-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, L6eQgPaSrpNutG9KOlj8F7F1h7lFGqlBCCdy1Ek3syHY7bolqDox+CnR7hxTchO2 fSCIoEXizwDhxbVjCNH7pA== 0000914121-09-001165.txt : 20091006 0000914121-09-001165.hdr.sgml : 20091006 20091006171211 ACCESSION NUMBER: 0000914121-09-001165 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20091006 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20091006 DATE AS OF CHANGE: 20091006 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ANGIODYNAMICS INC CENTRAL INDEX KEY: 0001275187 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 113146460 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-50761 FILM NUMBER: 091108641 BUSINESS ADDRESS: STREET 1: 603 QUEENSBURY AVE CITY: QUEENSBURY STATE: NY ZIP: 12804 BUSINESS PHONE: 5187981215 MAIL ADDRESS: STREET 1: 603 QUEENSBURY AVE CITY: QUEENSBURY STATE: NY ZIP: 12804 8-K 1 an17474402-8k.txt CURRENT REPORT 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 6, 2009 AngioDynamics, Inc. - -------------------------------------------------------------------------------- (Exact Name of Registrant as Specified in Charter) Delaware 000-50761 11-3146460 - -------------------------------------------------------------------------------- (State or Other Jurisdiction (Commission File (IRS Employer of Incorporation) Number) 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: |_| 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 - ----------- ----------- 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 ------------------------------- D. Joseph Gersuk Chief Financial Officer EXHIBIT INDEX Exhibit No. Description - ----------- ----------- 99.1 Press Release dated October 6, 2009. EX-99.1 2 an17474402-ex99_1.txt PRESS RELEASE EXHIBIT 99.1 [ANGIODYNAMICS] For Immediate Release
Company Contact: Investor Relations Contacts: Media Contact: AngioDynamics, Inc. EVC Group, Inc. EVC Group, Inc. - ------------------- --------------- --------------- 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 ----------------------
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 ------------------------------ Aug 31, Aug 31, 2009 2008 ---------- ---------- (unaudited) Net sales $ 50,092 $ 44,323 Cost of sales 19,960 16,866 ---------- ---------- Gross profit 30,132 27,457 ---------- ---------- % 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 ---------- ---------- Total operating expenses 26,557 23,635 ---------- ---------- Operating income 3,575 3,822 Other income (expense), net (165) (251) ---------- ---------- Income before income taxes 3,410 3,571 Provision for income taxes 1,299 1,360 ---------- ---------- Net income $ 2,111 $ 2,211 ========== ========== 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 ------------------------------ Aug 31, Aug 31, 2009 2008 ---------- ---------- (unaudited) Operating income $ 3,575 $ 3,822 Amortization of intangibles 2,272 2,251 Depreciation 738 654 ---------- ---------- EBITDA $ 6,585 $ 6,727 ========== ========== 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 ------------------------------ Aug 31, Aug 31, 2009 2008 ---------- ---------- (unaudited) Net Sales by Business Unit Peripheral Vascular $ 21,059 $ 18,434 Access 16,231 15,686 Oncology/Surgery 12,802 10,203 ---------- ---------- Total $ 50,092 $ 44,323 ========== ========== Net Sales by Geography United States $ 45,028 $ 39,261 International 5,064 5,062 ---------- ---------- Total $ 50,092 $ 44,323 ========== ==========
ANGIODYNAMICS, INC. AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS (in thousands)
Aug 31, May 31, 2009 2009 ------------ ------------ (unaudited) (2) Assets Current Assets Cash and cash equivalents $ 32,168 $ 27,909 Marketable securities 36,588 40,278 ------------ ------------ 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 ------------ ------------ 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 ------------ ------------ Total Assets $ 409,280 $ 408,703 ============ ============ 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 ------------ ------------ Total Liabilities 33,251 36,509 Stockholders' equity 376,029 372,194 ------------ ------------ 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 ------------- ------------- (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) ------------- ------------- Net cash provided by operating activities 1,139 1,671 ------------- ------------- 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 ------------- ------------- Net cash provided by (used in) investing activities 2,716 (6,446) ------------- ------------- Cash flows from financing activities: Repayment of long-term debt (85) (9,785) Proceeds from exercise of stock options and ESPP 575 1,140 ------------- ------------- Net cash provided by (used in) financing activities 490 (8,645) ------------- ------------- Effect of exchange rate changes on cash (86) (102) ------------- ------------- Increase (Decrease) in cash and cash equivalents 4,259 (13,522) ------------- ------------- Cash and cash equivalents Beginning of period 27,909 32,040 ------------- ------------- End of period $ 32,168 $ 18,518 ============= =============
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