UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

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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):  September 28, 2017

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:

☐

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))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02 – Results of Operations and Financial Condition

 

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, 2017. 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 September 28, 2017.

 

 

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:  September 28, 2017	By:	/s/ Stephen A. Trowbridge
		Stephen A. Trowbridge
		Senior Vice President and General Counsel

EXHIBIT INDEX

 

 

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FOR IMMEDIATE DISTRIBUTION

 

AngioDynamics Reports Fiscal 2018 First Quarter Results

·	Q1 net sales of $85.4 million, down 3% year-over-year

·	Q1 GAAP earnings per share of $0.00; adjusted EPS of $0.12

·	Q1 operating cash generation of $3.0 million; free cash flow generation of $2.5 million

·	Company reaffirms fiscal 2018 guidance

ALBANY, N.Y., September 28, 2017 (GLOBE NEWSWIRE) – AngioDynamics (NASDAQ:ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, today reported first quarter financial results for the 2018 fiscal year ended August 31, 2017.

“The first quarter of fiscal 2018 reflects early results of our commitment to improving our core operational efficiency and strengthening our business,” said Jim Clemmer, President and Chief Executive Officer of AngioDynamics. “Sales for our Oncology/Surgery business saw an 11 percent increase over last year, primarily driven by Solero, which received FDA clearance during the fiscal 2017 fourth quarter. In addition, we saw strong sales from other areas of our business, including Fluid Management, Thrombus Management, the BioFlo family of products and NanoKnife disposables. We remain committed to our strategic plan and will continue to invest in the right areas to drive sustainable, long-term growth.”

First Quarter 2018 Financial Results

Net sales for the fiscal first quarter were $85.4 million, down 3 percent compared to $88.1 million a year ago. Currency did not have an impact in the quarter.

Of the decline, $1.6 million is related to the Core/Angiographic Catheter business. During the same period of the 2017 fiscal year, we saw a $4.0 million increase in sales as a result of the inventory build by our customers related to a previously disclosed competitor product recall.

Peripheral Vascular net sales in the first quarter were $49.9 million, down from $52.0 million in the fiscal year 2017 first quarter as a result of declines in the Venous and Core businesses, offset by growth in Fluid Management and Thrombus Management. Vascular Access net sales were $23.2 million in the first quarter, down from $25.0 million a year ago as a result of declines of

 

 

 

non-BioFlo products, offset by growth in the BioFlo family of products. First quarter Oncology/Surgery net sales were $12.3 million, up from $11.1 million in the fiscal year 2017 first quarter, primarily due to sales related to the recently launched Solero Microwave Tissue Ablation System.

Overall U.S. net sales in the first quarter were $68.9 million, down from $72.2 million a year ago due to declines in Venous and Core businesses, offset by growth in the Oncology portfolio. Overall International net sales in the first quarter were $16.5 million, up from $15.9 million a year ago due to increased sales across the Oncology/Surgery business.

The Company recorded a net loss of less than one hundred thousand dollars, or $0.00 on a per share basis in the first quarter of fiscal 2018. The Company recorded net income of $1.3 million, or $0.04 on a per share basis, in the first quarter of fiscal 2017.

Gross margins for the first quarter of 2018 were 48.3 percent, compared to 51.1 percent a year ago. The decline in gross margin is primarily driven by a recall and voluntary market withdrawal of the Acculis Microwave Tissue Ablation System which was initiated in the fourth quarter of fiscal 2017.

Excluding the items shown in the attached quarterly non-GAAP reconciliation table, adjusted net income for the first quarter of fiscal 2018 was $4.6 million, or $0.12 per share, compared to an adjusted net income of $6.4 million, or $0.17 per share, in the first quarter of fiscal 2017. Adjusted EBITDAS in the first quarter of fiscal 2018, excluding the items shown in the attached reconciliation table, was $10.6 million compared to $14.2 million in the first quarter of fiscal 2017.

In the first quarter of fiscal 2018, the Company generated $3.0 million in operating cash flow and $2.5 million in free cash flow. As of August 31, 2017, cash and cash equivalents were $48.2 million and debt was $96.3 million.

“There were a couple of factors that impacted our financial results during the first quarter when compared to prior year, including decisions we made to address the recall and voluntary market withdrawal of Acculis and the inventory build in our Core/Angiographic Catheter business,” said Michael C. Greiner, Executive Vice President and Chief Financial Officer of AngioDynamics, adding that. “Our results for the first quarter were in-line with our expectations and given the strength of our overall execution we are reaffirming our fiscal 2018 guidance to reflect that confidence.”

Fiscal Year 2018 Financial Guidance

The Company reaffirmed its FY2018 financial guidance of a net sales range of $352 to $359 million, adjusted earnings per share (EPS) of $0.64 to $0.68 and free cash flow of greater than $35 million. 

Conference Call

 

 

 

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 EBITDAS; adjusted net income, adjusted earnings per share and free cash flow. 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

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 fourth 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 fourth-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, 2017. 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.

 

 

 

ANGIODYNAMICS, INC. AND SUBSIDIARIES
CONSOLIDATED INCOME STATEMENTS
(in thousands, except per share data)
	Three months ended
	August 31,		August 31,
	2017		2016
	(unaudited)
Net sales	$     85,411		$     88,098
Cost of sales (exclusive of intangible amortization)	44,182		43,066
Gross profit	41,229		45,032
% of net sales	48.3%		51.1%
Operating expenses
Research and development	6,441		6,709
Sales and marketing	19,402		19,455
General and administrative	8,056		8,201
Amortization of intangibles	4,096		4,235
Change in fair value of contingent consideration	105		443
Acquisition, restructuring and other items, net	2,989		2,417
Total operating expenses	41,089		41,460
Operating  income	140		3,572
Other (expense), net	(156)		(669)
Income (loss) before income taxes	(16)		2,903
Income tax expense	19		1,603
Net income (loss)	$          (35)		$       1,300
Earnings (loss) per share
Basic	$       (0.00)		$        0.04
Diluted	$       (0.00)		$        0.04
Weighted average shares outstanding
Basic	36,919		36,319
Diluted	36,919		36,698

 

 

ANGIODYNAMICS, INC. AND SUBSIDIARIES
GAAP TO NON-GAAP RECONCILIATION
(in thousands, except per share data)
	Reconciliation of Gross Profit to non-GAAP Adjusted Gross Profit
		Three months ended
		August 31,		August 31,
		2017		2016
		(unaudited)
	Gross profit	$    41,229		$  45,032
	Inventory charge included in cost of sales	-		(1)
	Adjusted gross profit	$    41,229		$  45,031
	Adjusted gross profit % of sales	48.3%		51.1%
	Reconciliation of Net Income to non-GAAP Adjusted Net Income:
		Three months ended
		August 31,		August 31,
		2017		2016
		(unaudited)
	Net income (loss)	$        (35)		$    1,300
	Inventory charge included in cost of sales	-		(1)
	Amortization of intangibles	4,096		4,235
	Change in fair value of contingent consideration	105		443
	Acquisition, restructuring and other items, net (1)	2,989		2,417
	Tax effect of non-GAAP items (2)	(2,564)		(1,996)
	Adjusted net income	$      4,591		$    6,398
	Reconciliation of Diluted Earnings Per Share to non-GAAP Adjusted Diluted Earnings Per Share:
		Three months ended
		August 31,		August 31,
		2017		2016
		(unaudited)
	Diluted earnings (loss) per share	$      (0.00)		$      0.04
	Amortization of intangibles	0.11		0.11
	Change in fair value of contingent consideration	0.00		0.01
	Acquisition, restructuring and other items, net (1)	0.08		0.06
	Tax effect of non-GAAP items (2)	(0.07)		(0.05)
	Adjusted diluted earnings per share	$       0.12		$      0.17
	Adjusted diluted sharecount	37,230		36,698
	(1)  Includes costs related to mergers and acquisition activities, integrations, restructurings, asset impairments and write-offs, litigation, and other items.
	(2)  Represents the net tax effect of non-GAAP adjustments.  Based on our historical non-GAAP earnings, our tax effect of non-GAAP items has been calculated assuming no valuation allowance on our deferred tax assets and an effective tax rate of 36%.

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