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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 June 30, 2021

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) 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 July 30, 2021, 45,380,233 shares of the registrant’s common stock, $.01 par value, were outstanding.

 

 

 

 

 


 

 

TABLE OF CONTENTS

 

PART I - FINANCIAL INFORMATION:

Page

 

 

 

Item 1.

Condensed Consolidated Financial Statements (unaudited)

3

 

 

 

 

Condensed Consolidated Balance Sheets as of June 30, 2021 and March 31, 2021

3

 

 

 

 

Condensed Consolidated Statements of Operations for the three months ended June 30, 2021 and 2020

4

 

 

 

 

Condensed Consolidated Statements of Comprehensive (Loss) Income for the three months ended June 30, 2021 and 2020

5

 

 

 

 

Condensed Consolidated Statements of Stockholders’ Equity for the three months ended June 30, 2021 and 2020

6

 

 

 

 

Condensed Consolidated Statements of Cash Flows for the three months ended June 30, 2021 and 2020

7

 

 

 

 

Notes to Condensed Consolidated Financial Statements (unaudited)

8

 

 

 

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

26

 

 

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

35

 

 

 

Item 4.

Controls and Procedures

35

 

 

 

PART II - OTHER INFORMATION:

 

 

 

 

Item 1.

Legal Proceedings

36

 

 

 

Item 1A.

Risk Factors

36

 

 

 

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

36

 

 

 

Item 3.

Defaults Upon Senior Securities

36

 

 

 

Item 4.

Mine Safety Disclosures

36

 

 

 

Item 5.

Other Information

36

 

 

 

Item 6.

Exhibits

37

 

 

 

Signatures

38

 

 

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, STEMI DTU, Automated Impella Controller and Abiomed Breethe OXY-1 System 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, “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 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)

(in thousands, except share data)

 

 

 

June 30, 2021

 

 

March 31, 2021

 

ASSETS

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

175,454

 

 

$

232,710

 

Short-term marketable securities

 

 

347,577

 

 

 

350,985

 

Accounts receivable, net

 

 

88,645

 

 

 

97,179

 

Inventories

 

 

83,661

 

 

 

81,059

 

Prepaid expenses and other current assets

 

 

34,536

 

 

 

26,032

 

Total current assets

 

 

729,873

 

 

 

787,965

 

Long-term marketable securities

 

 

281,776

 

 

 

264,085

 

Property and equipment, net

 

 

198,234

 

 

 

197,129

 

Goodwill

 

 

79,006

 

 

 

78,568

 

Other intangibles, net

 

 

41,904

 

 

 

42,150

 

Deferred tax assets

 

 

4,958

 

 

 

11,380

 

Other assets

 

 

122,643

 

 

 

113,082

 

Total assets

 

$

1,458,394

 

 

$

1,494,359

 

LIABILITIES AND STOCKHOLDERS' EQUITY

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

 

29,807

 

 

$

34,842

 

Accrued expenses

 

 

56,462

 

 

 

66,046

 

Deferred revenue

 

 

24,094

 

 

 

24,322

 

Other current liabilities

 

 

2,760

 

 

 

3,759

 

Total current liabilities

 

 

113,123

 

 

 

128,969

 

Other long-term liabilities

 

 

11,314

 

 

 

10,162

 

Contingent consideration

 

 

25,577

 

 

 

24,706

 

Deferred tax liabilities

 

 

858

 

 

 

847

 

Total liabilities

 

 

150,872

 

 

 

164,684

 

Commitments and contingencies (Note 16)

 

 

 

 

 

 

 

 

Stockholders' equity:

 

 

 

 

 

 

 

 

Class B Preferred Stock, $.01 par value

 

 

 

 

 

 

Authorized - 1,000,000 shares; Issued and outstanding - none

 

 

 

 

 

 

 

 

Common stock, $.01 par value

 

 

454

 

 

 

453

 

Authorized - 100,000,000 shares; Issued 48,070,443 shares as of June 30, 2021 and 47,929,402 shares as of March 31, 2021

 

 

 

 

 

 

 

 

Outstanding 45,377,715 shares as of June 30, 2021 and 45,270,948 shares as of March 31, 2021

 

 

 

 

 

 

 

 

Additional paid in capital

 

 

815,416

 

 

 

800,690

 

Retained earnings

 

 

801,482

 

 

 

828,007

 

Treasury stock at cost 2,692,728 shares as of June 30, 2021 and 2,658,454 shares as of March 31, 2021

 

 

(297,619

)

 

 

(288,030

)

Accumulated other comprehensive loss

 

 

(12,211

)

 

 

(11,445

)

Total stockholders' equity

 

 

1,307,522

 

 

 

1,329,675

 

Total liabilities and stockholders' equity

 

$

1,458,394

 

 

$

1,494,359

 

 

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 June 30,

 

 

 

2021

 

 

2020

 

Revenue

 

$

252,585

 

 

$

164,850

 

Costs and expenses:

 

 

 

 

 

 

 

 

Cost of revenue

 

 

45,188

 

 

 

35,983

 

Research and development

 

 

37,708

 

 

 

26,357

 

Selling, general and administrative

 

 

103,484

 

 

 

68,444

 

Acquired in-process research and development

 

 

115,490

 

 

 

 

 

 

 

301,870

 

 

 

130,784

 

(Loss) income from operations

 

 

(49,285

)

 

 

34,066

 

Other income:

 

 

 

 

 

 

 

 

Investment income, net

 

 

1,050

 

 

 

2,397

 

Other income, net

 

 

38,885

 

 

 

24,613

 

 

 

 

39,935

 

 

 

27,010

 

(Loss) income before income taxes

 

 

(9,350

)

 

 

61,076

 

Income tax provision

 

 

17,175

 

 

 

16,488

 

Net (loss) income

 

$

(26,525

)

 

$

44,588

 

 

 

 

 

 

 

 

 

 

Net (loss) income per share - basic

 

$

(0.59

)

 

$

0.99

 

Weighted average shares outstanding - basic

 

 

45,311

 

 

 

45,010

 

 

 

 

 

 

 

 

 

 

Net (loss) income per share - diluted

 

$

(0.59

)

 

$

0.98

 

Weighted average shares outstanding - diluted

 

 

45,311

 

 

 

45,549

 

 

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

 

4


 

 

ABIOMED, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Comprehensive (Loss) Income (Unaudited)

(in thousands)

 

 

 

For the Three Months Ended June 30,

 

 

 

2021

 

 

2020

 

Net (loss) income

 

$

(26,525

)

 

$

44,588

 

Other comprehensive (loss) income:

 

 

 

 

 

 

 

 

Foreign currency translation gains

 

 

83

 

 

 

1,360

 

Unrealized losses on derivative instrument

 

 

(217

)

 

 

(461

)

Net unrealized (losses) gains on marketable securities

 

 

(632

)

 

 

1,755

 

Other comprehensive (loss) income

 

 

(766

)

 

 

2,654

 

 

 

 

 

 

 

 

 

 

Comprehensive (loss) income

 

$

(27,291

)

 

$

47,242

 

 

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) income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(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

 

 

 

 

 

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

 

 

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 Three Months Ended June 30,

 

 

 

2021

 

 

2020

 

Operating activities:

 

 

 

 

 

 

 

 

Net (loss) income

 

$

(26,525

)

 

$

44,588

 

Adjustments to reconcile net income to net cash provided by operating activities:

 

 

 

 

 

 

 

 

Depreciation and amortization

 

 

6,907

 

 

 

5,480

 

Acquired in-process research & development

 

 

115,490

 

 

 

 

Bad debt recoveries

 

 

(59

)

 

 

(277

)

Stock-based compensation

 

 

12,608

 

 

 

9,298

 

Write-down of inventory and other

 

 

3,508

 

 

 

1,717

 

Accretion on marketable securities

 

 

918

 

 

 

94

 

Change in fair value of other investments

 

 

(17,648

)

 

 

(23,823

)

Gain on previously held interest in preCARDIA

 

 

(20,980

)

 

 

 

Deferred tax provision

 

 

6,299

 

 

 

12,946

 

Change in fair value of contingent consideration

 

 

871

 

 

 

801

 

Other non-cash operating activities

 

 

751

 

 

 

970

 

Changes in assets and liabilities:

 

 

 

 

 

 

 

 

Accounts receivable

 

 

8,763

 

 

 

3,014

 

Inventories

 

 

(5,770

)

 

 

(211

)

Prepaid expenses and other assets

 

 

(8,697

)

 

 

485

 

Accounts payable

 

 

(4,762

)

 

 

(4,458

)

Accrued expenses and other liabilities

 

 

(16,037

)

 

 

(19,584

)

Deferred revenue

 

 

(278

)

 

 

719

 

Net cash provided by operating activities

 

 

55,359

 

 

 

31,759

 

Investing activities:

 

 

 

 

 

 

 

 

Purchases of marketable securities

 

 

(139,021

)

 

 

(62,066

)

Proceeds from the sale and maturity of marketable securities and other

 

 

123,823

 

 

 

139,813

 

Purchases of other investments and intangible assets

 

 

(3,866

)

 

 

(2,000

)

Acquisition of preCARDIA, net of cash acquired

 

 

(82,821

)

 

 

 

Acquisition of Breethe, net of cash acquired

 

 

 

 

 

(51,947

)

Purchases of property and equipment

 

 

(7,170

)

 

 

(10,044

)

Net cash (used for) provided by investing activities

 

 

(109,055

)

 

 

13,756

 

Financing activities:

 

 

 

 

 

 

 

 

Proceeds from the exercise of stock options

 

 

2,120

 

 

 

1,010

 

Taxes paid related to net share settlement upon vesting of stock awards

 

 

(9,590

)

 

 

(9,857

)

Repurchase of common stock

 

 

 

 

 

(11,310

)

Net cash used for financing activities

 

 

(7,470

)

 

 

(20,157

)

Effect of exchange rate changes on cash and cash equivalents

 

 

3,910

 

 

 

(2,872

)

Net (decrease) increase in cash and cash equivalents

 

 

(57,256

)

 

 

22,486

 

Cash and cash equivalents at beginning of period

 

 

232,710

 

 

 

192,341

 

Cash and cash equivalents at end of period

 

$

175,454

 

 

$

214,827

 

 

 

 

 

 

 

 

 

 

Supplemental disclosure of cash flow information:

 

 

 

 

 

 

 

 

Cash paid for income taxes

 

$

14,998

 

 

$

2,831

 

Supplemental disclosure of non-cash activities:

 

 

 

 

 

 

 

 

Contingent consideration related to the acquisition of Breethe

 

 

 

 

 

13,900

 

Property and equipment in accounts payable and accrued expenses

 

 

1,014

 

 

 

2,044

 

Right-of-use assets obtained in exchange for lease liabilities

 

 

283

 

 

 

804

 

 

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 Business

ABIOMED, Inc. (the “Company” or “ABIOMED”) is a 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. Our 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 Preparation and Summary of Significant Accounting Policies

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles, or GAAP, for interim financial reporting as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”) and in accordance with Article 10 of Regulation S-X. Accordingly, they do not include all of the information and note disclosures required by GAAP for complete financial statements. These statements should be read in conjunction with the consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended March 31, 2021 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 months ended June 30, 2021 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, 2021 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 risks and uncertainties as a result of the ongoing COVID-19 pandemic. 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. The full extent to which the pandemic will directly or indirectly impact the Company's business, results of operations and financial condition, including sales, expenses, manufacturing, clinical trials, research and development costs, reserves and allowances, fair value measurements, asset impairment charges, contingent consideration obligations, and the effectiveness of the Company's hedging instruments, will depend on future developments that are highly uncertain and difficult to predict. These developments include, but are not limited to: the duration and spread of the ongoing COVID-19 pandemic (including new variants of COVID-19), its severity, the actions to contain the virus or address its impact, the timing, distribution, and efficacy of vaccines and other treatments, U.S. and foreign government actions to respond to the reduction in global economic activity, and how quickly and to what extent normal economic and operating conditions can resume.

While the 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. Hospitals are generally managing the pandemic better currently than they have in the earlier part of the pandemic due to more testing, improved protocols, more experience with the effects of COVID-19 and a greater number of vaccinated caregivers. During these challenging times, the Company’s priorities have been to support its clinician partners, protect the well-being of its employees and maintain continuous access to its life-saving technologies while offering front-line in-hospital support. The Company has established onsite COVID-19 testing and vaccination for its employees in both Danvers, Massachusetts and Aachen, Germany, set up temperature-taking stations, administered thousands of COVID-19 tests to date and provided personal protective equipment for its employees in order to maintain a safe working environment.

8


 

The Company’s proactive testing program has reduced exposure with early detection, reduced employee anxiety and enabled its manufacturing facilities to operate at full capacity in line with local social distancing requirements. The Company also took proactive actions in order to mitigate the business impact of COVID-19 on its financial operations and it continues to monitor closely in order the business impact of COVID-19. Despite the ongoing challenges posed by COVID-19, including the recent global resurgence, the Company continues to invest strategically in engineering, regulatory, clinical trials and manufacturing in order to support its future growth initiatives and sales and marketing activities, with a particular focus on training and education initiatives to drive utilization of its products and recovery awareness for acute heart failure patients.

The Company continues to closely monitor the impact of COVID-19 on all aspects of its business and geographies, including its impact on its customers, employees, suppliers, vendors, business partners and distribution channels. The extent to which the COVID-19 pandemic impacts the Company’s business, results of operations, and financial condition will depend on future developments, which are highly uncertain and are difficult to predict. Even after the ongoing COVID-19 pandemic has subsided, the Company may continue to experience materially adverse impacts on its financial condition and results of operations.

Recently Adopted Accounting Pronouncements

In December 2019, the Financial Accounting Standards Board (“FASB”) issued ASU 2019-12, Simplifying the Accounting for Income Taxes (ASC 740). The ASU enhances and simplifies various aspects 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, separate 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. The Company adopted this standard as of April 1, 2021 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, 2021 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 our condensed consolidated financial statements.

 

Note 3. Acquisitions

Acquisition of preCARDIA, Inc.

The Company acquired 100% interest in 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. The purchase price included cash consideration of $82.8 million for the remaining interest in preCARDIA, paid to the selling shareholders and for transaction costs associated with the acquisition and $32.4 million representing the Company’s previously owned minority interest in preCARDIA. The Company recognized a gain of $21.0 million related to its previously owned minority interest in preCARDIA, within the condensed consolidated statement of operations for the three months ended June 30, 2021.

In connection with the acquisition, the Company acquired net assets of $115.2 million, which included $115.5 million related to the fair value of the in-process research and development asset and $0.3 million for net liabilities assumed. Since the acquired technology platform is pre-commercial and has not reached technical feasibility, the cost of the in-process research and development asset was expensed, resulting in a charge of $115.5 million to the condensed consolidated statement of operations for the three months ended June 30, 2021.

Acquisition of Breethe, Inc.

9


 

The Company acquired Breethe, Inc. (“Breethe”), a Maryland corporation, on April 24, 2020. Breethe is engaged in research and development 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 $55.0 million in cash, with additional potential payouts up to a maximum of $55.0 million payable based on the achievement of certain technical, regulatory and commercial milestones.

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.

10


 

Note 4. Net (Loss) Income Per Share

Basic net (loss) income per share is computed by dividing net (loss) income by the weighted average number of common shares outstanding during the period. Diluted net (loss) income per share is computed by dividing net (loss) income by the weighted average number of dilutive common shares outstanding during the period. Diluted shares outstanding are 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 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 of basic and diluted net (loss) income per share for each period presented three months ended June 30, 2021 and 2020 (in thousands, except per share data):

 

 

 

 

 

For the Three Months Ended June 30,

 

 

 

 

2021

 

 

 

2020

 

Net (loss) income

 

$

(26,525

)

 

$

44,588

 

 

 

 

 

 

 

 

 

 

Weighted average shares – basic

 

 

45,311

 

 

 

45,010

 

 

 

 

 

 

 

 

 

 

Net (loss) income per share – basic

 

$

(0.59

)

 

$

0.99

 

 

 

 

For the Three Months Ended June 30,