angio_8k.htm
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
__________

FORM 8-K
 
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
 

Date of Report (Date of earliest event reported):  April 2, 2009

AngioDynamics, Inc.
(Exact Name of Registrant as Specified in Charter)


Delaware
000-50761
11-3146460
(State or Other Jurisdiction of Incorporation)
(Commission File
Number)
(IRS Employer
Identification No.)

 
  603 Queensbury Avenue, Queensbury, New York 
  12804
 
  (Address of Principal Executive Offices)     
 (Zip Code)
 
(518) 798-1215
(Registrant’s telephone number, including area code)
 
 Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
 
o
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
o
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
o
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2 (b))
 
o
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4 (c))
 
 

 
Item 2.02 – Results of Operations and Financial Condition.

On April 2, 2009, AngioDynamics, Inc. (the “Company”) issued a press release announcing financial results for the fiscal third quarter ended February 28, 2009.
 
The information set forth in Item 2.02 of this Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
 
Forward-Looking Statements

This document and its attachments include “forward-looking statements” intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Investors can identify these statements by the fact that they do not relate strictly to historical or current facts. These statements contain words such as “expect,” “reaffirm,” “anticipate,” “plan,” “believe,” “estimate,” “may,” “will,” “predict,” “project,” “might,” “intend,” “potential,” “could,” “would,” “should,” “estimate,” “seek,” “continue,” “pursue,” or “our future success depends,” or the negative or other variations thereof or comparable terminology, are intended to identify such forward-looking statements. In particular, they include statements relating to, among other things, future actions, strategies, future performance and future financial results of the Company.  These forward-looking statements are based on current expectations and projections about future events.

Investors are cautioned that forward-looking statements are not guarantees of future performance or results and involve risks and uncertainties that cannot be predicted or quantified and, consequently, the actual performance or results of the Company may differ materially from those expressed or implied by such forward-looking statements.  Such risks and uncertainties include, but are not limited to, the factors described from time to time in the Company's reports filed with the SEC, including the Company's Form 10-K for the fiscal year ended May 31, 2008, financial community and rating agency perceptions of the Company; the effects of economic, credit and capital market conditions on the economy in general, and on medical device companies in particular; domestic and foreign health care reforms and governmental laws and regulations; third-party relations and approvals, technological advances and patents attained by competitors; and challenges inherent in new product development, including obtaining regulatory approvals.  In addition to the matters described above, the ability of the Company to develop its products, future actions by the FDA or other regulatory agencies, results of pending or future clinical trials, the outcome of pending patent litigation, overall economic conditions, general market conditions, market acceptance, foreign currency exchange rate fluctuations, and the effects on pricing from group purchasing organizations and competition and the ability of the Company to integrate purchased businesses, may affect the actual results achieved by the Company. 

Any forward-looking statements are made pursuant to the Private Securities Litigation Reform Act of 1995 and, as such, speak only as of the date made. The
 

 
Company disclaims any obligation to update the forward-looking statements. Investors are cautioned not to place undue reliance on these forward-looking statements which speak only as of the date stated, or if no date is stated, as of the date of this document.


Item 9.01 – Financial Statements and Exhibits.

(d)               Exhibits.
 

 Exhibit No.
 
Description
 
99.1
 
Press Release dated April 2, 2009.




SIGNATURE
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.


   
ANGIODYNAMICS, INC.
   
(Registrant)
       
       
Date: April 2, 2009
By:
 
/s/ D. Joseph Gersuk
     
D. Joseph Gersuk
     
Chief Financial Officer
       




EXHIBIT INDEX

 Exhibit No.
 
Description
 
99.1
 
Press Release dated April 2, 2009.

angio_99-1.htm

Exhibit 99.1
For Immediate Release
 

Company Contact:
Investor Relations Contacts:
Media Contact:
AngioDynamics, Inc.
D. Joseph Gersuk, CFO
(800) 772-6446 x1608
jgersuk@AngioDynamics.com
EVC Group, Inc.
Doug Sherk / Jenifer Kirtland
(415) 896-6820
dsherk@evcgroup.com
jkirtland@evcgroup.com
EVC Group, Inc.
Steve DiMattia
(646) 201-5445
sdimattia@evcgroup.com
 

AngioDynamics Reports Financial Results for Fiscal 2009 Third Quarter
 
 
·
Net Sales Increase 21% to $49.4 Million
 
 
·
Net Income of $1.9 Million and EPS of $0.08; EPS of $0.15 Prior to Expense Associated with Completion of CEO Transition
 
 
·
(Non GAAP) EBITDA of $5.7 Million or $0.23 Per Share
 
 
·
Conference Call Begins Today at 4:30 p.m. Eastern Time
 
 
QUEENSBURY, N.Y. April 2, 2009AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative medical devices used by interventional radiologists and surgeons for the minimally-invasive treatment of cancer and peripheral vascular disease, today reported financial results for the fiscal third quarter and nine months ended February 28, 2009. Financial results include the acquisition of Diomed assets since June 17, 2008, the date of acquisition, and the acquisition of FlowMedica assets since January 12, 2009, the date of acquisition.

Net sales in the third quarter were $49.4 million, a 21% increase over the $40.7 million reported in the third quarter a year ago. Gross margin in the third quarter was 61.1% compared with 62.2% a year ago. With the completion of the CEO transition announced on December 3, 2008, the Company recorded a provision in the quarter for all current and future costs associated with the Employment Agreement and Non-Statutory Stock Option Agreement entered into on January 20, 2009, with its former chief executive officer, Eamonn Hobbs, and certain costs associated with the recruitment of its new CEO, Jan Keltjens, under an agreement entered into on January 19, 2009. The costs related to the foregoing, inclusive of stock-based compensation, were $2.8 million.

Operating income was $2.6 million in the third quarter, inclusive of the cost of the CEO transition, compared with $7.6 million in the prior year third quarter, which included a gain on the settlement of litigation. Excluding these two items, operating income increased 23% in the third quarter to $5.5 million from $4.5 million a year ago. Net income was $1.9 million or $0.08 per share in the third quarter, compared with $4.9 million or $0.20 per share a year ago. Excluding the aforementioned two items, net
 

 
income increased 26% in the third quarter to $3.7 million from $2.9 million a year ago. EBITDA (Non GAAP) was $5.7 million or $0.23 per share in the third quarter and $10.0 million or $0.41 per share in the third quarter a year ago. Excluding the aforementioned two items, EBITDA increased 25% to $8.5 million or $0.35 per share in the third quarter from $6.8 million or $0.28 per share a year ago.

For the nine months ended February 28, 2009, net sales of $142.2 million increased 19% over the $119.7 million reported in the prior year period; gross margin increased to 61.4% from 61.2% in the prior year period; operating income was $11.3 million compared with $15.9 million in the prior year period; net income was $7.0 million or $0.29 per share, compared with $10.4 million or $0.43 per share in the prior year period; and EBITDA (Non GAAP) was $20.2 million or $0.82 per share, compared with $22.6 million or $0.93 per share in the prior year period. Excluding the aforementioned CEO transition costs and gain on settlement of litigation, for the nine months ended February 28, 2009, operating income increased 13% to $14.4 million from $12.8 million in the prior year period; net income increased 6% to $8.9 million from $8.4 million in the prior year period; and EBITDA (Non GAAP) increased 19% to $23.2 million or $0.95 per share, compared with $19.5 million or $0.80 per share in the prior year period.

AngioDynamics reported cash and investments of $62.3 million and long-term debt of $7.2 million at February 28, 2009.

In fiscal 2009, AngioDynamics began operating three business units: Peripheral Vascular, Access and Oncology/Surgery. Peripheral Vascular sales were $20.7 million in the quarter, an increase of 35% from the third quarter a year ago, inclusive of the laser ablation products acquired from Diomed and the Benephit® product line acquired from FlowMedica. Access sales were $17.2 million in the quarter, an increase of 8% from the third quarter a year ago, and Oncology/Surgery sales grew 22% to $11.5 million from the third quarter a year ago.

“Our third quarter results illustrate how smoothly our CEO transition has gone as we recorded solid growth across all of our business units,” said Jan Keltjens, President and CEO. “I would like to thank Eamonn Hobbs for his support during our transition and for all his contributions to AngioDynamics. Since joining the Company, I’ve visited our principal operating locations in New York, Georgia, California and England to become familiar with our people and our products, and have met some of our customers and industry associations. As a result, I am more excited than ever about the potential of our company.

“For the remainder of fiscal 2009 and beyond, I look forward to working with our team to maximize our opportunities,” continued Mr. Keltjens. “We have a strong and growing oncology/surgery business that is in a position to potentially help millions of patients through our exciting IRE technology. We are focusing our efforts with the NanoKnife™ IRE System on continuing pre-clinical studies to advance the technology and support regulatory filings, enhancing our focus on driving clinical programs towards gaining labeling for specific indications, and
 

 
building professional education programs. Our goal is to use evidence-based medicine to build a strong IRE offering and a successful and sustainable business benefitting a large group of patients.

“We also will be working to build our market-leading laser vein ablation business, the Benephit Targeted Renal Therapy™ product line and our access product lines, as well as reinvigorating our product development effort. Our overall goal is to capitalize on our numerous opportunities while maintaining our business model that generates substantial operating cash flow and positions us to drive a growth strategy through focused internal and external investments,” Mr. Keltjens concluded.

Highlights of the quarter and more recent activities include the following:

 
·
AngioDynamics completed the product development integration of the acquired Diomed business with the February launch of NeverTouch® – FRS. The company’s product set has now been expanded to enable the use of the NeverTouch fiber on the Delta series laser, as well as lasers formerly manufactured by Diomed.

 
·
The assets of privately-held FlowMedica Inc., a leader in the emerging field of Targeted Renal Therapy were purchased for $1.75 million plus an earn out based on 2011 net sales. The Benephit product line has been integrated into AngioDynamics Peripheral Vascular business unit. Targeted Renal Therapy is a therapeutic approach which delivers drugs directly to the kidneys to prevent and treat acute kidney injury (AKI), which results from many common interventional and surgical procedures.

 
·
Positive clinical uses of NanoKnife continued, as six sites in the U.S., Australia, Germany and Italy have completed a total of 48 IRE procedures for percutaneous prostate, percutaneous and laparoscopic liver, percutaneous kidney, lymph node, and lung lesions as of the date of this release. The physicians performing the procedures have reported either same day patient discharge, in the case of prostate procedures, or typically a one-day stay, in the case of hepatic or renal procedures. Physicians have also commented on short procedure times compared to thermal ablation modalities. Most patients treated continue to comment on a distinct lack of, or very minimal pain, especially when compared to previous thermal focal therapy treatments.

 
·
Two independent pre-clinical pancreatic IRE safety studies have concluded with promising results. One of these studies is now entering a second phase to gather longer-term chronic data and to gain a more in-depth understanding of pathology results. In addition, in Australia, the Therapeutic Good Administration has approved the NanoKnife System for commercial sale and similar approval has been obtained from the Canadian Health Protection Branch.
 


 
 
·
Study results published in the December 2008 edition of the Journal of Urology demonstrated the benefits of using the Habib® 4X radio frequency resection device in procedures to treat kidney malignancies compared to a control group using other common means. These benefits include significantly diminished blood loss, far fewer adverse events and a shorter operative time.
 

Fiscal 2009 Guidance
 
AngioDynamics has updated its outlook for fiscal 2009 incorporating the results from the third fiscal quarter and the acquisition of FlowMedica assets:
 
 
·
Net sales in the range of $195 million to $198 million
 
 
·
Gross margin in the range of 61% to 62%
 
 
·
GAAP operating income in the range of $17 million to $18 million
 
 
·
EBITDA in the range of $29 million to $30 million
 
 
·
GAAP EPS in the range of $0.42 to $0.45, inclusive of the expenses incurred for the CEO transition 
 
 
Conference Call
 
AngioDynamics management will host a conference call to discuss its third quarter results today beginning at 4:30 p.m. Eastern Time. To participate in the live call by telephone, please dial 1 (800) 257-7087 from the U.S. or for international callers, please dial +1 (303) 262-2140.
 
In addition, individuals can listen to the call on the Internet by visiting the investor relations portion of the AngioDynamics Web site at http://investor.angiodynamics.com. To listen to the live call, please go to the Web site 15 minutes prior to its start to register, download and install the necessary audio software.
 
A replay will be available on the Web site. A telephone replay will be available from 6:30 p.m. Eastern time on April 2, 2009, through 11:59 p.m. Eastern time on April 9, 2009, by dialing 1 (800) 405-2236 (domestic) or +1 (303) 590-3000 (international) and entering the passcode: 11128472#.

 
Use of Non-GAAP Measures
 
Management uses non-GAAP measures to establish operational goals, and believes that non-GAAP measures may assist investors in analyzing the underlying trends in AngioDynamics’ business over time. Investors should consider these non-GAAP measures in addition to, not as a substitute for or as superior to, financial reporting measures prepared in accordance with GAAP. In this news release, the Company has reported non-GAAP EBITDA, (earnings before interest, taxes, depreciation and amortization), and non-GAAP EBITDA per share. Management uses these measures in its internal analysis and review of operational performance. Management believes that these measures provide investors with useful information in comparing the Company’s performance over different periods, particularly when comparing this period to periods in
 

 
which the Company did not incur any expenses relating to these activities or items. By using these non-GAAP measures, management believes that investors get a better picture of the performance of the Company’s underlying business. Management encourages investors to review the Company’s financial results prepared in accordance with GAAP to understand the Company’s performance taking into account all relevant factors, including those that may only occur from time to time but have a material impact on the Company’s financial results. Please see the tables that follow for a reconciliation of GAAP to non-GAAP measures.
 

About AngioDynamics

AngioDynamics, Inc. (“AngioDynamics” or the “Company”) is a leading provider of innovative medical devices used by interventional radiologists, surgeons and other physicians for the minimally-invasive treatment of cancer and peripheral vascular disease. The Company’s diverse product line includes market-leading radiofrequency ablation and irreversible electroporation resection systems, vascular access products, angiographic products and accessories, dialysis products, angioplasty products, drainage products, thrombolytic products, embolization products and venous products. More information is available at www.angiodynamics.com.

Safe Harbor

This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements regarding AngioDynamics’ expected future financial position, results of operations, cash flows, business strategy, budgets, projected costs, capital expenditures, products, competitive positions, growth opportunities, plans and objectives of management for future operations, as well as statements that include the words such as “expects,” “reaffirms” “intends,” “anticipates,” “plans,” “believes,” “seeks,” “estimates,” or variations of such words and similar expressions, are forward-looking statements. These forward looking statements are not guarantees of future performance and are subject to risks and uncertainties. Investors are cautioned that actual events or results may differ from the Company’s expectations. Factors that may affect the actual results achieved by the Company include, without limitation, the ability of the Company to develop its existing and new products, future actions by the FDA or other regulatory agencies, results of pending or future clinical trials, overall economic conditions, general market conditions, market acceptance, foreign currency exchange rate fluctuations, the effects on pricing from group purchasing organizations and competition, the ability of the Company to integrate purchased businesses as well as the risk factors listed from time to time in the SEC filings of AngioDynamics, Inc., including but not limited to its Annual Report on Form 10-K for the year ended May 31, 2008. The Company does not assume any obligation to publicly update or revise any forward-looking statements for any reason.

 
In the United States, NanoKnife has been cleared by the FDA for use in the surgical ablation of soft tissue. This document may discuss the use of NanoKnife for specific clinical indications for which it is not cleared in the United States at this time.
 
(Tables to Follow)
 

 
ANGIODYNAMICS, INC. AND SUBSIDIARIES
CONSOLIDATED INCOME STATEMENTS
(in thousands, except per share data)
 
 
   
Three months ended
   
Nine months ended
 
   
Feb 28,
   
Feb 29,
   
Feb 28,
   
Feb 29,
 
   
2009
   
2008
   
2009
   
2008
 
   
(unaudited)
   
(unaudited)
 
                         
Net sales
  $ 49,447     $ 40,725     $ 142,234     $ 119,748  
Cost of sales
    19,225       15,407       54,862       46,474  
    Gross profit
    30,222       25,318       87,372       73,274  
    % of net sales
    61.1 %     62.2 %     61.4 %     61.2 %
                                 
Operating expenses
                               
   Research and development
    4,692       3,955       13,079       10,360  
   Sales and marketing
    13,651       11,725       40,735       33,540  
   General and administrative
    4,085       3,409       12,359       11,604  
   Amortization of intangibles
    2,323       1,777       6,816       5,006  
   Gain on settlement of litigation
    -       (3,151 )     -       (3,151 )
   CEO transition costs
    2,841       -       3,041       -  
    Total operating expenses
    27,592       17,715       76,030       57,359  
    Operating income
    2,630       7,603       11,342       15,915  
Other income (expense), net
    93       238       (658 )     688  
Income before income taxes
    2,723       7,841       10,684       16,603  
Provision for income taxes
    811       2,951       3,654       6,233  
    Net income
  $ 1,912     $ 4,890     $ 7,030     $ 10,370  
                                 
Earnings per common share
                               
    Basic
  $ 0.08     $ 0.20     $ 0.29     $ 0.43  
    Diluted
  $ 0.08     $ 0.20     $ 0.29     $ 0.43  
                                 
Weighted average common shares
                               
    Basic
    24,366       24,123       24,342       24,042  
    Diluted
    24,484       24,404       24,501       24,343  
 
 
 

 
 
ANGIODYNAMICS, INC. AND SUBSIDIARIES
CONSOLIDATED INCOME STATEMENTS
(in thousands, except per share data)
 
Reconciliation of Operating Income to non-GAAP EBITDA:
             
                         
   
Three months ended
   
Nine months ended
 
   
Feb 28,
   
Feb 29,
   
Feb 28,
   
Feb 29,
 
   
2009
   
2008
   
2009
   
2008
 
   
(unaudited)
   
(unaudited)
 
                         
Operating income
  $ 2,630     $ 7,603     $ 11,342     $ 15,915  
                                 
Amortization of intangibles
    2,323       1,777       6,816       5,006  
Depreciation
    709       589       1,998       1,683  
EBITDA
  $ 5,662     $ 9,969     $ 20,156     $ 22,604  
                                 
EBITDA per common share
                               
Basic
  $ 0.23     $ 0.41     $ 0.83     $ 0.94  
Diluted
  $ 0.23     $ 0.41     $ 0.82     $ 0.93  
                                 
Weighted average common shares
                               
Basic
    24,366       24,123       24,342       24,042  
Diluted
    24,484       24,404       24,501       24,343  
 
 

 
 
ANGIODYNAMICS, INC. AND SUBSIDIARIES
NET SALES BY BUSINESS UNIT AND BY GEOGRAPHY
(in thousands)
 
   
Three months ended
   
Nine months ended
 
   
Feb 28,
   
Feb 29,
   
Feb 28,
   
Feb 29,
 
   
2009
   
2008
   
2009
   
2008
 
   
(unaudited)
   
(unaudited)
 
                         
Net Sales by Business Unit
                       
Peripheral Vascular
  $ 20,743     $ 15,411     $ 60,947     $ 45,884  
Access
    17,176       15,846       48,931       46,322  
Oncology/Surgery
    11,528       9,468       32,356       27,542  
Total
  $ 49,447     $ 40,725     $ 142,234     $ 119,748  
                                 
                                 
                                 
                                 
Net Sales by Geography
                               
United States
  $ 44,074     $ 37,021     $ 126,262     $ 108,617  
International
    5,373       3,704       15,972       11,131  
Total
  $ 49,447     $ 40,725     $ 142,234     $ 119,748  
 
 
 
 

 
 
ANGIODYNAMICS, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(in thousands)
 
 
   
Feb 28,
   
May 31,
 
   
2009
   
2008
 
   
(unaudited)
     
(2)
 
Assets
             
Current Assets
             
 
Cash and cash equivalents
  $ 26,776     $ 32,040  
 
Restricted cash
    -       68  
 
Marketable securities
    35,557       46,182  
 
        Total cash and investments
    62,333       78,290  
                 
 
Receivables, net
    26,501       26,642  
 
Inventories, net
    32,415       22,901  
 
Deferred income taxes
    8,063       10,902  
 
Prepaid expenses and other
    5,305       3,147  
 
        Total current assets
    134,617       141,882  
                 
Property, plant and equipment, net
    22,600       21,163  
Intangible assets, net
    70,065       71,311  
Goodwill
    161,990       162,707  
Deferred income taxes
    7,425       6,860  
Other non-current assets
    3,882       4,824  
 
        Total Assets
  $ 400,579     $ 408,747  
                   
Liabilities and Stockholders' Equity
               
Current portion of long-term debt
  $ 350     $ 10,040  
Contractual payments on acquisition of business, net
    5,164       9,625  
Other current liabilities
    20,370       19,537  
Litigation provision
    -       6,757  
Long-term debt, net of current portion
    6,810       7,075  
 
        Total Liabilities
    32,694       53,034  
                 
Stockholders' equity
    367,885       355,713  
 
        Total Liabilities and Stockholders' Equity
  $ 400,579     $ 408,747  
                 
Shares outstanding
    24,426       24,268  
                 
                 
                 
(2)
Derived from audited financial statements
               
 
 

 
 
ANGIODYNAMICS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
 
   
Nine months ended
 
   
Feb 28,
   
Feb 29,
 
   
2009
   
2008
 
   
(unaudited)
 
             
Cash flows from operating activities:
           
 Net income
  $ 7,030     $ 10,370  
 Depreciation and amortization
    8,814       6,689  
 Tax effect of exercise of stock options
    (104 )     223  
 Deferred income taxes
    2,438       4,901  
 Stock-based compensation
    4,508       3,658  
 Other
    912       602  
 Changes in operating assets and liabilities
               
 Receivables
    1,198       (2,242 )
 Inventories
    (6,444 )     1,881  
 Accounts payable and accrued liabilities
    1,704       (509 )
 Litigation provision
    (6,757 )     (3,151 )
 Other
    (259 )     (2,290 )
 Net cash provided by operating activities
    13,040       20,132  
                 
 Cash flows from investing activities:
               
 Additions to property, plant and equipment
    (3,472 )     (4,792 )
 Acquisition of intangible assets and business
    (17,078 )     (3,471 )
 Change in restricted cash
    68       (9,195 )
 Purchases, sales and maturities of marketable securities, net
    10,516       9,650  
 Net cash used in investing activities
    (9,966 )     (7,808 )
                 
Cash flows from financing activities:
               
 Repayment of long-term debt
    (9,955 )     (230 )
 Proceeds from exercise of stock options and ESPP
    1,765       3,209  
 Other
    (148 )     30  
 Net cash (used in) provided by financing activities
    (8,338 )     3,009  
                 
 Increase (decrease) in cash and cash equivalents
    (5,264 )     15,333  
                 
Cash and cash equivalents
               
 Beginning of period
    32,040       28,313  
 End of period
  $ 26,776     $ 43,646