UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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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): October 6, 2009
AngioDynamics, Inc.
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(Exact Name of Registrant as Specified in Charter)
Delaware 000-50761 11-3146460
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(State or Other Jurisdiction (Commission File (IRS Employer
of Incorporation) Number) Identification No.)
603 Queensbury Avenue, Queensbury, New York 12804
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(Address of Principal Executive Offices) (Zip Code)
(518) 798-1215
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(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:
|_| Written communications pursuant to Rule 425 under the Securities Act (17
CFR 230.425)
|_| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
|_| Pre-commencement communications pursuant to Rule 14d-2(b) under the
Exchange Act (17 CFR 240.14d-2 (b))
|_| 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 October 6, 2009, AngioDynamics, Inc. (the "Company") issued a press
release announcing financial results for the fiscal first quarter ended August
31, 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, 2009, 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
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99.1 Press Release dated October 6, 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: October 6, 2009 By: /s/ D. Joseph Gersuk
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D. Joseph Gersuk
Chief Financial Officer
EXHIBIT INDEX
Exhibit No. Description
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99.1 Press Release dated October 6, 2009.
EXHIBIT 99.1
[ANGIODYNAMICS]
For Immediate Release
Company Contact: Investor Relations Contacts: Media Contact:
AngioDynamics, Inc. EVC Group, Inc. EVC Group, Inc.
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D. Joseph Gersuk, CFO Doug Sherk / Jenifer Kirtland Steve DiMattia
(800) 772-6446 x1608 (415) 896-6820 (646) 201-5445
jgersuk@AngioDynamics.com dsherk@evcgroup.com sdimattia@evcgroup.com
- ------------------------- ------------------- ----------------------
jkirtland@evcgroup.com
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AngioDynamics Reports Fiscal First Quarter 2010 Financial Results
o Net Sales Increase 13% to $50.1 Million
o Net Income of $2.1 Million, or $0.09 EPS vs. $0.09 EPS in Q1FY09
o Conference Call Begins Today at 4:30 p.m. Eastern Time
QUEENSBURY, N.Y. October 6, 2009 -- AngioDynamics (NASDAQ: ANGO), a leading
provider of innovative medical devices for minimally-invasive treatment of
cancer and peripheral vascular disease, today reported financial results for the
fiscal first quarter ended August 31, 2009.
Net sales in the first quarter were $50.1 million, a 13% increase over the $44.3
million reported in the first quarter a year ago. Gross margin was 60.2%
compared with 61.9% a year ago, with the decline primarily attributable to
product mix, material cost increases, a competitive pricing environment and
utilization factors. Operating income was $3.6 million in the quarter compared
with $3.8 million a year ago. Net income in the first quarter was $2.1 million
or $0.09 per share compared with $2.2 million, or $0.09 per share a year ago.
The decline in net income is primarily attributable to increased operating
expenses associated with sales and marketing programs and the Company's
continuing investment in irreversible electroporation (IRE) technology.
AngioDynamics reported cash and investments of $68.8 million and long-term debt
of $6.7 million at August 31, 2009.
Peripheral Vascular sales increased by 14% from the first quarter a year ago to
$21.1 million, and included sales of the Benephit(R) renal infusion system
acquired from FlowMedica in January 2009, as well as the sales from the
acquisition of Diomed assets since June 17, 2008. Access sales were $16.2
million in the quarter, an increase of 3% from the first quarter a year ago, and
Oncology/Surgery sales grew 25% to $12.8 million from the first quarter a year
ago.
"We made early progress in some of the areas of focus we established for the
company, yet have hard work ahead of us," said Jan Keltjens, President & CEO.
"Our sales growth for the quarter was driven by our Oncology/Surgery business
unit, as well as our laser vein ablation, or VenaCure EVLT(TM), product line.
VenaCure EVLT sales benefited from the increased focus of our commercial team
and the fundamental strength of our NeverTouch(R) technology.
"Our gross margin was impacted by sales mix, pricing pressures and cost
increases on certain purchased products," continued Mr. Keltjens. "We are
addressing this through our stated focus on manufacturing excellence and
inventory management. We believe this focus will result in gross margin
improvement and lower inventory levels beginning in the second half of the
fiscal year. In addition, our focus on innovation keeps us on schedule to launch
an additional seven new products, for a total of 11, by the end of the fiscal
year."
Highlights of the quarter and more recent activities include the following:
o Shawn P. McCarthy was named Senior Vice President and General Manager of
the Company's Peripheral Vascular Business Unit. Mr. McCarthy was formerly
Vice President of Marketing at Cordis, a division of Johnson & Johnson.
o NanoKnife(R) continues to be utilized by physicians at various
institutions who have treated an additional 20 patients since mid-July.
The total number of patients treated to date by the NanoKnife at eight
centers now stands at 86. Procedures have been performed in five organs
(prostate, liver, lung, kidney and lymph nodes). In all cases the safety
profile for this non-thermal ablation technology remains impressive.
NanoKnife IRE sales were $74,000 in the first quarter.
o The IRE development program is making steady progress with an
investigational device exemption (IDE) application for a focal prostate
cancer study submitted to the FDA and for which we are in the process of
responding to additional questions from the agency. In addition, an IDE
application for a pancreatic cancer study is scheduled for FDA submission
before the end of this calendar year. Pre-clinical work on lung and whole
gland prostate are underway while pre-clinical work for pancreatic, focal
prostate and liver studies are either complete or in the process of being
completed this calendar year.
o Launched the Benephit PROVIDE registry, an independently managed
comprehensive clinical registry. It is designed to gather data on the
clinical use of the Benephit renal infusion system by approximately 2,100
patients during the next several years.
o Commenced commercial shipments of the StarBurst(R) XLi-enhanced Semi-Flex
probe, the first radiofrequency ablation device specifically designed to
deliver a 7cm ablation of a tumor in a single placement during Computed
Tomography-aided procedures.
o Commenced commercial shipments of the DuraMax(TM) stepped chronic dialysis
catheter. This new catheter is the first internally developed and
manufactured dialysis catheter introduced by the Company. DuraMax
incorporates AngioDynamics Curved Tip(TM) Catheter Technology, a design
platform employed to provide higher blood flow and lower recirculation,
and to reduce the potential for clots.
o A study, published in the July edition of Endovascular Today by Dr. Lowell
Kabnick, Director of New York University Vein Center and Associate
Professor of Surgery at the Division of Vascular Surgery at NYU Medical
Center, that compared treatments of varicose veins with a bare-tip laser
fiber against the new covered-tip VenaCure EVLT NeverTouch laser fiber
showed easier postoperative recovery, reduced bruising and other benefits
from the NeverTouch treatment.
Fiscal 2010 Guidance
The Company revised its outlook for fiscal 2010 to the following:
o Net sales in the range of $211 million to $215 million, an increase
of 8-10% over fiscal 2009 net sales (an increase from previous
guidance of $209 million to $215 million)
o Gross margin in the range of 61-62% of net sales
o GAAP operating income in the range of $18 million to $20 million, an
increase of 12-24%
o EBITDA in the range of $30 million to $32 million, an increase of
8-15%
o GAAP EPS in the range of $0.45 to $0.47, inclusive of a $0.24 EPS
impact from IRE investments (an increase from previous guidance of
$0.43 to $0.47)
Conference Call
AngioDynamics management will host a conference call to discuss its first
quarter results today beginning at 4:30 p.m. Eastern Time. To participate in the
live call by telephone, please dial 1 (877) 941-1848 from the U.S. or for
international callers, please dial +1 (480) 629-9722.
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 October 6, 2009, through 11:59 p.m. Eastern time
on October 13, 2009, by dialing 1 (800) 406-7325 (domestic) or +1 (303) 590-3030
(international) and entering the passcode: 4159408#.
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,
AngioDynamics has reported non-GAAP EBITDA (income before interest, taxes,
depreciation and amortization). Management uses this measure in its internal
analysis and review of operational performance. Management believes that this
measure provides investors with useful information in comparing AngioDynamics'
performance over different periods. By using this non-GAAP measure, management
believes that investors get a better picture of the performance of
AngioDynamics' underlying business. Management encourages investors to review
AngioDynamics' financial results prepared in accordance with GAAP to understand
AngioDynamics' performance taking into account all relevant factors, including
those that may only occur from time to time but have a material impact on
AngioDynamics' financial results. Please see the tables that follow for a
reconciliation of Operating Income 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 and irreversible electroporation ablation 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, 2009. The Company does not assume any obligation to
publicly update or revise any forward-looking statements for any reason.
In addition to his academic credentials, Dr. Kabnick is a paid consultant to
AngioDynamics.
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
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Aug 31, Aug 31,
2009 2008
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(unaudited)
Net sales $ 50,092 $ 44,323
Cost of sales 19,960 16,866
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Gross profit 30,132 27,457
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% of net sales 60.2% 61.9%
Operating expenses
Research and development 4,849 3,962
Sales and marketing 15,359 13,091
General and administrative 4,077 4,331
Amortization of intangibles 2,272 2,251
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Total operating expenses 26,557 23,635
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Operating income 3,575 3,822
Other income (expense), net (165) (251)
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Income before income taxes 3,410 3,571
Provision for income taxes 1,299 1,360
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Net income $ 2,111 $ 2,211
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Earnings per common share
Basic $ 0.09 $ 0.09
Diluted $ 0.09 $ 0.09
Weighted average common shares
Basic 24,432 24,298
Diluted 24,590 24,474
ANGIODYNAMICS, INC. AND SUBSIDIARIES
CONSOLIDATED INCOME STATEMENTS
(in thousands, except per share data)
Reconciliation of Operating Income to non-GAAP EBITDA:
Three months ended
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Aug 31, Aug 31,
2009 2008
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(unaudited)
Operating income $ 3,575 $ 3,822
Amortization of intangibles 2,272 2,251
Depreciation 738 654
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EBITDA $ 6,585 $ 6,727
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EBITDA per common share
Basic $ 0.27 $ 0.28
Diluted $ 0.27 $ 0.27
Weighted average common shares
Weighted average common shares
Basic 24,432 24,298
Diluted 24,590 24,474
ANGIODYNAMICS, INC. AND SUBSIDIARIES
NET SALES BY BUSINESS UNIT AND BY GEOGRAPHY
(in thousands)
Three months ended
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Aug 31, Aug 31,
2009 2008
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(unaudited)
Net Sales by Business Unit
Peripheral Vascular $ 21,059 $ 18,434
Access 16,231 15,686
Oncology/Surgery 12,802 10,203
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Total $ 50,092 $ 44,323
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Net Sales by Geography
United States $ 45,028 $ 39,261
International 5,064 5,062
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Total $ 50,092 $ 44,323
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ANGIODYNAMICS, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(in thousands)
Aug 31, May 31,
2009 2009
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(unaudited) (2)
Assets
Current Assets
Cash and cash equivalents $ 32,168 $ 27,909
Marketable securities 36,588 40,278
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Total cash and investments 68,756 68,187
Receivables, net 23,383 27,181
Inventories, net 44,344 36,928
Deferred income taxes 9,248 9,337
Prepaid income taxes 3,831 3,694
Prepaid expenses and other 3,122 3,271
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Total current assets 152,684 148,598
Property, plant and equipment, net 22,327 22,183
Intangible assets, net 65,491 67,770
Goodwill 161,974 161,974
Deferred income taxes 2,876 4,263
Other non-current assets 3,928 3,915
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Total Assets $ 409,280 $ 408,703
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Liabilities and Stockholders' Equity
Current portion of long-term debt $ 245 $ 265
Contractual payments on acquisition of business, net 4,946 5,227
Other current liabilities 21,315 24,207
Long-term debt, net of current portion 6,745 6,810
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Total Liabilities 33,251 36,509
Stockholders' equity 376,029 372,194
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Total Liabilities and Stockholders' Equity $ 409,280 $ 408,703
============ ============
Shares outstanding 24,496 24,428
(2) Derived from audited financial statements
ANGIODYNAMICS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
Three months ended
------------------------------------
Aug 31, Aug 31,
2009 2008
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(unaudited) (unaudited)
Cash flows from operating activities:
Net income $ 2,111 $ 2,211
Depreciation and amortization 3,010 2,905
Tax effect of exercise of stock options 29 (74)
Deferred income taxes 1,467 2,278
Stock-based compensation 1,187 1,200
Other (103) 172
Changes in operating assets and liabilities
Receivables 3,830 3,544
Inventories (7,165) (2,114)
Accounts payable and accrued liabilities (3,226) 387
Litigation provision -- (6,757)
Other (1) (2,081)
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Net cash provided by operating activities 1,139 1,671
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Cash flows from investing activities:
Additions to property, plant and equipment (930) (1,286)
Acquisition of intangible assets and businesses -- (10,597)
Change in restricted cash -- 68
Purchases, sales and maturities of marketable securities, net 3,646 5,369
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Net cash provided by (used in) investing activities 2,716 (6,446)
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Cash flows from financing activities:
Repayment of long-term debt (85) (9,785)
Proceeds from exercise of stock options and ESPP 575 1,140
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Net cash provided by (used in) financing activities 490 (8,645)
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Effect of exchange rate changes on cash (86) (102)
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Increase (Decrease) in cash and cash equivalents 4,259 (13,522)
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Cash and cash equivalents
Beginning of period 27,909 32,040
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End of period $ 32,168 $ 18,518
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