UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K

xANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended May 31, 2017
For the fiscal year ended May 31, 2021

OR

¨TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from              to             
For the transition period from to

Commission file number 0-50761
AngioDynamics, Inc.
(Exact name of registrant as specified in its charter)


ango-20210531_g1.gif

Delaware11-3146460
(State or other jurisdiction of

incorporation or organization)
(I.R.S. Employer

Identification No.)
14 Plaza Drive Latham, New York12110
(Address of principal executive offices)(Zip Code)

14 Plaza Drive, Latham, New York 12110
(Address of principal executive offices and zip code)
(518) 795-1400
Registrant’s telephone number, including area code (518) 795-1400
 
Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading SymbolName of each exchange on which registered
Common Stock, par value $.01 per shareANGONASDAQ Global Select Market
Securities registered pursuant to Section 12(g) of the Act:
None
(Title of Class)
 
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.    Yes  ¨    No  x
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act.    Yes  ¨    No  x
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes  x    No  ¨
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate website, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes  x   No  ¨
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K.  x
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See definitions of “large accelerated filer”, “accelerated filer”, “smaller reporting company” and "emerging growth company" in Rule 12b-2 of the Exchange Act. (Check one):





Large accelerated filer  ¨
Accelerated filerx
Non-accelerated filer¨
Smaller reporting company¨
Emerging growth company¨
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.  Yes      No  
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes  ¨    No  x

As of November 30, 2016,2020, the last business day of the registrant’s most recently completed second fiscal quarter, the aggregate market value of the registrant’s common stock held by non-affiliates was approximately $605,494,808$496,277,118 computed by reference to the last sale price of the common stock on that date as reported by The NASDAQ Global Select Market.

As of August 2, 2017,July 26, 2021 there were 36,580,57538,444,076 shares of the registrant’s common stock outstanding.



DOCUMENTS INCORPORATED BY REFERENCE
The information required for Part III of this Annual Report on Form 10-K is incorporated by reference to the registrant’s Proxy Statement for its 20172021 Annual Meeting of Stockholders to be filed within 120 days of the registrant's fiscal year ended May 31, 2017.

2021.




AngioDynamics, Inc. and Subsidiaries
INDEX
 
Page
Part I:Page
Part I:
Item 1.
Item 1A.
Item 1B.
Item 2.
Item 3.
Item 4.
Part II:
Item 5.
Item 6.
Item 7.
Item 7A.
Item 8.
Item 9.
Item 9A.
Item 9B.
Part III:
Item 10.
Item 11.
Item 12.
Item 13.
Item 14.
Part IV:
Item 15.

1




Part I
Unless otherwise indicated in this report, "AngioDynamics," the "Company," "we," "our" or "us" refers to AngioDynamics, Inc and our consolidated subsidiaries.
Disclosure Regarding Forward-Looking Statements
This annual report on Form 10-K, including the sections entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” 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 words such as “expects,” “reaffirms,” “intends,” “anticipates,” “plans,” “believes,” “seeks,” “estimates,” “projects,” 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 materially from our expectations, expressed or implied. Factors that may affect our actual results achieved include, without limitation, our ability to develop existing and new products, future actions by FDA or other regulatory agencies, results of pending or future clinical trials, the results of ongoing litigation, overall economic conditions, general market conditions, market acceptance, foreign currency exchange rate fluctuations, the effects on pricing from group purchasing organizations and competition, our ability to integrate purchased businesses and other factors including natural disasters and pandemics (such as the scope, scale and duration of the impact of COVID-19). Other risks and uncertainties include, but are not limited to, the factors described from time to time in our reports filed with the Securities and Exchange Commission (the "SEC").
Although we believe that the assumptions underlying the forward-looking statements contained herein are reasonable, any of the assumptions could be inaccurate and, therefore, there can be no assurance that the forward-looking statements included in this quarterly report on Form 10-K will prove to be accurate. In light of the significant uncertainties inherent in the forward-looking statements included herein, the inclusion of such information should not be regarded as a representation by us or any other person that our objectives and plans will be achieved. Any forward-looking statements are made pursuant to the Private Securities Litigation Reform Act of 1995 and, as such, 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 report. AngioDynamics disclaims any obligation to update the forward-looking statements. 
Disclosure Regarding Trademarks
This report includes trademarks, tradenames and service marks that are our property or the property of other third parties. Solely for convenience, such trademarks and tradenames sometimes appear without any “™” or “®” symbol. However, failure to include such symbols is not intended to suggest, in any way, that we will not assert our rights or the rights of any applicable licensor, to these trademarks and tradenames. For a complete listing of all our trademarks, tradenames and service marks please visit www.angiodynamics.com/IP.
Item 1.Business.

Item 1. Business.
OVERVIEW

AngioDynamics, Inc. (together with its subsidiaries, "AngioDynamics," the "Company," "we," "our" or "us") designs, manufactures and sells a wide range of medical, surgical and diagnostic devices used by professional healthcare providers for the treatment of peripheral vascular disease, vascular access and for use in oncology and surgical settings. Our devices are generally used in minimally invasive, image-guided procedures.

HISTORY

AngioDynamics was founded in Queensbury, N.Y., U.S., in 1988. Queensbury was chosen due to its location1988 and began manufacturing and shipping product in the heartearly 1990s. The Company is headquartered in Latham, N.Y., with manufacturing primarily out of "Catheter Valley," an area in New York's Adirondack Region named for its long history of catheter and other medical device manufacturing.the Queensbury facility. Initially dedicated to the research and development of products used in interventional radiology, AngioDynamics began manufacturing and shipping product in the early 1990s. The Company soon became well established as a producer of diagnostic catheters for non-coronary angiography and thrombolytic delivery systems.

The companyCompany grew over the following years as a result of acquisitions of companies including RITA Medical Systems in January 2007, Oncobionic in May 2008, Vortex Medical, Inc. in October 2012, Clinical Devices in August 2013, the assets of Diomed in June 2008 and FlowMedicathe assets of Microsulis Medical Limited in January 2009.2013. These acquisitions added product lines including market-leading ablation and NanoKnife systems, vascular access products, angiographic products and accessories, dialysis products, drainage products, thrombolytic products, embolization products and venous products and targeted renal therapy products. More recentlyIn May 2012, the Company acquired Navilyst Medical's Fluid Management business, which the Company sold in May 2012, AngioDynamics2019 to Medline Industries, Inc. pursuant to an asset purchase agreement.
2


In August 2018, the Company acquired Navilystthe BioSentry product line from Surgical Specialties, LLC. In September 2018, the Company acquired RadiaDyne, which included endorectal and vaginal balloons. On October 2, 2019, the Company acquired Eximo Medical, bringing market-leading fluid management systems into our portfolio. The acquisition significantly expandedLtd., a pre-commercial stage medical device company and its proprietary 355nm laser atherectomy technology (now called Auryon), which treats Peripheral Artery Disease. On December 17, 2019, the Company's scale, doubling its share ofCompany acquired the vascular access market while building critical mass in the peripheral vascular market.C3 Wave tip location asset from Medical Components Inc.

Headquartered in Latham, N.Y., AngioDynamics is publicly traded on the NASDAQ stock exchange under the symbol ANGO.

PRODUCTS

Our product offerings fall within three Global Business Units (GBUs): PeripheralEndovascular Therapies (formerly, Vascular Interventions and Therapies ("VIT")), Oncology/Surgery ("OS") and Vascular Access and Oncology/Surgery.("VA"). All products discussed below have been cleared for sale in the United States by the Food and Drug Administration (FDA).Administration. International regulatory clearances vary by product and jurisdiction.
Peripheral VascularEndovascular Therapies Products

AngioDynamics’ Peripheral VascularEndovascular Therapies product offerings support the medical areas of Venous Insufficiency, Thrombus Management, Fluid Management andAtherectomy, Peripheral Products (Core) and Venous Insufficiency.
Thrombus Management
Our Thrombus Management portfolio includes the proprietary AngioVac venous drainage cannula and circuit, as well as catheter directed thrombolytic devices, including the Uni-Fuse system, the Uni-Fuse+ system, the Pulse Spray system and SpeedLyser infusion catheters. AngioDynamics offers a range of options when treating thrombus and removing fresh, soft thrombi or emboli.
AngioVac
Our AngioVac venous drainage system includes a Venous Drainage Cannula and Extracorporeal Circuit. The cannula is indicated for use as a venous drainage cannula and for removal of fresh, soft thrombi or emboli during extracorporeal bypass. The AngioVac circuit is indicated for use in procedures requiring extracorporeal circulatory support for periods of up to six hours. AngioVac devices are for use with other manufacturers’ off-the-shelf pump, filter and reinfusion cannula, to facilitate venous drainage as part of an extracorporeal bypass procedure.
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The AngioVac venous drainage cannula is a 22 French flat coil-reinforced cannula designed with a proprietary self-expanding nitinol reinforced funnel shaped distal tip. The funnel shaped tip enhances venous drainage flow when the distal tip is exposed by retracting the sheath, helps prevent clogging of the cannula with commonly encountered undesirable intravascular material, and facilitates embolic removal of such extraneous material.
Auryon
The Auryon Atherectomy System is one of our latest advancement in peripheral arterial disease. The Auryon system is designed to deliver an optimized wavelength, pulse width, and amplitude to remove lesions while preserving vessel wall endothelium. Additionally, the Auryon system includes aspiration which enhances the safety of the procedure. Regardless of lesion type, the Auryon system provides exceptional safety and efficacy. The Auryon system is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions, including in-stent restenosis (ISR).
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3


Thrombolytic Catheters
Thrombolytic catheters are used to deliver thrombolytic agents, which are drugs that dissolve blood clots in hemodialysis access grafts, arteries, veins and surgical bypass grafts. AngioDynamics’ Uni-Fuse infusion catheter features pressure response outlets, a proprietary, time-tested slit technology that provides a consistent, even distribution of fluid volume along the entire length of the infusion pattern, resulting in a 12-fold advantage over standard side-hole catheters.
We also offer the Pulse-Spray infusion system for high pressure, pulsed delivery of lytic agents to shorten treatment time, and the SpeedLyser infusion system built for dialysis grafts and fistulas.¹
Peripheral Products (Core)
We offer a comprehensive portfolio for minimally invasive peripheral products. Product categories include an extensive line of angiographic catheters and diagnostic and interventional guidewires, percutaneous drainage catheters and coaxial micro-introducer kits.
¹ Yusuf SW, et al. Immediate and Early Follow-up Results of Pulse Spray Thrombolysis in Patients with Peripheral Ischaemia. British Journal of Surgery 1995; 82:338-340.
Angiographic Products and Accessories
Angiographic products and accessories are used during peripheral diagnostic and interventional procedures. These products permit physicians to reach targeted locations to deliver contrast media for visualization purposes and therapeutic agents and devices, such as percutaneous transluminal angioplasty (PTA) balloons. Angiographic products consist of angiographic catheters and guidewires.
Our angiographic catheter line includes the following brands, all with radiopaque tips to assure excellent visibility under fluoroscopy:
Soft-Vu flush catheters are available in flush and selective varieties. Flush catheters are used in procedures where a high flow of contrast is required for “big picture” diagnostics. Anomalies discovered through a flush angiogram may require further investigation into a vessel of interest. Soft-Vu selective catheters are used to gain access to smaller or more distal vessels and advance the catheter or wire into the diseased section.
Accu-Vu sizing catheters feature radiopaque marker bands at the distal (farthest away) portion of the catheter to provide a highly accurate measurement of the patient’s anatomy. This enables precise measurement for interventional devices such as stents.
AngiOptic catheters have total catheter radiopacity, ensuring tip-to-hub visibility. This catheter is also constructed with a firm tip material that enhances stability during high-flow injections, providing excellent pushability.
Mariner catheters have a hydrophilic coating that, when combined with water, reduces friction. This makes insertion potentially easier and more comfortable for the patient, and can also be used for advancing through tortuous anatomy.
AngioDynamics guidewires include Nit-Vu (featuring a kink-resistant NiTi alloy core facilitating smooth navigation through tortuous vasculature and accurate wire control) and PTFE (Polytetrafluoroethylene) Coated diagnostic guidewires (fixed core and movable core).

AngioDynamics catheters and guidewires are available in more than 500 tip configurations and lengths.
Drainage Products
Drainage products percutaneously drain abscesses and other fluid pockets. An abscess is a tender inflamed mass that typically must be drained by a physician. AngioDynamics offers two brands of drainage catheters for multi-purpose/general, nephrostomy and biliary drainage: Total Abscession and Exodus. Each offer features and benefits depending on case presentation and physician preferences.
Micro Access Kits
Our Micro Access sets provide interventional physicians a smaller introducer system for minimally-invasive procedures. Our Micro Access product line provides physicians with the means to choose from the wide selection of configurations, including guidewire, needle and introducer options. Two lines are available in stiff/standard, 10cm or 15cm and echogenic for visibility under ultrasound guidance: Micro Introducer Kit and Ministick Max.
¹ Yusuf SW, et al. Immediate and Early Follow-up Results of Pulse Spray Thrombolysis in Patients with Peripheral Ischaemia. British Journal of Surgery 1995; 82:338-340.

4




Venous Insufficiency

VenaCure EVLT laser system

Our VenaCure EVLT (endovenous laser treatment) system products are used in endovascular laser procedures to treat superficial venous disease (varicose veins). Superficial venous disease is a malfunction of one or more valves in the leg veins whereby blood refluxes or does not return to the heart, thereby pooling in the legs and leading to symptoms such as pain, swelling and skin changes.ulcerations. The VenaCure EVLT system uses laser energy to stop the reflux by ablating (collapsing and destroying) the affected vein. Blood is then re-routed to other healthy veins.
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The procedure is minimally invasive and generally takes less than an hour, typically allowing the patient to quickly return to normal activities with minimal post-operative pain. More than one millionactivities.
The VenaCure EVLT procedures have been performed.

VenaCure EVLTsystem is sold as a system that includes diode laser hardware and procedure kits which include disposable laser fiber components, an access sheath, access wires and needles. Our VenaCure EVLT 1470 nanometer wavelength laser allows physicians to more efficiently heat the vein wall using lower power settings thereby reducing the risk of collateral damage. The NeverTouch tip fiber eliminates laser tip contact with the vein wall, which in turn minimizes perforations of the vein wall that typically result in less pain and bruising as compared to traditional bare-tip fibers. The NeverTouch tip also maximizes ultrasonic visibility, making it easier for physicians to use. Procedure kits are available in a variety of lengths and configurations to accommodate varied patient anatomies.

The VenaCure EVLT system comes with a comprehensive physician training program and extensive marketing support.

Oncology/Surgery Products
Asclera (polidocanol) Injection

Asclera (polidocanol) injection is the only FDA-approved sclerosant with an indication to treat uncomplicated spider veins and uncomplicated reticular veins in the lower extremity. AngioDynamics distributes Asclera through a global agreement with the manufacturer and their distributor. In a multicenter, randomized, double-blind, placebo and comparator-controlled trial in patients with spider or reticular varicose veins, 95% of patients treated with Asclera showed good improvement or complete treatment success as rated by physicians and 87% of patients were satisfied or very satisfied with their Asclera treatment. ¹

Polidocanol can be produced through compounding, but only in certain situations and for specific medical needs. In July 2016, the FDA drafted guidance clarifying the parameters for compounding essentially copies of approved and/or commercially available drug products due to the higher risk for patients versus those that have been FDA approved.

Thrombus Management

Our Thrombus Management portfolio includes the proprietary AngioVac venous drainage cannula and circuit, as well as catheter directed thrombolytic devices and Uni-Fuse infusion catheters. AngioDynamics offers a range of options when treating thrombuscomprehensive ablation technologies, including thermal tissue ablation systems (microwave energy and removing fresh, soft thromboli or emboli.radiofrequency energy), surgical resection and the Irreversible Electroporation ("IRE") technology, the NanoKnife System, an innovative alternative to thermal ablation.

IRE Ablation
AngioVac

NanoKnife
The NanoKnife Ablation System is an alternative to traditional thermal ablation that received 510(k) clearance from the Food and Drug Administration for the surgical ablation of soft tissue. The NanoKnife Ablation System utilizes low energy direct current electrical pulses to permanently open pores in target cell membranes. These permanent pores or nano-scale defects in the cell membranes result in cell death. The treated tissue is then removed by the body’s natural processes in a matter of weeks, mimicking natural cell death. Unlike other ablation technologies, the NanoKnife Ablation System does not achieve tissue ablation using thermal energy.
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The NanoKnife Ablation System consists of two major components: a Low Energy Direct Current, or LEDC Generator and needle-like electrode probes. Up to six (6) electrode probes can be placed into or around the targeted soft tissue. Once the probes are in place, the user enters the appropriate parameters for voltage, number of pulses, interval between pulses, and the pulse length into the generator user interface. The generator then delivers a series of short electric pulses between each electrode probe. The energy delivery is hyperechoic and can be monitored under real-time ultrasound.

5


Microwave Ablation
Solero Microwave Tissue Ablation (MTA) System
The Solero MTA System features the Solero Microwave (MW) Generator and the specially designed Solero MW Applicators. The solid state Solero MW Generator with a 2.45 GHz operating frequency can power up to 140W for optimized power delivery and fast ablations. The Solero MW Applicator’s optimized ceramic tip diffuses MW energy nearly spherically, and its patented cooling channel with thermocouple provides real-time monitoring to help protect non-targeted tissue during the ablation. In addition, the Solero MTA System offers physicians scalability with a single applicator designed for multiple, predictable ablation volumes by varying time and wattage. Solero is a single applicator system able to complete up to a 5 cm ablation in six (6) minutes at maximum power.
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The Solero MTA System and Accessories are indicated for the ablation of soft tissue during open procedures. The Solero MTA System is not intended for cardiac use.
Radiofrequency Ablation
StarBurst Radiofrequency Ablation Devices
Radiofrequency Ablation (RFA) products use radiofrequency energy to provide a minimally invasive approach to ablating solid cancerous or benign tumors. Our AngioVac venous drainageStarBurst Radiofrequency Ablation devices deliver radiofrequency energy to raise the temperature of cells above 45-50°C, causing cellular death. The physician inserts the disposable needle electrode device into the targeted body tissue, typically under ultrasound, CT or Magnetic Resonance Imaging (MRI) guidance.
During the procedure, our system includesautomatically adjusts the amount of energy delivered in order to maintain the temperature necessary to ablate the targeted tissue. For a Venous Drainage Cannulatypical 5 cm ablation using our StarBurst Xli-enhanced disposable device, the ablation process takes approximately ten (10) minutes. The RFA system consists of a radiofrequency generator and Extracorporeal Circuit. a family of disposable devices.
In addition to thermal ablation systems and the NanoKnife Ablation System, AngioDynamics also offers Habib 4X Surgical Resection devices that are used in minimally invasive laparoscopic surgery procedures in surgical specialties such as Hepato-Biliary, GI, Surgical Oncology, Transplant Surgery and Urology (Partial Nephrectomy Resections). It is clinically indicated to assist in coagulation of tissue during intraoperative and laparoscopic procedures.
BioSentry Tract Sealant System
The cannulaBioSentry tract sealant system deploys a self-expanding hydrogel plug into the pleural space following a percutaneous lung biopsy, creating an airtight seal that closes the pleural puncture. Depth markings provide accurate and consistent placement based on CT-guided measurements, while the depth adjustment wheel and locking mechanisms ensure proper plug deployment. The hydrogel plug is made from a synthetic tissue-friendly polymer that fully reabsorbs into the body and the coaxial adapter mates with a coaxial needle to ensure a proper fit and delivery of the plug. The BioSentry Tract Sealant System is indicated for use assealing pleural punctures to significantly reduce the risk of pneumothoraxes (air leaks) associated with percutaneous, transthoracic needle lung biopsies and to provide accuracy in marking a venous drainage cannula andbiopsy location for removal of fresh, soft thrombi or embolivisualization during extracorporeal bypass. The cardiopulmonary bypass circuit is indicated for use in procedures requiring extracorporeal circulatory support for periods of up to six hours. AngioVac devices are for use with other manufacturers’ off-the-shelf pump, filter and reinfusion cannula, to facilitate venous drainage as part of an extracorporeal bypass procedure.surgical resection.
IsoLoc Endorectal Balloon

The AngioVac venous drainage cannulaIsoLoc Endorectal Balloon's unique, customer-driven design is the result of collaborations with Radiation Oncologists, Therapists and Physicists with one goal in mind, to create a 22 French coil-reinforced cannula designed with a balloon actuated, expandable funnel shaped distal tip. new standard for endorectal balloons (ERB) in the oncology space.
The proprietary funnel shaped tip enhances venous drainage flow when the balloon is inflated, prevents cloggingdesign of the cannula with commonly encountered undesirable intravascular material,IsoLoc device not only addresses patient comfort, but also simplifies three challenging clinical scenarios that many physicians face when using radiation therapy for and/or in relation to the prostate. First, it's gas-release tip removes rectal gas and facilitates en bloc removal of such extraneous material.







¹ Weiss, Voigts, Howell (2011) Absence of Concentration Congruity in Six Compounded Polidocanol Samples Obtainedreduces prostate motion for Leg Sclerotherapy. American Society for Dermatologic Surgery, Inc., Volume 37: 1-4


Thrombolytic Catheters

Thrombolytic catheters are used to deliver thrombolytic agents, which are drugs that dissolve blood clots in hemodialysis access grafts, arteries, veins and surgical bypass grafts. AngioDynamics’ Uni-Fuse infusion catheter features pressure response outlets, a patented, time-tested slit technology that provides a consistent, even distribution of fluid volume alonggaseous patients. Secondly, the entire lengthstructure of the infusion pattern, resultingERB aids in defining the anatomy for difficult planning scenarios with post-radical patients. Lastly, the IsoLoc device repositions and lifts the bowel in patients that have a 12-fold advantage over standard side-hole catheters.²low-lying bowel.

We also offer
6


Alatus Vaginal Balloon Packing System
The Alatus device was developed with the Pulse-Spray infusion system for high pressure, pulsed delivery of lytic agentpatient's comfort in mind and to shortenassist the physician to move healthy tissue away from the radiation treatment time, andfield. Prior to the Speed Lyser infusion system built for dialysis grafts and fistulas.

Fluid Management

Our Fluid Management product offerings includeAlatus device, the NAMIC® Fluid Management portfolio. Since 1969, the NAMIC product line has been a leader in providing clinicians high quality, dependable devices that help in the diagnosis and treatment of cardiovascular and peripheral vascular disease. The NAMIC product line includes an extensive offering of manifolds, contrast management systems, closed fluid systems, guidewires, disposable transducers and interventional accessories. These devices are utilized together and allow clinicians to aspirate or inject contrast, saline, remove waste and monitor invasive blood pressures throughout the procedure.

Peripheral Products (Core)

We offer a comprehensive portfolio for minimally invasive peripheral products. Product categories include an extensive line of angiographic catheters and diagnostic and interventional guidewires, percutaneous drainage catheters and coaxial micro-introducer kits.

Angiographic Products and Accessories

Angiographic products and accessories are used during peripheral diagnostic and interventional procedures. These products permit physicians to reach targeted locations to deliver contrast media for visualization purposes and therapeutic agents and devices, such as percutaneous transluminal angioplasty (PTA) balloons. Angiographic products consist of angiographic catheters and guidewires.

Our angiographic catheter line includes the following brands, all with radiopaque tips to assure excellent visibility under fluoroscopy:

Soft-Vu flush catheters are available in flush and selective varieties. Flush Catheters are used in procedures where a high flow of contrast is required for “big picture” diagnostics. Anomalies discovered through a flush angiogram may require further investigation into a vessel of interest. Soft-Vu selective catheters are used to gain access to smaller or more distal vessels and advance the catheter or wireclinician would push gauze into the diseased section.
Accu-Vu sizing catheters feature radiopaque marker bandsvagina to move the bladder and bowel away from the radiation treatment field. Inserting gauze into the vagina can be uncomfortable before treatment and unpleasant at the distal (farthest away) portionend of treatment as it tends to dry out before removing.
Studies have shown, relative to traditional gauze packing, the catheter to provideAlatus device offers a highly accurate measurement of the patient’s anatomy. This enables precise measurement for interventional devices (stents, filters, etc.)
AngiOptic catheters have total catheter radiopacity, ensuring tip-to-hub visibility. This catheter is also constructed with a firm tip material that enhances stability during high-flow injections, providing excellent pushability.
Mariner catheters have a hydrophilic coating that, when combined with water, reduces friction. This makes insertion potentially easier and more comfortable procedure for the patient, reduces the need for post-procedural pain medication and can also be used for advancing through tortuous anatomy.

AngioDynamics guidewires include Nit-Vu (featuring a kink-resistant NiTi alloy core facilitating smooth navigation through tortuous vasculature and accurate wire control) and PTFE Coated (fixed core and movable core) diagnostic guidewires.

AngioDynamics catheters and guidewires are available in more than 500 tip configurations and lengths.






² Yusuf SW, et al. Immediate and Early Follow-up Results of Pulse Spray Thrombolysis in Patients with Peripheral Ischaemia. British Journal of Surgery 1995; 82:338-340.


Drainage Products

Drainage products percutaneously drain abscesses and other fluid pockets. An abscess is a tender inflamed mass that typically must be drained by a physician. AngioDynamics offers two brands of drainage catheters for multi-purpose/general, nephrostomy and biliary drainage: Total Abscession and Exodus. Each offer features and benefits depending on case presentation and physician preferences.

Micro Access Kits

Our Micro Access sets provide interventional physicians a smaller introducer system for minimally-invasive procedures. Our Micro Access product line provides physicians with the means to choosemoves healthy tissue away from the wide selection of configurations, including guidewire, needle and introducer options. Two lines are available in stiff/standard, 10cm or 15cm and echogenic for visibility under ultrasound guidance: Micro Introducer Kit and Ministick Max.

radiation field.
Vascular Access Products

Our portfolio of Vascular Access products includes a broad offering of peripherally inserted central catheters (PICCs), midline catheters, implantable ports, dialysis catheters and related accessories and supplies. These products are used primarily to deliver primarily, short-term drug therapies, such as chemotherapeutic agents and antibiotics, into the central venous system. Delivery to the circulatory system allows drugs to mix with a large volume of blood as compared to intravenous drug delivery into a superficial vessel. Our Vascular Access product family also includes the proprietary BioFlo catheter.catheter and C3 Wave tip location.

BioFlo®
AngioDynamics offers the BioFlo catheter, the only catheter on the market with Endexo Technology, a material more resistant to thrombus accumulation, in vitro (based on platelet count). Endexo Technology is a permanent and non-eluting polymer that is “blended” into the polyurethane from which the catheter is made. It is present throughout the catheter, including the extraluminal, intraluminal and cut catheter surface of the tip. Endexo Technology remains present for the life of the catheter. BioFlo’sThe BioFlo catheter’s long-term durability and efficacy is intended to provide clinicians a high degree of safety and confidence in providing better patient care and improved patient outcomes. BioFlo catheters are available across the Vascular Access family of products, including PICCs, midlines, ports and dialysis catheters.
ango-20210531_g7.jpg

Midlines
Midline catheters are inserted via the same veins used for PICC placement in the middle third of the upper arm; however, the midline catheter is advanced and placed so that the catheter tip is level or near the level of the axilla and distal to the shoulder. Our Midline product offerings include:
BioFlo Midline: Our BioFlo Midline Catheter which incorporates Endexo Technology, is an effective solution to preserving a patient’s peripheral access. It provides a cost-effective alternative to multiple IV site rotations for patients who need short-term venous access.
PICCs

A peripherally inserted central catheter, or PICC, is a long thin catheter that is inserted into a peripheral vein, typically in the upper arm, and advanced until the catheter tip terminates in a large vein in the chest near the heart to obtain intravenous access. PICCs can typically be used for prolonged periods of time and provide an alternative to central venous catheters. Our PICC product offerings include:

BioFlo® PICC: Our BioFlo line is the only power injectable PICC available that incorporates Endexo Technology into the manufacturing and design of the catheter. Advanced features such as large lumen diameters allow the BioFlo® PICC to deliver the power injection flow rates required for contrast-enhanced Computed Tomography (CT) scans compatible with up to 325 psi CT injections.
BioFlo® Midline: The BioFlo Midline Catheter is an effective solution to preserving a patient’s peripheral access. It provides a cost-effective alternative to multiple IV site rotations for patients who need short-term venous access.
Xcela PICC: The Xcela® PICC line is designed to provide a high degree of safety, ease and confidence in patient care. Advanced features such as large lumen diameters allow the Xcela® PICC to deliver the power injection flow rates required for contrast-enhanced CTs compatible with up to 325 psi CT injections.
PASV® Valve Technology: The PASV® Valve Technology is available in both BioFlo and Xcela lines and is designed to automatically resist backflow and reduce blood reflux that could lead to catheter-related complications.

BioFlo PICC: Our BioFlo PICC line is the only power injectable PICC available that incorporates Endexo Technology into the manufacturing and design of the catheter. Advanced features such as large lumen diameters allow the BioFlo PICC to deliver the power injection flow rates required for contrast-enhanced Computed Tomography (CT) scans compatible with up to 325 psi CT injections.

Xcela PICC: The Xcela PICC line is designed to provide a high degree of safety, ease and confidence in patient care. Advanced features such as large lumen diameters allow the Xcela PICC to deliver the power injection flow rates required for contrast-enhanced CTs compatible with up to 325 psi CT injections.

PASV Valve Technology: The PASV Valve Technology is available in both BioFlo and Xcela lines and is designed to automatically resist backflow and reduce blood reflux that could lead to catheter-related complications.



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C3 Wave PICC tip location system
The C3 Wave system is our innovative, wireless, app-based ECG system eliminates the need for a confirmatory chest x-ray of PICC tip placement, allowing greater patient access to the Company’s proprietary BioFlo PICCs.
Ports

Ports are implantable devices utilized for the central venous administration of a variety of medical therapies and for blood sampling and diagnostic purposes. Central venous access facilitates a more systemic delivery of treatment agents, while mitigating certain harsh side effects of certain treatment protocols and eliminating the need for repeated access to peripheral veins. Depending upon needle gauge size and the port size, a port can be utilized for up to approximately 2,000 accesses once implanted in the body. Our ports are used primarily in systemic or regional short- and long-term cancer treatment protocols that require frequent infusions of highly concentrated or toxic medications (such as chemotherapy agents, antibiotics or analgesics) and frequent blood samplings. Our port products and accessories include:

BioFlo Port: Our BioFlo Port was the first port available featuring a catheter with Endexo Technology. Advanced features of the BioFlo Port include multiple profile and catheter options, a large septum area for ease of access and the ability to administer contrast through a CT injection for purposes of imaging.
BioFlo® Port: Our BioFlo Port is the only port available that features a catheter with Endexo Technology. Advanced features of the BioFlo Port include multiple profile and catheter options, a large septum area for ease of access and the ability to administer contrast through a CT injection for purposes of imaging.
SmartPort®: The Smart Port power-injectable port with Vortex technology offers the ability for a clinician to access a vein for both the delivery of medications or fluids and for administering power-injected contrast to perform a (CT) scan. The ability to access a port for power-injected contrast studies eliminates the need for additional needle sticks in the patient’s arm and wrist veins. Once implanted, repeated access to the bloodstream can be accomplished with greater ease and less discomfort. Our Smart Port is available in mini and low-profiles to accommodate more patient anatomies.
Vortex®: Our Vortex port technology line of ports is a clear-flow port technology that, we believe, revolutionized port design. With its rounded chamber, the Vortex port is designed to have no sludge-harboring corners or dead spaces. This product line consists of titanium, plastic and dual-lumen offerings.
PASV® Valve Technology: The PASV® Valve Technology is designed to automatically resist backflow and reduce blood reflux that could lead to catheter-related complications.
LifeGuard®: The LifeGuard Safety Infusion Set and The LifeGuard Vision are used to infuse our ports and complement our port and vascular access catheters. The needles’ low profile design is intended to allow clinicians to easily dress the site.

SmartPort, SmartPort+, SmartPort Plastic: The SmartPort power-injectable port with Vortex technology offers the ability for a clinician to access a vein for both the delivery of medications or fluids and for administering power-injected contrast to perform a CT scan. The ability to access a port for power-injected contrast studies eliminates the need for additional needle sticks in the patient’s arm and wrist veins. Once implanted, repeated access to the bloodstream can be accomplished with greater ease and less discomfort. Our SmartPort port line is available in standard, mini and low-profiles to accommodate more patient anatomies. The SmartPort+ port line combines Vortex technology with BioFlo catheters. In addition to the three titanium port body sizes, there is a plastic port body.
Vortex: Our Vortex port technology line of ports is a clear-flow port technology that, we believe, revolutionized port design. With its rounded chamber, the Vortex port is designed to have no sludge-harboring corners or dead spaces. This product line consists of titanium, plastic and dual-lumen offerings.
PASV Valve Technology: The PASV Valve Technology is designed to automatically resist backflow and reduce blood reflux that could lead to catheter-related complications.
LifeGuard: The LifeGuard Safety Infusion Set and The LifeGuard Vision are used to infuse our ports and complement our port and vascular access catheters. The needles’ low profile design is intended to allow clinicians to easily dress the site.
Dialysis Products

We market a completean extensive line of dialysis products that provide short and long-term vascular access for dialysis patients. Dialysis, or cleaning of the blood, is necessary in conditions such as acute renal failure, chronic renal failure and end-stage renal disease (ESRD). We currently offer a variety of dialysis catheters, including:

BioFlo® DuraMax: Our BioFlo DuraMax is the only dialysis catheter with Endexo Technology. Advanced features of the BioFlo DuraMax dialysis catheter include large inner diameter lumens designed for long term patency, a proprietary guidewire lumen to facilitate catheter exchanges and Curved Tip Technology that allows the catheter to self-center in the Superior Vena Cava (SVC).
DuraMax®: The DuraMax catheter is a stepped-tip catheter designed to improve ease of use, dialysis efficiency and overall patient outcomes.

BioFloDuraMax: Our BioFlo DuraMax dialysis catheter is the only dialysis catheter with Endexo Technology. Advanced features of the BioFlo DuraMax dialysis catheter include large inner diameter lumens designed for long term patency, a proprietary guidewire lumen to facilitate catheter exchanges and Curved Tip Technology that allows the catheter to self-center in the Superior Vena Cava (SVC).
DuraMax: The DuraMax catheter is a stepped-tip catheter designed to improve ease of use, dialysis efficiency and overall patient outcomes.
In addition, AngioDynamics also offers other renal therapies, including DuraFlow™our DuraFlow Chronic Hemodialysis Catheter, Schon Chronic Hemodialysis Catheter, EVENMORE Chronic Hemodialysis Catheter, EMBOSAFE™EMBOSAFE Valved Splitable Sheath Dilator and Perchik™Perchik Button Suture Retention Device.

Oncology/Surgery Products

AngioDynamics offers a range of comprehensive ablation technologies, including thermal tissue ablation systems (microwave energy and radiofrequency energy), surgical resection and the NanoKnife System, an innovative alternative to thermal ablation.











NanoKnife® System

The NanoKnife® System is an alternative to traditional thermal ablation that has received 510(k) clearance from the Food and Drug Administration for the surgical ablation of soft tissue. The NanoKnife Ablation System utilizes low energy direct current electrical pulses to permanently open pores in target cell membranes. These permanent pores or nano-scale defects in the cell membranes result in cell death. The treated tissue is then removed by the body’s natural processes in a matter of weeks, mimicking natural cell death. Unlike other ablation technologies, NanoKnife Ablation System does not achieve tissue ablation using thermal energy.

The NanoKnife Ablation System consists of two major components: a Low Energy Direct Current, or LEDC Generator and needle-like electrode probes. Up to six (6) electrode probes can be placed into or around the targeted soft tissue. Once the probes are in place, the user enters the appropriate parameters for voltage, number of pulses, interval between pulses, and the pulse length into the generator user interface. The generator then delivers a series of short electric pulses between each electrode probe. The energy delivery is hyperechoic and can be monitored under real-time ultrasound.

Microwave Ablation

Solero Microwave Tissue Ablation (MTA) System

The Solero MTA System features the Solero Microwave (MW) Generator and the specially designed Solero MW Applicators. The solid state Solero MW Generator with a 2.45 GHz operating frequency can power up to 140 W for optimized power delivery and fast ablations. The Solero MW Applicator’s optimized ceramic tip diffuses MW energy nearly spherically, and its patented cooling channel with thermocouple provides real-time monitoring to help protect non-targeted tissue ablation. In addition, the Solero MTA System offers physicians scalability with a single applicator designed for multiple, predictable ablation volumes by varying time and wattage. Solero is a single applicator system able to complete up to a 5 cm ablation in six (6) minutes at maximum power.

The Solero MTA System and Accessories are indicated in the U.S. for the ablation of soft tissue during open procedures. The Solero MTA System is not intended for cardiac use.

Acculis Microwave Tissue Ablation (MTA) System

When configured for use with the Accu2i pMTA Applicators, the Acculis MTA System includes the Sulis VpMTA Generator, optional MTA Temperature Probes, Acculis Local Control Station (LCS) and Accu2i pMTA Applicators. Designed for physicians trained in image-guided ablation procedures, intraoperative ultrasound and/or CT guided needle placement, the system is used for thermal coagulation of soft tissue. By utilizing 2.45 GHz of microwave energy, the Acculis MTA System can complete ablations up to 5 cm in six minutes with a single applicator. Applicators are available in 14 cm, 19 cm and 29 cm lengths, offering flexibility in selecting the appropriate length for the procedure.

Radiofrequency Ablation

StarBurst Radiofrequency Ablation Devices

Radiofrequency Ablation (RFA) products use radiofrequency energy to provide a minimally invasive approach to ablating solid cancerous or benign tumors. Our StarBurst Radiofrequency Ablation Devices deliver radiofrequency energy to raise the


temperature of cells above 45-50°C, causing cellular death. The physician inserts the disposable needle electrode device into the targeted body tissue, typically under ultrasound, CT or Magnetic Resonance Imaging (MRI) guidance.

During the procedure, our system automatically adjusts the amount of energy delivered in order to maintain the temperature necessary to ablate the targeted tissue. For a typical 5 cm ablation using our StarBurst ® Xli-enhanced disposable device, the ablation process takes approximately ten minutes. The RFA system consists of a radiofrequency generator and a family of disposable devices.

In addition to thermal ablation systems and NanoKnife, AngioDynamics also offers Habib 4X Surgical Resection Devices that are used in minimally invasive laparoscopic surgery (MILS) procedures in surgical specialties such as Hepato-Biliary, GI, Surgical Oncology, Transplant Surgery and Urology (Partial Nephrectomy Resections). It is clinically indicated to assist in coagulation of tissue during intraoperative and laparoscopic procedures.

RESEARCH & DEVELOPMENT

Our growth depends in large part on the continuous introduction of new and innovative products, together with ongoing enhancements to our existing products. This happens through internal product development, technology licensing, strategic alliances and strategic alliances. We recognize the importance of, and intend to continue to make investments in, research and development (R&D).

acquisitions. Our R&D teams work closely with our marketing teams, sales force and regulatory and compliance teams to incorporate customer feedback into our development and design process. We believe that we have a reputation among interventional physicians as a strong partner for developing high quality products because of our tradition of close physician collaboration, dedicated market focus, responsiveness and execution capabilities for product development and commercialization. We recognize the importance of, and intend to continue to make investments in, research and development (R&D).


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COMPETITION

We encounter significant competition across our product lines and in each market in which our products are sold. These markets are characterized by rapid change resulting from technological advances, scientific discoveries and changing customer needs and expectations. We face competitors, ranging from large manufacturers with multiple business lines, to small manufacturers that offer a limited selection of products.

Our primary device competitors include: Boston Scientific Corporation; Cook Medical; C.R. Bard; Medical Components, Inc. (Medcomp)(MedComp); TeleFlex Medical; Becton Dickinson; Smiths Medical, a subsidiary of Smiths Group plc; Medtronic; Merit Medical; Terumo Medical Corporation; Johnson and JohnsonJohnson; Philips Healthcare; Inari Medical; Varian Medical Systems and Total Vein Systems.

We believe our products compete primarily based on their quality, clinical outcomes, ease of use, reliability, physician familiarity and cost-effectiveness. In the current environment of managed care, which is characterized by economically motivated buyers, consolidation among health care providers, increased competition and declining reimbursement rates, we have been increasingly required to compete on the basis of price. We believe that our continued competitive success will depend upon our ability to develop or acquire scientifically advanced technology, apply our technology cost-effectively across product lines and markets, attract and retain skilled personnel, obtain patent or other protection for our products, obtain required regulatory and reimbursement approvals, manufacture and successfully market our products either directly or through outside parties, and maintain sufficient inventory to meet customer demand.

SALES AND MARKETING

We sell our broad line of quality devices in the United States primarily through a direct sales force and internationally through a combination of direct sales and distributor relationships. We support our customers and sales organization with a marketing staff that includes product managers, customer service representatives and other marketing specialists.

We focus our sales and marketing efforts on interventional radiologists, interventional cardiologists, vascular surgeons, urologists, and interventional and surgical oncologists.

oncologists and critical care nurses.
MANUFACTURING

We manufacture certain proprietary components and products and then assemble, inspect, test and package our finished products. By designing and manufacturing many of our products from raw materials, and assembling and testing our subassemblies and products, we believe that we are able to maintain better quality control, ensure compliance with applicable regulatory standards and our internal specifications, and limit outside access to our proprietary technology. We have custom-


designedcustom-designed proprietary manufacturing and processing equipment and have developed proprietary enhancements for existing production machinery.

We own or lease four primarymanufacture most of our products from two owned manufacturing properties, one in Queensbury, NY and one small facility in Glens Falls, NY, providing capabilities which include manufacturing, service, offices, engineering and research and we lease distribution warehouses and offices.warehouses. These facilities are registered with the FDA and have been certified to ISO 13485 standards, as well as the CMD/CAS Canadian Medical Device Regulations.standards. ISO 13485 is a quality system standard that satisfies European Union regulatory requirements, thus allowing us to market and sell our products in European Union countries. AngioDynamics is certified under the Medical Device Single Audit Program ("MDSAP") which allows a recognized auditing organization to conduct a single regulatory audit of a medical device manufacturer to satisfy the relevant requirements of the regulatory authorities participating in the program. International partners that are participating in the MDSAP include:
Therapeutic Goods Administration of Australia
Brazil’s Agência Nacional de Vigilância Sanitária
Health Canada
Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency
U.S. Food and Drug Administration
Our manufacturing facilities are subject to periodic inspections by regulatory authorities to ensure compliance with domestic and non-U.S. regulatory requirements. See “Government Regulation” section of this reportItem 1 for additional information. See Part I, Item 2 "Properties" of this report for details on each manufacturing location.

In February 2017, we announced the consolidation of our global operations into two facilities located in New York State. Operations being done in the Denmead, U.K. and Manchester, Ga. manufacturing facilities will be consolidated into the Glens Falls and Queensbury, N.Y. facilities.

BACKLOG

Historically, we ship the majority of products within 24-48 hours of receiving an order, and accordingly our backlog is not significant.order.

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INTELLECTUAL PROPERTY

Patents, trademarks and other proprietary rights are very important to our business. We also rely upon trade secrets, manufacturing know-how, technological innovations and licensing opportunities to maintain and improve our competitive position. We regularly monitor and review third-party proprietary rights, including patents and patent applications, as available, to aid in the development of our intellectual property strategy, avoid infringement of third-party proprietary rights, and identify licensing opportunities.

The companyCompany owns an extensive portfolio of patents and patent applications in the United States and in certain foreign countries. The portfolio also includes exclusive licenses to third party patents and applications.

Most of our products are sold under the AngioDynamics trade name or trademark. Additionally, products are also sold under product trademarks and/or registered product trademarks owned by AngioDynamics, Inc., or an affiliate or subsidiary. Some products contain trademarks of companies other than AngioDynamics.

See Part I. Item 3 of"Legal Proceedings" and Note 17 to the consolidated financial statements in this reportAnnual Report on Form 10-K for additional details on litigation regarding proprietary technology.

LITIGATION

We operate in an industry characterized by extensive patent litigation. Patent litigation can result in significant damage awards and injunctions that could prevent the manufacture and sale of affected products, or result in significant royalty payments in order to continue selling thethose products. While it is not possible to predict the outcome of patent litigation incidents to our business, we believe the costs associated with this type of litigation could have a material adverse impact on our consolidated results of operations, financial position, or cash flows. The medical device industry is also susceptible to significant product liability claims. These claims may be brought by individuals seeking relief on their own behalf or purporting to represent a class. In addition, product liability claims may be asserted against us in the future based on events we are not aware of at the present time. At any given time, we are involved in a number of product liability actions. For additional information, see both Part I. Item 3 of this report"Legal Proceedings" and Note 1517 to the consolidated financial statements in this Annual Report on Form 10-K.

GOVERNMENT REGULATION

The products we manufacture and market are subject to regulation by the United States Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act, or FDCA, and international regulations toin our specific target markets.







United States FDA Regulation

Before a new medical device can be introduced into the market, a manufacturer generally must obtain marketing clearance or approval from the FDA through either a 510(k) submission (a premarket notification) or a premarket approval application (PMA).

The 510(k) procedure is available only in particular circumstances. The 510(k) clearance procedure is available only if a manufacturer can establish that its device is “substantially equivalent” in intended use and in safety and effectiveness to a “predicate device,” which is a legally marketed device with 510(k) clearance in class I or II or preamendmentpre-amendment status based upon products commercially distributed on or before May 28, 1976. After a device receives 510(k) clearance, any modification that could significantly affect its safety or effectiveness, or that would constitute a major change in its intended use, requires a new 510(k) clearance. The 510(k) clearance procedure including questions and responses may take up to 12 months. In some cases, supporting clinical data may be required. The FDA may determine that a new or modified device is not substantially equivalent to a predicate device or may require that additional information, including clinical data, be submitted before a determination is made, either of which could significantly delay the introduction of new or modified device products. If a device cannot demonstrate substantial equivalence, it may be subject to either a de novo submission or a PMA.

The PMA application procedure is more comprehensive than the 510(k) procedure and typically takes several yearsmore time to complete. The PMA application must be supported by scientific evidence providing pre-clinical and clinical data relating to the safety and efficacy of the device and must include other information about the device and its components, design, manufacturing and labeling. The FDA will approve a PMA application only if a reasonable assurance that the device is safe and effective for its intended use can be provided. As part of the PMA application review, the FDA will inspect the manufacturer’s facilities for compliance with its Quality System Regulation, or QSR. As part of the PMA approval the FDA may place restrictions on the device, such as requiring additional patient follow-up for an indefinite period of time. If the FDA’s evaluation of the PMA application or the manufacturing facility is not favorable, the FDA may deny approval of the PMA application or issue a “not approvable” letter. The FDA may also require additional clinical trials, which can delay the PMA approval process by several years. After the PMA is approved, if significant changes are made to a device, its manufacturing or labeling, a PMA supplement containing additional information must be filed for prior FDA approval.

Historically, our products have been introduced into the market using the 510(k) procedure and we have never had to use the PMA procedure.

The process of FDA submissions requires extensive and expensive validations and testing. The financial outlay for this is large andtesting which requires a significant amount of time.time and financial resources. Recent changes in both regulations and FDA perspectives have increased both time and testing
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requirements, which have caused and are expected to continue to cause significant delays and increased costs for approvals. The parameters for increased testing haveclearances and will continue to cause severe delays.approvals. The increased focus by the FDA on such issues as chemical identification of all colorants, non-acceptance of certain colorants (certain forms of carbon black) and other concerns, continue to cause problemschallenges and delays. In addition, changes to existing products call into question previously approved devices and result in additional costs for testing and material analysis.

After a product is placed on the market, the product and its manufacturer are subject to pervasive and continuing regulation by the FDA. The FDA enforces these requirements by inspection and market surveillance. Our suppliers also may be subject to FDA inspection; this has resulted in several suppliers altering price structures for medical device companies. The additional costs due to testing and potential for lawsuits due to material contamination or unforeseen chemical/allergenic reactions has led to some manufacturers actively refusing to supply to medical device companies. The financial expenditure needed to maintain compliance to the requirements of the FDA are extensive and ever increasing. Specific systems are needed to maintain compliance to baseline requirements. In addition, complex systems are needed to ensure that specific violations such as ‘off label promotion’ are avoided. The FDA has specific requirements for labeling and marketing materials. These need extensive policing and evaluation. Penalties for breach of off label promotion can result in significant fines to the company.

The devices manufactured by us are also are subject to the QSR, which imposes elaborate testing, control, documentation and other quality assurance procedures. Every phase of production, including raw materials, components and subassembly, manufacturing, testing, quality control, labeling, tracing of consignees after distribution and follow-up and reporting of complaint information is governed by the FDA’s QSR. Device manufacturers are required to register their facilities and list their products with the FDA and certain state agencies. The FDA periodically inspects manufacturing facilities and, if there are alleged violations, the operator of a facility must correct them or satisfactorily demonstrate the absence of the violations or face regulatory action. Penalties for failureFailure to maintain compliance towith the QSR includemay result in the issuance of one or more Forms 483 or warning letters, and could potentially result in a consent decrees.decree. Failure to maintain the QSR appropriately could result in the developmentissuance of further warning letters. In addition, non-compliance with applicable FDA requirements can result in, among other things, fines, injunctions, civil penalties, recall or


seizure of products, total or partial suspension of production, failure of the FDA to grant marketing approvals, inability to obtain clearances or approvals for products, withdrawal of marketing approvals, a recommendation by the FDA to disallow us to enter into government contracts, andand/or criminal prosecutions. The FDA also has the authority to request repair, replacement or refund of the cost of any device manufactured or distributed by us.

Other U.S. Regulatory Bodies

We and our products are also subject to a variety of state and local laws in those jurisdictions where our products are, or will be, marketed,marketed. We and our products are also subject to a variety of federal, state and local laws relating to matters such as safe working conditions, manufacturing practices, environmental protection, fire hazard control and disposal of hazardous or potentially hazardous substances. In addition, we are subject to various federal and state laws governing our relationships with the physicians and others who purchase or make referrals for our products. For instance, federal law prohibits payments of any form that are intended to induce a referral for any item payable under Medicare, Medicaid or any other federal healthcare program. Many states have similar laws. There can be no assurance that we will not be required to incur significant costs to comply with such laws and regulations now or in the future, or that such laws or regulations will not have a material adverse effect upon our ability to do business.

International Regulation

Internationally, all of our current products are considered medical devices under applicable regulatory regimes, and we anticipate that this will be true for all of our future products. Sales of medical devices are subject to regulatory requirements in many countries. The regulatory review process may vary greatly from country to country. For example, the European Union has a dedicated set of regulations regarding medical devices, specifically regulating their design, manufacturing, clinical trials, labeling and adverse event reporting. Devices that comply with those requirements are entitled to bear a Conformité Européenne, or CE Mark, indicating that the device conforms to the essential requirements of the applicable directives and can be commercially distributed in countries that are members of the European Union. Similar regulations are in place for Canada, Japan, China and most other countries.

In some cases, we rely on our international distributors to obtain regulatory approvals, complete product registrations, comply with clinical trial requirements and complete those steps that are customarily taken in the applicable jurisdictions.

International sales of medical devices manufactured in the United States that are not approved or cleared by the FDA for use in the United States, or are banned or deviate from lawful performance standards, are subject to FDA export requirements. Before exporting such products to a foreign country, we must first comply with the FDA’s regulatory procedures for exporting unapproved devices.

The process of obtaining approval to distribute medical products is costly and time-consuming in virtually all the major markets where we sell medical devices. We cannot assure that any new medical devices we develop will be approved in a timely or cost-effective manner or approved at all. There can be no assurance that new laws or regulations regarding the release or sale of medical devices will not delay or prevent sale of our current or future products.

THIRD-PARTY REIMBURSEMENT AND ANTI-FRAUD AND CORRUPT PRACTICES REGULATION

United States

The delivery of our devices is subject to regulation by the Department of Health and Human Services (HHS) and comparable state and non-U.S. agencies responsible for reimbursement and regulation of health care items and services. U.S. laws and regulations are imposed primarily in connectionconjunction with the Medicare and Medicaid programs, as well as the government’s interest in regulating the quality and cost of health care. Foreign governments also impose regulations in connectionconjunction with their health care reimbursement programs and the delivery of health care items and services.

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U.S. federal health care laws apply when we or customers submit claims for items or services that are reimbursed under Medicare, Medicaid, or other federally-funded health care programs. The principal U.S. federal laws include: (1) the Anti-kickback Statute which prohibits offers to pay or receive remuneration of any kind for the purpose of including or rewarding referrals of items or services reimbursable by a federal health care program;program, subject to certain safe harbor exceptions; (2) the False Claims Act which prohibits the submission of false or otherwise improper claims for payment to a federally-funded health care program, including claims resulting from a violation of the Anti-kickback Statute; (3) the Stark law which prohibits physicians from referring Medicare or Medicaid patients to a provider that bills these programs for the provision of certain designated health services if the physician (or a member of the physician’s immediate family) has a financial relationship with that provider; and (4) health care fraud statutes that prohibit false statements and improper claims to any third-party payer. There are often similar state false claims,


anti-kickback, and anti-self-referral and insurance laws that apply to state-funded Medicaid and other health care programs and private third-party payers. In addition, the U.S. Foreign Corrupt Practices Act (FCPA) can be used to prosecute companies in the U.S. for arrangements with physicians or other parties outside the U.S. if the physician or party is a government official of another country and the arrangement violates the law of that country.

International

Our success in international markets will depend largely upon the availability of reimbursement from the third-party payors through which healthcare providers are paid in those markets. Reimbursement and healthcare payment systems vary significantly by country. The main types of healthcare payment systems are government sponsored healthcare and private insurance. Reimbursement approval must be obtained individually in each country in which our products are marketed. Outside the U.S., we generally rely on our distributors to obtain reimbursement approval in the countries in which they will sell our products. There can be no assurance that reimbursement approvals will be received.

See Part I. Item 1A "Risk Factors" in this Annual Report on Form 10-K.
INSURANCE

Our product liability insurance coverage is limited to a maximum of $10 million per product liability claim and an annual aggregate policy limit of $10 million, subject to a self-insured retention of $500,000 per occurrence and $2 million in the aggregate. The policy covers, subject to policy conditions and exclusions, claims of bodily injury and property damage from any product sold or manufactured by us.

There is no assurance that this level of coverage is adequate. We may not be able to sustain or maintain this level of coverage and cannot assure you that adequate insurance coverage will continue to be available on commercially reasonable terms, or at all. A successful product liability claim or other claim, with respect to uninsured or underinsured liabilities, could have a material adverse effect on our business.

See Part I. Item 1A "Risk Factors" in this Annual Report on Form 10-K.
ENVIRONMENTAL, HEALTH AND SAFETY

We are subject to federal, state and local laws, rules, regulations and policies governing the use, generation, manufacture, storage, air emission, effluent discharge, handling and disposal of certain hazardous and potentially hazardous substances used in connection with our operations. Our operations are also subject to laws and regulations related to occupational health and safety. We maintain safety, training and maintenance programs as part of our ongoing efforts to ensure compliance with applicable laws and regulations.

Although we believe that we have complied with environmental, health and safety laws and regulations in all material respects and, to date, have not been required to take any action to correct any noncompliance, there can be no assurance that we will not be required to incur significant costs to comply with environmental regulations in the future.

EMPLOYEES

As of May 31, 2017,2021, we had approximately 1,250800 full time employees. None of our employees are represented by a labor union and we have never experienced a work stoppage. In the highly competitive medical device industry, we consider attracting, developing, and retaining talented people in technical, operational, marketing, sales, research, management and other positions to be critical to our long-term growth strategy. Our ability to recruit and retain such talent depends on several factors, including compensation and benefits, talent development, career opportunities and work environment. Our goal is to create a diverse and inclusive culture that encourages an environment where employees feel welcomed, respected and valued. We are an equal opportunity/affirmative action employer committed to making employment decisions without regard to race, religion, ethnicity or national origin, gender, sexual orientation, gender identity or expression, age, disability, protected veteran status or any other characteristics protected by law.

The engagement of our workforce is crucial to delivering on our competitive strategy, and we place high importance on informed and engaged employees. We communicate frequently and transparently with our employees through a variety of communication methods, including video and written communications, town hall meetings and our company intranet. As a result of the COVID-19 pandemic, we also further strengthened our communication platforms. Our employee communications

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during the pandemic have kept our employees informed on critical priorities, important actions being taken by management in response to the pandemic and continued efforts to protect employee health, safety and well-being.
Executive Officers of the Company

The following table sets forth certain information with respect to our executive officers.
NameAgePosition
James C. Clemmer5357President and Chief Executive Officer
Michael C. GreinerStephen A. Trowbridge4447Executive Vice President and Chief Financial Officer
Stephen A. TrowbridgeMarna Bronfen-Moore4354Senior Vice President and General Counsel
Barbara A. Kucharczyk44Senior Vice President Global Operations
Warren G. Nighan48Senior Vice President Quality & Regulatory Affairs
Heather J. Daniels-Cariveau43Senior Vice President, Human Resources
Benjamin H. Davis52Senior Vice President Business Development
Chad T. Campbell4650Senior Vice President and General Manager, Vascular Access
Richard A. StarkScott Centea5243Senior Vice President and General Manager, Oncology/SurgeryEndovascular Therapies
Robert A. SimpsonBenjamin H. Davis4556Senior Vice President, Business Development
David D. Helsel57Senior Vice President, Global Operations
Warren G. Nighan52Senior Vice President, Quality and Regulatory Affairs
Laura Piccinini51Senior Vice President and General Manager, Peripheral VascularInternational
Richard Rosenzweig54Senior Vice President, General Counsel and Secretary

James C. Clemmer became our President and Chief Executive Officer in April 2016. Prior to joining AngioDynamics, Mr. Clemmer served as President of the $1.8 billion medical supplies segment at Covidien plc. where he directed the strategic and day-to-day operations for global business divisions that collectively manufactured 23 different product categories. In addition, he managed global manufacturing, research and development, operational excellence, business development and all other functions associated with the medical supplies business. Prior to his role at Covidien, Mr. Clemmer served as Group President at Kendall Healthcare (which was acquired by Tyco International in 1994), where he managed the USU.S. business across five divisions and built the strategic plan for the medical supplies segment before itCovidien was spun off from Tyco. Mr. Clemmer began his career at Sage Products, Inc. Mr. Clemmer currently serves on the Board of Directors for AngioDynamics and previously served on the Board of Directors for Lantheus Medical Imaging. Mr. Clemmer is a graduate of the Massachusetts College of Liberal Arts, where he served as interim president from August 2015 until March 1, 2016.

Michael C. Greiner joined AngioDynamics as theStephen A. Trowbridge was appointed Executive Vice President and Chief Financial Officer in August 2016. Mr. Greiner most recentlyFebruary 2020, having served as Interim Chief Financial Officer since October 2019. Prior to his appointment as Chief Financial Officer, he served as the Chief Financial Officer at Extreme Reach. Prior to Extreme Reach, Mr. Greiner served as Senior Vice President Corporate Finance and Chief Accounting Officer at Cimpress N.V. (Vistaprint N.V.), Global Controller for GE’s Water and Processing Technologies division and in leadership roles at Bausch & Lomb and Wyeth. Mr. Greiner is also an advisor for Mirah, Inc., a measurement-based behavioral health company, and serves as the President of the Foundation for Faces of Children. Mr. Greiner received a Bachelor and Master of Science in Accounting from Fairleigh Dickinson University and Master of Business Administration from the Columbia Business School. Mr. Greiner is also a Certified Public Accountant.

Stephen A. Trowbridge joined AngioDynamics as corporate counsel in June 2008, becoming our Vice President and General Counsel in June 2010 andCompany’s Senior Vice President and General CounselCounsel. He joined AngioDynamics in August 2013. Mr. Trowbridge manages AngioDynamics’ legal matters, including corporate governance, mergersJune 2008 as Corporate Counsel. In addition to serving as the Company’s CFO and acquisitions,managing the finance securities regulation, litigation, regulatory matters, intellectual property and compliance.functions, Mr. Trowbridge also overseesmanaged the Company’s clinical affairs, medical affairs and healthcare economics departments.Legal function on an interim basis until January 30, 2021. Prior to AngioDynamics, Mr. Trowbridge served as a Corporate Counsel at Philips Healthcare and Intermagnetics General Corporation. Mr. Trowbridge began his career with Cadwalader, Wickersham & Taft LLP in the firm’s Mergers and Acquisitions and Securities Group. Mr. Trowbridge received a Bachelor of Science in Science and Technology Studies from Rensselaer Polytechnic Institute, a Juris Doctor from the University of Pennsylvania Law School, and a Master of Business Administration from Duke University’s Fuqua School of Business.

Barbara A. Kucharczyk joined AngioDynamics in June 2012 and was promoted to Senior Vice President Global Operations in June 2015. Prior to AngioDynamics, Ms. Kucharczyk served as the Focus Factory Manager for the Vascular Therapy division at Covidien (Medtronic). Before Covidien, Ms. Kucharczyk was the Plant Manager for the Forest Products Group at Hexion Specialty Chemicals, Inc. Ms. Kucharczyk received a Bachelor of Science in Chemistry from the State University of New York at Fredonia, a Bachelor of Science in Chemical Engineering from the State University of New York Center at Buffalo and a Master of Business Administration from Rensselaer Polytechnic Institute.

Warren G. Nighan Marna I. Bronfen-Moorejoined AngioDynamics as the Senior Vice President of Quality and Regulatory AffairsHuman Resources in April 2017. Before joining AngioDynamics, Mr. Nighan was as a quality and regulatory consultant to clientsSeptember 2019 bringing with her over 20 years of experience in FDA-regulated industries, specializing in execution and management of quality systems implementation and remediation. Previously, Mr. Nighan served as the Executive Vice President of Global Clinical, Quality Affairs and Regulatory Affairs at Haemonetics Corporation, Vice


President of Quality/Regulatory/Clinical/Technical Services at St. Jude Medical’s Atrial Fibrillation Division, and Corporate Vice President of Quality/Compliance at Tyco Healthcare/Covidien (Medtronic). Mr. Nighan earned a Bachelor and Master of Science in Nursing from Northeastern University’s Bouvé College of Health Sciences.

Heather J. Daniels Cariveau joined AngioDynamics in October 2016 as the Senior Vice President of Human Resources.medical device industry. Prior to joining AngioDynamics, Ms. Daniels CariveauBronfen-Moore spent almost three years at Hologic as the Vice President, Global Human Resources, for both the Corporate Functions and Asia Pacific. Before Hologic, Ms. Bronfen-Moore served as aVice President, Human Resources for Global Vice PresidentOperations, Quality, and Regulatory at Zimmer Biomet, leading tacticalHaemonetics, Director, Human Resources for Boston Scientific, and strategic HR initiativesin various leadership roles of increasing responsibility at C. R. Bard, Inc. Ms. Bronfen-Moore began her professional career as the Head of Human Resources for the Spine, Dental, Market Access/Healthcare Economics and Craniomaxillofacial/Thoracic businesses. Before Zimmer Biomet, Ms. Daniels Cariveau served in senior HR roles at GE, Datacard, Honeywell International, Inc. and CignaBurrows Paper Corporation. Ms. Daniels CariveauBronfen-Moore holds a Bachelor of Arts degree from Purdue University in Broadcast Journalism and Spanish from the University of St. Thomas in St. Paul, Minn. and aPsychology, Master of Arts in Human Resources and Industrial Relations from the University of Minnesota Carlson School of Management in Minneapolis, Minn.

Benjamin H. Davis joined AngioDynamics as Senior Vice President of Business Development in March 2015. Prior to joining AngioDynamics, Mr. Davis most recently was the Vice President Business Integration at C.R. Bard, Inc. where he also served as the Divisional Head of Business Development from 2004 -2013. Before joining C.R. Bard, Inc. Mr. Davis held the position of Chief Financial Officer and Treasurer at Axya Medical Inc. He holds a Bachelor of Science in Business AdministrationIndustrial/Organizational Psychology from Bryant CollegeRensselaer Polytechnic Institute, and Mastercompleted all of the coursework requirements for a PhD in Business Administration in FinanceManagement from Bentley University Graduate School of Business.Rensselaer Polytechnic Institute.

Chad T. Campbell joined AngioDynamics in May 2016 as the Senior Vice President and General Manager for the Vascular Access Global Business Unit. In his role, Mr. Campbell oversees research and development and global commercialization of the Global Business Unit’s portfolio. Mr. Campbell joined AngioDynamics from Medtronic where he served as the Vice President of Marketing for the Patient Care and Safety business after serving as the Vice President of Marketing for the SharpSafety business at Covidien (Medtronic). During his tenure at Covidien, Mr. Campbell also held roles including Director of Marketing, Area Vice President of Sales, Region Manager, Product Manager and Account Manager. Mr. Campbell received a Bachelor of Arts from the University of Kentucky.

Richard A. Stark Scott Centeajoined AngioDynamics in 20072005 as a sales representative serving the Carolinas. During his tenure, he has served in a variety of positions with increased responsibility including VP of Corporate Accounts where he was in charge of
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leading a team of individuals to execute Health System Purchasing Contracts. From there Mr. Centea assumed the role of VP of Marketing for Endovascular Therapies, before being promoted into his most recent and current role as Sr. Vice President/General Manager of Endovascular Therapies and Peripheral Artery Disease. Mr. Centea currently holds board positions with the American Venous Forum (AVF) and the Capital District American Heart Association. Mr. Centea holds a Bachelor of Arts in Communications from Newberry College.
Benjamin H. Davis joined AngioDynamics as Senior Vice President of Business Development in March 2015. Prior to joining AngioDynamics, Mr. Davis most recently was the Vice President of Business Integration at C. R. Bard, Inc. where he also served as the Divisional Head of Business Development from 2004-2013. Before joining C. R. Bard, Inc., Mr. Davis held the position of Chief Financial Officer and Treasurer at Axya Medical Inc. He holds a Bachelor of Science in Business Administration from Bryant College and Master in Business Administration in Finance from Bentley University Graduate School of Business.
David D. Helsel currently serves as Senior Vice President of Global Operations and has been with AngioDynamics since December 2017. Prior to joining AngioDynamics he was Senior Vice President, Global Supply Chain, at Hill-Rom Holdings for almost three years. Before that, Mr. Helsel worked at Haemonetics for three years where he served as Executive Vice President for Global Manufacturing and also spent almost nineteen years in various positions with increasing responsibility at Covidien, including Vice President of Operations for the Surgical Solutions Division and Medical Supplies Division. An expert in Lean and Six Sigma, Mr. Helsel also served as Global Director of Operational Excellence, supporting sixty-three manufacturing facilities. Mr. Helsel holds a Bachelor of Science in Mechanical Engineering from LeTourneau University.
Warren G. Nighan joined AngioDynamics as the Senior Vice President of Quality and Regulatory Affairs in April 2017. Before joining AngioDynamics, Mr. Nighan was a quality and regulatory consultant to clients in FDA-regulated industries, specializing in execution and management of quality systems implementation and remediation. Previously, Mr. Nighan served as the Executive Vice President of Global Clinical, Quality Affairs and Regulatory Affairs at Haemonetics Corporation, Vice President of Quality/Regulatory/Clinical/Technical Services at St. Jude Medical’s Atrial Fibrillation Division, and Corporate Vice President of Quality/Compliance at Tyco Healthcare/Covidien (Medtronic). Mr. Nighan earned a Bachelor and Master of Science in Nursing from Northeastern University’s Bouvé College of Health Sciences.
Laura Piccinini joined AngioDynamics as Senior Vice President and General Manager for International in June 2021. Ms. Piccinini brings more than 25 years of experience in leadership roles in the Oncology/SurgeryMedical Device industry, with an extensive background in the field of respiratory and surgical care. From June 2020 to June 2021, she served as CEO and a member of the Board of Directors for Respiratory Motion, Inc. Prior to that, from 2017 to 2020, she served as Global Business Unit. InHead of Commercial Operations for the Implants business unit at Nobel Biocare Systems, then a Danaher subsidiary now part of Envista Holdings. From 2015 to 2017, Ms. Piccinini served as President of EMEA at Covidien and prior to that at Stryker. Ms. Piccinini is a graduate of the Parma University of Medicine, where she received a nursing degree with specializations in ICU, Anesthesia, and First Aid as a Helicopter Flight Coordinator.
Richard C. Rosenzweig joined AngioDynamics as Senior Vice President General Counsel and Secretary in February 2021. Mr. Rosenzweig brings to his role Mr. Stark oversees researchmore than 20 years of experience in executive leadership providing legal guidance, governance and developmentcompliance oversight, and strategic business direction to global commercialization of the Global Business Unit’s portfolio.medical device and health care companies, including C. R. Bard for more than ten years where he most recently served as Vice President, Law, and Assistant Secretary, Phibro Animal Health Corporation and Impath, Inc. as Senior Vice President, General Counsel and Secretary, and Johnson & Johnson as Director, Licensing and Acquisitions. Prior to AngioDynamics, Mr. Stark servedRosenzweig advised companies in the medical device industry as a district sales manager with RITA Medical, which was later acquired by AngioDynamics. Prior to RITA,an independent consultant on corporate development initiatives. Mr. Stark spent several years in field sales with Woodside Biomedical and Arrow International (Teleflex). Stark holds aRosenzweig received his Bachelor of Arts in Psychology from California StateBrandeis University and his Juris Doctor from Boston University School of Chico in Chico, California.

Robert A. Simpson joined AngioDynamics in February 2017Law. He is an advisor to TEAMFund, an impact investment fund, serves as the Senior Vice PresidentChair and General Manager for the Peripheral Vascular Global Business Unit. In his role, Mr. Simpson oversees research and development and global commercializationChair-Elect of the Global Business Unit’s portfolio. Prior to AngioDynamics, Mr. Simpson served as the Vice President and General ManagerDirector’s Leadership Council of the Patient Care Global Business at Medtronic. He was responsible for leading the business strategy and operations while ensuring global execution. Prior to his role within the Patient Care business, Mr. Simpson led strategy and business development for Medtronic’s Patient Monitoring & Recovery business. Mr. Simpson also held various leadership roles in Sales and Marketing during his time at Covidien (Medtronic) and Alcon (Novartis). Mr. Simpson received a Bachelor of Science in Management Science - Finance from the State UniversityRutgers Cancer Institute of New York at GeneseoJersey, and has completedis a comprehensive, executive leadership development program at Babson College.

member of the Director’s Leadership Council for Rutgers Biomedical and Health Sciences, an academic medical center.
AVAILABLE INFORMATION

Our corporate headquarters is located at 14 Plaza Drive, Latham, New York 12110. Our phone number is (518) 795-1400. Our website is www.angiodynamics.com.

We make available, free-of-charge through our website, our Annual Reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) of the Securities Exchange Act of 1934, as amended, as soon as reasonably practicable after we electronically file or furnish such materials to the Securities and Exchange Commission, or SEC. In addition, our website includes, among other things, charters of the various committees of our Board of Directors and our code of business conduct and ethics applicable to all employees, officers and directors. Within the time period required by the SEC, we will post on our website any amendment to the code of business conduct and ethics and any waiver applicable to any executive officer, director or senior financial officer. We use our website as a means of disclosing material non-public
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information and for complying with our disclosure obligations under Regulation FD. Accordingly, investors should monitor our website, in addition to following our press releases, SEC filings and public conference calls and webcasts. We use these channels as well as social media and blogs to communicate with the public about our company, our services and other issues. It is possible that the information we post on social media and blogs could be deemed to be material information. Therefore, we encourage investors, the media, and others interested in our Company to review the information we post on the social media channels and blogs listed on our website. Any stockholder also may obtain copies of these documents, free of charge, by sending a request in writing to our investor relations department: AngioDynamics, 14 Plaza Drive, Latham, N.Y. 12210,Corporate headquarters, Attention: Caitlin Stefanik.Saleem Cheeks. Information on our website or connected to our website is not incorporated by reference into this Annual Report on Form 10-K.



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Item 1A.Risk Factors.

Item 1A. Risk Factors.
In addition to the other information contained in this Annual Report on Form 10-K and in our other filings with the Securities and Exchange Commission, the following risk factors should be considered carefully by investors in evaluating the Company'sour business. Our financial and operating results are subject to a number of factors,risks and uncertainties, including those set forth below, many of which are not within our control. These factors include those set forth below. Our business, financial condition, or results of operations and/or liquidity could be materially and adversely affected by any of these risks. Additionalrisks or by additional risks not presently known to us or that we currently deem immaterial may also adversely affect our business, financial condition or results of operations.immaterial.

RISKS RELATED TO OUR BUSINESS AND INDUSTRY

Consolidation in the healthcare industry could have an adverse effect on our revenues and results of operations.

Many healthcare industry companies, including medical device companies, are consolidating to create new companies with greater market power. As the healthcare industry consolidates, competition to provide goods and services to industry participants will become more intense. These industry participants may try to use their market power to negotiate price concessions or reductions for medical devices that incorporate components produced by us. If we are forced to reduce our prices because of consolidation in the healthcare industry, our revenues would decrease and our consolidated earnings, financial condition, or cash flow would suffer.


We face intense competition in the medical device industry.industry which continues to experience consolidation. We may be unable to compete effectively with respect to technological innovation and price which may have ana material adverse effect on our revenues, financial condition, or results of operations.operations and/or liquidity.


The markets for our products are highly competitive and we expect competition to continue to intensify. The medical device industry is characterized by rapid technological change, frequent product introductions and evolving customer requirements. Our customers consider many factors when choosing products, including technology, features and benefits, quality, reliability, ease of use, clinical or economic outcomes, availability, price and customer service. We face competition globally from a wide range of companies, many of whom have substantially greater financial, marketing and other resources than us. We may not be able to compete effectively, and we may lose market share to our competitors. Our primary device competitors include: Boston Scientific Corporation; Cook Medical; C.R. Bard; Medical Components, Inc. (Medcomp)(MedComp); TeleFlex Medical; Becton Dickinson; Smiths Medical, a subsidiary of Smiths Group plc; Medtronic; Merit Medical; Terumo Medical Corporation; Johnson and JohnsonJohnson; Philips Healthcare; Inari Medical; Varian Medical Systems and Total Vein Systems. Many of our competitors have substantially greater:

financial and other resources to devote to product acquisitions, research and development, marketing and manufacturing;
variety of products;
technical capabilities;
history of developing and introducing new products;
patent portfolios that may present an obstacle to our conduct of business;
name recognition; and
distribution networks and in-house sales forces.

Our competitors may succeed in adapting faster than us to changing customer needs or requirements, in developing and introducing technologies and products earlier, in obtaining patent protection (which could create barriers to market entry for us) or regulatory clearance earlier, or in commercializing new products or technologies more rapidly than us. Our competitors may also develop products and technologies that are superior to those we are developingours or that otherwise could render our products obsolete or noncompetitive. In addition, weThe trend of increased consolidation in the medical technology industry has resulted in companies with greater scale and market power, intensifying competition and increasing pricing pressure. We may also face competition from providers of other medical therapies, such as pharmaceutical companies, that may offer non-surgical therapies for conditions that are currently, or in the future may be, treated using our products. Our products are generally sold at higher prices than those of our competitors. However, in the current environment of managed care, which is characterized by economically motivated buyers, consolidation among healthcare providers, increased competition and declining reimbursement rates, we are increasingly being required to compete on the basis of price. If we are not able to compete effectively, our market share and revenuesrevenue may decline.

We face intenseIn addition, the increasing purchasing power of health systems, group purchasing organizations (“GPOs”) and integrated health delivery networks (“IDNs”), together with increased competition from other companies,and declining reimbursement rates, has resulted increasingly with the Company competing on the basis of price. Due to the highly competitive nature of the GPO and IDN contracting processes, we may not be able to obtain market prices for our products or obtain or maintain contract positions with major GPOs and IDNs, which could adversely impact our profitability. Also, sales through a GPO or IDN can be significant to our business and our inability to retain contracts with our customers, or acquire additional contracts, could have a material adverse effect on our business, financial condition, results of operations and/or liquidity.
Our inability to continue to effectively develop, acquire and/or market new products and technologies could have a material adverse effect on our business, financial condition and/or results of operations and/or financial condition.

operations.
The medical device business is intensely competitive andmarket for our devices is characterized by rapid technological change, frequentnew product introductions, technological improvements, changes in physician requirements and evolving customer requirements. Our customers consider many factors when choosing among products, including features and reliability, quality, technology, clinical or economic outcomes, availability, price and services provided by the manufacturer. We face competition globally from a wide range of companies, some of which may have greater resources than us, which may enable them to adapt faster than us to customer needs or changes in customer requirements.industry standards. Product introductions, alternative products or enhancements by competitors that provide better features, clinical outcomes or economic


value and/or offer lower pricing may make our products or proposed products obsolete or less competitive. In addition, the trend of consolidation in thelife cycles are relatively short because medical device industrymanufacturers continually develop more effective and among our customers could resultless expensive versions of existing devices in greater competition and pricing pressures.

As a result, weresponse to physician demand. We engage in product development and improvement programs to maintain and improve our competitive position. These developmentOur products are technologically complex and improvementthese programs involve significant planning, market studies, investment in research and development, clinical trials and regulatory clearances or approvals and may require more time and expense than anticipated to bring such products to market. We may not, however, be successful in enhancing existing products, or developing newproducts or technologies that will achieve regulatory approval, be developed or manufactured in a cost effectivecost-effective manner, obtain appropriate intellectual property protection or receive market acceptance and weacceptance. We also may be unable to recover all or a meaningful part of our investment in suchthese products or technologies. Additionally, there can be no assurance that the size of the markets in which we compete will increase above existing levels or not decline, that we will be able to maintain, gain or regain market share or that we can compete effectively on the basis of price or that the number of procedures in which our products are used will increase above existing levels or not decline.

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In particular, the future prospects of many of our high growth products, such as the NanoKnife system, the AngioVac system and the Auryon system, rely on continued market development and continued generation of clinical data pursuant to clinical trials conducted by us, our competitors or other third parties. If the results of these trials are not what we expect or fail to generate meaningful clinical data, it may adversely impact our ability to obtain product approvals. If any of these products fail to achieve clinical acceptance or are perceived unfavorably by the market, it could severely limit our ability to drive revenue growth, which could have a material adverse effect on our business, financial condition, results of operations and/or liquidity. See Risk Factor titled “Our business and prospects rely heavily upon our ability to successfully complete clinical trials, including our NanoKnife DIRECT Clinical study, our Auryon Pathfinder study and clinical studies for AngioVac. We may choose to, or may be required to, suspend, repeat or terminate our clinical trials if they are not conducted in accordance with regulatory requirements, the results are negative or inconclusive or the trials are not well designed.”
As part of our business strategy, we also pursueexpect to continue to engage in business development activities which includes selectively evaluating and pursuing the acquisition of complementary businesses, technologies and products. These activities may result in substantial investment of our time and financial resources and competition for targets may be significant. We may not be able to identify appropriate acquisition candidates, consummate transactions, or obtain agreements with favorable terms.terms or obtain any necessary financing or regulatory approvals. Further, once a business is acquired, any inability to successfully integrate the business or achieve anticipated cost savings or operating synergies, decreases in customer loyalty or product orders, failure to retain and develop its workforce, failure to establish and maintain appropriate controls, higher or unanticipated expenses, or unknown or contingent liabilities could adversely affect our ability to realize the anticipated benefits of any acquisition. The evaluation and integration of an acquired business, whether or not successful, requires significant efforts which may result in additional expenses and divert the attention of our management and technical personnel from other projects.
If we proceed with one or more significant acquisitions in which the consideration consists of cash, a substantial portion of our available cash could be used to consummate the acquisitions. If we consummate one or more acquisitions in which the consideration consists of capital stock, our stockholders could suffer significant dilution of their interest in us. In addition, we could incur or assume significant amounts of indebtedness in connection with acquisitions. These transactions are inherently risky and may not enhance our financial position or results of operations or create value for our shareholders as they are based on projections and assumptions which are uncertain and subject to change and there can be no assurance that any past or future transaction will be successful.
If we fail to develop and successfully manufacture and launch new products, generate satisfactory clinical results, provide sufficient economic value, enhance existing products, or identify, acquire and integrate complementary businesses, technologies and products or if we experience a decrease in market size or market share or declines in average selling price or procedural volumes, or otherwise fail to compete effectively, we may not achieve our growth goals, which could have a material adverse effect on our business, financial condition and/or results of operations and/or financial condition could be adversely affected.

operations.
If we do not maintain our reputation with interventional physicians, interventional and surgical oncologists and critical care nurses our growth will be limited and our business could be harmed.

Physicians typically influence the medical device purchasing decisions of the hospitals and other healthcare institutions in which they practice. Consequently, our reputation with interventional physicians, interventional and surgical oncologists and critical care nurses is criticalcrucial to our continued growth. We believe that we have built a positive reputation based on the quality of our products, our physician-driven product development efforts, our marketing and training efforts and our presence at medical society meetings. Any actual or perceived diminution in the quality of our products, or our failure or inability to maintain these other efforts, could damage our reputation with interventional physicians and cause our growth to be limited and our business to be harmed.

If we fail to develop or market new products and enhance existing products, we could lose market share to our competitors and our results of operations could suffer.

The market for interventional devices is characterized by rapid technological change, new product introductions, technological improvements, changes in physician requirements and evolving industry standards. To be successful, we must continue to develop and commercialize new products and to enhance versions of our existing products. Our products are technologically complex and require significant research, planning, design, development and testing before they may be marketed. This process generally takes at least 12 to 18 months from initial concept and may take up to several years. In addition, product life cycles are relatively short because medical device manufacturers continually develop smaller, more effective and less expensive versions of existing devices in response to physician demand.

Our success in developing and commercializing new and enhanced versions of our products is affected by our ability to:
recruit engineers;
timely and accurately identify new market trends;
accurately assess customer needs;
minimize the time and costs required to obtain regulatory clearance or approval;
adopt competitive pricing;
timely manufacture and deliver products;
accurately predict and control costs associated with the development, manufacturing and support of our products; and


anticipate and compete effectively with our competitors’ efforts.

Market acceptance of our products depends in part on our ability to demonstrate that our products are cost-effective and easier to use, as well as offer technological advantages. Additionally, we may experience design, manufacturing, marketing or other difficulties that could delay or prevent our development, introduction or marketing of new products or new versions of our existing products. As a result of such difficulties and delays, our development expenses may increase and, as a consequence, our results of operations could suffer.

Development and sales of our products are dependent on a number of factors beyond our control, and our inability to make and complete research and development investments, enhance the product development process and be innovative to solve customer needs with respect to the respective products may adversely affect our business, financial condition and results of operations.

A significant aspect of our growth strategy is the continued market development of products including NanoKnife, AngioVac, Venacure EVLT and BioFlo products.

There can be no guarantee that we will be able to develop and manufacture additional next generation or updated products on commercially favorable terms, or at all. NanoKnife and AngioVac are developing technologies and the inability of either of them to achieve clinical acceptance, as well as our inability to generate meaningful clinical data to convince providers of the clinical and economic benefits of our BioFlo platform, could severely limit our ability to drive revenue growth.

We currently have FDA 510(k) clearance to market NanoKnife products for soft tissue ablation. If we are not able to secure FDA approval to conduct investigational device exemption (IDE) trials or marketing approval for additional or more specific indications, through 510(k) clearance, pre-market approval or otherwise, our ability to market our NanoKnife products will be restrictedharmed, which may have an adverse effect on our business, financial condition and results of operations.

Undetected defects may increase our costs and impair the market acceptance of our products.

Our products have occasionally contained, and may in the future contain, undetected defects. When these problems occur, we must divert the attention of our engineering personnel to address them. There is no assurance that we will not incur warranty or repair costs, be subject to liability claims for damages related to product defects, or experience manufacturing, shipping or other delays or interruptions as a result of these defects in the future. Our insurance policies may not provide sufficient protection should a claim be asserted. In addition, the occurrence of defects may result in significant customer relations problems and injury to our reputation, and may impair market acceptance of our products.

We, our competitors or other third parties, may engage in clinical trials with respect to our products. The results of these trials may be unfavorable, or perceived as unfavorable by the market, and could have a material adverse effect on our business, financial condition, or results of operations.

operations and/or liquidity.
Our productsbusiness and prospects depend heavily on the NanoKnife system, which is currently approved for the surgical ablation of soft tissue. If we are unable to secure expanded specific regulatory approvals for the NanoKnife system, our business and prospects may be the subject of clinical trials conducted by us, our competitors or third partiesmaterially harmed.
Our NanoKnife System is indicated for the purposessurgical ablation of obtaining regulatory clearances or to gather market data. Unfavorable or inconsistent clinical data from existing or future clinical trials conducted by us, bysoft tissue. The long-term prospects for our competitors or by third parties, or the FDA's or the market's perception of this clinical data,NanoKnife business may adversely impactrely on securing expanded indications for specific disease states and treatments. Based on our current indication, our ability to obtain product approvals, our position in,promote the NanoKnife system and shareprovide training with respect to the use of the markets inNanoKnife system is limited to the surgical ablation of soft tissue. In the fourth quarter of our 2019, we received approval from the FDA to initiate our DIRECT clinical trial to study the use of the NanoKnife system for the treatment of Stage III pancreatic cancer. If we are not able to successfully complete this trial and secure clearances or approvals for expanded indications for our NanoKnife system, including for the treatment of Stage III pancreatic cancer, or if expanded indications are significantly delayed or limited, our business and prospects may be materially harmed and we may need to delay our initiatives or even significantly curtail
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operations, which we participate andcould have a material adverse effect on our business, financial condition, results of operations and/or future prospects.liquidity.

Our business and prospects rely heavily upon our ability to successfully complete clinical trials, including, but not limited to, our NanoKnife DIRECT clinical study, our NanoKnife PRESERVE clinical study, our Auryon Pathfinder study and clinical studies for AngioVac.We may choose to, or may be required to, suspend, repeat or terminate our clinical trials if they are not conducted in accordance with regulatory requirements, the results are negative or inconclusive or the trials are not well designed.
Clinical trials must be conducted in accordance with the applicable laws and regulations in the jurisdictions in which the clinical trials are conducted, including FDA’s current Good Clinical Practices. The clinical trials are subject to oversight by the FDA, regulatory agencies in other jurisdictions, ethics committees and institutional review boards at the medical institutions where the clinical trials are conducted. Clinical trial protocols may require a large number of patients to be enrolled in the trials. Patient enrollment is a function of many factors, including the size of the patient population for the target indication, the proximity of patients to clinical sites, the eligibility criteria for the trial, the existence of competing clinical trials and the availability of alternative or new treatments. Clinical trials may be suspended by the FDA or by a regulatory agency in another jurisdiction at any time if the FDA or the regulatory agency finds deficiencies in the conduct of these trials or it is believed that these trials expose patients to unacceptable health risks.
We, the FDA or regulatory agencies in other jurisdictions might delay or terminate our clinical trials for various reasons, including insufficient patient enrollment, fatalities, unforeseen adverse side effects by enrolled patients or the development of new therapies that require us to revise or amend our clinical trial protocols. Patients may be discouraged from enrolling in our clinical trials if the trial protocol requires them to undergo extensive follow-up to assess safety and effectiveness, if they determine that the treatments received under the trial protocols are not attractive or involve unacceptable risks or discomforts or if they participate in contemporaneous clinical trials of competing products.
In addition, we rely on contract research organizations, or CROs, with respect to conducting our clinical trials. We may experience significant cost overruns associated with, and we may encounter difficulties managing, these CROs. Termination of our clinical trials or significant delays in completing our clinical trials could have a material adverse effect on our business, financial condition, results of operations and/or liquidity.
If we are unable to convince customers that our products can improve the cost structure of their business, our revenue growth and profitability may be materially and adversely impacted.

Worldwide initiatives to contain healthcare costs have led governmentgovernments and the private sector to enact cost containment efforts as a means of managing the growth of health care utilization. Common techniques include policies on price regulation, competitive pricing, bidding and tender mechanics, coverage and payment, comparative effectiveness of therapies, technology assessments, and managed-care arrangements. These changes are causing the marketplace to put increased emphasis on the delivery of more cost-effective medical devices and therapies. Government programs, including Medicare and Medicaid, private health care insurance, and managed-care plans have attempted to control costs by limiting the amount of reimbursement they will pay for particular procedures or treatments, tying reimbursement to outcomes, shifting to population health management, and other mechanisms designed to constrain utilization and contain costs. Simultaneously, hospitals are redefining their role in health care delivery as many assume much more risk and control of the total cost of patient care. To successfully make this transformation, health systems are consolidating, purchasing or partnering with physicians and post-acute care providers, while also narrowing networks thus allowing greater control over outcomes. Today, many systems are


becoming ‘mini’ payer/provider organizations. These newly redesigned health systems are creating mechanisms such as value analysis and centralized purchasing functions that set pricing and in some cases limit the number of vendors that can participate in the purchasing program. Hospitals are also aligning interests with physicians through employment and other arrangements, such as gainsharing, where a hospital agrees with physicians to share any realized cost savings resulting from the physicians’ collective change in practice patterns such as standardization of devices where medically appropriate. This has created an increasing level of price sensitivity among customers for our products. Some third-party payers must also approve coverageproducts and set reimbursement levels for new or innovative devices or therapies before they will reimburse health care providers who use the medical devices or therapies. Even thoughcould have a new medical device may have been cleared for commercial distribution, we may find limited demand for the device until coverage and sufficient reimbursement levels have been obtained from governmental and private third-party payers. In addition, some private third-party payers require that certain procedures or that the use of certain products be authorized in advance as amaterial adverse effect on our business, financial condition, of reimbursement. International examples of cost containment initiatives and health care reforms advancing clinical outcomes as the key to market access are emerging in France, Germany, the Netherlands and the UK. This new criteria can severely restrict coverage, reduce reimbursement and delay access to key markets with requirements for incremental clinical benefit and coverage with evidence development.

Cost-containment efforts of group purchasing organizations could adversely affect our selling prices, financial position and results of operations.

Many of our existing and potential customers have become members of group purchasing organizations, operations and/or GPOs, and integrated delivery network, or IDNs, in an effort to reduce costs. GPOs and IDNs negotiate pricing arrangements with healthcare product manufacturers and distributors and offer the negotiated prices to affiliated hospitals and other members. GPOs and IDNs typically award contracts on a category-by-category basis through a competitive bidding process. Bids are generally solicited from multiple manufacturers with the intention of driving down pricing. Due to the highly competitive nature of the GPO and IDN contracting processes, we may not be able to obtain market prices for our products or obtain or maintain contract positions with major GPOs and IDNs, which could adversely impact our profitability. Also, sales through a GPO or IDN can be significant to our business and if we are unable to retain contracts with our customers, or acquire additional contracts, our financial results may be negatively impacted.

liquidity.
We are dependent on single and limited source suppliers which subjects our business and results of operations to risks of supplier business interruptions.

We currently purchase significant amounts of several key products and product components from single and limited source suppliers and anticipate that we will do so for future products as well. Any delays in delivery of or shortages in those or other products and components could interrupt and delay manufacturing of our products and result in the cancellation of orders for our products. Any or all of these suppliers could discontinue the manufacture or supply of these products and components at any time. Due to FDA and other business considerations, we may not be able to identify and integrate alternative sources of supply in a timely fashion or at all. Any transition to alternate suppliers may result in production delays and increased costs and may limit our ability to deliver products to our customers. Furthermore, if we are unable to identify alternative sources of supply, we would have to modify our products to use substitute components, which may cause delays in shipments, backlogs, increased prices for our products or increased design and manufacturing costs and increased prices for our products.costs.

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In addition, we purchase certain products as a distributor for the manufacturer of those products, including Asclera,. Operational, quality or regulatory issues of the manufacturers of the products we distribute could constrain or interrupt the availability of those products or services.products. Any constraint or interruption in the supply of finished products that we distribute could materially impact our ability to sell products, and have a material adverse effect on our ability to sell products, ourbusiness, financial condition, and our results of operations.

operations and/or liquidity.
We are heavily dependent on third-party distributors to generate a substantial portion of our international revenues and are at the risk of these distributors also selling for our competitors, along with beingfailing to be financially viable to be ableand failing to effectively distribute our products and make timely payment.in compliance with applicable laws.

Outside of the U.SNorth America we rely heavily on third party distributors, either on acountry-by-countrybasis or on a multi-country, regional basis, to market, sell and distribute our products where we do not have a direct sales and marketing presence (including, among others, China, Japan, Brazil, the Middle East and many European countries). As such, our revenue, if any, depends on the terms of such arrangements and the distributors’ efforts. These efforts may turn out not to be sufficient and our third-party distributors may not effectively sell our products. International distributors accounted for approximately 72%64% of international revenues for the fiscal year ended May 31, 2017.2021. If we are unable to maintain our relationships or establish direct sales capabilities on acceptable terms or at all, we may lose significant revenue or be unable to achieve our growth aspirations. In certain circumstances, distributors may also sell competing products, to our own or products for competing diagnostic modalities, and may have incentives to shift sales towards those competing products. As a result, we cannot assure you that our international distributors will increase or maintain our current levels of unit sales or increase or maintain our current unit pricing, which, in turn, could have a material adverse effect on our business, financial condition, results of operations financial condition and cash flows.and/or liquidity. In addition, there is a risk that our distributors will not be financially viable due to current economic and/or regulatory events in their respective countries.


countries or remit payments to us in a timely manner. If our distributors fail to comply with applicable laws or fail to effectively market and sell our products, our financial condition and results of operations could be materially and adversely impacted.
Failure to secure adequate reimbursement for our products could materially impair our ability to grow revenue and drive profitability.

Our products are used in medical procedures generally coveredand purchased principally by governmenthospitals or physicians which typically bill various third-party payors, such as governmental programs (e.g., Medicare, Medicaid and comparable foreign programs), private health plans.

insurance plans and managed care plans, for the healthcare services provided to their patients. The ability of our customers to obtain appropriate reimbursement for products and services from third-party payors is critical to the success of medical device companies because it affects which products customers purchase and the prices they are willing to pay. In general, a third-party payor only covers a medical product or procedure when the plan administrator is satisfied that the product or procedure improves health outcomes, including quality of life or functional ability, in a safe and cost-effective manner. Even if a device has received clearance or approval for marketing by the FDA, there is no assurance that third-party payors, including Medicare and managed care companies, will cover the cost of the device and related procedures.

In many instances, third-party payors use price schedules that do not vary to reflect the cost of the products and equipment used in performing those procedures. In other instances, payment or reimbursement is separately available for the products and equipment used, in addition to payment or reimbursement for the procedure itself. Even if coverage is available, third-party payors may place restrictions on the circumstances where they provide coverage or may offer reimbursement that is not sufficient to cover the cost of our products.

Third-party payors who cover the cost of medical products or equipment, in addition to allowing a general charge for the procedure, often maintain lists of exclusive suppliers or approved lists of products deemed to be cost-effective. Authorization from those third-party payors is required prior to using products that are not on these lists as a condition of reimbursement. If our products are not on the approved lists of third-party payors, healthcare providers must determine if the additional cost and effort required in obtaining prior authorization, and the uncertainty of actually obtaining coverage, is justified by any perceived clinical benefits from using our products.

Finally, the advent of contracted fixed rates per procedure has made it difficult to receive reimbursement for disposable products, even if the use of these products improves clinical outcomes. In addition, many third-party payors are moving to managed care systems in which providers contract to provide comprehensive healthcare for a fixed cost per person. Managed care providers often attempt to control the cost of healthcare by authorizing fewer elective surgical procedures. Under current prospective payment systems, such as the diagnosis related group system and the hospital out-patient prospective payment system, both of which are used by Medicare and in many managed care systems used by private third-party payors, the cost of our products will be incorporated into the overall cost of a procedure and not be separately reimbursed. As a result, we cannot be certain that hospital administrators and physicians will purchase our products, despite the clinical benefits and opportunity for cost savings that we believe can be derived from their use. If hospitals and physicians cannot obtain adequate reimbursement for our products or the procedures in which they are used, this could have a material adverse effect on our business, financial condition, results of operations and/or liquidity.
Reimbursement varies by country and cash flows could suffer a material adverse impact.

Our success in international markets will depend largely uponcan significantly impact the availabilityacceptance of reimbursement from the third-party payors through which healthcare providers are paid in those markets. Reimbursement and healthcare payment systems vary significantly by country. The main typesnew technology. Implementation of healthcare payment systems are government sponsored healthcare and private insurance. Reimbursement approval must be obtained individuallyreforms in each country in which our products are marketed. Outside the United States and in other countries may limit, reduce or eliminate reimbursement for our products and adversely affect both our pricing flexibility and the demand for our products. Even when we generally rely on our distributors to obtaindevelop a promising new product, we may find limited demand for the product unless reimbursement approval is obtained from private and governmental third-party payors. Changes in healthcare systems in the countriesUnited States or elsewhere in a manner that significantly reduces
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reimbursement for procedures using our medical devices or denies coverage for these procedures, or adverse decisions relating to our products by administrators of these systems in coverage or reimbursement issues, would have an adverse impact on the acceptance of our products and the prices which they will sell our products. There can be no assurance that reimbursement approvals will be received. The failurecustomers are willing to secure reimbursement approvals in international markets could materially impact our financial position and results of operations.

pay for them.
If a product liability claim is brought against us or our product liability insurance coverage is inadequate, our business could be harmed.

The design, manufacture and marketing of the types of medical devices we sell entail an inherent risk of product liability. Our products are used by physicians to treat seriously ill patients. We are periodically subject to product liability claims, and patients or customers may in the future bring claims against us in a number of circumstances and for a number of reasons, including if our products were misused, if a component of our product fails, if theirour manufacture or design was flawed, if theythe product produced unsatisfactory results or if the instructions for use and operating manuals and disclosure of product related risks for our products were found to be inadequate. In addition, individuals or groups seeking to represent a class may file suit against us. The outcome of litigation, particularly class action lawsuits, is difficult to assess or quantify. Plaintiffs in these types of lawsuits often seek recovery of very large or indeterminate amounts, including not only actual damages, but also punitive damages. The magnitude of the potential losses relating to these lawsuits may remain unknown for substantial periods of time.

We carry a product liability policy with a limit of $10,000,000$10.0 million per product liability claim and an aggregate policy limit of $10,000,000,$10.0 million, subject to a self-insured retention of $500,000$0.5 million per occurrence and $2,000,000$2.0 million in the aggregate. We believe, based on claims made against us in the past, our existing product liability insurance coverage is reasonably adequate to protect us


from any liabilities we might incur. However, there is no assurance that this coverage will be sufficient to satisfy any claim made against us. In addition, we may not be able to continue to maintain adequate coverage at a reasonable cost and on reasonable terms, if at all. Any product liability claim brought against us, with or without merit, could increase our product liability insurance rates or prevent us from securing any coverage in the future. Additionally, if one or more product liability claims is brought against us for uninsured liabilities or is in excess of our insurance coverage, our financial condition, and results of operations and/or liquidity could be negatively impacted. Further, such claims may require us to recall some of our products, which could result in significant costs to us and could divert management’s attention from our business.

We may be exposed to risks associated with acquisitions, including integration risks and risks associated with methods of financing and the impact of accounting treatment. Accordingly, completed acquisitions may not enhance our financial position or results of operations as they are based projections and assumptions which are uncertain and subject to change.

Part of our growth strategy is to acquire businesses and technologies that are complementary to ours. There is no assurance that acquisition opportunities will be available on acceptable terms, or at all, or that we will be able to obtain necessary financing or regulatory approvals. Any acquisitions that we do undertake would be accompanied by the risks commonly encountered in acquisitions, including the:

potential disruption of our business while we evaluate opportunities, complete acquisitions and develop and implement new business strategies to take advantage of these opportunities;
inability of our management to maximize our financial and strategic position by incorporating an acquired technology or business into our existing offerings;
our inability to achieve the cost savings and operating synergies anticipated in the acquisition, which would prevent us from achieving the positive earnings gains expected as a result of the acquisition;
diversion of management attention from ongoing business concerns to integration matters;
difficulty of maintaining uniform standards, controls, procedures and policies;
challenges in demonstrating to our customers that the acquisition will not result in adverse changes in customer service standards or business focus;
possible cash flow interruption or loss of revenue as a result of change of ownership transitional matters;
difficulty of assimilating the operations and personnel of acquired businesses;
potential loss of key employees of acquired businesses, and the impairment of relationships with employees and customers as a result of changes in management; and
uncertainty as to the long-term success of any acquisitions we may make including the impact on contingent liabilities.

There is no assurance that any completed acquisition will be accretive to our margins or profits in the short term or in the long term. If we proceed with one or more significant acquisitions in which the consideration consists of cash, a substantial portion of our available cash could be used to consummate the acquisitions. If we consummate one or more acquisitions in which the consideration consists of capital stock, our stockholders could suffer significant dilution of their interest in us. In addition, we could incur or assume significant amounts of indebtedness in connection with acquisitions. Further, acquisitions could also result in significant goodwill and/or amortization charges for acquired businesses or technologies.

Failure to attract additional capital which we may require to expand our business could curtail our growth.

We may require additional capital to expand our business. If cash generated internally is insufficient to fund capital requirements, we will require additional debt or equity financing. In addition, we may require financing to fund any significant acquisitions we may seek to make. Needed financing may not be available or, if available, may not be available on terms satisfactory to us and may result in significant stockholder dilution. Covenants in our existing financing agreements may also restrict our ability to obtain additional debt financing. If we fail to obtain sufficient additional capital in the future, we could be forced to curtail our growth strategy by reducing or delaying capital expenditures and acquisitions, selling assets, restructuring our operations or refinancing our indebtedness.

International and national economic and industry conditions constantly change, and could materially and adversely affect our business, financial condition and results of operations.

Our business, financial condition and results of operation are affected by many changing economic, industry and other conditions beyond our control. Actual or potential changes in international, national, regional and local economic, business and financial conditions, including recession, inflation and trade protection measures, creditworthiness of our customers, may negatively affect consumer preferences, perceptions, spending patterns or demographic trends, any of which could adversely affect our business, financial condition, or results of operations. Our customers may experience financial difficulties operations and/or be unableliquidity.
We are subject to borrow money to fund their


operations, which may adversely impact their ability or decision to purchase or pay for our products. Disruptionsmacro-economic fluctuations in the credit markets have previously resulted,U.S. and could again result, in volatility, decreased liquidity, widening of credit spreads,worldwide economy. Concerns about consumer and investor confidence, volatile corporate profits and reduced availabilitycapital spending, international conflicts, terrorist and military activity, civil unrest and pandemic illness could reduce customer orders or cause customer order cancellations. In addition, political and social turmoil may put further pressure on economic conditions in the United States and abroad. The global economy has been periodically impacted by the effects of financing.global economic downturns (such as recently related to COVID-19). There can be no assurance that there will not be further such events or deterioration in the global economy. These economic conditions make it more difficult for us to accurately forecast and plan our future financing will be available to us on acceptable terms, if at all. An inability to obtain necessary additional financing on acceptable terms may have an adverse impact on us and on our ability to execute on our business plan.activities.

We are subject to a variety of market and financial risks due to our international operations that could adversely affect those operations or our profitability and operating results.

Although our stock is traded on the New York Stock Exchange, we are a global Company. Operations in countriesSales outside of the U.S., which account accounted for approximately 19% percent of our net sales for theduring our fiscal year ended May 31, 2017, are accompanied by certain financial2021. We anticipate that sales from international operations will continue to represent a significant portion of our total sales, and other risks that would not be faced by a Company operating purely within the U.S. Wewe intend to continue to pursue growth opportunities in salesour expansion into emerging and/or faster-growing markets outside the U.S., especially in emerging markets, which could expose us to greater risks associated with international Our sales and operations. Our profitability andfrom our international operations are and will continue to be, subject to a number of risks and potential costs,uncertainties that could have a material adverse effect on our business, financial condition and/or results of operations, many of which we cannot predict, including:

fluctuations in currency exchange rates;rates which may, in some instances affect spending behavior and reduce cash flows and revenue outside the U.S.;
healthcare reform legislation;
multiple non-U.S. regulatory requirementrequirements that are subject to change and that could restrict our ability to manufacture and sell our products;
local product preferences and product requirements;
longer-term receivables than are typical in the U.S.; and/or the ability to obtain payment;
trade protection measures and import or export licensing requirements;
less intellectual property protection in some countries outside the U.S. than exists in the U.S.;
different labor regulations and workforce instability;
political instability;
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the potential payment of U.S. income taxes on earnings of certain foreign subsidiaries subject to U.S. taxation upon repatriation;
the expiration and non-renewal of foreign tax rulings;
potentiallypotential negative consequences from changes in or interpretation of tax laws;laws, including changes in our effective tax rate or the applicable tax rate in one or more jurisdictions; and
economic instability and inflation, recession or interest rate fluctuations.


There are recent legislative proposalsIn addition, the United Kingdom’s (“UK”) departure from the European Union (“EU”) (commonly known as “Brexit”) has created uncertainties affecting business operations in the UK, the EU and a number of other countries, including with respect to tax profitscompliance with the regulatory regimes regarding the labeling and registration of U.S. affiliates which are earned abroad.the products we sell in these markets. While it is impossible for uswe have taken proactive steps to predict whether thesemitigate possible disruption to our operations, we could face increased costs, volatility in exchange rates, market instability and other proposals will be implemented, or how they will ultimately impact us, they may materially impact our resultsrisks, depending on the effects of operations if, for example, our profits earned abroad are subject to U.S. income tax, or we are otherwise disallowed deductions as a result of these profits.

On June 23, 2016, the United Kingdom (U.K.) held a referendum in which voters approved an exit from the E.U., commonly referred to as “Brexit”.  As a result of the referendum, it is expected that the British government will begin negotiating the terms of the U.K.’sexisting and future relationship with the E.U.  Although it is unknown what those terms will be, it is possible that there will be greater restrictions on imports and exportsagreements between the U.K.UK and E.U. countriesEU regarding Brexit and increased regulatory complexities. These changes may adversely affect our operations and financial results.

Finally, changes in currency exchange rates may reduce the reported value of our revenues outside the U.S, net of expenses, and cash flows. We cannot predict changes in currency exchange rates, the impact of exchange rate changes, nor the degree to which we will be able to manage the impact of currency exchange rate changes.

Continuing worldwide economic instability, including challenges faced by the Eurozone countries, could adversely affect our revenues, financial condition or results of operations.

Since fiscal year 2008, the global economy has been impacted by the sequential effects of an ongoing global financial crisis. There can be no assurance that there will not be further deterioration in the global economy. Our customers and vendors may experience financial difficulties or be unable to borrow money to fund their operations which may adversely impact their ability to purchase our products or to pay for our products on a timely basis, if at all. As with our customers and vendors, these economic conditions make it more difficult for us to accurately forecast and plan our future business activities. In addition, trade receivables are in many countries (including, but not limited to, Greece, Ireland, Portugal, and Spain). Repayment of these receivables is dependent upon the financial stability of the economies of those countries.



In light of these global economic fluctuations, we continue to monitor the creditworthiness of customers located outside the U.S. Failure to receive payment of all or a significant portion of these receivables could adversely affect our results of operations. Further, there are concerns for the overall stability and suitability of the Euro as a single currency, given the economic and political challenges facing individual Eurozone countries. Continuing deterioration in the creditworthiness of the Eurozone countries, the withdrawal of one or more member countries from the EU, or the failure of the Euro as a common European currency could adversely affect our revenues, financial condition or results of operations.

EU/UK trading relationship.
Our business could be harmed if we lose the services of our keycannot hire or retain qualified personnel.

Our business depends upon our ability to attract and retain highly qualified personnel, including managerial, sales and technical personnel. We compete for key personnel with other companies, healthcare institutions, academic institutions, government entities and other organizations. We do not have written employment agreements with our executive officers, other than the CEO. Our ability to maintain and expand our business may be impaired if we are unable to retain our current key personnel or hire or retain other qualified personnel in the future.future, including personnel for our manufacturing facilities. If we are not able to hire and retain personnel in our manufacturing facilities, we may not meet our production demand. In addition, our sales force is highly talented and there is high competition in the sales industry which could have an adverse effect on our business if there is significant turnover.

RISKS RELATED TO OPERATIONS

If we are unable to manage our growth profitably, our business, financial results and stock price could suffer.

Our future financial results will depend in part on our ability to profitably manage our growth. Management will need to maintain existing customers and attract new customers, recruit, retain and effectively manage employees, as well as expand operations and integrate customer support and financial control systems. If integration-relatedintegration-related expenses and capital expenditure requirements are greater than anticipated or if we are unable to manage our growth profitably, our financial results and the market price of our common stock may decline.

In recent years we have begun to implement our operational excellence initiatives which include a number of restructuring, realignment and cost reduction initiatives. While we have realized some efficiencies from these actions, weWe may not realize the benefits of these initiatives to the extent or on the timing we anticipated. Further, such benefits may be realized later than expected,anticipated and the ongoing difficulties in implementing these measures may be greater than anticipated, which could cause us to incur additional costs or result in business disruptions. In addition, if these measures are not successful or sustainable, we may undertake additional realignment and cost reduction efforts, which could result in significant additional charges. Moreover, if our restructuringcharges and realignment efforts prove ineffective,adversely impact our ability to achieve our other strategic goals and business plans may be adversely affected.

plans.
We have incurred significantmay fail to attract additional capital necessary to expand our business or may incur additional indebtedness which, imposestogether with our current indebtedness levels, could impose operating and financial restrictions on us which, together with ouras a result of debt service obligations which could significantly limit our ability to execute our business strategy and increase the risk of default underor curtail our debt obligations.

growth.
We borrowed an aggregatemay require additional capital to expand our business. If cash generated internally is insufficient to fund capital requirements, we may require additional debt or equity financing. In addition, we may require financing to fund any significant acquisitions we may seek to make. Disruptions in the capital markets have previously resulted, and could again result, in volatility, decreased liquidity, and widening of approximately $97.5 million as of May 31, 2017.credit spreads, which could make needed financing either unavailable or available on terms unsatisfactory to us which could result in significant stockholder dilution.
We may incur additional indebtedness or draw additional amounts on our existing credit facilities in the future subject to limitations contained in the agreements governing our debt. The interest rate on thesepotential borrowings iscould be a floating rate which could expose us to the risk of increased interest expense in the future. The terms of our credit facilitiesindebtedness could require us to comply with certain financial maintenance covenants. In addition, the terms of our existing indebtedness also include, certainand any future indebtedness could include, covenants restricting or limiting our ability to take certain actions.

These covenants maycould adversely affect our ability to obtain additional financing, to finance future operations, or limit our ability to pursue certain business opportunities or take certain corporate actions. The covenants maycould also restrict our flexibility in planning for changes in our business and the industry and could make us more vulnerable to economic downturns and adverse developments.

Our ability to meet our cash requirements, including our debt service obligations, will be dependent upon our operating performance, which will be subject to general economic and competitive conditions and to financial, business and other factors affecting our operations, many of which are or may be beyond our control. We cannot provide assurance that our business operations will generate sufficient cash flows from operations to fund these cash requirements and debt service obligations. If our operating results, cash flow or capital resources prove inadequate, we could face substantial liquidity problems and might be required to dispose of material assets or operations to meet our debt and other obligations. If we are unable to service our debt, we could be forced to reduce or delay planned expansions and capital expenditures, sell assets, restructure or refinance our debt or seek additional equity capital, and we may be unable to take any of these actions on satisfactory terms or in a timely manner. Further, any of these actions may not be sufficient to allow us to service our debt obligations or may have an adverse impact on our business. Our debt agreements limit our ability to take certain of these actions. Our failure to generate sufficient


operating cash flow to pay our debts or to successfully undertake any of these actions could have a material adverse effect on us.

In addition, the degree to which we are leveraged as a result of the indebtedness incurred in connection with an acquisition or otherwise could materially and adversely affect our ability to obtain additional financing for working capital, capital expenditures, acquisitions, debt service requirements or other purposes, could make us more vulnerable to general adverse economic, regulatory and industry conditions,developments, could limit our flexibility in planning for, or reacting to, changes and opportunities in the markets in which we compete, could place us at a competitive disadvantage compared to our competitors that have less debt or could require us to dedicate a substantial portion of our cash flow to service our debt.

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DespiteOur ability to meet our substantial indebtedness, we may incur morecash requirements, including our debt service obligations, could be dependent upon our operating performance, which would be subject to general economic and competitive conditions and to financial, business and other factors affecting our operations, many of which could exacerbate the risks described above.

be beyond our control. We maycannot provide assurance that our business operations would generate sufficient cash flows from operations to fund potential cash requirements and debt service obligations. If our operating results, cash flow or capital resources prove inadequate, we could face substantial liquidity problems and might be ablerequired to incur substantial additional indebtedness in the future subjectdispose of material assets or operations to the limitations contained in the agreements governingmeet our debt. Although these agreements restrict us from incurring additional indebtedness, these restrictions are subject to important exceptionsdebt and qualifications. For example, we are generally permitted to incur certain indebtedness, including indebtedness arising in the ordinary course of business and indebtedness relating to acquisition activities. See “Management’s Discussion and Analysis of Financial Condition and Results of Operations-Liquidity and Capital Resources”other obligations. If we incurincurred indebtedness and were unable to service our debt, we could be forced to reduce or delay planned expansions and capital expenditures, sell assets, restructure or refinance our debt or seek additional equity capital, and we could be unable to take any of these actions on satisfactory terms or in a timely manner. Further, any of these actions may not be sufficient to allow us to service our potential debt the risks that we and they now face as a resultobligations or could have an adverse impact on our business. Our potential debt agreements could limit our ability to take certain of these actions. Our failure to generate sufficient operating cash flow to pay our higher leverage could intensify.

Our international sales and operations are subjectpotential debts or to risks and uncertainties that vary by country and whichsuccessfully undertake any of these actions could have a material adverse effect on our business and/or results of operations.us.

Sales outside the United States accounted for approximately 19% of our net sales during our fiscal year ended May 31, 2017. We anticipate that sales from international operations will continue to represent a significant portion of our total sales, and we intend to continue our expansion into emerging and/or faster-growing markets outside the United States. Our sales and profitability from our international operations are subject to risks and uncertainties that can vary by country, and include those related to political and economic conditions, foreign currency exchange rate fluctuations, changes in tax laws, regulatory and reimbursement programs and policies, and the protection of intellectual property rights. These risks and uncertainties could have a material adverse effect on our business and/or results of operations.

Foreign currency exchange rate may adversely affect our business, financial condition and results of operations.

We are exposed to a variety of market risks, including the effects of changes in foreign currency exchange rates. Products manufactured in, and sold into, foreign markets represent a significant portion of our operations. When the United States dollar strengthens or weakens in relation to the foreign currencies of the countries in which we sell or manufacture our products, such as the euro, our United States dollar-reported revenue and income will fluctuate. As a result of the June 23, 2016 referendum by British voters to exit the European Union, global markets and foreign currencies have been adversely impacted and the value of the Pound Sterling has sharply declined as compared to the U.S. Dollar and other currencies. This volatility in foreign currencies is expected to continue as the U.K. negotiates and executes its exit from the European Union but it is uncertain over what time period this will occur. The effects of currency rate fluctuations and changes in the relative values of currencies may, in some instances, have a significant effect on our business, financial condition, results of operations and cash flows.

Our goodwill, intangible assets and fixed assets are subject to potential impairment.

impairment; we have recorded significant goodwill impairment charges and may be required to record additional charges to future earnings if our goodwill or intangible assets become impaired.
A significant portion of our assets consists of goodwill, intangible assets and fixed assets, the carrying value of which may be reduced if we determine that those assets are impaired.

impaired, including intangible assets from recent acquisitions. During the fourth quarter of fiscal year 2021, the Company made the decision to abandon the OARtrac product technology and trademark. This resulted in an impairment charge of $14.0 million. The impairment charge is recorded in "Acquisition, restructuring and other items, net", on the Consolidated Statement of Operations (see Note 19).
Most of our intangible and fixed assets have finite useful lives and are amortized or depreciated over their useful lives on either a straight-line basis or over the expected period of benefit or as revenues are earned from the sales of the related products. The underlying assumptions regarding the estimated useful lives of these intangible assets are reviewed annuallyquarterly and more often if an event or circumstance occurs making it likely that the carrying value of the assets may not be recoverable and are adjusted through accelerated amortization if necessary. Whenever events or changes in circumstances indicate that the carrying value of the assets ismay not be recoverable we test intangible assets for impairment based on estimates of future cash flows. Factors that may be considered a change in circumstances indicating that the carrying value of our intangible assets and/or goodwill may not be recoverable include a decline in stock price and market capitalization, slower growth rates in our industry or our own operations and/or other materially adverse events that have implications on the profitability of our business. When testing for impairment of definite-lived intangible assets held for use, the Company groups assets at the lowest level for which cash flows are separately identifiable. The Company operates as a single asset group. If an intangible asset is considered to be impaired, the amount of the impairment will equal the excess of the carrying value over the fair value of the asset.

Goodwill is required to be tested for impairment at least annually. We review our single reporting unit for potential goodwill impairment in the third fiscal quarter of each year as part of our annual goodwill impairment testing, and more often if an event or circumstance occurs making it likely that impairment exists. We conduct impairment testing based on our current business strategy in light of present industry and economic


conditions, as well as future expectations. The annual goodwill impairment review performed in December 20162020 indicated no goodwill impairments.

In fiscal year 2020, we recorded a goodwill impairment loss of $158.6 million. If actual results differ from the assumptions and estimates used in the goodwill and intangible asset calculations, we could incur future impairment or amortization charges, which could negatively impact our financial condition and results of operations.

We may be limited in our ability to utilize, or may not be able to utilize, net operating loss carryforwards to reduce our future tax liability.

IRC Section 382 and related provisions contain rules that limit for U.S. federal income tax purposes the ability of a Company that undergoes an “ownership change” to utilize its net operating loss carryforwards and certain other tax attributes existing as of the date of such ownership change. Our Federal net operating loss carryforwards as of May 31, 20172021 after considering IRC Section 382 limitations are $161.6$134.6 million. The expiration of the Federal net operating loss carryforwards is as follows: $29.8$8.6 million between 20172022 and 2023, and $131.8$79.4 million between 20272028 and 2037.2037 and $46.6 million indefinitely. Our state net operating loss carryforwards as of May 31, 20172021 after considering remaining IRC Section 382 limitations are $32.7$20.0 million which expire in various years from 20172029 to 2037.2041. Future ownership changes within the meaning of IRC Section 382 may also subject our tax loss carryforwards to annual limitations which would restrict our ability to use them to offset our taxable income in periods following the ownership changes.

See Note 910 to our consolidated financial statements included in our Annual Report on Form 10-K for the fiscal year ended May 31, 20172021 for a further discussion of our tax loss carryovers.

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Fluctuations in our effective tax rate and changes to tax laws may adversely affect us.

As an international Company, we are subject to taxation in numerous countries, states and other jurisdictions. Our effective tax rate is derived from a combination of applicable tax rates in the various countries, states and other jurisdictions in which we operate. In preparing our financial statements, we estimate the amount of tax that will become payable in each of these jurisdictions. Our effective tax rate may, however, differ from the estimated amount due to numerous factors, including a change in the mix of our profitability from country to country and changes in tax laws. Any of these factors could cause us to experience an effective tax rate significantly different from previous periods or our current expectations, which could have an adverse effect on our business, financial condition and results of operations and cash flows.

We rely on the proper function, availability and security of information technology systems to operate our business and aA cyber-attack or other breach of theseour information technology systems could have a material adverse effect on our business, financial condition and/or results of operations.

We rely on information technology systems to process, transmit, and store electronic information in our day-to-day operations. Similar to other large multi-national companies, the size and complexity of our information technology systems makes them vulnerable to a cyber-attack,cyber-attacks, malicious intrusion, breakdown, destruction, lossintrusions, breakdowns, destructions, losses of data privacy, or other significant disruption.disruptions. Our information systems require an ongoing commitment of significant resources to maintain, protect, and enhance existing systems and develop new systems to keep pace with continuing changes in information processing technology, evolving systems and regulatory standards, the increasing need to protect patient and customer information, and changing customer patterns. In addition, third parties may attempt to hack into our products to obtain data relating to patients with our products or our proprietary information.
Any failure by us to maintain or protect our information technology systems and data integrity, including from cyber-attacks, ransomware, intrusions or other breaches, could result in the unauthorized access to patient data and personally identifiable information, theft of intellectual property, or other misappropriation of assets, or otherwise compromise our confidential or proprietary information and disrupt our operations. Any of these events, in turn, may cause us to lose existing customers, have difficulty preventing, detecting, and controlling fraud, have disputes with customers, physicians, and other health care professionals, be subject to legal claims and liability, have regulatory sanctions or penalties imposed, have increases in operating expenses, incur expenses or lose revenues as a result of a data privacy breach or theft of intellectual property, or suffer other adverse consequences, any of which could have a material adverse effect on our business, financial condition and/or results of operations.

Any disaster at our manufacturing facilities or those of our suppliers could disrupt our ability to manufacture our products for a substantial amount of time, which could cause our revenues to decrease. This risk is more significant as we consolidate our plants in fiscal year 2018.

time.
We conduct our manufacturing and assembly at facilities in Queensbury, New York and Glens Falls, New York, Manchester, Georgia, and Denmead, England.York. It would be difficult, expensive and time-consuming to transfer resources from one facility to


the other and/or replace or repair these facilities and ouror manufacturing equipment if they were significantly affected by a disaster. Additionally, we might be forced to rely on third-party manufacturers or to delay production of our products. Insurance for damage to our properties and the disruption of our business from disasters may not be sufficient to cover all of our potential losses and may not continue to be available to us on acceptable terms, or at all. In addition, ifIf one of our principal suppliers were to experience a similar disaster, uninsured loss or under-insured loss, we might not be able to obtain adequate alternative sources of supplies or products or could face significant delays and incur substantial expense in doing so.products. Any significant uninsured loss, prolonged or repeated disruption, or inability to operate experienced by us or any of our principal suppliers could cause significant harm to our business, financial condition, and results of operations.

Once the plant consolidation is complete, manufacturing and assembly will only take place in Queensbury, New York and Glens Falls, New York. If we were significantly affected by a disaster, we no longer have an option to transfer manufacturing to another facility so we would be forced to rely on third-party manufacturers operations and/or would have to delay production of our products.

liquidity.
Anti-takeover provisions in our organizational documents and Delaware law may discourage or prevent a change of control, even if an acquisition would be beneficial to our stockholders, which could cause our stock price to decline and prevent attempts by our stockholders to replace or remove our current management.

Our amended and restated certificate of incorporation and our amended and restated bylaws contain provisions that may enable our management to resist a change in control. For example, our Board of Directors is classified so that not all members of our Board of Directors are elected at one time and our Board of Directors is authorized, without prior stockholder approval, to create and issue “blank check” preferred stock with rights senior to those of our common stock and stockholder action by written consent is prohibited. We are also subject to the provisions of Section 203 of the Delaware General Corporation Law, which may prohibit certain business combinations with stockholders owning 15% or more of our outstanding voting stock. These provisions may discourage, delay or prevent a change in the ownership of our Company or a change in our management. In addition, these provisions could limit the price that investors would be willing to pay in the future for shares of our common stock. Such provisions include:

our board of directors is authorized, without prior stockholder approval, to create and issue “blank check” preferred stock, with rights senior to those of our common stock;
our board of directors is classified so that not all members of our board of directors are elected at one time, which may make it more difficult for a person who acquires control of a majority of our outstanding voting stock to replace our directors;
advance notice requirements for stockholders to nominate individuals to serve on our board of directors or for stockholders to submit proposals that can be acted upon at stockholder meetings;
stockholder action by written consent is prohibited; and
stockholders are not permitted to cumulatively vote for the election of directors.

We are also subject to the provisions of Section 203 of the Delaware General Corporation Law, which may prohibit certain business combinations with stockholders owning 15% or more of our outstanding voting stock.

These and other provisions in our amended and restated certificate of incorporation, amended and restated bylaws and Delaware law could make it more difficult for stockholders or potential acquirers to obtain control of our board of directors or initiate actions that are opposed by our then-current board of directors, including delaying or impeding a merger, tender offer or proxy contest involving our Company. Any delay or prevention of a change of control transaction or changes in our boardBoard of directorsDirectors could cause the market price of our common stock to decline.

The COVID-19 pandemic has negatively impacted our business and operations around the world and may continue to materially and adversely impact our business, operations and financial results.
The COVID-19 pandemic has created significant disruption and uncertainty in the global economy, has negatively impacted our business, results of operations and financial condition, and we anticipate that it may continue to negatively impact our business, results of operations and financial condition for the foreseeable future.
Numerous national, international, state and local jurisdictions have imposed, and others in the future may impose, a variety of government orders and restrictions for their residents to control the spread of COVID-19. Such orders or restrictions may cause significant alteration of our operations, work stoppages, slowdowns and delays, travel restrictions and event cancellations, among other effects, thereby significantly and negatively impacting our operations. Other disruptions or potential
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disruptions include (i) restrictions on our personnel and personnel of business partners to travel and access customers for training and case support; (ii) reductions in spending by our customers; (iii) delays in approvals by regulatory bodies; (iv) diversion of or limitations on employee resources that would otherwise be focused on the operations of our business, including because of sickness of employees or their families or the desire of employees to avoid contact with large groups of people; (v) reductions in our sales team, including through layoffs, furloughs or other losses of sales representatives; (vi) additional government requirements or other incremental mitigation efforts that may further impact our or our suppliers’ capacity to manufacture our products; (vii) disruption of our research and development activities; and (viii) delays in ongoing studies and pre-clinical trials.
In addition, elective procedures that use our products significantly decreased in number during fiscal year 2021, as health care organizations around the world prioritized the treatment of patients with COVID-19 and reduced spending in other areas. For example, in the United States, governmental authorities have recommended, and in certain cases required, that elective, deferrable, specialty and other procedures and appointments, be suspended or canceled to avoid non-essential patient exposure to medical environments and potential infection with COVID-19 and to focus limited resources and personnel capacity toward the treatment of COVID-19 patients. Many of these procedures that use our products have been suspended or postponed. While certain of these procedures have resumed in certain locations, it is unclear when or if all procedures in all locations will resume. Similarly, our clinical trials may be materially impacted by the coronavirus as hospitals prioritize treating coronavirus patients.
In addition, most of the hospitals and clinics that purchase our products have instituted strict procedures at their facilities in an effort to prevent the spread of COVID-19, including restrictions on sales representatives entering these facilities. This has been, and currently remains, a major impediment to our sales efforts, as supporting existing customers and acquiring new customers is much more difficult in this environment. These restrictions have had an effect on our sales and, until they are lifted, our business, operations and financial results will continue to be adversely impacted.
These challenges and restrictions will likely continue for the duration of the pandemic, which is uncertain, and may even continue beyond the pandemic. Many areas are relaxing restrictions and resuming business operations, but a resurgence in infections or mutations of the coronavirus that causes COVID-19 could cause authorities to reinstate such restrictions or impose additional restrictions. All of these factors also may cause or contribute to disruptions and delays in our logistics and supply chain. The extent to which the COVID-19 pandemic impacts our business, operations and financial results will depend on future developments that are uncertain and cannot be predicted, including new information that may emerge concerning the severity and spread of the virus and the actions by government entities, our customers and other parties to contain the virus or treat its impact, among others. To the extent the COVID-19 pandemic adversely affects our business, operations and financial results, it may also have the effect of heightening other risks described herein, such as those relating to general economic conditions, demand for our products, relationships with suppliers and sales efforts.
RISKS RELATED TO THE REGULATORY ENVIRONMENT

Reforms to the United States healthcare system may adversely affect our business.

A significant portion of our patient volume is derived from U.S. government healthcare programs, principally Medicare, which are highly regulated and subject to frequent and substantial changes. For example, in March 2010, the President signed one of the most significant healthcare reform measures in decades, the Healthcare Reform Act. The Healthcare Reform Act contains a number of provisions that affect coverage and reimbursement of drug products and medical imaging procedures in which our drug products are used. See “Business-Regulatory Matters-Healthcare Reform Act and Related Laws.” We cannot assure you that the Healthcare Reform Act, as currently enacted or as amended in the future, will not adversely affect our business and financial results, and we cannot predict how future federal or state legislative, judicial or administrative changes relating to healthcare reform will affect our business.

In addition, other legislative changes have been proposed and adopted since the Healthcare Reform Act was enacted. The Budget Control Act of 2011 includes provisions to reduce the federal deficit. The Budget Control Act, as amended, resulted in the imposition of 2% reductions in Medicare payments to providers, which went into effect on April 1, 2013 and will remain in effect through 2024 unless additional Congressional action is taken. Any significant spending reductions affecting Medicare,


Medicaid or other publicly funded or subsidized health programs that may be implemented and/or any significant taxes or fees that may be imposed on us, as part of any broader deficit reduction effort or legislative replacement to the Budget Control Act, could have an adverse impact on our results of operations.

In addition, federal spending is also subject to a statutory debt ceiling. If the federal debt reaches the statutory debt ceiling, Congress must enact legislation to suspend enforcement of, or increase, the statutory debt ceiling. If Congress fails to do so before the ceiling is reached and, as a result, is unable to satisfy its financial obligations, including under Medicare, Medicaid and other publicly funded or subsidized health programs, our results of operations could be adversely impacted.

The full impact on our business of the Healthcare Reform Act and the other new laws is uncertain. Nor is it clear whether other legislative changes will be adopted or how those changes would affect our industry generally or our ability to successfully commercialize our products or the development of new products.

Under the statutory Medicare sustainable growth rate formula, payments under the Medicare Physician Fee Schedule could have decreased significantly over the past several years without congressional intervention. In the past, when the application of the statutory formula would have resulted in lower payments, Congress has passed interim legislation to prevent the reductions. In 2014, Congress again prevented the negative update factor from going into effect until March 31, 2015. If Congress fails to intervene to prevent the negative update factor in the future through either another temporary measure or a permanent revision to the statutory formula, payments to physicians may be reduced.

Our industry is experiencing greater scrutiny and regulation by governmental authorities, which has led to certain costs and business distractions as we respond to inquiries and comply with new regulations, and may lead to greater governmental regulation in the future.

Our medical devices and our business activities are subject to rigorous regulation by the FDA and numerous other federal, state and foreign governmental authorities. These authorities and members of Congress have been increasing their scrutiny of our industry. In addition, certain states, including Massachusetts, have recently passed or are considering legislation restricting our interactions with health care providers and requiring disclosure of many payments to them. The federal government has recently introduced similar legislation, which may or may not preempt state laws. Recent Supreme Court case law has clarified that the FDA’s authority over medical devices preempts state tort laws, but legislation has been introduced at the federal level to allow state intervention, which could lead to increased and inconsistent regulation at the state level. We anticipate that the government will continue to scrutinize our industry closely, and that additional regulation by governmental authorities may increase compliance costs, exposure to litigation and other adverse effects to our operations.

We are subject to a comprehensive system of federal, state and international laws and regulations, and we could be the subject of investigations, enforcement actions or face lawsuits and monetary or equitable judgments.

We operate in many parts of the world, and our operations are affected by complex state, federal and international laws relating to healthcare, environmental protection, antitrust, anti-corruption, anti-bribery, fraud and abuse, export control, tax, employment and laws regarding privacy, personally identifiable information and protected health information, including, for example, the Food, Drug and Cosmetic Act (“FDCA”), various FDA and international regulations relating to, among other things, the development, quality assurance, manufacturing, importation, distribution, marketing and sale of, and billing for, our products, the federal Anti-Kickback Statute and Federal False Claims Act (Note 17), the U.S. Foreign Corrupt Practices Act (“FCPA”), and similar anti-bribery laws in international jurisdictions, including the UK BriberyAnti-Bribery Act, of 2010, the federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), General Data Protection Regulation (“GDPR”), domestic and other foreign data protection, data security and privacy laws, laws related to the collection, storage, use and disclosure of personal data and laws and regulations relating to sanctions and money laundering. We are subject to periodic inspections to determine compliance with the FDA’s Quality System Regulation requirements, current medical device adverse event reporting regulations, and similar foreign rules and regulations. Despite our training and compliance programs, our internal control policies and procedures may not always protect us from negligent, reckless or criminal acts committed by our employees or agents. The failure to comply with these laws and regulatory standards, allegations of such non-compliance or the discovery of previously unknown problems with a product or manufacturer: (i) could result in FDA Form-483 notices and/or warning letters or the foreign equivalent, fines, delays or suspensions of regulatory clearances, investigations, detainment, seizures or recalls of products (with the attendant expenses), the banning of a particular device, an order to replace or refund the cost of any device previously manufactured or distributed, operating restrictions and/or civil or criminal prosecution, and/or penalties, as well as decreased sales as a result of negative publicity and product liability claims; and (ii) could expose us to breach of contract claims, fines and penalties, costs for remediation and harm to our reputation; (iii) could result in criminal or civil sanctions, including substantial fines, imprisonment and exclusion from participation in healthcare programs such as Medicare and Medicaid and health programs outside the United States; and (iv) could otherwise disrupt our business and could have a material adverse effect on our business, financial condition, results of operations financial condition and/or liquidity.

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Most of our products must receive clearance or approval from the FDA or comparable regulatory agencies abroad before they can be marketed or sold. State, federal and foreign registration regulations are both evolving and subject to varied levels of



interpretation and enforcement. It can be costly and time-consuming to obtain and maintain regulatory approvals to market a medical device. Approvals might not be granted on a timely basis, if at all, for new devices, new indications for use or certain modifications or enhancements to previously approved products. Even after a device receives regulatory approval it remains subject to significant regulatory and quality requirements, such as manufacturing, recordkeeping, renewal, recertification or reporting and other post market approval requirements, which may include clinical, laboratory or other studies. Product approvals by the FDA and other foreign regulators can be withdrawn due to failure to comply with regulatory standards or the occurrence of unforeseen problems following initial approval or may be re-classified to a higher regulatory classification, such as requiring a Pre-Market Approval (“PMA”) for a previously cleared 510(k) device. Regulations are also subject to change as a result of legislative, administrative or judicial action, which may further increase our costs or reduce sales. Our failure to maintain approvals, obtain approval for new products or comply with other applicable regulatory requirements could adversely affect our business, results of operations, financial condition and/or liquidity.

The healthcare industry is under continued scrutiny from state, federal and international governments, including with respect to industry practices in the area of sales and marketing,marketing. Certain states, including provisionsMassachusetts, have recently passed or are considering legislation restricting our interactions with health care providers and requiring disclosure of the Physician Payment Sunshine Act.many payments to them. The federal government has recently introduced similar legislation, which may or may not preempt state laws. If our marketing, sales or other activities fail to comply with the FDA’s or other comparable foreign regulatory agencies’ regulations or guidelines, or other applicable laws, we may be subject to warnings from the FDA or investigations or enforcement actions from the FDA, Medicare, the Office of Inspector General of the U.S. Department of Health and Human Services or other government agencies or enforcement bodies. Additionally, inWe anticipate that the European Union, a new draft Medical Device Regulation was published in 2016 imposing stricter requirements for the marketinggovernment will continue to scrutinize our industry closely, and sale of medical devicesthat additional regulation by governmental authorities may increase compliance costs, increase exposure to litigation and grants Notified Bodies increased post-market surveillance authority. The Company is monitoring the implementation of the regulation and has undertaken initial actionsmay have other adverse effects to move toward compliance based on the published draft of the regulation.our operations. The Company’s failure to comply with any marketing or sales regulations or any other applicable regulatory requirements could adversely affect our business, results of operations, financial condition and/or liquidity.

In the recent past, medical device manufacturers have been the subject of investigations from government agencies related to their relationships with doctors, product sales and marketing and off-label promotion of products, among other activities or practices. If an enforcement action involving the Company were to occur, it could result in penalties, fines, detainment, seizures, recalls, product bans, operating restrictions (which may include loss of a license or authorization), the exclusion of our products from reimbursement under government-funded programs and/or prohibitions on our ability to sell our products, and could have a material adverse effect on our business, results of operations, financial condition and/or liquidity. In addition, remediation of any issues identified by the FDA or other regulators could require facility upgrades, process changes, additional labeling requirements or other measures, any of which could have a material adverse effect on our business and/or results of operations. See Item 3. “Legal Proceedings” below for a description of the subpoenas and Civil Investigation Demands from a number of State Attorneys General and investigative subpoena from the Department of Defense, in each case, seeking information related to certain of the Company’s products.

In addition, lawsuits by or otherwise involving employees, customers, licensors, licensees, suppliers, vendors, business partners, distributors, shareholders or competitors with respect to how we conduct our business could be very costly and could substantially disrupt our business. Disputes from time-to-time with companies or individuals are not uncommon, and we cannot assure you that we will be able to resolve these disputes on terms favorable to us. See Item 3. “Legal Proceedings” below for a description of lawsuits against the Company. The occurrence of an adverse monetary or equitable judgment or a large expenditure in connection with a settlement of any of these matters could have a material adverse effect on our business, financial condition, results of operations financial condition and/or liquidity.

We are subject to healthcare fraud and abuse regulations that could result in significant liability, require us to change our business practices and restrict our operations in the future.

We are subject to various federal, state and local laws targeting fraud and abuse in the healthcare industry, including anti-kickback and false claims laws. Violations of these laws are punishable by criminal or civil sanctions, including substantial fines, imprisonment and exclusion from participation in healthcare programs such as Medicare and Medicaid and health programs outside the United States. These laws and regulations are wide ranging and subject to changing interpretation and application, which could restrict our sales or marketing practices. Furthermore, since many of our customers rely on reimbursement from Medicare, Medicaid and other governmental programs to cover a substantial portion of their expenditures, our exclusion from such programs as a result of a violation of these laws could have a material adverse effect on our business, results of operations, financial condition and cash flow.






If we or some of our suppliers fail to comply with the FDA’s Quality System Regulation, or QSR, and other applicable postmarketpost-market requirements, our manufacturing operations could be disrupted, our product sales and profitability could suffer, and we may be subject to a wide variety of FDA enforcement actions.

After a device is placed on the market, numerous regulatory requirements apply. We are subject to inspection and marketing surveillance by the FDA to determine our compliance with all regulatory requirements. Our failure to comply with applicable regulatory requirements could result in the FDA or a court instituting a wide variety of enforcement actions against us, including a public "Warning Letter"; an order to shut down some or all manufacturing operations; a recall of products; fines or civil penalties; seizure or detention of our products; refusing our requests for 510(k) clearance or a PMA of new or modified products; withdrawing 510(k) clearance or PMA approvals already granted to us; and criminal prosecution.

Our manufacturing processes and those of some of our suppliers must comply with the FDA’s Quality System Regulation, or QSR, which governs the methods used in, and the facilities and controls used for, the design, testing, manufacture, control, quality assurance, installation, servicing, labeling, packaging, storage and shipping of medical devices.devices, and with current medical device adverse event reporting regulations, and similar foreign rules and regulations. The FDA enforces the QSR through unannounced inspections. Despite our training and compliance programs, our internal control policies and procedures may not always protect us from negligent, reckless or criminal acts committed by our employees or agents. If we, or one of our suppliers, fail a QSR inspection, or if a corrective action plan adopted by us or one of our suppliers is not sufficient, the FDA may bring an enforcement action, and our operations could be disrupted and our manufacturing delayed. We are also subject to the FDA’s general prohibition against promoting our products for unapproved or “off-label” uses, the FDA’s adverse event reporting requirements and the FDA’s reporting requirements for field correction or product removals. The FDA has recently placed increased emphasis on its scrutiny of compliance with the QSR and these other postmarketpost-market requirements.

If we, or one of our suppliers, violate the FDA’s requirements or fail to take adequate corrective action in response to any significant compliance issue raised by the FDA, the FDA can take various enforcement actions which could cause our product sales and profitability to suffer.

In addition, most other countries require us and our suppliers to comply with manufacturing and quality assurance standards for medical devices that are similar to those in force in the United States before marketing and selling our products in those countries. If we, or our suppliers, should fail to do so, we would lose our ability to market and sell our products in those countries.

If we cannot obtain and maintain marketing clearance or approval from governmental agencies, we will not be able to sell our products.

Our products are medical devices that are subject to extensive regulation in the United States and in the foreign countries in which they are sold. Unless an exemption applies, each medical device that we wish to market in the United States must receive either 510(k) clearance or premarket approval (PMA)Pre-Market Approval (“PMA”) from the FDA before the product can be sold. Either process can be lengthy and expensive. The FDA’s 510(k) clearance procedure, also known as “premarket notification,” is the process we have used for our current products. This process usually takes from four to twelve months from the date the premarket notification is submitted to the FDA, but may take significantly longer. Although we have obtained 510(k) clearances for our current products, our clearancesEven after a device receives regulatory approval it remains subject to significant regulatory and quality requirements, such as manufacturing, recordkeeping, renewal, recertification or reporting and other post market approval requirements, which may be revokedinclude clinical, laboratory or other studies.
Product approvals by the FDA if safetyand other foreign regulators can be withdrawn due to failure to comply with regulatory standards or effectivenessthe occurrence of unforeseen problems develop with the devices.following initial approval or may be re-classified to a higher regulatory classification, such as requiring a PMA for a previously cleared 510(k) device. The PMA process is much more costly, lengthy and uncertain. It generally takes from one to three years from the date the application is submitted to, and filed with the FDA, and may take even longer. In addition, any modification to an FDA-cleared medical device that could significantly affect its safety or effectiveness, or that would constitute a major change or modification in its intended use, requires a new FDA 510(k) clearance or, possibly, a PMA.
Regulatory regimes in other countries similarly require approval or clearance prior to our marketing or selling products in those countries. We rely on our distributors to obtain regulatory clearances or approvals of our products outside of the United
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States. If we are unable to obtain additional clearances or approvals needed to market existing or new products in the United States or elsewhere or obtain these clearances or approvals in a timely fashion or at all, or if our existing clearances are revoked, our revenues and profitability may decline.

Modifications to our current products may require new marketing clearances or approvals or require us to cease marketing or recall the modified products until such clearances or approvals are obtained.

Any modification to an FDA-cleared medical device that could significantly affect its safety or effectiveness, or that would constitute a major change or modification in its intended use, requires a new FDA 510(k) clearance or, possibly, a premarket approval. The FDA requires every manufacturer to make its own determination as to whether a modification requires a new 510(k) clearance or premarket approval, but the FDA may review and disagree with any decision reached by the manufacturer. We have modified aspects of some of our devices since receiving regulatory clearance. We believed that some of these modifications did not require new 510(k) clearance or premarket approval and, therefore, we did not seek new 510(k) clearances or premarket approvals. In the future, we may make additional modifications to our products after they have received FDA clearance or approval and, in appropriate circumstances, determine that new clearance or approval is unnecessary. Regulations in other countries in which we market or sell, or propose to market or sell, our products may also


require that we make judgments about changes to our products and whether or not those changes are such that regulatory approval or clearance should be obtained. In the United States and elsewhere, regulatory authorities may disagree with our past or future decisions not to seek new clearance or approval and may require us to obtain clearance or approval for modifications to our products. If that were to occur for a previously cleared or approved product, we may be required to cease marketing or recall the modified device until we obtain the necessary clearance or approval. Under these circumstances, we may also be subject to significant regulatory fines or other penalties. If any of the foregoing were to occur, our financial condition and results of operations could be negatively impacted.

Even after receiving regulatory clearance or approval, ourOur products may be subject to product recalls, which may harm our reputation and divert managerial and financial resources.

The FDA and similar governmental authorities in other countries have the authority to order mandatory recall of our products or order their removal from the market if there are material deficiencies or defects in design, manufacture, installation, servicing or labeling of the device, or if the governmental entity finds that our products would cause serious adverse health consequences. A government mandated voluntary recall or field action by us could occur as a result of component failures, manufacturing errors or design defects, including labeling defects. Any recall of our products may harm our reputation with customers and divert managerial, engineering and financial resources.

There is no assurance that we will not incur warranty or repair costs, be subject to liability claims for damages related to product defects, or experience manufacturing, shipping or other delays or interruptions as a result of these defects in the future. Our insurance policies may not provide sufficient protection should a claim be asserted. A recall of any of our products could harm our reputation, divert managerial and financial resources and have a material adverse effect on our business, financial condition, results of operations and/or liquidity.
We may be subject to fines, penalties, injunctions or costly investigations if we are determined to be promoting the use of our products for unapproved or “off-label” uses.

If we are incorrect in our belief that our promotional materials and training methods regarding physicians are conducted in compliance with regulations of the FDA and other applicable regulations, and the FDA determines that our promotional materials or training constitutes promotion of an unapproved use, the FDA could request that we modify our training or promotional materials or subject us to regulatory enforcement actions, including the issuance of a warning letter, injunction, seizure, civil fine and criminal penalties. It is also possible that other federal, state or foreign enforcement authorities might take action if they consider promotional or training materials to constitute promotion of an unapproved use, which could result in significant fines or penalties under other statutory authorities, such as laws prohibiting false claims for reimbursement. Any of these results could have a material adverse effect on our business, financial position orcondition, results of operations.operations and/or liquidity.

In June 2014 we received a subpoena from the U.S. Department of Justice (the “DOJ”) requesting documents in relation to a criminal and civil investigation the DOJ is conducting regarding BTG International, Inc.’s LC Bead product beginning in 2003. RITA Medical Systems and AngioDynamics, Inc., after our acquisition of RITA, was the exclusive distributor of LC Beads in the United States from 2006 through December 31, 2011. We are cooperating fully with this investigation and at this time are unable to predict its scope, duration or outcome. In April 2015 we received a subpoena from the DOJ requesting documents in relation to a criminal and civil investigation the DOJ is conducting regarding purported promotion of certain of our VenaCure EVLT products for un-cleared indications. As of May 31, 2017 the Company accrued $12.5 million for these matters and in August 2017, the Company agreed in principle with the government to resolve these matters for approximately $12.5 million.
If our employees or agents violate the U.S. Foreign Corrupt Practices Act or anti-bribery laws in other jurisdictions, we may incur fines or penalties, or experience other adverse consequences.

We are subject to the U.S. Foreign Corrupt Practices Act, or FCPA, and similar anti-bribery laws in international jurisdictions, including the UK Anti-Bribery Act, which generally prohibit companies and their intermediaries from making improper payments to non-U.S. officials for the purpose of obtaining or retaining business. Because of the predominance of government-sponsored healthcare systems around the world, many of our customer relationships outside of the United States are with governmental entities and are therefore subject to such anti-bribery laws. Our sales to customers and distributors outside of the United States have been increasing and we expect them to continue to increase in the future. If our employees or agents violate the provisions of the FCPA or other anti-bribery laws, we may incur fines or penalties, we may be unable to market our products in other countries or we may experience other adverse consequences which could have a material adverse effect on our operating results or financial condition.

Laws and regulations governing the export of our products could adversely impact our business.

If the U.S. government imposes strict sanctions on Iran, our revenue could be impacted.
The U.S. Department of the Treasury’s Office of Foreign Assets Control (OFAC), and the Bureau of Industry and Security at the U.S. Department of Commerce (BIS), administer certain laws and regulations that restrict U.S. persons and, in some instances, non-U.S. persons, in conducting activities, transacting business with or making investments in certain countries, governments, entities and individuals subject to U.S. economic sanctions. Due to our international operations, we are subject to


such laws and regulations, which are complex, restrict our business dealings with certain countries and individuals, and are constantly changing. Further restrictions may be enacted, amended, enforced or interpreted in a manner that materially impacts our operations.

In fiscal year 2021 we generated $1.5 million of revenue for sales to distributors doing business in Iran. We continuously review our ability to sell products to distributors that conduct business in Iran in accordance with all applicable U.S. laws. If laws, rules or regulations of the United States with respect to doing business in, or with parties that do business in, Iran change to restrict our ability to generate revenue in Iran, our revenue could decline, impacting our results of operations.
From time to time, certain of our subsidiarieswe have limited business dealings in countries subject to comprehensive sanctions, including Iran, Sudan, Syria, Cuba and those in the region of Crimea. Certain of our subsidiaries sell medical devices and surgical tools, and may provide related services, to distributors and other purchasing bodies in such countries.sanctions. These business dealings represent an insignificant amount of our consolidated revenues and income, butmay expose us to a heightened risk of violating applicable sanctions regulations. Violations of these regulations are punishable by civil penalties, including fines, denial of export privileges, injunctions, asset seizures, debarment from government contracts, and revocations or restrictions of licenses, as well asand/or criminal fines and imprisonment. We have established policies and procedures designed to assist with our compliance with such laws and regulations. However, there can be no assurance that our policies and procedures will effectively prevent us from violating these regulations in every transaction in which we may engage, and such a violation could adversely affect our reputation, business, financial condition, results of operations and cash flows.

26

Changes in reimbursement levels by governmental or other third-party payors for procedures using our products may cause our revenues to decline.


Our products are purchased principally by hospitals or physicians which typically bill various third-party payors, such as governmental programs (e.g. Medicare, Medicaid and comparable foreign programs), private insurance plans and managed care plans, for the healthcare services provided to their patients. The ability of our customers to obtain appropriate reimbursement for products and services from third-party payors is critical to the success of medical device companies because it affects which products customers purchase and the prices they are willing to pay. Reimbursement varies by country and can significantly impact the acceptance of new technology. Implementation of healthcare reforms in the United States and in other countries may limit, reduce or eliminate reimbursement for our products and adversely affect both our pricing flexibility and the demand for our products. Even when we develop a promising new product, we may find limited demand for the product unless reimbursement approval is obtained from private and governmental third party payors.

Third-party payors have adopted, and are continuing to adopt, a number of healthcare policies intended to curb rising healthcare costs. These policies include:

controls on government-funded reimbursement for healthcare services and price controls on medical products and services providers;
challenges to the pricing of medical procedures or limits or prohibitions on reimbursement for specific devices and therapies through other means; and
the introduction of managed care systems in which healthcare providers contract to provide comprehensive healthcare for a fixed cost per person.

We are unable to predict whether federal, state or local healthcare reform legislation or regulation affecting our business may be proposed or enacted in the future, or what effect any such legislation or regulation would have on our business. Changes in healthcare systems in the United States or elsewhere in a manner that significantly reduces reimbursement for procedures using our medical devices or denies coverage for these procedures, or adverse decisions relating to our products by administrators of these systems in coverage or reimbursement issues, would have an adverse impact on the acceptance of our products and the prices which our customers are willing to pay for them.

RISKS RELATED TO INTELLECTUAL PROPERTY

If we fail to adequately protect our intellectual property rights, we may not be able to generate revenues from new or existing products and our business may suffer.

Our success depends in part on obtaining, maintaining and enforcing our patents, trademarks and other proprietary rights, and our ability to avoid infringing the proprietary rights of others. We take precautionary steps to protect our technological advantages and intellectual property. We rely upon patent, trade secret, copyright, know-how and trademark laws, as well as license agreements and contractual provisions, to establish our intellectual property rights and protect our products. However, no assurances can be made that any pending or future patent applications will result in the issuance of patents, that any current or future patents issued to, or licensed by, us will not be challenged or circumvented by our competitors, or that our patents will not be found invalid.



Patent positions of medical device companies, including our Company, are uncertain and involve complex and evolving legal and factual questions. The coverage sought in a patent application can be denied or significantly reduced either before or after the patent is issued. Consequently, there can be no assurance that any of our pending patent applications will result in an issued patent. There is also no assurance that any existing or future patent will provide significant protection or commercial advantage, or whether any existing or future patent will be circumvented by a more basic patent, thus requiring us to obtain a license to produce and sell the product. Generally, patent applications can be maintained in secrecy for at least 18 months after their earliest priority date. In addition, publication of discoveries in the scientific or patent literature often lags behind actual discoveries. Therefore, we cannot be certain that we were the first to invent the subject matter covered by each of our pending U.S. patent applications or that we were the first to file non-U.S. patent applications for such subject matter.

Additionally, we rely on trade secret protection for certain unpatented aspects of our proprietary technology. There can be no assurance that others will not independently develop or otherwise acquire substantially equivalent proprietary information or techniques, that others will not gain access to our proprietary technology or disclose such technology, or that we can meaningfully protect our trade secrets. We have a policy of requiring key employees and consultants to execute confidentiality agreements upon the commencement of an employment or consulting relationship with us. Our confidentiality agreements also require our employees to assign to us all rights to any inventions made or conceived during their employment with us. We also generally require our consultants to assign to us any inventions made during the course of their engagement by us. There can be no assurance, however, that these agreements will provide meaningful protection or adequate remedies for us in the event of unauthorized use, transfer or disclosure of confidential information or inventions.

If we are not able to adequately protect our intellectual property, our market share, financial condition and results of operations may suffer.

If third parties claim that our products infringe their intellectual property rights, we may be forced to expend significant financial resources and management time defending against such actions and our financial condition and our results of operations could suffer.

Third parties may claim that our products infringe their patents and other intellectual property rights. Identifying third-party patent rights can be particularly difficult because, in general, patent applications can be maintained in secrecy for at least 18 months after their earliest priority date.date, and publication of discoveries in the scientific or patent literature often lag behind actual discoveries. Some companies in the medical device industry have used intellectual property infringement litigation to gain a competitive advantage. If a competitor were to challenge our patents, licenses or other intellectual property rights, or assert that our products infringe its patent or other intellectual property rights, we could incur substantial litigation costs, be forced to make expensive changes to our product design, pay royalties or other fees to license rights in order to continue manufacturing and selling our products, or pay substantial damages. Third-party infringement claims, regardless of their outcome, would not only consume our financial resources but also divert our management’s time and effort. Such claims could also cause our customers or potential customers to purchase competitors’ products or defer or limit their purchase or use of our affected products until resolution of the claim.

See Part I, Item 3 "Legal Proceedings" of this report for additional details on litigation regarding proprietary technology.
RISKS RELATED TO OUR STOCK PRICE

Our future operating results are difficult to predict and may vary significantly from quarter to quarter, which may adversely affect the price of our common stock.

The ongoing introduction of new products and services that affect our overall product mix make the prediction of future operating results difficult. You should not rely on our past results as any indication of future operating results. The price of our common stock will likely fall in the event that our operating results do not meet the expectations of analysts and investors. Comparisons of our quarterly operating results are an unreliable indication of our future performance because they are likely to vary significantly based on many factors, including:

the level of sales of our products and services in our markets;
our ability to introduce new products or services and enhancements in a timely manner;
the demand for and acceptance of our products and services;
27


the success of our competition and the introduction of alternative products or services;
our ability to command favorable pricing for our products and services;
the growth of the market for our devices and services;
the expansion and rate of success of our direct sales force in the United States and internationally and our independent distributors internationally;
actions relating to ongoing FDA compliance;
our ability to integrate acquired assets or companies;
the effect of intellectual property disputes;


the size and timing of orders from independent distributors or customers;
the attraction and retention of key personnel, particularly in sales and marketing, regulatory, manufacturing and research and development;
unanticipated delays or an inability to control costs;
general economic conditions as well as those specific to our customers and markets; and
���seasonal fluctuations in revenue due to the elective nature of some procedures.

Our stock price may be volatile, which may cause the value of our stock to decline or subject us to a securities class action litigation.

The trading price of our common stock price may be volatile and could be subject to wide fluctuations in price in response to various factors, many of which are beyond our control, including:

general economic, industry and market conditions;
actionsattributable to outside factors and/or unrelated to operating performance. Such factors may include comments by institutionalsecurities analysts or other large stockholders;
the depththird parties, including blogs, articles, message boards and liquidity of the market for our common stock;
volumesocial and timing of orders for our products;
developments generally affecting medical device companies;
the announcement of new products or product enhancements by us or our competitors;
changes in earnings estimates or recommendations by securities analysts;
investor perceptions ofother media coverage which may not be attributable to us and our business, including changes in market valuations of medical device companies; andmay not be reliable or accurate.
our results of operations and financial performance.

In addition, the stock market in general, and theThe NASDAQ Stock Market and the market for medical devices companies in particular have experienced substantial price and volume volatility that is often seemingly unrelated to the operating performance of particularthe companies. These broad market fluctuations may cause the trading price of our common stock to decline. In the past, securities class action litigation has often been brought against a company after a period of volatility in the market price of its common stock. We may become involved in this type of litigation in the future. Any securities litigation claims brought against us could result in substantial expense and the diversion of management’s attention from our business.

We may not attain the guidance set forth in the three-year plan that was presented to our investors in April 2017 which could have an adverse impact on our stock price.

In April 2017, guidance targets for revenue, adjusted earnings per share, adjusted EBITDAS, free cash flow, adjusted gross margin and leverage for the next three years were presented to our investors. If we do not achieve this guidance this could have an adverse effect on our stock price as investors could begin to lose confidence in the performance of the Company and its ability to forecast and execute.


28



Item 1B.Unresolved Staff Comments.
Item 1B. Unresolved Staff Comments.
None.



Item 2.Properties.

Item 2. Properties.
During the year ended May 31, 2017,2021, we operated in the following locations:

LocationPurposePurpose
Approx.

Sq. Ft.
Property

Type
Latham, NYCorporate headquarters55,00039,000 
Leased
Glens Falls, NYManufacturingManufacturing41,000 189,000
Owned
Queensbury, NYManufacturing and distribution129,000194,000 
Owned
Manchester, GA*
Marlborough, MA
Research and developmentManufacturing and distribution31,000 60,000
Leased
Marlborough, MAAmsterdam, NLSelling, marketing and administrativeResearch & Development8,100 31,000
Leased
Denmead, U.K.*
Rehovot, IL
Research and developmentManufacturing4,300 7,500
Leased
Amsterdam, NLSelling, Marketing & Administrative10,100
Leased

In addition, we lease sales offices in various other jurisdictions.

*These two locations will be closed as part of the Operational Consolidation strategy during fiscal year 2018.


Item 3.Legal Proceedings.
Item 3. Legal Proceedings.

Information regarding legal proceedings is included in Note 17 to our consolidated financial statements in this Annual Report on Form 10-K.
C.R. Bard, Inc. v. AngioDynamics, Inc.

On January 11, 2012, C.R. Bard, Inc. (“Bard”) filed a suit in the United States District Court of Utah claiming certain of our implantable port products infringe on three U.S. patents held by Bard (the "Utah Action"). Bard is seeking unspecified damages and other relief. The Court denied Bard’s motion for pre-trial consolidation with separate actions it filed on the same day against Medical Components, Inc. and Smiths Medical ASD, Inc., but had asked for supplemental briefing on the issue of whether to conduct a common Markman hearing. Meanwhile, we filed petitions for reexamination in the US Patent and Trademark Office ("PTO") which seek to invalidate all three patents asserted by Bard in the litigation. Our petitions were granted and 40 of Bard's 41 patent claims were rejected and, following further proceedings, the Patent Office issued a Final Rejection of all 40 claims subject to reexamination. Thereafter, Bard filed appeals to the PTO Board of Appeals and Interferences for all three reexams. The parties completed briefing on the appeals and oral argument was held on June 18, 2015. The Patent Office issued decisions in the three appeals. In one (issued on March 11, 2016 for US Patent No. 7,785,302), the rejections of six of the ten claims under reexamination were affirmed, but were reversed on four of the ten claims. In the second (issued on March 24, 2016 for U.S. Patent No. 7,959,615), the rejections of eight of the ten claims under reexamination were affirmed but the rejections of the other two of the ten claims were reversed. In the third (issued on March 29 for U.S. Patent No. 7,947.022) the rejections of all twenty claims under reexamination were affirmed. Bard then filed Requests for Rehearing in all three reexamination appeals and the Company filed Requests for Rehearing in two of the reexamination appeals (the ‘302 and ‘615 patent reexaminations). Each party filed comments in Opposition to the other party’s Rehearing Requests,. The PTO has since issued decisions denying all Rehearing Requests - - on February 1, 2017 for the ‘302; on February 17, 2017 for the ‘022; and on February 21, 2017 for the ‘615. In the ‘302 and ‘022, the PTO modified its characterization of one prior art reference. Bard has since filed a Notice of Appeal to the Federal Circuit Court of Appeals in all three reexams and we filed Cross-Appeals in the ‘302 and the ‘615 reexams. The parties are in the process of preparing and filing the various appellate briefs, starting with Bard’s Opening Brief which is currently due on July 31, 2017 and ending with our Reply Brief which is currently due on November 6, 2017.The Utah Action has been stayed pending final resolution of the PTO process. We believe these claims are without merit and intend to defend them vigorously. We have not recorded an expense related to the outcome of this litigation because it is not yet possible to determine if a potential loss is probable nor reasonably estimable.

On March 10, 2015, C.R. Bard, Inc. and Bard Peripheral Vascular, Inc. (“Bard”) filed suit in the United States District Court for the District of Delaware claiming certain of our implantable port products infringe on three U.S. patents held by Bard (the “Delaware Action). Bard is seeking unspecified damages and other relief. The patents asserted in the Delaware Action are different than those asserted in the Utah Action. On June 1, 2015, we filed two motions in response to Bard’s Complaint - one sought transfer to the District of Utah where the Utah Action is currently pending, and the other sought dismissal of the entire complaint on grounds that none of the claims in the asserted patents is directed to patent eligible subject matter under Section 101 of the Patent Statute and in light of recent authority from the U. S. Supreme Court. On January 12, 2016, the court issued a decision denying both motions. We have since served an Answer and Counterclaim to which Bard has served a Reply. On March 10, 2016, the Court held a case management conference, and, on March 14, 2016, the court entered a Scheduling Order which set, inter alia, a Markman hearing for March 10, 2017, a summary judgment hearing for December 8, 2017 and trial for March 12, 2018. The parties have served various discovery requests on each other, and have been producing documents to each other; on May 27, 2016 Bard served its Infringement Contentions which identified all the port products accused of infringement; and, on June 24, 2016, we served Invalidity Contentions which detail various grounds for invalidating the three asserted patents. The parties completed briefing on the claim construction issues and the Markman hearing was held on March 10, 2017. A decision is expected on or about May 12, 2017, and the Court issued its Claim Construction Order on May 19, 2017. The Court has since amended the Scheduling Order to provide for the completion of Expert Discovery on October 30, 2017; briefing on Case-Dispositive Motions between November 17, 2017 and January 24, 2018 with oral argument set for February 22, 2018 and trial to commence May 29, 2018.We believe these claims are without merit and intend to defend them vigorously. We have not recorded an expense related to the outcome of this litigation because it is not yet possible to determine if a potential loss is probable nor reasonably estimable.

AngioDynamics, Inc. v. C.R. Bard, Inc.

On May 30, 2017, we commenced an action in the United States District Court for the Northern District of New York entitled AngioDynamics, Inc. v. C.R. Bard, Inc. and Bard Access Systems, Inc. (“Bard”).  In this action, we allege that Bard has illegally tied the sales of its tip location systems to the sales of its PICCs.  We allege that this practice violates the federal antitrust laws and has had, and continues to have, an anti-competitive effect in the market for PICCs.  We seek both monetary damages and injunctive relief.  The Court has set an initial case management conference for August 29, 2017.



Governmental Investigations

In June 2014 we received a subpoena from the U.S. Department of Justice (the “DOJ”) requesting documents in relation to a criminal and civil investigation the DOJ is conducting regarding BTG International, Inc.’s LC Bead® product beginning in 2003.  RITA Medical Systems and AngioDynamics, Inc., after its acquisition of RITA, was the exclusive distributor of LC Beads in the United States from 2006 through December 31, 2011.  We are cooperating fully with this investigation.

In April 2015 we received a subpoena from the DOJ requesting documents in relation to a criminal and civil investigation the DOJ is conducting regarding purported promotion of certain of AngioDynamics’ VenaCure EVLT products for un-cleared indications.  We are cooperating fully with this investigation.

As of May 31, 2017 the Company accrued $12.5 million for these matters and in August 2017, the Company agreed in principle with the government to resolve these matters for approximately $12.5 million.
Item 4.Mine Safety Disclosures.

Item 4. Mine Safety Disclosures.
Not applicable.
29


Part II
 
Item 5.Market for Registrant’s Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities.
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities.
Our common stock is traded on Thethe Global Select Market tier of Thethe NASDAQ Stock Market LLC, (formerly the Nasdaq National Market), under the symbol “ANGO.”
The following table sets forth, for the fiscal quarters indicated, the high and low sale prices for our common stock as reported by Thethe NASDAQ Stock Market.
Sale Price
Sale Price HighLow
High Low
Year ended May 31, 2017   
Year ended May 31, 2021Year ended May 31, 2021
Fourth Quarter$17.58
 $15.08
Fourth Quarter$25.12 $20.61 
Third Quarter$17.81
 $15.89
Third Quarter$21.58 $13.77 
Second Quarter$17.54
 $15.40
Second Quarter$14.38 $9.10 
First Quarter$16.83
 $12.16
First Quarter$12.01 $8.26 
   
Sale Price Sale Price
High Low HighLow
Year ended May 31, 2016   
Year ended May 31, 2020Year ended May 31, 2020
Fourth Quarter$12.72
 $10.76
Fourth Quarter$11.75 $8.33 
Third Quarter$12.70
 $10.02
Third Quarter$16.90 $11.40 
Second Quarter$14.87
 $11.24
Second Quarter$19.26 $14.23 
First Quarter$16.80
 $14.31
First Quarter$21.89 $18.27 
As of August 2, 2017,July 26, 2021, there were 197170 holders of record of our common stock.
Dividends
We did not declare any cash dividends on our common stock during our last three fiscal years. We do not anticipate paying any cash dividends on our common stock for the foreseeable future.
Performance Graph
The graph below matches AngioDynamics, Inc.’s cumulative 5-year total shareholder return on common stock with the cumulative total returns of the NASDAQ Composite index, the RDG SmallCap Medical Devices index, and the NASDAQ Medical Equipment index. The graph tracks the performance of a $100 investment in our common stock and in each index


(with (with the reinvestment of all dividends) from May 31, 20122016 to May 31, 2017.2021. The stock price performance included in this graph is not necessarily indicative of future stock price performance.


30


ango-20210531_g8.jpg

Item 6.Selected Financial Data.
Item 6. Selected Financial Data.
You should read the following selectedInformation required by this Item 6 is not included as we are electing to exclude this information pursuant to Regulation S-K Item 301, as amended.
For financial data in conjunction withand discussion of our consolidatedresults of operations and financial statements and the related notes andposition, refer to Part II, Item 7 “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included elsewhereand Part II, Item 8 “Financial Statements and Supplementary Data” contained in this Annual Report on Form 10-K.
The consolidated statements of operations data for the fiscal years ended May 31, 2017, May 31, 2016, and May 31, 2015, and the consolidated balance sheet data as of May 31, 2017 and May 31, 2016, are derived from the consolidated financial statements that are included elsewhere in this Annual Report on Form 10-K. The consolidated statements of operations data for the fiscal years ended May 31, 2014 and May 31, 2013, and the consolidated balance sheet data as of May 31, 2015, May 31, 2014 and May 31, 2013, are derived from our audited consolidated financial statements not included in this Annual Report on Form 10-K. Historical results are not necessarily indicative of the results of operations to be expected for future periods. See Note 14 of “Notes to Consolidated Financial Statements” for a description of the method that we used to compute our historical basic and diluted net income per share attributable to common stockholders.

31


 Year ended May 31,
(in thousands, except per share information)2017 2016 2015 2014 2013
Consolidated Statements of Operations Data:         
Net sales$349,643
 $353,890
 $356,534
 $354,425
 $341,916
Gross profit (exclusive of intangible amortization)176,169
 174,316
 175,796
 180,174
 168,514
Operating expenses         
Research and development25,269
 25,053
 26,594
 28,124
 26,091
Sales and marketing78,819
 83,743
 82,351
 85,696
 77,790
General and administrative31,406
 30,583
 30,031
 26,511
 25,809
Amortization of intangibles17,296
 17,964
 17,966
 16,562
 16,599
Change in fair value of contingent consideration(15,261) 948
 (8,096) (1,908) 1,583
Acquisition, restructuring and other items, net (a)27,510
 12,591
 26,257
 10,873
 13,800
Medical device excise tax(1,837) 2,416
 4,142
 3,829
 1,600
Total operating expenses163,202
 173,298
 179,245
 169,687
 163,272
Operating income (loss)12,967
 1,018
 (3,449) 10,487
 5,242
Total other (expenses), net(3,120) (4,271) (4,682) (5,301) (6,579)
Net income (loss)$5,008
 $(43,590) $(3,388) $2,347
 $(1,051)
Earnings (loss) per share         
Basic$0.14
 $(1.21) $(0.09) $0.07
 $(0.03)
Diluted$0.14
 $(1.21) $(0.09) $0.07
 $(0.03)


(a)Acquisition, restructuring and one-time items include restructuring expenses or expenses incurred as part of M&A, product discontinuance, legal settlements and legal costs that are related to litigation that is not in the ordinary course of business.





 As of May 31,
(in thousands)2017 2016 2015 2014 2013
Consolidated Balance Sheet Data:         
Cash, cash equivalents and marketable securities$48,759
 $33,986
 $20,080
 $17,914
 $23,955
Working capital82,398
 79,527
 90,283
 81,071
 71,643
Total assets707,961
 726,194
 773,058
 798,576
 790,561
Long-term debt, including current portion (1)
96,320
 120,541
 137,660
 142,660
 142,500
Contingent consideration (2)
12,761
 38,275
 47,384
 67,231
 75,049
Total long-term liabilities121,418
 152,239
 167,444
 195,750
 201,317
Total stockholders’ equity515,027
 507,228
 545,099
 536,885
 526,324
(1) See Note 1 for adoption of new accounting standard.
(2) See Note 3 for explanation on the change.

Item 7.Management’s Discussion and Analysis of Financial Conditions and Results of Operations.

Item 7. Management’s Discussion and Analysis of Financial Conditions and Results of Operations.
The following information should be read together with the audited consolidated financial statements and the notes thereto and other information included elsewhere in this annual report on Form 10-K.

Forward-Looking Statements

This Annual Report on Form 10-K, including the sections entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations”, containsdiscussion may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements regarding AngioDynamics’ expectedrelated to future events and our future financial position, results of operations, cash flows, business strategy, budgets, projected costs, capital expenditures, products, competitive positions, growth opportunities, acquisitions, plans and objectives of management for future operations, as well as statementsperformance 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 performancebased on current expectation and are subject to risks and uncertainties. Investors are cautioned thatOur actual events or results may differ materially from our expectations. Factors that may affect the actual results include, without limitation, our ability to develop our existing and new products, future actions by the FDA or other regulatory agencies, resultsthose anticipated in any forward-looking statements as a result of pending or future clinical trials, the results of ongoing litigation, overall economic conditions, general market conditions, market acceptance, foreign currency exchange rate fluctuations, the effects on pricing from group purchasing organizations and competition, the loss of any of our key customers or reduction in the purchase of our products by any such customers, and our ability to integrate acquired businesses as well as the riskmany factors, listedincluding those set forth in Part I, Item 1A, of"Risk Factors" and "Disclosure Regarding Forward-Looking Statements" included in this Annual Report on Form 10-K.

Although we believe that the assumptions underlying the forward-looking statements contained hereinFor all periods presented in Management's Discussion and Analysis of Financial Conditions and Results of Operations, all sales, cost of sales, expenses, gains and income taxes are reasonable, anyexclusive of the assumptions could be inaccurate and, therefore, there can be no assurance that the forward-looking statements included in this Annual Report on Form 10-K will prove to be accurate. In light of the significant uncertainties inherent in the forward-looking statements included herein, the inclusion of such information should not be regarded as a representation by us or any other person that our objectives and plans will be achieved. 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. We disclaim 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.

Fluid Management.
EXECUTIVE OVERVIEW

Company and Market

We design, manufacture and sell a wide range of medical, surgical and diagnostic devices used by professional healthcare providers for vascular access, for the treatment of peripheral vascular disease and for use in oncology and surgical settings. Our devices are generally used in minimally invasive, image-guided procedures. MostMany of our products are intended to be used once and then discarded, or they may be temporarily implanted for short- or longer-term use.

Our business operations cross a variety of markets. Our financial performance is impacted by changing market dynamics, which have included an emergence of value-based purchasing by healthcare providers, consolidation of healthcare providers,


the increased role of the consumer in health care decision-making and an aging population, among others. In addition, our growth is impacted by changes within our sector, such as the merging of competitors to gain scale and influence; changes in the regulatory environment for medical device; and fluctuations in the global economy.

Our sales and profitability growth also depends, in part, on the introduction of new and innovative products, together with ongoing enhancements to our existing products. Expansions toof our product offerings are created through internal and external product development, technology licensing and strategic alliances. We recognize the importance of, and intend to continue to make investments in research and development activities and selective business development opportunities and feel confident that our existing capital structure and free cash flow generation will allow us to properly fund those activities.

provide growth opportunities.
We sell our products in the United States primarily through a direct sales force, and outside the U.S. through a combination of a direct sales and distributor relationships. Our end users include interventional radiologists, interventional cardiologists, vascular surgeons, urologists, interventional and surgical oncologists and critical care nurses. We expect our businesses to grow in both sales and profitability through geographic expansion, market penetration,by expanding geographically, penetrating new product introductionsmarkets, introducing new products and increasing our direct presence internationally.

The COVID-19 global pandemic has impacted our business and may pose future risks. Even with the public health actions that have been taken to reduce the spread of the virus, there may continue to be disruptions with respect to consumer demand, hospital operating procedures and workflow, our ability to continue to manufacture products, the reliability of our supply chain and inflation. Accordingly, management continues to evaluate the Company’s liquidity position, communicate with and monitor the actions of our customers and suppliers, and review our near-term financial performance.
In the third quarter of fiscal year 2021, a benefit of $1.9 million was recorded as a result of the employee retention credit that the Company filed for under the provisions of the Coronavirus Aid, Relief and Economic Security Act (the "CARES Act").
In evaluating the operating performance of our business, management focuses on revenue, gross margin, operating income, earnings per share and cash flow from operations. A summary of these key financial metrics for the year ended May 31, 2021 compared to the year ended May 31, 2020 follows:
Year ended May 31, 2021:
Revenue increased by 10.2% to $291.0 million
Gross margin as a percentage of sales decreased by 300 bps to 53.9%
Operating loss decreased by $131.8 million to $35.3 million
Cash flow from operations increased by $38.6 million to cash provided by operations of $24.1 million
The ongoing recovery from the COVID-19 pandemic has had a varying impact on each of our three businesses. Our Endovascular Therapies and Vascular Access businesses performed the strongest of the businesses during the year. The
32


number of procedures continued to improve from the COVID-19 lows in the second half of last fiscal year. Our Oncology business continued to face pressure from reductions in procedure volumes due to challenges resulting from the COVID-19 pandemic and the resulting challenging capital spending environment. During fiscal year 2021, we focused on the following areas in responding to the COVID-19 pandemic:
Supporting and progressing our key growth initiatives (the AngioVac, Auryon and NanoKnife systems);
Managing operating expenses; and
Managing our cash and balance sheet.
Strategic Initiatives to Drive Growth

As the Company has previously announced, the Company is focused on its ongoing transformation from a company with a broad portfolio of largely undifferentiated products to a more focused medical technology company that delivers unique and innovative health care solutions. The Company believes that this transformation will enable the Company to shift the portfolio from the mature, lower-growth markets where we have competed in the past by investing in technology and products that provide access to larger and faster growing markets. As such, we believe the growth in the near to mid-term will be driven by our high technology products including Auryon, Mechanical Thrombectomy (which includes AngioVac and thrombolytics) and NanoKnife. We will refer to these high technology product lines as our Med Tech business and we will refer to the remainder of the portfolio as our Med Device business.
Throughout the year, we introduced strategic moves designed to streamline our business, improve our overall business operations and position ourselves for growth. Those initiatives included:

Introduction of new corporate strategy. As outlined in an Investor Day held in New York City in the fourth quarter, leadership introduced a strategic approach that would include portfolio management with product categories designated into “invest” and “maintain” businesses; continued efforts to improve operational performance; international expansion; and an ability to pursue growth through organic and inorganic opportunities through strong cash generation. In addition to introducing the strategy, the company also put forth projected financial metrics anticipated for the 2018, 2019 and 2020 fiscal years.

Operational Consolidation. Product development process. The Company announced a planned consolidation of operations from the Manchester, GA and Denmead, UK facilities into the Glens Falls and Queensbury, NY manufacturing facilities in the third quarter. The consolidation will result in streamlined operations, reduced costs, optimized inventory management and gross margin improvement. As part of the plan, the Company expects to incur restructuring expenses, including severance and retention, equipment transfer, set-up and purchases, regulatory expenses, lease termination expenses and other miscellaneous expenses. The plan is expected to be completed in the third quarter of fiscal year 2018.

Implementation of a new product development process. The company introduced a robustcontinued its disciplined product development process which is intended to improve the Company’s ability to bring new products to market.

Rationalization This included the launch of underperforming or below-cost products. This initiative eliminated more than 900 SKUsAuryon and was partneredSmartPort+, along with a price increase on products that did not have a profitable cost structure.

New members of the executive leadership team. Following his arrival in April 2016, President and Chief Executive Officer James C. Clemmer welcomed several members to the AngioDynamics leadership team, including Executive Vice President and Chief Financial Officer Michael C. Greiner, Senior Vice President of Quality and Regulatory Affairs Warren G. Nighan, Senior Vice President and General Manager of the Vascular Access Global Business Unit Chad T. Campbell, Senior Vice President and General Manager of the Peripheral Vascular Global Business Unit Robert A. Simpson and Senior Vice President of Human Resources Heather J. Daniels Cariveau.

Recent Developments

In addition to the deliberate actions taken by management as listed above, several significant developments occurred over the course of the fiscal year which impacted our business, including:

The Company added two members to the Board of Directors, Eileen Auen and Jan Reed. Auen most recently served as Executive Chairman of Helios, a $1 billion healthcare services firm. Reed most recently was Senior Vice President, General Counsel and Corporate Secretary at Walgreens Boots Alliance.

The Company made the decision to discontinue its investment in the TiLo product that was acquired in August 2013 as part of the Clinical Devices acquisition. This decision resulted in the write-off of the acquired in-processcontinued research and development (IPR&D) of $3.6 million along with a $3.1 million gain from the reduction in the fairactivities to expand on our Mechanical Thrombectomy portfolio.
Value Creation. To create value of contingent consideration liability associated withand drive future milestones that will no longer be met.



The Company revised the sales projections for the AngioVac product as a result of reviews performed by executive management across all products. The adjustments to the sales projections resulted in a $13.4 million gain from the reduction in the fair value of the contingent liability that is based on lower projected sales volume over the contractual earn out period.

The Company decided to terminate its agreements with EmboMedics. The termination of these agreements resulted in a write-off of the initial $2.0 million investment in EmboMedics (Note 2).
The Board of Directors approved a share repurchase program (the “Repurchase Program”) under which they authorizedgrowth, the Company the optionplans to repurchase uppractice dispassionate portfolio optimization and continue to $25.0 millionfocus on areas of its outstanding common stock during the twenty-four month period ending November 6, 2018. During the secondcompelling unmet needs including those that are patient-centric and fourth quarter of fiscal year 2017,evidenced-based. In addition, the Company repurchased a total of 870,000 shares of common stock in the open market at an aggregate cost of $13.6 million under the Repurchase Program.
The Company entered into a new credit agreement ("Credit Agreement") which provides for a $100.0 million senior secured term loan facility ("Term Loan") and a $150.0 million senior secured revolving credit facility ("Revolving Facility", and together with the Term Loan, "The Facilities") along with up to a $20.0 million sublimit for letters of credit and a $5.0 million limit for swing line loans. With the proceeds from the Credit Agreement, the existing credit facility that was entered into in September 2013 was paid down in full.

The Company announced to employees an Operational Consolidation strategy which included the consolidation of the Manchester, GA and Denmead, UK facilities into the Glens Falls and Queensbury, NY manufacturing facilities. As part of the plan, the Company expects to incur restructuring expenses, including severance and retention, equipment transfer, set-up and purchases, regulatory expenses, lease termination expenses and other miscellaneous expenses. The plan is expected to be completed in the third quarter of fiscal year 2018.

Following completion of the sale of common stock pursuant to the Underwriting Agreement, Avista Capital Partners’ beneficial ownership in AngioDynamics has been reduced to zero as they sold their entire position in AngioDynamics.  As a result, in accordance with the terms of his appointment to AngioDynamics’ Board of Directors and the terms of the Stockholders Agreement, David Burgstahler resigned as a director on April 12, 2017.

The Company filed a lawsuit alleging that C.R. Bard has violated federal antitrust laws by illegally tying the sale of its tip location systems to its line of peripherally inserted central catheters. The Company claims that these actions by Bard are preventing competition in the marketplace and limiting patient access to superior technology.

The Company issued a voluntary recall of its Acculis probes that were sold over the past two years. As a result of this voluntary recall, the company decided to also do a voluntary market withdrawal of its Acculis capital systems and discontinue selling the product. The voluntary recall resulted in a deferral of revenue of $2.6 million and an increase of $2.6 million in inventory and hardware asset reserves. The total impact to income before taxes of the recall was $4.5 million. Additional costs will be incurred in fiscal year 2018 related to the market withdrawal of the Acculis capital systems.

The Company received notification in the fourth quarter of 2017 that a $1.8 million refund from the Internal Revenue Service related to prior medical device taxes paid would be received.
As of May 31, 2017 the Company accrued $12.5 million for these matters and in August 2017, the Company agreed in principle with the government to resolve these matters for approximately $12.5 million.

Management's Use of Non-GAAP Measures

Net sales “on a constant currency basis” is a non-GAAP measure. The Company analyzes net sales on a constant currency basis to better measure the comparability of results between periods. Because changes in foreign currency exchange rates have a non-operating impact on net sales, the Company believes that evaluating growth in net sales on a constant currency basis provides an additional and meaningful assessment of net sales to both management and the company’s investors. Constant currency growth rates are calculated by subtracting the current period's local currency sales at the prior period’s exchange rate from the current period’s local currency sales at the current period’s exchange rate.

Constant currency growth rates are not indicative of changes in corresponding cash flows. The limitation of these non-GAAP measures is that they do not reflect results on a standardized reporting basis. Non-GAAP measures are intended to supplement the applicable GAAP disclosures and should not be viewed as replacements of GAAP results.



pursuing targeted global expansion opportunities.
Critical Accounting Policies and Use of Estimates

Our significant accounting policies are summarized in Note 1 to Notes to"Basis of Presentation, Business Description and Summary of Significant Accounting Policies" in the Consolidated Financial Statements included elsewhere in this Annual Report onour Form 10-K. While all of these significant accounting policies affect the reporting of our financial condition and results of operations, we view certain of these policies as critical. Policies determined to be critical are those policies that have the most significant impact on our financial statements and require us to use a greater degree of judgment and/or estimates. Actual results may differ from those estimates. The accounting policies identified as critical are as follows:

Revenue Recognition

WeUnder ASC 606, revenue is recognized when a customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation.
The Company contracts with its customers based on customer purchase orders, which in accordancemany cases are governed by master purchasing agreements. The Company’s contracts with customers are generally accepted accounting principlesfor product only, and do not include other performance obligations such as outlinedservices or other material rights. As part of its assessment of each contract, the Company evaluates certain factors including the customer’s ability to pay (or credit risk). For each contract, the Company considers the promise to transfer products, each of which is distinct, to be the identified performance obligations.
Transaction prices of products are typically based on contracted rates. Product revenue is measured as the amount of consideration the Company expects to receive in exchange for transferring products to a customer. To the extent the transaction price includes variable consideration, the Company estimates the amount of variable consideration that should be included in the SEC’s authoritative guidancetransaction price utilizing the expected value method. As such, revenue is recorded net of rebates, returns and other deductions.
If a contract contains a single performance obligation, the entire transaction price is allocated to the single performance obligation. Contracts that contain multiple performance obligations require an allocation of the transaction price based on revenue recognition which requires that four criteria be met before revenue can be recognized: (i) persuasive evidence that an arrangement exists; (ii)the
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estimated relative standalone selling prices of the promised products underlying each performance obligation. The Company has standard pricing for its products and determines standalone selling prices based on the price at which the performance obligation is fixedsold separately. Contracts with our customers typically include a single performance obligation related to the sale of our products.
Revenue is recognized when control of the product is transferred to the customer (i.e., when the Company’s performance obligation is satisfied), which occurs at a point in time, and may be upon shipment from the Company’s manufacturing site or determinable; (iii) collectabilitydelivery to the customer’s named location, based on the contractual shipping terms of a contract. In determining whether control has transferred, the Company considers if there is reasonably assured;a present right to payment from the customer and (iv)when physical possession, legal title and risks and rewards of ownership have transferred to the customer.
The Company typically invoices customers upon satisfaction of identified performance obligations. As the Company’s standard payment terms are 30 to 90 days from invoicing, the Company does not provide any significant financing to its customers. Sales, value add, and other taxes collected on behalf of third parties are excluded from revenue.
The Company enters into agreements to place placement and evaluation units (“units”) at customer sites, but the Company retains title to the units. The duration of these agreements are typically a year and the customer has the right to use the unit at no upfront charge in connection with the customer’s ongoing purchase of disposables. These types of agreements include an embedded operating lease for the right to use the units. In these arrangements, revenue recognized for the sale of the disposables is not allocated between the disposal revenue and lease revenue due to the insignificant value of the units in relation to the total agreement value.
Revenues from product delivery has occurred or services have been rendered. Decisions relative to criterion (iii) regarding collectabilitysales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established for discounts, returns, rebates and allowances that are offered within contracts between the Company and its customers. These reserves are based upon our judgments,on the amounts earned or to be claimed on the related sales and are classified as discussed under “Accounts Receivable” in Note 1, and should conditions changea current liability.
A receivable is recognized in the future and cause us to determine this criterion is not met; our results of operations may be affected. We recognize revenue, net of sales taxes assessed by any governmental authority, as productsperiod the Company ships the product. Payment terms on invoiced amounts are shipped, based on F.O.B. shipping pointcontractual terms when titlewith each customer and riskgenerally coincide with revenue recognition. Accordingly, the Company does not have any contract assets associated with the future right to invoice its customers. In some cases, if control of loss passesthe product has not yet transferred to customers. We negotiate shippingthe customer or the timing of the payments made by the customer precedes the Company’s fulfillment of the performance obligation, the Company recognizes a contract liability that is included in deferred revenue in the accompanying consolidated balance sheets.
The Company provides certain customers with rebates and credit termsallowances that are explicitly stated in the Company’s contracts and are recorded as a reduction of revenue in the period the related product revenue is recognized. The Company establishes a liability for such amounts, which is included in accrued expenses in the accompanying consolidated balance sheets. These rebates and allowances result from performance-based offers that are primarily based on attaining contractually specified sales volumes and administrative fees the Company is required to pay to group purchasing organizations.
The Company generally offers customers a customer-by-customer basis and products are shipped at an agreed upon price. All productlimited right of return. Product returns after 30 days must be pre-approved by usthe Company and customers may be subject to a 20% restocking charge. To be accepted, a returned product must be unadulterated, undamaged and have at least 12twelve months remaining prior to its expiration date. Charges for discounts, returns, rebatesThe Company estimates the amount of its product sales that may be returned by its customers and other allowances are recognizedrecords this estimate as a deduction fromreduction of revenue on an accrual basis in the period in which the related product revenue is recorded.recognized. The accrual forCompany currently estimates product return liabilities using its historical product return information and considers other factors that it believes could significantly impact its expected returns, including product recalls. During the year ended May 31, 2021, such product returns discounts and other allowances iswere not material.
Inventory
Inventories are stated at the lower of cost or net realizable value based on the Company’s history.

Income Taxes

We calculate income tax expensefirst-in, first-out cost method and consist of raw materials, work in process and finished goods. Appropriate consideration is given to deterioration, obsolescence, expiring and other factors in evaluating net realizable value. When we evaluate inventory for each jurisdictionexcess quantities and obsolescence, we utilize historical product usage experience and expected demand for establishing our reserve estimates. Our actual product usage may vary from the historical experience and estimating demand is inherently difficult which may result in which we operate. This involves estimating actual current taxes due plus assessing temporary differences arising from differing treatment for taxus recording excess and accounting purposesobsolete inventory amounts that are recorded as deferred tax assets and liabilities. We periodically evaluate deferred tax assets, capital loss carryforwards and tax credit carryforwardsdo not match the required amounts. An increase to determine their recoverability based primarily on our ability to generate future taxable income and capital gains. Where it is more-likely-than-not these will not be recovered, we estimate a valuation allowance and recordinventory reserves results in a corresponding additional tax expenseincrease in our statementcost of operations.

We file income tax returns inrevenue. Inventories are written off against the U.S. federal jurisdiction and various state and foreign jurisdictions. In the normal course of business wereserve when they are subject to examination by taxing authorities throughout the world. Fiscal years 2014 through 2017 remain open to examination by the various tax authorities. We analyzed filing positions in all of the Federal and state jurisdictions where we are required to file income taxes, as well as all open tax years in these jurisdictions and believe that our income tax filing positions and deductions will be sustained on audit and we do not anticipate any adjustments will result in a material adverse effect on our financial condition, results of operations or cash flows.

physically disposed.
Acquisitions and Contingent Consideration

In a business combination,The Company allocates the acquisition methodpurchase price of accounting requires thatacquired companies to the identifiabletangible and intangible assets acquired and liabilities assumed be measured atbased on their estimated fair values. The estimates used to value with goodwill being the excess valuenet assets acquired are based in part on
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historical experience and information obtained from the management of consideration paid over the fairacquired company. The Company generally values the identifiable intangible assets acquired using a discounted cash flow model. The significant estimates used in valuing certain of the intangible assets include, but are not limited to: future expected cash flows of the asset, discount rates to determine the present value of the future cash flows, attrition rates of customers, royalty rates and expected technology life cycles. The Company also estimates the useful lives of the intangible assets based on the expected period over which the Company anticipates generating economic benefit from the asset.
The Company’s estimates of fair value are based on assumptions believed to be reasonable at that time. If management made different estimates or judgments, material differences in the fair values of the net identifiable assets acquired. IP R&Dacquired may result.
Certain of the Company’s business combinations involve potential payment of future consideration that is capitalized and recorded as an indefinite-lived intangible asset atcontingent upon the acquisition date,achievement of certain product development milestones and/or contingent on the acquired business reaching certain performance milestones. The Company records contingent consideration is recorded at fair value at the date of acquisition date, and transaction costs are expensedbased on the consideration expected to be transferred, estimated as incurred. When the Company acquires net assets that are not accounted for as a business combination, no goodwill is recognized.

probability weighted future cash flows, discounted back to present value. The fair value of the liability for contingent consideration recordedis measured using projected payment dates, discount rates, probabilities of payment, and projected revenues (for revenue-based considerations). Projected revenues are based on the acquisition date is based on probability weighted estimated cash flow streams, discounted back to present value using aCompany’s most recent internal operational budgets and long-range strategic plans. The discount rate used is determined at the time of measurement in accordance with accepted valuation methods. The liability for contingentmethodologies. Changes in projected revenues, probabilities of payment, discount rates, and projected payment dates may result in adjustments to the fair value measurements. Contingent consideration is remeasured to fair value at each reporting period with changes recordedusing Level 3 inputs, and the change in earnings untilfair value, including accretion for the contingencypassage of time, is resolved.

recognized as income or expense within operating expenses in the consolidated statements of income. Contingent consideration payments made soon after the acquisition date are classified as investing activities in the consolidated statements of cash flows. Contingent consideration payments not made soon after the acquisition date that are related to the acquisition date fair value are reported as financing activities in the consolidated statements of cash flows, and amounts paid in excess of the original acquisition date fair value are reported as operating activities in the consolidated statements of cash flows.
Goodwill and Intangible Assets

Intangible assets other than goodwill, indefinite lived intangible assets and in process research and development ("IP R&D") are amortized over their estimated useful lives, which range between two to eighteen years, on either a straight-line


basis over the expected period of benefit or as revenues arerevenue is earned from the sales of the related products. Weproduct. The Company periodically reviewreviews the estimated useful lives of our intangible assets and reviewreviews such assets for impairment whenever events or changes in circumstances indicate that the carrying value of the assets may not be recoverable. Such conditions could include significant adverse changes in the business climate, current-period operating or cash flow losses, significant declines in forecasted operations, or a current expectation that an asset group will be disposed of before the end of its useful life. When testing for impairment of definite-lived intangible assets held for use, the Company groups assets at the lowest level for which cash flows are separately identifiable. The Company operates as a single asset group. If a triggering event is deemed to exist, the Company performs an undiscounted operating cash flow analysis to determine if an impairment exists. If an intangible asset is considered to be impaired, the amount of the impairment will equal the excess of the carrying value over the fair value of the asset.

Acquired IP R&D is not amortized until completion and development of the project, at which time the IP R&D becomes an amortizable asset with an appropriate useful life and an amortization method is determined. If the related project is not completed in a timely manner or the project is terminated or abandoned, we may have an impairment related to the IP R&D, calculated as the excess of the asset’s carrying value over its fair value.

Our policy defines IP R&D as the value assigned to those projects for which the related products have not received regulatory approval and have no alternative future use. Determining the portion of the purchase price allocated to IP R&D requires us to make significant estimates. The amount of the purchase price allocated to IP R&D is determined by estimating the future cash flows of each project or technology and discounting the net cash flows back to their present values. The discount rate used is determined at the time of measurement in accordance with accepted valuation methods. These methodologies include consideration of the risk of the project not achieving commercial feasibility.

Goodwill and other intangible assets that have indefinite useful lives are not amortized, but rather, are tested for impairment annually or more frequently if impairment indicators arise. Goodwill represents the excess of the purchase price over the fair value of the net tangible and identifiable intangible assets acquired in each business combination. Goodwill and intangible assets have been recorded at either incurred or allocated cost. Allocated costs were based on respective fair market values at the date of acquisition.

For goodwill, the impairment test requires a comparison of the estimated fair value of the reporting unit to which the goodwill is assigned to the sum of the carrying value of the assets and liabilities of that reporting unit. The determination of reporting units also requires management judgment. We considerThe Company considers whether a reporting unit exists within a reportable segment based on the availability of discrete financial information that is regularly reviewed byinformation. The Company operates as a single operating segment management.with one reporting unit and consequently evaluates goodwill for impairment based on an evaluation of the fair value of the Company as a whole. If the sum of the carrying value of the assets and liabilities of a reporting unit exceeds the fair value of the reporting unit, the carrying value of the reporting unit’s goodwill is reduced to its implied fair value through an adjustment to the goodwill balance, resulting in an impairment charge. The Company utilizes either discounted cash flow models or other valuation models, such as comparative transactions and market multiples, to determine
Determining the fair value of oura reporting unit. We must makeunit is judgmental and requires the use of significant estimates and assumptions, about future cash flows, futureincluding revenue growth rates, operating plans,margins, discount rates comparable companies,and future market multiples, purchase price premiumsconditions, among others. Changes in assumptions or estimates could materially affect the estimated fair value, and other factorstherefore could affect the likelihood and amount of a potential impairment.
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As detailed in those models. Different assumptionsNote 9, "Goodwill and judgment determinations could yield different conclusions that would resultIntangible Assets" in the Consolidated Financial Statements including on our Form 10-K, during the fourth quarter of fiscal year 2021, the Company made the decision to abandon the OARtrac product technology and trademark. This resulted in an impairment charge to income inof $14.0 million. In the period that such change or determination was made.

Contingencies

We are involved, bothfourth quarter of fiscal year 2020, the Company recorded a goodwill impairment loss of $158.6 million as a plaintiff and a defendant, in various legal proceedings that arise in the ordinary course of business, including patent infringement and product liability, as further discussed in Note 15 to our consolidated financial statements. Accruals recorded for various contingencies including legal proceedings, self insurance and other claims, are based on judgment, the probability of losses and, where applicable, the consideration of opinions of internal and/or external legal counsel, internal and/or external technical consultants and actuarially determined estimates. When a range is established but a best estimate cannot be made, we record the minimum loss contingency amount, which could be zero. An estimate is often initially developed substantially earlier than the ultimate loss is known and is reevaluated each accounting period. As information becomes known, additional loss provision is recorded when either a best estimate can be made or the minimum loss amount is increased. When events result in an expectation of a more favorable outcome than previously expected, our best estimate is changed to a lower amount. We record receivables from third-party insurers up to the amountfair value of the related liability when we have determined that existing insurance policies will provide reimbursement. In making this determination, we consider applicable deductibles, policy limits andreporting unit was less than its carrying value. There were no adjustments to goodwill for the historical payment experience of the insurance carriers. Receivables are not netted against the related liabilities for financial statement presentation.year ended May 31, 2021 other than foreign currency translation adjustments.

Results of Operations for the years ended May 31, 20172021 and 2016

2020
For the fiscal year ended May 31, 2017,2021, we reported net incomeloss from continuing operations of $5.0$31.5 million, or $0.14 income per diluted share, on net sales of $349.6 million compared to a fiscal 2016 net loss of $43.6 million, or $1.21$0.82 loss per diluted share, on net sales of $353.9$291.0 million compared to a fiscal year 2020 net loss of $166.8 million, or $4.39 loss per diluted share, on net sales of $264.2 million.





Net Sales

Net sales - Net sales are derived from the sale of our products and related freight charges, less discounts, rebates and returns.

Net sales for the year ended May 31, 20172021 and 20162020 were:

For the year ended May 31,Year ended May 31,
(in thousands)2017 2016 % Growth Currency Impact (Pos) Neg Constant Currency Growth Non-GAAP(in thousands)20212020% Change
Net Sales by Product Category    Net Sales by Product Category
Peripheral Vascular$208,602
 $205,620
 1% 
Endovascular Therapies Endovascular Therapies$135,079 $112,706 19.9 %
Vascular Access96,481
 99,375
 (3)%  Vascular Access101,310 94,299 7.4 %
Oncology/Surgery44,560
 48,895
 (9)%  Oncology/Surgery54,621 57,152 (4.4)%
Total349,643
 353,890
 (1)% 0% (1)%Total$291,010 $264,157 10.2 %
    
Net Sales by Geography    Net Sales by Geography
United States$282,168
 $285,824
 (1)% 0% (1)% United States$237,043 $207,980 14.0 %
International67,475
 68,066
 (1)% 2% 1% International53,967 56,177 (3.9)%
Total$349,643
 $353,890
 (1)% 0% (1)%Total$291,010 $264,157 10.2 %
For the year ended May 31, 2017,2021, net sales decreased $4.2increased $26.9 million to $349.6$291.0 million compared to the year ended May 31, 2016.2020. The prior year net sales numbers, specifically in the fourth quarter, were significantly impacted by the COVID-19 global pandemic.

Endovascular Therapies
ConsolidatedTotal Endovascular Therapies sales increased $22.4 million or 19.9%. Auryon, which was acquired as part of the Eximo acquisition in the second quarter of fiscal year 2020, contributed $11.1 million in disposable sales. The AngioVac business grew $8.0 million as the Company continued to see increased case volumes in AngioVac, which increased 39% from the prior year. Additionally, Core Peripheral product sales increased $5.6 million. EVLT remained consistent with the prior year.
U.S. Endovascular Therapies net sales increased $22.5 million due to increased case volume in AngioVac, increased Core Peripheral product sales and U.S.$11.1 million in sales of Auryon. These increases were partially offset by decreased sales volume in EVLT.
International Endovascular Therapies net sales decreased from$0.1 million.
Vascular Access
Total Vascular Access sales increased $7.0 million due to increased sales of PICCs, Ports, Midlines and Dialysis of $2.5 million, $1.3 million, $3.1 million and $0.1 million, respectively. These increases are partially the result of a large order in the United Kingdom related to the COVID-19 pandemic for $5.2 million in the first quarter of fiscal year 2021 along with the distribution agreement with MedComp for the sale of certain PICC products. BioFlo product lines comprised 52% of overall Vascular Access sales compared to 51% in the prior year.
U.S. Vascular Access net sales increased $4.3 million primarily due to increased PICCs, Ports and Midline sales of $1.1 million, $1.4 million and $1.5 million, respectively. These increases are attributed to a group purchasing
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organization agreement that was signed in the third quarter of the prior fiscal year, new strategic relationships and the launch of SmartPort+.
International Vascular Access net sales increased by $2.7 million primarily as a result of decreased net sales from Vascular Access and Oncology Surgery.a large order in the United Kingdom related to the COVID-19 pandemic for $5.2 million. This decrease was partially offset by 1%decreased PICC sales in Latin America of $1.6 million.
Oncology/Surgery
Total Oncology/Surgery sales decreased $2.5 million year over year growthyear. The sales were significantly impacted by the challenging capital spending environment as a result of the COVID-19 pandemic, as Microwave and NanoKnife capital sales decreased $4.2 million. Of this decrease, $2.1 million is due to a large NanoKnife distributor order in our Peripheral Vascular franchise.the Asia-Pacific region ("APAC") in the prior year. Radiofrequency Ablation sales also decreased $1.6 million, Balloon product sales decreased by $1.1 million and other sales decreased $0.7 million. These decreases were partially offset by increased Microwave and NanoKnife disposable sales of $2.1 million and $1.2 million, respectively, and increased BioSentry sales of $2.0 million.

Peripheral Vascular

Total Peripheral VascularU.S. Oncology net sales increased $3.0by $2.3 million primarily attributabledue to increased NanoKnife disposable sales volume of Angiographic$1.5 million, BioSentry sales of $2.0 million and Core productsMicrowave disposable sales of $9.9$1.3 million. ThisThe increased NanoKnife disposable sales volumeis the result of the increased capital base that was developed in the prior year along with increased case volumes as hospitals have begun to lift restrictions on procedures. This was partially offset by a decreasedecreased NanoKnife capital sales of volume in Fluid Management, Venous$1.1 million and AngioVacBalloon product sales of $5.6$1.1 million. The decrease in Fluid Management was attributed to a discontinuance of our inflation device and automation challenges in the European markets. Although AngioVac procedures were up year over year, AngioVac unit
International Oncology sales decreased by $1.4 million due to available inventory already in the market place.
US Peripheral Vascular sales increased $2.8 million and international Peripheral Vascular sales increased $0.2 million which was primarily due to increased sales volume of Angiographic catheters. This increased sales volume was offset by a decrease in volume in Fluid Management, Venous and AngioVac.

Vascular Access

Total Vascular Access sales decreased $2.9 million primarily in our non-BioFlo businesses. Our BioFlo product line grew by $4.8 million primarily driven by growth in Midlines.
US Vascular Access sales declined by 5% due to softness across the portfolio offset by Midline and BioFlo dialysis which continued to gain traction in the marketplace.
International Vascular Access sales increased 15% due to the market penetration of BioFlo PICCs.

Oncology/Surgery

Total Oncology/Surgery sales decreased $4.3 million year over year primarily due to fewer sales of capital units in Microwave and NanoKnife as well as the $2.6 million deferral of revenue related to the Acculis probe recall that was announced in the fourth quarter of fiscal year 2017.


U.S. Oncology/Surgery declined by 8%, driven primarily through lower capital and disposable sales in Radio Frequency and Microwave offset by NanoKnife growth.year. The decrease is also attributed to a $1.4 million deferral of revenue related to the Acculis probe recall that was announced in the fourth quarter of fiscal year 2017.
International Oncology/Surgery sales decreased 10% year over year as a result ofdriven by lower NanoKnife capital and disposable sales of $3.0 million and decreased Radiofrequency Ablation sales of $2.1 million as a $1.2result of market pressures and hospital restrictions due to the COVID-19 pandemic. Of the $3.0 million deferral of revenuedecrease in NanoKnife capital and disposable sales, $2.1 million was related to the Acculis probe recall that was announceda NanoKnife distributor order in APAC in the fourth quarter of fiscal year 2017.

prior year.
Gross Profit, Operating expenses, and Other income (expense)
Year ended May 31,
(in thousands)20212020% Change
Gross profit (exclusive of intangible amortization)$156,788 $150,272 4.3 %
Gross profit % of sales53.9 %56.9 %
Research and development$36,390 $29,682 22.6 %
% of sales12.5 %11.2 %
Selling and marketing$81,306 $78,634 3.4 %
% of sales27.9 %29.8 %
General and administrative$35,918 $37,872 (5.2)%
% of sales12.3 %14.3 %
  For the year ended May 31,
(in thousands) 2017 2016 % Change
Gross profit (exclusive of intangible amortization) $176.2
 $174.3
 1.1 %
Gross profit % of sales 50.4% 49.3%  
Research and development $25.3
 $25.1
 0.8 %
% of sales 7.2% 7.1%  
Selling and marketing $78.8
 $83.7
 (5.9)%
% of sales 22.5% 23.7%  
General and administrative $31.4
 $30.6
 2.6 %
% of sales 9.0% 8.6%  

Gross profit - Gross profit consists of net sales less the cost of goods sold, which includes the costs of materials, products purchased from third parties and sold by us, manufacturing personnel, royalties, freight, business insurance, depreciation of property and equipment and other manufacturing overhead.overhead, exclusive of intangible amortization.

GrossWhile gross profit increased by $1.9$6.5 million compared to the prior year. The increase is attributable to the following:
In fiscal year, 2017, a net charge of $4.5 million was recorded as a result of the Acculis probe recall.
In fiscal year 2016, a $5.9 million charge related to the write-off of Celerity inventory on hand and hardware assets after the business decision to no longer pursue the Celerity Navigation project.
The remaining increase is driven by net productivity offset by price and mix of products.
The increase in gross profit as a percentage of 1.1%sales decreased 300 basis points. The change is attributedprimarily attributable to the factors noted above.following:

Sales volume positively impacted gross profit by $16.6 million year over year;
Net productivity negatively impacted gross profit by $10.0 million primarily as a result of under absorption, and to a lesser extent inflation, of $5.1 million and start-up costs of $4.0 million related to the Auryon launch. The under absorption in manufacturing operations was due to the Company maintaining staffing levels during the COVID-19 global pandemic to mitigate risk, along with a focus on working capital management through inventory reduction;
Mix negatively impacted gross margin by $0.8 million as a result of the large order in the United Kingdom for lower gross margin products and decreased NanoKnife capital sales. This was partially offset by increased AngioVac sales; and
A benefit of $0.7 million was recorded to gross profit which represents a portion of the employee retention credit that the Company filed for under the provisions of the CARES Act in the third quarter of the current year.

37


Research and development expensesexpense - Research and development (“R&D”) expenses includeexpense includes internal and external costs to develop new products, enhance existing products, validate new and enhanced products, manage clinical, regulatory and medical affairs.

R&D expense increased $0.2$6.7 million compared to the prior year. The increase is primarily attributable to the following:

AngioVac platform expansion, the NanoKnife DIRECT© study and the Pathfinder study increased $3.6 million and Auryon related expenses increased by $2.7 million;
Increased headcountOutside consultant expense and other expense increased $0.5 million and travel expenses decreased $0.5 million;
Compensation and benefits increased $0.7 million, of which $0.4 million related to variable compensation; and
A benefit of $0.3 million was recorded to R&D expense which represents a portion of the employee retention credit that the Company filed for under the provisions of the CARES Act in the R&D department compared tothird quarter of the prior year resulted in $1.2 million in additional expense as well as expenses associated with consultants of $0.6 million and severance of $0.4 million.current year.
These increases were partially offset by less project spend of $1.2 million, $0.6 million in samples and $0.2 million in travel and other expenses.
R&D expense as a percentage of sales remained consistent year over year.

Sales and marketing expensesexpense - Sales and marketing (“S&M”) expenses consistexpense consists primarily of salaries, commissions, travel and related business expenses, attendance at medical society meetings, product promotions and marketing activities.

S&M expense decreasedincreased by $4.9$2.7 million compared to the prior year. The decreaseincrease is primarily attributable to the following:

Expense related to the build-out of the Auryon sales and marketing teams to prepare for full product launch of $7.7 million;
There was a decrease in headcount from the prior year which resulted in a $2.5Travel expense decreased $2.4 million decrease in salaries and benefits.
The decrease in headcount along with a focus on reduceddue to less travel spend resulted in a decrease in travel expenses of $1.3 million.
There was a $0.7 million decrease in trade shows and meeting expenses along with a $0.7 million decrease in samples as a result of the COVID-19 pandemic. In addition, tradeshow and other expense decreased $1.2 million primarily due to the cancellation of events;
Compensation and benefits decreased $0.7 million due to decreased salaries as a focus on reducing expenses.
These decreases wereresult of open roles partially offset by severanceincreased variable compensation and commissions; and
A benefit of $0.8 million.


As a result of these decreases in S&M expenses, the percentage of S&M$0.9 million was recorded to sales decreased 1.2%.and marketing expense which represents a portion of the employee retention credit that the Company filed for under the provisions of the CARES Act in the third quarter of the current year.


General and administrative expensesexpense - General and administrative (“G&A”) expenses includeexpense includes executive management, finance, information technology, human resources, business development, legal, and the administrative and professional costs associated with those activities.

G&A expense increaseddecreased by $0.8$2.0 million compared to the prior year. The increasedecrease is primarily attributable to the following:

Legal and professional fees relating to ongoing litigation that is within the normal course of business decreased $3.7 million;
IncreasedCompensation and benefits increased approximately $2.1 million primarily as a result of increased variable compensation and stock based compensation expense; and
Decreased consulting and other expense related to the new grant for the CEO along with two new board members of $1.7 million. Along with the stock based compensation increase, bonus for fiscal year 2017 was accrued at a higher rate than the prior year which resulted in a $1.0$0.1 million increase to G&A expense.
Along with the appointmentand decreased travel expense of new members in the executive leadership team, recruiting and relocation expenses resulted in an increase of $0.5 million from the prior year
There was also an increase in professional fees of $0.3 million related to audit fees and director fees partially offset by a decrease in legal fees.
These increases were partially offset by decreases in compensation benefits of $0.5$0.2 million as a result of a reduction in benefit claims, depreciation expense of $0.8 million, $0.2 million in facilities expenses including insurance, lease expenses and utilities, bad debt favorability of $0.4 million and other miscellaneous decreases in expenses of $0.4 million.the COVID-19 pandemic.

Year ended May 31,
(in thousands)20212020$ Change
Amortization of intangibles$18,136 $18,121 $15 
Goodwill impairment$— $158,578 $(158,578)
Change in fair value of contingent consideration$89 $(11,531)$11,620 
Acquisition, restructuring and other items, net$20,232 $6,014 $14,218 
Other expense$(769)$(1,037)$268 
  For the year ended May 31,
(in thousands) 2017 2016 $ Change
Amortization of intangibles $17.3
 $18.0
 $(0.7)
Change in fair value of contingent consideration $(15.3) $0.9
 $(16.2)
Acquisition, restructuring and other items, net $27.5
 $12.6
 $14.9
Medical device excise tax $(1.8) $2.4
 $(4.2)
Other expense $(3.1) $(4.3) $1.2

Amortization of intangibles - Represents the amount of amortization expense that was taken on intangiblesintangible assets held by the Company.

Amortization expense remained consistent compared to the prior year.
Goodwill Impairment - Represents the impairment charge taken on goodwill.
The decreaseCompany recorded a non-cash goodwill impairment charge of $0.7$158.6 million is primarily relatedfor the year ended May 31, 2020 as the fair value of the reporting unit was less than its carrying value. There were no adjustments to intangible assets that became fully amortized.goodwill for the year ended May 31, 2021 other than foreign currency translation adjustments.

38


Change in fair value of contingent consideration - Represents changes in contingent consideration driven by changes to estimated future payments on earn-out liabilities created through acquisitions and amortization of present value discounts on long-term contingent consideration.


The decreasechange is primarily due to a write-off of $13.4 million that was taken on the AngioVac product as a result of decreases in futureRadiaDyne revised sales projections that eliminated any payments above minimums and a write-off of $3.1 million on the TiLo product as thetechnical milestone willthat would not be achieved. This resulted in a $9.2 million and $2.7 million reduction in the fair value of the contingent liability in the prior year.
During the current year, a decision was partiallymade to no longer pursue the final RadiaDyne technical milestone, which resulted in a reduction in the liability of $0.8 million. This reduction in the fair value was offset by normal amortization of the present value discount onof the Eximo contingent liabilities.consideration recorded in the second quarter of fiscal year 2020.

Acquisition, restructuring and other items, net - Acquisition, restructuring and other items, net represents costs associated with mergers and acquisitions, restructuring expenses, legal costs that are related to litigation that is not in the ordinary course of business, legal settlements and other one-time items.

Acquisition, restructuring and other items, net increased by $14.9$14.2 million compared to the prior year. The increase is attributable to the following:

In Q2Legal expense, related to litigation that is outside of the normal course of business, of $6.2 million was recorded in fiscal year 2017,2021 compared to $2.7 million in the intangible assetsprior year. Included in legal for fiscal year 2021, is a $1.0 million settlement expense;
There was no M&A expense incurred in fiscal year 2021 compared to $0.8 million in the prior year;
In fiscal year 2021, the Company incurred $0.4 million of expense to move manufacturing facilities as a result of the sale of the Fluid Management business compared to $2.8 million in the prior year;
As part of the sale of the Fluid Management business, the Company entered into a transition services agreement with Medline for certain legal, human resource, tax, accounting and information technology services from the Company for a period not to exceed 24 months. As a result of the transition services agreement, the Company invoiced Medline $1.0 million in fiscal year 2021 compared to $1.8 million in the prior year;
Other expenses of $0.8 million consists of severance associated with TiLo were written off for $3.6organizational changes, compared to $1.5 million in the prior year; and
A $14.0 million impairment charge was recorded in fiscal year 2021 as a result of the decision to discontinue our investment inabandon the TiLoOARtrac product along with a $2.0 million write-off of the investment in Embomedics due to termination of the agreement. The prior year had asset impairments of $0.4 million.technology and trademark.
There was $1.3 million of
Other expense related to the plant consolidation which consisted mainly of severance and start-up costs to move the product lines including equipment transfer expenses, accelerated depreciation for assets that will not be transferred, validation and other start up costs. The prior year had accelerated depreciation related to the Operational Excellence program of $1.0 million along with $0.5 million in other expenses.


A litigation settlement accrual for $12.5 million was recorded in the fourth quarter of fiscal year 2017.
Legal expenses of $7.0 million which was a decrease of $0.5 million from the prior year.
Other miscellaneous items decreased $2.2 million from the prior year primarily attributable to a decrease in M&A expenses of $2.5 million offset by a gain in the prior year of $0.7 million related to the modification of stock based compensation awards for the former CEO.

Medical device excise tax - Medical device excise tax is assessed on our U.S. product sales subject to exclusions and adjustments.

The Medical Device Excise Tax was suspended on January 1, 2016 therefore, fiscal year 2016 had seven months of the tax. In the current year, there is a $1.8 million refund from the Internal Revenue Service related to prior medical device taxes paid.

Other expenses- Other expenses includeexpense includes interest expense, foreign currency impacts, bank fees, and amortization of deferred financing costs.

The decrease in other expensesexpense from the prior year of $1.2$0.3 million wasis primarily due to lower interest expense on lower outstanding debt and lower interest rates under the Credit Agreement along with unrealized foreign currency unrealized gains from re-measurement offset byof $0.4 million and the write offprior year write-off of the deferred financing fees fromassociated with the original credit facility.
old Credit Facility of $0.6 million. This was partially offset by increased interest expense of $0.2 million for the $20.0 million outstanding on the Revolving Facility at the end of fiscal year 2021 compared to $40.0 million outstanding in the prior year. In addition, interest income decreased by $0.3 million.
Income Tax Provision (Benefit)Benefit
  For year ended May 31,
(in thousands) 2017 2016
Income tax expense (benefit) $4.8
 $40.3
Effective tax rate including discrete items 49% (1,240)%

Year ended May 31,
(in thousands)20212020
Income tax benefit$(4,504)$(1,348)
Effective tax rate12 %%
Our effective tax rate was 49%a benefit of 12% for fiscal 2017year 2021 compared with (1,240)%an effective tax rate benefit of 1% for the prior year. The current year effective tax rate reflects expense of $4.8 milliondiffers from the U.S. statutory rate primarily driven bydue to the impact of the US valuation allowance, foreign taxes, and other non-deductible permanent items (such as non-deductible meals and entertainment, Section 162(m) excess compensation and non-deductible share-based compensation). The prior year effective tax rate differs from the deferredU.S. Federal statutory tax liability relatedrate of 21% primarily due to intangibles that have an indefinite reversal period and cannot be usedno tax benefit being recorded on the goodwill impairment of $158.6 million.
The Company regularly assesses its ability to support therealize its deferred tax assets. The prior year rate primarily reflects income tax expenseAssessing the realization of $40.4 million related to full valuation allowance on our US net deferred tax assets that was established during fiscal 2016 and the deferred tax liability related to intangibles that have an indefinite reversal period and cannot be used to support the deferred tax assets.

At May 31, 2017, we had a net deferred tax liability of $26.1 million, after a valuation allowance on our USrequires significant management judgment. In determining whether its deferred tax assets of $48.3 million.  The increase in the valuation allowance during fiscal 2017 was $6.1 million.

A valuation allowance is provided if based upon the weight of available evidence, it isare more likely than not that some or all ofrealizable, the deferred tax assets will not be realized. After careful consideration and weighing of all the available positive and negative evidence, the weight given to the three year cumulative loss and lack of a recent history of core earnings was difficult to overcome and a full valuation allowance related to the U.S. deferred tax assets was established in the period ending May 31, 2016. Management consideredCompany evaluated all available positive and negative evidence, atand weighted the evidence based on its objectivity.
39


Evidence the Company considered included its history of net operating losses, which resulted in the Company recording a full valuation allowance for its deferred tax assets in fiscal year 2016, except the naked credit deferred tax liability.
Based on the review of all available evidence, the Company determined that it has not yet attained a sustained level of profitability and the objectively verifiable negative evidence outweighed the positive evidence. Therefore, the Company has provided a valuation allowance on its federal and state net operating loss carryforwards, federal and state R&D credit carryforwards and other net deferred tax assets that have a limited life and are not supportable by the naked credit deferred tax liability sourced income as of May 31, 2017, and considering2021. The Company will continue to assess the cumulative loss in the U.S. over the three year period, determined thatlevel of the valuation allowance is still required. Management will continueIf sufficient positive evidence exists in future periods to reevaluate the positive and negative evidence at each reporting period and if future results as projected in the U.S. and the Company's tax planning strategies are favorable,support a release of some or all of the valuation allowance, may be removed, which couldsuch a release would likely have a favorable material impact on the Company'sCompany’s results of operations in the period in which it is recorded.

Results of Operations for the years ended May 31, 2016 and 2015

For the fiscal year ended May 31, 2016, we reported net loss of $43.6 million, or $1.21 loss per basic and diluted common share, on net sales of $353.9 million compared to a fiscal 2015 net loss of $3.4 million, or $0.09 per basic and diluted common share, on net sales of $356.5 million.

Net Sales

Net sales - Net sales are derived from the sale of our products and related freight charges, less discounts and returns.

Net sales for the year ended May 31, 2016 and 2015 were:


 For the year ended May 31,
(in thousands)2016 2015 % Growth Currency Impact (Pos) Neg Constant Currency Growth Non-GAAP
Net Sales by Product Category         
       Peripheral Vascular$205,620
 $196,890
 4%    
       Vascular Access99,375
 107,754
 (8)%    
       Oncology/Surgery48,895
 51,890
 (6)%    
Total353,890
 356,534
 (1)% 3% 2%
          
Net Sales by Geography         
       United States$285,824
 $284,122
 1% —% 1%
       International68,066
 72,412
 (6)% 4% (2)%
Total$353,890
 $356,534
 (1)% 1% —%

For year ended May 31, 2016, net sales decreased $2.6 million to $353.9 million compared to the year ended May 31, 2015. As shown in the table above, while consolidated net sales decreased by 1% excluding the negative impact from fluctuations in currency exchange rates, our sales were flat year over year. The decline in net sales from vascular access and oncology surgery was partially offset by 4% year over year growth in our peripheral vascular franchise. Our international sales were significantly impacted by unfavorable movement in currency exchange rates, particularly the Euro, British pound and Canadian dollar

Peripheral Vascular sales increased $8.7 million primarily attributable to increased sales of AngioVac, Core and Venus products. While Vascular Access sales decreased $8.4 million primarily in our non-BioFlo businesses, our BioFlo line of products continued to gain traction in the marketplace. Oncology/Surgery sales decreased $3.0 million primarily due to fewer capital sales across all product lines compared to prior year. This was partially offset by increases in the sales of disposables in our Microwave and NanoKnife product lines.

U.S. sales increased $1.7 million due to growth in the Peripheral Vascular products, offset by a reduction in Vascular Access and Oncology/Surgery sales. While total US Vascular Access sales declined by $6.2 million overall, we saw growth in our U.S. BioFlo product lines of 18% year over year. U.S. Oncology/Surgery declined by $1.6 million, driven primarily through lower capital sales offset by growth in disposables. International sales decreased 2% on a constant-currency basis, due to a decline in Thermal Ablation and in the Vascular Access product lines.

Gross Profit, Operating expenses, and Other income (expense)
  For the year ended May 31,
(in thousands) 2016 2015 % Change
Gross profit $174.3
 $175.8
 (0.9)%
Gross profit % of sales 49.3% 49.3%  
Research and development $25.1
 $26.6
 (5.6)%
% of sales 7.1% 7.5%  
Selling and marketing $83.7
 $82.4
 1.6 %
% of sales 23.7% 23.1%  
General and administrative $30.6
 $30.0
 2.0 %
% of sales 8.6% 8.4%  

Gross profit - Gross profit consists of net sales less the cost of goods sold, which includes the costs of materials, products purchased from third parties and sold by us, manufacturing personnel, royalties, freight, business insurance, depreciation of property and equipment and other manufacturing overhead. The $1.5 million decrease compared to 2015 is primarily attributable to a $5.9 million charge related to the write-off of Celerity inventory on hand and hardware assets after the business decision to no longer pursue the Celerity Navigation project. The prior year gross profit included a $4.8 million charge related to the voluntary Morpheus recall.



Research and development expenses - Research and development (“R&D”) expenses include internal and external costs to develop new products, enhance existing products, validate new and enhanced products, manage clinical, regulatory and medical affairs. The decrease in R&D costs for the year ended May 31, 2016 is due to reductions in project spend and restructuring. As a percentage of net sales, R&D expenses were 7.1% for fiscal 2016, compared to 7.5% for fiscal 2015.

Sales and marketing expenses - Sales and marketing (“S&M”) expenses consist primarily of salaries, commissions, travel and related business expenses, attendance at medical society meetings, product promotions and marketing activities. Increases in S&M expense for the year ended May 31, 2016 is the result of investments made in the US sales force focused around retention and improved sales performance along with an increase in credit card fees. As a percentage of net sales, S&M expenses were 23.7% for fiscal 2016 compared to 23.1% for fiscal 2015.

General and administrative expenses - General and administrative (“G&A”) expenses include executive management, finance, information technology, human resources, business development, legal, and the administrative and professional costs associated with those activities. Increases in G&A expenses for the year ended May 31, 2016 are primarily the result of increased legal and audit fees.

  For the year ended May 31,
(in thousands) 2016 2015 $ Change
Amortization of intangibles $18.0
 $18.0
 $
Change in fair value of contingent consideration $0.9
 $(8.1) $9.0
Acquisition, restructuring and other items, net $12.6
 $26.3
 $(13.7)
Medical device excise tax $2.4
 $4.1
 $(1.7)
Other expense $(4.3) $(4.7) $0.4

Amortization of intangibles - Amortization of intangibles for the year ended May 31, 2016 remained consistent with the prior year.

Change in fair value of contingent consideration - Represents changes in contingent consideration driven by changes to estimated future payments on earn-out liabilities created through acquisitions and amortization of present value discounts on long-term contingent consideration. The decrease from the prior year is due to a $10.5 million gain recognized as a result of reducing the estimated present value of future payments due on earn-outs in the prior year compared to $1 million in gains in 2016. These gains were partially offset in each period by amortization of the present value discount on the contingent liabilities.

Acquisition, restructuring and other items, net - Expense for fiscal 2016 consists of $7.5 million of litigation expense, $2.5 million of M&A related expenses, $1.9 million of severance, $0.7 million of a gain related to the modification of stock based compensation awards for the former CEO and $1.0 million of accelerated depreciation associated with our operational excellence program, and other miscellaneous items. Expense for fiscal 2015 consists of $9.1 million of fixed and long-term asset impairments, $6.4 million of impairment on the NAMIC trademark, other costs associated with litigation, the recall of Morpheus, our operational excellence program, and other miscellaneous items. The impairment charges were primarily driven by a change in strategy within our fluid management product development pipeline, as we moved away from our planned design of an Automated Power Injector.

Medical device excise tax - Medical device excise tax is assessed on our U.S. product sales subject to exclusions and adjustments. The decrease as compared to the prior year is attributable to the suspension of the medical device excise tax as of January 1, 2016.

Other expenses - Other expenses include interest expense, foreign currency impacts, bank fees, and amortization of deferred financing costs. The increase in other expenses was primarily related to foreign currency losses.









Income Tax Provision (Benefit)
  For year ended May 31,
(in thousands) 2016 2015
Income tax expense (benefit) $40.3
 $(4.7)
Effective tax rate including discrete items (1,240)% 58%

Our effective tax rate was (1,240)% for fiscal 2016 compared with 58% for the prior year. The current year rate reflects expense of $40.4 million related to a full valuation allowance on our US net deferred tax assets. The prior year rate reflects the benefit of $9.2 million nontaxable adjustment to the contingent liabilities related to Vortex Medical and Clinical Devices, and a seven month benefit from the R&D tax credit that expired on December 31, 2014, offset by non-deductible interest expense related to contingent payments, true-ups of our fiscal year 2014 US income tax returns and the impact of the elimination of the ASC 718 APIC pool.

At May 31, 2016, we had a net deferred tax liability of $21.7 million, after recording a valuation allowance of $42.2 million. The increase in the valuation allowance was $40.4 million.

While the net deferred tax asset at May 31, 2016 before the valuation allowance was $19.9 million, the Company was required to record a valuation allowance of $40.4 million due to deferred tax liabilities related to intangibles of $20.5 million that have an indefinite reversal period and can not be used to support the deferred tax asset.

operations.
Liquidity and Capital Resources

We regularly review our liquidity and anticipated capital requirements in light of the significant uncertainty created by the COVID-19 global pandemic. We believe that our current cash on hand and availability under our Revolving Facility provide sufficient liquidity to meet our anticipated needs for capital for at least the next 12 months. We are closely monitoring receivables and payables.
Our cash and cash equivalents totaled $47.5$48.2 million as of May 31, 2017,2021, compared with $32.3$54.4 million as of May 31, 2016. Marketable securities totaled $1.2 million and $1.7 million as of May 31, 2017 and 2016, respectively, and consist of auction rate securities.2020. As of May 31, 2017,2021, total debt outstanding related to the Revolving Facility was $97.5 million comprised of a term loan. The net debt to Consolidated EBITDA, as defined by the Credit Agreement (Note 11), is 1.4x.$20.0 million. The fair value of the contingent consideration liability as of May 31, 20172021 was $12.8$15.7 million.

The table below summarizes our cash flows for the years ended May 31, 2017, 20162021 and 2015:2020:
For the year ended May 31,Year ended May 31,
(in thousands)2017 2016 2015(in thousands)20212020
Cash provided by (used in):     Cash provided by (used in):
Operating activities$55,745
 $45,216
 $25,685
Operating activities$24,093 $(14,554)
Investing activities(2,551) (7,569) (12,736)Investing activities(13,711)(63,345)
Financing activities(37,983) (23,663) (10,465)Financing activities(16,986)(95,242)
Effect of exchange rate changes on cash and cash equivalents
 (42) (198)Effect of exchange rate changes on cash and cash equivalents330 (65)
Net change in cash and cash equivalents$15,211
 $13,942
 $2,286
Net change in cash and cash equivalents$(6,274)$(173,206)
During the twelve monthsyears ended May 31, 20172021 and 2016,2020, cash flows consisted of the following:

Cash provided by (used in) operating activitiesactivities:

Year ended 2021:
Net income wasloss of $31.5 million, plus the non-cash items, primarily driven by higher gross margins, lower salesdepreciation and marketing expenses as well asamortization and share-based compensation, along with the medical device tax refund. Also impacting net income, werechanges in working capital below, contributed to cash provided by operations of $24.1 million.
In fiscal year 2021, working capital was favorably impacted by decreased inventory on hand of $11.5 million and increased accounts payable and accrued liabilities of $4.9 million. This was partially offset by increased accounts receivable of $4.2 million.
Year ended 2020:
Net loss of $166.8 million plus the non-cash items, which consistedprimarily driven by the goodwill impairment, depreciation and amortization and share-based compensation, along with the changes in working capital below, contributed to cash used in operations of $15.3$14.6 million.
Working capital was negatively impacted by increased inventory on hand of $18.8 million and decreased accounts payable and accrued liabilities of contingent consideration gains, $2.0$15.5 million. Accounts receivable had a favorable impact of $11.9 million on working capital as a result of the sale of the Fluid Management business and decreased sales in the write-offfourth quarter as a result of the Embomedics investment and $3.6 million in intangible write-offs related to TiLo. In addition, the prior year net income included a full valuation allowance on the Company's net operating losses.impact from COVID-19.
With regards to working capital, the Company focused on optimizing both DSO and DPO which contributed to $15.2 million of working capital improvement. With respect to inventory, the $2.4 million reserve for Acculis inventory partially offset the inventory build related to the plant consolidation.

40







Cash used in investing activitiesactivities:

Year ended 2021:
$3.05.2 million of cash was used for fixed asset additions and $8.5 million of Auryon placement and evaluation units.
Year ended 2020:
$45.8 million payment to acquire Eximo Medical Ltd. and $10.0 million payment to acquire the C3 Wave tip location asset from Medical Components, Inc. Refer to Note 2 of the financial statements; and
$7.2 million in fixed asset additions compared to fixed asset additions of $2.3 million in the prior year.
$0.5 million in proceeds from an auction rate security that was called during fiscal year 2017.
The prior year also had $2.0 million in warrant additionsprimarily related to EmboMedics and $3.3 million in intangible asset additions related to the Merz Distribution Agreement.

building improvements along with maintenance of equipment.
Cash used in financing activitiesactivities:

Year ended 2021:
Net $23.9$20.0 million in repaymentspayments on long-term debt after the proceeds from the Credit Agreement and repayment of the old credit agreement compared to $16.3 millionRevolving Facility in repayments in the prior year. The increase from the prior year is due to the fact that the revolver was paid down in full as of the third quarter of fiscal year 2017.2021; and
$1.3 million in deferred financing fees related to the new credit agreement.
$10.73.0 million of proceeds from stock option and ESPP activity comparedactivity.
Year ended 2020:
$132.5 million repayment of long-term debt in conjunction with the new Credit Agreement that was entered into at the beginning of the first quarter of fiscal year 2020. Refer to $2.4Note 12 of the financial statements;
$40.0 million indraw on the prior year. The large increase is related to the exerciseRevolving Facility;
$0.8 million of outlays from stock based awards from executive management turnover that took place over the past year.option and ESPP activity; and
$9.91.2 million payment on earn-out liabilities which is consistentliabilities.
On June 3, 2019 and in connection with the prior year.
$13.6 million fromcompletion of the repurchase of common shares in fiscal 2017.
On November 7, 2016,Fluid Management divestiture, the Company repaid all amounts outstanding under its existing Credit Agreement and entered into a new Credit Agreement. The Credit Agreement that provides for a $100.0$125.0 million senior secured term loan facility and a $150.0 million senior secured revolving credit facility,Revolving Facility, which includes upan uncommitted expansion feature that allows the Company to increase the total revolving commitments and/or add new tranches of term loans in an aggregate amount not to exceed $75.0 million.  The Credit Agreement includes customary representations, warranties and covenants, and acceleration, indemnity and events of default provisions, including, among other things, two financial covenants. One financial covenant requires us to maintain a $20.0fixed charge coverage ratio of not less than 1.25 to 1.00. The other financial covenant requires us to maintain a total leverage ratio of not greater than 3.00 to 1.00. The total leverage ratio is based upon our trailing twelve months total adjusted EBITDA (as defined in the Credit Agreement). The amount that we can borrow under our Credit Agreement is directly based on our leverage ratio. The interest rate on the Revolving Facility at May 31, 2021 was 1.36%.
On December 17, 2019, the Company made a $15.0 million sublimit for lettersdraw on the Revolving Facility as part of creditthe acquisition of the C3 Wave tip location asset from Medical Components Inc. that is described Note 2 to the financial statements. In the fourth quarter of fiscal year 2020, the Company made an additional $25.0 million draw on the Revolving Facility. In December 2020 and a $5.0March 2021, payments of $10.0 million sublimit for swingline loans.

each were made on the Revolving Facility. We believe that our current cash and investment balances,balance, together with cash generated from operations and access to our revolving credit facility,Revolving Facility, will provide sufficient liquidity to meet our anticipated needs for capital for at least the next 12 months. If we seek to make significant acquisitions of other businesses or technologies in the future for cash, we may require external financing.
Our contractual obligations as of May 31, 20172021 are set forth in the table below (in thousands). We have no variable interest entities or other off-balance sheet obligations.
41


Cash Payments Due By Period as of May 31, 2017 Cash payments due by period as of May 31, 2021
(in thousands)Total 
Less than
One Year
 1-3 Years 3-5 Years 
After 5
Years
(in thousands)TotalLess than
One Year
1-3 Years3-5 YearsAfter 5
Years
Contractual Obligations:         Contractual Obligations:
Long term debt and interest$106,469
 $7,372
 $29,935
 $69,162
 $
Long term debt and interest$21,008 $504 $20,504 $— $— 
Operating leases (1)9,717
 2,214
 4,951
 2,552
 
Operating leases (1)
10,724 2,923 5,032 2,598 171 
Purchase obligations (1)49,762
 8,443
 26,597
 9,189
 5,533
Acquisition-related future obligations (2)13,058
 9,750
 3,308
 
 
Purchase obligations (2)
Purchase obligations (2)
4,697 4,697 — — — 
Acquisition-related future obligations (3)
Acquisition-related future obligations (3)
20,000 — 15,000 5,000 — 
Royalties44,000
 2,500
 10,000
 10,500
 21,000
Royalties47,700 3,800 7,600 7,600 28,700 
Other834
 167
 500
 167
 
Litigation mattersLitigation matters975 975 — — — 
$223,840
 $30,446
 $75,291
 $91,570
 $26,533
$105,104 $12,899 $48,136 $15,198 $28,871 
(1) Operating leases include short-term leases that are not recorded on our consolidated balance sheet under ASU No. 2016-02.
(1)The non-cancelable operating leases and inventory purchase obligations are not reflected on our consolidated balance sheets under accounting principles generally accepted in the United States of America.
(2)Acquisition-related future obligations include scheduled minimum payments and contingent payments based upon achievement of performance measures or milestones such as sales or profitability targets, the achievement of research and development objectives or the receipt of regulatory approvals. The amount represents the undiscounted value of contingent liabilities recorded on the balance sheet. Timing of payments are as contractually scheduled, or where contingent, the Company's best estimate of payment timing.

(2) The inventory purchase obligations are not reflected on our consolidated balance sheets under accounting principles generally accepted in the United States of America.
(3) Acquisition-related future obligations include scheduled minimum payments and contingent payments based upon achievement of performance measures or milestones such as sales or profitability targets, the achievement of research and development objectives or the receipt of regulatory approvals. The amount represents the undiscounted value of contingent liabilities recorded on the balance sheet. Timing of payments are as contractually scheduled, or where contingent, the Company's best estimate of payment timing.

Results of Operations for the years ended May 31, 2020 and 2019
For management discussion and analysis of our 2020 financial results and liquidity compared with 2019, see Part II, Item 7 "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Annual Report on Form 10-K for the year ended May 31, 2020 filed on August 10, 2020.
Recent Accounting Pronouncements

Refer to Note 1 of the Notes to the Consolidated Financial Statements for Recently issuedIssued Accounting Pronouncements.



42


Item 7A.Quantitative and Qualitative Disclosures about Market Risk.

Item 7A. Quantitative and Qualitative Disclosures about Market Risk.
FOREIGN CURRENCY EXCHANGE RATE RISK

We are exposed to market risk from changes in currency exchange rates, as well as interest rate fluctuations on our credit facility and investments that could impact our results of operations and financial position.

We transact sales in currencies other than the U.S. Dollar, particularly the Euro, British pound and Canadian dollar. Approximately 7.2%6.6% of our sales in fiscal 2017year 2021 were denominated in foreign currencies. We do not have expenses denominated in foreign currencies at the level of our sales and as a result, our profitability is exposed to currency fluctuations. When the U.S. Dollar strengthens, our sales and gross profit will be negatively impacted. In addition, we have assets and liabilities denominated in non-functional currencies which are remeasured at each reporting period, with the offset to changes presented as a component of Other (Expenses)(Expense) Income. Significant non-functional balances include accounts receivable due from a sub-sectionsome of our international customers.

INTEREST RATE RISK

On November 7, 2016,June 3, 2019, we entered into the Credit Agreement which provides for a $100 million senior secured Term Loan and a $150$125.0 million Revolving Facility. Interest on both the Term Loan and Revolving Facility isfacility will be based, at the Company’s option, on either a base rate of LIBOR or Eurodollaralternate base rate, plus an applicable margin which increases as ourtied to the Company’s total leverage ratio increases, with theand having ranges between 0.25% and 0.75% for base rate loans and Eurodollar rate having ranges of 0.50% tobetween 1.25% and 1.50% to 2.25% respectively.1.75% for LIBOR loans. In the event of default, the interest rate may be increased by 2.0%. A 50 basis point (0.50%) increase or decrease inAs of May 31, 2021, there was $20.0 million outstanding on the Revolving Facility. The interest rate would result approximately in a $2.0 million increase or decrease in interest expense overon the life of the agreement.

Revolving Facility at May 31, 2021 was 1.36%.
CONCENTRATION OF CREDIT RISK

Financial instruments, which potentially subject the Company to significant concentrations of credit risk, consist primarily of cash and cash equivalents, our credit facility and trade accounts receivable.

The Company maintains cash and cash equivalents at various institutions and performs periodic evaluations of the relative credit standings of these financial institutions to ensure their credit worthiness. In addition, the Credit Agreement is structured across five above investment grade banks. The Company has the ability to draw equally amongst the five banks which limits the concentration of credit risk of one institution.

Concentration of credit risk with respect to trade accounts receivable is limited due to the large number of customers that purchase products from the Company. No single customer represents more than 10% of total sales. The Company monitors the creditworthiness of its customerscustomers. As the Company’s standard payment terms are 30 to which it grants credit terms in90 days from invoicing, the normal course of business.Company does not provide any significant financing to its customers. Although the Company does not currently foresee a significant credit risk associated with the outstanding accounts receivable, repayment is dependent upon the financial stability of our customers.

Item 8.Financial Statements and Supplementary Data.
Item 8. Financial Statements and Supplementary Data.
Financial statements and supplementary data required by Part II, Item 8 are included in Part IV of this report asand indexed asunder Item 15 (a) (1) and (2) of this report, and are incorporated by reference into this Item 8. 
Item 9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.
None.

43



Item 9A.Controls and Procedures.

Item 9A. Controls and Procedures.
Evaluation of disclosure controls and procedures

As of the end of the period covered by this report, our management, under the supervision and with the participation of our Chief Executive Officer and our Chief Financial Officer, evaluated the effectiveness of the design and operation of our disclosure controls and procedures pursuant to Rule 13a-15(b) of the Securities Exchange Act of 1934, as amended. Based on


that evaluation, the Chief Executive Officer and the Chief Financial Officer concluded that our disclosure controls and procedures as of the end of the period covered by this report were effective to provide reasonable assurance that the information required to be disclosed by us in reports filed under the Securities Exchange Act of 1934, as amended, is recorded, processed, summarized and reported within the time periods specified in the SEC rules and forms and is accumulated and communicated to management, including our Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure.

Management’s Report on Internal Control Over Financial Reporting

Our management is responsible for establishing and maintaining adequate internal control over financial reporting for our Company. Internal control over financial reporting is defined in Rules 13a-15(f) and 15d-15(f) promulgated under the Securities Exchange Act of 1934, as amended, as a process designed by, or under the supervision of, our principal executive and principal financial officers and effected by our boardBoard of directors,Directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with accounting principles generally accepted in the United States and includes those policies and procedures that:

Pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of our assets;
Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with accounting principles generally accepted in the United States, and that our receipts and expenditures are being made only in accordance with authorizations of our management and members of our boardBoard of directors;Directors; and
Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on our financial statements.

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

Our management has assessed the effectiveness of our internal control over financial reporting as of May 31, 2017.2021. In making this assessment, management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in Internal Control-Integrated Framework (2013). Based on this evaluation, management concluded that our internal control over financial reporting was effective as of May 31, 2017.

2021.
The effectiveness of our internal control over financial reporting as of May 31, 20172021 has been audited by Deloitte & Touche LLP, an independent registered public accounting firm, as stated in their report which appears herein.

Changes in Internal Control over Financial Reporting    

There was no change in our internal control over financial reporting for the fiscal quarter ended May 31, 2017 other than items described below related to our remediation actions,2021 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

44


Remediation of Prior Material Weakness in Internal Control Over Financial Reporting

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Management of the Company previously identified and disclosed the following material weakness that existed as of May 31, 2016.

We did not design and maintain effective internal controls over the accounting for the annual goodwill impairment test.  Specifically, we did not design and maintain effective controls to review in sufficient detail the cash flow projections and significant valuation model assumptions used in the goodwill impairment test as of December 31, 2015. 

During 2017, management of the Company was actively engaged in remediation efforts to address the material weakness noted above. The following actions were taken:

The design of the annual goodwill impairment test control was updated to ensure the sufficiency of the control procedures. Specifically, if the discounted cash flow method is required for performing the goodwill impairment test, detailed procedures over the cash flow projections and valuation model assumptions are appropriately detailed to instruct the operating effectiveness of the control.


Sufficient documentation was prepared, reviewed and retained over the goodwill impairment test performed as of December 31, 2016.

Based upon the significant actions taken and the testing and evaluation of the effectiveness of our internal control over financial reporting, management of the Company has concluded the material weakness in the Company’s controls no longer existed as of May 31, 2017.

























































Report of Independent Registered Public Accounting Firm



To the Shareholders and the Board of Directors and Stockholders of
AngioDynamics, Inc.
Latham, New York

Opinion on Internal Control over Financial Reporting

We have audited the internal control over financial reporting of AngioDynamics, Inc. and subsidiaries (the "Company"“Company”) as of May 31, 2017,2021, based on criteria established in Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission. Commission (COSO). In our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of May 31, 2021, based on criteria established in Internal Control — Integrated Framework (2013) issued by COSO.

We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated financial statements as of and for the year ended May 31, 2021, of the Company and our report dated July 27, 2021, expressed an unqualified opinion on those financial statements.

Basis for Opinion
The Company'sCompany’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying Management’s Report on Internal Control over Financial Reporting. Our responsibility is to express an opinion on the Company'sCompany’s internal control over financial reporting based on our audit. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.


We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States).PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.


Definition and Limitations of Internal Control over Financial Reporting
A company'scompany’s internal control over financial reporting is a process designed by, or under the supervision of, the company's principal executive and principal financial officers, or persons performing similar functions, and effected by the company's board of directors, management, and other personnel to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company'scompany’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company'scompany’s assets that could have a material effect on the financial statements.


Because of theits inherent limitations, of internal control over financial reporting including the possibility of collusion or improper management override of controls, material misstatements due to error or fraud may not be preventedprevent or detected on a timely basis.detect misstatements. Also, projections of any evaluation of the effectiveness of the internal control over financial reporting to future periods are subject to the risk that the controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

In our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of May 31, 2017, based on the criteria established in Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission.

We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the consolidated financial statements and financial statement schedule as of and for the year ended May 31, 2017 of the Company and our report dated August 4, 2017 expressed an unqualified opinion on those consolidated financial statements and financial statement schedule.




/s/ Deloitte & Touche LLP

Boston, Massachusetts
August 4, 2017




July 27, 2021
45



Item 9B.Other Information.
Item 9B. Other Information.
None.

46




Part III
Certain information required by Part III is omitted from this Annual Report on Form 10-K because we will file a definitive proxy statement within 120 days after the end of our fiscal year end pursuant to Regulation 14A (the “Proxy Statement”) for our annual meetingAnnual Meeting of Stockholders, currently scheduled for October 2017.2021. The information included in the Proxy Statement under the respective headings noted below is incorporated herein by reference.


Item 10.Directors, Executive Officers and Corporate Governance.

Item 10. Directors, Executive Officers and Corporate Governance.
Information required in this Annual Report on Form 10-K with respect to Executive Officers is contained in the discussion titled “Executive Officers of the Company” in Part I of this Annual Report on Form 10-K. The balance of the information required by Item 10 is incorporated herein by reference to our Proxy Statement under the heading “Election of Directors”. 


Item 11.Executive Compensation.

Item 11. Executive Compensation.
The information required by Item 11 is incorporated herein by reference to our Proxy Statement under the heading “Executive Compensation”. 


Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.

Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
The information required by this caption is incorporated herein by reference to our Proxy Statement under the heading “Ownership of Securities”. 


Item 13.Certain Relationships and Related Transactions, and Director Independence.

Item 13. Certain Relationships and Related Transactions, and Director Independence.
The information required by this caption is incorporated herein by reference to our Proxy Statement under the heading “Certain Relationships and Related Transactions”. 


Item 14.Principal Accounting Fees and Services.
Item 14. Principal Accounting Fees and Services.
The information required by this caption is incorporated herein by reference to our Proxy Statement under the headings “Audit Matters—Principal Accounting Fees and Services and—Policy on Audit Committee Pre-approval of Audit and Permissible Non-Audit Services of Independent Registered Public Accounting Firm”.

47




Part IV


Item 15.Exhibits, Financial Statement Schedules.
Item 15. Exhibits, Financial Statement Schedules.
(a)(1)Financial Statements
The following consolidated financial statements and supplementary data of Registrant and its subsidiaries required by Part II, Item 8, are included in Part IV of this report:
 
(2)Financial Statement Schedules
The following consolidated financial statement schedule is included in Part IV of this report:
 
All other schedules are omitted because they are not applicable, or not required, or because the required information is included in the consolidated financial statements or notes thereto.

48



Report of Independent Registered Public Accounting Firm



REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Shareholders and the Board of Directors and Stockholders of
AngioDynamics, Inc.
Latham, New York

Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheetsheets of AngioDynamics, Inc. and subsidiaries (the "Company") as of May 31, 2017,2021 and 2020, the related consolidated statementstatements of operations, comprehensive income (loss), stockholders' equity, and cash flows, for each of the yearthree years in the period ended May 31, 2017. Our audit also included2021, and the financial statementrelated notes and the schedule for the year ended May 31, 2017 listed in the Index at Item 15. These consolidated15 (collectively referred to as the "financial statements"). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of May 31, 2021 and 2020, and the results of its operations and its cash flows for each of the three years in the period ended May 31, 2021, in conformity with accounting principles generally accepted in the United States of America.
We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company's internal control over financial statement schedulereporting as of May 31, 2021, based on criteria established in Internal Control — Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission and our report dated July 27, 2021, expressed an unqualified opinion on the Company's internal control over financial reporting.
Basis for Opinion
These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on these consolidatedthe Company’s financial statements and financial statement schedule based on our audit.

audits. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our auditaudits in accordance with the standards of the Public Company Accounting Oversight Board (United States).PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includesmisstatement, whether due to error or fraud. Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence supportingregarding the amounts and disclosures in the financial statements. An auditOur audits also includes assessingincluded evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audit provides a reasonable basis for our opinion.

In our opinion, such consolidated financial statements present fairly, in all material respects,presentation of the financial position of AngioDynamics, Inc. and subsidiaries as of May 31, 2017, and the results of their operations and their cash flows for the year ended May 31, 2017, in conformity with accounting principles generally accepted in the United States of America. Also, in our opinion, such financial statement schedule, when considered in relation to the basic consolidated financial statements taken as a whole, present fairly, in all material respects, the information set forth therein.

We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the Company's internal control over financial reporting as of May 31, 2017, based on the criteria established in Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission and our report dated August 4, 2017 expressed an unqualified opinion on the Company's internal control over financial reporting.




/s/ Deloitte & Touche LLP
Boston, Massachusetts
August 4, 2017





Report of Independent Registered Public Accounting Firm


Tothe Board of Directors and Stockholders of AngioDynamics, Inc.

In our opinion, the consolidated balance sheet as of May 31, 2016 and the related consolidated statements of operations, of comprehensive income (loss), of stockholders’ equity, and of cash flows for each of the two years in the period ended May 31, 2016 present fairly, in all material respects, the financial position of AngioDynamics, Inc. and its subsidiaries (the Company) as of May 31, 2016 and the results of their operations and their cash flows for each of the two years in the period ended May 31, 2016, in conformity with accounting principles generally accepted in the United States of America. In addition, in our opinion, the financial statement schedule listed in the index appearing under Item 15(a)(2) for each of the two years in the period ended May 31, 2016 presents fairly, in all material respects, the information set forth therein when read in conjunction with the related consolidated financial statements. These financial statements and financial statement schedule are the responsibility of the Company's management. Our responsibility is to express an opinion on these financial statements and financial statement schedule based on our audits. We conducted our audits of these financial statements in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, and evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

Critical Audit Matter

The critical audit matter communicated below is a matter arising from the current-period audit of the financial statements that was communicated or required to be communicated to the audit committee and that (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.

Inventories – Excess Quantities and Obsolescence — Refer to Notes 1 & 6
Critical Audit Matter Description
The Company evaluates inventory each reporting period for excess quantities and obsolescence, establishing reserves when necessary based upon historical experience, assessment of economic conditions, and expected demand. Once recorded, these reserves are considered permanent adjustments to the carrying value of inventory. As of May 31, 2021, the Company has inventories of $48.6 million, net of excess quantities and obsolescence reserves.
We identified the reserve for excess quantities and obsolete inventory as a critical audit matter because of the significant estimates and assumptions management makes to quantify and to record the reserve, including the determination of expected demand. This required a high degree of auditor judgment and an increased extent of effort when performing audit procedures to evaluate the methodology and the reasonableness of assumptions including expected demand.
How the Critical Audit Matter Was Addressed in the Audit
Our audit procedures related to the reserve for excess quantities and obsolete inventory including management’s estimate of expected demand, included the following, among others:
We tested the effectiveness of controls over inventory, including those over the estimation of reserves for excess quantities and obsolescence.
We evaluated the reasonableness of the Company's excess and obsolete inventory policy, considering historical experience and the underlying assumptions.
We tested the calculation of the excess and obsolete reserve pursuant to the Company's policy, on a sample basis, including the completeness and accuracy of the data used in the calculation.
We performed a retrospective review by comparing management’s prior year projections of future demand by product, with actual product sales in the current year to identify potential bias in the inventory reserve.

49


We held discussions with senior financial and operating management to determine whether any strategic, regulatory, or operational changes in the business were consistent with the projections of future demand that were utilized as the basis for the reserves recorded.
We considered the existence of contradictory evidence based on consideration of internal communication to management and the board of directors, Company press releases, and analysts' reports, as well as any changes within the business.

/s/ PricewaterhouseCoopersDeloitte & Touche LLP

Boston, Massachusetts
August 1, 2016July 27, 2021




We have served as the Company’s auditor since 2016.

50


AngioDynamics, Inc. and Subsidiaries
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
 
 Year ended May 31,
 202120202019
Net sales$291,010 $264,157 $270,634 
Cost of sales (exclusive of intangible amortization)134,222 113,885 114,634 
Gross profit156,788 150,272 156,000 
Operating expenses
Research and development36,390 29,682 28,258 
Sales and marketing81,306 78,634 76,829 
General and administrative35,918 37,872 34,902 
Amortization of intangibles18,136 18,121 17,056 
Goodwill impairment158,578 
Change in fair value of contingent consideration89 (11,531)(6,776)
Acquisition, restructuring and other items, net20,232 6,014 15,127 
Total operating expenses192,071 317,370 165,396 
Operating loss(35,283)(167,098)(9,396)
Other expenses
Interest expense, net(861)(907)(5,099)
Other income (expense), net92 (130)(207)
Total other expenses, net(769)(1,037)(5,306)
Loss from continuing operations before income tax benefit(36,052)(168,135)(14,702)
Income tax benefit(4,504)(1,348)(3,556)
Net loss from continuing operations(31,548)(166,787)(11,146)
Income from discontinued operations, net of income tax72,486 
Net income (loss)$(31,548)$(166,787)$61,340 
Loss per share - continuing operations
Basic$(0.82)$(4.39)$(0.30)
Diluted$(0.82)$(4.39)$(0.30)
Income per share - discontinued operations
Basic$$$1.93 
Diluted$$$1.93 
Income (loss) per share
Basic$(0.82)$(4.39)$1.64 
Diluted$(0.82)$(4.39)$1.64 
Weighted average shares outstanding
Basic38,342 37,961 37,485 
Diluted38,342 37,961 37,485 
 Year ended May 31,
 2017 2016 2015
Net sales$349,643
 $353,890
 $356,534
Cost of sales (exclusive of intangible amortization)173,474
 179,574
 180,738
Gross profit176,169
 174,316
 175,796
Operating expenses     
Research and development25,269
 25,053
 26,594
Sales and marketing78,819
 83,743
 82,351
General and administrative31,406
 30,583
 30,031
Amortization of intangibles17,296
 17,964
 17,966
Change in fair value of contingent consideration(15,261) 948
 (8,096)
Acquisition, restructuring and other items, net27,510
 12,591
 26,257
Medical device excise tax(1,837) 2,416
 4,142
Total operating expenses163,202
 173,298
 179,245
Operating income (loss)12,967
 1,018
 (3,449)
Other (expenses) income     
Interest expense, net(2,839) (3,385) (3,193)
Other expense(281) (886) (1,489)
Total other expenses, net(3,120) (4,271) (4,682)
Income (loss) before income tax expense (benefit)9,847
 (3,253) (8,131)
Income tax expense (benefit)4,839
 40,337
 (4,743)
Net income (loss)$5,008
 $(43,590) $(3,388)
Earnings (loss) per share     
Basic$0.14
 $(1.21) $(0.09)
Diluted$0.14
 $(1.21) $(0.09)
Weighted average shares outstanding     
Basic36,617
 36,161
 35,683
Diluted36,959
 36,161
 35,683



The accompanying notes are an integral part of these consolidated financial statements.


6051




AngioDynamics, Inc. and Subsidiaries
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
(in thousands)
 
 Year ended May 31,
 202120202019
Net income (loss)$(31,548)$(166,787)$61,340 
Other comprehensive income (loss), before tax:
Unrealized gain on marketable securities33 
Reclassification adjustment for gains included in net income(116)
Foreign currency translation gain (loss)4,494 11 (317)
Other comprehensive income (loss), before tax4,494 11 (400)
Income tax benefit (expense) related to items of other comprehensive income (loss)
Other comprehensive income (loss), net of tax4,494 11 (400)
Total comprehensive income (loss), net of tax$(27,054)$(166,776)$60,940 
 Year ended May 31,
 2017 2016 2015
Net income (loss)$5,008
 $(43,590) $(3,388)
Other comprehensive income (loss), before tax:     
Unrealized gain (loss) on marketable securities12
 (11) (120)
Unrealized gain (loss) on interest rate swap
 257
 296
Foreign currency translation gain (loss)(545) (112) (264)
Other comprehensive income (loss), before tax(533) 134
 (88)
Income tax benefit (expense) related to items of other comprehensive income (loss)
 (92) (64)
Other comprehensive income (loss), net of tax(533) 42
 (152)
Total comprehensive income (loss), net of tax$4,475
 $(43,548) $(3,540)




The accompanying notes are an integral part of these consolidated financial statements.


6152




AngioDynamics, Inc. and Subsidiaries
CONSOLIDATED BALANCE SHEETS
(in thousands, except share data)
May 31, 2021May 31, 2020
Assets
Current Assets
Cash and cash equivalents$48,161 $54,435 
Accounts receivable, net of allowances of $1,919 and $2,150, respectively35,405 31,263 
Inventories48,614 59,905 
Prepaid expenses and other8,699 7,310 
Total current assets140,879 152,913 
Property, plant and equipment, net37,073 28,312 
Intangible assets, net168,977 197,136 
Goodwill201,316 200,515 
Other assets13,193 15,338 
Total Assets$561,438 $594,214 
Liabilities and Stockholders' Equity
Current Liabilities
Accounts payable$19,630 $19,096 
Accrued liabilities35,459 29,380 
Current portion of contingent consideration836 
Other current liabilities2,495 2,133 
Total current liabilities57,584 51,445 
Long-term debt20,000 40,000 
Deferred income taxes19,955 24,057 
Contingent consideration, net of current portion15,741 14,811 
Other long-term liabilities8,701 9,029 
Total Liabilities121,981 139,342 
Commitments and Contingencies (Note 17)00
Stockholders’ Equity
Preferred stock, par value $0.01 per share, 5,000,000 shares authorized; 0 shares issued and outstanding
Common stock, par value $0.01 per share, 75,000,000 shares authorized; 38,920,951 and 38,448,536 shares issued and 38,550,951 and 38,078,536 shares outstanding at May 31, 2021 and 2020, respectively377 374 
Additional paid-in capital573,507 561,871 
Accumulated deficit(131,866)(100,318)
Treasury stock, 370,000 shares, at cost at May 31, 2021 and 2020, respectively(5,714)(5,714)
Accumulated other comprehensive loss3,153 (1,341)
Total Stockholders' Equity439,457 454,872 
Total Liabilities and Stockholders' Equity$561,438 $594,214 
 May 31,
2017
 May 31,
2016
Assets   
Current Assets   
Cash and cash equivalents$47,544
 $32,333
Marketable securities, at fair value1,215
 1,653
Accounts receivable, net of allowances of $2,945 and $4,372, respectively44,523
 52,867
Inventories54,506
 55,370
Prepaid income taxes336
 788
Prepaid expenses and other5,790
 3,243
Total current assets153,914
 146,254
Property, plant and equipment, net45,234
 48,284
Other assets1,886
 3,827
Intangible assets, net145,675
 166,577
Goodwill361,252
 361,252
Total Assets$707,961
 $726,194
Liabilities and Stockholders' Equity   
Current Liabilities   
Accounts payable$18,087
 $15,616
Accrued liabilities38,804
 21,942
Current portion of long-term debt5,000
 16,250
Current portion of contingent consideration9,625
 12,919
Total current liabilities71,516
 66,727
Long-term debt, net of current portion91,320
 104,291
Deferred income taxes26,112
 21,684
Contingent consideration, net of current portion3,136
 25,356
Other long-term liabilities850
 908
Total Liabilities192,934
 218,966
Commitments and Contingencies (Note 15)
 
Stockholders’ Equity   
Preferred stock, par value $.01 per share, 5,000,000 shares authorized; no shares issued and outstanding
 
Common stock, par value $.01 per share, 75,000,000 shares authorized; 37,210,091 and 36,420,403 shares issued and 36,840,091 and 36,278,098 shares outstanding at May 31, 2017 and 2016, respectively367
 363
Additional paid-in capital532,705
 525,775
Accumulated deficit(11,007) (16,015)
Treasury stock, 370,000 and 142,305 shares, at cost at May 31, 2017 and 2016, respectively(5,714) (2,104)
Accumulated other comprehensive loss(1,324) (791)
Total Stockholders' Equity515,027
 507,228
Total Liabilities and Stockholders' Equity$707,961
 $726,194

The accompanying notes are an integral part of these consolidated financial statements.


6253




AngioDynamics, Inc. and Subsidiaries
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
Year ended May 31, 2017, 2016 and 2015
(in thousands, except share data)
 
Common StockAdditional
paid in
capital
Retained
earnings (accumulated deficit)
Accumulated
other
comprehensive
income (loss)
Treasury StockTotal
SharesAmountSharesAmount
Balance at May 31, 201837,594,493 $370 $543,762 $5,129 $(952)(370,000)$(5,714)$542,595 
Net income61,340 61,340 
Exercise of stock options134,253 1,525 1,526 
Issuance/cancellation of restricted stock units177,538 (667)(667)
Issuance of performance share units5,235 
Purchase of common stock under Employee Stock Purchase Plan72,863 1,171 1,172 
Stock-based compensation9,249 9,249 
Other comprehensive loss, net of tax(400)(400)
Balance at May 31, 201937,984,382 $372 $555,040 $66,469 $(1,352)(370,000)$(5,714)$614,815 
Net loss(166,787)(166,787)
Exercise of stock options50,636 560 561 
Issuance/cancellation of restricted stock units312,951 (2,537)(2,537)
Purchase of common stock under Employee Stock Purchase Plan100,567 1,216 1,217 
Stock-based compensation7,592 7,592 
Other comprehensive income, net of tax11 11 
Balance at May 31, 202038,448,536 $374 $561,871 $(100,318)$(1,341)(370,000)$(5,714)$454,872 
Net loss(31,548)(31,548)
Exercise of stock options123,536 1,929 1,930 
Issuance/cancellation of restricted stock units184,685 (223)(223)
Purchase of common stock under Employee Stock Purchase Plan164,194 1,305 1,307 
Stock-based compensation8,625 8,625 
Other comprehensive income, net of tax4,494 4,494 
Balance at May 31, 202138,920,951 $377 $573,507 $(131,866)$3,153 (370,000)$(5,714)$439,457 
 Common Stock 
Additional
paid in
capital
 
Retained
earnings (accumulated deficit)
 
Accumulated
other
comprehensive
loss
 Treasury Stock Total
Shares Amount    Shares Amount
Balance at May 31, 201435,442,004
 $353
 $508,354
 $30,963
 $(681) (142,305) $(2,104) $536,885
Net loss      (3,388)       (3,388)
Exercise of stock options341,446
 3
 4,335
         4,338
Issuance/cancellation of restricted stock units141,274
 2
 
         2
Purchase of common stock under Employee Stock Purchase Plan119,001
 2
 1,414
         1,416
Stock-based compensation    5,998
         5,998
Other comprehensive income (loss), net of tax        (152)     (152)
Balance at May 31, 201536,043,725
 $360
 $520,101
 $27,575
 $(833) (142,305) $(2,104) $545,099
Net loss      (43,590)       (43,590)
Exercise of stock options101,040
 1
 1,296
         1,297
Issuance/cancellation of restricted stock units137,681
 1
 (332)         (331)
Purchase of common stock under Employee Stock Purchase Plan137,957
 1
 1,470
         1,471
Stock-based compensation    3,240
         3,240
Other comprehensive income (loss), net of tax        42
     42
Balance at May 31, 201636,420,403
 $363
 $525,775
 $(16,015) $(791) (142,305) $(2,104) $507,228
Net income      5,008
       5,008
Exercise of stock options751,062
 7
 9,858
         9,865
Issuance/cancellation of restricted stock units158,341
 1
 (587)         (586)
Issuance of performance share units23,405
 
 
         
Purchase of common stock under Employee Stock Purchase Plan129,185
 1
 1,418
         1,419
Stock-based compensation    6,183
         6,183
Treasury stock retirement(642,305) (2) (9,942)     642,305
 9,944
 
Common stock repurchased370,000
 (3)       (870,000) (13,554) (13,557)
Other comprehensive income (loss), net of tax        (533)     (533)
Balance at May 31, 201737,210,091
 $367
 $532,705
 $(11,007) $(1,324) (370,000) $(5,714) $515,027



The accompanying notes are an integral part of these consolidated financial statements.


6354




AngioDynamics, Inc. and Subsidiaries
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
Year ended May 31, Year ended May 31,
2017 2016 2015 202120202019
Cash flows from operating activities:     Cash flows from operating activities:
Net income (loss)$5,008
 $(43,590) $(3,388)Net income (loss)$(31,548)$(166,787)$61,340 
Adjustments to reconcile net income (loss) to net cash provided by operating activities:     
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:
Depreciation and amortization24,811
 28,115
 29,861
Depreciation and amortization25,916 23,805 25,880 
Non-cash lease expenseNon-cash lease expense2,456 2,070 
Goodwill impairmentGoodwill impairment158,578 
Stock based compensationStock based compensation8,625 7,592 9,249 
Gain on dispositionGain on disposition(46,592)
Transaction costs for dispositionTransaction costs for disposition(4,030)
Change in fair value of contingent considerationChange in fair value of contingent consideration89 (11,531)(6,776)
Deferred income tax provision4,428
 39,983
 (5,123)Deferred income tax provision(4,805)(1,568)(2,655)
Stock based compensation6,183
 3,240
 5,998
Changes in accounts receivable allowances(313) 2,377
 1,448
Changes in accounts receivable allowances207 429 (202)
Write-off of other assets2,685
 
 
Change in fair value of contingent consideration(15,261) 948
 (8,096)
Loss on impairment/disposal of long-term assets3,930
 806
 9,381
Loss on impairment of intangible assets
 384
 6,400
Asset impairments and disposalsAsset impairments and disposals14,228 1,321 2,495 
Other(586) 90
 181
Other(147)86 (5)
Changes in operating assets and liabilities, net of effects of acquisitions:     
Changes in operating assets and liabilities:Changes in operating assets and liabilities:
Accounts receivable8,479
 3,131
 2,095
Accounts receivable(4,162)11,918 (3,177)
Inventories687
 11,976
 (5,648)Inventories11,539 (18,845)(1,428)
Prepaid expenses and other(3,520) 712
 (1,170)Prepaid expenses and other(3,181)(6,155)(1,871)
Accounts payable, accrued liabilities and other long-term liabilities19,214
 (2,956) (6,254)
Net cash provided by operating activities55,745
 45,216
 25,685
Accounts payable, accrued and other liabilitiesAccounts payable, accrued and other liabilities4,876 (15,467)5,212 
Net cash provided by (used in) operating activitiesNet cash provided by (used in) operating activities24,093 (14,554)37,440 
Cash flows from investing activities:     Cash flows from investing activities:
Additions to property, plant and equipment(3,001) (2,326) (11,383)Additions to property, plant and equipment(5,187)(7,235)(3,118)
Acquisition of intangible assets
 (3,268) (1,353)
Acquisition of warrants
 (2,000) 
Proceeds from sale or maturity of marketable securities450
 25
 
Net cash used in investing activities(2,551) (7,569) (12,736)
Additions to placement and evaluation unitsAdditions to placement and evaluation units(8,524)
Proceeds from disposition of discontinued operationsProceeds from disposition of discontinued operations169,242 
Cash paid for acquisitionsCash paid for acquisitions(55,760)(84,920)
Acquisition of intangiblesAcquisition of intangibles(350)
Proceeds from sale of marketable securitiesProceeds from sale of marketable securities1,350 
Net cash provided by (used in) investing activitiesNet cash provided by (used in) investing activities(13,711)(63,345)82,554 
Cash flows from financing activities:     Cash flows from financing activities:
Repayment of long-term debt(140,381) (16,250) (20,000)Repayment of long-term debt(20,000)(132,500)(15,000)
Proceeds from issuance of and borrowings on long-term debt116,471
 
 15,000
Proceeds from exercise of stock options and ESPP10,698
 2,437
 5,757
Proceeds from borrowings on long-term debtProceeds from borrowings on long-term debt40,000 55,000 
Deferred financing costs on long-term debtDeferred financing costs on long-term debt(775)
Payment of acquisition related contingent consideration(9,850) (9,850) (11,222)Payment of acquisition related contingent consideration(1,208)(8,100)
Deferred financing costs on long-term debt(1,364) 
 
Repurchase of common stock(13,557) 
 
Net cash used in financing activities(37,983) (23,663) (10,465)
Proceeds (outlays) from exercise of stock options and employee stock purchase planProceeds (outlays) from exercise of stock options and employee stock purchase plan3,014 (759)2,031 
Net cash provided by (used in) financing activitiesNet cash provided by (used in) financing activities(16,986)(95,242)33,931 
Effect of exchange rate changes on cash and cash equivalents
 (42) (198)Effect of exchange rate changes on cash and cash equivalents330 (65)(380)
Increase in cash and cash equivalents15,211
 13,942
 2,286
(Decrease) increase in cash and cash equivalents(Decrease) increase in cash and cash equivalents(6,274)(173,206)153,545 
Cash and cash equivalents at beginning of year32,333
 18,391
 16,105
Cash and cash equivalents at beginning of year54,435 227,641 74,096 
Cash and cash equivalents at end of year$47,544
 $32,333
 $18,391
Cash and cash equivalents at end of year$48,161 $54,435 $227,641 
 

The accompanying notes are an integral part of these consolidated financial statements.


6455




AngioDynamics, Inc. and Subsidiaries
CONSOLIDATED STATEMENTS OF CASH FLOWS—(Continued)
(in thousands)
 Year ended May 31,
 2017 2016 2015
Supplemental disclosures of cash flow information:     
Supplemental disclosure of non-cash investing and financing activities:     
Contractual obligations for purchase of fixed assets$26
 $75
 $140
Contractual obligations for tax basis adjustment
 
 779
Cash paid (received) during the year for:     
Interest$2,969
 $3,063
 $3,151
Income taxes(102) 332
 699
 Year ended May 31,
 202120202019
Supplemental disclosure of non-cash investing and financing activities:
Increase (decrease) in accounts payable for purchases of fixed assets$(139)$224 $(114)
Fair value of contingent consideration for acquisitions14,900 25,100 
Fair value of acquisition consideration included in accrued expenses4,650 
Cash paid during the year for:
Interest$731 $413 $5,115 
Income taxes313 682 426 
 





The accompanying notes are an integral part of these consolidated financial statements.


6556




AngioDynamics, Inc. and Subsidiaries
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

1. BASIS OF PRESENTATION, BUSINESS DESCRIPTION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Basis of Presentation and Description of Business

The consolidated financial statements include the accounts of AngioDynamics, Inc. and its wholly owned subsidiaries, (collectively, "us", "we", or the “Company”).
The Company designs, manufactures and sells a wide range of medical, surgical and diagnostic devices used by professional healthcare providers for vascular access, for the treatment of peripheral vascular disease and in oncology and surgical settings. The devices are generally used in minimally invasive, image-guided procedures. Most of the Company's products are intended to be used once and then discarded, or they may be temporarily implanted for short- or long-term use.

On May 31, 2019, the Company completed the sale of the Fluid Management business and all of the assets used primarily in connection with the Fluid Management business (Note 3). As the disposal of this business represents a strategic shift with a major effect on the Company's operations, for all periods presented in the Consolidated Statements of Operations and Comprehensive Income, all sales, costs, expenses, gains and income taxes attributable to Fluid Management have been reported under the captions, “Income from Discontinued Operations, Net of Income Tax.”  Cash flows used in or provided by Fluid Management have been reported in the Consolidated Statements of Cash Flows under operating and investing activities.
Accounting Principles

The consolidated financial statements and accompanying notes have been prepared in conformity with accounting principles generally accepted in the United States of America ("GAAP").

Principles of Consolidation

The consolidated financial statements include the accounts of AngioDynamics and itits subsidiaries (all of which are wholly owned). All intercompany balances and transactions have been eliminated.

Use of Estimates

The preparation of consolidated financial statements, in conformity with accounting principles generally accepted in the United States of America, requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements. Estimates also affect reported amounts of sales and expenses during the reporting period. Actual results could differ from those estimates.

Reclassifications

Certain reclassifications have been made to conform the prior year consolidated financial statements and notes to the current year presentation. These include a reclassification of bad debt expense from Sales and Marketing to General and Administrative.  The amount of the reclassification related to fiscal year 2016 is $1.0 million and fiscal year 2015 is $0.9 million. The adoption of ASC Update No. 2015-03 resulted in a reclassification of $0.9 million from other assets to long-term debt in the Company's consolidated balance sheet as of May 31, 2016.
Cash and Cash Equivalents
The Company considers all unrestricted highly liquid investments with an initial maturity of less than three months at the date of purchase to be cash equivalents. The Company maintains cash and cash equivalent balances with financial institutions in the United States in excess of amounts insured by the Federal Deposit Insurance Corporation.

Marketable Securities

Marketable securities, which include auction rate investments, are classified as “available-for-sale securities” and are reported at fair value, with unrealized gains and losses excluded from operations and reported as a component of accumulated other comprehensive income (loss), net of the related tax effects, in stockholders’ equity. Cost is determined using the specific identification method. The Company holds investments in auction rate securities in order to generate higher than typical money market rate investment returns. Auction rate securities typically are high credit quality, generally achieved with municipal bond insurance. As of May 31, 2017 and 2016, the Company had $1.2 million and $1.7 million, respectively, in investments in two auction rate securities issued by New York state and local government authorities that failed auctions. The authorities are current in their interest payments on the securities.



Fair Value Instruments

The carrying amount of the Company's cash and cash equivalents, accounts receivable, accounts payable and long-term debt approximates fair value due to the short-term nature or market interest rates of these items. The Company bases the fair value of short-term investments on quoted market prices or other relevant information generated by market transactions involving identical or comparable assets. The Company measures and records derivative financial instruments at fair value. See Note 35 for further discussion of financial instruments that are carried at fair value on a recurring and nonrecurring basis.

Accounts Receivable

Accounts receivable, principally trade receivables, are generally due within 30 to 90 days and are stated at amounts due from customers, net of an allowance for estimated sales returns and doubtful accounts. The Company performs ongoing credit evaluations of customers and adjusts credit limits based upon payment history and the customer’s current creditworthiness, as determined by a review of their current credit information. The Company continuously monitors aging reports, collections and payments from customers, and a provision for estimated credit losses is maintained based upon historical experience and any specific customer collection issues that have been identified. While such credit losses have historically been within expectations
57


and the provisions established, the Company cannot guarantee that the same credit loss rates will be experienced in the future. The Company writes off accounts receivable when they are determined to be uncollectible.

Inventories

Inventories are stated at the lower of cost (usingor net realizable value based on the first-in, first-out method)cost method and consist of raw materials, work in process and finished goods. The standard cost of finished goods and work-in-process inventory is composed of material, labor and manufacturing overhead, which approximates actual cost. In addition to stating inventory at the lower of cost or market. Appropriate consideration is given to deterioration, obsolescence, expiring and other factors in evaluating net realizable value.value, we also evaluate inventory each reporting period for excess quantities and obsolescence, establishing reserves when necessary based upon historical experience, assessment of economic conditions and expected demand. Once recorded, these reserves are considered permanent adjustments to the carrying value of inventory An increase to inventory reserves results in a corresponding increase in cost of revenue. Inventories are written off against the reserve when they are physically disposed.

Property, Plant and Equipment

Property, plant and equipment are stated at cost, less accumulated depreciation. Depreciation is computed using the straight-line method over the estimated useful lives of the assets. Placement and evaluation units represent capital equipment placed at customer locations under placement or evaluation agreements for which depreciation expense is included in cost of sales on the Consolidation Statements of Operations. Refer below for useful lives by category:
Estimated useful lives
Building and building improvements4 to 39 years
Computer software and equipment3 to 5 years
Machinery and equipment35 to 8 years
Computer softwarePlacement and equipmentevaluation units3 to 105 years
The Company evaluates property, plant and equipment for impairment periodically to determine if changes in circumstances or the occurrence of events suggest the carrying value of the asset or asset group may not be recoverable. Expenditures for repairs and maintenance are charged to expense as incurred. Renewals and betterments are capitalized.

Goodwill and Intangible Assets

Intangible assets other than goodwill, indefinite lived intangible assets and acquired in process research and development ("IP R&D&D") are amortized over their estimated useful lives, which range between two and to eighteen years, on either a straight-line basis over the expected period of benefit or as revenues arerevenue is earned from the sales of the related products.product. The Company periodically reviews the estimated useful lives of intangible assets and reviewreviews such assets or asset groups for impairment whenever events or changes in circumstances indicate that the carrying value of the assetassets may not be recoverable. Such conditions could include significant adverse changes in the business climate, current-period operating or cash flow losses, significant declines in forecasted operations, or a current expectation that an asset group is not recoverable.will be disposed of before the end of its useful life. When testing for impairment of definite-lived intangible assets held for use, the Company groups assets at the lowest level for which cash flows are separately identifiable. The Company determinesoperates as a single asset group. If a triggering event is deemed to exist, the fair value of the reporting unit based on the market valuation approach or the income approach.Company performs an undiscounted operating cash flow analysis to determine if an impairment exists. If an intangible asset or asset group is considered to be impaired, the amount of the impairment will equal the excess of the carrying value over the fair value of the asset.

Acquired IP R&D has an indefinite life and is not amortized until completion of the development of the project, at which time the IP R&D becomes an amortizable asset. If the related project is not completed in a timely manner or the project is terminated or abandoned, the Company may have an impairment related to the IP R&D, calculated as the excess of the asset’s carrying value over its fair value.

The Company's policy defines IP R&D as the value assigned to those projects for which the related products have not received regulatory approval and have no alternative future use. Determining the portion of the purchase price allocated to IP R&D requires us to make significant estimates. The amount of the purchase price allocated to IP R&D is determined by estimating the future cash flows of each project or technology and discounting the net cash flows back to their present values.

The discount rate used is determined at the time of measurement in accordance with accepted valuation methods. These methodologies include consideration of the risk of the project not achieving commercial feasibility.

Goodwill is the amount by which the cost of acquired net assets in a business combination exceeded the fair value of net identifiable assets on the date of purchase. Goodwill and other intangible assets that have indefinite useful lives are not amortized, but rather, are tested for impairment annually or more frequently if impairment indicators arise.

Goodwill represents the excess of the purchase price over the fair value of the net tangible and identifiable intangible assets acquired in each business combination. Goodwill and intangible assets have been recorded at either incurred or allocated cost. Allocated costs were based on respective fair market values at the date of acquisition.
For goodwill, the impairment test requires a comparison of the estimated fair value of the reporting unit to which the goodwill is assigned to the carrying value of the assets and liabilities of that reporting unit. The determination of reporting units also requires management judgment. The Company considers whether a reporting unit exists within a reportable segment based on the availability of discrete financial information. The Company operates as a single operating segment with 1 reporting unit and consequently evaluates goodwill for impairment based on an evaluation of the fair value of the Company as a whole. If the carrying value of the reporting unit exceeds the fair value of the reporting unit, the carrying value of the reporting unit’s goodwill is reduced to its implied fair value through an adjustment to the goodwill balance, resulting in an impairment charge. The Company utilizes either discounted cash flow models or other valuation models, such as comparative transactions and market multiples, to determine the fair value of our reporting unit. The Company makes assumptions about future cash flows, future operating plans, discount rates, comparable companies, market multiples, purchase price premiums and other factors in those models. Different assumptions and judgment determinations could yield different conclusions that would result in an impairment charge to income in the period that such change or determination was made.

58


Contingent Consideration

The fair value of the liability for contingent consideration recorded on the acquisition date for a business combination is based on probability weighted estimated cash flow streams, discounted back to present value using a discount rate determined in accordance with accepted valuation methods and reflective of the risk associated with the estimated cash flow streams. The liability for contingent consideration is remeasured to fair value at each reporting period with changes recorded in earnings until the contingency is resolved.

Revenue Recognition

The Company recognizes revenue when the following four criteria has been met: (i) persuasive evidence that an arrangement exists; (ii) the price is fixed or determinable; (iii) collectability is reasonably assured; and (iv) product delivery has occurredit transfers control of promised goods or services have been rendered. The Company recognizes revenue, net of sales taxes assessed by any governmental authority, as products are shipped, based on shipping terms, and when title and risk of loss passes to customers. The Company negotiates shipping and credit terms on a customer-by-customer basis and products are shipped atits customers in an agreed upon price. All product returns must be pre-approved byamount that reflects the consideration to which the Company expects to be entitled to in exchange for those goods and customers may be subject to a 20% restocking charge. To be accepted, a returned product must be unadulterated, undamaged and have at least twelve months remaining prior to its expiration date. Chargesservices. See Note 4, “Revenue from Contracts with Customers” for discounts, returns, rebates and other allowances are recognized as a deduction from revenuefurther discussion on an accrual basis in the period in which the revenue is recorded. The accrual for product returns, discounts and other allowances is based on the Company’s history.revenue.

Shipping and handling costs, associated with the distribution of finished products to customers, are recorded in costs of goods sold and are recognized when the related finished product is shipped to the customer. Amounts charged to customers for shipping are recorded in net sales.

Research and Development

Research and development costs, including salaries, consulting fees, building costs, utilities and administrative expenses that are related to developing new products, enhancing existing products, validating new and enhanced products, managing clinical, regulatory and medical affairs are expensed as incurred.





Income Taxes

The Company calculates income tax expense for each jurisdiction in which it operates. This involves estimating actual current taxes due plus assessing temporary differences arising from differing treatment for tax and accounting purposes that are recorded as deferred tax assets and liabilities. The Company periodically evaluates deferred tax assets, capital loss carryforwards and tax credit carryforwards to determine their recoverability based primarily on the Company's ability to generate future taxable income and capital gains. Where it is more-likely-than-not these will not be recovered, the Company estimates a valuation allowance and records a corresponding additional tax expense in the consolidated statement of operations.

The Company recognizes and measures uncertain tax positions taken or expected to be taken in a tax return utilizing a two-step approach. The Company first determines if the weight of available evidence indicates that it is more likely than not that the tax position will be sustained on audit, including resolution of any related appeals or litigation processes. The second step is that the Company measures the tax benefit as the largest amount that is more likely than not to be realized upon ultimate settlement. The Company recognizes interest and penalties related to uncertain tax positions in the provision for income taxes on the consolidated statements of operations.

Warranty Costs

The Company makes periodic provisions for expected warranty costs. Historically, warranty costs have been insignificant.
Stock BasedStock-Based Compensation

Stock-based compensation expense reflects the fair value of stock-based awards measured at the grant date and recognized over the relevant service period. The expense recognized includes the impact of forfeitures as they occur. The Company estimates the fair value of each stock-based award on the measurement date using either the current market price of the stock, the Black-Scholes option valuation model, or the Monte Carlo Simulation valuation model. The Black-Scholes and Monte Carlo Simulation valuation models incorporate assumptions as to stock price volatility, the expected life of options or restricted stock units, a risk-free interest rate and dividend yield. The Company recognizes stock-based compensation expense related to options, restricted stock units and market based performance stock units on a straight-line basis over the service period of the award, which is generally 4 years for options and restricted stock units and 3 years for market based performance stock units.
Foreign Currency Translation

The functional currency of most of the Company's foreign subsidiaries is the local currency in which the subsidiary operates. For foreign operations where the local currency is considered to be the functional currency, the Company translates assets and liabilities into U.S. dollars at the exchange rate on the balance sheet date. The Company translates income and expense items at average rates of exchange prevailing during each period. The Company accumulates translation adjustments in accumulated other comprehensive loss, a component of stockholders’ equity.

For foreign operations where the U.S. dollar is considered to be the functional currency, the Company remeasures monetary assets and liabilities into U.S. dollars at the exchange rate on the balance sheet date and non-monetary assets and liabilities are remeasured into U.S. dollars at historical exchange rates. The Company translates income and expense items at average rates of exchange prevailing during each period. The Company recognizes remeasurement adjustments as a component of other expense in the consolidated statements of operations.

Transaction gains or losses that arise from exchange rate fluctuations on transactions denominated in a currency other than the functional currency are included in other expense in the statements of operations as incurred.

Derivative Financial Instruments

The Company is exposed to market risks, including changes in foreign currency and interest rates. The Company periodically enters into certain derivative financial instruments to hedge the underlying economic exposure.

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Derivative instruments are presented in the consolidated financial statements at their fair value. Changes in the fair value of derivative financial instruments are either recognized periodically in income or in stockholders’ equity as a component of accumulated other comprehensive income (loss) depending on whether the derivative financial instrument qualifies for hedge accounting and, if so, whether it qualifies as a fair value or cash flow hedge. Generally, the changes in the fair value of derivatives accounted for as fair value hedges are recorded in income along with the portions of the changes in the fair value of hedged items that relate to the hedged risks. Changes in the fair value of derivatives accounted for as cash flow hedges, to the extent they are effective as hedges, are recorded in accumulated other comprehensive income (loss). There were no derivative instruments held by the Company as of May 31, 2021 and 2020.

Contingencies

The Company is subject to various legal proceedings that arise in the ordinary course of business, including patent infringement and product liability matters. The Company records accruals for contingencies when it is probable the liability has been incurred and the amount can be reasonably estimated. Legal fees are expensed as incurred. Insurance recoveries related to potential claims are recognized up to the amount of the recorded liability when coverage is confirmed and the estimated recoveries are probable of payment. These recoveries are not netted against the related liabilities for financial statement presentation.

Recently Issued Accounting Pronouncements - Adopted

In April 2015, the Financial Accounting Standards Board ("FASB") issued ASC Update No. 2015-03, Interest-Imputation of Interest (Subtopic 835-30): Simplifying the Presentation of Debt Issuance Costs. Update No. 2015-03 requires debt issuance costs related to a recognized debt liability to be presented in the balance sheet as a direct deduction from the carrying amount of that debt liability, consistent with debt discounts. Update No. 2015-03 is effective for annual reporting periods beginning after December 15, 2015 and interim periods within those reporting periods. This was adopted in the first quarter of fiscal 2017 and the Company reclassified $0.9 million from other assets to long-term debt, net in the balance sheet as of May 31, 2016.

Recently Issued Accounting Pronouncements - Not Yet Applicable or Adopted

In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (ASU 2014-09). ASU 2014-09The following table provides a single, comprehensivedescription of recent accounting model for revenues arising from contracts with customerspronouncements that supersedes most ofmay have a material effect on the existing revenue recognition guidance, including industry-specific guidance. Under this model, revenue is recognized at an amount that an entity expects to be entitled to upon transferring control of goods or services to a customer, as opposed to when risks and rewards transfer to a customer under existing revenue recognition guidance. ASU 2014-09 is effective for the Company beginning in its fiscal year 2019, and may be applied retrospectively to all prior periods presented or through a cumulative adjustment to the opening retained earnings balance in the year of adoption. The Company is currently in the process of evaluating the impact of ASU 2014-09 on itsCompany's consolidated financial statements.statements:


In July 2015, the FASB
Recently Issued Accounting Pronouncements - Adopted
StandardDescriptionDate AdoptedEffect on the Consolidated Financial Statements
ASU 2018-13, Fair Value Measurement (Topic 820)
This ASU removes, modifies and adds various disclosure requirements related to fair value disclosures. Disclosures related to transfers between fair value hierarchy levels will be removed and further detail around changes in unrealized gains and losses for the period and unobservable inputs used in determining level 3 fair value measurements will be added, among other changes.June 1, 2020The Company adopted the new standard in the first quarter of fiscal year 2021 and it did not have an impact on the Company's consolidated financial statements.
ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments
This ASU replaces the current incurred loss impairment methodology for financial assets measured at amortized cost with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information, including forecasted information, to develop credit loss estimates.June 1, 2020The Company adopted the new standard in the first quarter of fiscal year 2021 and it did not have an impact on the Company's consolidated financial statements.

Recently Issued Accounting Pronouncements - Not Yet Applicable or Adopted
There are no new accounting pronouncements issued ASC Update No. 2015-11, Inventory (Topic 330): Simplifying the Measurement of Inventory. Update No. 2015-11 more closely aligns the measurement of inventory in U.S. GAAP with the measurement of inventory in International Financial Reporting Standards by requiring companies using the first-in, first-out and average costs methods to measure inventory using the lower of cost and net realizable value, where net realizable value is the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. Update No. 2015-11 is effective for annual reporting periods beginning after December 15, 2016 and interim periods within those fiscal years. Update No. 2015-11 should be applied prospectively with earlier application permitted as of the beginning of an interim or annual reporting period. The adoption of Update No. 2015-11 is notthat are expected to have a material impact on our consolidated financial statements.
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2. ACQUISITIONS
C3 Wave Tip Location Acquisition
On December 17, 2019, the Company acquired the C3 Wave tip location asset from Medical Components Inc.("MedComp") for an aggregate purchase price of $10.0 million with $5.0 million of potential future contingent consideration related to technical milestones. This acquisition filled a gap in the Vascular Access portfolio and supports the Company's strategic plan. The Company accounted for this acquisition as an asset purchase. The Company recorded the amount paid at closing as inventory of $0.6 million and intangible assets of a trademark of $0.9 million and product technology of $8.5 million. The intangible assets will be amortized over 15 years. The contingent consideration is comprised of technical milestones and will be accounted for when the contingency is resolved or becomes probable and reasonably estimable.
Eximo Acquisition
On October 2, 2019, the Company entered into a share purchase agreement to acquire Eximo Medical, Ltd., a pre-commercial stage medical device company with a proprietary 355nm laser atherectomy technology. The aggregate purchase price of $60.7 million included an upfront payment of $45.8 million and contingent consideration with an estimated fair value of $14.9 million. This acquisition expanded and complemented the Company’s Endovascular Therapies product portfolio by adding the 355nm laser atherectomy technology (Auryon) which treats Peripheral Artery Disease.
The Company accounted for the Eximo acquisition under the acquisition method of accounting for business combinations. Accordingly, the cost to acquire the assets was allocated to the underlying net assets in proportion to estimates of their respective fair values. The excess of the purchase price over the estimated fair value of the net assets acquired was recorded as goodwill. Goodwill is non-deductible for income tax purposes.
The Company has not disclosed the amount of revenue and earnings for sales of Eximo products since acquisition, nor proforma information, because these amounts are not significant to the Company's financial position or results of operations.

In February 2016,statements. Acquisition-related costs associated with the FASB issued ASU 2016-02, Leases (Topic 842). ASU 2016-02 increases transparencyEximo acquisition, which are included in "acquisition, restructuring and comparability among organizations by recognizing lease assets and liabilities on the balance sheet and disclosing key information about leasing arrangements. For leases with a term or twelve months or less, a lessee is permitted to make an accounting policy election by class of underlying asset not to recognize lease assets and liabilities. ASU 2016-02 is effective for fiscal years beginning after December 15, 2018 and early application is permitted. The Company is currentlyother items, net" in the processaccompanying Consolidated Statements of evaluating the impact of ASU 2016-02 on its consolidated financial statements.

In March 2016, the FASB issued ASU 2016-09, Compensation - Stock Based Compensation (Topic 718: Improvements to Employee Share-Based Payment Accounting). ASU 2016-09 simplifies and improves various aspects of ASC 718 for share-based payments, including income tax items and the classification of these items on the statement of cash flows. ASU 2016-09 is effective for annual periods beginning after December 31, 2016 and early application is permitted. The Company is currently in the process of evaluating the impact of ASU 2016-09 on its consolidated financial statements.

In August 2016, the FASB issued ASU No. 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments (ASU 2016-15). ASU 2016-15 identifies how certain cash receipts and cash payments are presented and classified in the Statement of Cash Flows under Topic 230. ASU 2016-15 is effective for the Company for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years. ASU 2016-15 should be applied retrospectively and early adoption is permitted, including adoption in an interim period. The Company is currently in the process of evaluating the impact of ASU 2016-15 on its consolidated financial statements.

In January 2017, the FASB issued ASU 2017-04, Intangibles - Goodwill and Other (Topic 350), which simplifies the subsequent measurement of goodwill by eliminating steps from the goodwill impairment test. ASU 2017-04 should be adopted for annual or interim goodwill impairment testsOperations, were approximately $0.6 million in fiscal years beginning after December 15, 2019. ASU 2017-04 should be applied prospectively and early adoptions is permitted, including adoption in an interim period.year 2020. The Company is currently evaluatingfollowing table summarizes the impact of ASU 2017-04 on its consolidated financial statements.final aggregate purchase price allocated to the net assets acquired:


2. OTHER ASSETS

In 2015, the Company filed an 8-K stating that it executed a non-binding letter of intent to enter into a strategic relationship with privately-held EmboMedics Inc., which develops injectable and resorbable embolic microspheres.

(in thousands)Final allocation
Accounts receivable$50 
Inventory150 
Prepaid and other current assets54 
Long-term deposits51 
Property, plant and equipment397 
Intangible assets:
Product technology60,300 
Goodwill11,427 
Total assets acquired$72,429 
Liabilities assumed
Accounts payable$84 
Other current liabilities615 
Deferred tax liabilities11,070 
Total liabilities assumed$11,769 
Net assets acquired$60,660 
The Company made an initial $2.0 million purchase of non-transferable warrants in a subsidiary of EmboMedics which become exercisable upon a change of control of EmboMedics. The Company did not have significant influence, or controlfinalized the allocation of the subsidiary. This initial investment was recorded at costpurchase price to the assets acquired and liabilities assumed in the Company reviewed for impairment at each balance sheet date.

In the secondfourth quarter of fiscal year 2017,2020.
The value assigned to the product technology was derived using the multi-period excess earnings method under the income approach. This approach estimates the excess earnings generated over the lives of the customers that existed as of the acquisition date and discounts such earnings to present value. The product technology is deemed to have a useful life of fifteen years and will be amortized on a straight-line basis over the useful life.
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The goodwill arising from the acquisition consists largely of synergies and economies of scale the Company decidedhopes to terminate its agreementsachieve from combining the acquired assets with EmboMedics.the Company's current operations.
RadiaDyne Acquisition
On September 21, 2018, the Company acquired RadiaDyne, a privately held medical diagnostic and device company that designs and develops patient dose monitoring technology to improve cancer treatment outcomes. The terminationaggregate purchase price of $75.0 million included an upfront payment of $47.9 million, contingent consideration with an estimated fair value of $22.3 million, an indemnification holdback of $4.6 million and a purchase price holdback of $0.2 million. The fair value of contingent consideration of $22.3 million was comprised of $16.5 million for the revenue milestones and $5.8 million for the technical milestones. The indemnification holdback was recorded in accrued liabilities at May 31, 2020 and was released during fiscal year 2021.
This acquisition expanded the Company’s growing Oncology business by adding RadiaDyne’s oncology solutions, including the IsoLoc/ImmobiLoc and Alatus balloon stabilizing technologies.
The Company accounted for the RadiaDyne acquisition under the acquisition method of accounting for business combinations. Accordingly, the cost to acquire the assets was allocated to the underlying net assets in proportion to estimates of their respective fair values. The excess of the purchase price over the estimated fair value of the net assets acquired was recorded as goodwill. Goodwill is deductible for income tax purposes.
The Company has not disclosed the amount of revenue and earnings for sales of RadiaDyne products since acquisition, nor proforma information, because these agreementsamounts are not significant to the Company's financial statements. Acquisition-related costs associated with the RadiaDyne acquisition, which are included in "acquisition, restructuring and other items, net" in the accompanying Consolidated Statements of Operations, were approximately $1.6 million in fiscal year 2019. The following table summarizes the final aggregate purchase price allocated to the net assets acquired:
(in thousands)Final allocation
Accounts receivable$900 
Inventory732 
Prepaid and other current assets98 
Property, plant and equipment133 
Intangible assets:
RadiaDyne trademark400 
OARtrac trademark200 
RadiaDyne legacy product technology1,500 
OARtrac product technology18,900 
RadiaDyne customer relationships4,600 
Goodwill47,982 
Total assets acquired$75,445 
Liabilities assumed
Accounts payable$352 
Accrued expenses106 
Total liabilities assumed$458 
Net assets acquired$74,987 
The Company finalized the allocation of the purchase price to the assets acquired and liabilities assumed in the fourth quarter of fiscal year 2019.
The values assigned to the RadiaDyne and OARtrac trademark and product technologies were derived using the relief-from-royalties method under the income approach. This approach is used to estimate the cost savings that accrue for the owner of an intangible asset who would otherwise have to pay royalties or licensing fees on revenues earned through the use of the asset if they had not owned the rights to use the assets. The net after-tax royalty savings are calculated for each year in the remaining economic life of the intangible asset and discounted to present value. The trademarks were deemed to have a useful life of five to seven years and the product technologies were deemed to have a useful life of seven to ten years. Both are amortized on a straight-line basis over their useful life.
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The value assigned to customer relationships was derived using the multi-period excess earnings method under the income approach. This approach estimates the excess earnings generated over the lives of the customers that existed as of the acquisition date and discounts such earnings to present value. Customer relationships are amortized on a straight-line basis over fifteen years.
The goodwill arising from the acquisition consists largely of synergies and economies of scale the Company hopes to achieve from combining the acquired assets with the Company's current operations.
During the fourth quarter of fiscal year 2021, the Company made the decision to abandon the OARtrac product technology and trademark. This resulted in a write-offan impairment charge of $14.0 million. The impairment charge is recorded in "Acquisition, restructuring and other items, net", on the Consolidated Statement of Operations (see Note 19). At May 31, 2021, the fair value of the initial $2.0contingent liability for RadiaDyne is zero (see Note 5).
BioSentry Acquisition
On August 14, 2018, the Company acquired the BioSentry product from Surgical Specialties, LLC (“SSC”), for an aggregate purchase price of $39.8 million investmentof which $37.0 million was paid on August 14, 2018 and $2.8 million was recorded as contingent consideration. The contingent consideration liability was recorded at fair value and was paid in EmboMedicsthe fourth quarter of fiscal year 2019 upon fulfillment of hydrogel orders by SSC.
The Company accounted for the BioSentry acquisition under the acquisition method of accounting for business combinations. Accordingly, the cost to acquire the assets was allocated to the underlying net assets in proportion to estimates of their respective fair values. The excess of the purchase price over the estimated fair value of the net assets acquired was recorded as goodwill. Goodwill is deductible for income tax purposes.
The Company has not disclosed the amount of revenue and earnings for sales of BioSentry products since acquisition, nor proforma information, because these amounts are not significant to the Company's financial statements. Acquisition-related costs associated with the BioSentry acquisition, which isare included in acquisition, restructuring and other items,expenses, net in the accompanying Consolidated Statements of Operations, were approximately $1.0 million in fiscal year 2019. The following table summarizes the final purchase price allocated to the net assets acquired:
(in thousands)Final allocation
Inventory$50 
Property, plant and equipment10 
Intangible assets:
    BioSentry trademark2,500 
    BioSentry product technology20,900 
    Customer relationships2,600 
Goodwill13,740 
Net assets acquired$39,800 
The Company finalized the allocation of the purchase price to the assets acquired and liabilities assumed in the fourth quarter of fiscal year 2019.
The values assigned to the BioSentry trademark and product technologies were derived using the relief-from-royalties method under the income approach. This approach is used to estimate the cost savings that accrue for the owner of an intangible asset who would otherwise have to pay royalties or licensing fees on revenues earned through the use of the asset if they had not owned the rights to use the assets. The net after-tax royalty savings are calculated for each year in the remaining economic life of the intangible asset and discounted to present value. The trademark and product technologies are deemed to have a fifteen year useful life and are amortized on a straight-line basis over their useful life.
The value assigned to customer relationships was derived using the multi-period excess earnings method under the income approach. This approach estimates the excess earnings generated over the lives of the customers that existed as of the acquisition date and discounts such earnings to present value. Customer relationships are amortized on a straight-line basis over ten years.
The goodwill arising from the acquisition consists largely of synergies and economies of scale the Company hopes to achieve from combining the acquired assets with the Company's current operations.
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3. DIVESTITURES    
Fluid Management
On May 31, 2019, the Company completed the sale of the NAMIC Fluid Management business (the “Divestiture”) and all of the assets used primarily in connection with the Fluid Management business to Medline Industries, Inc. (“Medline”) pursuant to an asset purchase agreement dated April 17, 2019 (the “Asset Purchase Agreement”). Total consideration received by the Company for the Divestiture in the fourth quarter of fiscal year 2019 was $169.2 million in cash and resulted in a gain of $46.6 million after working capital adjustments of $0.6 million. The gain is recorded in discontinued operations. On June 3, 2019, a portion of the net proceeds were used to retire the outstanding balance on the Term Loan and Revolving Facility and the remaining net proceeds will continue to be invested in the business.
Pursuant to a transition services agreement entered into and effective on the closing of the transaction, the Company supplied certain services to Medline. Medline received certain legal, human resource, tax, accounting and information technology services from the Company which ended in the fourth quarter of fiscal year 2021.
As a result of the Divestiture, the results of operations from the Fluid Management business are reported in the accompanying consolidated statements of operations.operations as “Income from discontinued operations, net of income tax” for the year ended May 31, 2019.

The following table summarizes the financial results of discontinued operations:
(in thousands)May 31, 2019
Net sales$88,850 
Cost of sales (exclusive of amortization)52,978 
Gross profit35,872 
Operating expenses
Research and development1,177 
Sales and marketing4,129 
General and administrative271 
Amortization of intangibles2,716 
Total operating expenses8,293 
Operating income27,579 
Gain on divestiture46,592 
Income from discontinued operations before income taxes74,171 
Income tax expense(1,685)
Income from discontinued operations$72,486 

In accordance with GAAP, only expenses specifically identifiable and related to a business to be disposed may be allocated to discontinued operations. As such, the selling and marketing, research and development and general and administrative expenses recorded in discontinued operations include corporate costs incurred directly in support of the Fluid Management portfolio.
3.The Company applied the “Intraperiod Tax Allocation” rules under ASC 740, which requires the allocation of an entity’s total annual income tax provision among continuing operations and, in the Company’s case, discontinued operations. Included in the $1.6 million income tax expense for fiscal year 2019 is $0.6 million tax expense related to the gain on the Divestiture. The taxes on the gain were calculated using various state statutory tax rates and are partially offset by the utilization of historical state net operating losses. There are no current federal taxes on the gain due to utilization of historical net operating losses which had a corresponding valuation allowance.
The table below provides a reconciliation of the gain recorded on the sale of the Fluid Management business:
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(in thousands)
Proceeds received from Divestiture$169,242 
Working capital adjustment(612)
Fluid Management assets:
Inventories11,029 
Property, plant and equipment, net16,624 
Intangible assets, net15,047 
Goodwill75,308 
Total Fluid Management assets118,008 
Transaction costs for Divestiture (1)
4,030 
Gain on sale of the Fluid Management business before income taxes$46,592 
(1) Costs include advisory fees, legal fees and professional fees
Proceeds from the sale of Fluid Management have been presented in the Consolidated Statements of Cash Flows under investing activities for the fiscal year ended May 31, 2019.  Total operating and investing cash flows of discontinued operations for the fiscal year ended May 31, 2019 is comprised of the following, which exclude the effect of income taxes:
(in thousands)2019
Net cash provided by operating activities$2,245 
Net cash provided by investing activities982 
4. REVENUE FROM CONTRACTS WITH CUSTOMERS
Revenue Recognition
Under ASC 606, revenue is recognized when a customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation.
The Company has one primary revenue stream which is the sales of its products.
Disaggregation of Revenue
The following tables summarize net product revenue by Global Business Unit and geography for the years ended May 31, 2021, 2020 and 2019:
Year ended May 31, 2021Year ended May 31, 2020
(in thousands)United StatesInternationalTotalUnited StatesInternationalTotal
Net sales
Endovascular Therapies$121,427 $13,652 $135,079 $98,965 $13,741 $112,706 
Vascular Access81,088 20,222 101,310 76,768 17,531 94,299 
Oncology34,528 20,093 54,621 32,247 24,905 57,152 
Total$237,043 $53,967 $291,010 $207,980 $56,177 $264,157 
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Year ended May 31, 2019
(in thousands)United StatesInternationalTotal
Net sales
Endovascular Therapies$106,767 $13,134 $119,901 
Vascular Access79,611 15,119 94,730 
Oncology30,579 25,424 56,003 
Total$216,957 $53,677 $270,634 
Net Product Revenue
The Company's products consist of a wide range of medical, surgical and diagnostic devices used by professional healthcare providers for vascular access, for the treatment of peripheral vascular disease and for use in oncology and surgical settings. The Company's devices are generally used in minimally invasive, image-guided procedures. Most of the Company's products are intended to be used once and then discarded, or they may be implanted for short or long term use. The Company sells its products to its distributors and to end users, such as interventional radiologists, interventional cardiologists, vascular surgeons, urologists, interventional and surgical oncologists and critical care nurses.
Contracts and Performance Obligations
The Company contracts with its customers based on customer purchase orders, which in many cases are governed by master purchasing agreements. The Company’s contracts with customers are generally for product only, and do not include other performance obligations such as services or other material rights. As part of its assessment of each contract, the Company evaluates certain factors including the customer’s ability to pay (or credit risk). For each contract, the Company considers the promise to transfer products, each of which is distinct, to be the identified performance obligations.
Transaction Price and Allocation to Performance Obligations
Transaction prices of products are typically based on contracted rates. Product revenue is measured as the amount of consideration the Company expects to receive in exchange for transferring products to a customer, net of any variable consideration as described below.
If a contract contains a single performance obligation, the entire transaction price is allocated to the single performance obligation. Contracts that contain multiple performance obligations require an allocation of the transaction price based on the estimated relative standalone selling prices of the promised products underlying each performance obligation. The Company has standard pricing for its products and determines standalone selling prices based on the price at which the performance obligation is sold separately.
Revenue Recognition
Revenue is recognized when control of the product is transferred to the customer (i.e., when the Company’s performance obligation is satisfied), which occurs at a point in time, and may be upon shipment from the Company’s manufacturing site or delivery to the customer’s named location, based on the contractual shipping terms of a contract.
In determining whether control has transferred, the Company considers if there is a present right to payment from the customer and when physical possession, legal title and risks and rewards of ownership have transferred to the customer.
The Company typically invoices customers upon satisfaction of identified performance obligations. As the Company’s standard payment terms are 30 to 90 days from invoicing, the Company does not provide any significant financing to its customers.
The Company enters into agreements to place placement and evaluation units (“units”) at customer sites, but the Company retains title to the units. The duration of these agreements are typically a year and the customer has the right to use the unit at no upfront charge in connection with the customer’s ongoing purchase of disposables. These types of agreements include an embedded operating lease for the right to use the units. In these arrangements, revenue recognized for the sale of the disposables is not allocated between the disposal revenue and lease revenue due to the insignificant value of the units in relation to the total agreement value.
Sales, value added, and other taxes collected on behalf of third parties are excluded from revenue.

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Variable Consideration
Reserves: Revenue from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established for discounts, returns, rebates and allowances that are offered within contracts between the Company and its customers. These reserves are based on the amounts earned or to be claimed on the related sales and are classified as a contra asset.
Rebates and Allowances:The Company provides certain customers with rebates and allowances that are explicitly stated in the Company’s contracts and are recorded as a reduction of revenue in the period the related product revenue is recognized. The Company establishes reserves for such amounts, which is included in accrued expenses in the accompanying consolidated balance sheets. These rebates and allowances result from performance-based offers that are primarily based on attaining contractually specified sales volumes and administrative fees the Company is required to pay to group purchasing organizations.
Product Returns: The Company generally offers customers a limited right of return. Product returns after 30 days must be pre-approved by the Company and customers may be subject to a 20% restocking charge. To be accepted, a returned product must be unadulterated, undamaged and have at least twelve months remaining prior to its expiration date. The Company estimates the amount of its product sales that may be returned by its customers and records this estimate as a reduction of revenue in the period the related product revenue is recognized. The Company currently estimates product return liabilities using its historical product return information and considers other factors that it believes could significantly impact its expected returns, including product recalls. During the year ended May 31, 2021, such product returns were not material.
Contract Balances with Customers
A receivable is generally recognized in the period the Company ships the product. Payment terms on invoiced amounts are based on contractual terms with each customer and generally coincide with revenue recognition. Accordingly, the Company does not have any contract assets associated with the future right to invoice its customers. In some cases, if control of the product has not yet transferred to the customer or the timing of the payments made by the customer precedes the Company’s fulfillment of the performance obligation, the Company recognizes a contract liability that is included in deferred revenue in the accompanying consolidated balance sheets.
The following table presents changes in the Company’s receivables, contract assets and contract liabilities with customers:
(in thousands)May 31, 2021May 31, 2020
Receivables$35,405 $31,263 
Contract assets$$
Contract liabilities$426 $545 
During the years ended May 31, 2021 and 2020, the Company had additions to contract liabilities of $1.0 million and $2.1 million, respectively. This was offset by $1.2 million and $2.2 million in revenue that was recognized during the years ended May 31, 2021 and 2020, respectively.
Costs to Obtain or Fulfill a Customer Contract
Under ASC 606, the Company recognizes an asset for incremental costs of obtaining a contract with a customer if it expects to recover those costs. The Company’s sales incentive compensation plans qualify for capitalization since these plans are directly related to sales achieved during a period of time. However, the Company has elected the practical expedient under ASC 340-40-25-4 to expense the costs as they are incurred within selling and marketing expenses since the amortization period is less than one year.
The Company accounts for shipping and handling activities related to contracts with customers as costs to fulfill the promise to transfer the associated products. Shipping and handling costs, associated with the distribution of finished products to customers, are recorded in costs of goods sold and are recognized when the related finished product is shipped to the customer. Amounts charged to customers for shipping are recorded in net sales.
5. FAIR VALUE OF FINANCIAL INSTRUMENTS

On a recurring basis, the Company measures certain financial assets and financial liabilities at fair value based upon quoted market prices, where available. Where quoted market prices or other observable inputs are not available, the Company applies valuation techniques to estimate fair value. FASB ASC Topic 820, Fair Value Measurements and Disclosures, establishes a three-level valuation hierarchy for disclosure of fair value measurements. The categorization of financial assets
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and financial liabilities within the valuation hierarchy is based upon the lowest level of input that is significant to the measurement of fair value. The three levels of the hierarchy are defined as follows:

Level 1 - Inputs to the valuation methodology are quoted market prices for identical assets or liabilities.

Level 2 - Inputs to the valuation methodology are other observable inputs, including quoted market prices for similar assets or liabilities and market-corroborated inputs.

Level 3 - Inputs to the valuation methodology are unobservable inputs based on management’s best estimate of inputs market participants would use in pricing the asset or liability at the measurement date, including assumptions about risk.

The Company's financial instruments include cash and cash equivalents, marketable securities, accounts receivable, marketable securities, accounts payable and contingent consideration. The carrying amount of cash and cash equivalents, accounts receivable, and accounts payable approximates fair value due to their immediate or short-term maturities. The recurring fair value measurements using significant unobservable inputs (Level 3) relate to marketable securities, which are comprised of auction rate securities, and contingent consideration liabilities.


The following tables provide information by level for assets and liabilities that are measured at fair value on a recurring basis:
 Fair Value Measurements using inputs considered as:
(in thousands)Level 1Level 2Level 3Fair Value at May 31, 2021
Financial Liabilities
Contingent consideration for acquisition earn outs$$$15,741 $15,741 
Total Financial Liabilities$$$15,741 $15,741 
Fair Value Measurements using inputs considered as:
(in thousands)Level 1Level 2Level 3Fair Value at May 31, 2020
Financial Liabilities
Contingent consideration for acquisition earn outs$$$15,647 $15,647 
Total Financial Liabilities$$$15,647 $15,647 
 
Fair Value Measurements
using inputs considered as:
  
(in thousands)Level 1 Level 2 Level 3 Fair Value at May 31, 2017
Financial Assets       
Marketable securities$
 $
 $1,215
 $1,215
Total Financial Assets$
 $
 $1,215
 $1,215
Financial Liabilities       
Contingent liability for acquisition earn outs$
 $
 $12,761
 $12,761
Total Financial Liabilities$
 $
 $12,761
 $12,761
 
Fair Value Measurements
using inputs considered as:
  
(in thousands)Level 1 Level 2 Level 3 Fair Value at May 31, 2016
Financial Assets       
Marketable securities$
 $
 $1,653
 $1,653
Total Financial Assets$
 $
 $1,653
 $1,653
Financial Liabilities       
Contingent liability for acquisition earn outs$
 $
 $38,275
 $38,275
Total Financial Liabilities$
 $
 $38,275
 $38,275
There were no transfers in and out of Level 1, 2 and 3 measurements for the years ended May 31, 20172021 and 2016.

The table below presents the changes in fair value components of Level 3 instruments in the year ended May 31, 2017 (in thousands of dollars):

Financial Assets Financial Liabilities
(in thousands)Fair Value Measurements
Using Significant
Unobservable Inputs
(Level 3)
 Fair Value Measurements
Using Significant
Unobservable Inputs (Level 3)
Balance at May 31, 2016$1,653
 $38,275
Change in fair value of contingent consideration, net (1)
 (15,261)
Currency (gain) loss from remeasurement
 (153)
Fair market value adjustments12
 
Sale of securities(450) 
Contingent consideration payments
 (10,100)
Balance at May 31, 2017$1,215
 $12,761

The Company made the decision to discontinue its investment in the TiLo product that was acquired in August 2013 as part of the Clinical Devices acquisition. This decision resulted in the write-off of the acquired in-process research and development (IPR&D) of $3.6 million along with a $3.1 million gain from the reduction in the fair value of contingent consideration liability associated with future milestones that will no longer be met. The write-off of the IPR&D is included in acquisition, restructuring and other, net on the consolidated statement of operations.

The Company revised the sales projections for the AngioVac product as a result of reviews performed by executive management across all products. The adjustments to the sales projections resulted in a $13.4 million gain from the reduction in the fair value of the contingent liability that is based on lower projected sales volume over the contractual earn out period.

The Company decided to terminate its agreement with EmboMedics which resulted in a $2.0 million write-off of our investment in EmboMedics (Note 2).

2020.
The table below presents the changes in fair value components of Level 3 instruments infor the year ended May 31, 2016 (in thousands of dollars):2021:
 Financial Assets Financial Liabilities
(in thousands)Fair Value Measurements
Using Significant
Unobservable Inputs
(Level 3)
 Fair Value Measurements
Using Significant
Unobservable Inputs (Level 3)
Balance at May 31, 2015$1,689
 $47,384
Change in fair value of contingent consideration (1)
 948
Currency (gain) loss from remeasurement
 43
Fair market value adjustments(36) 
Contingent consideration payments
 (10,100)
Balance at May 31, 2016$1,653
 $38,275

Financial Liabilities
(in thousands)Fair Value Measurements Using Significant Unobservable Inputs (Level 3)
Balance at May 31, 2020$15,647 
Change in present value of contingent consideration (1)
89 
Currency (gain) loss from remeasurement
Balance at May 31, 2021$15,741 
(1) Change in the fair value of contingent consideration is included in earnings and comprised of changes in estimated earn out payments based on projections of companyCompany performance and amortization of the present value discount.

68


Marketable SecuritiesThe table below presents the changes in fair value components of Level 3 instruments for the year ended May 31, 2020:

Financial Liabilities
(in thousands)Fair Value Measurements Using Significant Unobservable Inputs (Level 3)
Balance at May 31, 2019$13,486 
Contingent consideration liabilities recorded as a result of the acquisitions (Note 2)14,900 
Change in fair value of contingent consideration (1)
(11,531)
Contingent consideration payments(1,208)
Balance at May 31, 2020$15,647 
Marketable securities consist solely(1) Change in the fair value of an auction rate security. Assumptions associated with the auction rate security include the interest rate benchmarks, the probabilitycontingent consideration is included in earnings and comprised of full repaymentchanges in estimated earn out payments based on projections of Company performance and amortization of the principal consideringpresent value discount.
During fiscal year 2020, the credit quality and guaranteesCompany revised the sales projections for RadiaDyne products as a result of reviews performed by executive management. The adjustments to the sales projections over the contractual earn-out period resulted in place, anda $9.2 million reduction in the ratefair value of return required by investors to own such securities given the current liquidity risk.

contingent liability. It was also determined that one of the technical milestones would not be achieved, which resulted in an additional reduction in the liability of $2.7 million. At May 31, 2021, there are no remaining amounts payable for the RadiaDyne contingent consideration.
Contingent Liability for Acquisition Earn Outs

CertainSome of the Company's business combinations involve the potential for the payment of future contingent consideration upon the achievement of certain product development milestones and/or various other favorable operatingperformance conditions. Payment of the additional consideration is generally contingent on the acquired company reaching certain performance milestones, including attaining specified revenue levels or achieving product development targets. Contingent consideration is recorded at the estimated fair value of the contingent milestone payments on the acquisition date. The fair value of the contingent milestone consideration is remeasured at the estimated fair value at each reporting period with the change in fair value recognized as income or expense within change in fair value of contingent consideration in the consolidated statementstatements of operations.income.

Contingent consideration liabilities will be remeasured toThe Company measures the initial liability and remeasures the liability on a recurring basis using Level 3 inputs as defined under authoritative guidance for fair value each reporting period using projected net sales, discount rates, probabilities of payment and projected payment dates. Projected contingent payment amounts are discounted back to the current periodmeasurements which is determined using a discounted cash flow model.model applied to projected net sales, using probabilities of achieving projected net sales and projected payment dates. Projected net sales are based on internal projections and extensive analysis of the target market and the sales potential. Increases in projected net sales and probabilities of payment may result in higher fair value measurements in the future. Increases in discount rates and the projected time to payment may result in lower fair value measurements in the future. Increases or decreases in any valuation inputs in isolation may result in a significantly lower or higher fair value measurement in the future.

The recurring Level 3 fair value measurements of the contingent consideration liabilities include the following significant unobservable inputs as of May 31, 2017:2021:
(in thousands)
Fair value at
May 31, 2017
 
Valuation
Technique
 
Unobservable
Input
 Range(in thousands)Fair ValueValuation TechniqueUnobservable InputRange
Revenue based payments$12,761
 Discounted cash flow Discount rate
Probability of payment
Projected fiscal year of payment
 4%
100%
2018 - 2022
Revenue based payments$15,741 Discounted cash flowDiscount rate5%
Probability of payment66% - 100%
Projected fiscal year of payment2024 - 2025
At May 31, 2017,2021, the estimated potential amount of undiscounted future contingent consideration that the Company expects to pay as a result of all completed acquisitions is approximately $13.1$20.0 million. The milestones, including revenue projections and technical milestones, associated with the contingent consideration must be reached in future periods ranging from fiscal years 2021 to 2025 in order for the associated consideration to be paid.
Items Measured at Fair Value on a Nonrecurring Basis
During the fourth quarter of fiscal year 2021, the Company made the decision to abandon the OARtrac product technology and trademark. This resulted in an impairment charge of $14.0 million. The Company recorded a goodwill impairment charge of $158.6 million which represents the remaining contractual minimum payments.



4. MARKETABLE SECURITIES
Asas of May 31, 2017, marketable securities2020 to write down the carrying value of the reporting unit to fair value using Level 3 inputs.
There were no other items measured at fair value on a nonrecurring basis during the year ended May 31, 2020 or May 31, 2021.

69


6. INVENTORIES
Inventories are stated at lower of cost and net realizable value (using the first-in, first-out method). Inventories consisted of the following:
 
Amortized
cost
 
Gross
Unrealized
Gains
 
Gross
Unrealized
Losses
 
Fair
Value
(in thousands) 
Available-for-sales securities       
New York State government agency obligations$1,350
 $
 $(135) $1,215
 $1,350
 $
 $(135) $1,215
As of May 31, 2016, marketable securities consisted of the following:
 
Amortized
cost
 
Gross
Unrealized
Gains
 
Gross
Unrealized
Losses
 
Fair
Value
(in thousands) 
Available-for-sales securities       
New York State government agency obligations$1,800
 $
 $(147) $1,653
 $1,800
 $
 $(147) $1,653
The amortized cost and fair value of marketable securities as of May 31, 2017, by contractual maturity, are shown below. Expected maturities may differ from contractual maturities because borrowers may have the right to call or prepay obligations with or without call or prepayment penalties.
 
Amortized
cost
 
Fair
Value
(in thousands) 
As of May 31, 2017:   
Due in one year or less$
 $
Due after one through five years
 
Due after five through twenty years (1)
1,350
 1,215
 $1,350
 $1,215
(1) This auction rate security represents investments available for current operations and are classified as current in the consolidated balance sheets.

5. INVENTORIES
As of May 31, 2017 and 2016, inventories consisted of the following:
May 31, 2017 May 31, 2016
(in thousands) (in thousands)May 31, 2021May 31, 2020
Raw materials$17,563
 $21,669
Raw materials$22,925 $23,308 
Work in process12,602
 10,700
Work in process8,022 8,318 
Finished goods24,341
 23,001
Finished goods17,667 28,279 
Total$54,506
 $55,370
Total$48,614 $59,905 
The Company periodically reviews its inventory for both obsolescence and loss of value. The Company makes assumptions about the future demand for and market value of the inventory. Based on these assumptions, the Company estimates the amount of obsolete, expiring and slow moving inventory. The total inventory reserve at May 31, 20172021 and 20162020 was $7.3$3.8 million and $12.6$4.7 million, respectively. Of the $7.3 million, $2.4 million relates to the inventory reserve for Acculis inventory as a result of the recall (Note 10). Of the $12.6 million in the prior year, $5.8 million relates to the reserve of Celerity inventory on-hand at May 31, 2016.

6.7. PREPAID EXPENSES AND OTHER
As of May 31, 2017 and 2016, prepaidPrepaid expenses and other consisted of the following:
(in thousands)May 31, 2021May 31, 2020
Deposits$2,795 $689 
Employee Retention Tax Credit1,911 
Software licenses1,286 1,002 
TSA receivable2,911 
License fees166 203 
Trade shows132 296 
Rent268 246 
Other prepaid taxes379 414 
Other1,760 1,549 
Total$8,699 $7,310 
 May 31, 2017 May 31, 2016
(in thousands) 
Software licenses$582
 $282
License fees118
 108
Trade shows162
 278
Rent121
 127
Other prepaid taxes208
 160
Medical device excise tax receivable1,837
 
Other2,762
 2,288
Total$5,790
 $3,243

7.8. PROPERTY, PLANT AND EQUIPMENT, NET
As of May 31, 2017 and 2016, property,Property, plant and equipment are summarized as follows:
May 31, 2017 May 31, 2016
(in thousands) (in thousands)May 31, 2021May 31, 2020
Building and building improvements$40,597
 $39,585
Building and building improvements$28,979 $27,119 
Computer software and equipmentComputer software and equipment26,302 24,730 
Machinery and equipment25,434
 24,078
Machinery and equipment14,208 13,602 
Computer software and equipment25,668
 24,691
Placement and evaluation unitsPlacement and evaluation units9,530 
Construction in progress1,464
 1,743
Construction in progress3,217 3,050 
93,163
 90,097
82,236 68,501 
Less accumulated depreciation and amortization(49,652) (43,536)
Less accumulated depreciationLess accumulated depreciation(45,635)(40,661)
43,511
 46,561
36,601 27,840 
Land and land improvements1,723
 1,723
Land and land improvements472 472 
$45,234
 $48,284
$37,073 $28,312 
Depreciation expense for fiscal 2017, 2016years 2021, 2020 and 20152019 was $6.0$5.7 million, $8.2$3.3 million and $9.8$3.1 million, respectively.

8.



70


9. GOODWILL AND INTANGIBLE ASSETS

Intangible assets other than goodwill are amortized over their estimated useful lives on either a straight-line basis or proportionately to the benefit being realized. Useful lives range from two to eighteen years. The Company periodically reviews the estimated useful lives of intangible assets and review such assets or asset groups for impairment whenever events or changes in circumstances indicate that the carrying value of the assets or asset groups may not be recoverable. If an intangible asset or asset group is considered to be impaired, the amount of the impairment will equal the excess of the carrying value over the fair value of the asset.

Goodwill
Goodwill is not amortized, but rather, is tested for impairment annually or more frequently if impairment indicators arise. Goodwill represents the excess of the purchase price over the fair value of the net tangible and identifiable intangible assets acquired in each business combination.

The Company's annual testing for impairment of goodwill was completed as of December 31, 2016.2020. The Company operates as a single operating segment with one1 reporting unit and consequently evaluates goodwill for impairment based on an evaluation of the fair value of the Company as a whole. The Company determines the fair value of the reporting unit based on the market valuation approach and concluded that it was not more-likely-than-not that the fair value of the Company's reporting unit was less than its carrying value.

Even though the Company determined that there was no0 goodwill impairment as of December 31, 2016,2020, the future occurrence of a potential indicator of impairment, such as a significant adverse change in legal, regulatory, business or economic conditions or a more-likely-than-not expectation that the reporting unit or a significant portion of the reporting unit will be sold or disposed of, would require an interim assessment for the reporting unit prior to the next required annual assessment as of December 31, 2017. The Company continued to assess for potential impairment through May 31, 2017 and noted no events that would be considered a triggering event. 2021.
There were no adjustments to goodwill for the year ended May 31, 2021 other than foreign currency translation adjustments. For the year ended May 31, 2020 the Company recorded a goodwill impairment charge of $158.6 million to write down the carrying value of the reporting unit to fair value.
Definite Lived Intangible Assets
Definite lived intangible assets consist primarily of product technologies and customer relationships and are amortized over their estimated useful lives, which range between two to eighteen years, on either a straight-line basis over the expected period of benefit or as revenues are earned from the sales of the related product. Amortization expense was $18.1 million, $18.1 million and $17.1 million for fiscal years 2021, 2020 and 2019, respectively. During the fourth quarter of fiscal year 2021, the Company made the decision to abandon the OARtrac product technology and trademark. This resulted in an impairment charge of $14.0 million. The impairment charge is recorded in "Acquisition, restructuring and other items, net", on the Consolidated Statement of Operations (see Note 19). There were no impairment charges on definite lived intangible assets for the years ended May 31, 20172020 and 2016.2019.
As of May 31, 2017 and 2016, intangibleIntangible assets consisted of the following:
 May 31, 2021
(in thousands)Gross carrying
value
Accumulated
amortization
Net carrying
value
Product technologies$236,907 $(97,343)$139,564 
Customer relationships60,291 (34,164)26,127 
Trademarks9,950 (6,905)3,045 
Licenses6,087 (5,846)241 
$313,235 $(144,258)$168,977 
May 31, 2020
(in thousands)Gross carrying
value
Accumulated
amortization
Net carrying
value
Product technologies$251,569 $(88,547)$163,022 
Customer relationships60,160 (30,018)30,142 
Trademarks10,150 (6,691)3,459 
Licenses6,087 (5,574)513 
$327,966 $(130,830)$197,136 



71


 May 31, 2017
 
Gross carrying
value
 
Accumulated
amortization
 
Net carrying
value
(in thousands) 
Product technologies$147,172
 $(59,696) $87,476
Customer relationships56,375
 (19,194) 37,181
Trademarks28,400
 (9,069) 19,331
Licenses4,487
 (3,821) 666
Distributor relationships1,250
 (229) 1,021
 $237,684
 $(92,009) $145,675

 May 31, 2016
 
Gross carrying
value
 
Accumulated
amortization
 
Net carrying
value
(in thousands) 
Product technologies$148,387
 $(51,313) $97,074
Customer relationships88,389
 (47,133) 41,256
Trademarks28,470
 (6,242) 22,228
Licenses7,931
 (6,716) 1,215
Distributor relationships2,150
 (946) 1,204
In process R&D3,600
 
 3,600
 $278,927
 $(112,350) $166,577

AmortizationExpected future amortization expense was $17.3 million, $18.0 million and $18.0 million for fiscal years 2017, 2016 and 2015, respectively.
Annual amortization of theserelated to the intangible assets is expected to approximate the following amounts for each of the next fivefollowing fiscal years:years is as follows:
(in thousands)
2022$15,156 
202315,595 
202414,111 
202515,131 
202416,138 
2025 and thereafter92,846 
$168,977 
(in thousands) 
2018$16,500
201916,132
202014,578
202113,627
202212,952
2023 and thereafter71,886
 $145,675


9.10. INCOME TAXES

The components of income (loss)loss from continuing operations before income tax expense (benefit) for the years ended May 31benefit are as follows:

 2017 2016 2015
(in thousands) 
Income (loss) before tax expense:
 
 
US$8,825
 $(4,444) $(8,965)
Non-US1,022
 1,191
 834
 $9,847
 $(3,253) $(8,131)
Year ended May 31,
(in thousands)202120202019
Loss from continuing operations before tax expense:
U.S.$(31,595)$(166,984)$(15,593)
Non-U.S.(4,457)(1,151)891 
$(36,052)$(168,135)$(14,702)
Income tax expense (benefit)benefit is comprised of the following:
Year ended May 31,
(in thousands)202120202019
Current
U.S.100 96 128 
Non U.S.201 124 289 
301 220 417 
Deferred
U.S.(3,375)(1,122)(3,948)
Non U.S.(1,430)(446)(25)
(4,805)(1,568)(3,973)
Income tax benefit$(4,504)$(1,348)$(3,556)

72

 2017 2016 2015
(in thousands) 
Current
 
 
Federal$
 $34
 $(242)
State and local141
 103
 205
Non U.S.270
 217
 417
 411
 354
 380
Deferred4,428
 39,983
 (5,123)
Income tax expense (benefit)$4,839
 $40,337
 $(4,743)


In the fiscal years 2017 and 2016 income tax expense, the Company recorded tax expense of $4.8 million and $40.3 million, respectively, primarily driven by the impact of recording a deferred tax liability related to the amortization of intangibles, for tax purposes, that have an indefinite reversal period and cannot be used to support the deferred tax assets in fiscal 2017 and recording a valuation allowance of $40.4 million on the U.S. deferred tax assets in fiscal 2016.

In the fiscal year 2015 income tax benefit, the Company recorded a tax benefit of $4.7 million, primarily driven by a benefit of the $9.2 million nontaxable adjustment to the contingent liabilities related to Vortex Medical and Clinical Devices, and a seven month benefit from the R&D tax credit that expired on December 31, 2014, offset by non-deductible interest expense related to contingent payments, true-ups of our fiscal year 2014 US income tax returns and the impact of the elimination of the ASC 718 APIC pool.

Temporary differences that give rise to deferred tax assets and liabilities are summarized as follows:
 May 31, 2017 May 31, 2016
(in thousands) 
Deferred tax assets
 
Net operating loss carryforward$55,975
 $52,593
Stock-based compensation2,653
 4,135
Federal and state R&D tax credit carryforward2,548
 2,145
Inventories2,407
 4,535
Expenses incurred not currently deductible6,522
 3,018
Accrued liabilities1,289
 339
Gross deferred tax asset71,394
 66,765
Deferred tax liabilities
 
Excess tax over book depreciation and amortization49,158
 46,240
 49,158
 46,240
Valuation Allowance(48,348) (42,209)
Net deferred tax liability$(26,112) $(21,684)

The Company's Federal net operating loss carryforwards as of May 31, 2017 after considering IRC Section 382 limitations are $161.6 million. The expiration of the Federal net operating loss carryforwards are as follows: $29.8 million between 2017 and 2023 and $131.8 million between 2027 and 2037.

The Company's state net operating loss carryforwards as of May 31, 2017 after considering remaining IRC Section 382 limitations are $32.7 million which expire in various years from 2017 to 2037.

As a result of certain realization requirements of ASC 718, the table of deferred tax assets and liabilities shown above does not include certain deferred tax assets as of May 31, 2017 and 2016 that arose directly from tax deductions related to equity compensation greater than compensation recognized for financial reporting. Equity will be increased by $0.6 million if and when such excess tax benefits are ultimately realized.

A valuation allowance is provided if based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. After careful consideration and weighing of all the available positive and negative evidence, the weight given to the three year cumulative loss and lack of a recent history of core earnings was difficult to overcome and a full valuation allowance related to the U.S. deferred tax assets was established in the period ending May 31, 2016. Management considered all available positive and negative evidence at May 31, 2017, and considering the cumulative loss in the U.S. over the three year period, determined that the valuation allowance is still required. Management will continue to reevaluate the positive and negative evidence at each reporting period and if future results as projected in the U.S. and the Company's tax planning strategies are favorable, the valuation allowance may be removed, which could have a favorable material impact on the Company's results of operations in the period in which it is recorded.

(in thousands)May 31, 2021May 31, 2020
Deferred tax assets
Net operating loss carryforward$31,564 $26,697 
Stock-based compensation3,556 2,923 
Federal and state R&D tax credit carryforward6,715 5,412 
Inventories884 1,071 
Expenses incurred not currently deductible3,091 1,927 
Accrued liabilities73 95 
Gross deferred tax asset45,883 38,125 
Deferred tax liabilities
Depreciation and amortization48,744 49,023 
48,744 49,023 
Valuation allowance(17,035)(13,114)
Net deferred tax liability$(19,896)$(24,012)
The net deferred tax liability in the U.S. as of May 31, 20172021 and 20162020 principally relates to tax amortization of intangibles that have an indefinite reversal period for book purposes, andalso known as a “naked credit deferred tax liability”, that cannot be usedconsidered as a source of income to supportrecover the deferred tax asset. In addition, during the fiscal year ended May 31, 2020 a net deferred tax liability of $11.0 million was recorded in purchase accounting related to the stock acquisition of Eximo Medical Ltd. primarily related to book intangibles offset by tax net operating losses.

The Company's U.S. Federal net operating loss carryforwards as of May 31, 2021 after considering IRC Section 382 limitations are $134.6 million. The expiration of the Federal net operating loss carryforwards are as follows: $8.6 million between 2022 and 2023, $79.4 million between 2028 and 2037 and $46.6 million indefinitely.
The Company's state net operating loss carryforwards as of May 31, 2021 after considering remaining IRC Section 382 limitations are $20.0 million which expire in various years from 2029 to 2041. The Company has Israel tax net operating losses of $13.5 million that can be carried forward indefinitely.
Beginning in 2018, except for the Global Intangible Low-Taxed Income, the Company will no longer record United States federal income tax on its share of the income of its foreign subsidiaries, nor will it record a benefit for foreign tax credits related to that income. Upon distribution of these earnings in the form of dividends or otherwise, the Company would be subject to withholding taxes payable, where applicable, to foreign countries, but would have no further federal income tax liability. The Company intends to indefinitely reinvest the unremitted foreign earnings of all other subsidiaries as of May 31, 2021, as well as all subsequent earnings generated by all of our foreign subsidiaries. Determining the amount of unrecognized deferred tax liability related to any additional outside basis difference in these entities is not practical.
The Company regularly assesses its ability to realize its deferred tax assets. Assessing the realization of deferred tax assets requires significant management judgment. In determining whether its deferred tax assets are more likely than not realizable, the Company evaluated all available positive and negative evidence, and weighted the evidence based on its objectivity. Evidence the Company considered included its history of net operating losses, which resulted in the Company recording a full valuation allowance for its deferred tax assets in fiscal year 2016, except the naked credit deferred tax liability.
Based on the review of all available evidence, the Company determined that it has not yet attained a sustained level of profitability and the objectively verifiable negative evidence outweighed the positive evidence. Therefore, the Company has provided a valuation allowance on its federal and state net operating loss carryforwards, federal and state R&D credit carryforwards and other net deferred tax assets that have a limited life and are not supportable by the naked credit deferred tax liability sourced income as of May 31, 2021. The Company will continue to assess the level of the valuation allowance required. If sufficient positive evidence exists in future periods to support a release of some or all of the valuation allowance, such a release would likely have a material impact on the Company’s results of operations.

73


The Company's consolidated income tax expense has differed from the amount that would be provided by applying the U.S. Federal statutory income tax rate to the Company's income before income taxes for the following reasons:

Year ended May 31,
(in thousands)202120202019
Income tax benefit at federal statutory tax rate of 21.0%, 21.0% and 28.6%, respectively$(7,571)$(35,308)$(3,087)
State income taxes, net of Federal tax benefit(462)(40)(177)
Impact of Non-U.S. operations(293)(100)76 
Research and development tax credit(1,303)(1,152)(936)
Meals and entertainment116 171 190 
Goodwill impairment33,301 
Change in valuation allowance3,921 1,426 175 
Effect of elimination of stock compensation APIC pool526 162 
Other562 192 203 
Income tax benefit$(4,504)$(1,348)$(3,556)
 For the year ended May 31,
 2017 2016 2015
(in thousands) 
Income tax expense (benefit) at statutory tax rate of 35%$3,447
 $(1,139) $(2,845)
Effect of graduated tax rates(98) 33
 81
State income taxes, net of Federal tax benefit(22) (215) (21)
Impact of Non-US operations403
 (162) 133
Research and development tax credit(403) (499) (604)
Meals and entertainment266
 329
 
Non-deductible interest on contingent payments174
 262
 265
Non-taxable gain on revaluation of contingent consideration liability(5,576) (170) (3,102)
Tax law changes
 
 (454)
Change in valuation allowance6,139
 40,685
 
Effect of elimination of stock compensation APIC pool1,380
 739
 1,253
IPR&D intangible write-off(1,224) 
 
Other nondeductible expenses219
 207
 498
Over (under) accrual of prior year Federal and State taxes(3) 356
 38
Other137
 (89) 15
Income tax expense (benefit)$4,839
 $40,337
 $(4,743)

During fiscal year 2020, the Company recorded a goodwill impairment of $158.6 million. The Company has made the tax accounting policy election to first allocate the impairment to the Company’s nondeductible goodwill based on the Company’s pre-impairment nondeductible goodwill balance.
The following table provides a reconciliation of the beginning and ending amount of unrecognized tax benefits:
Year ended May 31,
(in thousands)(in thousands)202120202019
Unrecognized tax benefits balance at June 1Unrecognized tax benefits balance at June 1$464 $464 $464 
For the year ended May 31,
2017 2016 2015
(in thousands) 
Unrecognized tax benefits balance at June 1$899
 $
 $
Increase in gross amounts of tax positions related to prior years
 899
 
Decrease in gross amounts of tax positions related to prior years due to U.S. tax reformDecrease in gross amounts of tax positions related to prior years due to U.S. tax reform
Decrease due to lapse in statute of limitationsDecrease due to lapse in statute of limitations
Unrecognized tax benefits balance at May 31$899
 $899
 $
Unrecognized tax benefits balance at May 31$464 $464 $464 
The table above includes unrecognized tax benefits associated with the calculation of limitations placed on the utilization of tax attributes related to an acquired company. If recognized, $0.1 million of the balance of unrecognized tax benefits as of May 31, 2017 would affect the effective tax rate and the balance of $0.8$0.5 million would result in adjustments to other tax accounts.  
The Company recognizes interest and penalties related to unrecognized tax benefits as a component of income tax expense. There are no0 accrued interest and penalties recognized in the consolidated balance sheet as of May 31, 20172021 and May 31, 2016.2020.
The Company files income tax returns in the U.S. federal jurisdiction and various state and foreign jurisdictions. In the normal course of business the Company is subject to examination by taxing authorities throughout the world. Fiscal years 20142018 through 20172020 remain open to examination by the various tax authorities.
The Company does not anticipate that the amount of unrecognized tax benefits will significantly change in the next twelve months.
The accumulated undistributed earnings of the Company’s foreign operations were approximately $5.3 million, and are intended to remain indefinitely invested in foreign operations. Accordingly, no taxes have been provided on these earnings as of
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May 31, 2017. If these earnings were distributed, the Company would be subject to both foreign withholding taxes and U.S. income taxes that may not be fully offset by foreign tax credits. A reasonable estimate of the deferred tax liability on these earnings is not practicable at this time.
10.11. ACCRUED LIABILITIES
As of May 31, 2017 and 2016, accruedAccrued liabilities consist of the following:
(in thousands)May 31, 2021May 31, 2020
Payroll and related expenses$20,408 $13,059 
Outside services4,256 2,222 
Royalties2,663 2,392 
Accrued severance548 794 
Sales and franchise taxes631 634 
Litigation matters975 
Indemnification holdback5,000 
Other5,978 5,279 
Total$35,459 $29,380 
 
May 31,
2017
 
May 31,
2016
(in thousands) 
Payroll and related expenses$11,383
 $9,414
Royalties2,885
 2,489
Accrued severance2,075
 1,524
Sales and franchise taxes856
 565
Outside services1,622
 2,063
Litigation matters (Note 15)12,500
 
Acculis recall liability2,563
 
Other4,920
 5,887
Total$38,804
 $21,942
12. LONG-TERM DEBT

InOn June 3, 2019 and in connection with the fourth quartercompletion of fiscal year 2017,the Fluid Management divestiture, the Company issued a voluntary recall ofrepaid all amounts outstanding under its Acculis probes that were sold over the past two years. As a result of this voluntary recall, the Company decided to also do a voluntary market withdrawal of its Acculis capital systemsexisting Credit Agreement and discontinue selling the product. The voluntary recall resulted in a deferral of revenue of $2.6 million and an increase of $2.6 million in inventory and hardware asset reserves. The total impact to income before taxes of the recall was $4.5 million.

11. LONG-TERM DEBT

On November 7, 2016, the Company entered into a new Credit Agreement with the lenders party thereto, JPMorgan Chase Bank, N.A., as administrative agent, and Bank of America, N.A. and KeybankKeyBank National Association, as co-syndication agents, and JPMorgan Chase Bank, N.A., Merrill Lynch, Pierce, Fenner & Smith Incorporated and Keybank National Association as joint bookrunners and joint lead arrangers.agents.
The Credit Agreement provides for a $100.0$125.0 million senior secured term loan facility and a $150.0 million senior secured revolving credit facility (the “Revolving Facility”), which includes up to a $20.0 million sublimit for letters of credit and a $5.0 million sublimit for swingline loans.
On November 7, 2016,an uncommitted expansion feature that allows the Company borrowed $100.0 million underto increase the Term Loan and approximately $16.5 million under the Revolving Facilitytotal revolving commitments and/or add new tranches of term loans in an aggregate amount not to repay the balance of $116.5 million under the former credit agreement. In February 2017 the revolver was paid off in full. As of May 31, 2017 and 2016 the carrying value of long-term debt approximates its fair market value.
exceed $75.0 million.  The proceeds of the Revolving Facility may be used for general corporate purposesto refinance certain existing indebtedness of the Company and its subsidiaries, to finance the working capital needs, and for general corporate purposes (including permitted acquisitions), of the Company and its subsidiaries.
The Facilities haveCredit Agreement has a five year maturity. Interest on both the Term Loan and Revolving Facility arefacility is based, at the Company’s option, on either a base rate of LIBOR or Eurodollaralternate base rate, plus an applicable margin which increases astied to the Company’s total leverage ratio increases, with theand having ranges between 0.25% and 0.75% for base rate loans and Eurodollar rate having ranges of 0.50% tobetween 1.25% and 1.50% to 2.25% respectively. In case of1.75% for LIBOR loans. After default, the interest rate may be increased by 2.0%. The Revolving Facilityfacility also carries a commitment fee of 0.20% to 0.35%0.25% per annum on the unused portion. The interest rate on the Term Loan at May 31, 2017 was 2.55%.
The Company's obligations under the FacilitiesRevolving Facility are unconditionally guaranteed, jointly and severally, by the Company's material direct and indirect domestic subsidiaries (the “Guarantors”). All obligations of the Company and the Guarantors under the FacilitiesRevolving Facility are secured by first priority security interests in substantially all of the assets of the Company and the Guarantors.


The Credit Agreement includes customary representations, warranties and covenants, and acceleration, indemnity and events of default provisions, including, among other things, two2 quarterly financial covenants as follows: 
maximumMaximum leverage ratio of consolidated total indebtedness* to consolidated EBITDA* of not greater than 3.503.00 to 1.00(during (during certain periods following material acquisitions the ratio shall be increased to 3.753.50 to 1.00).
fixedFixed charge coverage ratio of consolidated EBITDA minus consolidated capital expendituresexpenditures* to consolidated interest expenseexpense* paid or payable in cash plus scheduled principal payments in respect of indebtedness under the Credit Agreement of not less than 1.25 to 1.00.
* The definitions of consolidated total indebtedness, consolidated EBITDA, consolidated capital expenditures and consolidated EBITDAinterest expense are maintainedspecifically defined in the credit agreement included as an exhibit to Form 8-k8-K filed on November 10, 2016.June 6, 2019.

As of May 31, 2021 there was $20.0 million outstanding on the Revolving Facility. As of May 31, 2021 and May 31, 2020, the carrying value of long-term debt approximated its fair market value.
The interest rate on the Revolving Facility at May 31, 2021 was 1.36%.
The Company was in compliance with boththe Credit Agreement covenants as of May 31, 2017.2021.

The Company's maturities of principal obligations under the credit agreement are as follows, as of May 31, 2017:
75


(in thousands) 
2018$5,000
20195,000
20207,500
202111,250
202268,750
     Total term loan97,500
Revolving facility
     Total debt97,500
Less: Unamortized debt issuance costs(1,180)
     Total96,320
Less: Current portion of long-term debt(5,000)
     Total long-term debt, net of current portion$91,320


12.13. RETIREMENT PLANS

The Company has a 401(k) plan under which eligible employees can defer a portion of their compensation, part of which is matched by the Company. Matching contributions were $4.2$3.8 million, $3.7$3.2 million and $3.7$3.6 million in 2017, 20162021, 2020 and 2015,2019, respectively. There are also various immaterial foreign retirement plans.

13.14. STOCKHOLDERS’ EQUITY

Capitalization

On October 29, 2014, the Board of Directors approved the Amended and Restated Certificate of Incorporation (the “Amended Certificate”). Under the Amended Certificate, the authorized capital stock is 80,000,000 shares, consisting of 75,000,000 shares of common stock, par value $.01 per share and 5,000,000 shares of preferred stock, par value $.01 per share.

The holders of common stock are entitled to one1 vote for each share held. Subject to preferences applicable to any outstanding shares of preferred stock, the holders of common stock are entitled to receive ratably dividends, if any, as may be declared by the Board of Directors out of funds legally available for dividend payments. If the Company liquidates, dissolves, or winds up, the holders of common stock are entitled to share ratably in all assets remaining after payment of liabilities and liquidation preferences of any outstanding shares of preferred stock. Holders of common stock have no pre-emptive rights or rights to convert their common stock into any other securities. There are no redemption or sinking fund provisions applicable to

the common stock. The rights, preferences and privileges of the holders of common stock are subject to, and may be adversely affected by, the rights of the holders of shares of any series of preferred stock that the Company may designate in the future.

The boardBoard of directorsDirectors has the authority to (i) issue the undesignated preferred stock in one or more series, (ii) determine the powers, preferences and rights and the qualifications, limitations or restrictions granted to or imposed upon any wholly un-issued series of undesignated preferred stock and (iii) fix the number of shares constituting any series and the designation of the series, without any further vote or action by the Company's stockholders.

Stock Options

2004 Stock and Incentive Award Plan

The 2004On October 13, 2020, the Company's shareholders approved the 2020 Stock and Incentive Award Plan (the “2004“2020 Plan”). The 2020 Plan provides for the grant of incentive stock options, to employees and for the grant of non-statutory stock options, restricted stock, restricted stock units, stock appreciation rights, performance share units, performance shares and other incentive awards to the Company's employees, directors and other service providers. A total of 7,000,0002.4 million shares of common stock have been reserved for issuance under the 2004 Plan, of which up2020 Plan.
Prior to 800,000 shares may be issued upon the exercise of incentive stock options. The compensation committeeadoption of the Board of Directors administers the 2004 Plan. The committee determines vesting terms and the exercise price of options granted2020 Plan, equity awards were issued under the 2004 Plan, but for all incentive stock options the exercise price must at least be equal to the fair market value of common stock on the date of grant. The term of an incentive stock option may not exceed ten years.

On October 25, 2016, the Company amended the 2004 Stock and Incentive Award Plan to increased(the “2004 Plan”). The adoption of the shares2020 Plan did not impact the administration of common stock reserved for issuance by 250,000 shares.

equity awards issued under the 2004 Plan but following the adoption of the 2020 Plan, equity award grants are no longer made under the 2004 Plan.
As of May 31, 2017,2021, there remained approximately 2.42.3 million shares available for granting under the 20042020 Plan.
The following table summarizes information about stock option activity for the fiscal year ended May 31, 2017.2021:
SharesWeighted average exercise priceWeighted average remaining contractual lifeAggregate intrinsic value (in thousands)
2017
Shares 
Weighted-
average
exercise
price
 
Weighted
average
remaining
contractual
life
 
Aggregate
intrinsic
value (in
thousands)
Outstanding at beginning of year2,281,618
 $14.45
    
Outstanding at beginning of year - June 1, 2020Outstanding at beginning of year - June 1, 20201,938,753 $16.89 
Granted667,691
 $16.83
  Granted528,809 $11.41 
Exercised(826,286) $13.45
  Exercised(137,237)$16.45 
Forfeited(342,924) $16.03
  Forfeited(132,895)$18.38 
Expired(112,656) $19.08
    Expired(50,470)$12.33 
Outstanding at end of year1,667,443
 $15.01
 4.66 $1,513
Outstanding at end of year - May 31, 2021Outstanding at end of year - May 31, 20212,146,960 $15.59 6.24$16,176 
Options exercisable at year-end659,463
 $14.26
 2.88 $913
Options exercisable at year-end1,067,686 $16.26 3.91$7,324 
Options expected to vest in future periods884,906
 $15.50
 5.83 $527
Options expected to vest in future periods1,079,274 $14.92 8.53$8,852 
Stock options are granted at exercise prices equal to the quoted market price of common stock at the date of the grant. Options vest 25% per year over four years for employees and 100% after one year for consultants. Grants to directors vest 33.33% per year over three years.employees. Stock options granted prior to May 1, 2007 and after June 1, 2017 expire on the tenth anniversary of the grant date. Stock options granted on or afterbetween May 1, 2007 through May 31, 2017 expire on the seventh anniversary of the grant date.

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The Company measures the fair value of each stock option grant at the date of grant using a Black-Scholes option pricing model. The weighted average grant-date fair value of options granted during the years ended May 31, 2017, 20162021, 2020 and 20152019 was $4.70, $4.16,$3.97, $5.46, and $4.74,$6.53, respectively. The following assumptions were used in arriving at the fair value of options granted during 2017, 20162021, 2020 and 2015,2019, respectively: risk-free interest rates of 1.30%0.34%, 1.48%1.63% and 1.54%2.78%; expected volatility of 31%39%, 31%, and 31%; and expected lives of 4.804.96 years, 4.814.91 years, and 4.764.79 years. The Company does not declare dividends therefore a dividend yield of zero was used for the years ended May 31, 2017, 20162021, 2020 and 2015.2019. Risk-free interest rates reflect the yield on

zero-coupon U.S. Treasury bonds whose maturity period equals the expected term of the option. Expected volatilities are based on the historical volatility of the Company's stock. The expected option lives are based on historical experience of employee exercise behavior.

The total intrinsic value of options exercised during the years ended May 31, 2017, 20162021, 2020 and 20152019 was $2.8$0.8 million, $0.1$0.5 million, and $1.6$1.4 million, respectively. As of May 31, 2017,2021, there was $3.7$3.9 million of total unrecognized compensation cost related to non-vested options, which is expected to be recognized over a weighted average period of 36 years.

Cash received from option exercises during 2017, 20162021, 2020 and 20152019 was $9.9$1.9 million, $1.3$0.6 million and $4.3 million, respectively. The tax benefit realized from stock options exercised during the years ended May 31, 2016 and 2015 were $0.1 million and $0.5$1.5 million, respectively. Due to the valuation allowance there was no0 tax benefit realized from stock option exercises during the yearyears ended May 31, 2017.2021, 2020 and 2019.

Performance Share and Restricted Stock Unit and Performance Share Awards

The Company grants restricted stock units to certain employees under the 2020 Plan, and historically under the 2004 Plan, which give the recipients the right to receive shares of Company stock upon vesting. The restricted stock unit awards vest in four equal annual installments overbeginning on the termfirst anniversary of the grants.grant date. Restricted stock unit awards granted to directors vest over one year. Unvested restricted stock unit awards will be forfeited if the recipient ceases to be employed by the Company.

 The following table summarizes information about restricted stock unit activity for the year ended May 31, 2017.2021:
Restricted Stock UnitsWeighted Average Grant-Date Fair Value
  
Weighted Average
Grant-Date Fair Value
Non-vested at beginning of year549,777
 $14.62
Non-vested at beginning of year, June 1, 2020Non-vested at beginning of year, June 1, 2020464,921 $19.65 
Granted255,032
 $16.54
Granted533,708 $10.40 
Vested(182,320) $16.10
Vested(205,202)$10.02 
Canceled(183,192) $15.95
Canceled(31,324)$17.30 
Non-vested at end of year439,297
 $15.55
Non-vested at end of year, May 31, 2021Non-vested at end of year, May 31, 2021762,103 $13.28 
The fair value of each restricted stock unit is the market price of Company stock on the date of grant. The weighted average grant date fair value of restricted stock units granted during the years ended May 31, 2017, 20162021, 2020 and 20152019 was $16.54, $15.21$10.40, $20.35 and $14.75,$20.87, respectively. The total intrinsic value of restricted stock units (meaning the fair value of the units on the date of vest) vesting during the years ended May 31, 2017, 20162021, 2020 and 20152019 was $2.9$2.1 million, $2.5$3.9 million, and $2.4$4.6 million, respectively. As of May 31, 2017,2021, there was $4.9$6.5 million of total unrecognized compensation cost related to non-vested restricted stock awards, which is expected to be recognized over a weighted average period of 3 years.

The Company grants performance share awards to certain employees under the 2020 Plan, and historically under the 2004 Plan, which gives the recipients the right to receive shares of Company stock if certain criteria is met. The performance criteria is established by the compensation committee for vesting of the performance share awards and may include factors such as the achievement of relative total shareholder return ("TSR"), certain sales, operating income and earnings per share (“EPS”) goals. Performance share awards are subject to additional conditions, including the recipient’s continued employment with the Company.


 The following table summarizes information about performance unit award activity for the year ended May 31, 2017.2021:

 Performance Unit Awards 
Weighted Average
Grant-Date Fair Value
Non-vested at beginning of year435,892
 $19.16
Granted93,400
 $22.61
Vested(37,184) $14.48
Canceled(130,944) $21.54
Non-vested at end of year361,164
 $18.54



Performance Unit AwardsWeighted Average Grant-Date Fair Value
Non-vested at beginning of year, June 1, 2020273,121 $22.07 
Granted232,236 $9.72 
Vested$
Canceled(129,066)$21.28 
Non-vested at end of year, May 31, 2021376,291 $14.72 
During fiscal year 2021 and 2020, the Company granted performance unit awards. Performance unit awards subject to vesting are based on the Company's level of attainment of the performance targets which are set for each of the three
77


performance years 2017, 2016 and 2015, wealong with continued employment of the grantee. At the end of the three year period, the vested shares are subject to modification based on the Company’s TSR targets relative to the percentage appreciation of a specified index of companies for the respective three-year period.
During fiscal year 2019, the Company granted performance unit awards that include a three-year market condition. Vesting of the performance unit awards is based on the Company's level of attainment of specified total shareholder return ("TSR")TSR targets relative to the percentage appreciation of a specified index of companies for the respective three-year periods. It is also subject to the continued employment of the grantees.
In order to estimate the fair value of such awards, we used a Monte Carlo Simulation valuation model on the date of the grant.grant was used. For the years ended May 31, 2017, 20162021, 2020 and 2015,2019, the weighted average grant date fair market value for new grants was $22.61, $18.07$9.72, $14.06 and $19.83,$28.62, respectively. Compensation cost is recognized over the performance period which is typically three years. As of May 31, 2017, 0.4 million performance share units with a weighted average remaining contractual term of 3 years and $4.22021, there was $2.1 million of unrecognized compensation cost were outstanding.

which is expected to be recognized over a weighted average period of 2 years.
Compensation Expense

The following tables represents the break out of share-based compensation included in the Company's consolidated statement of operations.operations:
 For the year ended May 31,Year ended May 31,
(in thousands) 2017 2016 2015(in thousands)202120202019
Cost of sales $299
 $172
 $143
Cost of sales$768 $655 $461 
Research and development 314
 349
 229
Research and development1,152 971 724 
Sales and marketing 1,762
 1,489
 1,685
Sales and marketing1,641 1,665 1,952 
General and administrative 4,026
 2,291
 3,941
General and administrative5,064 4,301 6,112 
Acquisition, restructuring and other items, net (218) (1,061) 
 $6,183
 $3,240
 $5,998
$8,625 $7,592 $9,249 
The income tax benefit on the compensation expense recognized for all share-based compensation arrangements was $2.2$2.0 million, $1.0$1.7 million and $2.0$2.1 million for the years ended May 31, 2017, 20162021, 2020 and 2015,2019, respectively. The income tax benefit for 20172021, 2020 and 20162019 are negated by the full valuation allowance established as of May 31, 2016.

recorded against the deferred tax assets.
Employee Stock Purchase Plan

The Employee Stock Purchase Plan (the “Stock Purchase Plan”) provides a means by which employees (the “participants”) are given an opportunity to purchase the Company's common stock through payroll deductions. A total of 2,500,0004,000,000 shares of common stock have been reserved for issuance under the Stock Purchase Plan. Shares are offered through two2 purchase periods, each with duration of approximately 6 months, commencing on the first business day of the first and third fiscal quarters. An employee is eligible to participate in an offering period if, on the first day of an offering period, he or she has been employed in a full-time capacity for at least six months, with a customary working schedule of 20 or more hours per week and more than five months in a calendar year. Employees who own stock possessing 5% or more of the total combined voting power or value of all classes of stock are not eligible to participate in the Stock Purchase Plan. The purchase price of the shares of common stock acquired on each purchase date will be the lower of (i) 85% of the fair market value of a share of common stock on the first day of the offering period or (ii) 85% of the fair market value of a share of common stock on the last day of the purchase period, subject to adjustments made by the Board of Directors. The Stock Purchase Plan is intended to qualify as an “employee stock purchase plan” within the meaning of Section 423 of the Internal Revenue Code. During the yearyears ended May 31, 2015,2017, 2019 and 2021, an additional 800,000500,000, 1,000,000 and 500,000 shares of the Company's common stock, have beenrespectively, were reserved for issuance under the Stock Purchase Plan. During the year ended May 31, 2017, an additional 500,000 shares of the Company's common stock have been reserved for issuance under the Stock Purchase Plan.
The Company uses the Black-Scholes option-pricing model to calculate the purchase date fair value of the shares issued under the Stock Purchase Plan and recognize expense related to shares purchased ratably over the offering period. During the years ended May 31, 2017, 20162021, 2020 and 2015, 129,185, 137,9572019, 164,194, 100,567 and 119,00172,863 shares, respectively, were issued at an average price of $11.00, $10.67$7.95, $12.11 and $11.89,$16.08, respectively, under the Stock Purchase Plan. As of May 31, 2017, 1.32021, 2.4 million shares remained available for future purchases under the Stock Purchase Plan.




Share Repurchases

On November 6, 2016, the Board of Directors approved the Repurchase Program under which they authorized the Company the option to repurchase up to $25.0 million of its outstanding common stock during the twenty-four month period ending November 6, 2018. During the second quarter of fiscal year 2017, the Company repurchased 500,000 shares of common stock in the open market at an aggregate cost of $7.8 million under the Repurchase Program. During the fourth quarter of fiscal year 2017, the Company repurchased 370,000 shares of common stock in the open market at an aggregate cost of $5.7 million under the Repurchase Program. As of May 31, 2017, $11.4 million remained available for repurchase under the Repurchase Program.

In February 2017, the Company retired 642,305 shares of treasury stock. These retired shares are now included in the Company’s pool of authorized but unissued shares. The retired stock had a carrying value of approximately $9.9 million and $0.01 was the par value that was deducted from common stock and the remaining $9.9 million was deducted from additional paid-in capital.
14.15. EARNINGS PER SHARE
Basic earnings per share are based on the weighted average number of common shares outstanding. In addition, diluted earnings per share include the dilutive effect of potential common stock consisting of stock options, restricted stock units and performance stock units, provided that the inclusion of such securities is not anti-dilutive. In periods with a net loss, stock
78


options and restricted stock units are not included in the computation of basic loss per share as the impact would be anti-dilutive.
The following table reconciles basic to diluted weighted average shares outstanding for the years ended May 31, 2017, 20162021, 2020 and 2015:2019:
Year ended May 31,
202120202019
Basic38,342,476 37,961,224 37,484,573 
Effect of dilutive securities
Diluted38,342,476 37,961,224 37,484,573 
Securities excluded as their inclusion would be anti-dilutive3,285,354 2,581,006 2,200,318 
16. LEASES
 For the year ended May 31,
 2017 2016 2015
Basic36,616,859
 36,161,383
 35,683,139
Effect of dilutive securities342,391
 
 
Diluted36,959,250
 36,161,383
 35,683,139
      
Securities excluded as their inclusion would be anti-dilutive1,058,790
 3,277,037
 2,862,414
Adoption of ASU No. 2016-02, Leases (Topic 842)

15. COMMITMENTS AND CONTINGENCIES

Leases

On June 1, 2019, the Company adopted ASU No. 2016-02 using the modified retrospective approach. This ASU increases transparency and comparability among organizations by recognizing lease assets and liabilities on the balance sheet and disclosing key information about leasing arrangements. Comparative periods prior to adoption have not been retrospectively adjusted.
The Company elected the three practical expedients that permit an entity to a) not reassess whether expired or existing contracts contain leases, b) not reassess lease classification for existing or expired leases, and c) not consider whether previously capitalized initial direct costs would be appropriate under the new standard. Further, the Company has elected to not recognize leases with terms of 12 months or less on the balance sheet, and elected to account for lease and non-lease components as a single component for certain classes of assets.
The adoption of this standard resulted in the recording of an additional lease asset and lease liability of approximately $5.6 million. The standard did not have a material impact on the Company's Consolidated Statement of Operations, Stockholders Equity or Cash Flows.
Leases
The Company determines if an arrangement is committed under non-cancelablea lease at inception of the contract. The Company has operating leases for facilitiesbuildings, primarily for office space, R&D, manufacturing and equipment. warehousing.
Operating lease right-of-use (“ROU”) assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. Many of the lease agreements contain renewal or termination clauses that are factored into the determination of the lease term if it is reasonably certain that these options would be exercised. The Company recognizes lease expense for these leases on a straight-line basis over the lease term.
The following table presents supplemental balance sheet information related to leases:
(in thousands)Balance Sheet LocationMay 31, 2021May 31, 2020
Assets
Operating lease ROU assetOther assets$9,382 $10,146 
Liabilities
Current operating lease liabilitiesOther current liabilities2,415 2,077 
Non-current operating lease liabilitiesOther long-term liabilities7,319 8,345 
Total lease liabilities$9,734 $10,422 
The interest rate implicit in lease agreements is typically not readily determinable, and as such the Company used the incremental borrowing rate based on the information available at commencement date in determining the present value of future payments. The incremental borrowing rate is defined as the interest the Company would pay to borrow on a collateralized basis, considering factors such as length of lease term. The following table presents the weighted average remaining lease term and discount rate:
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May 31, 2021May 31, 2020
Weighted average remaining term (in years)4.125.00
Weighted average discount rate3.8 %4.2 %
The maturities of the lease liabilities for each of the following fiscal years is:
(in thousands)May 31, 2021
2021$2,735 
20222,787 
20232,209 
20241,454 
20251,148 
2026 and thereafter171 
Total lease payments$10,504 
Less: Imputed Interest770 
Total lease obligations$9,734 
Less: Current portion of lease obligations2,415 
Long-term lease obligations$7,319 
During fiscal 2017, 2016the years ended May 31, 2021 and 2015, aggregate rental costs under allMay 31, 2020, the Company recognized operating lease expense which includes immaterial short-term leases were approximately $2.5 million, $2.5of $3.2 million and $3.4 million, respectively. Future annual payments under non-cancelable operating leases inRent expense prior to adoption of ASC 842 amounted to $2.5 million for the aggregate, of which one includes an escalation clause, with initial remaining terms of more than one year atended May 31, 2017, are summarized2019.
As of May 31, 2021 and 2020, the expenses on the Consolidated Statement of Operations were classified as follows (in thousands):follows:
(in thousands)May 31, 2021May 31, 2020
Cost of sales$820 $1,138 
Research and development857 583 
Sales and marketing407 397 
General and administrative1,123 1,233 
$3,207 $3,351 

The following table presents supplemental cash flow and other information related to leases for the year ended May 31, 2021 and 2020:
(in thousands)May 31, 2021May 31, 2020
Cash paid for amounts included in the measurement of lease liabilities
Operating cash flows from operating leases$2,698 $2,372 
ROU assets obtained in exchange for lease liabilities
Operating leases1,585 6,918 
(in thousands) 
2018$2,214
20192,066
20201,860
20211,025
2022 and thereafter2,552
 $9,717

17. COMMITMENTS AND CONTINGENCIES
Other Commitments and Contingencies

The following table summarizes the Company's other future commitments and contingencies as of May 31, 2017.2021:
(in thousands)Total20222023202420252026 and thereafter
Purchase obligations (1)
$4,697 $4,697 $$$$
Royalties (2)
47,700 3,800 3,800 3,800 3,800 32,500 
$52,397 $8,497 $3,800 $3,800 $3,800 $32,500 
(1) The non-cancelable inventory purchase obligations are not reflected on the consolidated balance sheets under accounting principles generally accepted in the United States of America.
80


(in thousands)Total 2018 2019 2020 2021 2022 and thereafter
Purchase obligations (1)$49,762
 $8,443
 $8,726
 $9,162
 $8,709
 $14,722
Royalties44,000
 2,500
 3,000
 3,500
 3,500
 31,500
Other834
 167
 167
 167
 167
 166
 $94,596
 $11,110
 $11,893
 $12,829
 $12,376
 $46,388
(1)The non-cancelable inventory purchase obligations are not reflected on our consolidated balance sheets under accounting principles generally accepted in the United States of America.
(2) These are future minimum royalty payments.
Legal Proceedings

The Company is involved in various legal proceedings, including commercial, intellectual property, product liability, and regulatory matters of a nature considered normal for its business. The Company accrues for amounts related to these matters if it is probable that a liability has been incurred, and an amount can be reasonably estimated. The Company discloses such matters when there is at least a reasonable possibility that a material loss may have been incurred. However, the Company cannot predict the outcome of any litigation or the potential for future litigation.
C.R. Bard, Inc. v. AngioDynamics, Inc.

On January 11, 2012, C.R. Bard, Inc. (“Bard”) filed a suit in the United States District Court of Utah claiming certain of ourthe Company's implantable port products infringe on three3 U.S. patents held by Bard (the "Utah Action"(US Patent Nos. 7,785,302, 7,959,615 (“615”) and 7,947,022). Bard is seeking unspecified damages and other relief. The Court denied Bard’s motion for pre-trial consolidation with separate actions it filed on the same day against Medical Components, Inc. and Smiths Medical ASD, Inc., but had asked for supplemental briefing on the issue of whether to conduct a common Markman hearing. Meanwhile, we filed petitions forcase was stayed pending reexamination in the US Patent and Trademark Office ("PTO"USPTO") which seek to invalidate all three patents asserted by Bard in. Following the litigation. Our petitions were granted and 40 of Bard's 41 patent claims were rejected and, following furtherreexamination proceedings, the Patent Office issued a Final Rejection of all 40 claims subject to reexamination. Thereafter, Bard filed appeals to the PTO Board of Appeals and Interferences for all three reexams. The parties completed briefing on the appeals and oral argument was held on June 18, 2015. The Patent Office issued decisions in the three appeals. In one (issued on March 11, 2016 for US Patent No. 7,785,302), the rejections of six of the ten claims under reexamination were affirmed, but were reversed on four of the ten claims. In the second (issued on March 24, 2016 for U.S. Patent No. 7,959,615), the rejections of eight of the ten claims under reexamination were affirmed but the rejections of the other two of the ten claims were reversed. In the third (issued on March 29 for U.S. Patent No. 7,947.022) the rejections of all twenty claims under reexamination were affirmed. Bard has since filed Requests for Rehearing in all three reexamination appeals and the Company filed Requests for Rehearing in two of the reexaminationparties’ related appeals (the ‘302 and ‘615 patent reexaminations). Each party has filed comments in Opposition to the other party’s Rehearing Requests,. The PTO has since issued decisions denying all Rehearing Requests - - on February 1, 2017 for the ‘302; on February 17, 2017 for the ‘022; and on February 21, 2017 for the ‘615. In the ‘302 and ‘022, the PTO modified its characterization of one prior art reference. Bard has since filed a Notice of Appeal to the Federal Circuit Courtwhich resulted in further proceedings at the USPTO, certain claims of Appeals in all three reexamsthe 615 patent were held invalid, while the remaining claims of the 615 patent and we filed Cross-Appealsthe other 2 patents were upheld over the prior art references considered in the ‘302reexamination proceedings. Thereafter, the case was transferred from the District of Utah to the United States District Court for the District of Delaware (“District of Delaware”). A scheduling order was entered on March 23, 2021. The Company filed a Motion to Amend its Answer and the ‘615 reexams.Counterclaims on April 14, 2021. This motion seeks to add counterclaims for infringement of U.S. Patent Nos. 9,168,365; 9,895,523; and 10,632,295, as well as a counterclaim of inequitable conduct, and remains pending. The parties are in the process of preparing and filing the various appellate briefs, starting with Bard’s Opening Brief which is currently dueCompany served its initial invalidity contentions on July 31, 2017 and ending2, 2021, consistent with our Reply Brief which is currently due on November 6, 2017.the scheduling order. The Utah Action has been stayed pending final resolution of the PTO process. We believe

Company believes these claims are without merit and intendintends to defend them vigorously. We haveThe Company has not recorded an expense related to the outcome of this litigation because it is not yet possible to determine if a potential loss is probable nor reasonably estimable.

On March 10, 2015, C.R. Bard Inc. and Bard Peripheral Vascular Inc. (“Bard”) filed suit in the United States District Court for the District of Delaware claiming certain of ourthe Company's implantable port products infringe on three3 U.S. patents held by Bard (the “Delaware Action)(US Patent Nos. 8,475,417, 8,545,460, 8,805,478). The case proceeded through trial which began on March 4, 2019. On day four of the jury trial, at the close of Bard’s case, the Court granted the Company's oral motion for judgment as a matter of law as well as its motions for summary judgment on the grounds that the asserted patents are invalid, ineligible, not infringed and not willfully infringed. On May 10, 2019, the Company filed a motion for attorney fees and non-taxable expenses under 35 USC Sec. 285. Bard is seeking unspecified damagesappealed the judgment to the Federal Circuit and other relief.on November 10, 2020, the Federal Circuit reversed the judgment in part with respect to Section 101, and vacated and remanded the trial court’s invalidity and non-infringement judgments. The patents asserted in the Delaware Action are different than those asserted in the Utah Action.Company filed a combined Petition for rehearing and rehearing en banc on December 10, 2020, which was denied on January 15, 2021. The Federal Circuit issued its mandate on January 22, 2021. On June 1, 2015, we filed two motions in response to Bard’s Complaint - one sought transfer toMarch 15, 2021, the District of Utah whereDelaware entered an order requiring the Utah Action is currently pending,parties to submit status reports and denied as moot the other sought dismissal of the entire complaint on grounds that none of the claims in the asserted patents is directed to patent eligible subject matter under Section 101 of the Patent StatuteCompany’s motion for attorney’s fees and in light of recent authority from the U. S. Supreme Court. On January 12, 2016, the court issued a decision denying both motions. We have since served an Answer and Counterclaim to which Bard has served a Reply. On March 10, 2016, the Court held a case management conference, and,expenses. The parties submitted status reports on March 14, 2016, the court entered a Scheduling Order which set, inter alia, a Markman hearing for March 10, 2017, a summary judgment hearing for December 8, 2017 and trial for March 12, 2018.29, 2021. The parties have served various discovery requests on each other, and have been producing documents to each other; on May 27, 2016 Bard servedmatter remains pending. The Company maintains its Infringement Contentions which identified all the port products accused of infringement; and, on June 24, 2016, we served Invalidity Contentions which detail various grounds for invalidating the three asserted patents. The parties completed briefing on the claim construction issues and the Markman hearing was held on March 10, 2017 and the Court issued its Claim Construction Order on May 19, 2017. The Court has since amended the Scheduling Order to provide for the completion of Expert Discovery on October 30, 2017; briefing on Case-Dispositive Motions between November 17, 2017 and January 24, 2018 with oral argument set for February 22, 2018 and trial to commence May 29, 2018. We believe thesebelief that Bard’s claims are without merit and intend to defend them vigorously. We havemerit. The Company has not recorded an expense related to the outcome of this litigation because it is not yet possible to determine if a potential loss is probable nor reasonably estimable.

On March 8, 2021, Bard filed suit in the District of Delaware asserting certain of the Company’s port products (including certain related infusion sets) infringe U.S. Patent Nos. 8,025,639, 9,603,992 (“992”) and 9,603,993 (“993”). On May 20, 2021, the Company filed a Motion to Dismiss Bard’s claims with respect to the 992 and 993 patents, and the motion remains pending. The Company maintains its belief that Bard’s claims are without merit. The Company has not recorded an expense related to the outcome of this litigation because it is not yet possible to determine if a potential loss is probable nor reasonably estimable.
AngioDynamics, Inc. v. C.R. Bard, Inc.

On May 30, 2017, wethe Company commenced an action in the United States District Court for the Northern District of New York entitled AngioDynamics, Inc. v. C.R. Bard, Inc. and Bard Access Systems, Inc. (“Bard”). In this action, we allegethe Company alleges that Bard has illegally tied the sales of its tip location systems to the sales of its PICCs. We allegeThe Company alleges that this practice violates the federal antitrust laws and has had, and continues to have, an anti-competitive effect in the market for PICCs. We seekThe Company seeks both monetary damages and injunctive relief. TheBard moved to dismiss on September 8, 2017. On August 6, 2018 the court denied Bard’s motion in its entirety. Bard made a motion for summary judgment which was denied in its entirety in a decision issued by the Court has seton May 5, 2021. Bard also raised a series of challenges targeted at one of AngioDynamics’ expert witnesses, which the Court denied in part and granted in part in decisions on May 5, 2021 and June 11, 2021. Discovery is largely complete, and the case is expected to proceed to trial in 2022.

81


Merz North America Settlement
On May 16, 2019, Merz North America, Inc. (“Merz”) commenced an initial case management conference for August 29, 2017.

Governmental Investigations

In June 2014 we received a subpoena from the U.S. Department of Justice (the “DOJ”) requesting documents in relation to a criminal and civil investigation the DOJ is conducting regarding BTG International, Inc.’s LC Bead® product beginning in 2003.  RITA Medical Systems and AngioDynamics, Inc., after its acquisition of RITA, was the exclusive distributor of LC Beadsaction in the United States from 2006 through December 31, 2011.  We are cooperating fullyDistrict Court for the Southern District of New York entitled Merz North America, Inc. v. AngioDynamics, Inc. In this action, Merz alleged breach of contract against AngioDynamics based on a March 1, 2016 Distribution Agreement. On June 28, 2019, AngioDynamics reached a settlement with this investigation.Merz. AngioDynamics made a lump-sum payment of $2.5 million to Merz in return for dismissal of the case with prejudice during the first quarter of fiscal year 2020. The case was subsequently dismissed.

In April 2015 we received a subpoena from the DOJ requesting documents in relation to a criminal and civil investigation the DOJ is conducting regarding purported promotion of certain of AngioDynamics’ VenaCure EVLT products for un-cleared indications.  We are cooperating fully with this investigation.

As of May 31, 2017 the Company accrued $12.5 million for these matters and in August 2017, the Company agreed in principle with the government to resolve these matters for approximately $12.5 million.

16.18. SEGMENTS AND GEOGRAPHIC INFORMATION

Segment information

The Company considers its business to be a single segment entity related to the development, manufacture and sale on a global basis of medical devices for vascular access, surgery, peripheral vascular disease and oncology. The Company's chief operating decision maker (CEO) evaluates the various global product portfolios on a net sales basis. Executives reporting in to the CEO include those responsible for operations and supply chain management, research and development, sales, franchise

marketing and certain corporate functions. The CEO evaluates profitability, investment and cash flow metrics on a consolidated worldwide basis due to shared infrastructure and resources.

Total sales by product category are summarized below (in thousands):below:
For the year ended May 31, Year ended May 31,
(in thousands)2017 2016 2015(in thousands)202120202019
Net sales by Product Category     Net sales by Product Category
Peripheral Vascular$208,602
 $205,620
 $196,890
Endovascular TherapiesEndovascular Therapies$135,079 $112,706 $119,901 
Vascular Access96,481
 99,375
 107,754
Vascular Access101,310 94,299 94,730 
Oncology/Surgery44,560
 48,895
 51,890
Oncology/Surgery54,621 57,152 56,003 
Total$349,643
 $353,890
 $356,534
Total$291,010 $264,157 $270,634 
Geographic information

Total sales for geographic areas are summarized below (in thousands):below:
For the year ended May 31, Year ended May 31,
(in thousands)2017 2016 2015(in thousands)202120202019
Net sales by Geography     Net sales by Geography
United States$282,168
 $285,824
 $284,122
United States$237,043 $207,980 $216,957 
International67,475
 68,066
 72,412
International53,967 56,177 53,677 
Total$349,643
 $353,890
 $356,534
Total$291,010 $264,157 $270,634 
For fiscal years 2017, 20162021, 2020 and 2015, International2019, international sales as a percentage of total net sales were 19%, 19%21% and 20%, respectively. Sales to any one country outside the U.S., as determined by shipment destination, did not comprise a material portion of net sales in any of the last three fiscal years. In addition, no one customer represents more than 10% of consolidated net sales. 99% of long-lived assets are located within the United States.

17.19. ACQUISITION, RESTRUCTURING AND OTHER ITEMS, NET

For the years ended May 31, 2017, 2016 and 2015 acquisition,Acquisition, restructuring and other items, net consisted of:

82


For the year ended May 31,Year ended May 31,
(in thousands)2017 2016 2015(in thousands)202120202019
Legal$19,480
 $7,487
 $4,959
Intangible and other asset impairment5,604
 352
 15,504
Legal (1)
Legal (1)
$6,161 $2,666 $7,802 
Mergers and acquisitions (2)
Mergers and acquisitions (2)
782 4,030 
Transition service agreement (3)
Transition service agreement (3)
(1,032)(1,799)
Divestiture (4)
Divestiture (4)
393 2,809 
Intangible and other asset impairment (5)
Intangible and other asset impairment (5)
13,953 1,704 
Restructuring1,348
 1,462
 1,997
Restructuring26 289 
Other1,078
 3,290
 3,797
Other756 1,530 1,302 
Total$27,510
 $12,591
 $26,257
Total$20,232 $6,014 $15,127 

(1) Legal expenses related to litigation that is outside the normal course of business.
Of(2) Mergers and acquisitions expenses related to investment banking, legal and due diligence.
(3) Transition services agreement that was entered into as a result of the $19.5sale of the Fluid Management business.
(4) Divestiture expenses incurred to transition manufacturing from Glens Falls, NY to Queensbury, NY.
(5) During the fourth quarter of fiscal year 2021, the Company made the decision to abandon the OARtrac product technology and trademark. This resulted in an impairment charge of $14.0 million
Included in legal for fiscal year 2017, $12.52021, is a $1.0 million relates to a reservesettlement expense. Included in legal for DOJfiscal years 2020 and 2019 are settlements received for the Biolitec litigation of $0.5 million and $3.4 million, respectively. The settlement (see Note 15) and the remainingreceived partially offsets legal expenses relates to DOJ matters.

Restructuring

The Company evaluates its performance and looks for opportunities to improve the overall operations of the Company on an ongoing basis. As a result of this evaluation, certain restructuring initiatives are taken to enhance the Company’s overall operations.


Operational Consolidation

On February 1, 2017, the Company announced to employees an operational consolidation plan (the “plan”) to consolidate manufacturing facilities in Manchester, GA and Denmead, UK into the Glens Falls and Queensbury, NY facilities. This plan will streamline and optimize the manufacturing functions into one centralized location increasing the utilization of the Glens Falls and Queensbury facilities, optimizing inventory and reducing cost of goods sold through savings in overhead expenses and direct labor. The restructuring activities associated with the plan are expected to be completed in the third quarter of fiscal year 2018.

The following table provides a summary of estimated costs associated with the plan:

Total estimated amount expected to be incurred (in millions)
Termination benefits$1.75 to $2.25
Plant consolidation (1)
$2.25 to $2.50
Regulatory filings$0.75 to $1.00
Contract cancellations$0.75 to $1.00
Other$0.75 to $1.00
$6.25 to $7.75
(1) Equipment transfer, validation and other start-up costs to prepare the facilities for the new product lines.

The Company recorded restructuring chargespaid related to the plan duringsettlement proceedings. In addition, the year ended May 31, 2017 of $1.3 million. There were no costs associated with this plan in$2.5 million accrual for the prior year. Termination benefits are only earned if an employee stays until their termination date; therefore, the expenses related to termination benefits are being recorded ratably over the service period.

The following table presents a rollforwardsettlement of the restructuring reserve for the year ended May 31, 2017:
        Contract    
  Termination Plant Regulatory Cancellation Other  
  Benefits Consolidation Filings Costs Costs Total
(in thousands)            
Balance at May 31, 2016 $
 $
 $
 $
 $
 $
Charges 851
 494
 
 
 3
 1,348
Non-cash adjustments 
 (108) 
 
 
 (108)
Cash payments 
 (275) 
 
 (3) (278)
Balance at May 31, 2017 $851
 $111
 $
 $
 $
 $962

The Company’s restructuring liability of $1.0 millionMerz contract termination is mainly comprised of accruals for termination benefits which are expected to be paid in the next twelve months and are included in accruedlegal expenses on the consolidated balance sheet.

for fiscal year 2019. 
18.
20. ACCUMULATED OTHER COMPREHESIVECOMPREHENSIVE INCOME (LOSS)

Changes in each component of accumulated other comprehensive income (loss), net of tax, are as follows for fiscal 2017years 2021 and 2016:2020:

(in thousands)Foreign currency translation gain (loss)
Balance at May 31, 2019$(1,352)
Other comprehensive income before reclassifications, net of tax11 
Net other comprehensive income$11 
Balance at May 31, 2020$(1,341)
Other comprehensive income (loss) before reclassifications, net of tax4,494 
Net other comprehensive loss$4,494 
Balance at May 31, 2021$3,153 
83


(in thousands) Foreign currency translation gain (loss) Unrealized gain (loss) on marketable securities Unrealized gain (loss) on interest rate swap Total
Balance at May 31, 2015 $(648) $(23) $(162) $(833)
Other comprehensive income (loss) before reclassifications, net of tax (112) (8) 162
 42
Amounts reclassified from accumulated other comprehensive income 
 
 
 
Net other comprehensive income (loss) $(112) $(8) $162
 $42
Balance at May 31, 2016 $(760) $(31) $
 $(791)
Other comprehensive income (loss) before reclassifications, net of tax (545) 12
 
 (533)
Amounts reclassified from accumulated other comprehensive income 
 
 
 
Net other comprehensive income (loss) $(545) $12
 $
 $(533)
Balance at May 31, 2017 $(1,305) $(19) $
 $(1,324)
         


19. QUARTERLY INFORMATION (unaudited)

Quarterly results of operations during the fiscal years ended May 31, 2017 and 2016 are as follows:
 2017
 
First
quarter
 
Second
quarter
 
Third
quarter
 
Fourth
quarter
(in thousands, except per share data) 
Net sales$88,098
 $89,029
 $85,602
 $86,914
Gross profit45,032
 45,010
 43,792
 42,335
Net income (loss) (1)
1,300
 13,734
 2,887
 (12,913)
Earnings (loss) per common share       
Basic0.04
 0.37
 0.08
 (0.35)
Diluted0.04
 0.37
 0.08
 (0.35)

(1) Included within net income (loss) during the fourth quarter of fiscal 2017 is the $12.5 million charge for a litigation reserve (Note 15) and $4.5 million impact relating to the Acculis recall (Note 10).
 2016
 
First
quarter
 
Second
quarter
 
Third
quarter
 
Fourth
quarter
(in thousands, except per share data) 
Net sales$83,753
 $89,284
 $87,434
 $93,419
Gross profit43,371
 45,884
 43,534
 41,527
Net income (loss) (1)
(775) (334) 594
 (43,075)
Earnings (loss) per common share       
Basic(0.02) (0.01) 0.02
 (1.19)
Diluted(0.02) (0.01) 0.02
 (1.19)

(1) Included within net income (loss) during the fourth quarter of fiscal year 2016 is the $40.4 million valuation allowance that was recorded (Note 9).
The data in the schedules above has been intentionally rounded to the nearest thousand and therefore the quarterly     amounts may not sum to the full year amounts.




AngioDynamics, Inc. and Subsidiaries
 
SCHEDULE II -VALUATION AND QUALIFYING  ACCOUNTS
(in thousands)
Column AColumn B Column C Column D Column E
(in thousands)(in thousands)SCHEDULE II -VALUATION AND QUALIFYING  ACCOUNTS
Description
Balance at
Beginning
of Year
 
Additions -
Charged  to
costs and
expenses
 Deductions 
Balance at
End of Period
DescriptionBalance at Beginning of YearAdditions - Charged to costs and expensesDeductionsBalance at End of Period
Year Ended May 31, 2015       
Year Ended May 31, 2019Year Ended May 31, 2019
Allowance for deferred tax asset$1,531
 $467
 $(207) $1,791
Allowance for deferred tax asset$26,607 $$(14,919)$11,688 
Allowance for sales returns and doubtful accounts$1,736
 $1,846
 $(539) $3,043
Allowance for sales returns and doubtful accounts$2,466 $393 $(953)$1,906 
Year Ended May 31, 2016       
Year Ended May 31, 2020Year Ended May 31, 2020
Allowance for deferred tax asset$1,791
 $40,685
 $(267) $42,209
Allowance for deferred tax asset$11,688 $1,426 $$13,114 
Allowance for sales returns and doubtful accounts$3,043
 $3,748
 $(2,419) $4,372
Allowance for sales returns and doubtful accounts$1,906 $1,218 $(974)$2,150 
Year Ended May 31, 2017       
Year Ended May 31, 2021Year Ended May 31, 2021
Allowance for deferred tax asset$42,209
 $6,139
 $
 $48,348
Allowance for deferred tax asset$13,114 $3,921 $$17,035 
Allowance for sales returns and doubtful accounts$4,372
 $(291) $(1,136) $2,945
Allowance for sales returns and doubtful accounts$2,150 $1,833 $(2,064)$1,919 
 








84


EXHIBITS
Incorporated by Reference
Exhibit NumberDescription of ExhibitsFormExhibitFiling Date
2.28-K2.1October 12, 2012
2.38-K2.1April 18, 2019
3.1.110-Q3.1October 7, 2005
3.1.210-K3.1.2August 10, 2015
3.28-K10.1October 21, 2015
10.18-K10.1June 6, 2019
10.1.3DEF 14AAugust 30, 2018
10.1.6

10-Q10.1September 29, 2017
10.1.7

10-K10.1.7July 23, 2018
10.1.810-Q10.1.8January 8, 2020
10.1.9DEF 14ASeptember 3, 2020
10.2DEF 14ASeptember 3, 2020
10.310-Q10.1October 12, 2004
10.3.110-K10.3.1July 23, 2018
10.4.310-Q10.2October 5, 2016
10.4.410-Q10.2September 29, 2017
10.4.510-K10.4.5July 23, 2018
10.4.610-Q10.4.6January 8, 2021
10.58-K10.3May 12, 2005
10.6S-110.2May 3, 2000
85


Incorporated by Reference
Exhibit NumberDescription of ExhibitsFormExhibitFiling Date
10.7S-110.11February 13, 1998
10.8S-1/A10.3June 14, 2000
10.9S-899.2July 8, 2005
10.10S-899.1July 8, 2005
10.118-K10.1May 12, 2006
10.11.18-K10.1April 6, 2016
10.128-K10.2April 6, 2016
10.12.210-K10.12.2August 10, 2020
10.1310-K/A10.13January 12, 2015
10.148-K10.3April 6, 2016
10.158-K10.4April 6, 2016
10.168-K10.5April 6, 2016
10.178-K10.6April 6, 2016
10.188-K10.1April 27, 2016
10.198-K10.1February 3, 2021
10.28-K10.2February 3, 2021
148-K14May 21, 2006
21
23
31.1
31.2
32.1
32.2
101.INSXBRL Instance Document
101.SCHXBRL Schema Document
101.CALXBRL Calculation Linkbase Documents
101.DEFXBRL Taxonomy Extension Definition Linkbase Document
101.LABXBRL Labels Linkbase Documents
101.PREXBRL Presentation Linkbase Documents

86


SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
 
ANGIODYNAMICS, INC.
Date:August 4, 2017July 27, 2021By:
/S/    HOWARD W. DONNELLY       
Howard W. Donnelly,

Chairman of the Board, Director
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
 
Date:July 27, 2021
/S/    HOWARD W. DONNELLY       
Howard W. Donnelly,
Chairman of the Board, Director
Date:July 27, 2021
/S/    JAMES C. CLEMMER 
James C. Clemmer,
President, Chief Executive Officer
(Principal Executive Officer)
Date:July 27, 2021
/S/    STEPHEN A. TROWBRIDGE
Stephen A. Trowbridge,
Executive Vice President, Chief Financial Officer,
(Principal Financial and Accounting Officer)
Date:July 27, 2021
/S/    WESLEY E. JOHNSON, JR.        
Wesley E. Johnson, Jr.,
Director
Date: August 4, 2017
/S/    HOWARD W. DONNELLY       
Howard W. Donnelly,
Chairman of the Board, Director
Date: August 4, 2017
/S/    JAMES C. CLEMMER
James C. Clemmer,
President, Chief Executive Officer
(Principal Executive Officer)
Date: August 4, 2017
/S/    MICHAEL C. GREINER
Michael C. Greiner
Executive Vice President, Chief Financial Officer, (Principal Financial and Principal Accounting Officer)
Date: August 4, 2017
/S/    WESLEY E. JOHNSON, JR.        
Wesley E. Johnson, Jr.,
Director
Date: August 4, 2017
/S/    JEFFREY G. GOLD        
Jeffrey G. Gold,
Director
Date: August 4, 2017
/S/    DENNIS S. METENY        
Dennis S. Meteny,
Director
Date: August 4, 2017
/S/    STEVEN R. LAPORTE        
Steven R. LaPorte,
Director
Date: August 4, 2017
/S/    KEVIN J. GOULD        
Kevin J. Gould,
Director
Date: August 4, 2017
/S/    JAN REED
Jan Reed,
Director
Date: August 4, 2017
/S/    EILEEN AUEN
Eileen Auen,
Director



EXHIBITS
(b)Exhibits
2.1Stockholders Agreement, dated as of May 22, 2012, among AngioDynamics, Inc. and the stockholders set forth on the signature pages thereto (incorporated by reference to Exhibit 2.2 of the Company’s current report on Form 8-K filed with the Commission on May 25, 2012).
2.2Stock Purchase Agreement, dated as of October 8, 2012, by and among AngioDynamics, Inc., Vortex Medical, Inc. (“Vortex”), the stockholders of Vortex set forth on the signature pages thereto, the option holders of Vortex set forth on the signature pages thereto and CHTP Management Services, Inc., as sellers’ representative (incorporated by reference to Exhibit 2.1 of the Company’s current report on Form 8-K, filed with the Commission on October 12, 2012).
3.1.1Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 of the Company’s quarterly report on Form 10-Q, filed with the Commission on October 7, 2005).
3.1.2Certificate of Amendment to the Amended and Restated Certificate of Incorporation of AngioDynamics, Inc. (incorporated by reference to Exhibit 3.1.2 of the Company's Annual Report on Form 10-K, filed with the Commission on August 10, 2015).
3.2Second Amended and Restated By-Laws, effective October 16, 2015 (incorporated by reference to Exhibit 10.1 of the Company’s current report on Form 8-K, filed with the Commission on October 21, 2015).
10.1
Credit Agreement, dated as of November 7, 2016, by and among AngioDynamics, Inc., the lenders party thereto, JPMorgan Chase Bank, N.A., as administrative agent, Bank of America, N.A. and Keybank National Association as co-syndication agents,  and JPMorgan Chase Bank, N.A., Merrill Lynch, Pierce, Fenner & Smith Incorporated and Keybank National Association as joint bookrunners and joint lead arrangers (incorporated by reference to Exhibit 10.1 to the Company’s current report on Form 8-K, filed with the Commission on November 10, 2016).

10.1.1AngioDynamics, Inc. 1997 Stock Option Plan, as amended by the Board and Shareholders on February 27, 2004 (incorporated by reference to Exhibit 10.2 of the Company’s registration statement on Form S-1, filed on March 5, 2004).
10.1.2AngioDynamics, Inc. 2004 Stock and Incentive Award Plan (as amended) (incorporated by reference to the Company’s Definitive Proxy Statement on Schedule 14A filed with the Commission on September 15, 2016).
10.1.3AngioDynamics 2013 Total Shareholder Return Performance Unit Agreement Program (incorporated by reference to Exhibit 10.2 of the Company's current report on Form 8-K filed with the Commission on November 5, 2013).
10.1.4AngioDynamics 2014 Total Shareholder Return Performance Unit Agreement Program (incorporated by reference to Exhibit 10.1.4 of the Company's Annual Report on Form 10-K filed with the Commission on January 12, 2015).
10.1.5
AngioDynamics 2015 Total Shareholder Return Performance Unit Agreement Program (incorporated by reference to Exhibit 10.1.5 of the Company’s Annual Report on Form 10-K filed with the Commission on August 10, 2015).

10.1.6
AngioDynamics 2016 Total Shareholder Return Performance Unit Agreement Program (incorporated by reference to Exhibit 10.1.6 of the Company’s Annual Report on Form 10-K filed with the Commission on August 1, 2016).

10.2AngioDynamics, Inc. Employee Stock Purchase Plan (as amended) (incorporated by reference to the Company’s Definitive Proxy Statement on Schedule 14A filed with the Commission on September 15, 2016).
10.3Form of Non-Statutory Stock Option Agreement pursuant to the AngioDynamics, Inc. Stock and Incentive Award Plan (incorporated by reference to Exhibit 10.1 of the Company’s quarterly report on Form 10-Q, filed with the Commission on October 12, 2004).
10.4.1Form of 2013 Performance Share Award Agreement pursuant to the AngioDynamics, Inc. 2004 Stock and Incentive Award Plan (incorporated by reference to Exhibit 10.2 of the Company’s current report on Form 8-K, filed with the Commission on May 12, 2005).
10.4.2Form of 2014 Performance Share Award Agreement pursuant to the AngioDynamics, Inc. 2004 Stock and Incentive Award Plan (incorporated by reference to Exhibit 10.4.2 of the Company's Annual Report on Form 10-K filed with the Commission on January 12, 2015).
10.4.3Form of 2015 Performance Share Award Agreement pursuant to the AngioDyanmics, Inc. 2004 Stock and Incentive Award Plan (incorporated by reference to Exhibit 10.4.3 of the Company’s Annual Report on Form 10-K filed with the Commission on August 10, 2015).


10.4.4Form of 2016 Performance Share Award Agreement pursuant to the AngioDyanmics, Inc. 2004 Stock and Incentive Award Plan (incorporated by reference to Exhibit 10.4.3 of the Company’s Annual Report on Form 10-K filed with the Commission on August 1, 2016).
10.5Date:Form of Restricted Stock Award Agreement pursuant to the AngioDynamics, Inc. 2004 Stock and Incentive Award Plan (incorporated by reference to the Company’s current report on Form 8-K, filed with the Commission on May 12, 2005).July 27, 2021
/S/    DENNIS S. METENY        
10.6Rita Medical Systems, Inc. 1994 Incentive Stock Plan (incorporated by reference to Exhibit 10.2 of Rita Medical Systems registration statement on Form S-1, filed with the Commission on May 3, 2000)Dennis S. Meteny,
10.7Horizon Medical Products, Inc. 1998 Stock Incentive Plan (incorporated by reference to Exhibit 10.11 of Horizon Medical Products’ registration statement on Form S-1, filed with the Commission on February 13, 1998.
10.8Rita Medical Systems, Inc. 2000 Stock Plan (incorporated by reference to Exhibit 10.3 of Rita Medical Systems registration statement on Form S-1/A, filed with the Commission on June 14, 2000).
10.9Rita Medical Systems, Inc. 2000 Directors’ Stock Plan, as amended on June 8, 2005 (incorporated by reference to Exhibit 99.2 of Rita Medical System’s registration statement on Form S-8, filed with the Commission on July 8, 2005).
10.10Rita Medical Systems, Inc. 2005 Stock and Incentive Plan (incorporated by reference to Exhibit 99.1 of Rita Medical System’s registration statement on Form S-8, filed with the Commission on July 8, 2005).
10.11Form of Indemnification Agreement of AngioDynamics, Inc. (incorporated by reference to Exhibit 10.1 of the Company’s current report on Form 8-K, filed with the Commission on May 12, 2006).
10.11.1Employment Agreement, dated April 1, 2016, between AngioDynamics, Inc. and James C. Clemmer (incorporated by reference to Exhibit 10.1 of the Company’s current report on Form 8-K, filed with the Commission on April 6, 2016).
10.11.2Employment Agreement, dated August 18, 2016, between AngioDynamics, Inc. and Michael C. Greiner (incorporated by reference to Exhibit 10.1 of the Company’s current report on Form 8-K, filed with the Commission on July 25, 2016).
10.12Change in Control Agreement, dated April 1, 2016, between AngioDynamics, Inc. and James C. Clemmer (incorporated by reference to Exhibit 10.2 of the Company’s current report on Form 8-K, filed with the Commission on April 6, 2016).
10.12.1Form of Severance Agreement of AngioDynamics, Inc. (incorporated by reference to Exhibit 10.1 of the Company’s current report on form 8-K, filed with the Commission on October 31, 2007).
10.13Form of Change in Control Agreement (incorporated by reference to Exhibit 10.13 of the Company's Annual Report on Form 10-K filed with the Commission on January 12, 2015).
10.13.1Change in Control Agreement, dated August 18, 2016, between AngioDynamics, Inc. and Michael C. Greiner (incorporated by reference to Exhibit 10.3 of the Company’s quarterly report on Form 10-Q, filed with the Commission on October 5, 2016).
10.14Performance Share Award Agreement, with a grant date of April 4, 2016, between AngioDynamics, Inc. and James C. Clemmer (incorporated by reference to Exhibit 10.3 of the Company’s current report on Form 8-K, filed with the Commission on April 6, 2016).
10.15AngioDynamics, Inc. Total Shareholder Return Performance Share Award Program - Performance Period Ending July 2019 (incorporated by reference to Exhibit 10.4 of the Company’s current report on Form 8-K, filed with the Commission on April 6, 2016).
10.16Stock Option Award Agreement, with a grant date of April 4, 2016, between AngioDynamics, Inc. and James C. Clemmer (incorporated by reference to Exhibit 10.5 of the Company’s current report on Form 8-K, filed with the Commission on April 6, 2016).
10.17Restricted Stock Unit Award Agreement, with a grant date of April 4, 2016, between AngioDynamics, Inc. and James C. Clemmer (incorporated by reference to Exhibit 10.6 of the Company’s current report on Form 8-K, filed with the Commission on April 6, 2016).
10.18Separation Agreement and General Release, dated April 22, 2016, between AngioDynamics, Inc. and Joseph M. DeVivo (incorporated by reference to Exhibit 10.1 of the Company’s current report on Form 8-K, filed with the Commission on April 27, 2016).
10.19AngioDynamics, Inc. Fiscal Year 2012 Senior Executive Equity Incentive Program (incorporated by reference to Exhibit 10.30 of the Company’s Annual Report on Form 10-K, filed with the commission on August 12, 2011).


Director
14Date:Code of Ethics (incorporated by reference to Exhibit 14 of the Company’s current report on Form 8-K, filed with the Commission on May 12, 2006).July 27, 2021
/S/    JAN S. REED
Jan S. Reed,
Director
21Subsidiaries
23Date:Consent of Deloitte & Touche LLP, an independent registered public accounting firm.July 27, 2021
/S/    EILEEN O. AUEN
23.1Consent of PricewaterhouseCoopers LLP, an independent registered public accounting firm.Eileen O. Auen,
31.1Certification by the Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.Director
31.2Certification by the Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1Date:Certification by the Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.July 27, 2021
/S/   KAREN A. LICITRA
32.2Certification by the Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.Karen A. Licitra,
101.INSXBRL Instance DocumentDirector
101.SCHXBRL Schema Document
101.CALDate:XBRL Calculation Linkbase DocumentsJuly 27, 2021
/S/   MICHAEL E. TARNOFF
101.DEFXBRL Taxonomy Extension Definition Linkbase DocumentMichael E. Tarnoff,
101.LABXBRL Labels Linkbase Documents
101.PREXBRL Presentation Linkbase DocumentsDirector








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