•

Worldwide Impella® heart pump revenue for the quarter totaled $199.5 million, an increase of 19% compared to revenue of $168.3 million during the same period of the prior fiscal year. Full year worldwide Impella heart pump revenue totaled $741.7 million for fiscal 2019, an increase of 30% compared to revenue of $570.9 million for the prior fiscal year.

•

U.S. Impella product revenue for the quarter totaled $169.7 million, an increase of 16% compared to revenue of $146.2 million during the same period of the prior fiscal year with U.S. patient usage of the Impella heart pumps up 14%, driven by lower growth in March. Full year U.S. Impella revenue totaled $639.3 million, up 27% compared to $505.1 million in the prior fiscal year with U.S. patient usage of the Impella heart pumps up 23%.

•

Outside the U.S., Impella product revenue for the quarter totaled $29.8 million, an increase of 35% compared to revenue of $22.1 million during the same period of the prior fiscal year. Full year Impella product revenue outside the U.S. totaled $102.4 million, an increase of 56% compared to $65.7 million in the prior fiscal year. Specifically, Japan revenue was $5.4 million for the quarter and $17.5 million for the year, up 212% and 503%, respectively, compared to prior fiscal year.

•

Gross margin for the fourth quarter of fiscal 2019 was 83.2% compared to 82.7% during the same period of fiscal 2018. For the full fiscal year 2019, gross margin was 83.2% compared to 83.4% in fiscal year 2018.

•

Operating income for the fourth quarter fiscal 2019 was $65.4 million, or 31.6% operating margin, compared to $47.6 million, or 27.3% operating margin in the same period of fiscal 2018. For the full fiscal year 2019, operating income was $224.8 million, or 29.2% of revenue, compared to $157.1 million, or 26.5% of revenue in the prior fiscal year.

•

Fourth quarter fiscal 2019 GAAP net income was $74.0 million, or $1.60 per diluted share, an increase of 101%, compared to GAAP net income of $36.8 million or $0.80 per diluted share for the prior fiscal year. Full fiscal year 2019 GAAP net income was $259.0 million, or $5.61 per diluted share, an increase of 131%, compared to $112.2 million, or $2.45 per diluted share for the prior fiscal year. Fourth quarter and full year fiscal GAAP net income includes a $23.6 million, or $0.51 per diluted share unrealized gain on our investment in Shockwave

Medical, Inc.

•

The company generated operating cash flow of $72.2 million in the fourth quarter and $254.0 million for the full fiscal year 2019. During fiscal 2019, the company deployed $71.8 million of cash to repurchase shares related to vested equity awards and $42.7 million for strategic investments in medical device technologies, including Shockwave Medical, Inc. As of March 31, 2019, the company had $513.4 million of cash and marketable securities and no debt.

•

On January 31, the company earned CE Mark for Impella Connect, the first-of-its kind cloud-based technology that enables secure, real-time, remote monitoring of patients on the Impella console for Abiomed clinical consultants and physicians from anywhere with internet connectivity.

•

On February 4, the FDA released a letter to health care providers on the Impella RP heart pump. On March 18, the company presented and published survival data from the 18-month post-approval study of 42 Impella RP patients at the American College of Cardiology’s (ACC) 68th Annual Scientific Session in New Orleans and submitted the post-approval study report to the FDA. The FDA recognizes salvage patients as those outside the Recover Right protocol (>48 hours in cardiogenic shock).   

•

On March 25, the company received Pharmaceuticals and Medical Devices Agency (PMDA) approval from the Japanese Ministry of Health, Labour & Welfare for the Impella CP^® heart pump.

•

On April 4, the company announced that cardiogenic shock survival rates have improved significantly in the three years since the Impella FDA PMA Approval. New data from the IQ Database on patients treated between April 2018 and March 2019 showed an increase in median survival from 51% to 67%, a relative increase of 34% in survival.  Additionally, results published by Dr. Tehrani at Inova Heart and Vascular Institute in the Journal of the American College of Cardiology demonstrate that best practice protocols with early use of percutaneous mechanical circulatory support in AMI cardiogenic shock increased survival at 30 days from 44% to 82% (p=0.0001).

•

On April 23, the company highlighted clinical data on its exclusive FDA approval for high-risk PCI and on the advantages of Protected PCI to enable complete revascularization and improved patient quality of life.  A new study was published in the Journal of Interventional Cardiology by Dr. Burzotta and found that six months after a Protected PCI, the number of patients with left ventricular ejection fraction (LVEF) greater than or equal to 35% increased from 22% to 67%.

•

Today, the company announced in a separate press release that the FDA approved the initiation of the ST-Elevation Myocardial Infarction Door-to-Unloading (STEMI DTU) pivotal randomized controlled trial.

Ingrid Goldberg

Tom Langford

Director, Investor Relations

Director, Communications & Public Relations

978-646-1590

978-882-8408

ir@abiomed.com

tlangford@abiomed.com

Abiomed, Inc. and Subsidiaries

Consolidated Balance Sheets

(Unaudited)

(in thousands, except share data)

March 31, 2019

March 31, 2018

ASSETS

Current assets:

Cash and cash equivalents

$

121,021

$

42,975

Short-term marketable securities

370,677

319,274

Accounts receivable, net

90,809

70,010

Inventories

80,942

50,204

Prepaid expenses and other current assets

13,748

11,808

Total current assets

677,197

494,271

Long-term marketable securities

21,718

37,502

Property and equipment, net

145,005

117,167

Goodwill

32,601

35,808

In-process research and development

15,208

16,705

Long-term deferred tax assets, net

77,502

70,746

Other assets

85,115

14,176

Total assets

$

1,054,346

$

786,375

LIABILITIES AND STOCKHOLDERS' EQUITY

Current liabilities:

Accounts payable

$

32,185

$

23,565

Accrued expenses and other liabilities

57,420

46,147

Deferred revenue

16,393

14,970

Total current liabilities

105,998

84,682

Other long-term liabilities

1,061

776

Contingent consideration

9,575

10,490

Long-term deferred tax liabilities

822

903

Total liabilities

117,456

96,851

Stockholders' equity:

Class B Preferred Stock, $.01 par value

—

—

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

Common stock, $.01 par value

451

444

Authorized - 100,000,000 shares; Issued - 47,026,226 shares at March 31, 2019 and 46,100,649 shares at March 31, 2018;

Outstanding - 45,122,985 shares at March 31, 2019 and 44,375,337 shares at March 31, 2018

Additional paid in capital

690,507

619,905

Retained earnings (Accumulated deficit)

399,473

140,457

Treasury stock at cost - 1,903,241 shares at March 31, 2019 and 1,725,312 shares at March 31, 2018

(138,852

)

(67,078

)

Accumulated other comprehensive income (loss)

(14,689

)

(4,204

)

Total stockholders' equity

936,890

689,524

Total liabilities and stockholders' equity

$

1,054,346

$

786,375

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,

2019

2018

2019

2018

Revenue

$

207,081

$

174,436

$

769,432

$

593,749

Costs and expenses:

Cost of revenue

34,848

30,098

129,567

98,581

Research and development

25,548

21,270

93,503

75,297

Selling, general and administrative

81,296

75,501

321,550

262,734

141,692

126,869

544,620

436,612

Income from operations

65,389

47,567

224,812

157,137

Other income:

Investment income, net

2,769

1,303

8,166

3,688

Other income (expense), net

30,372

(363

)

30,382

(388

)

33,141

940

38,548

3,300

Income before income taxes

98,530

48,507

263,360

160,437

Income tax provision

24,569

11,660

4,344

48,267

Net income (A)

$

73,961

$

36,847

$

259,016

$

112,170

Basic net income per share

$

1.64

$

0.83

$

5.77

$

2.54

Basic weighted average shares outstanding

45,091

44,320

44,911

44,153

Diluted net income per share (B)

$

1.60

$

0.80

$

5.61

$

2.45

Diluted weighted average shares outstanding

46,173

46,141

46,151

45,849

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

Effect of the Tax Reform Act on net deferred tax assets (1)

$

—

$

(593

)

$

—

$

21,364

Excess tax benefits related to stock-based compensation awards (2)

(798

)

(6,501

)

(69,267

)

(30,991

)

Unrealized gain on investment in Shockwave Medical - net of tax (3)

(23,636

)

—

(23,636

)

—

$

(24,434

)

$

(7,094

)

$

(92,903

)

$

(9,627

)

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

Effect of the Tax Reform Act on net deferred tax assets (1)

$

—

$

(0.01

)

$

—

$

0.47

Excess tax benefits related to stock-based compensation awards (2)

(0.02

)

(0.14

)

(1.50

)

(0.68

)

Unrealized gain on investment in Shockwave Medical - net of tax (3)

(0.51

)

—

(0.51

)

—

$

(0.53

)

$

(0.15

)

$

(2.01

)

$

(0.21

)

(1)  On December 22, 2017, the Tax Cut and Jobs Act was enacted into law, which among other items, reduced the U.S. federal statutory corporate income tax rate from 35% to 21% effective January 1, 2018. During the three months and year ended March 31, 2018, the company recorded tax expense adjustments related to the revaluation of its deferred taxes due to a reduction of the U.S. federal statutory corporate income tax rate.

(2) Amount represents the impact of excess tax benefits and shortfalls associated with stock-based awards in each respective period presented.

(3) In the fourth quarter of fiscal 2019, the company recorded an unrealized gain on its investment in Shockwave Medical of $31.2 million ($23.6 million, net of tax provision) and is recorded within other income (expense), net.