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): October 2, 2008
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 October 2, 2008, AngioDynamics, Inc.
(the “Company”) issued a press release announcing financial results for the
fiscal first quarter ended August 31, 2008.
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, 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 October 2, 2008.
|
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 2, 2008
|
By:
|
/s/
D. Joseph Gersuk
|
|
D.
Joseph Gersuk
|
||
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Chief
Financial Officer
|
||
EXHIBIT
INDEX
|
Exhibit No.
|
Description
|
|
|
99.1
|
Press
Release dated October 2, 2008.
|
|
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 First
Quarter
2009
|
·
|
Net
Sales Increase 18% to $44.3
Million
|
|
·
|
Net
Income of $2.2
Million
and EPS of $0.09
|
|
·
|
Significant
IRE NanoKnife™
Development
Progress
|
|
·
|
FY
2009 Net Sales Guidance of $205-$210 Million and GAAP EPS Guidance of
Approximately $0.55 Reaffirmed
|
|
·
|
Conference
Call Begins Today at 4:30 p.m. Eastern
Time
|
QUEENSBURY, N.Y.
October 2, 2008 — AngioDynamics, 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 first
quarter ended August 31, 2008. Financial results include the
acquisition of Diomed assets since June 17, 2008, the date of
acquisition.
Net sales in the fiscal first quarter
were $44.3 million, an 18% increase over the $37.5 million reported in the first
quarter a year ago. Gross margin rose in the first quarter to 61.9%
from 60.0% in the prior year’s first quarter. Operating income
increased in the first quarter to $3.8 million compared with $3.5 million a year
ago. Net income was $2.2 million or $0.09 per share in the fiscal
first quarter, as compared with $2.4 million or $0.10 per share for the
corresponding period one year ago. EBITDA (Non GAAP) increased 20% to
$6.7 million or $0.27 per share from $5.6 million or $0.23 in the first quarter
a year ago.
During the first quarter of fiscal 2009
AngioDynamics began operating three business units: Peripheral Vascular, Access
and Oncology/Surgery. Peripheral Vascular business unit sales were
$18.4 million in the quarter, an increase of 31% from the first quarter a year
ago, inclusive of the laser ablation products acquired from
Diomed. Access business unit sales were $15.7 million in the quarter,
an increase of 6% from the first quarter a year ago, and Oncology/Surgery sales
grew 18% to $10.2 million in the first quarter.
“Fiscal 2009 is off to a very good
start. The acquisition of Diomed has established AngioDynamics as the market leader in the laser
ablation of varicose veins. In addition, we
completed the reorganization of the Company into three market-focused business
units, and we continued to develop our IRE technology. I am pleased
with how rapidly we transitioned to our business unit operating
structure. We have nearly completed the planned 40% expansion of our
Peripheral Vascular and Access sales forces as well as made a number of other
significant hires,” said Eamonn P. Hobbs, President and CEO.
“During the quarter, we hired 35 former
Diomed employees and integrated them into our Peripheral Vascular business
unit. In addition, we immediately began implementing laser system and
disposable product transition strategies. Customer demand for the
EVLT® disposable products remained strong
during the quarter. However, first quarter laser system sales were
impacted by the market’s uncertainty regarding Diomed during the months leading
up to our acquisition. We believe we are gaining momentum in the
marketplace and expect laser systems sales to grow as the year progresses,”
added Mr. Hobbs.
“We continue to make significant
progress with NanoKnife, our first irreversible electroporation (IRE) product
development program,” continued Mr. Hobbs. “A key component of the
NanoKnife program is the placement of systems with key thought leaders,
including five of the top 10 cancer centers, in the U.S. and
Europe. While our original plan was to place a total of 20 units, we
have decided to increase the number to 25 due to the strong level of interest
from leading specialists. To date, 12 NanoKnife IRE Systems have been
installed and another 13 have been either shipped or are scheduled for
shipment,” added Mr. Hobbs.
“Investigator- sponsored clinical
studies for liver, pancreatic, kidney, and lung lesions are expected to begin
during our second and third fiscal quarters. We have had excellent
results with the 17 prostate cancer patients who have been treated with
NanoKnife in the U.S. In Italy, a second prostate cancer study with
Italian Ministry of Health approval has begun with Professor Maurizio Brausi at
the Carpi General Hospital near Bologna, Italy. In addition, we
continue to pursue Australian, Canadian, and European regulatory approvals.
During the quarter, we also made progress in developing pre-clinical program
protocols for uterine fibroid ablation, brain, pancreatic, kidney, liver, lung,
and endovascular therapies,” concluded Mr. Hobbs.
The Company reported cash and
investments at August 31, 2008 of $59.2 million and long term debt of $7.3
million.
Fiscal 2009 Guidance
The Company reaffirmed its outlook for
fiscal 2009 of net sales in the range of $205 - $210 million, GAAP operating
income in the range of $21-$22 million, GAAP EPS of approximately $0.55 and
EBITDA in the range of $33-35 million.
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
(800) 218-0204 from the U.S. or for international callers, please dial +1 (303)
262-2053.
In
addition, individuals can listen to the call on the Internet by visiting the
investor relations portion of the Company's Web site at
http://investor.angiodynamics.com. To listen to the live call, please
go to the website 15 minutes prior to its start to register, download, and
install the necessary audio software.
A replay will be available on the
website. A telephone replay will be available from 6:30 p.m. Eastern time on
October 2, 2008 through 11:59 p.m. Eastern time on October 9, 2008 by dialing 1
(800) 405-2236 (domestic) or +1 (303) 590-3000 (international) and entering the
passcode: 11119718#.
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 the
Company's 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 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. 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 the purchased Diomed 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.
###
(Tables to Follow)
|
ANGIODYNAMICS, INC. AND
SUBSIDIARIES
|
|||||||
|
CONSOLIDATED INCOME
STATEMENTS
|
|||||||
|
(in thousands,
except per share data)
|
|||||||
| Three months ended | ||||||||
|
August 31,
|
August 31,
|
|||||||
|
2008
|
2007
|
|||||||
|
(unaudited)
|
||||||||
|
Net sales
|
$ | 44,323 | $ | 37,526 | ||||
|
Cost of
sales
|
16,866 | 15,025 | ||||||
|
Gross
profit
|
27,457 | 22,501 | ||||||
|
% of net
sales
|
61.9 | % | 60.0 | % | ||||
|
Operating
expenses
|
||||||||
|
Research and
development
|
3,962 | 2,711 | ||||||
|
Sales and
marketing
|
13,091 | 10,549 | ||||||
|
General and
administrative
|
4,331 | 4,132 | ||||||
|
Amortization of
intangibles
|
2,251 | 1,588 | ||||||
|
Total operating
expenses
|
23,635 | 18,980 | ||||||
|
Operating
income
|
3,822 | 3,521 | ||||||
|
Other income (expense),
net
|
(251 | ) | 288 | |||||
|
Income before income
taxes
|
3,571 | 3,809 | ||||||
|
Provision for income
taxes
|
1,360 | 1,429 | ||||||
|
Net income
|
$ | 2,211 | $ | 2,380 | ||||
|
Earnings per common
share
|
||||||||
|
Basic
|
$ | 0.09 | $ | 0.10 | ||||
|
Diluted
|
$ | 0.09 | $ | 0.10 | ||||
|
Weighted average common
shares
|
||||||||
|
Basic
|
24,298 | 23,969 | ||||||
|
Diluted
|
24,474 | 24,244 | ||||||
|
ANGIODYNAMICS, INC. AND
SUBSIDIARIES
|
|||||||
|
CONSOLIDATED INCOME
STATEMENTS
|
|||||||
|
(in thousands, except per share
data)
|
|||||||
|
Reconciliation of Operating Income
to non-GAAP EBITDA:
|
|||||||
| Three months ended | ||||||||
|
August
31,
|
August 31,
|
|||||||
|
2008
|
2007
|
|||||||
|
(unaudited)
|
||||||||
|
Operating
income
|
$ | 3,822 | $ | 3,521 | ||||
|
Amortization of
intangibles
|
2,252 | 1,588 | ||||||
|
Depreciation
|
653 | 504 | ||||||
|
EBITDA
|
$ | 6,727 | $ | 5,613 | ||||
|
EBITDA per common
share
|
||||||||
|
Basic
|
$ | 0.28 | $ | 0.23 | ||||
|
Diluted
|
$ | 0.27 | $ | 0.23 | ||||
|
Weighted average common
shares
|
||||||||
|
Basic
|
24,298 | 23,969 | ||||||
|
Diluted
|
24,474 | 24,244 | ||||||
|
ANGIODYNAMICS, INC. AND
SUBSIDIARIES
|
||||||||
|
NET SALES BY BUSINESS UNIT AND BY
GEOGRAPHY
|
||||||||
|
(in
thousands)
|
||||||||
|
Three months
ended
|
||||||||
|
August 31,
|
August 31,
|
|||||||
|
2008
|
2007
|
|||||||
|
(unaudited)
|
||||||||
|
Net Sales by Business
Unit
|
||||||||
|
Peripheral
Vascular
|
$ | 18,434 | $ | 14,087 | ||||
|
Access
|
15,686 | 14,782 | ||||||
|
Oncology/Surgery
|
10,203 | 8,657 | ||||||
|
Total
|
$ | 44,323 | $ | 37,526 | ||||
|
Net Sales by
Geography
|
||||||||
|
United
States
|
$ | 39,261 | $ | 34,007 | ||||
|
International
|
5,062 | 3,519 | ||||||
|
Total
|
$ | 44,323 | $ | 37,526 | ||||
|
ANGIODYNAMICS, INC. AND
SUBSIDIARIES
|
|||||||||
|
CONSOLIDATED BALANCE
SHEETS
|
|||||||||
|
(in
thousands)
|
|||||||||
|
August
31,
|
May 31,
|
|||||||
|
2008
|
2008
|
|||||||
|
(unaudited)
|
(2)
|
|||||||
|
Assets
|
||||||||
|
Current
Assets
|
||||||||
|
Cash and cash
equivalents
|
$ | 18,518 | $ | 32,040 | ||||
|
Restricted
cash
|
- | 68 | ||||||
|
Marketable
securities
|
40,731 | 46,182 | ||||||
|
Total cash and
investments
|
59,249 | 78,290 | ||||||
|
Receivables,
net
|
24,375 | 26,642 | ||||||
|
Inventories,
net
|
28,199 | 22,901 | ||||||
|
Deferred income
taxes
|
8,450 | 10,902 | ||||||
|
Prepaid expenses and
other
|
5,162 | 3,147 | ||||||
|
Total current
assets
|
125,435 | 141,882 | ||||||
|
Property, plant and equipment,
net
|
22,253 | 21,163 | ||||||
|
Intangible assets,
net
|
72,759 | 71,311 | ||||||
|
Goodwill
|
164,522 | 162,707 | ||||||
|
Deferred income
taxes
|
7,199 | 6,860 | ||||||
|
Other non-current
assets
|
3,802 | 4,824 | ||||||
|
Total
Assets
|
$ | 395,970 | $ | 408,747 | ||||
|
Liabilities and Stockholders'
Equity
|
||||||||
|
Current portion of long-term
debt
|
$ | 340 | $ | 10,040 | ||||
|
Contractual payments on
acquisition of business, net
|
9,688 | 9,625 | ||||||
|
Other current
liabilities
|
19,005 | 19,537 | ||||||
|
Litigation
provision
|
- | 6,757 | ||||||
|
Long-term debt, net of current
portion
|
6,990 | 7,075 | ||||||
|
Total
Liabilities
|
36,023 | 53,034 | ||||||
|
Stockholders'
equity
|
359,947 | 355,713 | ||||||
|
Total
Liabilities and Stockholders' Equity
|
$ | 395,970 | $ | 408,747 | ||||
|
Shares
outstanding
|
24,362 | 24,268 | ||||||
| (2) Derived from audited financial statements |
|
ANGIODYNAMICS, INC. AND
SUBSIDIARIES
|
|
CONSOLIDATED STATEMENTS OF CASH
FLOWS
|
|
(in
thousands)
|
|
Three months
ended
|
||||||||
|
August
31,
|
August 31,
|
|||||||
|
2008
|
2007
|
|||||||
|
(unaudited)
|
||||||||
|
Cash flows from operating
activities:
|
||||||||
|
Net income
|
$ | 2,211 | $ | 2,380 | ||||
|
Depreciation and
amortization
|
2,905 | 2,092 | ||||||
|
Tax effect of exercise of stock
options
|
(74 | ) | 76 | |||||
|
Deferred income
taxes
|
2,278 | 981 | ||||||
|
Stock-based
compensation
|
1,200 | 1,211 | ||||||
|
Other
|
173 | 69 | ||||||
|
Changes in operating assets and
liabilities
|
||||||||
|
Receivables
|
3,544 | 965 | ||||||
|
Inventories
|
(2,114 | ) | (2,693 | ) | ||||
|
Accounts payable and accrued
liabilities
|
387 | (2,829 | ) | |||||
|
Litigation
provision
|
(6,757 | ) | 120 | |||||
|
Other
|
(2,081 | ) | (1,868 | ) | ||||
|
Net cash provided by operating
activities
|
1,672 | 504 | ||||||
|
Cash flows from investing
activities:
|
||||||||
|
Additions to property, plant and
equipment
|
(1,286 | ) | (2,604 | ) | ||||
|
Acquisition of intangible assets
and business
|
(10,597 | ) | (1,193 | ) | ||||
|
Change in restricted
cash
|
68 | 502 | ||||||
|
Purchases, sales and maturities of
marketable securities, net
|
5,369 | (2,768 | ) | |||||
|
Net cash used in investing
activities
|
(6,446 | ) | (6,063 | ) | ||||
|
Cash flows from financing
activities:
|
||||||||
|
Repayment of long-term
debt
|
(9,785 | ) | (70 | ) | ||||
|
Proceeds from exercise of stock
options and ESPP
|
1,140 | 738 | ||||||
|
Other
|
- | 4 | ||||||
|
Net cash (used in) provided by
financing activities
|
(8,645 | ) | 672 | |||||
|
Effect of exchange rate changes on
cash
|
(103 | ) | - | |||||
|
Decrease in cash and cash
equivalents
|
(13,522 | ) | (4,887 | ) | ||||
|
Cash and cash
equivalents
|
||||||||
|
Beginning of
period
|
32,040 | 28,313 | ||||||
|
End of
period
|
$ | 18,518 | $ | 23,426 | ||||