Press release

Abiomed Announces Record Revenue of $241 Million, up 17% Year Over Year, With 26.0% Operating Margin

FY 2021 Annual Revenue of $848 Million, Up 1%, with 27.1% Operating Margin during COVID-19 pandemic

DANVERS, Mass.--(BUSINESS WIRE)--Apr. 29, 2021-- Abiomed, Inc. (NASDAQ: ABMD), a leading provider of breakthrough heart support technologies today reported record fourth quarter fiscal 2021 revenue of $241.2 million compared to revenue of $206.7 million for the same period of fiscal 2020, driven by a record number of patients supported. For fiscal year 2021, total revenue was $847.5 million, up 1% compared to revenue of $840.9 million, and operating income was $229.6 million compared to operating income of $249.2 million in fiscal year 2020.

Recent financial and operating highlights include: 

  • Worldwide Impella® heart pump revenue for the quarter totaled $230.4 million, an increase of 17% compared to revenue of $197.4 million during the same period of the prior fiscal year. Full year worldwide Impella heart pump revenue totaled $806.3 million for fiscal 2021, compared to revenue of $806.8 million for fiscal 2020.
  • U.S. Impella product revenue for the quarter totaled $186.1 million, an increase of 13% compared to revenue of $164.0 million during the same period of the prior fiscal year with U.S. patient usage of the Impella heart pumps up 13%. Full year U.S. Impella revenue totaled $655.2 million, down 3% compared to $674.4 million in the prior fiscal year.
  • Outside the U.S., Impella product revenue for the quarter totaled $44.3 million, an increase of 33% compared to revenue of $33.4 million during the same period of the prior fiscal year. Full year Impella product revenue outside the U.S. totaled $151.1 million, an increase of 14% compared to $132.4 million in the prior fiscal year. Japan revenue was $11.6 million for the quarter and $42.9 million for the year, up 38% and 22%, respectively, compared to prior fiscal year.
  • Gross margin for the fourth quarter of fiscal 2021 was 80.9%, flat compared to the same period of fiscal 2020. For the full fiscal year 2021, gross margin was also 80.9% compared to 82.0% in fiscal year 2020.
  • Operating income for the fourth quarter fiscal 2021 was $62.8 million, or 26.0% operating margin, compared to $58.1 million, or 28.1% operating margin in the same period of fiscal 2020, due to incremental growth investments and stock-based compensation. For the full fiscal year 2021, operating income was $229.6 million, or 27.1% of revenue, compared to $249.2 million, or 29.6% of revenue in the prior fiscal year.
  • Fourth quarter fiscal 2021 GAAP net income was $56.9 million, or $1.24 per diluted share, which includes a $5.9 million, or $0.13 per diluted share, unrealized gain on our investment in Shockwave. This compared to GAAP net income of $31.8 million, or $0.70 per diluted share for the prior fiscal year, which included a $13.6 million, or $0.30 per diluted share, unrealized loss on our investment in Shockwave.
  • Full fiscal year 2021 GAAP net income was $225.5 million, or $4.94 per diluted share, which includes a $38.4 million, or $0.84 per diluted share, unrealized gain on our investment in Shockwave and $12.1 million, or $0.26 per diluted share, of excess tax benefits related to employee share-based compensation awards. This compared to GAAP net income was $203.0 million, or $4.43 per diluted share for the prior fiscal year.
  • The company generated operating cash flow of $86.5 million in the fourth quarter and $274.6 million for the full fiscal year 2021. As of March 31, 2021, the company had $847.8 million of cash and marketable securities and no debt.
  • On January 29, the company announced results from a large study of 356 patients treated with Impella 5.5 with SmartAssist at 16 U.S. and German centers which found a 79% survival rate at explant. A majority of surviving patients recovered their native heart function without needing further mechanical support or a heart transplant. The study was presented at The Society of Thoracic Surgeons (STS) 2021 Annual Meeting by lead author Edward Soltesz, MD, MPH, a cardiovascular and heart transplant surgeon at Cleveland Clinic’s Miller Family Heart, Vascular & Thoracic Institute.
  • On February 17, the company announced the appointment of Myron Rolle, MD, to the Abiomed Board of Directors, effective immediately. Dr. Rolle will serve as a member of the Governance and Nominating Committee and Regulatory and Compliance Committee of the board. Dr. Rolle is a neurosurgeon, Rhodes scholar, and former professional football player in the National Football League.
  • On April 15, the company announced that the first patient has been enrolled in PROTECT IV, a large, prospective, on-label, multi-center randomized controlled trial (RCT) that is designed to provide the level of clinical evidence needed to achieve a Class I guideline recommendationfor Impella in high-risk percutaneous coronary intervention (HRPCI). The first patient was enrolled at Ascension St. John Hospital in Detroit by Dr. Ted Schreiber and Dr. Amir Kaki.
  • On April 28, the company announced the appointment of Paula Johnson, MD, to the Abiomed Board of Directors, effective immediately. Dr. Johnson will serve as a member of the Governance and Nominating Committee of the board. Dr. Johnson is a cardiologist and the 14th president of Wellesley College. Previously, she was the founder and inaugural executive director of the Connors Center for Women’s Health and Gender Biology and was chief of the Division of Women’s Health at Brigham and Women’s Hospital in Boston.
  • On April 28, the company announced the final results from the National Cardiogenic Shock Initiative (NCSI), a single-arm, prospective study assessing outcomes associated with early mechanical circulatory support (MCS) in acute myocardial infarction cardiogenic shock (AMICS) patients treated with PCI. The study evaluated the outcomes of 406 consecutive patients who presented with AMICS from 80 sites throughout the United States, demonstrating a 71% survival to discharge with greater than 90% native heart recovery, when best practices are used, including placement of an Impella heart pump prior to revascularization (PCI).

“At Abiomed, our Patients First mindset gives us purpose and courage and we always seek opportunities to lead, manage, adapt and execute,” said Michael R. Minogue, Abiomed’s Chairman, President and Chief Executive Officer. “For this fiscal year, I would like to thank our employees and customers for their courage, dedication to patients and leadership throughout the pandemic. We exited the year slightly up in revenue, profitable and stronger than ever before.”

FISCAL YEAR 2022 OUTLOOK

The company anticipates fiscal year 2022 global revenue to be in the range of $990 million to $1,030 million, representing 17% to 22% growth compared to fiscal year 2021 The company is also giving its fiscal year 2022 guidance for GAAP operating margin to be in the range of 24% to 26%. The company plans to give another formal forecast for the fiscal year on our next earnings call.

EARNINGS CONFERENCE CALL DETAILS

The company will host a conference call to discuss the quarterly and full year results at 8:00 a.m. ET on Thursday, April 29, 2021. The conference call will be hosted by Michael R. Minogue, Chairman, President and Chief Executive Officer and Todd A. Trapp, Vice President and Chief Financial Officer.

To listen to the call live, please tune into the webcast via https://edge.media-server.com/mmc/p/u4c589ep or dial (855) 212-2361; the international number is (678) 809-1538. A replay of this conference call will be available beginning at 11:00 a.m. ET April 29, 2021 through 11:00 a.m. ET on May 6, 2021. The replay phone number is (855) 859-2056; the international number is (404) 537-3406. The replay access code is 9899023.

ABOUT ABIOMED 

Based in Danvers, Massachusetts, USA, Abiomed, Inc. is 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 performing the pumping of the heart. For additional information, please visit: www.abiomed.com. Abiomed, Impella, Impella 2.5, Impella 5.0, Impella LD, Impella CP, Impella RP, Impella 5.5, Impella Connect, and SmartAssist are registered trademarks of Abiomed, Inc., and are registered in the U.S. and certain foreign countries. Impella ECP, Impella XR Sheath, Impella BTR, CVAD, STEMI DTU, Automated Impella Controller and Abiomed Breethe OXY-1 System are pending trademarks of Abiomed, Inc.

FORWARD-LOOKING STATEMENTS

This release contains forward-looking statements, including, without limitation, statements regarding development of Abiomed's existing and new products, the company's progress toward commercial growth, and future opportunities and expected regulatory approvals. All statements, other than statements of historical facts, may be forward-looking statements. These forward-looking statements may be accompanied by such words as “anticipate,” “believe,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “potential,” “project,” “target,” “should,” “likely,” “will” and other words and terms of similar meaning. The company's actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including, without limitation: the scope, scale and duration of the impact of the COVID-19 pandemic, the company’s dependence on Impella® products for all of its revenues; the company’s ability to successfully compete against its existing or potential competitors; the acceptance of the company’s products by cardiac surgeons and interventional cardiologists; long sales and training cycles associated with expansion into new hospital cardiac centers; reduced market acceptance of the company’s products due to lengthy clinician training process; the company’s ability to effectively manage its growth; the company’s ability to successfully commercialize its products; the company’s ability to obtain regulatory approvals and market and sell its products in certain jurisdictions; enforcement actions and product liability suits relating to off-label uses of the company’s products; unsuccessful clinical trials or procedures relating to products under development; the company’s ability to maintain compliance with regulatory requirements; the failure of third-party payers to provide reimbursement of the company’s products; the company’s ability to increase manufacturing capacity to support continued demand for its products; the company or its vendors’ failure to achieve and maintain high manufacturing standards; the failure of the company’s suppliers to provide the components the company requires; the company’s ability to expand its direct sales activities into international markets; the outcome of ongoing securities class action litigation relating to our public disclosures, the company’s ability to integrate acquired companies into its operations and other risks and challenges detailed in the company's filings with the Securities and Exchange Commission (the “SEC”), including the most recently filed Annual Report on Form 10-K and the filings subsequently filed with or furnished to the SEC. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. Unless otherwise required by law, the company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this release or to reflect the occurrence of unanticipated events.

Abiomed, Inc. and Subsidiaries
Consolidated Balance Sheets
(Unaudited)
(in thousands, except share data)

 

March 31, 2021

 

 

March 31, 2020

 

ASSETS

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

232,710

 

 

$

192,341

 

Short-term marketable securities

 

 

350,985

 

 

 

250,775

 

Accounts receivable, net

 

 

97,179

 

 

 

84,650

 

Inventories

 

 

81,059

 

 

 

90,088

 

Prepaid expenses and other current assets

 

 

26,032

 

 

 

18,009

 

Total current assets

 

 

787,965

 

 

 

635,863

 

Long-term marketable securities

 

 

264,085

 

 

 

207,795

 

Property and equipment, net

 

 

197,129

 

 

 

164,931

 

Goodwill

 

 

78,568

 

 

 

31,969

 

Other intangibles, net

 

 

42,150

 

 

 

14,913

 

Deferred tax assets

 

 

11,380

 

 

 

43,336

 

Other assets

 

 

113,082

 

 

 

117,655

 

Total assets

 

$

1,494,359

 

 

$

1,216,462

 

LIABILITIES AND STOCKHOLDERS' EQUITY

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

34,842

 

 

$

32,774

 

Accrued expenses

 

 

66,046

 

 

 

75,107

 

Deferred revenue

 

 

24,322

 

 

 

19,147

 

Other current liabilities

 

 

3,759

 

 

 

4,857

 

Total current liabilities

 

 

128,969

 

 

 

131,885

 

Other long-term liabilities

 

 

10,162

 

 

 

9,305

 

Contingent consideration

 

 

24,706

 

 

 

9,000

 

Deferred tax liabilities

 

 

847

 

 

 

806

 

Total liabilities

 

 

164,684

 

 

 

150,996

 

Commitments and contingencies

 

 

 

 

 

 

 

 

Stockholders' equity:

 

 

 

 

 

 

 

 

Class B Preferred Stock, $.01 par value

 

 

 

 

 

 

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

 

 

 

 

 

 

 

 

Common stock, $.01 par value

 

 

453

 

 

 

451

 

Authorized - 100,000,000 shares; Issued 47,929,402 shares as of March 31, 2021 and 47,542,061 shares as of March 31, 2020

 

 

 

 

 

 

 

 

Outstanding 45,270,948 shares as of March 31, 2021 and 45,008,687 shares as of March 31, 2020

 

 

 

 

 

 

 

 

Additional paid in capital

 

 

800,690

 

 

 

739,133

 

Retained earnings

 

 

828,007

 

 

 

602,482

 

Treasury stock at cost 2,658,454 shares as of March 31, 2021 and 2,533,374 shares as of March 31, 2020

 

 

(288,030)

 

 

 

(265,411)

 

Accumulated other comprehensive loss

 

 

(11,445)

 

 

 

(11,189)

 

Total stockholders' equity

 

 

1,329,675

 

 

 

1,065,466

 

Total liabilities and stockholders' equity

 

 

1,494,359

 

 

 

1,216,462

Abiomed, Inc. and Subsidiaries
Consolidated Statements of Operations
(Unaudited)
(in thousands, except per share data)

Three Months Ended March 31,

 

 

Fiscal Years Ended March 31,

 

 

2021

 

2020

 

 

2021

 

2020

 

Revenue

$

241,246

 

$

206,658

 

 

$

847,522

 

$

840,883

 

Costs and expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of revenue

 

46,078

 

 

39,369

 

 

 

161,907

 

 

151,305

 

Research and development

 

31,989

 

 

25,346

 

 

 

121,875

 

 

98,759

 

Selling, general and administrative

 

100,375

 

 

83,891

 

 

 

334,183

 

 

341,600

 

 

 

178,442

 

 

148,606

 

 

 

617,965

 

 

591,664

 

Income from operations

 

62,804

 

 

58,052

 

 

 

229,557

 

 

249,219

 

Other income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

 

Investment income, net

 

1,049

 

 

3,100

 

 

 

6,717

 

 

12,167

 

Other income (expense), net

 

9,641

 

 

(21,839)

 

 

 

51,946

 

 

(4,561)

 

 

 

10,690

 

 

(18,739)

 

 

 

58,663

 

 

7,606

 

Income before income taxes

 

73,494

 

 

39,313

 

 

 

288,220

 

 

256,825

 

Income tax provision

 

16,638

 

 

7,515

 

 

 

62,695

 

 

53,816

 

Net income (A)

$

56,856

 

$

31,798

 

 

$

225,525

 

$

203,009

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic net income per share

$

1.26

 

$

0.71

 

 

$

5.00

 

$

4.49

 

Basic weighted average shares outstanding

 

45,246

 

 

45,040

 

 

 

45,140

 

 

45,179

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Diluted net income per share (B)

$

1.24

 

$

0.70

 

 

$

4.94

 

$

4.43

 

Diluted weighted average shares outstanding

 

45,783

 

 

45,575

 

 

 

45,674

 

 

45,816

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(A) Net income includes the effect of the following items:

 

 

 

 

 

 

 

 

 

 

 

 

 

Excess tax benefits related to stock-based compensation awards

 

(1,708)

 

 

(1,063)

 

 

 

(12,071)

 

 

(14,838)

 

Unrealized (gain) loss on investment in Shockwave Medical - net of tax

 

(5,946)

 

 

13,595

 

 

 

(38,379)

 

 

367

 

 

$

(7,654)

 

$

12,532

 

 

$

(50,450)

 

$

(14,471)

 

(B) Diluted net income per share includes the effect of the following items:

 

 

 

 

 

 

 

 

 

 

 

 

 

Excess tax benefits related to stock-based compensation awards

 

(0.04)

 

 

(0.02)

 

 

 

(0.26)

 

 

(0.32)

 

Unrealized (gain) loss on investment in Shockwave Medical - net of tax

 

(0.13)

 

 

0.30

 

 

 

(0.84)

 

 

0.01

 

 

$

(0.17)

 

$

0.28

 

 

$

(1.10)

 

$

(0.31)

 

1 Class I recommendations are strong and indicate that the treatment, procedure, or intervention is useful and effective and should be performed or administered for most patients under most circumstances. Halperin, J. et al., (2015). Circulation, 133:1426–1428

Todd Trapp
Vice President and Chief Financial Officer
978-646-1680
ttrapp@abiomed.com

Sarah Lima
Communications Manager
978-882-8211
slima@abiomed.com

Source: Abiomed, Inc.

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