Growing Shareholder Value

Press Releases

Planet abiomed Inc.
Oct 29,2020

Abiomed Announces Q2 FY 2021 Revenue of $210 Million, Up 27% Over Q1 FY 2021 and Up 2% Over Q2 FY 2020 With 29.2% Operating Margin

DANVERS, Mass.--(BUSINESS WIRE)--Oct. 29, 2020-- Abiomed, Inc. (NASDAQ: ABMD), a leading provider of breakthrough heart support technologies today reported second quarter fiscal 2021 revenue of $209.8 million, a sequential increase of 27% compared to Q1 fiscal year 2021 and a year over year increase of 2% compared to Q2 fiscal year 2020 despite the negative impact of COVID-19. Operating income was $61.3 million up 2%, compared to $60.2 million in the same period of fiscal 2020.

Recent financial and operating highlights include:

  • Worldwide Impella® heart pump revenue for the quarter totaled $199.7 million, a sequential increase of 29% compared to revenue of $155.4 million during Q1 fiscal year 2021 and a 1% increase compared to revenue of $196.9 million during Q2 fiscal year 2020.
  • U.S. Impella product revenue for the quarter totaled $163.2 million, a sequential increase of 29% compared to revenue of $126.2 million during Q1 fiscal year 2021 and a decrease of 1% compared to revenue of $164.7 million during Q2 fiscal year 2020 with U.S. patient usage of the Impella heart pumps up 24% over prior fiscal quarter and down 4% over prior fiscal year.
  • Outside the U.S., Impella product revenue for the quarter totaled $36.5 million, a sequential increase of 25% compared to revenue of $29.2 million during Q1 fiscal year 2021 and an increase of 13% compared to revenue of $32.2 million during Q2 fiscal year 2020. European Impella product revenue increased 29% compared to the prior fiscal quarter and 16% compared to the prior fiscal year. Japan Impella product revenue increased 14% compared to the prior fiscal quarter and 5% compared to the prior fiscal year.
  • Gross margin for the second quarter fiscal 2021 was 81.5% compared to 83.0% during the same period of fiscal 2020.
  • Operating income for the second quarter fiscal 2021 was $61.3 million, or 29.2% operating margin, compared to $60.2 million, or 29.4% operating margin in the same period of fiscal 2020.
  • Second quarter fiscal 2021 GAAP net income was $62.2 million, or $1.36 per diluted share, which includes a $8.2 million, or $0.18 per diluted share, gain on our investment in Shockwave and a $7.9 million, or $0.17 per diluted share, of excess tax benefits related to employee share-based compensation awards. This compared to GAAP net income of $13.1 million or $0.28 per diluted share for the prior fiscal year.
  • The company generated operating cash flow of $77.2 million in the second quarter. As of September 30, 2020, the company had $735.7 million of cash and marketable securities and no debt.
  • At the end of second quarter fiscal 2021, Abiomed has 929 patents and 835 patents pending due to our continued innovation and expanding our global reach.
  • In October, at TCT Connect, more than 20 presentations and abstracts were presented validating the benefits of a more complete revascularization with Impella heart pumps in high-risk percutaneous coronary intervention (PCI) patients and the value of Impella protocol-based treatment for survival and native heart recovery in cardiogenic shock and right heart failure patients. Key data presented includes:
    • New PROTECT III study data demonstrates reduced rates of MACCE (composite of death, stroke, myocardial infarction and repeat procedures) compared to the Protect II dataset (15% vs. 21.9%, p=0.035).
    • The Restore EF Study demonstrates the use of contemporary best practices with Impella-supported high-risk PCI enables a more complete revascularization and is associated with significant improvement of left ventricular ejection fraction (45% relative improvement), heart failure symptoms (80% reduction in NYHA Class III, IV), and anginal symptoms at follow up (99% reduction in CCS Angina Class III, IV).
    • Data from the RECOVER III post-market approval (PMA) study of AMI cardiogenic shock (AMICS) patients was presented in two studies. The first study, presented by Hemindermeet Singh, MD, of Ascension St. John Hospital, found an 18% relative improvement in overall survival in the recent cohort (2017 – 2019) versus a pre-PMA cohort (2008 – 2014), indicating increased adoption of the cardiogenic shock best practices, including placing Impella pre-PCI has led to an improvement in overall survival rates. The second study, presented by Tayyab Shah, MD, of the Yale School of Medicine, found that placing Impella pre-PCI in AMICS patients is associated with higher survival, particularly in women, as compared to post-PCI (74% relative survival benefit).
    • Two Impella RP studies find that early identification of right heart failure and early use of Impella RP is associated with significantly higher survival rates. The ongoing PMA post-approval study, RECOVER RIGHT, presented by Mark Anderson, MD, found patients who received Impella RP support within 48 hours of cardiogenic shock onset had a significantly higher survival rate than those who received delayed right-heart support (73% vs. 14%, p<0.001). Another study, presented by Babar Basir, DO, found persistent diastolic suction alarms on the Automated Impella Controller (AIC) and an elevated central venous pressure of greater than 12mmHg can be an early indication of Right Ventricular Failure.
  • On October 20, the company hosted a virtual investor meeting to review new clinical data presented at TCT Connect. The virtual meeting included a presentation from Chuck A. Simonton, MD, Vice President and Chief Medical Officer.
  • On October 26, the company announced the United States Food and Drug Administration (FDA) granted a 510(k) clearance for Abiomed’s Breethe OXY-1 cardiopulmonary bypass support system.
  • On October 28, the company announced the first two patients have been treated with the Impella ECP expandable percutaneous heart pump as part of an FDA Early Feasibility Study. Impella ECP is the smallest heart pump in the world.

“I am proud to report that we achieved our Q2 'Yellow' phase goals and grew sequentially, stabilized revenue in the US and increased revenue double digits outside of the U.S while advancing our regulatory, clinical and engineering milestones,” said Michael R. Minogue, Abiomed’s Chairman, President and Chief Executive Officer. “I am also proud of the Patients First commitment and leadership from our employees and customers to recover hearts and save lives every day.”

THIRD QUARTER 2021 REVENUE OUTLOOK

Similar to the revenue performance in the second quarter of fiscal year 2021, the company anticipates sequential improvement in revenue in the third quarter fiscal year 2021. At this time, the company anticipates third quarter fiscal year 2021 global revenue to be in the range of $221 million to $230 million, representing flat to 4% growth compared to third quarter fiscal year 2020.

EARNINGS CONFERENCE CALL DETAILS

The company will host a conference call to discuss the quarterly results at 8:00 a.m. ET on Thursday, October 29, 2020. The conference call will be hosted by Michael R. Minogue, Chairman, President and Chief Executive Officer and Todd A. Trapp, Vice President and Chief Financial Officer.

To listen to the call live, please tune into the webcast via https://edge.media-server.com/mmc/p/or57h3yj or dial (855) 212-2361; the international number is (678) 809-1538. A replay of this conference call will be available beginning at 11:00 a.m. ET October 29, 2020 through 10:00 a.m. ET on November 5, 2020. The replay phone number is (855) 859-2056; the international number is (404) 537-3406. The replay access code is 5992445.

ABOUT ABIOMED 

Based in Danvers, Massachusetts, USA, Abiomed, Inc. is a leading provider of medical devices that provide circulatory support. Our products are designed to enable the heart to rest by improving blood flow and/or performing the pumping of the heart. For additional information, please visit: www.abiomed.com. Abiomed, Impella, Impella 2.5, Impella 5.0, Impella LD, Impella CP, Impella RP, Impella 5.5, Impella Connect, and SmartAssist are registered trademarks of Abiomed, Inc., and are registered in the U.S. and certain foreign countries. Impella ECP, Impella XR Sheath, Impella BTR, CVAD, STEMI DTU, Automated Impella Controller and Abiomed Breethe OXY-1 System are pending trademarks of Abiomed, Inc.

FORWARD-LOOKING STATEMENTS

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

Abiomed, Inc. and Subsidiaries

 

Consolidated Balance Sheets

 

(Unaudited)

 

(in thousands, except share data)

 

 

 

 

 

 

 

 

 

 

 

 

September 30,
2020

 

 

March 31,
2020

 

ASSETS

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

202,241

 

 

$

192,341

 

Short-term marketable securities

 

 

330,843

 

 

 

250,775

 

Accounts receivable, net

 

 

80,909

 

 

 

84,650

 

Inventories

 

 

83,209

 

 

 

90,088

 

Prepaid expenses and other current assets

 

 

19,419

 

 

 

18,009

 

Total current assets

 

 

716,621

 

 

 

635,863

 

Long-term marketable securities

 

 

202,613

 

 

 

207,795

 

Property and equipment, net

 

 

175,582

 

 

 

164,931

 

Goodwill

 

 

78,122

 

 

 

31,969

 

In-process research and development

 

 

42,895

 

 

 

14,913

 

Deferred tax assets

 

 

29,547

 

 

 

43,336

 

Other assets

 

 

82,594

 

 

 

117,655

 

Total assets

 

$

1,327,974

 

 

$

1,216,462

 

LIABILITIES AND STOCKHOLDERS' EQUITY

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

21,734

 

 

$

32,774

 

Accrued expenses

 

 

57,227

 

 

 

75,107

 

Deferred revenues

 

 

21,314

 

 

 

19,147

 

Other current liabilities

 

 

4,938

 

 

 

4,857

 

Total current liabilities

 

 

105,213

 

 

 

131,885

 

Contingent consideration

 

 

24,417

 

 

 

9,000

 

Deferred tax liabilities

 

 

4,251

 

 

 

806

 

Other long-term liabilities

 

 

11,684

 

 

 

9,305

 

Total liabilities

 

 

145,565

 

 

 

150,996

 

Commitments and contingencies

 

 

 

 

 

 

 

 

Stockholders' equity:

 

 

 

 

 

 

 

 

Class B Preferred Stock, $.01 par value

 

 

 

 

 

 

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

 

 

 

 

 

 

 

 

Common stock, $.01 par value

 

 

452

 

 

 

451

 

Authorized - 100,000,000 shares; Issued - 47,847,023 shares at September 30, 2020 and 47,542,061 shares at March 31, 2020

 

 

 

 

 

 

 

 

Outstanding - 45,189,883 shares at September 30, 2020 and 45,008,687 shares at March 31, 2020

 

 

 

 

 

 

 

 

Additional paid in capital

 

 

767,527

 

 

 

739,133

 

Retained earnings

 

 

709,283

 

 

 

602,482

 

Treasury stock at cost - 2,657,140 shares at September 30, 2020 and 2,533,374 shares at March 31, 2020

 

 

(287,654

)

 

 

(265,411

)

Accumulated other comprehensive loss

 

 

(7,199

)

 

 

(11,189

)

Total stockholders' equity

 

 

1,182,409

 

 

 

1,065,466

 

Total liabilities and stockholders' equity

 

$

1,327,974

 

 

$

1,216,462

 

Abiomed, Inc. and Subsidiaries

 

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,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Revenue

 

$

209,764

 

 

$

204,974

 

 

$

374,614

 

 

$

412,640

 

Costs and expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of revenue

 

 

38,736

 

 

 

34,867

 

 

 

74,719

 

 

 

71,940

 

Research and development

 

 

30,525

 

 

 

23,969

 

 

 

56,882

 

 

 

47,759

 

Selling, general and administrative

 

 

79,167

 

 

 

85,956

 

 

 

147,611

 

 

 

172,034

 

 

 

 

148,428

 

 

 

144,792

 

 

 

279,212

 

 

 

291,733

 

Income from operations

 

 

61,336

 

 

 

60,182

 

 

 

95,402

 

 

 

120,907

 

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Investment income, net

 

 

1,822

 

 

 

2,932

 

 

 

4,219

 

 

 

5,981

 

Other income (expense), net

 

 

9,757

 

 

 

(45,756

)

 

 

34,370

 

 

 

(6,392

)

 

 

 

11,579

 

 

 

(42,824

)

 

 

38,589

 

 

 

(411

)

Income before income taxes

 

 

72,915

 

 

 

17,358

 

 

 

133,991

 

 

 

120,496

 

Income tax provision

 

 

10,702

 

 

 

4,287

 

 

 

27,190

 

 

 

18,502

 

Net income (A)

 

$

62,213

 

 

$

13,071

 

 

$

106,801

 

 

$

101,994

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic net income per share

 

$

1.38

 

 

$

0.29

 

 

$

2.37

 

 

$

2.25

 

Basic weighted average shares outstanding

 

 

45,104

 

 

 

45,319

 

 

 

45,057

 

 

 

45,267

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Diluted net income per share (B)

 

$

1.36

 

 

$

0.28

 

 

$

2.34

 

 

$

2.22

 

Diluted weighted average shares outstanding

 

 

45,661

 

 

 

45,912

 

 

 

45,609

 

 

 

46,031

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(A) Net income includes the following items:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Excess tax benefits related to stock-based compensation awards

 

$

(7,932

)

 

$

(469

)

 

$

(8,454

)

 

$

(13,290

)

(Gain) loss on investment in Shockwave Medical

 

 

(8,167

)

 

 

34,508

 

 

 

(26,101

)

 

 

4,496

 

 

 

$

(16,099

)

 

$

34,039

 

 

$

(34,555

)

 

$

(8,794

)

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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Excess tax benefits related to stock-based compensation awards

 

$

(0.17

)

 

$

(0.01

)

 

$

(0.19

)

 

$

(0.29

)

(Gain) loss on investment in Shockwave Medical

 

 

(0.18

)

 

 

0.75

 

 

 

(0.57

)

 

 

0.10

 

 

 

$

(0.35

)

 

$

0.74

 

 

$

(0.76

)

 

$

(0.19

)

 

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

Sarah Karr
Communications Manager
978-882-8211
skarr@abiomed.com

Source: 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.