Attached files

file filename
8-K - FORM 8-K - ABIOMED INCd387864d8k.htm

Exhibit 99.1

 

LOGO

ABIOMED ANNOUNCES Q4 FY 2017 REVENUE OF $124.7 MILLION, UP 33% OVER PRIOR YEAR AND TOTAL YEAR REVENUE OF $445.3 MILLION, UP 35% OVER PRIOR YEAR

DANVERS, Mass. — May 4, 2017Abiomed, Inc. (NASDAQ: ABMD), a leading provider of breakthrough heart support technologies, today reported fourth quarter fiscal 2017 revenue of $124.7 million, an increase of 33% compared to revenue of $94.0 million for the same period of fiscal 2016. For fiscal year 2017, total revenue was $445.3 million, up 35% compared to revenue of $329.5 million in fiscal year 2016.

Fourth quarter fiscal 2017 GAAP net income was $14.9 million or $0.33 per diluted share, impacted by $3.1 million or $0.07 per diluted share of one-time items, described below. For the full fiscal year, GAAP net income was $52.1 million or $1.17 per diluted share.

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

 

    Fiscal fourth quarter worldwide Impella® heart pump revenue totaled $118.9 million, an increase of 34% compared to revenue of $88.6 million during the same period of the prior fiscal year. Full year worldwide Impella revenue totaled $423.7 million, up 37% compared to $310.1 million for fiscal 2016.

 

    U.S. Impella heart pump revenue for the quarter grew 32% to $108.2 million from $81.8 million in the prior fiscal year with U.S. patient usage of the Impella heart pumps up 30%. Full year U.S. Impella revenue totaled $387.5 million, up 35% compared to $287.2 million in the prior fiscal year.

 

    The installed base for Impella 2.5® heart pumps in the U.S. grew by an additional 19 hospitals, which made initial purchases of Impella heart pumps, bringing the installed customer base to 1,138 sites. The installed customer base for Impella CP® heart pumps grew by 44 new U.S. hospitals, bringing the total number of Impella CP sites to 1,016. The installed customer base for Impella 5.0® heart pumps grew by 11 new U.S. hospitals, bringing the total number of Impella 5.0 sites to 453.

 

    An additional 7 sites made initial purchases of Impella RP® heart pumps during the quarter, bringing the total number of sites to 127.

 

    Gross margin for fiscal fourth quarter 2017 was 84.6% compared to 84.4% in the fourth quarter of fiscal 2016. For the full fiscal year, gross margin was 84.1% compared to 84.7% in the prior year.

 

    Operating income for the fourth quarter of fiscal 2017 was $29.0 million, or 23.3% operating margin, compared to $19.8 million, or 21.1% operating margin in the prior year period. For the full fiscal year, operating income was $90.1 million, or 20.2% of revenue, compared to $65.1 million, or 19.8% of revenue in the prior year.

 

    The Company generated $18.2 million in cash, cash equivalents and marketable securities in the fourth quarter of fiscal 2017, bringing the total to $277.1 million as of March 31, 2017. The Company currently has no debt.

 

   

Fourth quarter fiscal 2017 GAAP net income was $14.9 million or $0.33 per diluted share and full fiscal year GAAP net income was $52.1 million or $1.17 per diluted share. This compares


 

to GAAP net income for the fourth quarter of fiscal 2016 of $11.0 million or $0.24 per diluted share and full fiscal year GAAP net income of $38.1 million or $0.85 per diluted share. During the fourth quarter of fiscal 2017, the Company recorded a non-recurring income tax charge of $3.1 million, or $0.07 per diluted share, related to uncertainty about the utilization of research and development tax credits.

 

    Beginning in the first quarter of fiscal 2018, the Company will adopt a new accounting standard entitled “Improvements to Employee Share-Based Payment Accounting”. Under this new standard, excess tax benefits and deficiencies associated with employee share-based payments will no longer be recognized as additional paid-in capital on the balance sheet, but instead will be recognized directly to income tax expense or benefit in the income statement for the reporting period in which they occur. The adoption of the new accounting standard is likely to introduce positive fluctuations to net income, our tax provision and earnings per share this year, but will not impact Abiomed’s operating income or cash tax paid.

 

    On February 23, 2017, Abiomed announced that it has supported more than 50,000 patients in the U.S. with its Impella® heart pumps.

 

    On March 19, 2017 at the American College of Cardiology (ACC) 66th Annual Scientific Session in Washington, D.C, Abiomed announced and presented data from the Impella® Quality (IQ) Assurance Program, which includes the IQ Database and cVAD RegistryTM. The Abiomed IQ Assurance Program is a real-world collection of clinical information derived from the treatment of patients with Impella devices since 2008. Trends in the observational IQ Database, combined with information from Abiomed’s Institutional Review Board (IRB)-approved cVAD Registry have helped identify best practices and protocols that are associated with improved survival and native heart recovery in hospitals using Impella devices. The data presented also included new data from the Detroit Cardiogenic Shock Initiative (DCSI), which is an unprecedented collaboration between five heart hospitals in Detroit focused on systematic best practices to increase cardiogenic shock survival rates.

 

    On March 30, 2017, Abiomed announced the Grand Opening of Newly-Expanded manufacturing and training space at Danvers, Massachusetts headquarters.

 

    Today, Abiomed announced in a separate press release, the first patient enrolled in the STEMI Door to Unloading (DTU) feasibility study.

“Abiomed remains one of the fastest growing GAAP profitable companies and fiscal 2017 was another successful year as we achieved our corporate goals with two FDA approvals, approval in Japan, and dedicated DRGs from the Centers for Medicare and Medicaid Services (CMS),” said Michael R. Minogue, Chairman, President and Chief Executive Officer, Abiomed. “We want to thank our shareholders for their support and all of our employees and customers for their hard work and dedication to patients and our mission of heart recovery.”

FISCAL YEAR 2018 OUTLOOK

The Company is giving its fiscal year 2018 guidance for total revenues to be in the range of $555 million to $575 million, an increase of 25% - 29% over the prior year. The Company is also giving its fiscal year 2018 guidance for GAAP operating margin to be in the range of 22% to 24%.

EARNINGS CONFERENCE CALL DETAILS

The Company will host a conference call to discuss the results at 8 a.m. ET on Thursday, May 4, 2017. The conference call releasing full quarterly results will be hosted by Michael R. Minogue, Chairman, President and Chief Executive Officer and Michael Tomsicek, Vice President and Chief Financial Officer.

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. EDT May 4, 2017 through 11:00 a.m. EDT on May 7, 2017. The replay phone number is (855) 859-2056; the international number is (404) 537-3406. The replay access code is 3991529.


The ABIOMED logo, ABIOMED, Impella, Impella 2.5, Impella CP, Impella 5.0, Impella RP, and Recovering Hearts. Saving Lives. are registered trademarks of ABIOMED, Inc. in the U.S. and in certain foreign countries. cVAD Registry is a trademark 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

ir@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)

 

     March 31, 2017     March 31, 2016  

ASSETS

    

Current assets:

    

Cash and cash equivalents

   $ 39,040     $ 48,231  

Short-term marketable securities

     190,908       163,822  

Accounts receivable, net

     54,055       42,821  

Inventories

     34,931       26,740  

Prepaid expenses and other current assets

     8,024       6,778  
  

 

 

   

 

 

 

Total current assets

     326,958       288,392  

Long-term marketable securities

     47,143       1,000  

Property and equipment, net

     87,777       23,184  

Goodwill

     31,045       33,003  

In-process research and development

     14,482       15,396  

Long-term deferred tax assets, net

     34,723       58,534  

Other assets

     8,286       4,422  
  

 

 

   

 

 

 

Total assets

   $ 550,414     $ 423,931  
  

 

 

   

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

    

Current liabilities:

    

Accounts payable

   $ 20,620     $ 9,381  

Accrued expenses

     37,703       28,382  

Deferred revenue

     10,495       8,778  

Current portion of capital lease obligation

     799       —    
  

 

 

   

 

 

 

Total current liabilities

     69,617       46,541  

Other long-term liabilities

     3,251       220  

Contingent consideration

     9,153       7,563  

Long-term deferred tax liabilities

     783       832  

Capital lease obligation, net of current portion

     15,539       —    
  

 

 

   

 

 

 

Total liabilities

     98,343       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

     437       426  

Authorized - 100,000,000 shares; Issued - 45,249,281 shares at March 31, 2017 and 43,973,119 shares at March 31, 2016;

    

Outstanding - 43,673,286 shares at March 31, 2017 and 42,596,228 shares at March 31, 2016

    

Additional paid in capital

     565,962       508,624  

Accumulated deficit

     (46,959     (99,075

Treasury stock at cost - 1,575,995 shares at March 31, 2017 and 1,376,891 shares at March 31, 2016

     (46,763     (26,660

Accumulated other comprehensive loss

     (20,606     (14,540
  

 

 

   

 

 

 

Total stockholders’ equity

     452,071       368,775  
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 550,414     $ 423,931  
  

 

 

   

 

 

 


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,
 
     2017     2016      2017     2016  

Revenue:

         

Product revenue

   $ 124,654     $ 93,951      $ 445,195     $ 329,520  

Funded research and development

     26       6        109       23  
  

 

 

   

 

 

    

 

 

   

 

 

 
     124,680       93,957        445,304       329,543  
  

 

 

   

 

 

    

 

 

   

 

 

 

Costs and expenses:

         

Cost of product revenue

     19,261       14,663        70,627       50,419  

Research and development

     16,325       14,225        66,386       49,759  

Selling, general and administrative

     60,100       45,256        218,153       164,261  
  

 

 

   

 

 

    

 

 

   

 

 

 
     95,686       74,144        355,166       264,439  
  

 

 

   

 

 

    

 

 

   

 

 

 

Income from operations

     28,994       19,813        90,138       65,104  
  

 

 

   

 

 

    

 

 

   

 

 

 

Other income:

         

Investment income, net

     486       186        1,554       395  

Other (expense) income, net

     (124     228        (349     339  
  

 

 

   

 

 

    

 

 

   

 

 

 
     362       414        1,205       734  
  

 

 

   

 

 

    

 

 

   

 

 

 

Income before income taxes

     29,356       20,227        91,343       65,838  

Income tax provision

     14,457       9,229        39,227       27,691  
  

 

 

   

 

 

    

 

 

   

 

 

 

Net income

   $ 14,899     $ 10,998      $ 52,116     $ 38,147  
  

 

 

   

 

 

    

 

 

   

 

 

 

Basic net income per share

   $ 0.34     $ 0.26      $ 1.21     $ 0.90  

Basic weighted average shares outstanding

     43,579       42,463        43,238       42,204  

Diluted net income per share

   $ 0.33     $ 0.24      $ 1.17     $ 0.85  

Diluted weighted average shares outstanding

     44,924       45,112        44,658       44,895