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):  July 16, 2015

AngioDynamics, Inc.

(Exact Name of Registrant as Specified in Charter)

 

 

 

 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:

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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2 (b))

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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4 (c))

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Item 2.02 – Results of Operations and Financial Condition.

On July 16, 2015, AngioDynamics, Inc. (the "Company") issued a press release announcing financial results for the fiscal fourth quarter and fiscal year ended ended May 31, 2015.  A copy of the press release is attached hereto as Exhibit 99.1.

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," "optimistic," "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.

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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.

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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: July 17, 2015	By:	/s/ Stephen A. Trowbridge
		Stephen A. Trowbridge Senior Vice President and General Counsel

 

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EXHIBIT INDEX

Exhibit 99.1

 

 

FOR IMMEDIATE RELEASE

AngioDynamics Reports Fiscal 2015 Fourth Quarter and Full Year Financial Results

·	Fourth quarter fiscal 2015 net sales of $90.9 million; Full year net sales of $357 million

·	Fourth quarter fiscal 2015 GAAP loss of $0.02 per share; Non-GAAP adjusted net income of $0.14  per share; full year non-GAAP adjusted income of $0.58 per share

·	Fourth quarter fiscal 2015 operating cash generation of $10.8 million; Full year operating cash generation of $26.2 million

·	Preliminary FY2016 guidance of 2% - 4% sales growth and 7% - 14% adjusted EPS growth

ALBANY, N.Y., (July 16, 2015) – AngioDynamics (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, today reported financial results for the fourth quarter ended May 31, 2015.

"During the fourth quarter we built solid year-over-year sales momentum in our key product lines including BioFlo, AngioVac, and NanoKnife," said Joseph M. DeVivo, president and chief executive officer.  "Increasing market demand for BioFlo's reduction in the overall cost of care in PICC cases is now translating effectively into increased adoption across Ports and Dialysis catheters.  Strong peer-reviewed published data supporting NanoKnife's clinical efficacy in treating pancreatic and prostate cancers continues to drive increases in case volumes globally.  And, AngioVac continues to impress clinically as the new generation device, while only recently released in the market, is driving broader interest among clinicians.

"Our overall financial performance during the fourth quarter was impacted by our third quarter voluntary withdrawal of our Morpheus line of PICCs and continued foreign currency headwinds," continued Mr. DeVivo.  "As we enter fiscal 2016, we are addressing these challenges as well as executing our plan to realize increased operational consistency and efficiencies. Executing our plan will enable us to capitalize on the market's growing interest in our product portfolio designed to reduce healthcare delivery costs and improve patient outcomes while at the same time build cash flow from our operations."

Q4 FY15 Financial Results

Net sales of $90.9 million compared with $94.1 million in last fiscal year's fourth quarter.  On a constant currency basis and excluding the planned wind down of the Boston Scientific (BSC) supply agreement, sales for the fiscal fourth quarter decreased 2% year-over-year. Prior year results include $2.7 million of Morpheus product line sales.  The following sales comparisons exclude the BSC supply agreement.

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Peripheral Vascular net sales in the fourth quarter were $49.8 million compared to $50.9 million in fiscal year 2014 fourth quarter.  Vascular Access net sales were $27.1 million compared to $28.3 million in the year ago quarter. Oncology/Surgery net sales of $13 million compared with $13.7 million in the prior year's quarter. Overall, net sales in the U.S. were $72 million compared with $73.7 million the 2014 fourth quarter. International net sales were $17.9 million compared with $19.2 million in last year's fourth quarter.  On a constant currency basis, international sales were flat compared to the fiscal 2014 fourth quarter.

The Company's GAAP net loss was $0.8 million, or $0.02 loss per share, compared to net loss of $1.2 million, or $0.03 per share, in the fiscal 2014 fourth quarter. Excluding the items shown in the attached quarterly non-GAAP reconciliation table, adjusted net income was $5 million, or $0.14 per share, compared to net income of $6.2 million, or $0.17 per share, for the year ago quarter.  This includes $0.01 negative impact from movements in currencies, particularly the euro and Canadian dollar, which declined against the U.S. dollar.

Fourth quarter EBITDA was $9.1 million, or $0.25 per share, compared to $10.6 million, or $0.30 per share, in the year ago period. Adjusted EBITDA, excluding the items shown in the attached reconciliation table, was $13.4 million, or $0.37 per share, compared to $15.5 million, or $0.43 per share, in the year ago comparable period.

In the fourth quarter the Company generated $10.8 million in operating cash flow.  At May 31, 2015, cash and investments were $20.1 million and debt was $137.7 million.  During the fourth quarter the Company reduced its debt position by $11.3 million.

Recent Events

·	In early April, AngioDynamics launched its second-generation AngioVac, a full redesign of its innovative system aiming to increase procedural efficiency. The new system allows for shorter set up time, improves navigation, and increases functionality through a working port and angled tip.

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The Company saw regulatory developments in both domestic and international registrations. AngioDynamics received Food and Drug Administration (FDA) 510(k) clearance of a product line extension of the Company's BioFlo product family to now include a range of Midline catheters indicated for short-term intravenous therapies. Additionally, the Company received an updated 510(k) clearance in connection with the NanoKnife System generator and the FDA has issued Certificates to Foreign Governments (CFGs) for NanoKnife, which assists in registering the product for sale in Asia Pacific, Latin America, and Eastern Europe.

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NanoKnife gained further clinical traction with a published abstract by Dr. Robert Martin, Director of Surgical Oncology, University of Louisville, KY in the Annals of Surgery titled "Treatment of 200 Locally Advanced (Stage III) Pancreatic Adenocarcinoma Patients with Irreversible Electroporation: Safety and Efficacy."  Additionally, the Company saw the first patient treated, out of a planned enrollment of 200, in the Clinical Research Office of the Endourological Society (CROES) NanoKnife prostate cancer trial.

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The University of California, Los Angeles (UCLA) has initiated RAPID (Registry of AngioVac Procedures In Detail) led by John Moriarty, MD, Director of Cardiology Interventional Radiology Innovation at UCLA.  RAPID is a multicenter, prospective registry of real world AngioVac use. The registry is designed to evaluate outcomes data, as well as safety and effectiveness of the AngioVac

 

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system in the removal of fresh, soft thrombi or emboli within the central venous system. RAPID is supported by AngioDynamics through a research grant.

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The Company was awarded two contracts by Novation Consolidated Service Centers in the quarter. The first was a Tri-source BioFlo dialysis contract with Mid America Service Solutions (MSS), which was driven by demand for BioFlo Ports and PICCs.  The second was a Dual-source contract with Upper Midwest Consolidated Service Center (UMCSC) which includes the Mayo Clinic for anti-thrombogenic Ports and PICCs.

 

Full Year Financial Results

For the full year ended May 31, 2015, net sales were $357 million, a 1% increase compared to the $354.4 million reported a year ago. On a constant currency basis and excluding the planned wind down of the BSC supply agreement net sales grew 2%. The Company's net loss was $3.3 million, or $0.09 loss per share, compared to net income of $2.7 million, or $0.08 per share, reported a year ago. Excluding the items shown in the attached quarterly non-GAAP reconciliation table, adjusted net income was $21.2 million, or $0.58 per share, compared to net income of $20 million, or $0.56 per share, a year ago. EBITDA was $29.5 million, or $0.81 per share, compared to $41.1 million, or $1.16 per share, a year ago. Adjusted EBITDA, excluding the items shown in the attached reconciliation table, was $57.2 million, or $1.57 per share, compared to $55 million, or $1.55 per share, in the year ago period.  For the full year, the Company generated $26.2 million in operating cash flow.

Fiscal 2016 and Fiscal First Quarter Guidance

"We expect to deliver sales growth during fiscal year 2016," said Mark Frost, vice president and chief financial officer.  "For the full year, we believe net sales will range between $364 million to $370 million, representing 4% growth year-over-year at the top end of our range. Our outlook anticipates sales headwinds in the first half of fiscal 2016 from foreign currency impact and the discontinuation of our Morpheus line of PICCs and we expect these two factors will reduce annual revenue growth by 2%. Based on our sales expectations, we are anticipating adjusted earnings per share (EPS) without amortization to be $0.62-$0.66, 14% growth at the top end compared to fiscal 2015.  

"Because of the headwinds, we are anticipating first quarter net sales to range between $83 million and $87 million, flat on the top end compared to fiscal 2015," Mr. Frost continued.  "Adjusted EPS without amortization is expected to be in the range of $0.10 - $0.12."

Conference Call

AngioDynamics will host a conference call today at 4:30 p.m. Eastern Time to discuss its fourth quarter results. To participate in the live call by telephone, please call 1-888-364-3108 and reference the Conference ID: 8619179. In addition, a live webcast and archived replay of the call will be available at http://investors.angiodynamics.com. To access the live webcast, please go to the website 15 minutes prior to its start to register, download and install the necessary software.

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

 

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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 net sales, excluding a supply agreement; EBITDA (income before interest, taxes, depreciation and amortization); adjusted EBITDA; adjusted gross profit; adjusted net income and adjusted earnings per share. Additionally, this press release evaluates results on a constant currency basis. As a non-GAAP measure, constant currency excludes the impact of foreign currency exchange rate fluctuations. 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 AngioDynamics' performance over different periods. By using these non-GAAP measures, 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 non-GAAP measures to measures prepared in accordance with GAAP.

About AngioDynamics

AngioDynamics Inc. is a leading provider of innovative, minimally invasive medical devices used by professional healthcare providers for vascular access, surgery, peripheral vascular disease and oncology. AngioDynamics' diverse product lines include market-leading ablation systems, fluid management systems, vascular access products, angiographic products and accessories, angioplasty products, drainage products, thrombolytic products and venous products. More information is available at www.AngioDynamics.com.

Trademarks

AngioDynamics, the AngioDynamics logo, BioFlo and NanoKnife are trademarks and/or registered trademarks of AngioDynamics Inc., an affiliate or a subsidiary. Celerity is a trademark and/or registered trademark of Medical Components Inc.

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," "optimistic," 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, technological advances and patents attained by competitors, future actions by the FDA or other regulatory agencies, domestic and foreign health care reforms and government regulations, results of pending or future clinical trials, overall economic conditions, the results of on-going litigation, the effects of economic, credit and capital market conditions, 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, 2014; its Annual Report on Form 10-K/A for the fiscal year ended May 31, 2014; and its quarterly reports on form 10-Q for the

 

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fiscal quarters ended August 31, 2014, November 30, 2014, and February 28, 2014. AngioDynamics does not assume any obligation to publicly update or revise any forward-looking statements for any reason.

In the United States, the NanoKnife System has received a 510(k) clearance by the Food and Drug Administration for use in the surgical ablation of soft tissue, and is similarly approved for commercialization in Canada, the European Union and Australia. The NanoKnife System has not been cleared for the treatment or therapy of a specific disease or condition.

(Tables to Follow)

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