Press release

Abiomed Announced Q4 FY 2019 Revenue of $207 Million and 31.6% Operating Margin

FY 2019 Annual Revenue of $769 Million, Up 30%, and 29.2% Operating Margin

DANVERS, Mass.--(BUSINESS WIRE)--May 2, 2019-- Abiomed, Inc. (NASDAQ: ABMD), a leading provider of breakthrough heart recovery and support technologies, today reported fourth quarter fiscal 2019 revenue of $207.1 million, an increase of 19% compared to revenue of $174.4 million for the same period of fiscal 2018. For fiscal year 2019, total revenue was $769.4 million, up 30% compared to revenue of $593.7 million, and operating income was $224.8 million, up 43% compared to operating income of $157.1 million in fiscal year 2018.

“Q4 did not meet our expectations. I take full responsibility for our disappointing performance given a soft March, and we have already initiated a plan of action to correct the course. However, Abiomed had a solid year with 30% growth and improvement in margins. Most importantly, Abiomed’s clinical support, training, and education helped improve patient outcomes in both high-risk PCI and cardiogenic shock. Multiple publications continue to validate the benefits of Impella supported PCI and Impella best practices to help improve survival in cardiogenic shock,” said Abiomed Chairman, President and CEO, Michael R. Minogue. “I am confident in our innovation and business today as well as long-term outlook for Abiomed. We are creating the new Field of Heart Recovery.”

Recent financial and operating highlights include:

  • 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.

FISCAL YEAR 2020 OUTLOOK

The company is giving its fiscal year 2020 guidance for total revenues to be in the range of $900 million to $945 million, an increase of 17% to 23% over the prior year. The company is also giving its fiscal year 2020 guidance for GAAP operating margin to be in the range of 29% to 31%. The company plans to give another formal forecast for the fiscal year on the next earnings call.

EARNINGS CONFERENCE CALL DETAILS

The company will host a conference call to discuss the results at 8 a.m. EDT on Thursday, May 2, 2019. The conference call releasing full quarterly results 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/m6/p/sg8hmgr6 or dial (855) 212-2361; the international number is (678) 809-1538. A replay of this conference call will be available beginning at 12:00 p.m. EDTMay 2, 2019 through 12:00 p.m. EDT on May 9, 2019. The replay phone number is (855) 859-2056; the international number is (404) 537-3406. The replay access code is 2498807.

ABOUT ABIOMED

Based in Danvers, Massachusetts, 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. To learn more about the Impella platform of heart pumps, including their approved indications and important safety and risk information associated with the use of the devices, please visit: www.protectedpci.com.

The Abiomed logo, Abiomed, Impella, Impella 2.5, Impella 5.0, Impella LD, Impella CP, Impella RP, Impella Connect, and Recovering hearts. Saving lives. are registered trademarks of Abiomed, Inc. in the U.S. and in certain foreign countries.

FORWARD-LOOKING STATEMENTS

This release contains forward-looking statements, including statements regarding development of Abiomed's existing and new products, the company's progress toward commercial growth, and future opportunities and expected regulatory approvals. The company's actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including uncertainties associated with development, testing and related regulatory approvals, including the unpredictability of future operating results, complex manufacturing, high quality requirements, dependence on limited sources of supply, competition, technological change, government regulation, litigation matters, future capital needs and uncertainty of additional financing, and other risks and challenges detailed in the company's filings with the Securities and Exchange Commission, including the most recently filed Annual Report on Form 10-K and Quarterly Report on Form 10-Q. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. 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, 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.

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