Delaware
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000-50761
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11-3146460
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(State or Other Jurisdiction of Incorporation)
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(Commission File
Number)
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(IRS Employer
Identification No.)
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14 Plaza Drive Latham, New York
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12110
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(Address of Principal Executive Offices)
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(Zip Code)
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(518) 795-1400
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(Registrant’s telephone number, including area code)
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o
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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o
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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o
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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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o
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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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Exhibit No.
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Description
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99.1
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Press Release dated January 8, 2015.
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ANGIODYNAMICS, INC.
(Registrant) |
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Date: January 8, 2015
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By:
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/s/ Stephen A. Trowbridge | |
Name: Stephen A. Trowbridge | |||
Title: Senior Vice President and General Counsel | |||
Exhibit No.
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Description
|
|
99.1
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Press Release dated January 8, 2015.
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Company Contact:
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Investor Relations Contacts:
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Media Contact:
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AngioDynamics Inc.
Mark Frost, CFO
(800) 772-6446 x1981
mfrost@AngioDynamics.com
|
EVC Group, Inc.
Chris Dailey/Robert Jones
(646) 445-4801; (646) 201-5447
cdailey@evcgroup.com;
bjones@evcgroup.com |
EVC Group, Inc.
Dave Schemelia
(646) 201-5431
dave@evcgroup.com
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·
|
Second Quarter Fiscal 2015 Net Sales increased 4% to $92.1 million; 5% sales growth excluding supply agreement
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·
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GAAP EPS of $0.04; Non-GAAP adjusted net income of $0.17 per share, a 21% YOY increase
|
·
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EBITDA of $11.9 million; Adjusted EBITDA of $15.9 million, a 18% YOY increase
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·
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Company raises full-year adjusted EPS guidance to $0.66-$0.72
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·
|
The Company’s average daily trading volume tripled from approximately 100,000 shares to 300,000 shares after it was added to the S&P SmallCap 600 Index and the GICS Life & Health Insurance sub-industry index after the close of trading on Monday, October 20, 2014. The S&P SmallCap 600 Index consists of 600 small capitalization stocks defined as companies with market capitalizations between $400 million and $1.8 billion. Other criteria include financial viability, stock trading liquidity, public float size and corporate governance structure.
|
·
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AngioDynamics’ NanoKnife system received OPS procedure classification codes from the German Ministry of Health. Eleven new OPS Codes were introduced covering bile ducts, bone, liver, lung, stomach, adrenal gland, kidney, esophagus, prostate pancreas and rectum. This process is the first step in securing reimbursement for new medical technologies in Germany. Additionally, the Company received a DRG code for NanoKnife in the Pancreas in the Netherlands.
|
·
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The Company signed an agreement, effective January 1, 2015, with HealthTrust covering PICC (peripherally inserted central catheter) products. Under the terms of the agreement, AngioDynamics’ entire PICC portfolio, including its thromboresistant BioFlo PICC product line and Celerity tip location system, became available to HealthTrust members.
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·
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The Company received a Warning Letter from the FDA relating to observations noted during FDA’s inspection of the Company’s Navilyst Medical facilities located in Marlborough, Mass. and Glens Falls, N.Y. in 2014. The matters raised in the Warning Letter and observations focused on design control processes related to packaging validations and accelerated and real time aging testing in connection with the Company’s fluid management and PICC families of products, inconsistency of a manufacturing product test process used among similar valved PICC products, a particular verification test of valved PICC products and non-conforming product control
|
|
procedures. The Company takes these matters seriously and is committed to complying with all applicable laws, regulations and rules in connection with the manufacturing, sale and marketing of its products. The Company made a comprehensive response to the issues raised in the letter and is committed to working with FDA to resolve all outstanding issues.
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·
|
The Company saw regulatory developments in both domestic and international registrations and renewals. Recent U.S. approvals include two new FDA clearances for the AngioVac system updating the cannula design for improved vessel access and changes to the circuit to improve rapid connector set up. In addition the packaging for the system has been updated for easier access and storage. Other U.S. clearances included a VenaCure EVLT NeverTouch Procedure Kit and Tre’ Sheath and PICC Maximal Barrier Nursing Kit. Internationally, the Company gained NanoKnife registrations in New Zealand, Russia, Thailand and Hong Kong, as well as radio frequency ablation registrations in Israel and microwave in Thailand, along with various Vascular Access and Peripheral vascular registrations in Canada, Europe, Israel and China.
|
·
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AngioDynamics saw further clinical traction with NanoKnife, with two new papers published during the course of quarter. This included, “Systematic review of irreversible electroporation in the treatment of advanced pancreatic cancer,” published by EJSO online in August 2014 by Dr. Moir et al., and, “Irreversible Electroporation: A Novel Therapy for Stage III Pancreatic Cancer,” published by Advances in Surgery online in September 2014 by Dr. Weiss and Wolfgang from Johns Hopkins’ Department of Surgery.
|
Three months ended
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Six months ended
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|||||||||||||||
Nov 30,
|
Nov 30,
|
Nov 30,
|
Nov 30,
|
|||||||||||||
2014
|
2013
|
2014
|
2013
|
|||||||||||||
(unaudited)
|
(unaudited)
|
|||||||||||||||
Net sales
|
$ | 92,149 | $ | 88,571 | $ | 179,480 | $ | 172,215 | ||||||||
Cost of sales
|
44,493 | 43,686 | 85,999 | 84,750 | ||||||||||||
Gross profit
|
47,656 | 44,885 | 93,481 | 87,465 | ||||||||||||
% of net sales
|
51.7 | % | 50.7 | % | 52.1 | % | 50.8 | % | ||||||||
Operating expenses
|
||||||||||||||||
Research and development
|
6,069 | 7,003 | 12,787 | 13,712 | ||||||||||||
Sales and marketing
|
20,981 | 21,073 | 41,048 | 41,036 | ||||||||||||
General and administrative
|
7,973 | 6,411 | 15,296 | 13,097 | ||||||||||||
Amortization of intangibles
|
4,063 | 4,339 | 8,078 | 8,448 | ||||||||||||
Medical device tax
|
1,076 | 999 | 2,071 | 1,975 | ||||||||||||
Change in fair value of contingent consideration
|
617 | 940 | 1,418 | 1,673 | ||||||||||||
Acquisition, restructuring and other
|
2,302 | 2,679 | 4,966 | 4,681 | ||||||||||||
Total operating expenses
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43,081 | 43,444 | 85,664 | 84,622 | ||||||||||||
Operating income
|
4,575 | 1,441 | 7,817 | 2,843 | ||||||||||||
Other income (expense), net
|
(1,745 | ) | (1,791 | ) | (3,569 | ) | (3,756 | ) | ||||||||
Income (loss) before income taxes
|
2,830 | (350 | ) | 4,248 | (913 | ) | ||||||||||
Provision for (benefit from) income taxes
|
1,492 | (89 | ) | 2,440 | (279 | ) | ||||||||||
Net income (loss)
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$ | 1,338 | $ | (261 | ) | $ | 1,808 | $ | (634 | ) | ||||||
Earnings (loss) per common share
|
||||||||||||||||
Basic
|
$ | 0.04 | $ | (0.01 | ) | $ | 0.05 | $ | (0.02 | ) | ||||||
Diluted
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$ | 0.04 | $ | (0.01 | ) | $ | 0.05 | $ | (0.02 | ) | ||||||
Weighted average common shares
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||||||||||||||||
Basic
|
35,595 | 35,132 | 35,475 | 35,041 | ||||||||||||
Diluted
|
36,127 | 35,132 | 36,012 | 35,041 |
Reconciliation of Net Income to non-GAAP Adjusted Net Income:
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||||||||||||||||
Three months ended |
Six months ended
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|||||||||||||||
Nov 30,
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Nov 30,
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Nov 30,
|
Nov 30,
|
|||||||||||||
2014
|
2013
|
2014
|
2013
|
|||||||||||||
(unaudited)
|
(unaudited)
|
|||||||||||||||
Net income (loss)
|
$ | 1,338 | $ | (261 | ) | $ | 1,808 | $ | (634 | ) | ||||||
Amortization of intangibles
|
4,063 | 4,339 | 8,078 | 8,448 | ||||||||||||
Change in fair value of contingent consideration
|
617 | 940 | 1,418 | 1,673 | ||||||||||||
Amortization of inventory basis step-up (1)
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- | 75 | - | 75 | ||||||||||||
Acquisition, restructuring and other (2)
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2,302 | 2,679 | 4,966 | 4,681 | ||||||||||||
Tax effect of non-GAAP items (3)
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(2,089 | ) | (2,893 | ) | (4,389 | ) | (5,376 | ) | ||||||||
Adjusted net income
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$ | 6,231 | $ | 4,879 | $ | 11,881 | $ | 8,867 | ||||||||
Reconciliation of Diluted Earnings Per Share to non-GAAP Adjusted Diluted Earnings Per Share:
|
||||||||||||||||
Three months ended |
Six months ended
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|||||||||||||||
Nov 30,
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Nov 30,
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Nov 30,
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Nov 30,
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|||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||||
(unaudited)
|
(unaudited)
|
|||||||||||||||
Diluted earnings (loss) per share
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$ | 0.04 | $ | (0.01 | ) | $ | 0.05 | $ | (0.02 | ) | ||||||
Amortization of intangibles
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0.11 | 0.12 | 0.22 | 0.24 | ||||||||||||
Change in fair value of contingent consideration
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0.02 | 0.03 | 0.04 | 0.05 | ||||||||||||
Amortization of inventory basis step-up (1)
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- | 0.00 | - | 0.00 | ||||||||||||
Acquisition, restructuring and other (2)
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0.06 | 0.08 | 0.14 | 0.13 | ||||||||||||
Tax effect of non-GAAP items (3)
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(0.06 | ) | (0.08 | ) | (0.12 | ) | (0.15 | ) | ||||||||
Adjusted diluted earnings per share
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$ | 0.17 | $ | 0.14 | $ | 0.33 | $ | 0.25 | ||||||||
Adjusted diluted sharecount
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35,947 | 35,348 | 36,012 | 35,216 |
(1) Amortization of step-up of acquired inventory value in accounting for acquisitions.
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(2) Includes costs related to acquisitions, integrations, restructurings, debt refinancings, litigation, and other items.
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(3) Represents the net tax effect of non-GAAP adjustments.
|
Reconciliation of Net Income to EBITDA and Adjusted EBITDA:
|
||||||||||||||||
Three months ended
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Six months ended
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|||||||||||||||
Nov 30,
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Nov 30,
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Nov 30,
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Nov 30,
|
|||||||||||||
2014
|
2013
|
2014
|
2013
|
|||||||||||||
(unaudited)
|
(unaudited)
|
|||||||||||||||
Net income (loss)
|
$ | 1,338 | $ | (261 | ) | $ | 1,808 | $ | (634 | ) | ||||||
Provision for (benefit from) income taxes
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1,492 | (89 | ) | 2,440 | (279 | ) | ||||||||||
Other income (expense), net
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1,745 | 1,791 | 3,569 | 3,756 | ||||||||||||
Depreciation and amortization
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7,314 | 7,123 | 13,999 | 13,870 | ||||||||||||
EBITDA
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11,889 | 8,564 | 21,816 | 16,713 | ||||||||||||
Change in fair value of contingent consideration
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617 | 940 | 1,418 | 1,673 | ||||||||||||
Amortization of inventory basis step-up (1)
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- | 75 | - | 75 | ||||||||||||
Acquisition, restructuring and other (2,3)
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1,927 | 2,679 | 4,216 | 4,681 | ||||||||||||
Stock-based compensation
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1,506 | 1,271 | 2,901 | 2,423 | ||||||||||||
Adjusted EBITDA
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$ | 15,939 | $ | 13,529 | $ | 30,351 | $ | 25,565 | ||||||||
Per diluted share:
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||||||||||||||||
EBITDA
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$ | 0.33 | $ | 0.24 | $ | 0.61 | $ | 0.47 | ||||||||
Adjusted EBITDA
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$ | 0.44 | $ | 0.38 | $ | 0.84 | $ | 0.73 |
(1) Amortization of step-up of acquired inventory value in accounting for acquisitions.
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(2) Includes costs related to acquisitions, integrations, restructurings, debt refinancings, litigation, and other items.
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(3) Excludes depreciation expense captured in the depreciation and amortization component of the reconciliation.
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ANGIODYNAMICS, INC. AND SUBSIDIARIES
PRELIMINARY NET SALES BY PRODUCT CATEGORY AND BY GEOGRAPHY (unaudited in thousands)
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Three months ended (a)
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Six months ended (b)
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|||||||||||||||||||||||
Nov 30,
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Nov 30,
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%
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Nov 30,
|
Nov 30,
|
%
|
|||||||||||||||||||
2014
|
2013
|
Growth |
2014
|
2013
|
Growth
|
|||||||||||||||||||
|
|
|||||||||||||||||||||||
Net Sales by Product Category
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||||||||||||||||||||||||
Peripheral Vascular
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$ | 49,441 | $ | 48,815 | 1 | % | $ | 96,802 | $ | 94,360 | 3 | % | ||||||||||||
Vascular Access
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27,968 | 25,571 | 9 | % | 54,393 | 50,854 | 7 | % | ||||||||||||||||
Oncology/Surgery
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13,634 | 12,557 | 9 | % | 25,996 | 23,724 | 10 | % | ||||||||||||||||
Total Excluding Supply Agreement
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91,042 | 86,943 | 5 | % | 177,190 | 168,938 | 5 | % | ||||||||||||||||
Supply Agreement
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1,107 | 1,628 | -32 | % | 2,290 | 3,277 | -30 | % | ||||||||||||||||
Total
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$ | 92,149 | $ | 88,571 | 4 | % | $ | 179,480 | $ | 172,215 | 4 | % | ||||||||||||
0 | 0 | 0 | 0 | |||||||||||||||||||||
Net Sales by Geography
|
||||||||||||||||||||||||
United States
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$ | 72,059 | $ | 69,485 | 4 | % | $ | 140,438 | $ | 136,652 | 3 | % | ||||||||||||
International
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18,984 | 17,458 | 9 | % | 36,752 | 32,286 | 14 | % | ||||||||||||||||
Supply Agreement
|
1,107 | 1,628 | -32 | % | 2,290 | 3,277 | -30 | % | ||||||||||||||||
Total
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$ | 92,149 | $ | 88,571 | 4 | % | $ | 179,480 | $ | 172,215 | 4 | % |
(a) There were 62 sales days in the three months ended November 30, 2014 and 2013.
|
|||||
(b) There were 126 sales days in the six months ended November 30, 2014 and 2013.
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ANGIODYNAMICS, INC. AND SUBSIDIARIES
|
||||||||
CONSOLIDATED BALANCE SHEETS
|
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(in thousands)
|
||||||||
Nov 30,
|
May 31,
|
|||||||
2014
|
2014
|
|||||||
(unaudited)
|
(unaudited)
|
|||||||
Assets
|
||||||||
Current Assets
|
||||||||
Cash and cash equivalents
|
$ | 14,877 | $ | 16,105 | ||||
Marketable securities
|
1,698 | 1,809 | ||||||
Total cash and investments
|
16,575 | 17,914 | ||||||
Receivables, net
|
58,556 | 61,968 | ||||||
Inventories, net
|
75,315 | 61,234 | ||||||
Deferred income taxes
|
4,091 | 4,625 | ||||||
Prepaid income taxes
|
2,156 | 510 | ||||||
Prepaid expenses and other
|
6,753 | 5,471 | ||||||
Total current assets
|
163,446 | 151,722 | ||||||
Property, plant and equipment, net
|
67,553 | 66,590 | ||||||
Intangible assets, net
|
197,362 | 205,256 | ||||||
Goodwill
|
360,473 | 360,473 | ||||||
Deferred income taxes
|
7,236 | 10,403 | ||||||
Other non-current assets
|
3,260 | 4,447 | ||||||
Total Assets
|
$ | 799,330 | $ | 798,891 | ||||
Liabilities and Stockholders' Equity
|
||||||||
Accounts payable and accrued expenses
|
$ | 41,146 | $ | 49,547 | ||||
Current portion of long-term debt
|
6,250 | 5,000 | ||||||
Current portion of contingent consideration
|
9,795 | 10,918 | ||||||
Other current liabilities
|
746 | 1,288 | ||||||
Total current liabilities
|
57,937 | 66,753 | ||||||
Long-term debt, net of current portion
|
148,910 | 137,660 | ||||||
Contingent consideration, net of current portion
|
47,643 | 56,413 | ||||||
Other long-term liabilities
|
1,270 | 1,230 | ||||||
Total Liabilities
|
255,760 | 262,056 | ||||||
Stockholders' equity
|
543,570 | 536,835 | ||||||
Total Liabilities and Stockholders' Equity
|
$ | 799,330 | $ | 798,891 |
ANGIODYNAMICS, INC. AND SUBSIDIARIES
|
||||||||||||||||
CONSOLIDATED STATEMENTS OF CASH FLOWS
|
||||||||||||||||
(in thousands)
|
||||||||||||||||
Three months ended
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Six months ended
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|||||||||||||||
Nov 30,
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Nov 30,
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Nov 30,
|
Nov 30,
|
|||||||||||||
2014
|
2013
|
2014
|
2013
|
|||||||||||||
(unaudited) | (unaudited) | (unaudited) |
(unaudited)
|
|||||||||||||
Cash flows from operating activities:
|
||||||||||||||||
Net income (loss)
|
$ | 1,338 | $ | (261 | ) | $ | 1,808 | $ | (634 | ) | ||||||
Depreciation and amortization
|
7,314 | 7,123 | 13,999 | 13,870 | ||||||||||||
Amortization of acquired inventory basis step-up
|
- | 75 | - | 75 | ||||||||||||
Change in fair value of contingent consideration
|
617 | 940 | 1,418 | 1,673 | ||||||||||||
Tax effect of exercise of stock options
|
- | (85 | ) | - | (146 | ) | ||||||||||
Deferred income taxes
|
1,575 | 586 | 3,685 | 1,155 | ||||||||||||
Stock-based compensation
|
1,506 | 1,271 | 2,901 | 2,423 | ||||||||||||
Other
|
(61 | ) | 140 | 256 | 288 | |||||||||||
Changes in operating assets and liabilities
|
||||||||||||||||
Receivables
|
(2,746 | ) | (1,916 | ) | 3,069 | (123 | ) | |||||||||
Inventories
|
(4,894 | ) | (878 | ) | (14,081 | ) | (4,351 | ) | ||||||||
Accounts payable and accrued liabilities
|
(5,905 | ) | 2,133 | (6,138 | ) | 3,410 | ||||||||||
Other
|
(891 | ) | (670 | ) | (3,712 | ) | (1,882 | ) | ||||||||
Net cash provided by (used in) operating activities
|
(2,147 | ) | 8,458 | 3,205 | 15,758 | |||||||||||
Cash flows from investing activities:
|
||||||||||||||||
Additions to property, plant and equipment
|
(2,419 | ) | (4,288 | ) | (7,523 | ) | (7,191 | ) | ||||||||
Acquisition of businesses, net of cash acquired
|
- | - | - | (4,169 | ) | |||||||||||
Acquisition of intangible assets
|
(96 | ) | (150 | ) | (250 | ) | (150 | ) | ||||||||
Other cash flows from investing activities
|
- | - | - | 303 | ||||||||||||
Net cash provided by (used in) investing activities
|
(2,515 | ) | (4,438 | ) | (7,773 | ) | (11,207 | ) | ||||||||
Cash flows from financing activities:
|
||||||||||||||||
Repayment of long-term debt
|
(1,250 | ) | (143,750 | ) | (2,500 | ) | (143,750 | ) | ||||||||
Proceeds from issuance of long-term debt and revolver borrowings
|
15,000 | 141,410 | 15,000 | 141,410 | ||||||||||||
Payment of Contingent Consideration
|
(9,122 | ) | (8,350 | ) | (11,222 | ) | (9,300 | ) | ||||||||
Proceeds from exercise of stock options and ESPP
|
1,144 | 455 | 2,103 | 1,133 | ||||||||||||
Other cash flows from financing activities
|
- | (677 | ) | - | (677 | ) | ||||||||||
Net cash provided by (used in) financing activities
|
5,772 | (10,912 | ) | 3,381 | (11,184 | ) | ||||||||||
Effect of exchange rate changes on cash
|
(41 | ) | - | (41 | ) | 4 | ||||||||||
Increase (Decrease) in cash and cash equivalents
|
1,069 | (6,892 | ) | (1,228 | ) | (6,629 | ) | |||||||||
Cash and cash equivalents
|
||||||||||||||||
Beginning of period
|
13,808 | 22,065 | 16,105 | 21,802 | ||||||||||||
End of period
|
$ | 14,877 | $ | 15,173 | $ | 14,877 | $ | 15,173 | ||||||||
- | - |