Item 2.02 – Results of Operations and Financial Condition.

On January 7, 2016, AngioDynamics, Inc. (“AngioDynamics” or the “Company”) issued a press release announcing financial results for the fiscal second quarter ended November 30, 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 otherwise subject to the liabilities of that Section.  Furthermore, the information in Exhibit 99.1 shall not be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act.

Forward-Looking Statements

This document and its attachments contain 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, infringement of AngioDynamics’ technology or assertions that AngioDynamics’ technology infringes the technology of third parties, the ability of AngioDynamics to effectively compete against competitors that have substantially greater resources, 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, challenges with respect to third-party distributors or joint venture partners or collaborators, the results of sales efforts, the effects of product recalls and product liability claims, changes in key personnel, the ability of AngioDynamics to execute on strategic initiatives, 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, 2015 and its quarterly report on Form 10-Q for the fiscal period ended August 31, 2015. AngioDynamics does not assume any obligation to publicly update or revise any forward-looking statements for any reason.

Item 9.01 – Financial Statements and Exhibits.

 

Exhibit No.		Description
99.1		Press Release dated January 7, 2016.

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 7, 2016	By:	/s/ Stephen A. Trowbridge
		Stephen A. Trowbridge
		Senior Vice President and General Counsel

 

EXHIBIT INDEX

FOR IMMEDIATE RELEASE

AngioDynamics Reports Fiscal 2016 Second Quarter Results

·	Net sales of $89.2 million

·	GAAP loss of $0.01 per share; Non-GAAP adjusted EPS of $0.14

·	Operating cash generation of $9.6 million

ALBANY, N.Y., (January 7, 2016) – 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 second quarter of fiscal year 2016 ended November 30, 2015.

"In the second quarter, we managed the business effectively, despite lingering headwinds, and generated net sales of $89.2 million and adjusted EPS of $0.14, both of which were in the mid-range of our guidance," commented Joseph M. DeVivo, president and chief executive officer. "Our team has worked diligently to build a culture committed to quality and compliance and, in the quarter, our efforts were validated when the FDA removed the remaining warning letters against the Company. Additionally, we continue to execute our operational excellence plans and expect to complete the manufacturing transition from Queensbury to Glens Falls in January, which will further increase our operating leverage and improve cash flow generation. AngioDynamics now has a strong operational and regulatory foundation that we believe will contribute to top line growth, margin expansion and continued strong cash flow from operations.

"From a products perspective, overall Peripheral Vascular business grew 3%, driven by a strong performance in Thrombus Management, which grew 17%. In addition, BioFlo continued to grow across all product segments in our Vascular Access business, including a strong sales quarter for our midline and dialysis products. BioFlo now represents 41% of our Vascular Access franchise. In Oncology/Surgery, our growth driver products, Microwave and NanoKnife, showed significant procedural and utilization growth offsetting slower capital sales. We believe procedural and utilization growth are a better indication of the opportunity for those two products.

"As we begin the second half of our fiscal year, we are moving past the Morpheus withdrawal and foreign currency headwinds that have impacted our recent top line performance. We are now fully focused on building on our improved operational foundation to continue our commercial momentum, especially with our growth driver products."

Second Quarter 2016 Financial Results

Net sales for the fiscal second quarter were $89.2 million, compared with $92.1 million a year ago. On a constant currency basis and excluding the impact of the Morpheus product discontinuance, sales were down 1% compared to the second quarter last year.

 

The following comparisons exclude the BSC supply agreement.

Peripheral Vascular net sales in the second quarter were $51.1 million compared to $49.4 million in the fiscal year 2015 second quarter. Vascular Access net sales were $25.0 million compared to $28.0 million a year ago. Oncology/Surgery net sales were $12.4 million compared to $13.6 million in the prior year's second quarter. Overall, net sales in the U.S. were $70.7 million compared to $72.1 million in the 2015 fiscal year second quarter. International net sales were $17.8 million compared to $19.0 million a year ago, which included a 5% negative impact on revenues from foreign currency headwinds.

The Company's GAAP net loss was $0.4 million, or $0.01 loss per share, compared to a net income of $1.3 million, or $0.04 per share, in the second quarter of fiscal 2015. Excluding the items shown in the attached quarterly non-GAAP reconciliation table, adjusted net income was $5.1 million, or $0.14 per share, compared to adjusted net income of $6.2 million, or $0.17 per share, from the year ago second quarter.

EBITDA was $8.4 million, or $0.23 per share, compared to $11.9 million, or $0.33 per share, a year ago. Adjusted EBITDA, excluding the items shown in the attached reconciliation table, was $13.4 million, or $0.37 per share, compared to $15.9 million, or $0.44 per share, in the year ago comparable period.

In the second quarter, the Company generated $9.6 million in operating cash flow. At November 30, 2015, cash and investments were $20.6 million and debt was $133.9 million.

Six Months Financial Results

For the six months ended November 30, 2015, net sales were $172.9 million compared to the $179.5 million reported a year ago. The Company's net loss was $1.1 million, or $0.03 per share, compared to net income of $1.8 million, or $0.05 per share, reported a year ago. Excluding the items shown in the attached quarterly non-GAAP reconciliation table, adjusted net income was $9.0 million, or $0.25 per share, compared to net income of $11.9 million, or $0.33 per share, a year ago. EBITDA was $16.6 million, or $0.45 per share, compared to EBITDA of $21.8 million, or $0.61 per share, a year ago. Adjusted EBITDA, excluding the items shown in the attached reconciliation table, was $25.3 million, or $0.69 per share, compared to $30.4 million, or $0.84 per share, in the year ago period.

Recent Events

·

The Company received letters from the United Stated Food and Drug Administration (FDA) closing out warning letters it received from the FDA in January 2011 regarding certain promotional activities related to the NanoKnife System, in May 2011 related to the company's Queensbury facility and in November 2014 related to the Glens Falls and Marlborough facilities. These actions resolved all outstanding FDA warning letters against AngioDynamics.

·	The company received eight regulatory clearances for products in various international markets, a total of 16 in the first half of the 2016 fiscal year.

·	The NanoKnife System was approved by South Korea's Ministry of Food and Drug Safety for the ablation of soft tissue. The Company is selling the NanoKnife system to healthcare providers in South Korea through exclusive distribution partnerships.  NanoKnife is now approved in 45 countries worldwide.

 

 

·	The Americas Hepato-Pancreato-Billiary Association (AHPBA) registered its first patient into a registry to capture patient and effectiveness data on the use of Irreversible Electroporation (IRE) utilizing NanoKnife for patients with pancreatic cancer.

Fiscal Year 2016 and Third Quarter Financial Guidance

The Company revised its FY2016 net sales guidance to $353 to $359 million and adjusted earnings per share (EPS) of $0.59 to $0.63. The Company expects third quarter net sales to be in the range of $84 to $87 million and adjusted EPS of $0.10 to $0.14.

Conference Call

AngioDynamics will host a conference call today at 4:30 p.m. ET to discuss its second quarter results. To participate in the live call by telephone, please call 1-888-455-2263 and reference the Conference ID: 1443554. In addition, a live webcast and archived replay of the call will be available at investors.angiodynamics.com. To access the live webcast, please go to the website 15-minutes prior 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 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; adjusted sales growth; 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, Morpheus, NanoKnife and AngioVac, are trademarks and/or registered trademarks of AngioDynamics Inc., an affiliate or a subsidiary.

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, infringement of AngioDynamics' technology or assertions that AngioDynamics' technology infringes the technology of third parties, the ability of AngioDynamics to effectively compete against competitors that have substantially greater resources, 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, challenges with respect to third-party distributors or joint venture partners or collaborators, the results of sales efforts, the effects of product recalls and product liability claims, changes in key personnel, the ability of AngioDynamics to execute on strategic initiatives, 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, 2015 and its quarterly report on Form 10-Q for the fiscal period ended August 31, 2015. 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.

 

 

 

 

 

 

 

		Three months ended								Six months ended
		Nov 30,				Nov 30,				Nov 30,				Nov 30,
		2015				2014				2015				2014
		(unaudited)				(unaudited)				(unaudited)				(unaudited)
Cash flows from operating activities:
Net  income  (loss)		$	(362	)		$	1,338			$	(1,119	)		$	1,808
Adjustments to reconcile net income (loss) to net cash provided by operating activities:
Depreciation and amortization			7,197				7,299				14,420				13,999
Stock-based compensation			1,234				1,506				2,860				2,901
Change in fair value of contingent consideration			306				617				661				1,418
Fixed and intangible asset impairments and disposals			402				-				622				-
Deferred income taxes			(412	)			1,575				(607	)			3,685
Change in accounts receivable allowance			229				218				338				345
Other			(248	)			(279	)			(261	)			(89	)
Changes in operating assets and liabilities, net of acquisitions:
Receivables			(1,017	)			(2,746	)			4,908				3,069
Inventories			3,449				(4,894	)			(3,473	)			(14,081	)
Prepaid and other assets			354				(876	)			(1,600	)			(3,712	)
Accounts payable and accrued liabilities			(1,553	)			(5,905	)			(2,471	)			(6,138	)
Net cash provided by (used in) operating activities			9,579				(2,147	)			14,278				3,205
Cash flows from investing activities:
Additions to property, plant and equipment			(425	)			(2,419	)			(1,168	)			(7,523	)
Acquisition of intangible assets			-				(96	)			-				(250	)
Other cash flows from investing activities			25				-				25				-
Net cash provided by (used in) investing activities			(400	)			(2,515	)			(1,143	)			(7,773	)
Cash flows from financing activities:
Repayment of long-term debt			(2,500	)			(1,250	)			(3,750	)			(2,500	)
Proceeds from issuance  of long-term debt and revolver borrowings			-				15,000				-				15,000
Payment of Contingent Consideration			(7,750	)			(9,122	)			(9,850	)			(11,222	)
Proceeds from exercise of stock options and ESPP			(49	)			1,144				1,230				2,103
Net cash provided by (used in) financing activities			(10,299	)			5,772				(12,370	)			3,381
Effect of exchange rate changes on cash			(152	)			(41	)			(160	)			(41	)
Increase  (Decrease) in cash and cash equivalents			(1,272	)			1,069				605				(1,228	)
Cash and cash equivalents
Beginning of period			20,268				13,808				18,391				16,105
End of period		$	18,996			$	14,877			$	18,996			$	14,877