UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended May 31, 2023
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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For the transition period from to
Commission file number 0-50761
AngioDynamics, Inc.
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction of
incorporation or organization)
11-3146460
(I.R.S. Employer
Identification No.)
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
Title of each class
Common Stock, par value $.01 per share
Securities registered pursuant to Section 12(b) of the Act:
Trading Symbol
ANGO
Name of each exchange on which registered
NASDAQ 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 ☒
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 ☒
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 ☒ 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 ☒ 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. ☐
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
Non-accelerated filer
Emerging growth company
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Accelerated filer
Smaller reporting company
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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 ☒
As of November 30, 2022, 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 $450,329,930 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, 2023 there were 39,671,221 shares of the registrant’s common stock outstanding.
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 2023 Annual Meeting of Stockholders to be
filed within 120 days of the registrant's fiscal year ended May 31, 2023.
DOCUMENTS INCORPORATED BY REFERENCE
AngioDynamics, Inc. and Subsidiaries
INDEX
Part I:
Item 1.
Item 1A.
Item 1B.
Item 2.
Item 3.
Item 4.
Business
Risk Factors
Unresolved Staff Comments
Properties
Legal Proceedings
Mine Safety Disclosures
Part II:
Item 5.
Item 6.
Item 7.
Item 7A.
Item 8.
Item 9.
Item 9A.
Item 9B.
Item 9C.
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity
[Reserved]
Management’s Discussion and Analysis of Financial Condition and Results of Operations
Quantitative and Qualitative Disclosures About Market Risk
Financial Statements and Supplementary Data
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
Controls and Procedures
Other Information
Foreign Jurisdictions that Prevent Inspections
Part III:
Item 10.
Item 11.
Item 12.
Item 13.
Item 14.
Directors, Executive Officers and Corporate Governance
Executive Compensation
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
Certain Relationships and Related Transactions, and Director Independence
Principal Accounting Fees and Services
Part IV:
Item 15.
Exhibits, Financial Statement Schedules
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Page
2
16
30
30
30
30
31
32
33
44
44
44
45
47
47
48
48
48
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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 the words
such as "expects," "reaffirms," "intends," "anticipates," "plans," "believes," "seeks," "estimates," “projects”, "optimistic," or variations of such words and
similar expressions, are forward-looking statements. These forward-looking statements are not guarantees of future performance and are subject to risks and
uncertainties. Investors are cautioned that actual events or results may differ materially from AngioDynamics' expectations, expressed or implied. Factors
that may affect the actual results achieved by AngioDynamics include, without limitation, the scale and scope of the COVID-19 global pandemic, the ability
of AngioDynamics to develop its existing and new products, technological advances and patents attained by competitors, infringement of AngioDynamics'
technology or assertions that AngioDynamics' technology infringes the technology of third parties, the ability of AngioDynamics to effectively compete
against competitors that have substantially greater resources, future actions by the FDA or other regulatory agencies, domestic and foreign health care
reforms and government regulations, results of pending or future clinical trials, overall economic conditions (including inflation, labor shortages and supply
chain challenges including the cost and availability of raw materials), the results of on-going litigation, challenges with respect to third-party distributors or
joint venture partners or collaborators, the results of sales efforts, the effects of product recalls and product liability claims, changes in key personnel, the
ability of AngioDynamics to execute on strategic initiatives, the effects of economic, credit and capital market conditions, general market conditions, market
acceptance, foreign currency exchange rate fluctuations, the effects on pricing from group purchasing organizations and competition, the ability of
AngioDynamics to obtain regulatory clearances or approval of its products, or to integrate acquired businesses. 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 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, 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 does not assume any obligation to publicly update
or revise any forward-looking statements for any reason.
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.
OVERVIEW
AngioDynamics is a leading and transformative medical technology company focused on restoring healthy blood flow in the body's vascular system,
expanding cancer treatment options and improving quality of life for patients.
HISTORY
AngioDynamics was founded in Queensbury, N.Y., U.S., in 1988 and began manufacturing and shipping product in the early 1990s. The Company is
headquartered in Latham, N.Y., with manufacturing primarily out of the Queensbury facility. Initially dedicated to the research and development of products
used in interventional radiology, the Company soon became well established as a producer of diagnostic catheters for non-coronary angiography and
thrombolytic delivery systems.
The Company grew over the following years as a result of acquisitions of companies including RITA Medical Systems in January 2007, Oncobionic in
May 2008, the assets of Diomed in June 2008, Vortex Medical, Inc. in October 2012, the assets of Microsulis Medical Limited in January 2013, and Clinical
Devices in August 2013. These acquisitions added product lines
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including ablation and NanoKnife systems, vascular access products, angiographic products and accessories, dialysis products, drainage products,
thrombolytic products, embolization products and venous products. In May 2012, the Company acquired Navilyst Medical's Fluid Management business,
which the Company sold in May 2019 to Medline Industries, Inc. pursuant to an asset purchase agreement.
In August 2018, the Company acquired the 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, Ltd., 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 acquired the C3 Wave tip location asset from Medical Components Inc. On July 27, 2021, AngioDynamics acquired the
Camaro Support Catheter asset from QX Medical, LLC.
AngioDynamics is publicly traded on the NASDAQ stock exchange under the symbol ANGO.
PRODUCTS
Our product offerings fall within two segments, Med Tech and Med Device. All products discussed below have been cleared for sale in the United
States by the Food and Drug Administration. International regulatory clearances vary by product and jurisdiction.
Med Tech
Auryon
The Auryon Atherectomy System is one of our latest advancements 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 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),
and to aspirate thrombus adjacent to stenoses in native and stented
infrainguinal arteries.
Thrombectomy
Our Thrombus Management portfolio includes the AlphaVac Mechanical Thrombectomy System, 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.
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.
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AlphaVac
The AlphaVac System is an emergent mechanical aspiration device
that eliminates the need for perfusionist support. AlphaVac is offered in
both a 22 French flat coil-reinforced cannula and an 18 French braided
reinforced cannula each designed with a proprietary self-expanding nitinol
reinforced funnel shaped distal tip. AlphaVac is indicated for the non-
surgical removal of thrombi or emboli from vasculature as well as
aspiration of contrast media and other fluids from the vasculature. The
cannula is intended for use in the venous system. The handle is indicated as
a vacuum source for the AlphaVac MMA system.
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 slit technology that provides a
consistent, even distribution of fluid volume along the entire length of the infusion pattern, designed to provide an advantage over standard side-hole
catheters.
We also offer the Pulse-Spray infusion system for high pressure, pulsed delivery of lytic agents designed to shorten treatment time, and the SpeedLyser
infusion system built for dialysis grafts and fistulas.
NanoKnife
The NanoKnife IRE 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 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 System does not
achieve tissue ablation using thermal energy.
The NanoKnife 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.
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Med Device
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:
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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 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.
• 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 Polytetrafluoroethylene (PTFE) 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 kits 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.
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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. The 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.
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 is a BioFlo Midline Catheter
which incorporates Endexo Technology and 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:
•
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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.
C3 Wave PICC tip location system
The C3 Wave system is our innovative, wireless, app-based ECG system which 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:
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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.
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-
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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 features 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.
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Dialysis Products
We market an 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:
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BioFlo DuraMax: 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 our DuraFlow Chronic Hemodialysis Catheter, Acute Dialysis Catheter,
EVENMORE Chronic Hemodialysis Catheter, EMBOSAFE Valved Splitable Sheath Dilator and Perchik Button Suture Retention Device.
Venous Insufficiency
VenaCure EVLT laser system
Our VenaCure EVLT 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 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.
The procedure is minimally invasive and generally takes less than an hour, typically allowing the patient to quickly return to normal activities.
The VenaCure EVLT system 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.
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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.
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 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 (10) minutes.
The RFA system consists of a radiofrequency generator and 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 BioSentry 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 sealing 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 biopsy location for visualization during surgical resection.
IsoLoc Endorectal Balloon
The IsoLoc 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 new standard for endorectal balloons (ERB) in the oncology space.
The design of the 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, its' gas-release tip removes rectal gas and reduces prostate motion for gaseous
patients. Secondly, the structure of the ERB 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 low-lying bowel.
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Alatus Vaginal Balloon Packing System
The Alatus device was developed with the patient's comfort in mind and to assist the physician to move healthy tissue away from the radiation
treatment field. Prior to the Alatus device, the clinician would push gauze into the vagina 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 end of treatment as it tends to dry out before removing.
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 acquisitions. Our research and development
(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 R&D.
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; Medical Components, Inc. (MedComp); TeleFlex Medical;
Becton Dickinson; Medtronic; Merit Medical; Terumo Medical Corporation; Johnson and Johnson; 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 third 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, interventional and surgical 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-designed proprietary manufacturing and processing equipment and have developed proprietary enhancements for existing
production machinery.
We manufacture many 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. The manufacturing
facilities are registered with the FDA and have been certified to ISO 13485 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
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•
•
•
•
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 Item 1 for additional information. See Part I, Item 2 "Properties" in this Annual Report on Form
10-K for details on each manufacturing location.
During the fourth quarter of fiscal year 2022, AngioDynamics entered into a supply agreement with Precision Concepts, Costa Rica S.A., a Costa Rica
corporation, with its principal place of business in Alajuela, Costa Rica. Precision Concepts is manufacturing, storing, and handling certain products for the
Company and is registered with the FDA and certified to the ISO 13485 standard. The Company also relies on third party manufacturers for the
manufacturing of certain products.
BACKLOG
We have historically kept sufficient inventory on hand to ship product within 24-48 hours of order receipt to meet customer demand. In fiscal year
2023, the Company's ability to manufacture products, the reliability of our supply chain, labor shortages, backlog and inflation (including the cost and
availability of raw materials, direct labor and shipping) have impacted our business and resulted in a backlog of $2.7 million at the end of the fourth quarter.
We continue to focus on meeting the demand for our product and working towards standard inventory and backlog levels in fiscal year 2024. See Part I, Item
1A "Risk Factors" in this Annual Report on Form 10-K.
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 Company 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 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 "Legal Proceedings" and Note 17 to the consolidated financial statements in this Annual 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 those products. 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 "Legal Proceedings" and
Note 17 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 in 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) 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 (i) a device that has been cleared through the 510(k) clearance process; (ii) a device that was legally
marketed prior to May 28, 1976 (preamendments device); (iii) a device that was originally on the U.S. market as a Class III device (Premarket approval) and
later downclassified to Class II or I; (iv) or a 510(k) exempt device. After a device receives 510(k) clearance, any modification that could significantly affect
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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 a new or modified device. If a device cannot demonstrate substantial
equivalence, it may be subject to either a De Novo 510(k) submission or a PMA.
The PMA application procedure is more comprehensive than the 510(k) procedure and typically takes more 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 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.
FDA submissions require extensive validations and testing which requires a significant amount of time and financial resources. Recent changes in both
regulations and FDA perspectives have increased both time and testing requirements, which have caused and are expected to continue to cause significant
delays and increased costs for clearances and 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 challenges and delays. In addition, changes to existing
products call into question previously approved devices and result in additional costs for testing and material analysis.
The devices manufactured by us are also subject to the QSR, which imposes elaborate testing, control, documentation and other quality assurance
procedures on our manufacturing facilities. Every phase of production, including raw materials, components and subassembly, manufacturing, testing,
quality control, labeling, tracing of customers 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. Failure to maintain compliance with the QSR may result in the issuance of one or more Forms 483 or warning letters and
could potentially result in a consent decree. Failure to maintain the QSR appropriately could result in the issuance 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, and/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 subject to a variety of federal, state and local laws in those jurisdictions where our products are, or will be, 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.
In order to distribute and sell products into the European Union as well as a number of other countries including many Central European Free Trade
Agreement participants, Scandinavian, and Middle Eastern countries, a CE Mark is required. New
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products must be compliant with the Medical Device Regulation ("MDR") as of May 2021 and previously CE Marked products must become compliant
when their certification expires, with a transition period ending December 2027 for higher classification devices, or December 2028 for lower classification
devices. Products with an expiring certification must be in distribution before certification expiration dates to continue to be sold. Clinical evaluations of
products under MDR requires more information than previously required. All devices must have current clinical literature that specifically addresses data-
driven safety and performance criteria, and legacy devices often require additional biocompatibility, bench testing and redesign to address changes in
standards over time. Additionally, there can be extended time frames under MDR for product certifications that can be 12-18 months or longer. During that
time period, significant design modifications cannot be made.
Similar regulations are in place for Canada, Japan, China, Brazil 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 cleared, approved or certified in a timely or cost-effective manner or cleared,
approved or certified 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 conjunction
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 conjunction with their health care reimbursement programs and the delivery of health care items and services.
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 inducing or rewarding referrals of items or services reimbursable by a federal health care 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
The delivery of our devices in any market is subject to evolving regulation by the EU Medical Device Regulations, notified bodies and comparable
nation-specific bodies responsible for reimbursement and regulation of health care items and services. Our success in international markets will depend
largely upon the availability of reimbursement from the national public health payers as well as private, 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 maintain a healthcare economics team that works directly with providers, our distributors and health systems to
obtain reimbursement approval in the countries in which they will use or 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.
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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, 2023, we had approximately 815 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 technology industry, we consider attracting, developing, engaging and retaining high
performing talent in positions critical to our long-term growth strategy including but not limited to technical, operational, marketing, sales, research and
development, and management. Our ability to recruit and retain such talent depends on several factors, including culture, compensation and benefits, talent
development, career opportunities, recognition 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 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.
Name
James C. Clemmer
Stephen A. Trowbridge
Chad T. Campbell
Scott Centea
David D. Helsel
Laura Piccinini
Age
59
49
52
45
59
53
Position
President and Chief Executive Officer
Executive Vice President and Chief Financial Officer
Senior Vice President and General Manager, Vascular Access and Oncology
Senior Vice President and General Manager, Endovascular Therapies
Senior Vice President, Global Operations and Research and Development
Senior Vice President and General Manager, International
James C. Clemmer became our President and Chief Executive Officer (CEO) 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 U.S. business across
five divisions and built the strategic plan for the medical supplies segment before Covidien was spun off from Tyco. Mr. Clemmer began his career at Sage
Products, Inc. Mr. Clemmer currently serves on the Board of Directors for
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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 2016.
Stephen A. Trowbridge was appointed Executive Vice President and Chief Financial Officer (CFO) in February 2020, having served as Interim Chief
Financial Officer since October 2019. Prior to his appointment as CFO, he served as the Company’s Senior Vice President and General Counsel. He joined
AngioDynamics in June 2008 as Corporate Counsel. In addition to serving as the Company’s CFO and managing the finance functions, Mr. Trowbridge also
managed the Legal function on an interim basis until January 30, 2021. Prior to AngioDynamics, Mr. Trowbridge served as 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.
Chad T. Campbell joined AngioDynamics in May 2016 as the Senior Vice President and General Manager for Vascular Access. As of October 2021,
Mr. Campbell assumed responsibility of the Oncology Global Business Unit in addition to his role of General Manager for Vascular Access. 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.
Scott Centea joined AngioDynamics in 2005 as a sales representative serving the Carolinas. During his tenure, he has served in a variety of positions
with increased responsibility including Vice President of Corporate Accounts where he was in charge of leading a team of individuals to execute Health
System Purchasing Contracts. From there Mr. Centea assumed the role of Vice President of Marketing for Endovascular Therapies, before being promoted
into his most recent and current role as Senior 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.
David D. Helsel currently serves as Senior Vice President of Global Operations and Research and Development 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.
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 medical 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 Head 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.
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 SEC. In addition, our website includes, among other things, charters of the various
committees of our Board of Directors and our code of 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 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 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
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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 Corporate headquarters, Attention: 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.
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 our business. Our financial and operating results are subject
to a number of risks and uncertainties, including those set forth below, many of which are not within our control. Our business, financial condition, results of
operations and/or liquidity could be materially and adversely affected by any of these risks or by additional risks not presently known to us or that we
currently deem immaterial.
RISKS RELATED TO OUR BUSINESS AND INDUSTRY
We face intense competition in the medical device industry which continues to experience consolidation. We may be unable to compete effectively with
respect to technological innovation and price which may have a material adverse effect on our revenues, financial condition, results of 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; Medical Components, Inc. (MedComp); TeleFlex Medical; Becton Dickinson; Medtronic; Merit Medical; Terumo Medical
Corporation; Johnson and Johnson; Philips Healthcare; Inari Medical; Varian Medical Systems and Total Vein Systems.
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 ours or that otherwise could
render our products obsolete or noncompetitive. The 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. If we are not able to compete effectively, our market share and revenue may decline.
In addition, the increasing purchasing power of health systems, group purchasing organizations (“GPOs”) and integrated health delivery networks
(“IDNs”), together with increased competition 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.
The market for our devices is characterized by rapid technological change, new product introductions, technological improvements, changes in
physician requirements and evolving industry standards. Product life cycles are relatively short because medical device manufacturers continually develop
more effective and less expensive versions of existing devices in response to physician demand. We engage in product development and improvement
programs to maintain and improve our competitive position. Our products are technologically complex and these 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 new products or
technologies that will achieve regulatory approval, be developed or manufactured in a cost-effective manner, obtain appropriate intellectual property
protection or receive market acceptance. We also may be unable to recover all or a meaningful part of our investment in these 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, the AlphaVac 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, but not limited
to, our NanoKnife DIRECT clinical study, our NanoKnife PRESERVE clinical study, AlphaVac APEX-AV clinical 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 expect 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, obtain
agreements with favorable 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.
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 crucial 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, interventional and surgical oncologists, and critical
care nurses, and cause our growth to be limited and our business to be harmed, which could have a material adverse effect on our business, financial
condition, results of operations and/or 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, AlphaVac APEX-AV clinical 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
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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 governments 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. This has created an increasing level of price sensitivity among
customers for our products and could have a material adverse effect on our business, financial condition, results of operations and/or 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, raw materials 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 (like we
experienced during our 2022 and 2023 fiscal year) could interrupt and delay manufacturing of our products, lead to backlogs 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, raw materials and/or 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.
In addition, we purchase certain products as a distributor for the manufacturer of those products. Any constraint or interruption in the supply of raw
materials, other product components or finished products that we distribute could materially impact our ability to sell products, and have a material adverse
effect on our business, financial condition, results of 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, failing to be financially viable and failing to effectively distribute our products in compliance with
applicable laws.
Outside of North America we rely heavily on third party distributors, either on a country-by-country basis 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,
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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% of international revenues for the fiscal year ended May 31,
2023. International sales grew 12% in fiscal year 2023 as we continued to develop and foster partnerships with distributors such as Healthcare 21, Cardiva
and Mediplast. 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, 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 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 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 and 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. 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. 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. If our products are not on 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.
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 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. 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.
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,
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including if our products were misused, if a component of our product fails, if our manufacture or design was flawed, if the 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 $10.0 million per product liability claim and an aggregate policy limit of $10.0 million, subject to a
self-insured retention of $0.5 million per occurrence and $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, 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.
We may be exposed to risks associated with product line divestitures as we may never realize the expected benefits and could cause operational
disruptions with personnel, systems and infrastructure changes.
On June 8, 2023, the Company entered into an asset purchase agreement (the "Asset Purchase Agreement") with Merit Medical Systems, Inc. pursuant
to which Merit acquired the dialysis product portfolio and BioSentry tract sealant system biopsy businesses for $100.0 million in cash. The Company and
Merit entered into various agreements to facilitate the transition to Merit, including a Transactions Services Agreement and Contract Manufacturing
Agreement.
This divestiture along with potential future divestitures of certain product lines will allow us to transform ourselves into a high growth, highly profitable,
medical technology company. If we are unable to achieve our growth and profitability objectives due to competition, lack of acceptance of our products,
failure to generate favorable clinical data or gain regulatory approvals, or other risks as described in this section, or due to other events, we will not be
successful in transforming our business and may not see the appropriate market valuation. The divestiture of product lines will impact revenue, earnings and
cash flows, which over time we expect to replace by investing in higher margin revenue streams. There is a risk that we will be unable to replace the revenue,
earnings and cash flow that these product lines generated, or that the cost of such will be higher than expected. If we are unable to achieve our profit and
growth objectives, such failure will be exacerbated by the loss of revenue, earnings and cash flow generated by our divested product lines and could
materially impact our financial position and results of operations, resulting in a decline in our stock price.
The sale of product lines could require us to restructure significant personnel, systems and infrastructure. In some instances, we may enter into short term
transition service arrangements, under which the parties perform certain services for each other pending establishment of new processes and systems.
Although these transitions are thoroughly planned, it is not unlikely in a transaction of this complexity that disruptions could occur. If disruptions to our
financial controls, IT, administrative support, manufacturing or regulatory processes occur, and if such disruptions prove to be more severe than our planning
anticipated, this could have a material adverse effect on our business.
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, high 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, results of operations and/or liquidity.
We are subject to macro-economic fluctuations in the U.S. and worldwide economy. Concerns about consumer and investor confidence, volatile
corporate profits and reduced capital 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 global economic downturns (such as those 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 business activities.
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Volatility in the cost of raw materials, components, freight and energy increases the costs of producing and distributing our products. New laws or
regulations adopted in response to climate change could also increase energy and transportation costs, as well as the costs of certain raw materials and
components. Increases in oil prices may increase our packaging and transportation costs. Recently, the costs of labor, raw materials, transportation,
construction, services, and energy necessary for the production and distribution of our products have increased significantly. While we have implemented
cost containment measures, selective price increases and taken other actions to offset these inflationary pressures in our supply chain, we may not be able to
completely offset all the increases in our operational costs, any of which could adversely affect our business, financial condition, results of operations and/or
liquidity.
Sales outside the U.S. accounted for approximately 17% of our net sales during our fiscal year ended May 31, 2023. 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 U.S. Our sales and profitability from our international operations are subject to risks and 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 which may, in some instances affect spending behavior and reduce cash flows and revenue outside the U.S.;
healthcare reform legislation;
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• multiple non-U.S. regulatory requirements that are subject to change and could restrict our ability to manufacture and sell our products;
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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;
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;
potential negative consequences from changes in or interpretation of tax 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.
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Russia’s invasion and military attacks on Ukraine have triggered significant sanctions from U.S. and European leaders. These events may escalate and
have created increasingly volatile global economic conditions. Resulting changes in U.S. trade policy could trigger retaliatory actions by Russia, its allies
and other affected countries, including China, resulting in a “trade war.” A trade war could result in increased costs for raw materials we use in our
manufacturing and could result in Russia and other foreign governments imposing tariffs on products that we export outside the U.S. or otherwise limiting
our ability to sell our products abroad. These increased costs could have a material adverse effect on our business, financial condition and results of
operations. Furthermore, if the conflict between Russia and Ukraine continues for a long period of time, or if other countries, including the U.S., become
further involved in the conflict, we could face material adverse effects on our business, financial condition, results of operations and/or liquidity.
Our business could be harmed if we cannot 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, including personnel for our manufacturing facilities and
field based sales employees. If we are not able to hire and retain personnel in our manufacturing facilities, we may not meet our production demand. We have
experienced labor shortages in fiscal years 2022 and 2023 that significantly contributed to the backlog. In addition, our sales force is highly talented and we
face intense competition in our industry for sales personnel which could have an adverse effect on our business and revenue if there is significant turnover.
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-related expenses and capital expenditure
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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 operational excellence initiatives which include a number of restructuring, realignment and cost reduction
initiatives. We may not realize the benefits of these initiatives to the extent or on the timing we anticipated and the ongoing difficulties in implementing these
measures may be greater than anticipated and/or offset by inflationary pressures, which could cause us to incur additional costs or result in business
disruptions like the backlogs we have experienced in fiscal years 2022 and 2023. 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 expenses and adversely impact our ability to achieve
our other strategic goals and business plans.
We may fail to attract additional capital necessary to expand our business or may incur additional indebtedness which, together with our current
indebtedness levels, could impose operating and financial restrictions on us as a result of debt service obligations which could significantly limit our
ability to execute our business strategy or curtail our growth.
We may 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 and increases in the cost of capital have previously resulted, and could again result, in volatility, decreased liquidity, and widening of 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 potential borrowings could be a floating rate which could expose us to the risk of increased interest
expense in the future. The terms of indebtedness could require us to comply with certain financial maintenance covenants. In addition, the terms of our
existing indebtedness include, and any future indebtedness could include, covenants restricting or limiting our ability to take certain actions. These covenants
could adversely affect our ability to obtain additional financing, to finance future operations, to pursue certain business opportunities or take certain
corporate actions. The covenants could 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, 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.
Our ability to meet our cash 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 be beyond
our control. We cannot 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 required to dispose of material assets or operations to meet our debt and other obligations. If we incurred 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 obligations 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 potential debts or to successfully
undertake any of these actions could have a material adverse effect on us.
Inflationary pressure and unfavorable economic conditions could negatively affect our operations and business.
A significant deterioration in economic conditions, including economic slowdowns or recessions, increased unemployment levels, inflationary
pressures or disruptions to credit and capital markets, could lead to decreased consumer confidence and spending and availability of credit. For example, in
2022 and continuing into 2023, the United States and other certain foreign countries have experienced a rapid increase in inflation levels. Such heightened
inflationary levels may negatively impact demand for our products and increase our costs. Additionally, we finance a portion of our portfolio with unhedged
floating- rate debt from our Credit Agreement. The rapid increase in inflation during fiscal year 2023 led to a rapid increase in market interest rates, which
materially increased the interest rate on our floating rate debt. In addition, if rates continue to increase, we may incur significant additional expense and
adversely impact our ability to achieve our other strategic goals and business plans.
Our goodwill, intangible assets and fixed assets are subject to potential 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.
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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, 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 Statements of Operations (see Note 19, "Acquisition, restructuring and
other items, net" set forth in the Notes in the consolidated financial statements included in this Annual Report on Form 10-K).
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 quarterly 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 may 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 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. Prior to the first quarter of fiscal year 2023, the Company managed its operations as one reporting unit. At the
beginning of the first quarter of fiscal year 2023, the Company began to manage its operations as two operating segments and two reporting units, namely
Med Tech and Med Device (see Note 18 "Segment and Geographic Information" set forth in the Notes to our consolidated financial statements included in
this Annual Report on Form 10-K). The annual goodwill impairment review performed in April 2023 and 2022 indicated no goodwill impairments. As of
May 31, 2023, the Company concluded that the sale of the dialysis product portfolio and BioSentry tract sealant system biopsy businesses to Merit Medical
Systems, Inc. was a triggering event for the Med Device report unit. The Company utilized the income approach to determine the fair value of the remaining
Med Device reporting unit. Based on the results of this evaluation, the Company recorded a goodwill impairment charge of $14.5 million for the year ended
May 31, 2023 to write down the carrying value of the Med Device reporting unit to fair value. 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, 2023 after considering IRC Section 382 limitations are $169.7 million. The expiration of the Federal
net operating loss carryforwards is as follows: $5.2 million between 2023 and 2024, $79.4 million between 2028 and 2037 and $85.1 million indefinitely.
Our state net operating loss carryforwards as of May 31, 2023 after considering remaining IRC Section 382 limitations are $24.1 million which expire in
various years from 2029 to 2042. 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 10, "Income
Taxes" set forth in our consolidated financial statements included in our Annual Report on Form 10-K for the fiscal year ended May 31, 2023 for a further
discussion of our tax loss carryovers.
A cyber-attack or other breach of our, our distributors, or our supply chain partners' 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 cyber-attacks, malicious intrusions,
breakdowns, destruction, losses of data privacy, or other significant disruptions. Our distributors and supply chain partners face similar risks. Our
information systems require an ongoing commitment of 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 gain
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access into our systems or products or those of our supply chain partners to obtain data relating to patients or our proprietary information.
Any failure by us, our distributors, or our supply chain partners to maintain or protect information technology systems and data integrity, including
from cyber-attacks, ransomware, intrusions or other breaches, could result in the unauthorized access to supply chain partners or vendors and personally
identifiable information, theft of intellectual property, misappropriation of assets, or otherwise compromise confidential or proprietary information and
disrupt operations of our Company, our distributors, or our supply chain partners. Any of these events, in turn, may cause us to lose existing customers, have
difficulty preventing, detecting, and controlling fraud, have disputes with customers, our supply chain partners, 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.
We conduct manufacturing and assembly at facilities in Queensbury, New York, Glens Falls, New York, and other third parties in Costa Rica, Israel,
Latvia, China and other locations. It would be difficult, expensive and time-consuming to transfer resources from one facility to the other and/or replace or
repair these facilities or manufacturing equipment if they were significantly affected by a disaster. Additionally, we might be forced to rely on third-party
manufacturers or 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. If 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. 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, results of operations and/or 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. Any delay or prevention of a change of control transaction
or changes in our Board of Directors 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 and has negatively impacted our business and
results of operations and financial condition during fiscal years 2021, 2022 and 2023. Although the impact of COVID-19 and the resulting measures
decreased during 2023, they have the potential to continue to negatively impact our business, results of operations and financial condition in the 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 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 clearance, approvals or certifications 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’
24
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. We experienced a similar impact to procedure volumes with
the resurgence of COVID-19 in fiscal year 2022 which continued through fiscal year 2023. For example in fiscal year 2021, U.S. governmental authorities
had 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 so that limited resources and personnel could be
focused on the treatment of infected patients. Many of these procedures that use our products were suspended or postponed at times during fiscal years 2021,
2022 and 2023. Similarly, our clinical trials were impacted by COVID-19 as hospitals prioritized treating these patients. It is unclear when or if other
resurgences of COVID-19, or increased spread of its variants, may again cause a rise in infections and result in authorities and/or customers imposing
restrictions that could adversely affect our business, financial condition, results of operations and/or liquidity.
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 have relaxed restrictions from time-to-time and have resumed business operations, but a resurgence in infections or mutations of the
coronavirus that causes COVID-19 could cause authorities and/or our customers 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.
We could be negatively impacted by Environmental, Social and Governance (ESG), climate change and other sustainability-related matters.
Governments, investors, customers, employees and other stakeholders are increasingly focusing on corporate ESG practices and disclosures, including
risks associated with climate change and expectations in this area are rapidly evolving. Shifts in weather patterns caused by climate change are expected to
increase the frequency and severity of adverse weather conditions such as hurricanes, tornadoes, earthquakes, wildfires, droughts, extreme temperatures or
flooding, which could cause or contribute to reduced workforce availability, increased production and distribution costs and disruptions and delays in our
logistics and supply chain/operations as well as the operations of our customers. The increasing attention to corporate ESG initiatives and ESG risks could
result in reduced demand for products, reduced profits and increased investigations and litigation. If we are unable to satisfy any new criteria by which our
ESG practices may be assessed, investors may conclude that our policies and/or actions with respect to ESG matters and risks are inadequate. If we fail or
are perceived to have failed to accurately disclose our progress on such initiatives or goals, our reputation, business, financial condition and results of
operations could be adversely impacted.
RISKS RELATED TO THE REGULATORY ENVIRONMENT
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 Anti-Bribery Act, the federal Health Insurance Portability and Accountability
Act of 1996 (“HIPAA”), General Data Protection Regulation (“GDPR”), domestic and
25
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.
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; (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 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. 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. 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. We
anticipate that the government will continue to scrutinize our industry closely, and that additional regulation by governmental authorities may increase
compliance costs, increase exposure to litigation and may have other adverse effects to 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 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. 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 and/or liquidity.
If we or some of our suppliers fail to comply with the FDA’s Quality System Regulation, or QSR, and other applicable post-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.
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, 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 post-market requirements. 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 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
26
notification is submitted to the FDA, but may take significantly longer. 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 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 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.
In general, we intend to obtain Medical Device Regulation ("MDR") approvals for our principal products sold in the European Union ("EU") ahead of
expiration dates; however for multiple reasons, including but not limited to changing business strategies, labor shortages and contract resources,
administrative delays, increased costs of obtaining MDR certification, availability of necessary data and notified body capacity, certain products may not be
fully compliant at the time of CE mark expiration. The additional time and resources required to obtain MDR certification has been a significant factor in,
and will likely continue to influence, our decisions whether to discontinue sales and distribution of certain products in the EU.
Complying with and obtaining regulatory approval in foreign countries, including our efforts to comply with the requirements of the MDR, have and
will likely continue to lead to additional uncertainty, risk, expense and delay in commercializing products in certain foreign jurisdictions, which could have a
material adverse effect on our business, financial condition and/or results of operations.
Our 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 product, or if the governmental
entity finds that our products would cause serious adverse health consequences. A government mandated recall, 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 the use of our products 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 condition, results of operations and/or liquidity.
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.
27
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 2023 we generated $1.2 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, we have limited business dealings in countries subject to comprehensive sanctions. These business dealings may 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, revocations or restrictions of licenses, and/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.
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 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.
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, 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
28
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;
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, including inflationary pressure, 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, attributable to outside factors and/or unrelated to operating performance. Such factors may include comments by securities
analysts or other third parties, including blogs, articles, message boards and social and other media coverage which may not be attributable to us and may not
be reliable or accurate.
The NASDAQ Stock Market and medical devices companies in particular have experienced substantial price and volume volatility that is often
seemingly unrelated to the operating performance of the 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.
29
Item 1B. Unresolved Staff Comments.
None.
Item 2. Properties.
During the year ended May 31, 2023, we operated in the following locations:
Location
Latham, NY
Glens Falls, NY
Queensbury, NY
Queensbury, NY
Marlborough, MA
Amsterdam, NL
Rehovot, IL
Purpose
Corporate headquarters
Manufacturing
Manufacturing
Distribution
Research and development
Selling, marketing and administrative
Research and development
Approx.
Sq. Ft.
Property
Type
39,000
21,000
135,000
58,000
8,400
8,100
4,300
Lease
Owne
Owne
Lease
Lease
Lease
Lease
In addition, we lease sales offices in various other jurisdictions.
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.
Item 4. Mine Safety Disclosures.
Not applicable.
30
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities.
Our common stock is traded on the Global Select Market tier of the NASDAQ Stock Market LLC, 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 the NASDAQ Stock
Part II
Market.
Year ended May 31, 2023
Fourth Quarter
Third Quarter
Second Quarter
First Quarter
Year ended May 31, 2022
Fourth Quarter
Third Quarter
Second Quarter
First Quarter
Sale Price
High
Low
12.65 $
15.48 $
22.81 $
24.30 $
Sale Price
High
Low
24.50 $
29.16 $
30.97 $
28.49 $
8.29
12.06
12.51
17.83
17.98
20.46
23.36
22.99
$
$
$
$
$
$
$
$
As of August 2, 2023, there were 169 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, S&P 500 Health Care 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 the reinvestment of all dividends) from May 31, 2018 to
May 31, 2023. The stock price performance included in this graph is not necessarily indicative of future stock price performance.
31
Item 6. [Reserved]
32
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. This discussion may contain forward-looking statements related to future events and our future
financial performance that are based on current expectation and are subject to risks and uncertainties. Our actual results may differ materially from those
anticipated in any forward-looking statements as a result of many factors, including those set forth in Part I, Item 1A, "Risk Factors" and "Disclosure
Regarding Forward-Looking Statements" included in this Annual Report on Form 10-K.
Company and Market
AngioDynamics is a leading and transformative medical technology company focused on restoring healthy blood flow in the body's vascular system,
expanding cancer treatment options and improving quality of life for patients. 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. Many of our products are intended to be used once and
then discarded, or they may be temporarily implanted for short- or long-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 of 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 to 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 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 by expanding geographically, penetrating new
markets, introducing new products and increasing our presence internationally.
The COVID-19 global pandemic has impacted our business and may continue to pose future risks with the emergence of new variants. Even with the
public health actions that have been taken to reduce the spread of the virus, the market continues to experience disruptions with respect to consumer demand,
hospital operating procedures and workflow, trends that may continue. The Company's ability to manufacture products, the reliability of our supply chain,
labor shortages, backlog and inflation (including the cost and availability of raw materials, direct labor and shipping) have impacted our business, trends that
may continue. 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.
Commencing with the first quarter of fiscal year 2023, the Company began to manage its operations through two segments, Med Tech and Med Device
to align with the transformation from a company with a broad portfolio of largely undifferentiated products to a more focused medical technology company.
On August 30, 2022, the Company repaid all amounts outstanding under its then existing credit agreement and entered into a new Credit Agreement
that provides for a $75.0 million Revolving Facility and a $30.0 million Delayed Draw Term Loan. As of May 31, 2023, $25.0 million was drawn on the
Revolving Facility and $25.0 million was drawn on the Delayed Draw Term Loan. See Note 12 "Long-Term Debt" set forth in the Notes to the consolidated
financial statements.
During the fourth quarter of fiscal year 2023, the Company was in discussions with Merit Medical Systems, Inc. ("Merit") to sell the dialysis product
portfolio and BioSentry tract sealant system biopsy businesses. This qualified for held for sale accounting as of May 31, 2023. On June 8, 2023, the
Company entered into an asset purchase agreement (the "Asset Purchase Agreement") with Merit Medical Systems, Inc. pursuant to which Merit acquired
the dialysis product portfolio and BioSentry tract sealant system biopsy businesses for $100.0 million in cash subject to the terms and conditions of the Asset
Purchase Agreement. The Company and Merit entered into various agreements to facilitate the transition to Merit, including a Transactions Services
Agreement and Contract Manufacturing Agreement. The Company determined that the sale of the
33
businesses did not constitute a strategic shift that had a major effect on the Company’s operations or financial results and as a result, this transaction will not
be classified as discontinued operations.
As of May 31, 2023, the Company concluded that the sale of the dialysis product portfolio and BioSentry tract sealant system biopsy businesses to
Merit Medical Systems, Inc. was a triggering event for the Med Device reporting unit. The Company utilized the income approach to determine the fair
value of the remaining Med Device reporting unit. Based on the results of this evaluation, the Company recorded a goodwill impairment charge of $14.5
million for the year ended May 31, 2023 to write down the carrying value of the Med Device reporting unit to fair value.
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, 2023 compared to the year ended May 31, 2022 follows:
Year ended May 31, 2023:
Revenue increased by 7.1% to $338.8 million
•
• Med Tech growth of 22.8% and Med Device growth of 1.9%
•
•
•
•
Gross profit decreased by 100 bps to 51.4%
Net loss increased by $25.9 million to $52.4 million
Loss per share increased by $0.65 to a loss of $1.33
Cash flow from operations increased by $7.3 million resulting in cash provided by operations of $0.1 million
Our Med Tech business, comprised of Auryon, the Thrombectomy platform and NanoKnife grew 22.8% in fiscal year 2023. The growth in Auryon,
AlphaVac and NanoKnife disposables was partially offset by continued softness in AngioVac. Our Med Device business grew 1.9% in fiscal year 2023
driven by growth in Core, Dialysis, Ports and Microwave products.
Strategic Initiatives to Drive Growth
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 continue to be driven by our high
technology products including Auryon, Mechanical Thrombectomy (which includes AngioVac and AlphaVac) and NanoKnife.
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:
•
•
Product development process. The Company continued its disciplined product development process which is intended to improve the Company’s
ability to bring new products to market. This included:
◦
◦
◦
◦
Pathway expansion for Auryon in arterial thrombectomy and full market release of the hyrodphilic coated catheters;
FDA clearance of the AlphaVac F18 thrombectomy system;
Enrollment of patients in the APEX IDE study for the use of AlphaVac F18 to treat pulmonary embolism; and
Continued enrollment of patients in the PRESERVE study for the use of NanoKnife in the prostate.
Value Creation. To create value and drive future growth, the Company plans to practice dispassionate portfolio optimization and continue to focus
on areas of compelling unmet needs including those that are patient-centric and evidenced-based. In addition, the Company continues to pursue
targeted global expansion opportunities.
Critical Accounting Policies and Use of Estimates
Our significant accounting policies are summarized in Note 1 "Basis of Presentation, Business Description and Summary of Significant Accounting
Policies" in the consolidated financial statements included in this 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.
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
34
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 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 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 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 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. For
the duration of these agreements 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 add, and other taxes collected on behalf of third parties are excluded from revenue.
Revenues 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.
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. The Company is also required to pay administrative fees to group purchasing organizations.
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, 2023, such product returns were not material.
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
35
fulfillment of the performance obligation, the Company recognizes a contract liability that is included in deferred revenue in the accompanying Consolidated
Balance Sheets.
Inventory
Inventories are stated at the lower of cost or net realizable value based on the first-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 excess 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 us
recording excess and obsolete inventory amounts that do not match the required amounts. 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.
Acquisitions and Contingent Consideration
The Company allocates the purchase price of acquired companies to the tangible and intangible assets acquired and liabilities assumed based on their
estimated fair values. The estimates used to value the net assets acquired are based in part on historical experience and information obtained from the
management of the acquired 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 assets acquired may result.
Certain of the Company’s business combinations involve potential payment of future consideration that is contingent upon the achievement of certain
product development milestones and/or contingent on the acquired business reaching certain performance milestones. The Company records contingent
consideration at fair value at the date of acquisition based on the consideration expected to be transferred, estimated as the probability weighted future cash
flows, discounted back to present value. The fair value of contingent consideration is measured using projected payment dates, discount rates, probabilities
of payment, and projected revenues (for revenue-based considerations). Projected revenues are based on the Company’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
methodologies. 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 each reporting period using Level 3 inputs, and the change in fair value, including accretion for
the passage of time, is recognized as income or expense within operating expenses in the Consolidated Statements of Operations. 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 a straight-line basis over the expected period of benefit. The Company periodically
reviews the estimated useful lives of intangible assets and reviews such assets or asset groups 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. Prior to the first quarter of fiscal year 2023, the Company managed its operations as one reporting unit. At
the beginning of the first quarter of fiscal year 2023, the Company began to manage its operations as two operating segments and two reporting units, namely
Med Tech and Med Device (see Note 18 "Segment and Geographic Information" set forth in the Notes to our consolidated financial statements included in
this Annual Report on Form 10-K). The Company operates as two reporting units and two asset groups. 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.
36
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 each reporting unit to which the goodwill is assigned to the
carrying value of the assets and liabilities of those reporting units. 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
two operating segments with two reporting units and consequently evaluates goodwill for impairment based on an evaluation of the fair value of each
reporting unit. If the carrying value of the reporting units exceed the fair value, the carrying value is reduced to its fair value through an adjustment to the
goodwill balance, resulting in an impairment charge.
As detailed in Note 9, "Goodwill and Intangible Assets" set forth in the Notes to our consolidated financial statements included in this Annual Report
on Form 10-K, the Company recorded a goodwill impairment loss of $14.5 million for the year ended May 31, 2023 as the fair value of the Med Device
reporting unit was less than its carrying value.
There were no adjustments to goodwill for the Med Tech reporting unit for the year ended May 31, 2023 other than foreign currency translation
adjustments.
Results of Operations for the years ended May 31, 2023 and 2022
For the fiscal year ended May 31, 2023, the Company reported a net loss of $52.4 million, or a loss of $1.33 per diluted share, on net sales of $338.8
million compared to a net loss of $26.5 million, or a loss of $0.68 per diluted share, on net sales of $316.2 million in fiscal year 2022.
Net Sales
Net sales - Net sales are derived from the sale of our products and related freight charges, less discounts, rebates and returns.
(in thousands)
Net Sales
Med Tech
Med Device
Total
Net Sales by Geography
United States
International
Total
Year ended May 31,
2023
2022
$ Change
$
$
$
$
96,687 $
242,065
338,752 $
78,717 $
237,502 $
316,219 $
282,713 $
56,039
338,752 $
265,963 $
50,256 $
316,219 $
17,970
4,563
22,533
16,750
5,783
22,533
For the year ended May 31, 2023, net sales increased $22.5 million to $338.8 million compared to the year ended May 31, 2022. At May 31, 2023, the
Company had a backlog of $2.7 million compared to $8.4 million at the end of May 31, 2022.
The Med Tech business net sales increased $18.0 million for the year ended May 31, 2023 compared to the prior year. The change in sales from the prior
year was primarily driven by:
•
•
•
Increased Auryon sales of $12.0 million;
Growth in the thrombectomy platform of $3.0 million, which was driven by growth in the mechanical thrombectomy platform in AlphaVac sales of
$5.0 million, partially offset by softness in AngioVac; and
Increased NanoKnife sales of $3.0 million, which was driven by NanoKnife disposable sales in the U.S. and internationally which increased $3.3
million due to increased case volume. This increase was partially offset by decreased NanoKnife capital sales in the U.S.
The Med Device business net sales increased $4.6 million for the year ended May 31, 2023 compared to the prior year. The backlog, which primarily
impacted sales of Core and Vascular Access products, was $2.7 million at May 31, 2023 compared to $8.4 million at May 31, 2022. The change in sales from
the prior year was primarily driven by:
37
•
Increased sales of Core, Dialysis, Ports and Microwave sales of $5.4 million, $5.2 million, $1.4 million and $1.0 million, respectively. These
increases were partially offset by decreased Venous, PICCs, Midlines and other Oncology and Vascular Access sales of $3.6 million, $2.4 million,
$0.8 million and $1.6 million, respectively.
Gross Profit
(in thousands)
Med Tech
Gross profit % of sales
Med Device
Gross profit % of sales
Total
Gross profit % of sales
$
$
$
2023
61,966
64.1 %
112,280
46.4 %
174,246
51.4 %
$
$
$
Year ended May 31,
2022
52,584
66.8 %
113,148
47.6 %
165,732
52.4 %
$
$
$
$ Change
9,382
(868)
8,514
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,
exclusive of intangible amortization.
Total Company gross profit increased by $8.5 million compared to the prior year. The change from the prior year was primarily driven by:
•
•
•
•
•
•
Sales volume, which positively impacted gross profit by $13.2 million;
Production volume and other incentives which positively impacted gross profit by $11.3 million
Price and mix, which negatively impacted gross profit by $4.9 million;
Inflationary costs on raw materials, labor shortages and freight costs, which negatively impacted gross profit by $8.1 million;
Incremental depreciation on placement units of $2.2 million; and
A benefit of $0.8 million that was recorded as a result of the employee retention credit that the Company filed for under the provision of the CARES
Act in the prior year.
The Med Tech segment gross profit increased by $9.4 million compared to the prior year. The change from the prior year was primarily driven by:
•
•
•
•
•
Sales volume, which positively impacted gross profit by $13.9 million;
Production volume, manufacturing and other incentives which positively impacted gross profit by $2.1 million;
Pricing pressures and mix, which negatively impacted gross profit by $4.7 million;
Inflationary costs on raw materials, labor shortages and freight costs, which negatively impacted gross profit by $0.5 million; and
Incremental depreciation on placement units of $1.3 million.
The Med Device segment gross profit decreased by $0.9 million compared to the prior year. The change from the prior year was primarily driven by:
•
•
•
•
•
Sales volume, which positively impacted gross profit by $2.1 million;
Production volume, manufacturing and other incentives which positively impacted gross profit by $8.6 million;
Pricing pressures and mix, which negatively impacted gross profit by $3.7 million;
Inflationary costs on raw materials, labor shortages and freight costs, which negatively impacted gross profit by $7.6 million; and
Incremental depreciation on placement units of $0.3 million.
38
Operating Expenses and Other Income (expense)
(in thousands)
Research and development
% of sales
Selling and marketing
% of sales
General and administrative
% of sales
Year ended May 31,
2023
2022
$ Change
$
$
$
29,883
8.8 %
104,249
30.8 %
40,003
11.8 %
$
$
$
30,739
9.7 %
95,301
30.1 %
38,451
12.2 %
$
$
$
(856)
8,948
1,552
Research and development expense - Research and development (“R&D”) expense 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 decreased $0.9 million compared to the prior year. The change from the prior year was primarily driven by:
•
•
•
The timing of certain projects and clinical spend associated with the ongoing clinical trials, which decreased R&D expense by $1.1 million;
Compensation and benefits expenses, which decreased $0.3 million; and
A benefit of $0.5 million that was recorded as a result of the employee retention credit that the Company filed for under the provision of the CARES
Act in the prior year.
Sales and marketing expense - Sales and marketing (“S&M”) expense consists primarily of salaries, commissions, travel and related business expenses,
attendance at medical society meetings, product promotions and marketing activities.
S&M expense increased by $8.9 million compared to the prior year. The change from the prior year was primarily driven by:
•
•
•
•
Additional headcount from the build-out of the Auryon and mechanical thrombectomy sales and marketing teams, which increased compensation
and benefits expense by $3.1 million;
Travel, meeting, tradeshow and other selling expenses, which increased $3.7 million;
Other fixed expenses (utilities, insurance, depreciation, etc.), which decreased $0.6 million; and
A benefit of $2.8 million that was recorded as a result of the employee retention credit that the Company file for under the provision of the CARES
Act in the prior year.
General and administrative expense - General and administrative (“G&A”) expense includes executive management, finance, information technology, human
resources, business development, legal, and the administrative and professional costs associated with those activities.
G&A expense increased by $1.6 million compared to the prior year. The change from the prior year was primarily driven by:
•
•
Compensation and benefits expense, which decreased $0.5 million; and
Other outside consultant spend for legal and IT which increased $1.9 million.
(in thousands)
Amortization of intangibles
Goodwill impairment
Change in fair value of contingent consideration
Acquisition, restructuring and other items, net
Other expense
Year ended May 31,
2023
2022
$ Change
$
$
$
$
$
18,790 $
14,549 $
2,320 $
15,633 $
(3,256) $
19,458
—
1,212
9,042
(1,478)
$
$
$
$
$
(668)
14,549
1,108
6,591
(1,778)
Amortization of intangibles - Represents the amount of amortization expense that was taken on intangible assets held by the Company.
•
Amortization expense decreased $0.7 million compared to the prior year. The decrease is due to assets that became fully amortized in fiscal year
2023.
39
Goodwill impairment - Represents the impairment charge taken on goodwill.
•
The Company recorded a non-cash goodwill impairment charge of $14.5 million for the year ended May 31, 2023 as the fair value of the Med
Device reporting unit was less than its carrying value.
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 change in the fair value for the year ended May 31, 2023 is related to the Eximo contingent consideration and the increased probability of
achieving the revenue milestones. The first revenue milestone was achieved in May 2023 and will be paid in the first quarter of fiscal year 2024.
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 $6.6 million compared to the prior year. The change from the prior year was primarily driven by:
Legal expense, related to litigation that is outside of the normal course of business, which increased $2.4 million;
•
• Mergers and acquisition expense related to legal fees, which increased $0.3 million;
• Manufacturing relocation expense related to the move of certain manufacturing lines to Costa Rica, which increased $0.4 million;
•
•
Other expenses (mainly severance associated with organizational changes), which decreased $0.1 million; and
The payment to the Israeli Innovation Authority of $3.5 million related to grant funds that were provided to Eximo to develop the Auryon laser prior
to the acquisition in the second quarter of fiscal year 2020. These grant funds were fully repaid in the first quarter of fiscal year 2023 to satisfy the
obligation which was otherwise being paid as a royalty based on a percentage of sales.
Other expense - Other expense includes interest expense, foreign currency impacts, bank fees, and amortization of deferred financing costs.
•
The change in other expense of $1.8 million compared to the prior year, is primarily due to increased interest expense of $2.1 million and unrealized
foreign currency fluctuations of $0.2 million.
Income Tax Benefit
(in thousands)
Income tax benefit
Effective tax rate
Year ended May 31,
2023
2022
$
(1,995)
$
3.7 %
(3,402)
11.4 %
Our effective tax rate was a benefit of 3.7% for fiscal year 2023 compared with an effective tax rate benefit of 11.4% for the prior year. The current
year and prior year effective tax rates differ from the U.S. statutory rate primarily due to the impact of the valuation allowance, foreign taxes, and other non-
deductible permanent items (such as non-deductible meals and entertainment, Section 162(m) excess compensation), goodwill impairment and the impact of
stock-based compensation.
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, 2023. 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.
40
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 provides sufficient liquidity to meet our anticipated needs for capital for at least the next 12 months.
Our cash and cash equivalents totaled $44.6 million as of May 31, 2023, compared with $28.8 million as of May 31, 2022. As of May 31, 2023 and
2022, total debt outstanding related to the Credit Agreement was $50.0 million ($25.0 million on the Revolving Facility and $25.0 million on the Delayed
Draw Term Loan) and $25.0 million, respectively. The fair value of the contingent consideration liability as of May 31, 2023 was $19.3 million.
The table below summarizes our cash flows for the years ended May 31, 2023 and 2022:
(in thousands)
Cash provided by (used in):
Operating activities
Investing activities
Financing activities
Effect of exchange rate changes on cash and cash equivalents
Net change in cash and cash equivalents
During the years ended May 31, 2023 and 2022, cash flows consisted of the following:
Cash provided by (used in) operating activities:
Years ended May 31, 2023 and 2022:
Year ended May 31,
2023
2022
$
$
78 $
(9,746)
25,420
43
15,795 $
(7,194)
(19,307)
7,683
(518)
(19,336)
•
•
•
Net loss of $52.4 million and $26.5 million, respectively, plus the non-cash items, primarily driven by depreciation and amortization, goodwill
impairment and stock-based compensation, along with the changes in working capital below, contributed to cash provided by operations of $0.1
million for the year ended May 31, 2023 and cash used in operations of $7.2 million for the year ended May 31, 2022.
For the year ended May 31, 2023, working capital was unfavorably impacted by increased accounts receivable and inventory on hand of $1.3
million and $8.2 million, respectively. This was partially offset by increased accounts payable and accrued liabilities of $2.1 million.
For the year ended May 31, 2022, working capital was unfavorably impacted by increased accounts receivable, inventory on hand and prepaids of
$17.2 million, $2.8 million and $5.0 million respectively. This was partially offset by increased accounts payable and accrued liabilities of $3.9
million.
Cash used in investing activities:
Years ended May 31, 2023 and 2022:
•
•
•
•
$3.8 million and $4.3 million, respectively, of cash was used for fixed asset additions;
$5.4 million and $11.4 million, respectively, of cash was used for Auryon placement and evaluation unit additions;
$0.5 million of cash was used for the acquisition of an exclusive license in the first quarter of fiscal year 2023; and
$3.6 million of cash was used for the QX Medical asset acquisition in the first quarter of fiscal year 2022.
Cash provided by financing activities:
Years ended May 31, 2023 and 2022:
•
•
•
•
$70.0 million in proceeds on long-term debt less the repayment of $45.0 million associated with the new Credit Agreement in the first quarter of
fiscal year 2023. The $25.0 million draw on the Delayed Draw Term Loan associated with the new Credit Agreement is to fund the historical and
planned fiscal year 2023 purchases of Auryon placement and evaluation units. See Note 12 "Long-Term Debt" set forth in the Notes to the
consolidated financial statements;
$0.8 million of deferred financing costs associated with the new Credit Agreement;
$5.0 million draw on the Revolving Facility in the first quarter of fiscal year 2022 for the QX Medical asset acquisition; and
$1.2 million and $2.7 million, respectively, of proceeds from stock option and ESPP activity.
41
On August 30, 2022, the Company repaid all amounts outstanding under its then existing credit agreement and entered into a new Credit Agreement
that provides for a $75.0 million Revolving Facility and a $30.0 million Delayed Draw Term Loan, and also includes an 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 fixed 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 at May 31, 2023 applicable to each was 6.73%. The Company was in compliance with the Credit Agreement covenants
as of May 31, 2023.
In the first quarter of fiscal year 2023 and in connection with the new Credit Agreement, the Company drew $25.0 million on the Revolving Facility.
The Company also drew $25.0 million on the Delayed Draw Term Loan to fund the historical and planned fiscal year 2023 purchases of Auryon placement
and evaluation units for total long-term debt outstanding of $50.0 million. In the first quarter of fiscal year 2022, the Company made a $5.0 million draw on
the Revolving Facility in conjunction with the QX Medical asset acquisition. We believe that our current cash balance, together with cash generated from
operations and access to our 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 acquisitions of other businesses or technologies in the future for cash, we may require external financing.
Subsequent to fiscal year 2023, on June 8, 2023, the Company entered into an asset purchase agreement (the "Asset Purchase Agreement") with Merit
Medical Systems, Inc. ("Merit") pursuant to which Merit acquired the dialysis product portfolio and BioSentry tract sealant system biopsy businesses. The
Company and Merit entered into various agreements to facilitate the transition to Merit, including a Transactions Services Agreement and Contract
Manufacturing Agreement. The purchase price for the asset sale was $100.0 million in cash subject to the terms and conditions of the Asset Purchase
Agreement. In conjunction with the Asset Purchase Agreement, on June 8, 2023, AngioDynamics used a portion of the consideration received to repay all
amounts owed under AngioDynamics’ existing Credit Agreement, dated as of August 30, 2022, and as a result, the Credit Agreement was extinguished.
Our contractual obligations as of May 31, 2023 are set forth in the table below (in thousands). We have no variable interest entities or other off-balance
sheet obligations.
(in thousands)
Contractual Obligations:
(1)
Long term debt and interest
Operating leases
Purchase obligations
Acquisition-related future obligations
Royalties
(2)
Cash payments due by period as of May 31, 2023
Total
Less than
One Year
1-3 Years
3-5 Years
After 5
Years
$
$
50,108 $
5,940
3,166
20,000
39,840
119,054 $
50,108 $
2,366
3,166
15,000
3,640
74,280 $
— $
3,016
—
5,000
7,280
15,296 $
— $
558
—
—
7,280
7,838 $
—
—
—
—
21,640
21,640
(3)
(1) Operating leases include short-term leases that are not recorded on our Consolidated Balance Sheets under ASU No. 2016-02.
(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, 2022 and 2021
For management discussion and analysis of our 2022 financial results and liquidity compared with 2021, 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, 2022 filed on July 22, 2022.
42
Recent Accounting Pronouncements
Refer to Note 1 of the Notes to the consolidated financial statements for Recently Issued Accounting Pronouncements.
43
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 4.7% of our sales in
fiscal year 2023 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 (Expense) Income. Significant non-functional balances include accounts receivable due from some of our international customers.
INTEREST RATE RISK
Interest on the Revolving Facility and Delayed Draw Term Loan is based, at the Company's option, on a rate equal to (i) the Secured Overnight
Financing Rate ("SOFR") plus 0.10% (subject to a floor of 0%), or (ii) if the Company elects to treat a borrowing as an ABR Borrowing, an alternate base
rate based on SOFR, plus, in each case, an applicable margin of 1.25%, 1.50% or 1.75%, depending on the leverage ratio. If any amounts are not paid when
due, such overdue amounts will bear interest at an amount generally equal to 2.0% plus the existing loan rate. The Credit Agreement also carries a
commitment fee in the case of the Revolving Facility, and a ticking fee, in the case of the Delayed Draw Term Loans of 0.20% to 0.25% per annum on the
unused portion. As of May 31, 2023, there was $25.0 million outstanding on the Delayed Draw Term Loan and $25.0 million outstanding on the Revolving
Facility and the interest rate at May 31, 2023 was 6.73%.
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 Revolving 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 three 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 customers. 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. 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.
Financial statements and supplementary data required by Part II, Item 8 are included in Part IV of this report and indexed under 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.
None.
44
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 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 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 Board of 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, 2023. 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, 2023.
The effectiveness of our internal control over financial reporting as of May 31, 2023 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 year ended May 31, 2023 that has materially affected, or is reasonably
likely to materially affect, our internal control over financial reporting.
45
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Shareholders and the Board of Directors 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”) as of May 31, 2023, based on criteria
established in Internal Control — Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission
(COSO). In our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of May 31, 2023, 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, 2023, of the Company and our report dated August 3, 2023, expressed an unqualified opinion on
those financial statements.
Basis for Opinion
The Company’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’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 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’s internal control over financial reporting is a process designed 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’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’s assets that could have a material effect on the 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.
/s/ Deloitte & Touche LLP
Boston, Massachusetts
August 3, 2023
46
Item 9B. Other Information.
None.
Item 9C. Foreign Jurisdictions that Prevent Inspections.
Not applicable.
47
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 Meeting of Stockholders, currently scheduled
for October 2023. The information included in the Proxy Statement under the respective headings noted below is incorporated herein by reference.
Part III
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.
The information required by this caption 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.
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.
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.
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”.
48
Item 15. Exhibits, Financial Statement Schedules.
(a)(1) Financial Statements
Part IV
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:
Report of Independent Registered Public Accounting Firm (PCAOB ID 34)
Consolidated Statements of Operations—Year ended May 31, 2023, 2022 and 2021
Consolidated Statements of Comprehensive Loss - Year ended May 31, 2023, 2022 and 2021
Consolidated Balance Sheets—May 31, 2023 and May 31, 2022
Consolidated Statements of Stockholders’ Equity—Year ended May 31, 2023, 2022 and 2021
Consolidated Statements of Cash Flows—Year ended May 31, 2023, 2022 and 2021
Notes to Consolidated Financial Statements
(2) Financial Statement Schedules
The following consolidated financial statement schedule is included in Part IV of this report:
Schedule II—Valuation and qualifying accounts
All other schedules are omitted because they are not applicable, not required, or because the required information is included in the consolidated
financial statements or notes thereto.
(b) Exhibits
49
50
52
53
54
55
56
58
81
82
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Shareholders and the Board of Directors of
AngioDynamics, Inc.
Latham, New York
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of AngioDynamics, Inc. and subsidiaries (the "Company") as of May 31, 2023 and 2022, the
related consolidated statements of operations, comprehensive income (loss), stockholders' equity, and cash flows, for each of the three years in the period
ended May 31, 2023, and the related notes and the schedule listed in the Index at Item 15 (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, 2023 and 2022, and the results of
its operations and its cash flows for each of the three years in the period ended May 31, 2023, 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 reporting as of May 31, 2023, 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 August 3, 2023, 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 the Company's financial
statements based on our 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 audits in accordance with the standards of the 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, 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 regarding the amounts and disclosures in the financial statements. Our audits also included
evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial
statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matters
The critical audit matters communicated below are matters arising from the current-period audit of the financial statements that were 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 matters below, providing a separate opinion on the critical
audit matters 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, 2023, the Company has inventories of $55.3 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 design and 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.
50
• 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.
• 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.
Valuation of Goodwill for the Med Device Reporting Unit - Refer to Notes 1 & 9
At May 31, 2023, the Company's goodwill specific to the Med Device reporting unit was $40 million. As discussed in Note 1 of the consolidated financial
statements, goodwill is not amortized but rather is tested for impairment at least annually or more frequently if impairment indicators arise. In connection
with the Company’s determination that assets held for sale criteria was met as of May 31, 2023 with regard to a portion of its Med Device reporting unit, the
Company identified a triggering event requiring further assessment relating to the recoverability of its goodwill and therefore after performing its annual test
on its measurement date of April 30, 2023, performed an updated goodwill impairment test as of May 31, 2023.
The Company determined the amount of goodwill attributable to the disposal group and to the portion of the remaining Med Device reporting unit on a
relative fair value basis. The Company recorded a goodwill impairment charge of $14.5 million relating to its Med Device reporting unit for the year ended
May 31, 2023.
Auditing the annual goodwill impairment involves significant audit effort, as well as a degree of complexity and auditor judgment due to the estimation
required in determining the fair value of the reporting units or components thereof. In particular, the fair value estimates involve judgmental assumptions
including the amount and timing of expected future cash flows from revenue growth rates, EBITA margins, weighting of fair values, and discount rates. The
audit effort involved the use of professionals with specialized skill and knowledge.
How the Critical Audit Matter Was Addressed in the Audit
The primary procedures we performed to address this critical audit matter included:
• We tested the effectiveness of internal controls over the Company’s annual goodwill impairment analysis and its conclusions related to its updated
goodwill assessment as of May 31, 2023. This included controls over management’s review of the revenue growth rates, EBITA margins, weighting
of the fair values, and discount rates used in the valuation models.
• We performed risk assessment procedures over the Company’s goodwill impairment analysis, and evaluated the sensitivity of certain business
assumptions, including
Revenue growth rates
EBITA margins
◦
◦
◦ Weighting of fair values
◦
Discount rates used in the valuation models
• We considered the historical accuracy of management's estimates and evaluated the forecasts for reasonableness, comparing to historical results and
internal communications to management and the Board of Directors, as well as information generated from analyst and industry reports for the
Company and certain of its peer companies.
• With the assistance of our fair value specialists, we evaluated the revenue growth rates, EBITA margins, weighting of fair values, and discount rates
and reasonableness of the valuation methodology, including testing the underlying source information and the mathematical accuracy of the
calculations, and developing a range of independent estimates and comparing to those selected by management.
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/ Deloitte & Touche LLP
Boston, Massachusetts
August 3, 2023
We have served as the Company’s auditor since 2016.
51
AngioDynamics, Inc. and Subsidiaries
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
Net sales
Cost of sales (exclusive of intangible amortization)
Gross profit
Operating expenses
Research and development
Sales and marketing
General and administrative
Amortization of intangibles
Goodwill impairment
Change in fair value of contingent consideration
Acquisition, restructuring and other items, net
Total operating expenses
Operating loss
Other expenses
Interest expense, net
Other income (expense), net
Total other expenses, net
Loss before income tax benefit
Income tax benefit
Net loss
Loss per share
Basic
Diluted
Weighted average shares outstanding
Basic
Diluted
$
$
$
$
Year ended May 31,
2023
2022
2021
338,752 $
164,506
174,246
316,219 $
150,487
165,732
29,883
104,249
40,003
18,790
14,549
2,320
15,633
225,427
(51,181)
(2,702)
(554)
(3,256)
(54,437)
(1,995)
(52,442) $
(1.33) $
(1.33) $
39,480
39,480
30,739
95,301
38,451
19,458
—
1,212
9,042
194,203
(28,471)
(688)
(790)
(1,478)
(29,949)
(3,402)
(26,547) $
(0.68) $
(0.68) $
39,009
39,009
291,010
134,222
156,788
36,390
81,306
35,918
18,136
—
89
20,232
192,071
(35,283)
(861)
92
(769)
(36,052)
(4,504)
(31,548)
(0.82)
(0.82)
38,342
38,342
The accompanying notes are an integral part of these consolidated financial statements.
52
AngioDynamics, Inc. and Subsidiaries
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(in thousands)
Net loss
Other comprehensive income (loss), before tax:
Foreign currency translation gain (loss)
Other comprehensive income (loss), before tax
Income tax benefit (expense) related to items of other comprehensive income (loss)
Other comprehensive income (loss), net of tax
Total comprehensive loss, net of tax
Year ended May 31,
2023
2022
2021
(52,442) $
(26,547) $
(31,548)
(6,080)
(6,080)
—
(6,080)
(58,522) $
(1,796)
(1,796)
—
(1,796)
(28,343) $
4,494
4,494
—
4,494
(27,054)
$
$
The accompanying notes are an integral part of these consolidated financial statements.
53
AngioDynamics, Inc. and Subsidiaries
CONSOLIDATED BALANCE SHEETS
(in thousands, except share data)
May 31, 2023
May 31, 2022
Assets
Current Assets
Cash and cash equivalents
Accounts receivable, net of allowances of $2,150 and $1,939, respectively
Inventories
Prepaid expenses and other
Current assets held for sale
Total current assets
Property, plant and equipment, net
Intangible assets, net
Goodwill
Other assets
Non-current assets held for sale
Total Assets
Liabilities and Stockholders' Equity
Current Liabilities
Accounts payable
Accrued liabilities
Current portion of contingent consideration
Other current liabilities
Total current liabilities
Long-term debt
Deferred income taxes
Contingent consideration, net of current portion
Other long-term liabilities
Total Liabilities
Commitments and Contingencies (Note 17)
Stockholders’ Equity
Preferred stock, par value $0.01 per share, 5,000,000 shares authorized; no shares issued and outstanding
Common stock, par value $0.01 per share, 75,000,000 shares authorized; 39,981,422 and 39,541,173 shares
issued and 39,611,422 and 39,171,173 shares outstanding at May 31, 2023 and 2022, respectively
Additional paid-in capital
Accumulated deficit
Treasury stock, 370,000 shares, at cost at May 31, 2023 and 2022, respectively
Accumulated other comprehensive income (loss)
Total Stockholders' Equity
Total Liabilities and Stockholders' Equity
$
$
$
$
44,620 $
52,826
55,325
4,617
6,154
163,542
44,384
111,144
159,238
10,676
43,653
532,637 $
40,445 $
26,617
14,761
2,002
83,825
49,818
12,813
4,535
3,350
154,341
28,825
52,304
51,392
10,824
—
143,345
45,005
152,380
201,058
10,963
—
552,751
28,047
34,842
8,783
2,652
74,324
25,000
16,037
8,165
4,736
128,262
—
—
382
599,206
(210,855)
(5,714)
(4,723)
378,296
532,637 $
380
586,879
(158,413)
(5,714)
1,357
424,489
552,751
The accompanying notes are an integral part of these consolidated financial statements.
54
AngioDynamics, Inc. and Subsidiaries
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(in thousands, except share data)
Accumulated
other
comprehensive
income (loss)
Treasury Stock
Shares
Amount
Total
(1,341)
(370,000)
$
(5,714)
Accumulated
deficit
(100,318)
(31,548)
$
Common Stock
Shares
Amount
Additional
paid in
capital
Balance at May 31, 2020
38,448,536
$
374
$
561,871
$
Net loss
Exercise of stock options
Issuance/cancellation of restricted stock
units
Purchase of common stock under
Employee Stock Purchase Plan
Stock-based compensation
Other comprehensive income, net of tax
123,536
184,685
164,194
1
2
1,929
(223)
1,305
8,625
Balance at May 31, 2021
38,920,951
$
377
$
573,507
$
Net loss
Exercise of stock options
Issuance/cancellation of restricted stock
units
Issuance/cancellation of performance
share units
Purchase of common stock under
Employee Stock Purchase Plan
Stock-based compensation
Other comprehensive loss, net of tax
162,721
299,544
59,371
98,586
1
2
2,706
(1,900)
1,874
10,692
Balance at May 31, 2022
39,541,173
$
380
$
586,879
$
(131,866)
(26,547)
$
4,494
3,153
(370,000)
$
(5,714)
$
(158,413)
(52,442)
$
(1,796)
1,357
(370,000)
$
(5,714)
$
Net loss
Exercise of stock options
Issuance/cancellation of restricted stock
units
Issuance/cancellation of performance
share units
Purchase of common stock under
Employee Stock Purchase Plan
Stock-based compensation
Other comprehensive loss, net of tax
Balance at May 31, 2023
21,617
239,028
29,826
149,778
1
1
155
(720)
(312)
2,046
11,158
39,981,422
$
382
$
599,206
$
(210,855)
$
(6,080)
(4,723)
(370,000)
$
(5,714)
$
The accompanying notes are an integral part of these consolidated financial statements.
55
454,872
(31,548)
1,930
(223)
1,307
8,625
4,494
439,457
(26,547)
2,707
(1,900)
—
1,876
10,692
(1,796)
424,489
(52,442)
156
(720)
(312)
2,047
11,158
(6,080)
378,296
AngioDynamics, Inc. and Subsidiaries
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
Cash flows from operating activities:
Net loss
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:
$
(52,442) $
(26,547) $
(31,548)
Year ended May 31,
2023
2022
2021
Depreciation and amortization
Non-cash lease expense
Goodwill impairment
Stock based compensation
Change in fair value of contingent consideration
Deferred income tax provision
Changes in accounts receivable allowances
Asset impairments and disposals
Other
Changes in operating assets and liabilities:
Accounts receivable
Inventories
Prepaid expenses and other
Accounts payable, accrued and other liabilities
Net cash provided by (used in) operating activities
Cash flows from investing activities:
Additions to property, plant and equipment
Additions to placement and evaluation units
Cash paid for acquisitions
Acquisition of intangibles
Net cash used in investing activities
Cash flows from financing activities:
30,873
2,484
14,549
11,158
2,320
(2,311)
695
291
(513)
(1,299)
(8,198)
332
2,139
78
(3,812)
(5,394)
—
(540)
(9,746)
Proceeds from issuance of and borrowings on long-term debt
Repayment of long-term debt
Proceeds from borrowings on long-term debt
Deferred financing costs on long-term debt
Proceeds from exercise of stock options and employee stock purchase plan
Net cash provided by (used in) financing activities
Effect of exchange rate changes on cash and cash equivalents
Increase (decrease) in cash and cash equivalents
Cash and cash equivalents at beginning of year
Cash and cash equivalents at end of year
70,000
(45,000)
—
(751)
1,171
25,420
43
15,795
28,825
44,620 $
$
The accompanying notes are an integral part of these consolidated financial statements.
56
29,349
2,439
—
10,692
1,212
(3,708)
118
391
(93)
(17,151)
(2,796)
(5,012)
3,912
(7,194)
(4,297)
(11,410)
(3,600)
—
(19,307)
—
—
5,000
—
2,683
7,683
(518)
(19,336)
48,161
28,825 $
25,916
2,456
—
8,625
89
(4,805)
207
14,228
(147)
(4,162)
11,539
(3,181)
4,876
24,093
(5,187)
(8,524)
—
—
(13,711)
—
(20,000)
—
—
3,014
(16,986)
330
(6,274)
54,435
48,161
AngioDynamics, Inc. and Subsidiaries
CONSOLIDATED STATEMENTS OF CASH FLOWS—(Continued)
(in thousands)
Supplemental disclosure of non-cash investing and financing activities:
Increase (decrease) in accounts payable for purchases of fixed assets
Cash paid during the year for:
Interest
Income taxes
2023
Year ended May 31,
2022
2021
$
$
124 $
2,577 $
342
14 $
562 $
329
(139)
731
313
The accompanying notes are an integral part of these consolidated financial statements.
57
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, the "Company",
"we", "our", or "us").
The Company is a leading and transformative medical technology company focused on restoring healthy blood flow in the body's vascular system,
expanding cancer treatment options and improving the quality of life for patients.
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 its 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.
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.
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 5, "Fair Value of Financial Instruments" set forth in the Notes to our consolidated financial statements included
in this Annual Report on Form 10-K, 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 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 or net realizable value based on the first-in, first-out 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
58
lower of cost or net realizable 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 Consolidated Statements of Operations. Refer below for useful lives by
category:
Building and building improvements
Computer software and equipment
Machinery and equipment
Placement and evaluation units
Estimated useful lives
4 to 39 years
2 to 5 years
5 to 8 years
5 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 in process research and development ("IP R&D") are amortized over their
estimated useful lives, which range between two to eighteen years, on a straight-line basis over the expected period of benefit. The Company periodically
reviews the estimated useful lives of intangible assets and reviews such assets or asset groups 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. Prior to the first quarter of fiscal year 2023, the Company managed its operations as one reporting unit. At
the beginning of the first quarter of fiscal year 2023, the Company began to manage its operations as two operating segments and two reporting units, namely
Med Tech and Med Device (see Note 18 "Segments and Geographic Information" set forth in the Notes to our consolidated financial statements included in
this Annual Report on Form 10-K). The Company operates as two reporting units and two asset groups. 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.
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 each reporting unit to which the goodwill is assigned to the
carrying value of the assets and liabilities of those reporting units. 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
two operating segments with two reporting units and consequently evaluates goodwill for impairment based on an evaluation of the fair value of each
reporting unit. If the carrying value of the reporting units exceed the fair value, the carrying value is reduced to its fair value through an adjustment to the
goodwill balance, resulting in an impairment charge.
As detailed in Note 9, "Goodwill and Intangible Assets" set forth in the Notes to our consolidated financial statements included in this Annual Report
on Form 10-K, the Company recorded a goodwill impairment loss of $14.5 million for the year ended May 31, 2023 as the fair value of the Med Device
reporting unit was less than its carrying value.
59
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 it transfers control of promised goods or services to its customers in an amount that reflects the consideration
to which the Company expects to be entitled to in exchange for those goods and services. See Note 4, “Revenue from Contracts with Customers” set forth in
the Notes to our consolidated financial statements included in this Annual Report on Form 10-K for further discussion on revenue.
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 Statements 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.
Stock-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 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.
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 income (expense), net in the Consolidated Statements of Operations as incurred.
60
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.
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, 2023 and 2022.
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
Recently Issued Accounting Pronouncements - Adopted
Standard
ASU 2021-10, Government
Assistance (Topic 832):
Disclosures by Business Entities
about Government Assistance
Description
This ASU increases the transparency of government
assistance to include the disclosure of (1) the types
of assistance, (2) an entity's accounting for the
assistance, and (3) the effect of the assistance on an
entity's financial statements.
Effective Date
June 1, 2022 The Company adopted the new standard in the first
Effect on the Consolidated Financial Statements
quarter of fiscal year 2023 and it did not have an
impact on the Company's consolidated financial
statements.
Recently Issued Accounting Pronouncements - Not Yet Applicable or Adopted
Standard
Description
ASU 2021-08, Business
Combinations (Topic 805):
Accounting for Contract Assets
and Contract Liabilities from
Contracts with Customers
This ASU improves the accounting for acquired
revenue contracts with customers in a business
combination by addressing diversity in practice and
inconsistency related to recognition of an acquired
contract liability and payment terms and their effect
on subsequent revenue recognized by the acquirer.
Effect on the Consolidated Financial Statements
Effective Date
June 1, 2023 The Company plans to adopt the new standard in
the first quarter of fiscal year 2024 and does not
expect there to be a material impact to the
consolidated financial statements.
61
2. ACQUISITIONS
Camaro Support Catheter Asset Acquisition
On July 27, 2021, the Company acquired the Camaro support catheter (rebranded as Syntrax) from QX Medical, LLC for an aggregate purchase price
of $4.0 million, which included an upfront payment of $3.6 million and $0.4 million in purchase price holdbacks, along with $1.0 million of potential future
contingent consideration related to revenue milestones. This acquisition supports the Auryon product family and 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 and fixed assets of $0.1 million and an
intangible asset product technology of $3.9 million. The intangible asset will be amortized over 15 years. The contingent consideration is comprised of
revenue milestones and will be accounted for when the contingency is resolved or becomes probable and reasonably estimable.
3. ASSETS HELD FOR SALE
During the fourth quarter of fiscal year 2023, the Company was in discussions with Merit to sell the dialysis product portfolio and BioSentry tract
sealant system biopsy businesses. This qualified for held for sale accounting and the Company determined that the fair value of the net assets being sold
exceeded the carrying value as of May 31, 2023. The transaction was finalized on June 8, 2023.
The following table summarizes the major classes of assets held for sale:
(in thousands)
Current assets:
Inventories
Prepaid expenses and other
Total current assets held for sale
Non-current assets:
Property, plant and equipment, net
Intangible assets, net
Goodwill
Total non-current assets held for sale
4. REVENUE FROM CONTRACTS WITH CUSTOMERS
Revenue Recognition
As of May 31, 2023
$
$
$
$
4,154
2,000
6,154
44
17,629
25,980
43,653
Under ASC 606, Revenue from Contracts with Customers, 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 sales by Med Tech, Med Device and by geography:
(in thousands)
Net sales
Med Tech
Med Device
Total
United States
Year ended May 31, 2023
International
Total
United States
Year ended May 31, 2022
International
Total
$
$
84,332 $
198,381
282,713 $
12,355 $
43,684
56,039 $
96,687 $
242,065
338,752 $
69,939 $
196,024
265,963 $
8,778 $
41,478
50,256 $
78,717
237,502
316,219
62
(in thousands)
Net sales
Med Tech
Med Device
Total
Net Product Revenue
Year ended May 31, 2021
United States
International
Total
$
$
46,440 $
190,603
237,043 $
9,291 $
44,676
53,967 $
55,731
235,279
291,010
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 products 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
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. For
the duration of these agreements 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 add, and other taxes collected on behalf of third parties are excluded from revenue.
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
63
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. The Company is also required to pay administrative fees 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, 2023, 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)
Receivables
Contract assets
Contract liabilities
May 31, 2023
May 31, 2022
$
$
$
52,826 $
— $
499 $
52,304
—
526
During the years ended May 31, 2023 and 2022, the Company had additions to contract liabilities of $0.7 million and $2.2 million, respectively. This
was offset by $0.7 million and $2.1 million in revenue that was recognized during the years ended May 31, 2023 and 2022, respectively.
Costs to Obtain or Fulfill a Customer Contract
Under ASC 606, the Company may recognize 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 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.
64
•
•
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, accounts receivable, 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 contingent consideration liabilities.
The following tables provide information by level for assets and liabilities that are measured at fair value on a recurring basis:
(in thousands)
Financial Liabilities
Contingent consideration for acquisition earn outs
Total Financial Liabilities
(in thousands)
Financial Liabilities
Contingent consideration for acquisition earn outs
Total Financial Liabilities
Fair Value Measurements using inputs considered as:
Level 1
Level 2
Level 3
Fair Value at May 31,
2023
— $
— $
— $
— $
19,296 $
19,296 $
19,296
19,296
Fair Value Measurements using inputs considered as:
Level 1
Level 2
Level 3
Fair Value at May 31,
2022
— $
— $
— $
— $
16,948 $
16,948 $
16,948
16,948
$
$
$
$
There were no transfers between Level 1, 2 and 3 for the years ended May 31, 2023 and 2022.
The following tables present the changes in fair value components of Level 3 instruments:
(in thousands)
Balance at May 31, 2022
Change in present value of contingent consideration (1)
Currency gain from remeasurement
Balance at May 31, 2023
Financial Liabilities
Fair Value Measurements
Using Significant
Unobservable Inputs
(Level 3)
$
$
16,948
2,320
28
19,296
(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 Company
performance and amortization of the present value discount.
(in thousands)
Balance at May 31, 2021
Change in fair value of contingent consideration (1)
Currency loss from remeasurement
Balance at May 31, 2022
Financial Liabilities
Fair Value Measurements
Using Significant
Unobservable Inputs
(Level 3)
$
$
15,741
1,212
(5)
16,948
(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 Company
performance and amortization of the present value discount.
65
Contingent Liability for Acquisition Earn Outs
Some of the Company's business combinations involve the potential for the payment of future contingent consideration upon the achievement of certain
product development milestones or various other performance conditions. Payment of the additional consideration is generally contingent on the acquired
company reaching certain performance milestones, including attaining specified revenue levels or product development targets. Contingent consideration is
recorded at the estimated fair value of the contingent payments on the acquisition date. The fair value of the contingent 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 Statements of Operations.
The 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 measurements which is determined using a discounted cash flow 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 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, 2023:
(in thousands)
Revenue based payments
Fair Value
Valuation Technique
19,296 Discounted cash flow
$
Unobservable Input
Discount rate
Probability of payment
Projected fiscal year of payment
Range
5%
80% - 100%
2024 - 2025
At May 31, 2023, the amount of undiscounted future contingent consideration that the Company expects to pay as a result of all completed acquisitions
is approximately $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 2024 to 2029 in order for the associated consideration to be paid.
Items Measured at Fair Value on a Nonrecurring Basis
The Company recorded a goodwill impairment charge of $14.5 million for the year ended May 31, 2023 to write down the carrying value of the Med
Device reporting unit to fair value.
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.
There were no other items measured at fair value on a nonrecurring basis during the year ended May 31, 2023 or May 31, 2022.
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:
(in thousands)
Raw materials
Work in process
Finished goods
Total
May 31, 2023
May 31, 2022
$
$
28,679 $
6,708
19,938
55,325 $
28,251
7,186
15,955
51,392
The Company periodically reviews 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, 2023 and 2022 was $3.1 million and $3.7 million, respectively.
7. PREPAID EXPENSES AND OTHER
Prepaid expenses and other consisted of the following:
66
(in thousands)
Deposits
Employee Retention Tax Credit
Software licenses
License fees
Trade shows
Rent
Other prepaid taxes
Other
Total
8. PROPERTY, PLANT AND EQUIPMENT, NET
Property, plant and equipment are summarized as follows:
(in thousands)
Building and building improvements
Computer software and equipment
Machinery and equipment
Placement and evaluation units
Construction in progress
Less accumulated depreciation
Land and land improvements
May 31, 2023
May 31, 2022
894 $
—
1,501
217
448
191
264
1,102
4,617 $
2,106
4,194
1,255
172
328
240
328
2,201
10,824
May 31, 2023
May 31, 2022
29,660 $
27,435
17,023
26,355
2,444
102,917
(59,026)
43,891
493
44,384 $
29,425
27,292
15,453
21,009
2,402
95,581
(51,069)
44,512
493
45,005
$
$
$
$
Depreciation expense for fiscal years 2023, 2022 and 2021 was $11.9 million, $7.6 million and $5.7 million, respectively.
9. GOODWILL AND INTANGIBLE ASSETS
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 has historically performed its annual goodwill assessment during the third quarter of each fiscal year. During the fourth quarter of fiscal
year 2022, the Company changed its annual impairment assessment date from December 31 to April 30 to more closely align the impairment assessment date
with the Company's long term planning and forecasting process.
Prior to the first quarter of fiscal year 2023, the Company managed its operations as one reporting unit. At the beginning of the first quarter of fiscal
year 2023, the Company began to manage its operations as two operating segments and two reporting units, namely Med Tech and Med Device (see Note 18
"Segments and Geographic Information" set forth in the Notes to our consolidated financial statements included in this Annual Report on Form 10-K). As a
result of this change, goodwill was required to be allocated to each reporting unit and an interim goodwill impairment assessment was performed at the
Company and reporting unit levels. To determine the fair value of the individual reporting units and the entire company as of June 1, 2022, the Company
utilized the income approach. The income approach is based on the projected cash flows discounted to their present value using discount rates, that in the
Company's judgment, consider the timing and risk of the forecasted cash flows using internally developed forecasts and assumptions. Under the income
approach, the discount rate used is the average estimated value of a market participant’s cost of capital and debt, derived using customary market metrics.
Other significant assumptions include revenue growth rates, profitability projections, and terminal value growth rates. The market approach was also
considered; however, the income approach was chosen as the Company determined it is a better representation of both the Med Tech and Med Device
reporting units' projected long-term performance. The fair value of each
67
reporting unit and the Company as a whole was assessed to determine if there was any impairment. The Company compared each reporting unit's fair value
to the adjusted carrying value to conclude that there was no impairment for either reporting unit or the Company as a whole. The adjusted carrying value of
each reporting unit was used to calculate the Company's book value to compare to its market capitalization at the assessment date. Based on the results of
this evaluation, there were no adjustments to goodwill for either reporting unit or the Company as a whole as of August 31, 2022.
The Company's annual testing for impairment of goodwill was completed as of April 30, 2023. To determine the fair value of the two reporting units as
of April 30, 2023, the Company utilized the income approach for Med Tech and a combination of the income approach and market approach for Med Device.
The income approach is based on the projected cash flows discounted to their present value using discount rates, that in the Company's judgment, consider
the timing and risk of the forecasted cash flows using internally developed forecasts and assumptions. Under the income approach, the discount rate used is
the average estimated value of a market participant’s cost of capital and debt, derived using customary market metrics. Other significant assumptions include
revenue growth rates, profitability projections, and terminal value growth rates. The market approach estimates fair values based on the determination of
appropriate publicly traded market comparison companies and market multiples of revenue and earnings derived from those companies with similar
operating and investment characteristics. The market approach was also considered; however, the income approach was chosen as the Company determined
it is a better representation of the Med Tech reporting units' projected long-term performance. For Med Device, both the income and market approaches were
considered. The fair value of each reporting unit was assessed to determine if there was any impairment. The Company compared each reporting unit's fair
value to the adjusted carrying value to conclude that there was no impairment for either reporting unit. Based on the results of this evaluation, there were no
adjustments to goodwill for either reporting unit as of April 30, 2023.
The Company concluded that the sale of the dialysis product portfolio and BioSentry tract sealant system biopsy businesses to Merit Medical Systems,
Inc. was a triggering event for the Med Device report unit. As the Company concluded that this was the sale of a business, goodwill was allocated to the sale
based on the relative fair value of the dialysis and BioSentry businesses and is included in assets held for sale as of May 31, 2023. To determine the fair
value of the remaining Med Device reporting unit as of May 31, 2023, the Company utilized the income approach, as it was determined to be a better
representation of the remaining Med Device reporting unit's projected long-term performance.
Based on the results of this evaluation, the Company recorded a goodwill impairment charge of $14.5 million for the year ended May 31, 2023 to write
down the carrying value of the Med Device reporting unit to fair value. The impairment loss is disclosed separately on the face of the accompanying
consolidated statements of operations.
There were no adjustments to goodwill for the Med Tech reporting unit for the year ended May 31, 2023 other than foreign currency translation
adjustments. There were no adjustments to goodwill for the year ended May 31, 2022 other than foreign currency translation adjustments.
Goodwill for each reporting unit is allocated as follows:
(in thousands)
Balance June 1, 2022
Goodwill impairment
Assets held for sale
Foreign currency translation adjustments
Balance May 31, 2023
Med Tech
Year ended May 31, 2023
Med Device
Total
$
$
160,529 $
—
—
(1,291)
159,238 $
40,529 $
(14,549)
(25,980)
—
— $
201,058
(14,549)
(25,980)
(1,291)
159,238
Even though the Company determined that there was no goodwill impairment as of April 30, 2023 for the Med Tech reporting unit, 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 April 30, 2024.
Definite Lived Intangible Assets
Intangible assets other than goodwill are amortized over their estimated useful lives on a straight-line basis. Useful lives range from two to eighteen
years. The Company periodically reviews, and adjusts, if necessary, the estimated useful lives of its intangible assets and reviews 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.
68
In connection with the triggering event for the Med Device reporting unit as of May 31, 2023, long-lived assets were tested for impairment. As a result
of the undiscounted cash flow analysis that was performed, there were no impairments identified as of May 31, 2023.
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 Statements of Operations (see Note 19 "Acquisition, restructuring and other items, net" as set forth in the Notes to the consolidated financial
statements in this Annual Report on Form 10-K).
Intangible assets consisted of the following:
(in thousands)
Product technologies
Customer relationships
Trademarks
Licenses
(in thousands)
Product technologies
Customer relationships
Trademarks
Licenses
Gross carrying
value
May 31, 2023
Accumulated
amortization
Net carrying
value
211,751 $
57,509
7,450
4,837
281,547 $
(118,314) $
(40,755)
(6,660)
(4,674)
(170,403) $
93,437
16,754
790
163
111,144
Gross carrying
value
May 31, 2022
Accumulated
amortization
Net carrying
value
239,467 $
60,115
9,950
4,837
314,369 $
(112,141) $
(38,003)
(7,185)
(4,660)
(161,989) $
127,326
22,112
2,765
177
152,380
$
$
$
$
Amortization expense was $18.8 million, $19.5 million and $18.1 million for fiscal years 2023, 2022 and 2021, respectively.
Expected future amortization expense related to the intangible assets for each of the following fiscal years is as follows:
(in thousands)
2024
2025
2026
2027
2028
2029 and thereafter
10. INCOME TAXES
$
$
14,399
14,380
14,199
14,057
10,827
43,282
111,144
The components of loss before income tax benefit are as follows:
(in thousands)
Loss before tax expense:
U.S.
Non-U.S.
2023
Year ended May 31,
2022
2021
$
$
(45,240) $
(9,197)
(54,437) $
(28,495) $
(1,454)
(29,949) $
(31,595)
(4,457)
(36,052)
69
Income tax benefit is comprised of the following:
(in thousands)
Current
U.S.
Non U.S.
Deferred
U.S.
Non U.S.
Year ended May 31,
2023
2022
2021
129
187
316
(207)
(2,104)
(2,311)
120
186
306
(3,415)
(293)
(3,708)
100
201
301
(3,375)
(1,430)
(4,805)
Income tax benefit
$
(1,995) $
(3,402) $
(4,504)
Temporary differences that give rise to deferred tax assets and liabilities are summarized as follows:
(in thousands)
Deferred tax assets
Net operating loss carryforward
Stock-based compensation
Federal and state R&D tax credit carryforward
Inventories
Expenses incurred not currently deductible
Accrued liabilities
Gross deferred tax asset
Deferred tax liabilities
Depreciation and amortization
Valuation allowance
Net deferred tax liability
May 31, 2023
May 31, 2022
$
$
40,460 $
4,263
7,311
724
6,986
78
59,822
46,828
46,828
(25,759)
(12,765) $
40,759
4,617
6,320
853
1,914
72
54,535
50,320
50,320
(20,203)
(15,988)
The net deferred tax liability in the U.S. as of May 31, 2023 and 2022 principally relates to tax amortization of intangibles that have an indefinite
reversal period for book purposes, also known as a “naked credit deferred tax liability”, that cannot be considered as a source of income to recover the
deferred tax asset. In addition, included in the net deferred tax liability as of May 31, 2023 and 2022 is a net deferred tax liability of $5.8 million and
$8.8 million, respectively that was related to the stock acquisition of Eximo Medical Ltd. primarily related to book intangibles partially offset by tax net
operating losses and capitalized R&D expenditures.
The Company's U.S. Federal net operating loss carryforwards as of May 31, 2023 after considering IRC Section 382 limitations are $169.7 million. The
expiration of the Federal net operating loss carryforwards are as follows: $5.2 million between 2023 and 2024, $79.4 million between 2028 and 2037 and
$85.1 million indefinitely.
The Company's state net operating loss carryforwards as of May 31, 2023 after considering remaining IRC Section 382 limitations are $24.1 million
which expire in various years from 2029 to 2042. The Company has Israel tax net operating losses of $16.3 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, 2023,
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.
70
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, 2023. 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.
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:
(in thousands)
Income tax benefit at federal statutory tax rate of 21.0%, 21.0% and 21.0%, respectively
$
State income taxes, net of Federal tax benefit
Impact of Non-U.S. operations
Research and development tax credit
Meals and entertainment
Goodwill impairment
Non-deductible executive compensation
Change in valuation allowance
Stock based compensation
Other
Income tax benefit
$
Year ended May 31,
2023
2022
2021
(11,432) $
(353)
14
(991)
258
3,055
366
5,556
505
1,027
(1,995) $
(6,289) $
(536)
199
395
179
—
686
3,168
(1,616)
412
(3,402) $
The following table provides a reconciliation of the beginning and ending amount of unrecognized tax benefits:
(in thousands)
Unrecognized tax benefits balance at June 1
Decrease in gross amounts of tax positions related to prior years due to U.S. tax reform
Decrease due to lapse in statute of limitations
Unrecognized tax benefits balance at May 31
2023
Year ended May 31,
2022
2021
$
$
464 $
—
—
464 $
464 $
—
—
464 $
(7,571)
(462)
(293)
(1,303)
116
—
107
3,921
526
455
(4,504)
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, $0.5 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 no accrued
interest and penalties recognized in the Consolidated Balance Sheets as of May 31, 2023 and May 31, 2022.
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 2020 through 2022 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.
71
11. ACCRUED LIABILITIES
Accrued liabilities consist of the following:
(in thousands)
Payroll and related expenses
Outside services
Royalties
Research and development
Accrued severance
Sales and franchise taxes
Rebates
Other
Total
12. LONG-TERM DEBT
May 31, 2023
May 31, 2022
$
$
9,232 $
7,088
2,874
1,525
262
480
469
4,687
26,617 $
20,232
3,731
2,986
1,279
59
750
511
5,294
34,842
On August 30, 2022, the Company repaid all amounts outstanding under its then existing credit agreement and entered into a new Credit Agreement
(the "Credit Agreement") with its lenders, JPMorgan Chase Bank, N.A., as Administrative Agent, sole bookrunner, and sole lead arranger, and Bank of
America, N.A. and KeyBank National Association, as Syndication Agents.
The Credit Agreement provides for a $75.0 million secured revolving credit facility (the "Revolving Facility") and a $30.0 million delayed draw term
loan (the "Delayed Draw Term Loan"), and also includes an 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. Each exercise of such expansion feature must be
drawn in $5.0 million increments. The proceeds of the Revolving Facility may be used for general corporate purposes, including permitted acquisitions. The
proceeds of the Delayed Draw Term Loan may be used for general corporate purposes, including primarily to finance the manufacturing costs of the Auryon
laser capital equipment.
The Credit Agreement has a five-year maturity. Interest on the Revolving Facility and Delayed Draw Term Loan will be based, at the Company's
option, on a rate equal to (i) the Secured Overnight Financing Rate ("SOFR") plus 0.10% (subject to a floor of 0%), or (ii) if the Company elects to treat a
borrowing as an ABR Borrowing, an alternate base rate based on SOFR, plus, in each case, an applicable margin of 1.25%, 1.50% or 1.75%, depending on
the leverage ratio. If any amounts are not paid when due, such overdue amounts will bear interest at an amount generally equal to 2.0% plus the existing loan
rate. The Credit Agreement also carries a commitment fee in the case of the Revolving Facility, and a ticking fee, in the case of the Delayed Draw Term
Loans of 0.20% to 0.25% per annum on the unused portion.
The Company's obligations under the Credit Agreement 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 Credit Agreement 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, two quarterly financial covenants as follows:
• Maximum leverage ratio of consolidated total indebtedness* to consolidated EBITDA* of not greater than 3.00 to 1.00 (during certain periods
following material acquisitions the ratio shall be increased to 3.50 to 1.00).
• Fixed charge coverage ratio of consolidated EBITDA minus consolidated capital expenditures* to consolidated interest expense* 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 interest expense are specifically defined in the credit agreement
included as an exhibit to Form 8-K filed on August 31, 2022.
As of May 31, 2023 there was $25.0 million outstanding on the Revolving Facility and $25.0 million outstanding on the Delayed Draw Term Loan and
the interest rate at May 31, 2023 applicable to each was 6.73%. As of May 31, 2023 and May 31, 2022, the carrying value of long-term debt approximated its
fair market value.
72
(in thousands)
Revolving Facility
Delayed Draw Term Loan
Less: unamortized debit issuance costs
Total long-term debt
May 31, 2023
25,000
25,000
(182)
49,818
$
$
The Company was in compliance with the Credit Agreement covenants as of May 31, 2023.
On June 8, 2023, AngioDynamics used a portion of the consideration received from the sale of the dialysis and BioSentry businesses to repay all amounts
owed under AngioDynamics’ existing Credit Agreement, and as a result, the Credit Agreement was extinguished. Pursuant to the terms of the Credit
Agreement, AngioDynamics had the option to repay this facility prior to the maturity date without penalty.
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 million, $4.3 million and $3.8 million in 2023, 2022 and 2021, respectively. There are also various immaterial foreign
retirement plans.
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 one 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 Board of Directors 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
On October 13, 2020, the Company's shareholders approved the 2020 Stock and Incentive Award Plan (the “2020 Plan”). The 2020 Plan provides for
the grant of incentive stock options, 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. On November 3, 2022 the Company's
shareholders approved an amendment to the 2020 Plan to increase the reserve of shares of common stock available for future grants by 1,950,000 shares. As
of May 31, 2023, there remained approximately 2.9 million shares available for future grants under the 2020 Plan.
Prior to the adoption of the 2020 Plan, equity awards were issued under the 2004 Stock and Incentive Award Plan (the “2004 Plan”). The adoption of
the 2020 Plan did not impact the administration of 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.
73
The following table summarizes information about stock option activity for the fiscal year ended May 31, 2023:
Shares
Weighted average
exercise price
Weighted average
remaining contractual
life
Aggregate intrinsic
value (in thousands)
Outstanding at beginning of year - June 1, 2022
Granted
Exercised
Forfeited
Expired
Outstanding at end of year - May 31, 2023
Options exercisable at year-end
Options expected to vest in future periods
2,346,248 $
187,826 $
(47,824) $
(79,701) $
(200,000) $
2,206,549 $
1,408,208 $
798,341 $
17.13
21.54
14.79
20.02
12.14
17.90
17.12
19.28
5.89 $
4.77 $
7.86 $
—
—
—
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. 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 between May 1, 2007 through May 31, 2017 expire on the seventh anniversary of the grant date.
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, 2023, 2022 and 2021 was $9.27, $9.57, and $3.97, respectively. The following
assumptions were used in arriving at the fair value of options granted during 2023, 2022 and 2021, respectively: risk-free interest rates of 3.20%, 0.92% and
0.34%; expected volatility of 44%, 41%, and 39%; and expected lives of 5.14 years, 5.05 years, and 4.96 years. The Company does not declare dividends
therefore a dividend yield of zero was used for the years ended May 31, 2023, 2022 and 2021. 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, 2023, 2022 and 2021 was $0.2 million, $1.6 million, and $0.8 million,
respectively. As of May 31, 2023, there was $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 2 years.
Cash received from option exercises during 2023, 2022 and 2021 was $0.3 million, $2.7 million and $1.9 million, respectively. Due to the valuation
allowance there was no tax benefit realized from stock option exercises during the years ended May 31, 2023, 2022 and 2021.
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 beginning on the first
anniversary of the 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, 2023:
Non-vested at beginning of year, June 1, 2022
Granted
Vested
Canceled
Non-vested at end of year, May 31, 2023
Restricted Stock Units
Weighted Average Grant-
Date Fair Value
670,017 $
379,572 $
(275,007) $
(38,562) $
736,020
18.36
19.99
20.29
19.28
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, 2023, 2022 and 2021 was $19.99,
74
$26.24 and $10.40, 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, 2023, 2022 and 2021 was $5.6 million, $8.5 million, and $2.1 million, respectively. As of May 31, 2023, there was $9.1 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 2 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 following table summarizes information about performance unit award activity for the year ended May 31, 2023:
Non-vested at beginning of year, June 1, 2022
Granted
Vested
Canceled
Non-vested at end of year, May 31, 2023
Performance Unit
Awards
Weighted Average Grant-
Date Fair Value
449,473 $
175,386 $
(45,008) $
(31,321) $
548,530 $
17.02
21.53
20.54
20.16
19.23
During fiscal years 2023, 2022 and 2021, 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 performance years along 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.
In order to estimate the fair value of such awards, a Monte Carlo Simulation valuation model on the date of the grant was used. For the years ended
May 31, 2023, 2022 and 2021, the weighted average grant date fair market value for new grants was $23.71, $28.93 and $9.72, respectively. Compensation
cost is recognized over the performance period which is typically three years. As of May 31, 2023, there was $2.4 million of unrecognized compensation
cost which is expected to be recognized over a weighted average period of 1 year.
Compensation Expense
The following tables represents the break out of stock-based compensation included in the Company's Consolidated Statement of Operations:
(in thousands)
Cost of sales
Research and development
Sales and marketing
General and administrative
Year ended May 31,
2023
2022
2021
$
$
793 $
1,459
2,922
5,984
11,158 $
827 $
1,298
2,568
5,999
10,692 $
768
1,152
1,641
5,064
8,625
The income tax benefit on the compensation expense recognized for all stock-based compensation arrangements was $2.6 million, $2.5 million and
$2.0 million for the years ended May 31, 2023, 2022 and 2021, respectively. The income tax benefit for 2023, 2022 and 2021 are negated by the full
valuation allowance 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 5,000,000 shares of common stock have been reserved for issuance under the
Stock Purchase Plan. Shares are offered through two 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
75
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 years ended May 31, 2017, 2019 and 2021, an additional 500,000, 1,000,000 and 500,000 shares of
the Company's common stock, respectively, were reserved for issuance under the Stock Purchase Plan. On November 3, 2022 the Company's shareholders
approved an amendment to the employee stock purchase plan to increase the reserve of shares of common stock available for future grants by 1,000,000
shares.
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, 2023, 2022 and 2021, 149,778, 98,586
and 164,194 shares, respectively, were issued at an average price of $13.67, $19.02 and $7.95, respectively, under the Stock Purchase Plan. As of May 31,
2023, 3.2 million shares remained available for future purchases under the Stock Purchase Plan.
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 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:
Basic
Effect of dilutive securities
Diluted
2023
39,480,367
—
39,480,367
Year ended May 31,
2022
39,009,419
—
39,009,419
2021
38,342,476
—
38,342,476
Securities excluded as their inclusion would be anti-dilutive
3,491,099
3,465,738
3,285,354
16. LEASES
The Company determines if an arrangement is a lease at inception of the contract. The Company has operating leases for buildings, primarily for office
space, R&D, manufacturing and 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 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 following table presents supplemental balance sheet information related to leases:
76
(in thousands)
Assets
Operating lease ROU assets
Liabilities
Current operating lease liabilities
Non-current operating lease liabilities
Total lease liabilities
Balance Sheet Location
May 31, 2023
May 31, 2022
Other assets
Other current liabilities
Other long-term liabilities
$
$
5,113 $
1,922
3,316
5,238 $
6,974
2,560
4,703
7,263
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:
Weighted average remaining term (in years)
Weighted average discount rate
The maturities of the lease liabilities for each of the following fiscal years is:
May 31, 2023
May 31, 2022
3.05
4.1 %
3.25
3.8 %
(in thousands)
2024
2025
2026
2027
2028 and thereafter
Total lease payments
Less: Imputed Interest
Total lease obligations
Less: Current portion of lease obligations
Long-term lease obligations
May 31, 2023
2,097
1,621
1,329
375
174
5,596
358
5,238
1,922
3,316
$
$
$
$
During the years ended May 31, 2023 and May 31, 2022, the Company recognized operating lease expense, which includes immaterial short-term
leases, of $2.7 million and $2.8 million, respectively. The expenses on the Consolidated Statement of Operations were classified as follows:
(in thousands)
Cost of sales
Research and development
Sales and marketing
General and administrative
The following table presents supplemental cash flow and other information related to leases:
8
(in thousands)
Cash paid for amounts included in the measurement of lease liabilities
Operating cash flows from operating leases
ROU assets obtained in exchange for lease liabilities
Operating leases
$
$
$
May 31, 2023
May 31, 2022
881 $
193
162
1,458
2,694 $
890
257
160
1,495
2,802
May 31, 2023
May 31, 2022
2,742 $
2,723
840
36
77
17. COMMITMENTS AND CONTINGENCIES
Other Commitments and Contingencies
The following table summarizes the Company's other future commitments and contingencies as of May 31, 2023:
(in thousands)
Purchase obligations
(2)
Royalties
(1)
Total
2024
2025
2026
2027
2028 and
thereafter
$
$
3,166 $
39,840
43,006 $
3,166 $
3,640
6,806 $
— $
3,640
3,640 $
— $
3,640
3,640 $
— $
3,640
3,640 $
—
25,280
25,280
(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.
(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 the Company's implantable
port products infringe on three U.S. patents held by Bard (US Patent Nos. 7,785,302 ("302"), 7,959,615 (“615”) and 7,947,022 ("022")). The case was stayed
pending reexamination in the US Patent and Trademark Office ("USPTO"). Following the reexamination proceedings, and the parties’ related appeals to the
Federal Circuit which resulted in further proceedings at the USPTO, certain claims of the 615 patent were held invalid, while the remaining claims of the 615
patent and the other two patents were upheld over the prior art references considered in the reexamination 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”). On July 22, 2021, in another case against a
different defendant, the District of Utah invalidated multiple claims of the ‘302, ‘022, and ‘615 Patents under 35 USC §101, including claims asserted
against the Company. On December 27, 2021, the District of Delaware stayed the case pending the Federal Circuit's resolution of Bard's appeal from the
Utah Decision. On February 17, 2023, the Federal Circuit Reversed-in-Part, Vacated-in-Part, and Remanded the Utah Decision. The District of Delaware
lifted the stay on February 28, 2023 and held a status conference on March 23, 2023. A scheduling order has been entered, and a jury trial is currently
scheduled for April 29, 2024. 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 10, 2015, Bard and Bard Peripheral Vascular filed suit in the District of Delaware claiming certain of the Company's implantable port
products infringe on three U.S. patents held by Bard (US Patent Nos. 8,475,417, 8,545,460, 8,805,478). The case proceeded through trial which began on
March 4, 2019. 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. Bard appealed the judgment to the Federal
Circuit and on November 10, 2020, the Federal Circuit reversed the judgment in part with respect to Section 101 (subject matter eligibility), and vacated and
remanded the trial court’s invalidity and non-infringement judgments. Following remand from the Federal Circuit, a jury trial commenced in the District of
Delaware beginning November 14, 2022. On November 22, 2022, a jury entered a verdict finding that certain of the Company’s implantable port products
infringe certain claims of U.S. patents held by Bard. The issue of damages was bifurcated by the Court during trial and was not determined by the jury. On
June 1, 2023, following post-trial briefing, the Court issued its decision on the Company’s Renewed Judgement as a Matter of Law. The Court held the
asserted patent claims were invalid as anticipated, indefinite, ineligible, and not willfully infringed. The Court entered Judgment the same day in favor of the
Company. Bard has filed a Notice of Appeal to the Federal Circuit. 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.
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 and 9,603,993. On December 27, 2021, the District of Delaware stayed the case pending the Federal Circuit's
resolution of Bard's appeal of the Utah decision invalidating
78
multiple claims of the ‘302, ‘022, and ‘615 patents under 35 USC §101. Following the Federal Circuit’s decision on appeal, the District of Delaware lifted
the stay on February 28, 2023, and held a scheduling conference on March 23, 2023. A scheduling order has been entered, and a jury trial is currently
scheduled for June 9, 2025. 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.
18. SEGMENTS AND GEOGRAPHIC INFORMATION
Segment information
The Company regularly reviews its segments and the approach used by the chief operating decision maker, the President and Chief Executive Officer
("CEO"), and management to evaluate performance and allocate resources. Prior to the first quarter of fiscal year 2023, the Company considered the business
to be a single operating segment engaged in the development, manufacture and sale of medical devices for vascular access, peripheral vascular disease and
oncology on a global basis. Commencing with the first quarter of fiscal year 2023, the Company began to manage its operations through two segments, Med
Tech and Med Device to align with the transformation from a company with a broad portfolio of largely undifferentiated products to a more focused medical
technology company. The CEO evaluates these two segments based on net sales and gross margin to, among other items, allocate resources and assess
performance. Executives reporting to the CEO include those responsible for commercial operations, manufacturing operations, regulatory and quality and
certain corporate functions. The CEO evaluates all other elements of profitability, investment and cash flow metrics on a consolidated global basis due to
shared infrastructure and resources.
The Company manages its assets on a total company basis, not by operating segment; therefore, the CEO does not review any asset information by
operating segment and, accordingly, asset information is not reported or evaluated by operating segment. Total assets were $532.6 million as of May 31,
2023.
The table below summarizes net sales and gross margin by Med Tech and Med Device including prior periods during which the Company considered
the business to be a single operating segment, in order to conform to the current period presentation:
(in thousands)
Med Tech Net Sales
Gross Profit
Gross Margin
Med Device Net Sales
Gross Profit
Gross Margin
Total Net Sales
Gross Profit
Gross Margin
Geographic information
2023
Year ended May 31,
2022
2021
$
$
$
$
$
$
96,687
61,966
64.1 %
242,065
112,280
46.4 %
338,752
174,246
51.4 %
$
$
$
$
$
$
78,717
52,584
66.8 %
237,502
113,148
47.6 %
316,219
165,732
52.4 %
$
$
$
$
$
$
55,731
39,544
71.0 %
235,279
117,244
49.8 %
291,010
156,788
53.9 %
The table below summarizes net sales by geographic area based on external customer location:
(in thousands)
Net sales by Geography
United States
International
Total
Year ended May 31,
2023
2022
2021
$
$
282,713 $
56,039
338,752 $
265,963 $
50,256
316,219 $
237,043
53,967
291,010
79
For fiscal years 2023, 2022 and 2021, international sales as a percentage of total net sales were 17%, 16% and 19%, 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. 85% of long-lived assets are located within the United States.
19. ACQUISITION, RESTRUCTURING AND OTHER ITEMS, NET
Acquisition, restructuring and other items, net consisted of:
(1)
(2)
(in thousands)
Legal
Mergers and acquisitions
Transition service agreement
Divestiture
Intangible and other asset impairment
Israeli Innovation Authority prepayment
Manufacturing Relocation
Other
(5)
(3)
(4)
(7)
Total
(6)
Year ended May 31,
2023
2022
2021
$
$
9,998 $
368
—
—
—
3,544
1,091
632
15,633 $
7,625 $
59
—
—
—
—
644
714
9,042 $
6,161
1
(1,032)
393
13,953
—
—
756
20,232
(1) Legal expenses related to litigation that is outside the normal course of business.
(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 sale 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.
(6) In the first quarter of fiscal year 2023, a $3.5 million payment was made to the Israeli Innovation Authority to fully satisfy the obligation related to grant funds that were
provided to Eximo for development of the Auryon laser prior to the acquisition in the second quarter of fiscal year 2020.
(7) Expenses to relocate certain manufacturing lines from Queensbury, NY to Alajuela, Costa Rica.
Included in legal for fiscal year 2021 is a $1.0 million settlement expense. The settlement received partially offset legal expenses paid related to the
settlement proceedings.
20. ACCUMULATED OTHER COMPREHENSIVE INCOME (LOSS)
Changes in each component of accumulated other comprehensive income (loss), net of tax, are as follows:
(in thousands)
Balance at May 31, 2021
Other comprehensive income, net of tax
Net other comprehensive loss
Balance at May 31, 2022
Other comprehensive income, net of tax
Net other comprehensive loss
Balance at May 31, 2023
21. SUBSEQUENT EVENTS
Foreign currency
translation gain (loss)
3,153
$
(1,796)
(1,796)
1,357
(6,080)
(6,080)
(4,723)
$
$
$
$
On June 8, 2023, the Company entered into an asset purchase agreement (the "Asset Purchase Agreement") with Merit Medical Systems, Inc. pursuant
to which Merit acquired the dialysis product portfolio and BioSentry tract sealant system biopsy businesses for $100.0 million in cash. The Company and
Merit entered into various agreements to facilitate the transition to Merit, including a Transactions Services Agreement and Contract Manufacturing
Agreement. The Company determined that the sale of the businesses did not constitute a strategic shift that had a major effect on the Company’s operations
or financial results and as a result, this transaction will not be classified as discontinued operations.
80
On June 8, 2023, AngioDynamics used a portion of the consideration received in connection with the Transaction to repay all amounts owed under
AngioDynamics’ existing Credit Agreement, dated as of August 30, 2022, with 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., as sole bookrunner and sole
lead arranger, and as a result, the Credit Agreement was extinguished. Pursuant to the terms of the Credit Agreement, AngioDynamics had the option to
repay this facility prior to the maturity date without penalty.
AngioDynamics, Inc. and Subsidiaries
(in thousands)
Description
Year Ended May 31, 2021
Allowance for deferred tax asset
Allowance for sales returns and doubtful accounts
Year Ended May 31, 2022
Allowance for deferred tax asset
Allowance for sales returns and doubtful accounts
Year Ended May 31, 2023
Allowance for deferred tax asset
Allowance for sales returns and doubtful accounts
SCHEDULE II -VALUATION AND QUALIFYING ACCOUNTS
Balance at Beginning
of Year
Additions - Charged to
costs and expenses
Deductions
Balance at
End of Period
$
$
$
$
$
$
13,114 $
2,150 $
17,035 $
1,919 $
20,203 $
1,939 $
3,921 $
1,833 $
3,168 $
343 $
5,556 $
457 $
— $
(2,064) $
— $
(323) $
— $
(246) $
17,035
1,919
20,203
1,939
25,759
2,150
81
EXHIBITS
Exhibit
Number
2.2
2.3
2.4
3.1.1
3.1.2
3.2
10.1.3
10.1.6
Description of Exhibits
Stock 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.
Asset Purchase Agreement dated as of April 17, 2019 by and between
AngioDynamics, Inc. and Medline Industries Inc.
Asset Purchase Agreement dated as of June 8, 2023 by and between
AngioDynamics, Inc. and Merit Medical Systems, Inc.
Amended and Restated Certificate of Incorporation.
Certificate of Amendment to the Amended and Restated Certificate of
Incorporation of AngioDynamics, Inc.
Second Amended and Restated By-Laws, effective October 16, 2015.
AngioDynamics, Inc. 2004 Stock and Incentive Award Plan (as amended).
AngioDynamics 2017 Total Shareholder Return Performance Unit Agreement
Program.
Form
8-K
8-K
8-K
10-Q
10-K
8-K
DEF 14A
10-Q
Incorporated by Reference
Exhibit
2.1
Filing Date
October 12, 2012
2.1
2.4
3.1
3.1.2
10.1
10.1
April 18, 2019
June 14, 2023
October 7, 2005
August 10, 2015
October 21, 2015
August 30, 2018
September 29, 2017
10.1.7
AngioDynamics 2018 Total Shareholder Return Performance Unit Agreement
Program.
10-K
10.1.7
July 23, 2018
10.1.8
10.1.9
10.2
10.3
10.3.1
10.4.3
10.4.4
10.4.5
10.4.6
10.4.7
10.5
10.6
AngioDynamics 2019 Total Shareholder Return Performance Unit Agreement
Program.
AngioDynamics, Inc. 2020 Stock and Incentive Award Plan
AngioDynamics, Inc. Employee Stock Purchase Plan (as amended).
Form of Non-Statutory Stock Option Agreement pursuant to the AngioDynamics,
Inc. Stock and Incentive Award Plan.
Form of Non-Statutory Stock Option Agreement pursuant to the AngioDynamics,
Inc. Stock and Incentive Award Plan.
Form of 2016 Performance Share Award Agreement pursuant to the
AngioDynamics, Inc. 2004 Stock and Incentive Award Plan.
Form of 2017 Performance Share Award Agreement pursuant to the
AngioDynamics, Inc. 2004 Stock and Incentive Award Plan.
Form of 2018 Performance Share Award Agreement pursuant to the
AngioDynamics, Inc. 2004 Stock and Incentive Award Plan.
Form of 2020 Performance Share Award Agreement pursuant to the
AngioDynamics, Inc. 2004 Stock and Incentive Award Plan
Form of Performance Share Award Agreement pursuant to the 2020 Stock and
Incentive Award Plan
Form of Restricted Stock Award Agreement pursuant to the AngioDynamics, Inc.
2004 Stock and Incentive Award Plan.
Rita Medical Systems, Inc. 1994 Incentive Stock Plan.
10-Q
10.1.8
January 8, 2020
DEF 14A
DEF 14A
10-Q
10-K
10-Q
10-Q
10-K
10-Q
10-Q
8-K
S-1
September 3, 2020
September 3, 2020
October 12, 2004
July 23, 2018
October 5, 2016
September 29, 2017
July 23, 2018
January 8, 2021
10.1
10.3.1
10.2
10.2
10.4.5
10.4.6
10.4.7
September 30, 2021
10.3
10.2
May 12, 2005
May 3, 2000
82
Incorporated by Reference
Exhibit
Number
10.7
10.8
10.9
Description of Exhibits
Form
S-1
S-1/A
S-8
Exhibit
10.11
10.3
99.2
Filing Date
February 13, 1998
June 14, 2000
July 8, 2005
8-K
8-K
10.2
10.18
10.17
10.15
10.16
10.12
April 6, 2016
S-8
8-K
8-K
99.1
10.1
10.1
10.10
10.11
10.11.1
10.12.2
10.13
10.14
10.12.2
10.13
10.3
10-K
10-K/A
8-K
July 8, 2005
May 12, 2006
April 6, 2016
August 10, 2020
January 12, 2015
April 6, 2016
Horizon Medical Products, Inc. 1998 Stock Incentive Plan.
Rita Medical Systems, Inc. 2000 Stock Plan.
Rita Medical Systems, Inc. 2000 Directors’ Stock Plan, as amended on June 8,
2005.
Rita Medical Systems, Inc. 2005 Stock and Incentive Plan.
Form of Indemnification Agreement of AngioDynamics, Inc.
Employment Agreement, dated April 1, 2016, between AngioDynamics, Inc. and
James C. Clemmer.
Change in Control Agreement, dated April 1, 2016, between AngioDynamics, Inc.
and James C. Clemmer.
Form of Severance Agreement of AngioDynamics, Inc.
Form of Change in Control Agreement.
Performance Share Award Agreement, with a grant date of April 4, 2016, between
AngioDynamics, Inc. and James C. Clemmer.
AngioDynamics, Inc. Total Shareholder Return Performance Share Award
Program - Performance Period Ending July 2019.
Stock Option Award Agreement, with a grant date of April 4, 2016, between
AngioDynamics, Inc. and James C. Clemmer.
Restricted Stock Unit Award Agreement, with a grant date of April 4, 2016,
between AngioDynamics, Inc. and James C. Clemmer.
Separation Agreement and General Release, dated April 22, 2016, between
AngioDynamics, Inc. and Joseph M. DeVivo.
Amended and Restated Change in Control Agreement, by and between
AngioDynamics, Inc. and James C. Clemmer.
Form of Amended and Restated Change in Control Agreement with
AngioDynamics, Inc.
Code of Ethics.
Subsidiaries
Consent of Deloitte & Touche LLP, an independent registered public accounting firm.
Certification by the Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
Certification by the Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
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.
Certification 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.
101.INS
XBRL Instance Document
101.SCH XBRL Schema Document
101.CAL XBRL Calculation Linkbase Documents
101.DEF XBRL Taxonomy Extension Definition Linkbase Document
101.LAB XBRL Labels Linkbase Documents
101.PRE XBRL Presentation Linkbase Documents
14
21
23
31.1
31.2
32.1
February 3, 2021
February 3, 2021
October 1, 2021
April 27, 2016
April 6, 2016
April 6, 2016
April 6, 2016
10.19
10-K
10.2
10.2
32.2
10.4
10.6
10.1
10.5
10.1
8-K
8-K
8-K
8-K
8-K
14
83
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.
SIGNATURES
Date:
August 3, 2023
ANGIODYNAMICS, INC.
By:
/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:
August 3, 2023
Date:
August 3, 2023
Date:
August 3, 2023
Date:
August 3, 2023
Date:
August 3, 2023
Date:
August 3, 2023
Date:
August 3, 2023
Date:
August 3, 2023
Date:
August 3, 2023
Date:
August 3, 2023
/S/ HOWARD W. DONNELLY
Howard W. Donnelly,
Chairman of the Board, Director
/S/ JAMES C. CLEMMER
James C. Clemmer,
President, Chief Executive Officer
(Principal Executive Officer)
/S/ STEPHEN A. TROWBRIDGE
Stephen A. Trowbridge,
Executive Vice President, Chief Financial Officer,
(Principal Financial and Accounting Officer)
/S/ WESLEY E. JOHNSON, JR.
Wesley E. Johnson, Jr.,
Director
/S/ DENNIS S. METENY
Dennis S. Meteny,
Director
/S/ JAN S. REED
Jan S. Reed,
Director
/S/ EILEEN O. AUEN
Eileen O. Auen,
Director
/S/ KAREN A. LICITRA
Karen A. Licitra,
Director
/S/ MICHAEL E. TARNOFF
Michael E. Tarnoff,
Director
/S/ LORINDA A. BURGESS
Lorinda A. Burgess
Director
84
Subsidiaries of AngioDynamics, Inc.
Exhibit 21
Subsidiary
State of Incorporation or Organization
AngioDynamics UK Limited
AngioDynamics Netherlands B. V.
RITA Medical Systems, LLC
AngioDynamics France, SARL
AngioDynamics Canada Inc.
AngioDynamics Medical Brasil Servicos de Marketing Ltda.
RadiaDyne LLC
Eximo Medical, Ltd.
AngioDynamics VA LLC
United Kingdom
Netherlands
Delaware
France
Canada
Brazil
Texas
Israel
Delaware
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Exhibit 23
We consent to the incorporation by reference in Registration Statement Nos. 333-120057, 333-138456, 333-140627, 333-161355, 333-162844, 333-170619,
333-190640, 333-203441, 333-229814, 333-252209 and 333-269151 on Form S-8 of our reports dated August 3, 2023, relating to the financial statements of
AngioDynamics Inc. and the effectiveness of AngioDynamics Inc.'s internal control over financial reporting appearing in this Annual Report on Form 10-K
for the year ended May 31, 2023.
/s/ Deloitte & Touche LLP
Boston, Massachusetts
August 3, 2023
Exhibit 31.1
I, James C. Clemmer, certify that:
CERTIFICATION
1.
2.
3.
4.
(a)
(b)
(c)
(d)
5.
(a)
(b)
I have reviewed this annual report on Form 10-K of AngioDynamics, Inc.;
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this
report;
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the
financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in
Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-
15(f)) for the registrant and have:
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to
ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which this report is being prepared;
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, 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;
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent
fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially
affect, the registrant’s internal control over financial reporting; and
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to
the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably
likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control
over financial reporting.
Date: August 3, 2023
/ S / JAMES C. CLEMMER
James C. Clemmer, President,
Chief Executive Officer
Exhibit 31.2
I, Stephen A. Trowbridge, certify that:
CERTIFICATION
1.
2.
3.
4.
(a)
(b)
(c)
(d)
5.
(a)
(b)
I have reviewed this annual report on Form 10-K of AngioDynamics, Inc.;
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this
report;
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the
financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in
Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-
15(f)) for the registrant and have:
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to
ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which this report is being prepared;
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, 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;
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent
fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially
affect, the registrant’s internal control over financial reporting; and
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to
the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably
likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control
over financial reporting.
Date: August 3, 2023
/ S / STEPHEN A. TROWBRIDGE
Stephen A. Trowbridge, Executive Vice President,
Chief Financial Officer
CERTIFICATION OF CHIEF EXECUTIVE OFFICER PURSUANT TO TITLE 18,
UNITED STATES CODE, SECTION 1350, AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
Exhibit 32.1
I, James C. Clemmer, President, Chief Executive Officer and Director of ANGIODYNAMICS, Inc. (the “Company”), certify, pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002, 18 U.S.C. Section 1350, that, to the best of my knowledge:
1.
the annual report on Form 10-K of the Company for the fiscal year ended May 31, 2023 (the “Report”) fully complies with the requirements of
Section 13(a) or 15(d) of the Securities Exchange Act of 1934 (15 U.S.C. 78m or 78o(d)); and
2.
the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Date: August 3, 2023
/S/ JAMES C. CLEMMER
James C. Clemmer, President,
Chief Executive Officer
CERTIFICATION OF CHIEF FINANCIAL OFFICER PURSUANT TO TITLE 18,
UNITED STATES CODE, SECTION 1350, AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
Exhibit 32.2
I, Stephen A. Trowbridge, Chief Financial Officer of ANGIODYNAMICS, Inc. (the “Company”), certify, pursuant to Section 906 of the Sarbanes-Oxley Act
of 2002, 18 U.S.C. Section 1350, that, to the best of my knowledge:
1.
the annual report on Form 10-K of the Company for the fiscal year ended May 31, 2023 (the “Report”) fully complies with the requirements of
Section 13(a) or 15(d) of the Securities Exchange Act of 1934 (15 U.S.C. 78m or 78o(d)); and
2.
the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Date: August 3, 2023
/S/ STEPHEN A. TROWBRIDGE
Stephen A. Trowbridge, Executive Vice President,
Chief Financial Officer