulatory and commercial milestones (estimated to range from 15%10% to 75%50%) and projected revenues based on a Monte-Carlo valuation (12%) which are based on the Company’s most recent internal operational budgetsforecasts 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 sixthree months ended SeptemberJune 30, 2021:2022:
|
|
|
|
|
|
|
|
|
|
| (in thousands) |
| |
Balance, March 31, 2021 |
| $ | 24,706 |
| ||
Change in fair value |
|
| 108 |
| ||
Balance, September 30, 2021 |
| $ | 24,814 |
|
|
|
|
| |
|
| (in thousands) |
| |
Balance, March 31, 2022 | $ | 21,510 |
| |
Change in fair value |
| (3,359 | ) | |
Balance, June 30, 2022 | $ | 18,151 |
|
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.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 SeptemberJune 30, 20212022 and March 31, 2021,2022, the present value of expected payments related to the Company’s contingent consideration was $24.8$18.2 million and $24.7$21.5 million, respectively. The undiscounted value of the payments, assuming that all contingencies are met, would be $67.5$67.5 million as of Septemberboth June 30, 2021.2022 and March 31, 2022.
Note 7. Inventories, net
The components of inventories, net are as follows:
|
| September 30, 2021 |
|
| March 31, 2021 |
|
| June 30, 2022 |
|
| March 31, 2022 |
| ||||
|
| (in thousands) |
|
| (in thousands) |
| ||||||||||
Raw materials and supplies |
| $ | 26,082 |
|
| $ | 27,782 |
|
| $ | 30,970 |
|
| $ | 28,326 |
|
Work-in-progress |
|
| 36,025 |
|
|
| 35,187 |
|
|
| 38,707 |
|
|
| 34,788 |
|
Finished goods |
|
| 23,879 |
|
|
| 18,090 |
|
|
| 25,696 |
|
|
| 30,867 |
|
Inventories, net |
| $ | 85,986 |
|
| $ | 81,059 |
|
| $ | 95,373 |
|
| $ | 93,981 |
|
The Company’s inventories relate to its Impella® 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:
|
| June 30, 2022 |
|
| March 31, 2022 |
| ||
|
| (in thousands) |
| |||||
Land |
| $ | 10,391 |
|
| $ | 10,643 |
|
Building and building improvements |
|
| 153,191 |
|
|
| 152,374 |
|
Leasehold improvements |
|
| 1,787 |
|
|
| 1,810 |
|
Machinery, equipment and computer software |
|
| 104,845 |
|
|
| 104,407 |
|
Furniture and fixtures |
|
| 15,443 |
|
|
| 15,420 |
|
Construction in progress |
|
| 18,862 |
|
|
| 19,898 |
|
Total cost |
|
| 304,519 |
|
|
| 304,552 |
|
Less accumulated depreciation |
|
| (106,041 | ) |
|
| (102,062 | ) |
Property and equipment, net |
| $ | 198,478 |
|
| $ | 202,490 |
|
Depreciation expense related to property and equipment was $6.1 million and $6.4 million for the three months ended June 30, 2022 and 2021, respectively.
16
|
| September 30, 2021 |
|
| March 31, 2021 |
| ||
|
| (in thousands) |
| |||||
Land |
| $ | 10,822 |
|
| $ | 10,875 |
|
Building and building improvements |
|
| 151,395 |
|
|
| 148,870 |
|
Leasehold improvements |
|
| 1,393 |
|
|
| 439 |
|
Machinery, equipment and computer software |
|
| 96,822 |
|
|
| 91,784 |
|
Furniture and fixtures |
|
| 15,955 |
|
|
| 15,608 |
|
Construction in progress |
|
| 14,023 |
|
|
| 10,906 |
|
Total cost |
|
| 290,410 |
|
|
| 278,482 |
|
Accumulated depreciation |
|
| (93,226 | ) |
|
| (81,353 | ) |
Property and equipment, net |
| $ | 197,184 |
|
| $ | 197,129 |
|
Note 9. Goodwill and Other Intangible Assets, net
Goodwill
The carrying amount of goodwill as of SeptemberJune 30, 20212022 and March 31, 20212022 was $78.2$74.9 million and $78.6$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 sixthree months ended SeptemberJune 30, 20212022 are as follows:
|
| (in thousands) |
| |
Balance, March 31, 2022 |
| $ | 76,786 |
|
Foreign currency translation |
|
| (1,931 | ) |
Balance, June 30, 2022 |
| $ | 74,855 |
|
|
| (in thousands) |
| |
Balance, March 31, 2021 |
| $ | 78,568 |
|
Foreign currency translation impact |
|
| (402 | ) |
Balance, September 30, 2021 |
| $ | 78,166 |
|
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 0 accumulated impairment losses on goodwill.
Other Intangible Assets, net
Other intangible assets, net consists of the following:
|
|
|
|
|
|
|
|
|
| September 30, 2021 |
|
| March 31, 2021 |
|
| June 30, 2022 |
| |||||||||||||||||||||
|
| Weighted Average Useful Life (in years) |
|
| Cost |
|
| Accumulated Amortization |
|
| Net Carrying Value |
|
| Accumulated Amortization |
|
| Net Carrying Value |
|
| Weighted Average Amortization Period |
| Cost |
|
| Accumulated Amortization |
|
| Net Carrying Value |
| |||||||||
|
|
|
|
|
| (in thousands) |
|
|
| (in thousands) |
| |||||||||||||||||||||||||||
Finite-lived intangible assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
Developed technology |
|
| 14.1 |
|
| $ | 27,000 |
|
| $ | (1,650 | ) |
| $ | 25,350 |
|
|
| (750 | ) |
| $ | 26,250 |
|
| 13.4 |
| $ | 27,000 |
|
| $ | (3,000 | ) |
| $ | 24,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||
Indefinite-lived intangible assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||
In-process research and development |
|
|
|
|
|
| 15,712 |
|
|
| — |
|
|
| 15,712 |
|
|
| — |
|
|
| 15,900 |
|
|
|
| 14,168 |
|
|
| — |
|
|
| 14,168 |
| |
Total |
|
|
|
|
| $ | 42,712 |
|
| $ | (1,650 | ) |
| $ | 41,062 |
|
|
| (750 | ) |
| $ | 42,150 |
|
|
| $ | 41,168 |
|
| $ | (3,000 | ) |
| $ | 38,168 |
|
|
| March 31, 2022 |
| |||||||||||
|
| Weighted Average Amortization Period |
| 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. The estimated fair value of developed technology was determined using a probability-weighted income approach, which discounts expected future cash flows to present value. The projected cash flow estimates for the Breethe OXY-1 System were based on certain key assumptions, including estimates of future revenue and expenses, the stage of development of the technology at the acquisition date and the time and resources needed to complete development. 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 0 accumulated impairment losses on other intangible assets. The change in the indefinite-lived intangible assetsIPR&D balance for the sixthree months ended SeptemberJune 30, 2021, was2022, related to the impact of foreign currency translation.
17
Note 10. Other Assets
The components of other assets are as follows:
|
| September 30, 2021 |
|
| March 31, 2021 |
|
| June 30, 2022 |
|
| March 31, 2022 |
| ||||
|
| (in thousands) |
|
| (in thousands) |
| ||||||||||
Investment in Shockwave Medical |
| $ | 61,096 |
|
| $ | 38,655 |
|
| $ | 56,730 |
|
| $ | 61,535 |
|
Other investments (Note 6) |
|
| 55,418 |
|
|
| 62,995 |
|
|
| 79,636 |
|
|
| 70,314 |
|
Operating lease right of use asset (Note 11) |
|
| 5,099 |
|
|
| 6,109 |
| ||||||||
Operating lease right of use assets |
|
| 8,365 |
|
|
| 9,518 |
| ||||||||
Other intangible assets and other assets |
|
| 6,568 |
|
|
| 5,323 |
|
|
| 10,073 |
|
|
| 6,118 |
|
Total other assets |
| $ | 128,181 |
|
| $ | 113,082 |
|
| $ | 154,804 |
|
| $ | 147,485 |
|
Investment in Shockwave Medical
The fair value of the Company’s investment in Shockwave Medical, a publicly-traded medical device company, was $56.7 million and $61.5 million as of June 30, 2022 and March 31, 2022, respectively. During the three months ended SeptemberJune 30, 20212022 and 2020,2021, the Company recorded gainsa loss of $4.8$4.8 million and $10.8a gain of $17.6 million, respectively in interest and other income. During the six months ended September 30, 2021income, net.
Operating Lease Right of Use Assets
The Company has lease agreements for real estate including corporate offices and 2020, the Company recorded gainswarehouse space, vehicles and certain equipment. The balance of $22.4operating lease right-of-use assets included in other assets was $8.4 million and $34.7$9.5 million respectively in other income. During the six months ended Septemberas of June 30, 2020, the Company sold approximately 1.4 million of its shares in Shockwave Medical for cash proceeds of $67.9 million2022 and recognized a gain of $47.3 million. March 31, 2022, respectively
Other IntangibleLong-Term Assets and Other Assets
The Company’s other intangible assets and otherlong-term assets is comprised primarily of license manufacturing rights to certain technology from third parties and other long-term assets such as from third parties and other long-term assets such as prepayments related to the Company’s clinical trial activities.
Note 11. Leases
Lessee
The following table presents supplemental balance sheet information related to the Company’s operating leases:
|
| September 30, 2021 |
|
| March 31, 2021 |
| ||
|
| (in thousands) |
| |||||
Assets |
|
|
|
|
|
|
|
|
Operating lease right-of-use assets in other assets |
| $ | 5,099 |
|
| $ | 6,109 |
|
Liabilities |
|
|
|
|
|
|
|
|
Operating lease liabilities in other current liabilities |
|
| 1,785 |
|
|
| 2,459 |
|
Operating lease liabilities in other long-term liabilities |
|
| 3,302 |
|
|
| 3,657 |
|
Total operating lease liabilities |
| $ | 5,087 |
|
| $ | 6,116 |
|
Expense charged to operations under operating leases was $4.0 million and $5.7 million for the three and six months ended September 30, 2021, respectively.Expense charged to operations under operating leases was $1.1 million and $2.2 million for the three and six months ended September 30, 2020, respectively.
Future minimum lease payments under non-cancelable operating leases as of September 30, 2021 are as follows:
(in thousands, except lease term and discount rate) |
| |||
|
|
|
|
|
Fiscal Years Ending March 31, |
|
|
|
|
2022 (excluding the 6 months ended September 30, 2021) |
| $ | 1,043 |
|
2023 |
|
| 1,638 |
|
2024 |
|
| 1,397 |
|
2025 |
|
| 653 |
|
2026 |
|
| 75 |
|
Thereafter |
|
| 575 |
|
Total future minimum lease payments |
|
| 5,381 |
|
Less: present value adjustment |
|
| (294 | ) |
Total operating lease liabilities |
|
| 5,087 |
|
Less: operating lease liabilities in other current liabilities |
|
| (1,785 | ) |
Operating lease liabilities in other long-term liabilities |
| $ | 3,302 |
|
|
|
|
|
|
Weighted average remaining lease term |
| 4.55 |
| |
|
|
|
|
|
Weighted average discount rate |
|
| 2.32 | % |
Lessor
In March 2021, as part of the $17.5 million purchase of a building located in Danvers, Massachusetts, we assumed existing leases with third parties for a portion of the building which are classified as operating leases. The leases have annual escalating payments and the latest expires in March 2025 in accordance with the terms and conditions of the existing agreement. For the six months ended September 30, 2021, operating lease income was not material.
Note 12.11. Accrued Expenses
Accrued expenses consist of the following:
|
| September 30, 2021 |
|
| March 31, 2021 |
|
| June 30, 2022 |
|
| March 31, 2022 |
| ||||
|
| (in thousands) |
|
| (in thousands) |
| ||||||||||
Employee compensation |
| $ | 35,880 |
|
| $ | 40,954 |
|
| $ | 42,665 |
|
| $ | 50,649 |
|
Sales and income taxes |
|
| 14,555 |
|
|
| 1,931 |
| ||||||||
Research and development |
|
| 9,193 |
|
|
| 6,983 |
|
|
| 8,486 |
|
|
| 7,337 |
|
Professional, legal, and accounting fees |
|
| 2,426 |
|
|
| 1,957 |
| ||||||||
Marketing |
|
| 2,231 |
|
|
| 2,289 |
| ||||||||
Warranty |
|
| 1,941 |
|
|
| 2,053 |
|
|
| 1,912 |
|
|
| 1,935 |
|
Marketing |
|
| 1,660 |
|
|
| 3,674 |
| ||||||||
Sales and income taxes |
|
| 839 |
|
|
| 5,914 |
| ||||||||
Professional, legal and accounting fees |
|
| 1,656 |
|
|
| 1,479 |
| ||||||||
Other |
|
| 4,805 |
|
|
| 4,511 |
|
|
| 7,506 |
|
|
| 7,009 |
|
|
| $ | 56,744 |
|
| $ | 66,046 |
|
| $ | 79,011 |
|
| $ | 72,629 |
|
The accrual for employeeEmployee compensation consists primarily of accrued bonuses, accrued commissions and accrued employee benefitsbenefits. Other includes returns reserve, allowance for rebates and payroll taxes at September 30, 2021discounts and March 31, 2021.other miscellaneous accrued expenses.
Note 13.12. Stockholders’ Equity
Class B Preferred Stock
The Company has authorized 1,000,000 shares of Class B Preferred Stock, $.01$.01 par value, of which the board of directors can set the designation, rights and privileges. NaN 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$200.0 million of shares of its common stock. Under this stock repurchase program, 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
18
trading plans and under Rule 10b-18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). The stock repurchase program has no time limit and may be suspended for periods or discontinued at any time. The Company is funding the stock repurchase program with its available cash and marketable securities. The remaining authorization under the stock repurchase program was $103.8$89.3 million as of SeptemberJune 30, 2021.2022.
The Company did not buy shares through the stock repurchase program during either of the three or six months ended September 30, 2021. The following table provides shares bought through the stock repurchase programactivities during the three and six months ended September 30, 2020:quarter:
|
| For the Three Months Ended September 30, |
|
| For the Six Months Ended September 30, |
|
| For the Three Months Ended June 30, |
| |||||||
|
| 2020 |
|
| 2020 |
|
| 2022 |
|
| 2021 |
| ||||
Shares repurchased |
|
| — |
|
|
| 67,649 |
|
|
| 60,282 |
|
|
| 0 |
|
Average price per share |
|
| — |
|
| $ | 167.19 |
|
| $ | 240.79 |
|
|
| 0 |
|
Value of shares repurchased (in millions) |
|
| — |
|
| $ | 11.3 |
|
| $ | 14.5 |
|
|
| 0 |
|
Accumulated Other Comprehensive Loss
The components of accumulated other comprehensive loss are as follows (in thousands):
|
| Three and Six Months Ended September 30, 2021 |
| |||||||||||||
|
| Foreign Currency Translation Adjustments |
|
| Unrealized Gains (Losses) on Investments |
|
| Gains (Losses) on Derivative Instruments |
|
| Total |
| ||||
Balance, March 31, 2021 |
| $ | (14,718 | ) |
| $ | 1,369 |
|
| $ | 1,904 |
|
| $ | (11,445 | ) |
Other comprehensive income (loss) |
|
| 83 |
|
|
| (217 | ) |
|
| (632 | ) |
|
| (766 | ) |
Balance, June 30, 2021 |
|
| (14,635 | ) |
|
| 1,152 |
|
|
| 1,272 |
|
|
| (12,211 | ) |
Other comprehensive income (loss) |
|
| (2,693 | ) |
|
| 545 |
|
|
| (197 | ) |
|
| (2,345 | ) |
Balance, September 30, 2021 |
| $ | (17,328 | ) |
| $ | 1,697 |
|
| $ | 1,075 |
|
| $ | (14,556 | ) |
|
| Three Months Ended June 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 | ) |
|
| Three Months Ended June 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 | ) |
|
| Three and Six Months Ended September 30, 2020 |
| |||||||||||||
|
| Foreign Currency Translation Adjustments |
|
| Unrealized Gains (Losses) on Investments |
|
| Gains (Losses) on Derivative Instruments |
|
| Total |
| ||||
Balance, March 31, 2020 |
| $ | (16,860 | ) |
| $ | 1,672 |
|
| $ | 3,999 |
|
| $ | (11,189 | ) |
Other comprehensive income (loss) |
|
| 1,360 |
|
|
| 1,755 |
|
|
| (461 | ) |
|
| 2,654 |
|
Balance, June 30, 2020 |
|
| (15,500 | ) |
|
| 3,427 |
|
|
| 3,538 |
|
|
| (8,535 | ) |
Other comprehensive income (loss) |
|
| 2,416 |
|
|
| (814 | ) |
|
| (266 | ) |
|
| 1,336 |
|
Balance, September 30, 2020 |
| $ | (13,084 | ) |
| $ | 2,613 |
|
| $ | 3,272 |
|
| $ | (7,199 | ) |
Note 14.13. Stock-Based Compensation
The following table summarizes stock-based compensation expense by financial statement line item in the Company’s condensed consolidated statements of operationoperations for each of the three and six months ended SeptemberJune 30, 20212022 and 2020:2021:
|
| For the Three Months Ended September 30, |
|
| For the Six Months Ended September 30, |
|
| For the Three Months Ended June 30, |
| |||||||||||||||
|
|
| 2021 |
|
|
| 2020 |
|
|
| 2021 |
|
|
| 2020 |
|
| 2022 |
|
| 2021 |
| ||
|
| (in thousands) |
|
| (in thousands) |
| ||||||||||||||||||
Cost of revenue |
| $ | 1,300 |
|
| $ | 923 |
|
| $ | 2,330 |
|
| $ | 1,627 |
|
| $ | 1,396 |
|
| $ | 1,030 |
|
Research and development |
|
| 2,294 |
|
|
| 1,705 |
|
|
| 4,403 |
|
|
| 3,147 |
|
|
| 2,798 |
|
|
| 2,109 |
|
Selling, general and administrative |
|
| 12,155 |
|
|
| 8,937 |
|
|
| 21,624 |
|
|
| 16,089 |
|
|
| 9,168 |
|
|
| 9,469 |
|
|
| $ | 15,749 |
|
| $ | 11,565 |
|
| $ | 28,357 |
|
| $ | 20,863 |
|
| $ | 13,362 |
|
| $ | 12,608 |
|
19
Stock Options
The following table summarizes the stock option activity for the sixthree months ended SeptemberJune 30, 2021:2022:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||||
|
|
|
|
|
|
|
|
|
| Weighted |
|
|
|
|
|
|
|
|
|
|
|
| Weighted |
|
|
| ||||||
|
|
|
|
|
| Weighted |
|
| Average |
|
| Aggregate |
|
|
|
|
| Weighted |
| Average |
| Aggregate |
| |||||||||
|
|
|
|
|
| Average |
|
| Remaining |
|
| Intrinsic |
|
|
|
|
| Average |
| Remaining |
| Intrinsic |
| |||||||||
|
| Options |
|
| Exercise |
|
| Contractual |
|
| Value |
|
| Options |
| Exercise |
| Contractual |
| Value |
| |||||||||||
|
| (in thousands) |
|
| Price |
|
| Term (years) |
|
| (in thousands) |
|
| (in thousands) |
|
| Price |
|
| Term (years) |
|
| (in thousands) |
| ||||||||
Outstanding at beginning of period |
|
| 711 |
|
| $ | 141.87 |
|
| 5.46 |
|
|
|
|
|
|
| 595 |
|
| $ | 178.54 |
|
|
| 5.55 |
|
|
|
| ||
Granted |
|
| 62 |
|
|
| 286.76 |
|
|
|
|
|
|
|
|
|
|
| 2 |
|
|
| 275.58 |
|
|
|
|
|
|
| ||
Exercised |
|
| (152 | ) |
|
| 55.26 |
|
|
|
|
|
|
|
|
|
|
| (18 | ) |
|
| 84.37 |
|
|
|
|
|
|
| ||
Cancelled and expired |
|
| (9 | ) |
|
| 283.42 |
|
|
|
|
|
|
|
|
|
|
| (1 | ) |
|
| 284.46 |
|
|
|
|
|
|
| ||
Outstanding at end of period |
|
| 612 |
|
| $ | 175.86 |
|
|
| 5.90 |
|
|
| 95,180 |
|
|
| 578 |
|
| $ | 181.61 |
|
|
| 5.37 |
|
| $ | 50,807 |
|
Exercisable at end of period |
|
| 466 |
|
| $ | 149.39 |
|
| 4.98 |
|
|
| 85,599 |
|
|
| 503 |
|
| $ | 168.81 |
|
|
| 4.89 |
|
| $ | 50,099 |
| |
Options vested and expected to vest at end of period |
|
| 612 |
|
| $ | 175.86 |
|
|
| 5.90 |
|
|
| 95,180 |
|
|
| 578 |
|
| $ | 181.61 |
|
|
| 5.37 |
|
| $ | 50,807 |
|
Stock options generally vest and become exercisable annually over three years.years. The remaining unrecognized stock-based compensation expense for unvested stock option awards as of SeptemberJune 30, 2021,2022, was approximately $10.9$6.5 million and the estimated weighted-average period over which this cost is expected to be recognized is 2.01.8 years.
The aggregate intrinsic value of stock options exercised was $42.8$3.7 million for the sixthree months ended SeptemberJune 30, 2021.2022. The total cash received as a result of employee stock option exercises for the sixthree months ended SeptemberJune 30, 2021,2022, was approximately $8.4$1.5 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 waswere as follows:
|
| For the Three Months Ended June 30, |
| |||||
|
| 2022 |
|
| 2021 |
| ||
Weighted average grant-date fair value |
| $ | 121.69 |
|
| $ | 103.03 |
|
|
|
|
|
|
|
| ||
Valuation assumptions: |
|
|
|
|
|
| ||
Risk-free interest rate |
|
| 3.01 | % |
|
| 0.79 | % |
Expected option life (years) |
|
| 5.54 |
|
|
| 4.20 |
|
Expected volatility |
|
| 43.51 | % |
|
| 44.28 | % |
|
| For the Three Months Ended September 30, |
|
| For the Six Months Ended September 30, |
| ||||||||||
|
|
| 2021 |
|
|
| 2020 |
|
|
| 2021 |
|
|
| 2020 |
|
Weighted average grant-date fair value |
| $ | 115.99 |
|
| $ | 100.51 |
|
| $ | 103.48 |
|
| $ | 76.10 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Valuation assumptions: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Risk-free interest rate |
|
| 0.77 | % |
|
| 0.30 | % |
|
| 0.79 | % |
|
| 0.31 | % |
Expected option life (years) |
|
| 4.14 |
|
|
| 4.17 |
|
|
| 4.20 |
|
|
| 4.22 |
|
Expected volatility |
|
| 44.72 | % |
|
| 43.50 | % |
|
| 44.30 | % |
|
| 42.82 | % |
Restricted Stock Units
The following table summarizes activity of restricted stock units for the sixthree months ended SeptemberJune 30, 2021:2022:
|
|
|
|
|
| Weighted |
|
|
|
| Weighted |
| ||||
|
|
|
|
|
| Average |
|
|
|
| Average |
| ||||
|
| Number of |
|
| Grant Date |
|
| Number of |
| Grant Date |
| |||||
|
| Shares |
|
| Fair Value |
|
| Shares |
| Fair Value |
| |||||
|
| (in thousands) |
|
| (per share) |
|
| (in thousands) |
|
| (per share) |
| ||||
Restricted stock units at beginning of period |
|
| 301 |
|
| $ | 273.57 |
|
|
| 307 |
|
| $ | 274.32 |
|
Granted |
|
| 156 |
|
|
| 288.64 |
| ||||||||
Granted (1) |
|
| 258 |
|
|
| 266.07 |
| ||||||||
Vested |
|
| (103 | ) |
|
| 304.20 |
|
|
| (106 | ) |
|
| 282.80 |
|
Forfeited |
|
| (19 | ) |
|
| 270.35 |
|
|
| (3 | ) |
|
| 272.26 |
|
Restricted stock units at end of period |
|
| 335 |
|
| $ | 271.32 |
|
|
| 456 |
|
| $ | 267.00 |
|
(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 three months ended June 30, 2022 was $266.1. The total fair value of restricted stock units vested during the three months ended June 30, 2022 was $29.9 million.
Restricted stock units generally vest annually, over three years.years. The remaining unrecognized compensation expense for outstanding restricted stock units, including performanceperformance-based and market-based awards, as of SeptemberJune 30, 20212022 was $70.6$100.1 million and the estimated weighted-average period over which this cost is expected to be recognized is 2.1 2.4 years.
The weighted average grant-date fair value for restricted stock units granted during the six months ended September 30, 2021 was $288.64. The total fair value of restricted stock units vested during the six months ended September 30, 2021 was $31.4 million.20
Performance-Based Awards
The Company grants performance-based restricted stock units to certain executive officers and employees, which vest upon achievement of prescribed service milestones by the award recipients and the achievement of prescribed performance milestones by the Company.As of SeptemberJune 30, 2021,2022, 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 June 30, 2022 was $33.7 million and the weighted-average period over which this cost is expected to be recognized is 2.2 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 TSRtotal shareholder return (“TSR”) goals by the Company and the achievement of prescribed performance milestones by the Company, as defined in the respective agreements.
The relative total shareholder return (“TSR”) is based on the Company’s common stock in relation to the TSR of 20 peer companies over a defined period, based on a comparison of average closing stock prices during the 20 trading days prior to the first day of the performance period, reinstated dividends during each performance period and the average closing stock prices during the final 20 trading days of each performance period. The actual number of market-based restricted stock units that may be earned can range from 0% to 200% of the target number of shares. The payout percentage may be further adjusted based on the Company’s performance relative to the constituents of the S&P 500 Index on the first day of the performance period that are still actively trading on the last day of each performance period, as defined in the respective agreements.
The Company used a Monte-Carlo simulation model to estimate the grant-date fair value of the market-basedTSR restricted stock units. The fair value related to these awards areis recorded as compensation expense over the period from date of grant, based on the probable outcomes related to the prescribed performance targets on the outstanding awards,vesting term, regardless of the actual TSR outcome reached.
The table below sets forth the assumptions used to value the awardsoutstanding market-based restricted stock units and the estimated grant-date fair value:
|
| May 2021 |
|
| May 2020 |
|
| May 2021 |
|
| May 2020 |
| ||||
Risk-free interest rate |
|
| 0.3 | % |
|
| 0.2 | % |
|
| 0.3 | % |
|
| 0.2 | % |
Expected volatility |
|
| 44.8 | % |
|
| 35.5 | % |
|
| 44.8 | % |
|
| 35.5 | % |
Dividend yield |
|
| — |
|
|
| — |
|
|
| — |
|
|
| — |
|
Remaining performance period (years) |
|
| 2.8 |
|
| 1.9 - 2.9 |
|
| 2.8 |
|
| 2.9 |
| |||
Estimated fair value per share |
| $ | 292.40 |
|
| $347.05 - $349.28 |
|
| $ | 292.40 |
|
| $ | 349.28 |
| |
Target performance (number of shares) |
|
| 25,172 |
|
|
| 30,881 |
|
|
| 25,172 |
|
|
| 15,425 |
|
Note 15.14. Income Taxes
The Company’s income tax provision was $10.3$15.3 million and $10.7$17.2 million for the three months ended SeptemberJune 30, 20212022 and 2020, respectively. The Company’s income tax provision was $27.5 million and $27.2 million for the six months ended September 30, 2021, and 2020, respectively. The Company’s effective tax rate was 15.3%21.9% and 14.7%183.7% for the three months ended SeptemberJune 30, 20212022 and 2020, respectively. The Company’s effective tax rate was 47.5% and 20.3% for the six months ended September 30, 2021, and 2020, respectively. The effective tax rate differs from the statutory federal income tax rate of 21%21.0% primarily due to state and foreign income taxes and permanent differences offset by credits and excess tax benefits for the three months ended SeptemberJune 30, 20212022 and 2020 primarily due to the recognition of excess tax benefits associated with stock-based awards of $6.2 million and $7.9 million as an income tax benefit for the three months ended September 30, 2021 and 2020, respectively. The effective tax rate differs from the statutory federal income tax rate of 21% for the six months ended September 30, 2021 and 2020 primarily due to a non-deductible charge for in-process research and development related to the preCARDIA acquisition offset by excess tax benefits related to share-based compensation.compensation for the three months ended June 30, 2021. The Company recognized excess tax benefits associated with stock-based awards of $9.8$1.0 million and $8.5$3.6 million for the sixthree months ended SeptemberJune 30, 2022 and 2021, and 2020, respectively.
The Company is subject to the examination of its income tax returns by the Internal Revenue Service (“IRS”) 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 20122016 through 2015.2019. These tax audits did not materially impact the Company’s financial statements. The Company is currently undergoing an income tax audit by the German tax authorities on Abiomed Europe GMBH and ECP for fiscal years 2016 through 2019. All other tax years remain subject to examination by the federal,IRS, state and foreign tax authorities.
Note 16. Commitments15. 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.
21
Maquet Matters
In December 2015, theThe Company received a letter fromhas been litigating certain patents owned by Maquet Cardiovascular LLC (“Maquet”), a subsidiary of Getinge AB, asserting that the Company’s Impella® devices infringe certain claims with guidewire, lumen, rotor, purge and sensor features, which were in two Maquet patents and oneseparate cases pending patent application (which has since issued as a third patent) in the U.S. and elsewhere, and attaching a draft litigation complaint. The letter encouraged the Company to take a license from Maquet. In May 2016, the Company filed suit in U.S. District Court for the District of Massachusetts (“D. Mass.”Mass” or “the Court”) against Maquet, seekingsince 2016.
In May 2016, the Company filed a declaratory judgment action (the “2016 Action”) alleging that the Company’s Impella devices doit does not infringe Maquet’s cited patent rights.
In August 2016, Maquet sent a letterpatent. Following the claim construction (“Markman”) order issued in November 2018, and prior to the Company identifying four new Maquet U.S. continuation patent filings with claims that Maquet alleges are infringed by the Company’s Impella devices. The four U.S. continuation applications have been issued as patentsclose of Maquet but expired on September 1, 2020.
In September 2016, Maquetdiscovery, both parties filed a response to the Company’s suit in D. Mass., including various counterclaims alleging that the Company’s Impella 2.5®, Impella CP®, Impella 5.0®, and Impella RP® heart pumps infringe certain claimsseries of the three original issued U.S. patents (“2016 Action”). In July 2017, the Court granted a motion to add three of the four additional continuation patents to the 2016 Action. In April 2018, the Court conducted a Markman hearing on claim interpretation. On September 7, 2018, the judge issued a Memorandum and Order on Claim Construction, where he interpreted the disputed claim terms in the case. Maquet then filed a motion for reconsideration of the Court’s construction of one of the disputed claim terms. The motion was denied on May 22, 2019. As a result of the Court’s denial, only one of the six originally asserted patents is in dispute. The Company filed a motion for summary judgement (the “MSJ”) for the remaining patent on September 18, 2019 (non-infringement) and April 13, 2020 (invalidity). The parties argued the MSJ for non-infringement on November 19, 2019 and the MSJ for invalidity on August 20, 2020.
motions. On September 30, 2021, the Court granted the Company’s MSJMotion for Summary Judgement (“MSJ”) for non-infringement of the assertedtwo claims remaining in the remaining patent which expired on September 1, 2020. On October 20, 2021,this case. Maquet filed a motionmoved for reconsideration of the Order in favor ofMSJ order, which the Company.Court denied on November 30, 2021. The Company intends to file a response to Maquet’s motion in due time. Because the Court has not yet issuedentered a final judgement,judgement; therefore, the case is not yet appealable to the Federal Circuit.
In November 2017, Maquet filed a secondnew action in D. Mass (the “2017 Action”) alleging that the Company’s Impella 2.5®2.5®, Impella CP®CP®, and Impella 5.0®5.0® heart pumps infringe certain claims of another patent in the fourth additional U.S. continuation patent mentioned abovesame family (the seventh patent overall)overall between both cases). DiscoveryThe Parties submitted Markman briefs and argued their respective positions in the 2017 Action is ongoing.
In a series of letters during January and February 2019, Maquet informed the Company of seven new patent applications filed from the patents in the 2016 Action and 2017 Action with claims Maquet alleges would be infringed by the Impella® products if the new applications were to issue as patents. One of the newly issued patents has been added to the 2017 Action. A Markman hearing for the newly-added patent was held on November 18, 2019. A Markman order has not beenyet issued, yet. and discovery remains ongoing.
The asserted patentpatents in this caseboth cases expired on September 1, 2020. Discovery remains ongoing.
In the 2016 Action and 2017 Action, Maquet seeks injunctive relief and monetary damages in the form of a reasonable royalty, with three times the amount for alleged willful infringement. In its responses to the Company’s counterclaims, Maquet admits that its current commercially available products do not embody the claims of the asserted patents.
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
Thoratec MattersSegment Information
Thoratec Corporation (“Thoratec”), a subsidiaryOperating segments are components of Abbott Laboratories (“Abbott”), has challenged a number of Company-owned patents in Europe in connection with the launch of Thoratec’s HeartMate PHP™ medical device (“PHP”) in European enterprise for which separate financial information is available and the Company has counterclaimed for infringement in the District Court, or the Court of 1st Instance, in Düsseldorf. The litigation was stayed pending the Federal Court of Justice, the Court of 3rd and Last Instance in Germany for patent infringement cases, ruling on the validity and scope of the litigated patents. In September 2019, the Federal Court of Justice in Germany upheld the Company’s patents that are the subject of the patent infringement action for the sales and marketing of Thoratec’s PHP pump in Germany. Subsequently, the Court of 1st Instance in Düsseldorf lifted the stay, re-opened the litigation proceedings, and ruled in favor of the Company. The Court of 1st Instance acknowledged that Thoratec’s PHP product infringes two of the Company’s patents related to the key features of Impella® intravascular pump and future expandable heart pump, known as Impella ECP®. Abbott appealed and the oral hearing was held on August 26, 2021.
On September 23, 2021, the Appellate Court (the “Court of 2nd Instance”) in Düsseldorf upheld the rulingis evaluated regularly by the Court of 1st Instance in both cases and did not allow an appeal to the Federal Court of Justice. Thoratec has until the end of October 2021 to appeal the Court of 2nd Instance’s order denying appeal in both cases to the Federal Court of Justice. If Thoratec forgoes the appeal or the case is not heard by Federal Court of Justice, then the verdict will be deemed final and enforceable. The judgement will remain provisionally enforceable until the final resolution, which means that the Company is able to seek a court ordered injunction preventing the sale and marketing by Thoratec of PHP, should Thoratec attempt to launch HeartMate PHP in Germany.
These actions relate solely to Thoratec’s ability to manufacture and sell its PHP product in Europe and have no impact on the Company's ability to manufacture or sell its Impella® line of medical devices. The actions do not expose the Company to liability risk, except under local German law, which requires a losing party in a proceeding to pay a portion of the other party’s legal fees.
Securities Class Action Litigation
On or about August 6, 2019, the Company received a securities class action complaint filed on behalf of a single shareholder in the U.S. District Court for the Southern District of New York (“SDNY”), on behalf of himself and persons or entities that purchased or acquired the Company’s securities between January 31, 2019 through July 31, 2019. On October 7, 2019, a similar purported class action complaint was filed by a different shareholder on behalf of himself and persons or entities that purchased or acquired the Company’s securities between November 1, 2018 and July 31, 2019. Also, on October 7, 2019, four shareholders filed applications to be appointed lead plaintiff and for their counsel to be appointed lead counsel for the class. Two of those shareholders also filed motions to consolidate the two cases and two of the shareholders have withdrawn their applications to be lead plaintiff.
The complaints alleged that the Company violated Sections 10(b) and 20(a) of and Rule 10b-5 under the Exchange Act, in connection with allegedly misleading disclosures made by the Company regarding its financial condition and results of operations.
On June 29, 2020, SDNY issued an order consolidating the two cases and appointed Local 705 International Brotherhood of Teamsters Pension Fund as the lead plaintiff and Labaton Sucharow LLP as lead counsel. On September 17, 2020, the lead plaintiff filed an amended complaint in which it proposed a new class period of May 3, 2018 to July 31, 2019. As prescribed by a scheduling order, the Company filed a motion to dismiss on November 16, 2020. On September 21, 2021, SDNY granted the Company’s motion, dismissed the amended complaint, and gave the lead plaintiff leave to move to amend the complaint by October 12, 2021. On October 12, 2021, the Company and the lead plaintiff entered into a stipulation to voluntarily dismiss the securities class action and SDNY ordered dismissal of the case with prejudice on the same day. Under the terms of the stipulation, the lead plaintiff has agreed not to move for leave to amend the complaint and not to appeal the dismissal of the action.
Shareholder Derivative Litigation
On November 6 and 7, 2019, two shareholders filed derivative actions in SDNY that were subsequently consolidated. On November 8, 2019, another shareholder filed a derivative action in Massachusetts Suffolk County Superior Court. On January 7, 2020, another shareholder derivative action was filed in the U.S. District Court for the District of Delaware. The complaints in these actions rely on many of the same allegations as in the securities class actions, and assert that, between November 1, 2018 and July 31, 2019, the directors of the Company made or allowed to be made misleading public statements regarding the Company’s growth, ultimately harming the Company.
The Company has agreed with the plaintiffs in all three actions to stay the cases pending resolution of a motion to dismiss in the securities class actions. As a result of the stay, the Delaware action has been administratively closed.
Litigation Demand
On March 3, 2020, a shareholder sent a letter to the Board of Directors asserting that the directors of the Company made or allowed to be made misleading public statements regarding the Company’s growth. The letter relies on many of the same allegations as the securities class actions and derivative actions, and demands that the Board (i) undertake an independent investigation of the directors, (ii) bring suit against the directors on behalf of the Company, and (iii) take a number of additional affirmative actions to redress the purported wrongs. On March 30, 2020, the Company, after discussions with the Board of Directors, sent a written response to the shareholder’s counsel which they responded to on June 1, 2020. The Company then sent a further response to the shareholder’s counsel on June 15, 2020, affirming the decision to defer consideration of the litigation demand pending further developments in the securities class action suit. Following the filing of the amended complaint in the securities class action, described above, the same shareholder renewed their demand on September 29, 2020. The Company responded on October 9, 2020 and once again affirmed that it will defer consideration of the demand pending further substantive developments in the securities class action suit.
On November 5, 2020, a second shareholder sent a letter to the Board of Directors that made essentially the same demands as the September 29, 2020 letter from the first shareholder. The Company responded on November 23, 2020, noting that it will defer consideration of the demand pending further substantive developments in the securities class action suit.
The Company is unable to estimate the potential liability with respect to the various legal matters noted above. There are numerous factors that make it difficult to estimate reasonably 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 shareholder derivative litigations.
Note 17. Segment and Enterprise Wide Disclosures
The Company operates in 1 business segment: the research, development and sale of medical devices to assist or replace the pumping function of the failing heart. The Company’s chief operating decision makerdecision-maker (“CODM”) in deciding how to allocate resources and in assessing performance. The Company’s CODM (determined to be the Chief Executive Officer) does not manage any part ofreviews the Company separately,business, makes investment and theresource allocation of resourcesdecisions, and assessment ofassesses operating performance are based on the Company’s consolidated operating results. Rest of world sales (meaning salesThe Company operates as 1 reportable segment.
Geographic Information
Sales outside the U.S., primarily in Europe and Japan) accounted for 19% and 18%18% of total revenue for each of the three months ended SeptemberJune 30, 20212022 and 2020, respectively. Rest2021.
Geographic information about long-lived assets, net excluding goodwill and other intangible assets is as follows:
|
| June 30, 2022 |
|
| March 31, 2022 |
| ||
|
| (in thousands) |
| |||||
United States |
| $ | 146,573 |
|
| $ | 147,403 |
|
Europe |
|
| 55,832 |
|
|
| 59,368 |
|
Japan |
|
| 4,438 |
|
|
| 5,237 |
|
Total |
| $ | 206,843 |
|
| $ | 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 world sales (meaning sales outsideparticipating employees on the U.S., primarilybasis of percentages specified in Europeeach plan. Total expense related to the Company's matching contributions to the plans was $1.4 million and Japan) accounted$1.2 million for 19% and 18% of total revenue for each of the sixthree months ended SeptemberJune 30, 2022 and 2021, and 2020, respectively. The Company’s long-lived assets are located in the U.S., except for $56.9 million and $56.4 million at September 30, 2021 and March 31, 2021, respectively, which are located primarily in Germany.
22
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. Each forward-looking statement
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 isReport. The following discussion may contain forward-looking statements that reflect our plans, estimates and beliefs, which are subject to risks, uncertainties and uncertainties that could causeassumptions. Our actual results tocould differ materially from those expressed or implied by such statement. Factors that could cause actual results or conditions to differ from those anticipated by these and otherstatements. The forward-looking statements include: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 and resulting orpandemic; the impact of prolonged economic downturns on our operations and financial conditions; effects on our profitability if we are unable to manufacture our products as a result of natural or man-made disasters; fluctuations in foreign currency exchange rates;rates and inflation; climate change; corporate social responsibility and sustainability matters; our dependence on Impella®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; material impairments caused by shutdowns of the U.S. federal government; 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 including U.S. Tax Reform legislation;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 and the potential for dilution to our stockholders’ ownership interests through the sale of additional securities; changes in methods, estimates and judgments we use in applying our accounting policies; changes in accounting standards, tax laws and financial reporting requirements; the outcome of ongoing securities class action litigation relating to our public disclosures; and other factors discussed in “Part I, Item 1A. Risk Factors” of our annual report on Form 10-K for the year ended March 31, 2021 and the filing subsequently filed with or furnished to the SEC. Readers are cautioned not to place undue reliance on any forward-looking statements contained in this Report, which speak only as of the date of this Report. Any forward-looking statement made in this Report speaks only as of the date hereof. We undertake no obligation to update or revise these forward-looking statements whether as a result of new information, future events or otherwise, unless otherwise required by law.securities.
23
Overview
We are a leading provider of medical devices that provide circulatory support and oxygenation. Our products are designed to enable the heart to rest by improving blood flow and/or provide sufficient oxygenation to those in respiratory failure. We develop, manufacture and market proprietary products that are designed to enable the heart to rest heal and recover by improving blood flow to the coronary arteries and end-organs and/or temporarily assistingperforming the pumping function of the heart.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 the electrophysiology lab, the hybrid lab and in the heart surgery suite by cardiac surgeons. A physician may use our devicessurgeons for patients who are in need of hemodynamic support
prophylactically urgently 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.
Our strategic focus and the 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. We expect that most of our product and service revenue in the near future will be from our Impella devices. Our Impella 2.5, Impella CP, Impella 5.0, Impella LD, Impella 5.5 and Impella RP devices have U.S Food and Drug Administration or FDA and CE Mark approval which allows us to market these devices in the U.S. and European Union. We expect to continue to make additional pre-market approval, or PMA supplement submissions for our Impella portfolio of devices for additional indications. Our Impella 2.5, Impella CP and Impella 5.0 devices have regulatory approval from the Ministry of Health, Labor and Welfare, or MHLW, in Japan.
COVID-19 Pandemic
We are subject to additional risks and uncertainties as a result of the ongoing COVID-19novel coronavirus (“COVID-19”) pandemic. TheSince 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 its business, including, for example: supply shortages, particularlyour business. To ensure the health and safety of our product components; supply chain disruptions, which may limitglobal 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 abilitymanufacturing facilities to manufacture or distribute our products.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. During the second quarter of fiscal year 2022, we experienced varying levels of recovery across our product lines and geographic locations from the challenges caused by the pandemic. Despite these improvements, the impact of COVID-19 on our patient utilization volumes is likely to vary widely by country, region, and type. In particular, our Impella product revenue increased in the three and six months ended September 30, 2021 as a result of sales mix and higher patient utilization in the U.S., Germany and Japan as compared to the three and six months ended September 30, 2020, however, in the second quarter of fiscal year 2022, patient utilization of Impella heart pump devices was negatively impacted by an increase in COVID-19 hospitalizations and ongoing shortage of hospital workers that limited ICU capacity which contributed to some deferral of elective procedures. 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 we believe there may be a backlog of patients in need of medical attention that requires the use of our products, it is difficult to predict when or if those patients may ultimately seek treatment, and therefore, the extent to which COVID-19 may impact patient utilization and, consequently, product revenue.
To ensureincreased in the health and safetyfirst quarter of our global employees, we continue to offer onsite COVID-19 testing and vaccinationsfiscal year 2023, sales were impacted by slower than expected improvements 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.
hospital staffing shortages. We continue to closely monitor the impact of COVID-19 on all aspects of our business and geographies, including any impact on our customers, including the ongoing hospital labor shortages, 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, with a potential payout of $5 million payable based on achievement of a commercial milestone.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 sixthree months ended SeptemberJune 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 sixthree months ended SeptemberJune 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.
24
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 micro heart pump with an integrated motor and sensors. The devicetechnology 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 CE Mark and MHLWPMDA approvals which allows us to market these devicesit in the U.S., European Union and Japan, respectively. We expect to continue to make additional PMA supplement submissionsThe technology is also approved for our Impella portfolio of devices for additional indications. Our Impella 2.5, use in multiple other countries.
Impella CP and Impella 5.0 devices have regulatory approval from the MHLW in Japan. The Impella 2.5 device also has Health Canada approval which allows us to market the device in Canada.
Impella CP®
The Impella CP device provides blood flow of approximately one liter moreup to 4.3 liters of blood per minute than the Impella 2.5 device 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, and MHLW approvalPMDA approvals which allows us to market this deviceit in the U.S., European Union and Japan. We expect to continue to make additional PMA supplement submissionsJapan, respectively. The technology is also approved for our Impella portfolio of devices for additional indications of Impella CPuse in the U.S.multiple other countries.
Impella 5.0® and Impella LD®
The Impella 5.0 and Impella LD devices are percutaneous micro 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 orand Impella CP.CP devices.
Our Impella 5.0 and Impella LD devices have received FDA, CE Mark, and MHLW approvalPMDA approvals which allowsallow us to market these devicesthem in the U.S., European Union and Japan. We expect to continue to make additional PMA supplement submissionsJapan, respectively. The technology is also approved for our Impella portfolio of devices for additional indications. Our Impella 5.0 device also has Heath Canada approval which allows us to market the deviceuse in Canada. We expect to discontinue production and sale of the Impella LD device in fiscal 2022.multiple other countries.
Impella 5.5®
The Impella 5.5 device is designed to be a percutaneous micro 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 a 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 pumpdevice was introduced in the U.S. through a controlled rollout at hospitals with established heart recovery protocols beginning in fiscal year 2020. TheIn April 2018, the Impella 5.5 device received CE Mark approval in Europe in April 2018 is beingand was introduced in Europe through a similar controlled rollout. We have submitted an applicationrollout, similar to the PMDA forU.S. In November 2021, the Impella 5.5 device received PMDA approval and we began a controlled rollout in Japan.Japan in fiscal year 2022, similar to the U.S. and Europe.
Impella RP®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 these devicesthis technology in the U.S. and European Union. The Impella RP device is the first percutaneous single access 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 patient ambulation. We expect to continue to make additional PMA supplement submissionsanticipate making a regulatory submission for our Impella portfolio of devices for additional indicationsthis technology in fiscal year 2023..
25
Impella SmartAssist®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 under CE Markfor use in the European Union andmultiple other countries that require a CE Mark approval.countries.
Impella Connect®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 roll-outrollout of Impella Connect at certain hospital sites during fiscal year 2020 and have transitioned most of our customers in the U.S. andto this technology. We continue to introduce this technology to hospitals outside the U.S.
Abiomed Breethe OXY-1 SystemTMSystem™
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 as part ofin 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 a 510(k) clearance from the FDA for an all-in-one, compact cardiopulmonary bypass system. We will continue to conducthave 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 second half 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 (9Fr)(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, non-randomizedsingle 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 usedevice 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. Concurrently, we are finalizing theThe protocol of a single arm pivotal high-risk PCI study for the Impella ECP device, as part of an investigational device exemption (“IDE”) submission with, 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 XR Sheath™
The Impella XR Sheath is a low-profile sheath that expands and recoils, allowing for small bore access and closure with certain Impella heart pumps. It inserts at 10 French (Fr) and the flexible, nitinol braids momentarily expand during insertion, then recoil, simplifying access for complex interventions. The Impella XR sheath is intended to produce less trauma at the arterial access site compared to large bore sheaths. In December 2020, the Impella XR Sheath for our Impella 2.5 device received a 510(k) clearance from the FDA. The Impella XR Sheath for our Impella CP device is still in development and has not been cleared for commercial use or sale.
Impella BTR™
The Impella BTR device is designed to be a percutaneous, microweanable, smart heart pump with integrated motors and sensors. The Impella BTR device is designed to be smaller,allow for greater than six liters of blood flow per minute, provide up to one year of hemodynamic support and is expected to allow for greater than five liters of blood flow per minute. The Impella BTR device will also include a wearable driver designed for hospital discharge. The Impella BTR pumpdevice 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
26
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 third quarter of fiscal year 2022, the FDA authorized the preCARDIA early feasibility study to be expanded by 30 additional 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 PreparationPresentation 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 SeptemberJune 30, 2021,2022, 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, 2021.2022.
Results of Operations for the Three and Six Months Ended SeptemberJune 30, 20212022 compared with the Three and Six Months Ended SeptemberJune 30, 20202021
The following table sets forth certain condensed consolidated statements of operations data for the periods indicated as a percentage of total revenue:Revenue
|
| For the Three Months Ended September 30, |
|
| For the Six Months Ended September 30, |
|
| ||||||||||
|
| 2021 |
|
| 2020 |
|
| 2021 |
|
| 2020 |
|
| ||||
Revenue |
|
| 100.0 |
| % |
| 100.0 |
| % |
| 100.0 |
| % |
| 100.0 |
| % |
Costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenue |
|
| 17.7 |
|
|
| 18.5 |
|
|
| 17.8 |
|
|
| 19.9 |
|
|
Research and development |
|
| 16.5 |
|
|
| 14.6 |
|
|
| 15.7 |
|
|
| 15.2 |
|
|
Selling, general and administrative |
|
| 41.4 |
|
|
| 37.7 |
|
|
| 41.2 |
|
|
| 39.4 |
|
|
Acquired in-process research and development |
|
| — |
|
|
| — |
|
|
| 23.1 |
|
|
| — |
|
|
Total costs and expenses |
|
| 75.6 |
|
|
| 70.8 |
|
|
| 97.8 |
|
|
| 74.5 |
|
|
Operating Income |
|
| 24.4 |
|
|
| 29.2 |
|
|
| 2.2 |
|
|
| 25.5 |
|
|
Other income and income tax provision, net |
|
| (1.4 | ) |
|
| 0.5 |
|
|
| 3.8 |
|
|
| 3.0 |
|
|
Net income |
|
| 23.0 |
| % |
| 29.7 |
| % |
| 6.1 |
| % |
| 28.5 |
| % |
Revenue
The following table disaggregates our revenue by products and services:
|
| For the Three Months Ended September 30, |
|
| For the Six Months Ended September 30, |
| For the Three Months Ended June 30, |
| ||||||||||||||||||||||||||||||||||
|
|
| 2021 |
|
|
| 2020 |
|
|
| 2021 |
|
|
| 2020 |
| 2022 |
|
| 2021 |
|
| Change |
| ||||||||||||||||||
|
| (in thousands) |
|
| (in thousands) |
| Amount |
|
| % of Total revenue |
|
| Amount |
|
| % of Total revenue |
|
| Amount |
|
| % |
| |||||||||||||||||||
Product revenue |
| $ | 235,785 |
|
| $ | 199,676 |
|
| $ | 477,259 |
|
| $ | 355,093 |
| $ |
| 264,472 |
|
|
| 95 | % |
| $ |
| 241,474 |
|
|
| 96 | % |
| $ |
| 22,998 |
|
|
| 10 | % |
Service and other revenue |
|
| 12,357 |
|
|
| 10,088 |
|
|
| 23,468 |
|
|
| 19,521 |
|
|
| 12,677 |
|
|
| 5 | % |
|
|
| 11,111 |
|
|
| 4 | % |
|
|
| 1,566 |
|
|
| 14 | % |
Total revenue |
| $ | 248,142 |
|
| $ | 209,764 |
|
| $ | 500,727 |
|
| $ | 374,614 |
| $ |
| 277,149 |
|
|
| 100 | % |
| $ |
| 252,585 |
|
|
| 100 | % |
| $ |
| 24,564 |
|
|
| 10 | % |
The following table disaggregates our revenue by geographicalgeographic location:
|
| For the Three Months Ended September 30, |
|
| For the Six Months Ended September 30, |
| ||||||||||||||||||||||||||||||||||||
|
|
| 2021 |
|
|
| 2020 |
|
|
| 2021 |
|
|
| 2020 |
| For the Three Months Ended June 30, |
| ||||||||||||||||||||||||
|
| (in thousands) |
|
| (in thousands) |
| 2022 |
|
| 2021 |
|
| Change |
| ||||||||||||||||||||||||||||
U.S. |
| $ | 200,485 |
|
| $ | 172,147 |
|
| $ | 407,628 |
|
| $ | 306,872 |
| ||||||||||||||||||||||||||
| Amount |
|
| % of Total revenue |
|
| Amount |
|
| % of Total revenue |
|
| Amount |
|
| % |
| |||||||||||||||||||||||||
United States | $ |
| 226,520 |
|
|
| 82 | % |
| $ |
| 207,143 |
|
|
| 82 | % |
| $ |
| 19,377 |
|
|
| 9 | % | ||||||||||||||||
Europe |
|
| 32,527 |
|
|
| 25,350 |
|
|
| 64,764 |
|
|
| 45,008 |
|
|
| 33,836 |
|
|
| 12 | % |
|
| 32,237 |
|
|
| 13 | % |
|
| 1,599 |
|
|
| 5 | % | ||
Japan |
|
| 12,267 |
|
|
| 10,311 |
|
|
| 23,551 |
|
|
| 19,296 |
|
|
| 13,235 |
|
|
| 5 | % |
|
| 11,284 |
|
|
| 4 | % |
|
| 1,951 |
|
|
| 17 | % | ||
Rest of world |
|
| 2,863 |
|
|
| 1,956 |
|
|
| 4,784 |
|
|
| 3,438 |
|
|
| 3,558 |
|
|
| 1 | % |
|
|
| 1,921 |
|
|
| 1 | % |
|
|
| 1,637 |
|
|
| 85 | % |
Outside the U.S. |
|
| 50,629 |
|
|
| 18 | % |
|
|
| 45,442 |
|
|
| 18 | % |
|
|
| 5,187 |
|
|
| 11 | % | ||||||||||||||||
Total revenue |
| $ | 248,142 |
|
| $ | 209,764 |
|
| $ | 500,727 |
|
| $ | 374,614 |
| $ |
| 277,149 |
|
|
| 100 | % |
| $ |
| 252,585 |
|
|
| 100 | % |
| $ |
| 24,564 |
|
|
| 10 | % |
ImpellaThe following table disaggregates our product revenue by geographic location:
| For the Three Months Ended June 30, |
| ||||||||||||||||||||||||
| 2022 |
|
| 2021 |
|
| Change |
| ||||||||||||||||||
| Amount |
|
| % of Total revenue |
|
| Amount |
|
| % of Total revenue |
|
| Amount |
|
| % |
| |||||||||
United States | $ |
| 215,567 |
|
|
| 78 | % |
| $ |
| 197,459 |
|
|
| 78 | % |
| $ |
| 18,108 |
|
|
| 9 | % |
Europe |
|
| 32,569 |
|
|
| 12 | % |
|
|
| 31,229 |
|
|
| 12 | % |
|
|
| 1,340 |
|
|
| 4 | % |
Japan |
|
| 12,778 |
|
|
| 5 | % |
|
|
| 10,865 |
|
|
| 4 | % |
|
|
| 1,913 |
|
|
| 18 | % |
Rest of world |
|
| 3,558 |
|
|
| 1 | % |
|
|
| 1,921 |
|
|
| 1 | % |
|
|
| 1,637 |
|
|
| 85 | % |
Outside the U.S. |
|
| 48,905 |
|
|
| 18 | % |
|
|
| 44,015 |
|
|
| 17 | % |
|
|
| 4,890 |
|
|
| 11 | % |
Total product revenue | $ |
| 264,472 |
|
|
| 95 | % |
| $ |
| 241,474 |
|
|
| 96 | % |
| $ |
| 22,998 |
|
|
| 10 | % |
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.
Total Revenue
Total revenue The following is a discussion of our revenues for the three months ended SeptemberJune 30, 20212022.
27
Total Revenue
Total revenue increased by $38.3$24.6 million, or 18%10%, to $248.1 million from $209.8 million for the three months ended SeptemberJune 30, 2020. Total revenue for2021 to the sixthree months ended SeptemberJune 30, 2021 increased $126.1 million, or 34% to $500.7 million from $374.6 million for the six months ended September 30, 2020.2022. The increase in total revenue from the three and six months ended SeptemberJune 30, 20202021 to the three and six months ended SeptemberJune 30, 20212022 was driven by an increase in both Impella product revenue and service and other revenue, as further described below.below, despite the unfavorable impact of foreign exchange fluctuations due to the strengthening of the U.S. dollar.
Impella Product Revenue
Impella productProduct revenue forincreased by $23.0 million, or 10%, from the three months ended SeptemberJune 30, 2021 increased by $36.1 million, or 18%, to $235.8 million from $199.7 million for the three months ended SeptemberJune 30, 2020. Impella2022. U.S. product revenue forincreased by $18.1 million, or 9%, from the sixthree months ended SeptemberJune 30, 2021 to the three months ended June 30, 2022. Outside the U.S., product revenue increased by $122.2$1.6 million, or 34%85%, to $477.3 million from $355.1 million for the sixthree months ended SeptemberJune 30, 2020. Impella product2021 to the three months ended June 30, 2022.
Product revenue increased in the three and six months ended SeptemberJune 30, 20212022, primarily relateddue to sales mix and higher patient utilization in the U.S., Germany and Japan as compared to the three and six months ended SeptemberJune 30, 2020,2021 as we are experiencingexperienced varying levels of recovery across our product lines and geographic locations due tofrom the challenges caused by the COVID-19 pandemic. Despite these improvements,pandemic, partially offset by the unfavorable impact of COVID-19 on our patient utilization volumes is likelyforeign exchange fluctuations due to vary widely by country, region, and type. In the second quarterstrengthening of fiscal year 2022, patient utilization of Impella heart pump devices was negatively impacted by an increase in COVID-19 hospitalizations and ongoing shortage of hospital workers that limited ICU capacity which contributed to some deferral of elective procedures. 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 we believe there may be a backlog of patients in need of medical attention that requires the use of our products, it is difficult to predict when or if those patients may ultimately seek treatment, and therefore, the extent to which COVID-19 may impact patient utilization and, consequently, product revenue.U.S. dollar.
Service and Other Revenueother revenue
Service and other revenue forincreased by $1.6 million, or 14%, from the three months ended SeptemberJune 30, 2021 increased by $2.3 million, or 23%, to $12.4 million from $10.1 million for the three months ended SeptemberJune 30, 2020. Service and other revenue for the six months ended September 30, 2021 increased $4.0 million, or 21%, to $23.5 million from $19.5 million for the six months ended September 30, 2020.
2022. The increase in total service and other revenue from the three and six months ended September 30, 2020 to the three and six months ended September 30, 2021 was primarily due to an increase in preventative maintenance service contracts.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 of these higher volume customer sites in the U.S. have service contracts which typically have three-year terms.
Costs and Expenses
Cost of Revenue
| For the Three Months Ended June 30, |
| ||||||||||||||||||||||||
| 2022 |
|
| 2021 |
|
| Change |
| ||||||||||||||||||
| Amount |
|
| % of Total revenue |
|
| Amount |
|
| % of Total revenue |
|
| Amount |
|
| % |
| |||||||||
Cost of revenue | $ |
| 52,626 |
|
|
| 19 | % |
| $ |
| 45,188 |
|
|
| 18 | % |
| $ |
| 7,438 |
|
|
| 16 | % |
Cost of revenue increased by $7.4 million, or 16%, from the three months ended June 30, 2021 to the three months ended June 30, 2022. Gross margin was 81.0% for the three months ended SeptemberJune 30, 2021 increased by $5.2 million, or 13%, to $43.9 million from $38.7 million2022 and 82.1% for the three months ended SeptemberJune 30, 2020. Gross margin was 82.3% for the three months ended September 30, 2021 and 81.5% for the three months ended September 30, 2020.2021.
Cost of revenue for the six months ended September 30, 2021 increased by $14.4 million, or 19%, to $89.1 million from $74.7 million for the six months ended September 30, 2020. Gross margin was 82.2% for the six months ended September 30, 2021 and 80.1% for the six months ended September 30, 2020.
The increase in cost of product revenue from the three and six months ended September 30, 2020 to the three and six months ended September 30, 2021 was primarilyincreased due to increased production volume andour investment in direct labor and overhead as we expanded ourcontinue to expand the manufacturing capacity of our facilities in the U.S. and Germany. The increaseGermany, resulting in a corresponding decrease to gross margin from the three and six months ended September 30, 2020 to the three and six months ended September 30, 2021 was primarily due to a higher production volume and sales mix primarily associated with our initial launch of Impella 5.5.margin.
We expect that our ongoing investment in manufacturing capacity and the expansion of our Impella CP SmartAssist and Impella Connect platform may decrease gross margin slightly in the near future.Operating Expenses
| For the Three Months Ended June 30, |
| ||||||||||||||||||||||||
| 2022 |
|
| 2021 |
|
| Change |
| ||||||||||||||||||
| Amount |
|
| % of Total revenue |
|
| Amount |
|
| % of Total revenue |
|
| Amount |
|
| % |
| |||||||||
Research and development | $ |
| 40,477 |
|
|
| 15 | % |
| $ |
| 37,708 |
|
|
| 15 | % |
| $ |
| 2,769 |
|
|
| 7 | % |
Selling, general and administrative |
|
| 117,996 |
|
|
| 43 | % |
|
|
| 103,484 |
|
|
| 41 | % |
|
|
| 14,512 |
|
|
| 14 | % |
Acquired in-process research and development |
|
| - |
|
|
| 0 | % |
|
|
| 115,490 |
|
|
| 46 | % |
|
|
| (115,490 | ) |
|
| (100 | )% |
Total operating expenses | $ |
| 158,473 |
|
|
| 57 | % |
| $ |
| 256,682 |
|
|
| 102 | % |
| $ |
| (98,209 | ) |
|
| (38 | )% |
Research and Development Expenses
Research and development expenses forincreased by $2.8 million, or 7%, from the three months ended SeptemberJune 30, 2021 increased by $10.5 million, or 34%, to $41.0 million from $30.5 million forthe three months ended SeptemberJune 30, 2020.
Research and development expense for the six months ended September 30, 2021 increased $21.8 million, or 38% to $78.7 million from $56.9 million for the six months ended September 30, 2020.
2022. The increase in research and development expenses from the three and six months ended September 30, 2020 to the three and six months ended September 30, 2021 iswas primarily due to our increases in regulatory and quality hiring, ongoing product development initiatives relating to our existing and pipeline products, including the development of the Impella ECP™, preCARDIA, Impella BTR™ and Breethe OXY-1 System™, Impella XR Sheath™, Impella BTRTM and preCARDIA devices, the expansion of our engineering organization, continued investment in our
clinical trials, most notably the STEMI DTU and PROTECT IV studies, and our focus on clinical,
28
technological and quality initiatives for our products. The increase in research and development expenses was partially offset by a $3.4 million gain related to the change in fair value of our contingent consideration for the three months ended June 30, 2022.
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, and develop new technologies and conduct clinical studies. Research and development expenses can fluctuate with project timing.
Selling, General and Administrative Expenses
Selling, general and administrative expenses for the three months ended September 30, 2021 increased by $23.6 million, or 30%, to $102.8 million from $79.2 million for the three months ended September 30, 2020.
Selling, general, and administrative expenses for the six months ended September 30, 2021 increased $58.7 million, or 40%, to $206.3 million from $147.6 million for the six months ended September 30, 2020.
Selling, general and administrative expenses increased by $14.5 million, or 14%, from the three and six months ended SeptemberJune 30, 20202021 to the three and six months ended SeptemberJune 30, 20212022. The increase in selling, general and administrative expenses was primarily due to increases in commercial hiring, marketing, travel and clinical training and education initiatives and higher stock compensation expense.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.
Operating IncomeAcquired In-Process Research and Development Expenses
Operating incomeWe acquired 100% interest in preCARDIA on May 28, 2021, for a purchase price of $115.2 million. In connection with the three months ended September 30, 2021 decreased by $0.9acquisition, we acquired net assets of $115.2 million, to $60.4which included $115.5 million compared to $61.3 million operating income for the three months ended September 30, 2020. Operating margin was 24.4% for the three months ended September 30, 2021 compared to 29.2% for the three months ended September 30, 2020. The decrease in operating income and margin was primarily due to strategic investments in clinical, engineering, commercial, training and marketing initiatives which increased operating expenses as described above.
Operating income for the six months ended September 30, 2021 decreased by $84.2 million, to $11.2 million, compared to $95.4 million operating income for the six months ended September 30, 2020. Operating margin was 2.2% for the six months ended September 30, 2021 compared to 25.5% for the six months ended September 30, 2020. The decrease in operating income and margin was primarily duerelated to the preCARDIA acquisition in May 2021.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 sixthree months ended SeptemberJune 30, 2021.
Other IncomeInterest and other income, net
| Three Months Ended June 30, | |||||||||||||||||
| 2022 |
|
| 2021 |
|
| Change | |||||||||||
| Amount |
|
| Amount |
|
| Amount |
|
| % | ||||||||
Interest and other income, net | $ |
| 3,772 |
|
| $ |
| 39,935 |
|
|
| (36,163 | ) |
|
| (91 | ) | % |
OtherInterest and other income, net decreased by $4.8$36.2 million, to other income of $6.8 million foror 91%, from the three months ended SeptemberJune 30, 2021 compared to other income of $11.6 million for the three months ended SeptemberJune 30, 2020. The2022. This decrease was primarily due to the recognition of a $4.8 million gainloss from our investment in Shockwave Medical for the three months ended SeptemberJune 30, 2021,2022 compared to a $10.8$17.6 million gain from our investment in Shockwave Medical for the three months ended September 30, 2020.
Other income, increased by $8.2 million, to other income of $46.8 million for the six months ended SeptemberJune 30, 2021 compared to other incomeand the recognition of $38.6 million for the six months ended September 30, 2020. This increase was primarily due to a $21.0 million gain related to ourthe Company's previously owned minority interest in preCARDIA recognized upon the acquisition of preCARDIA in May 2021 and a $22.4 million gain from our investment in Shockwave Medical for the six months ended September 30, 2021, compared to a $34.7 million gain from our investment in Shockwave Medical for the six months ended September 30, 2020.
Income Tax Provision
Our income tax provision was $10.3 million and $10.7 million for the three months ended SeptemberJune 30, 20212021. These amounts were partially offset by a $4.7 million gain related to changes in fair value of our investments in medical technology companies, a $2.1 million gain related to foreign currency fluctuations and 2020, respectively. Our effective tax rate was 15.3% and 14.7%a $0.5 million increase in interest income related to marketable securities for the three months ended SeptemberJune 30, 2021 and 2020, respectively. Our2022.
Income tax provision
| Three Months Ended June 30, | |||||||||||||||||
| 2022 |
|
| 2021 |
|
| Change | |||||||||||
| Amount |
|
| Amount |
|
| Amount |
|
| % | ||||||||
Income tax provision | $ |
| 15,268 |
|
| $ |
| 17,175 |
|
|
| (1,907 | ) |
|
| (11 | ) | % |
The income tax provision was $27.5decreased by $1.9 million, and $27.2 million foror 11%, from the sixthree months ended SeptemberJune 30, 2021 and 2020, respectively.to the three months ended June 30, 2022. Our effective income tax rate was 47.5%21.9% and 20.3%183.7% for the sixthree months ended SeptemberJune 30, 20212022 and 2020,2021, respectively. The changedecrease in the effective income tax rate for the sixthree months ended SeptemberJune 30, 20212022 is primarily due to a non-deductible charge for in-process research and development related to the preCARDIA acquisition offset by an increase in excess tax benefits related to share-based compensation.
Net Income
Net income forthat occurred during the three months ended SeptemberJune 30, 2021 was $57.0 million, or $1.25 per basic share and $1.24 diluted share, compared to net income of $62.2 million, or $1.38 per basic share and $1.36 per diluted share, for three months ended September 30, 2020.2021.
Net income for the six months ended September 30, 2021, was $30.4 million, or $0.67 per basic share and $0.66 per diluted share, compared to net income of $106.8 million, or $2.37 per basic share and $2.34 per diluted share for the six months ended September 30, 2020.
Liquidity and Capital Resources
As of SeptemberJune 30, 2021,2022, our total cash, cash equivalents and short and long-term marketable securities totaled $861.5 million,$1.0 billion, an increase of $13.7$25.5 million compared to $847.8$978.7 million at March 31, 2021.2022. The increasechange in our total cash, cash equivalents and short and long-term marketable securities during the six months ended September 30, 2021 was primarily due to changes in working capital.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.
Following is a29
A summary of our cash flow activities:activities is as follows:
|
| For the Six Months Ended September 30, |
| |||||
|
| 2021 |
|
| 2020 |
| ||
Net cash provided by operating activities |
| $ | 115,931 |
|
| $ | 108,968 |
|
Net cash used for investing activities |
|
| (108,395 | ) |
|
| (81,314 | ) |
Net cash used for financing activities |
|
| (786 | ) |
|
| (14,711 | ) |
Effect of exchange rate changes on cash |
|
| 2,422 |
|
|
| (3,043 | ) |
Net increase in cash and cash equivalents |
| $ | 9,172 |
|
| $ | 9,900 |
|
|
| For the Three Months Ended June 30, |
| |||||
|
| 2022 |
|
| 2021 |
| ||
Net cash provided by operating activities |
| $ | 68,103 |
|
| $ | 55,359 |
|
Net cash provided by (used for) investing activities |
|
| 8,114 |
|
|
| (109,055 | ) |
Net cash used for financing activities |
|
| (23,936 | ) |
|
| (7,470 | ) |
Effect of exchange rate changes on cash and cash equivalents |
|
| (4,607 | ) |
|
| 3,910 |
|
Net increase (decrease) in cash and cash equivalents |
| $ | 47,674 |
|
| $ | (57,256 | ) |
Cash Provided by Operating Activities
For the sixthree months ended SeptemberJune 30, 2022, net cash provided by operating activities consisted of net income of $54.6 million, plus non-cash items of $14.2 million less cash used for working capital of $0.7 million. As discussed above, the change in net income was primarily due to an increase in operating expenses partially offset by an increase in revenue for the three months ended June 30, 2022 compared to the three months ended June 30, 2021. Adjustments for non-cash items consisted primarily of $13.4 million of stock-based compensation expense, $6.6 million of depreciation and amortization expense, $6.4 million in deferred tax provision,$2.6 million in inventory and other write-downs, $0.6 million in accretion on marketable securities and a $0.3 million net change in fair value of our investments in Shockwave Medical and other private medical technology companies. The decrease in cash from changes in working capital is primarily due to a $6.5 million increase in inventory to support growing sales volume, a $2.4 million decrease in deferred revenue and a $1.9 million increase in accounts receivable due to timing of collections partially offset by a $7.0 million increase in accounts payable, accrued expenses and other liabilities and a $3.1 million decrease in prepaid expenses and other assets.
For the three months ended June 30, 2021, cash provided by operating activities consisted of net incomeloss of $30.4$26.5 million, plus non-cash items of $132.1$108.7 million offset by cash used in working capital of $46.6$26.8 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$17.6 million net change in fair value of our investments in Shockwave Medical and other private medical technology companies, $28.4$12.6 million of stock-based compensation expense, $13.9$6.9 million of depreciation and amortization expense, $8.2$6.3 million in deferred tax provision, $6.2$3.5 million in inventory and other write-downs, and $1.8$0.9 million in accretion on marketable securities. The changedecrease in cash from changes in working capital included a $7.4$20.8 million decrease in accounts payable, accrued expenses and other liabilities and a $8.8 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$8.7 million increase in prepaid expenses and other assets and a $11.7$5.8 million increase in inventory due to the mix of customer demand and production.
Cash Provided by (Used for) Investing Activities
For the sixthree months ended SeptemberJune 30, 2020,2022, net cash provided by operatinginvesting activities consisted of net income of $106.8 million, adjustments for non-cash items of $19.7 million and cash used in working capital of $17.5 million. As discussed above, the change in net income was primarily due to modest increases in Impella revenue, lower selling, general and administrative expenses to reduced discretionary spending and hiring and gains from our investment in Shockwave Medical, partially offset by increases in research and development expenses due to product development and clinical initiatives relating to our existing and pipeline products and lower excess tax benefits. Adjustments for non-cash items consisted primarily of $20.9 million of stock-based compensation expense, $14.2included $19.5 million in deferred tax provision, $11.1 millionsales and maturities (net of depreciation and amortization expense, $3.1 million in inventory and other write-downs, and $0.5 million in accretion on marketable securities. The change in cash from working capital included a $4.8 million decrease in accounts receivable due to timing of collections, a $6.1 million decrease in inventory due to lower production volumes, a $32.1 million decrease in accounts payable and accrued expenses primarily due to payment of annual bonuses during the quarter ended September 30, 2020, and a $2.0 million increase in deferred revenue.
Cash Used for Investing Activities
For the six months ended September 30, 2021, net cash used for investing activities primarily consisted of $82.8 million for our acquisition of preCARDIA, $3.9 million for our investment in private medical technology companies, $7.3 million in purchasespurchases) of marketable securities, (net of sales), and $14.4offset by $6.8 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.Germany and $4.6 million for our investment in private medical technology companies.
For the sixthree months ended SeptemberJune 30, 2020,2021, net cash used for investing activities primarily consisted of $74.4included $15.2 million in purchases (net of maturities) from the sale of marketable securities (net of maturities), $52.2and $7.2 million in net cash for our acquisition of Breethe and $19.6 million used in 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. We also made an additional $3.1a $3.9 million investment in a
private medical technology companies. These amounts were partially offset by $67.9 million in proceeds fromcompanies during the salefirst quarter of Shockwave Medical securities.fiscal 2022.
Capital expenditures for fiscal year 20222023 are estimated to range from $30 million to $40 million to support$50 million, including, as part of the long-term development of our business, includingadditional 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 sixthree months ended SeptemberJune 30, 2021,2022, net cash used for financing activities included $12.1$14.5 million for repurchases of our common stock and $11.0 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$1.5 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.options.
For the sixthree months ended SeptemberJune 30, 2020,2021, net cash used for financing activities included $11.3 million for the repurchase of our common stock and $10.9$9.6 million in payments in lieu of issuance of common stock for payroll withholding taxes upon vesting of certain equity awards. These amounts wereawards offset by $5.6$2.1 million in proceeds from the exercise of stock options and $2.0 million in proceeds from the issuance of stock under the employee stock purchase plan.options.
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Operating Capital Resources and Liquidity Requirements
Our sources of cash liquidity are primarily from existing cash and cash equivalents, marketable securities and cash flows from operations. On SeptemberAs of June 30, 2021,2022, our total cash, cash equivalents, and short and long-term marketable securities totaled $861.5 million,$1.0 billion, an increase of $13.7$25.5 million compared to $847.8$978.7 million atas of March 31, 2021.2022. Marketable securities at Septemberas of June 30, 20212022 consisted of $619.7$823.7 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 $115.9$68.1 million and $109.0$55.4 million for the sixthree months ended SeptemberJune 30, 20212022 and 2020,2021, respectively. At SeptemberJune 30, 2021,2022, 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 repurchases andthrough 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. To date, we have primarily funded
We believe that our operations through product salessources of liquidity are sufficient to fund the current requirements of working capital, capital expenditures, and other financial commitments for at least the sale of equity securities.
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.
Off-Balance Sheet Arrangements
We had no off-balance sheet arrangements or guarantees of third-party obligations during the periods presented. An “off-balance sheet arrangement” generally entails a transaction, agreement or other contractual arrangement to which an entity unconsolidated with us, is a party under which we have any obligation arising under a guarantee contract, derivative instrument or variable interest or a retained or contingent interest in assets transferred to such entity or similar arrangement that serves as credit, liquidity or market risk support for such assets.
Contractual Obligations and Commercial Commitments
We have various contractual obligations, which are recorded as liabilities in our condensed consolidated financial statements. Other items are not recognized as liabilities in our condensed consolidated financial statements but are required to be disclosed. There have been no material changes, outside of the ordinary course of business, to our contractual obligations as previously disclosed in our Annual Report on Form 10-K for the fiscal year ended March 31, 2021.
ITEM 3: QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK
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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, 2021.2022.
ITEM 4. CONTROLS AND PROCEDURES
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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 SeptemberJune 30, 2021.2022. Based on this evaluation, our principal executive officer and principal financial officer concluded that, as of SeptemberJune 30, 2021,2022, 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 secondfirst quarter of our fiscal year ending March 31, 2022,2023, 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.
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PART II — OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
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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 16.15. Commitments and Contingencies” to our condensed consolidated financial statements and such information is incorporated herein by reference.
ITEM 1A. RISK FACTORS
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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"Part I, “ItemItem 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended March 31, 2021,2022, which could materially affect our business, financial condition or future results. The risk factors set forth below update, and should be read together with,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, 2021.2022.
Risks Related to Our Business, Industry and Operations
The various United States federal government orders and regulations directing employers to require their employees to be vaccinated could lead to labor disruptions, which could have a material adverse effect on our business and results of operations.
On September 9, 2021, President Biden issued an executive order obligating parties that contract with the federal government to require their employees to be fully vaccinated against COVID-19, with limited exceptions for certain accommodations. Additionally, on September 9, 2021, President Biden announced a plan directing the Department of Labor’s Occupational Safety and Health Administration (“OSHA”) to issue an emergency temporary standard requiring all private employers with 100 or more workers to mandate COVID-19 vaccination or produce a weekly test for all employees. As a company with more than 100 employees, we would thus be required to mandate COVID-19 vaccination of our workforce or require our unvaccinated employees to be tested weekly.
Given current information, it is not possible to predict with certainty the impacts the impending mandates would have on us. These mandates may result in increased costs, labor disruptions or employee attrition, which could be material as a substantial number of our employees are based in areas of the country where vaccination rates are below the national average. If we lose employees, it may be difficult in the current competitive labor market to find replacement employees, and this could have an adverse effect on future revenues and costs, which could be material. Additional uncertainty could be caused by competing and potentially conflicting laws and regulations, such as the recent executive order issued by the governor of Texas prohibiting vaccine mandates. Accordingly, the impending mandates when implemented could have a material adverse effect on our business and results of operations.
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 June 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.
(1) The Company’s policy is to consider shares to have been repurchased upon the settlement date of the transaction, which is typically three 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 remaining authorization under this program was $89.3 million as of June 30, 2022. 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. 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 2019 Share Repurchase Program and 2022 Share Repurchase Program have no time limit and may be suspended for periods or discontinued at any time. |
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ITEM 3. DEFAULTS UPON SENIOR SECURITIES None. |
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None.
ITEM 4. MINE SAFETY DISCLOSURES None. |
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None.
ITEM 5. OTHER INFORMATION |
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None.
None.
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ITEM 6. EXHIBITS
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Exhibit No. |
| Description |
| Filed with This Form 10-Q |
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3.1 |
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| S-3 |
| September 29, 1997 |
| 3.1 | |
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3.2 |
| Amended & Restated By-Laws, as Amended and Restated February 4, 2020 |
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| 10-K |
| May 21, 2020 |
| 3.2 |
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3.3 |
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| 8-K |
| March 21, 2007 |
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10.1* |
| Form of Indemnification Agreement by and between the Company and its directors and officers |
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| 8-K |
| August 13, 2021 (File No. 001-09585) |
| 10.1 |
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31.1 |
| Rule 13a—14(a)/15d—14(a) certification of principal executive officer |
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31.2 |
| Rule 13a—14(a)/15d—14(a) certification of principal accounting officer |
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32.1 |
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101 |
| The following financial information from the ABIOMED, Inc. Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, formatted in inline Extensible Business Reporting Language (XBRL): (i) Condensed Consolidated Balance Sheets (Unaudited) as of September 30, 2021 and March 31, 2021; (ii) Condensed Consolidated Statements of Operations (Unaudited) for the three and six months ended September 30, 2021 and 2020; (iii) Condensed Consolidated Statements of Comprehensive Income (Unaudited) for the three and six months ended September 30, 2021 and 2020; (iv) Condensed Consolidated Statements of Stockholders’ Equity (Unaudited) for the three and six months ended September 30, 2021 and 2020 (v) Condensed Consolidated Statements of Cash Flows (Unaudited) for the six months ended September 30, 2021 and 2020; and (vi) Notes to Condensed Consolidated Financial Statements (Unaudited). |
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104 |
| Cover page from the ABIOMED, Inc. Quarterly Report on Form 10-Q for the quarter ended September 30, 2021 formatted in iXBRL and contained in Exhibit 101 |
| X |
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* Management contract or compensatory plan, contract or arrangement.
SIGNATURES
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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.
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| ABIOMED, Inc. |
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Date: |
| /s/ TODD A. TRAPP |
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| Todd A. Trapp |
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| Executive Vice President and Chief Financial Officer |
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| (Authorized Signatory) |
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