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8-K - FORM 8-K - ABIOMED INCd297582d8k.htm

Exhibit 99.1

 

LOGO

ABIOMED ANNOUNCES Q3 FY 2017 REVENUE OF $114.7 MILLION, UP 34% OVER PRIOR YEAR

-    Largest Quarterly Sequential Revenue Increase in Company History

DANVERS, Mass. — January 26, 2017 Abiomed, Inc. (NASDAQ: ABMD), a leading provider of breakthrough heart support technologies, today reported third quarter fiscal 2017 revenue of $114.7 million, an increase of 34% compared to revenue of $85.8 million for the same period of fiscal 2016. Third quarter fiscal 2017 GAAP net income was $15.4 million or $0.34 per diluted share, compared to GAAP net income of $10.6 million or $0.23 per diluted share for the prior year period.

Financial and operating highlights during the third quarter of fiscal 2017 include:

 

    Fiscal third quarter worldwide revenue from Impella heart pumps totaled $109.2 million, an increase of 35% compared to revenue of $81.0 million during the same period of the prior fiscal year. U.S. revenue from Impella pumps grew 34% to $100.3 million and U.S. patient usage grew 32%.

 

    Outside the U.S., revenue from Impella heart pumps totaled $8.9 million and was up 47%, predominantly from Germany, which grew 80% in revenue from the prior fiscal year.

 

    The installed base for Impella 2.5™ heart pumps in the U.S. grew by an additional 20 hospitals, which made initial purchases of Impella heart pumps, bringing the installed customer base to 1,119 sites. The installed customer base for Impella CP® heart pumps grew by 49 new U.S. hospitals, bringing the total number of Impella CP sites to 972.

 

    An additional 8 sites made initial purchases of Impella RP® heart pumps during the quarter, bringing the total number of sites to 120.

 

    Gross margin for third quarter fiscal 2017 was 83.4% compared to 85.1% in the prior year period.

 

    Operating income for the third quarter of fiscal 2017 was $25.4 million, or 22.2% operating margin, compared to $17.5 million, or 20.4% operating margin in the prior year period.

 

    The Company generated $22.0 million in cash, cash equivalents and marketable securities, totaling $258.9 million as of December 31, 2016, compared to $236.9 million at September 30, 2016. The Company currently has no debt.

 

    On October 31, 2016, Abiomed launched the Impella Quality (IQ) Assurance Program. The mission of the program is to improve real-world outcomes in Protected PCI and cardiogenic shock patients through training, education and utilization of clinical guidelines, protocols and best practices derived from observational quality assurance data (IQ), Institutional Review Board (IRB) approved registry data (cVAD) and Investigational Device Exemption (IDE) approved FDA studies.

 

    On December 7, 2016, Abiomed announced that the Impella CP received expanded FDA Approval for High-Risk Percutaneous Coronary Intervention (PCI) Procedures

“These are the best of times for Abiomed, because the high risk patient population has been validated and only now with our regulatory approvals can we educate and train our customers to improve the standard of care through hemodynamic support. We began building this field of heart recovery less than


one year ago and in the medical technology industry history demonstrates the impact of FDA approvals on adoption”, said Michael R. Minogue, Chairman, President and Chief Executive Officer, Abiomed. “What makes Abiomed unique is Impella’s ability to be used effectively in a Hub and Spoke model to achieve Protected PCI and heart muscle recovery in your community.”

FISCAL YEAR 2017 OUTLOOK

The Company is increasing the lower end of its fiscal year 2017 revenue guidance with the new range of $440 million to $445 million, an increase in revenue of 34% to 35% from the prior year. This compares to the prior increased forecast of $435 million to $445 million. The Company projects revenue to be around $122 million for the fourth quarter of fiscal 2017 and is maintaining its fiscal year guidance for GAAP operating margin in the range of 18% to 20%.

CONFERENCE CALL

The Company will host a conference call to discuss the results on Thursday, January 26, 2017, at 8:00 a.m. EDT. Michael R. Minogue, Chairman, President and Chief Executive Officer; Michael Tomsicek, Vice President and Chief Financial Officer, will host the conference call.

To listen to the call live, please tune into the webcast via http://investor.abiomed.com or dial (855) 212-2361; the international number is (678) 809-1538. A replay of this conference call will be available beginning at 11 a.m. EST January 26, 2017 through 11 a.m. EST on January 29, 2017. The replay phone number is (855) 859-2056; the international number is (404) 537-3406. The replay access code is 44227123.

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

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

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 potential for future losses, 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.

For further information please contact:

Ingrid Goldberg

Director, Investor Relations

978-646-1590

igoldberg@abiomed.com

Adrienne Smith

Senior Director, Public Relations and Corporate Communications

978-646-1553

adsmith@abiomed.com


Abiomed, Inc. and Subsidiaries

Consolidated Balance Sheets

(Unaudited)

(in thousands, except share data)

 

     December 31, 2016     March 31, 2016  

ASSETS

    

Current assets:

    

Cash and cash equivalents

   $ 61,069      $ 48,231   

Short-term marketable securities

     179,640        163,822   

Accounts receivable, net

     50,178        42,821   

Inventories

     32,053        26,740   

Prepaid expenses and other current assets

     10,479        6,778   
  

 

 

   

 

 

 

Total current assets

     333,419        288,392   

Long-term marketable securities

     18,240        1,000   

Property and equipment, net

     60,909        23,184   

Goodwill

     30,562        33,003   

In-process research and development

     14,257        15,396   

Long-term deferred tax assets, net

     39,007        58,534   

Other assets

     4,570        4,422   
  

 

 

   

 

 

 

Total assets

   $ 500,964      $ 423,931   
  

 

 

   

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

    

Current liabilities:

    

Accounts payable

   $ 14,558      $ 9,381   

Accrued expenses

     34,539        28,382   

Deferred revenue

     9,004        8,778   

Current portion of capital lease obligation

     770        —     
  

 

 

   

 

 

 

Total current liabilities

     58,871        46,541   

Other long-term liabilities

     17        220   

Contingent consideration

     8,175        7,563   

Long-term deferred tax liabilities

     771        832   

Capital lease obligation, net of current portion

     15,750        —     
  

 

 

   

 

 

 

Total liabilities

     83,584        55,156   

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

     435        426   

Authorized - 100,000,000 shares; Issued - 45,081,996 shares at December 31, 2016 and 43,973,119 shares at March 31, 2016

    

Outstanding - 43,507,808 shares at December 31, 2016 and 42,596,228 shares at March 31, 2016

    

Additional paid in capital

     546,796        508,624   

Accumulated deficit

     (61,858     (99,075

Treasury stock at cost - 1,574,188 shares at December 31, 2016 and 1,376,891 shares at March 31, 2016

     (46,556     (26,660

Accumulated other comprehensive loss

     (21,437     (14,540
  

 

 

   

 

 

 

Total stockholders’ equity

     417,380        368,775   
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 500,964      $ 423,931   
  

 

 

   

 

 

 

 


Abiomed, Inc. and Subsidiaries

Consolidated Statements of Operations

(Unaudited)

(in thousands, except per share data)

 

     For the Three Months Ended
December 31,
    For the Nine Months Ended
December 31,
 
     2016     2015     2016     2015  

Revenue:

        

Product revenue

   $ 114,624      $ 85,789      $ 320,541      $ 235,569   

Funded research and development

     50        6        83        17   
  

 

 

   

 

 

   

 

 

   

 

 

 
     114,674        85,795        320,624        235,586   
  

 

 

   

 

 

   

 

 

   

 

 

 

Costs and expenses:

        

Cost of product revenue

     18,987        12,744        51,366        35,756   

Research and development

     16,349        13,755        50,061        35,534   

Selling, general and administrative

     53,935        41,853        158,053        119,005   
  

 

 

   

 

 

   

 

 

   

 

 

 
     89,271        68,352        259,480        190,295   
  

 

 

   

 

 

   

 

 

   

 

 

 

Income from operations

     25,403        17,443        61,144        45,291   
  

 

 

   

 

 

   

 

 

   

 

 

 

Other income (expense):

        

Investment income, net

     457        84        1,068        209   

Other (expense) income, net

     (34     (29     (225     111   
  

 

 

   

 

 

   

 

 

   

 

 

 
     423        55        843        320   
  

 

 

   

 

 

   

 

 

   

 

 

 

Income before income taxes

     25,826        17,498        61,987        45,611   

Income tax provision

     10,394        6,943        24,770        18,462   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net income

   $ 15,432      $ 10,555      $ 37,217      $ 27,149   
  

 

 

   

 

 

   

 

 

   

 

 

 

Basic net income per share

   $ 0.36      $ 0.25      $ 0.86      $ 0.64   

Basic weighted average shares outstanding

     43,431        42,427        43,125        42,118   

Diluted net income per share

   $ 0.34      $ 0.23      $ 0.83      $ 0.61   

Diluted weighted average shares outstanding

     44,770        44,949        44,597        44,805