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): January 5, 2010
|
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
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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
January 5, 2010, AngioDynamics, Inc. (the “Company”) issued a press release
announcing financial results for the fiscal second quarter ended November 30,
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 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 January 5, 2010.
|
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:
January 5, 2010
|
By:
|
/s/ D. Joseph Gersuk | |
| D. Joseph Gersuk | |||
| Chief Financial Officer | |||
EXHIBIT
INDEX
|
Exhibit No. |
Description |
|
|
99.1
|
Press
Release dated January 5, 2010.
|
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.
Chris
Gale
(646)
201-5431
cgale@evcgroup.com
|
AngioDynamics
Reports Fiscal Second Quarter 2010 Results
and
Raises Guidance
|
·
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Net
Sales Increase 10% to $53.5 Million
|
|
·
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NanoKnife®
IRE System Net Sales of $700,000
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·
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Net
Income Increase of 8% to $3.1 Million, or $0.13
EPS
|
|
·
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Operating
Cash Flow of $11.2 Million
|
|
·
|
Conference
Call Begins Today at 4:30 p.m. Eastern
Time
|
QUEENSBURY, N.Y. January 5, 2010 —
AngioDynamics (NASDAQ:
ANGO), a leading provider of innovative medical devices for the
minimally-invasive treatment of cancer and peripheral vascular disease, today
reported financial results for the fiscal second quarter ended November 30,
2009.
Net sales
in the second quarter were $53.5 million, a 10% increase over the $48.5 million
reported for the second quarter a year ago. Gross margin was 59.1%
compared with 61.3% a year ago, with the decline primarily attributable to lower
selling prices for certain products in a competitive pricing environment, higher
material costs for certain products and product mix. Operating income
was $5.3 million in the quarter compared with $4.9 million a year
ago. Net income was $3.1 million, or $0.13 per share, compared with
$2.9 million, or $0.12 per share, a year ago.
AngioDynamics
generated $11.2 million in cash flow from operations during the
quarter. At November 30, 2009, the Company had cash and investments
of $74.0 million and long-term debt of $6.9 million.
Oncology/Surgery
sales grew 28% to $13.6 million from the second quarter a year ago and included
$700,000 in NanoKnife IRE system sales. Peripheral Vascular sales
increased by 6% from the second quarter a year ago to $23.2 million, and
included $832,000 in sales of the Benephit® renal
infusion system acquired from FlowMedica in January 2009. Access
sales were $16.7 million in the quarter, an increase of 4% from the second
quarter a year ago.
For the
six months ended November 30, 2009, net sales were $103.6 million, a 12%
increase over the $92.8 million reported for the prior year period; gross margin
was 59.6% compared with 61.6% for the prior year; operating income was $8.9
million compared with $8.7 million for the prior year; net income was $5.2
million, or $0.21 per share, compared with $5.1 million, or $0.21 per share for
the prior year.
“Our
solid second quarter performance was led by strong sales from our
Oncology/Surgery business unit and good operating expense control, which
combined to offset the impact on our gross margin of product mix and a very
competitive pricing environment for many product categories,” said Jan Keltjens,
President and CEO. “All Oncology/Surgery products contributed to the
exceptional sales growth in this business unit this quarter, and we were
particularly pleased to see the initial market interest in our new NanoKnife IRE
system. In addition, we continued to gain positive clinical
experience with the NanoKnife system as more than 100 patients have been treated
with this promising technology.
“As we
look ahead, we anticipate the continuation of a challenging pricing environment
and are striving to achieve continued solid top line growth, operating
efficiencies and expense control to deliver bottom line
performance. Based on our first half momentum and planned second half
initiatives, today we are raising our guidance for the full fiscal year,”
concluded Mr. Keltjens.
Highlights
of the quarter, and more recent activities, include the following:
|
·
|
Stephen
J. McGill was appointed Senior Vice President and General Manager,
International, a newly created position. Mr. McGill served as
Senior Vice President, Global Sales for American Medical Systems and will
lead AngioDynamics’ efforts to target and expand its business in the
international arena.
|
|
·
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NanoKnife
IRE systems continue to be utilized by physicians at various institutions
globally who have treated an additional 18 patients since early October.
The total number of patients treated to date with the NanoKnife system at
nine centers now stands at 104. Of particular note is the
treatment of a patient with a pancreatic lesion over three weeks
ago. This patient was discharged shortly after the IRE
procedure without complication and continues to be free of complications.
Procedures have been performed in seven organs (prostate, liver,
lung, kidney, bone, pancreas and lymph nodes). In all cases the safety
profile for this non-thermal ablation technology remains
positive.
|
|
·
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The
introduction of a new family of micro-introducer kits and the Total
Abscession®
nephrostomy drain catheter brought the total number of new products
launched during fiscal 2010 to six. The Company remains on
track for a total of 11 launches in this fiscal
year.
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|
·
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On
November 30, AngioDynamics was added to the MSCI US Small Cap 1750
Index. The MSCI US Small Cap 1750 Index represents a universe
of small capitalization companies in the U.S. equity
market.
|
Fiscal
2010 Guidance
The
Company updated its outlook for fiscal 2010 to the following:
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·
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Net
sales in the range of $214 million to $217 million, an increase of 10-11%
over fiscal 2009 net sales (an increase from previous guidance of $211
million to $215 million)
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·
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Gross
margin in the range of 59-60% of net sales (a decrease from previous
guidance of 61-62%)
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·
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GAAP
operating income in the range of $19 million to $21 million (an increase
from previous guidance of $18 million to $20
million)
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·
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EBITDA
in the range of $31 million to $33 million (an increase from previous
guidance of $30 million to $32
million)
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|
·
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GAAP
EPS in the range of $0.46 to $0.48, inclusive of a $0.24 EPS impact from
IRE investments (an increase from previous guidance of $0.45 to
$0.47)
|
Conference
Call
AngioDynamics
management will host a conference call to discuss its second quarter results
today beginning at 4:30 p.m. Eastern Time. To participate in the live call by
telephone, please dial 1 (877) 941-2332.
In
addition, individuals can listen to the call on the Internet by visiting the
investor relations portion of the AngioDynamics Web site at http://investors.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. In addition, a replay of the call will be available at
http://investors.angiodynamics.com.
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 AngioDynamics’
expectations. Factors that may affect the actual results achieved by
AngioDynamics include, without limitation, the ability of AngioDynamics 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, the results of on-going litigation, general market
conditions, market acceptance, foreign currency exchange rate fluctuations, the
effects on pricing from group purchasing organizations and competition, the
ability of AngioDynamics to integrate purchased businesses as well as the risk
factors listed from time to time in AngioDynamics’ SEC filings, including but
not limited to its Annual Report on Form 10-K for the year ended May 31, 2009.
AngioDynamics 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
|
Six
months ended
|
|||||||||||||||
|
Nov
30,
|
Nov
30,
|
Nov
30,
|
Nov
30,
|
|||||||||||||
|
2009
|
2008
|
2009
|
2008
|
|||||||||||||
|
(unaudited)
|
(unaudited)
|
|||||||||||||||
|
Net
sales
|
$ | 53,459 | $ | 48,464 | $ | 103,551 | $ | 92,787 | ||||||||
|
Cost
of sales
|
21,852 | 18,771 | 41,812 | 35,637 | ||||||||||||
|
Gross
profit
|
31,607 | 29,693 | 61,739 | 57,150 | ||||||||||||
|
%
of net sales
|
59.1 | % | 61.3 | % | 59.6 | % | 61.6 | % | ||||||||
|
Operating
expenses
|
||||||||||||||||
|
Research
and development
|
4,763 | 4,425 | 9,612 | 8,387 | ||||||||||||
|
Sales
and marketing
|
15,042 | 14,315 | 30,401 | 27,611 | ||||||||||||
|
General
and administrative
|
4,031 | 3,821 | 8,108 | 7,947 | ||||||||||||
|
Amortization
of intangibles
|
2,451 | 2,242 | 4,723 | 4,493 | ||||||||||||
|
Total
operating expenses
|
26,287 | 24,803 | 52,844 | 48,438 | ||||||||||||
|
Operating
income
|
5,320 | 4,890 | 8,895 | 8,712 | ||||||||||||
|
Other
income (expense), net
|
(290 | ) | (500 | ) | (455 | ) | (751 | ) | ||||||||
|
Income
before income taxes
|
5,030 | 4,390 | 8,440 | 7,961 | ||||||||||||
|
Provision
for income taxes
|
1,901 | 1,483 | 3,200 | 2,843 | ||||||||||||
|
Net
income
|
$ | 3,129 | $ | 2,907 | $ | 5,240 | $ | 5,118 | ||||||||
|
Earnings
per common share
|
||||||||||||||||
|
Basic
|
$ | 0.13 | $ | 0.12 | $ | 0.21 | $ | 0.21 | ||||||||
|
Diluted
|
$ | 0.13 | $ | 0.12 | $ | 0.21 | $ | 0.21 | ||||||||
|
Weighted
average common shares
|
||||||||||||||||
|
Basic
|
24,518 | 24,362 | 24,472 | 24,330 | ||||||||||||
|
Diluted
|
24,729 | 24,563 | 24,662 | 24,536 | ||||||||||||
ANGIODYNAMICS,
INC. AND SUBSIDIARIES
CONSOLIDATED
INCOME STATEMENTS
(in
thousands, except per share data)
|
Reconciliation
of Operating Income to non-GAAP EBITDA:
|
||||||||||||||||
|
Three
months ended
|
Six
months ended
|
|||||||||||||||
|
Nov
30,
|
Nov
30,
|
Nov
30,
|
Nov
30,
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|||||||||||||
|
2009
|
2008
|
2009
|
2008
|
|||||||||||||
|
(unaudited)
|
(unaudited)
|
|||||||||||||||
|
Operating
income
|
$ | 5,320 | $ | 4,890 | $ | 8,895 | $ | 8,712 | ||||||||
|
Amortization
of intangibles
|
2,451 | 2,242 | 4,723 | 4,493 | ||||||||||||
|
Depreciation
|
758 | 636 | 1,496 | 1,289 | ||||||||||||
|
EBITDA
|
$ | 8,529 | $ | 7,768 | $ | 15,114 | $ | 14,494 | ||||||||
|
EBITDA
per common share
|
||||||||||||||||
|
Basic
|
$ | 0.35 | $ | 0.32 | $ | 0.62 | $ | 0.60 | ||||||||
|
Diluted
|
$ | 0.34 | $ | 0.32 | $ | 0.61 | $ | 0.59 | ||||||||
|
Weighted
average common shares
|
||||||||||||||||
|
Basic
|
24,518 | 24,362 | 24,472 | 24,330 | ||||||||||||
|
Diluted
|
24,729 | 24,563 | 24,662 | 24,536 | ||||||||||||
ANGIODYNAMICS, INC. AND
SUBSIDIARIES
NET
SALES BY BUSINESS UNIT AND BY GEOGRAPHY
(in
thousands)
|
Three
months ended
|
Six
months ended
|
|||||||||||||||
|
Nov
30,
|
Nov
30,
|
Nov
30,
|
Nov
30,
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|||||||||||||
|
2009
|
2008
|
2009
|
2008
|
|||||||||||||
|
(unaudited)
|
(unaudited)
|
|||||||||||||||
|
Net
Sales by Business Unit
|
||||||||||||||||
|
Peripheral
Vascular
|
$ | 23,167 | $ | 21,770 | $ | 44,226 | $ | 40,204 | ||||||||
|
Access
|
16,677 | 16,069 | 32,908 | 31,755 | ||||||||||||
|
Oncology/Surgery
|
13,615 | 10,625 | 26,417 | 20,828 | ||||||||||||
|
Total
|
$ | 53,459 | $ | 48,464 | $ | 103,551 | $ | 92,787 | ||||||||
|
Net
Sales by Geography
|
||||||||||||||||
|
United
States
|
$ | 47,624 | $ | 42,927 | $ | 92,652 | $ | 82,188 | ||||||||
|
International
|
5,835 | 5,537 | 10,899 | 10,599 | ||||||||||||
|
Total
|
$ | 53,459 | $ | 48,464 | $ | 103,551 | $ | 92,787 | ||||||||
ANGIODYNAMICS, INC. AND
SUBSIDIARIES
CONSOLIDATED
BALANCE SHEETS
(in
thousands)
|
Nov
30,
|
May
31,
|
||||||||
|
2009
|
2009
|
||||||||
|
(unaudited)
|
(2) | ||||||||
|
Assets
|
|||||||||
|
Current
Assets
|
|||||||||
|
Cash
and cash equivalents
|
$ | 36,256 | $ | 27,909 | |||||
|
Marketable
securities
|
37,772 | 40,278 | |||||||
|
Total
cash and investments
|
74,028 | 68,187 | |||||||
|
Receivables,
net
|
25,397 | 27,181 | |||||||
|
Inventories,
net
|
39,874 | 36,928 | |||||||
|
Deferred
income taxes
|
7,283 | 9,337 | |||||||
|
Prepaid
income taxes
|
3,502 | 3,694 | |||||||
|
Prepaid
expenses and other
|
1,543 | 3,271 | |||||||
|
Total
current assets
|
151,627 | 148,598 | |||||||
|
Property,
plant and equipment, net
|
22,600 | 22,183 | |||||||
|
Intangible
assets, net
|
63,033 | 67,770 | |||||||
|
Goodwill
|
161,974 | 161,974 | |||||||
|
Deferred
income taxes
|
3,212 | 4,263 | |||||||
|
Other
non-current assets
|
5,187 | 3,915 | |||||||
|
Total
Assets
|
$ | 407,633 | $ | 408,703 | |||||
|
Liabilities
and Stockholders' Equity
|
|||||||||
|
Current
portion of long-term debt
|
$ | 250 | $ | 265 | |||||
|
Contractual
payments on acquisition of business, net
|
- | 5,227 | |||||||
|
Other
current liabilities
|
19,964 | 24,207 | |||||||
|
Long-term
debt, net of current portion
|
6,680 | 6,810 | |||||||
|
Total
Liabilities
|
26,894 | 36,509 | |||||||
|
Stockholders'
equity
|
380,739 | 372,194 | |||||||
|
Total
Liabilities and Stockholders' Equity
|
$ | 407,633 | $ | 408,703 | |||||
|
Shares
outstanding
|
24,556 | 24,428 | |||||||
|
(2)
|
Derived
from audited financial statements
|
||||||||
|
CONSOLIDATED
STATEMENTS OF CASH FLOWS
|
||||||||
|
(in
thousands)
|
||||||||
|
Six
months ended
|
||||||||
|
Nov
30,
|
Nov
30,
|
|||||||
|
2009
|
2008
|
|||||||
|
(unaudited)
|
||||||||
|
Cash
flows from operating activities:
|
||||||||
|
Net
income
|
$ | 5,240 | $ | 5,118 | ||||
|
Depreciation
and amortization
|
6,219 | 5,782 | ||||||
|
Tax
effect of exercise of stock options
|
31 | (74 | ) | |||||
|
Deferred
income taxes
|
3,126 | 2,234 | ||||||
|
Stock-based
compensation
|
2,413 | 2,460 | ||||||
|
Other
|
(324 | ) | 714 | |||||
|
Changes
in operating assets and liabilities
|
||||||||
|
Receivables
|
1,816 | 2,010 | ||||||
|
Inventories
|
(2,767 | ) | (3,176 | ) | ||||
|
Accounts
payable and accrued liabilities
|
(4,304 | ) | (1,322 | ) | ||||
|
Litigation
provision
|
- | (6,757 | ) | |||||
|
Other
|
931 | (892 | ) | |||||
|
Net
cash provided by operating activities
|
12,381 | 6,097 | ||||||
|
Cash
flows from investing activities:
|
||||||||
|
Additions
to property, plant and equipment
|
(1,951 | ) | (2,459 | ) | ||||
|
Acquisition
of intangible assets and businesses
|
(5,350 | ) | (15,180 | ) | ||||
|
Change
in restricted cash
|
- | 68 | ||||||
|
Purchases,
sales and maturities of marketable securities, net
|
2,431 | 8,023 | ||||||
|
Net
cash provided by (used in) investing activities
|
(4,870 | ) | (9,548 | ) | ||||
|
Cash
flows from financing activities:
|
||||||||
|
Repayment
of long-term debt
|
(145 | ) | (9,870 | ) | ||||
|
Proceeds
from exercise of stock options and ESPP
|
971 | 1,145 | ||||||
|
Net
cash provided by (used in) financing activities
|
826 | (8,725 | ) | |||||
|
Effect
of exchange rate changes on cash
|
10 | (130 | ) | |||||
|
Increase
(Decrease) in cash and cash equivalents
|
8,347 | (12,306 | ) | |||||
|
Cash
and cash equivalents
|
||||||||
|
Beginning
of period
|
27,909 | 32,040 | ||||||
|
End
of period
|
$ | 36,256 | $ | 19,734 | ||||