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, 2025
OR
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from to
Commission file number 0-50761
AngioDynamics, Inc.
(Exact name of registrant as specified in its charter)
Delaware
11-3146460
(State or other jurisdiction of
incorporation or organization)
(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
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading Symbol
Name of each exchange on which registered
Common Stock, par value $.01 per share
ANGO
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
☐
Accelerated filer
☒
Non-accelerated filer
☐
Smaller reporting company
☐
Emerging growth company
☐
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under
Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. Yes ☒ No ☐
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error
to previously issued financial statements. ☐
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive
officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
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, 2024, 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 $245,095,250 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 July 16, 2025 there were 40,633,885 shares of the registrant’s common stock outstanding.
DOCUMENTS INCORPORATED BY REFERENCE
The information required for Part III of this Annual Report on Form 10-K is incorporated by reference to the registrant’s Proxy Statement for its 2025 Annual Meeting of Stockholders to be
filed within 120 days of the registrant's fiscal year ended May 31, 2025.
AngioDynamics, Inc. and Subsidiaries
INDEX
Page
Part I:
Item 1.
Business
2
Item 1A.
Risk Factors
15
Item 1B.
Unresolved Staff Comments
30
Item 1C.
Cyber Security
30
Item 2.
Properties
30
Item 3.
Legal Proceedings
31
Item 4.
Mine Safety Disclosures
31
Part II:
Item 5.
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity
32
Item 6.
[Reserved]
33
Item 7.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
34
Item 7A.
Quantitative and Qualitative Disclosures About Market Risk
44
Item 8.
Financial Statements and Supplementary Data
44
Item 9.
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
44
Item 9A.
Controls and Procedures
45
Item 9B.
Other Information
47
Item 9C.
Foreign Jurisdictions that Prevent Inspections
47
Part III:
Item 10.
Directors, Executive Officers and Corporate Governance
48
Item 11.
Executive Compensation
48
Item 12.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
48
Item 13.
Certain Relationships and Related Transactions, and Director Independence
48
Item 14.
Principal Accounting Fees and Services
48
Part IV:
Item 15.
Exhibits, Financial Statement Schedules
49
1
Part I
Unless otherwise indicated in this report, "AngioDynamics," the "Company," "we," "our" or "us" refers to AngioDynamics, Inc and our consolidated
subsidiaries.
Disclosure Regarding Forward-Looking Statements
This annual report on Form 10-K, including the sections entitled “Management’s Discussion and Analysis of Financial Condition and Results of
Operations,” contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements regarding
AngioDynamics' expected future financial position, results of operations, cash flows, business strategy, budgets, projected costs, capital expenditures,
products, competitive positions, growth opportunities, plans and objectives of management for future operations, as well as statements that include 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 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, tariffs, 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 dynamic, diversified medical technology company committed to expanding treatment options and improving patient outcomes and
quality of life by designing, manufacturing and selling products and technologies which aid clinicians in the treatment of patients with cardiovascular disease
and cancer diagnoses. Our execution strategy is built on innovative R&D, clinical and regulatory pathway expansion and customer centric sales
performance.
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.
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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 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, which the Company sold in June 2023 to Merit
Medical Systems, Inc. pursuant to an asset purchase agreement. 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.
On June 8, 2023, the Company completed the sale of the dialysis and BioSentry businesses to Merit Medical Systems, Inc. On February 15, 2024, the
Company completed the sale of its PICC and Midline businesses, which included the C3 Wave tip location asset, to Spectrum Vascular. As of February 29,
2024, the Company discontinued the RadioFrequency Ablation and Syntrax product lines.
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 and short pulse width to remove lesions while
preserving the vessel wall endothelium. Additionally, the Auryon system
features integrated aspiration which enhances the safety of the procedure.
Regardless of lesion type or location - whether above or below the knee -
the Auryon system provides safety, efficacy and versatility, supporting
femoral, pedal or radial access. 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 and the Uni-Fuse+ system. AngioDynamics offers a range of options when
treating thrombus and removing fresh, soft thrombi or emboli.
3
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.
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. The AlphaVac F18
system is indicated for the treatment of pulmonary embolism and allows for
the utilization in the non-surgical removal of thrombi or emboli from the
venous vasculature, reducing thrombus burden and improving right
ventricular function in patients with PE.
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.
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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. Full paralytic anesthesiology is required for safe IRE delivery.
In December 2024, the NanoKnife System received expanded FDA 510(k) clearance for the ablation of prostate tissue which broadens treatment
options for men and reinforces the system’s strong safety and efficacy profile.
Med Device
Peripheral Products (Interventional Devices)
We offer a comprehensive portfolio of products for use during minimally invasive procedures. Product categories include an extensive line of
angiographic catheters, guidewires, drainage catheters and micropuncture kits.
Angiographic Catheters & Guidewires
Our extensive line of various angiographic catheter configurations are designed to allow physicians to navigate and reach targeted anatomical locations
within a patient’s vasculature that are in need of angiographic diagnosis. Typically run over a diagnostic guidewire, our angiographic catheters allow
physicians to deliver contrast media to the desired location to determine the diagnosis and subsequent therapeutic modalities, as needed for the patient.
AngioDynamics offers three different angiographic catheter lines to meet physicians’ procedural needs. All of our catheters feature our soft, atraumatic,
super-radiopaque tip that is uniquely welded to our co-extruded nylon shaft, which provides excellent visibility under fluoroscopy and re-enforced tip
stability.
•
Soft-Vu Angiographic Catheters highlight the soft, atraumatic super-radiopaque and proprietary tip-to-shaft weld in a full offering of different tip
shapes, lengths and French sized flush and selective catheters. Flush catheters are used in procedures where a large volume of contrast is required to
deliver a concentrated bolus of contrast quickly for visualization or larger anatomical locations, such as the aorta or for run-offs into lower
extremities. Selective catheters are typically used to gain access to more specific vasculature within the body to deliver smaller amounts of contrast.
•
Mariner Hydrophilic Catheters also feature a hydrophilic coating on the distal 20cm of the catheter that reduces friction during catheter
advancement in the vasculature and allows for smooth navigation, as well as, optimum handling and control by the physician.
•
Accu-Vu Sizing Catheters are our line of flush catheters that also feature highly visible radiopaque marker bands, which are heat embedded, along
the catheter shaft, providing a smooth transition across the catheter shaft to ensure the marker bands will not separate from the shaft. These
radiopaque marker bands come in different patterns along the shaft and allow physicians, under fluoroscopy, to take measurements in different
anatomical locations for the placement of stents, IVC filters or other devices. The tight tolerances and consistent placement across the entire sizing
pattern, within +/-1mm of accuracy, provide a highly accurate measurement to the physician.
5
AngioDynamics offers a line of diagnostic and interventional guidewires which are designed to aid in delivering diagnostic and/or therapeutic devices
to the desired location.
•
The ADx Peripheral Vascular Guidewire line is AngioDynamics diagnostic line of guidewires that is available in a multitude of fixed core wire
configurations, including J-Tip and Bentson, in various lengths and outer diameters (OD). By utilizing a proprietary pre-coat process for the
Polytetrafluoroethylene (PTFE) and upholding tight specifications, our ADx Guidewires offer high quality and performance for physicians.
•
The NiT-Vu High Performance Micro Guidewires are our highly kink resistant nitinol shaft interventional wires that feature a highly visible
radiopaque tungsten tip and lubricious coating. The NiT-Vu wires are designed to reduce friction during wire advancement and also provides torque
control, flexibility and kink resistance.
Drainage Products
To aid physicians in percutaneous drainage procedures, AngioDynamics offers the Total Abscession Drainage Catheters. The Total Abscession
Drainage Catheter is available in Multipurpose/General and Biliary configurations, and also offers a Nephrostomy option. The portfolio offers options with a
radiopaque marker band at the distal tip to aid in placement.
•
The Total Abscession Drainage Catheter line offers a soft, kink resistant shaft that features the lubricious Blue Silk Finish for easier insertion and
pushability, while providing the optimal patient comfort. The unique Vault Locking Mechanism securely fixes the pigtail and prevents tampering or
accidental removal.
Micropuncture Kits
AngioDynamics offers physicians two micropuncture kit lines that are designed to start each procedure with ease and efficiency: Mini Stick MAX
Coaxial Microintroducer Kits and Micro-Introducer Kits. Each kit features a coaxial design with a 4F or 5F sheath introducer and stiff or standard dilator,
along with a 21G needle and various 0.018” access wire configurations.
•
Mini Stick MAX Coaxial Introducer kits contain a unique containment clip that keeps all the unique components of the kit together and organized.
The kit options include our AngioDynamics proprietary coaxial introducer with smooth transition at the tip, translucent 21G needle with bevel
indicator and 0.018” access wire available in three different wire material configurations.
•
The Micro-Introducer Kits offer a variety of configurations that aid in simplifying set up and gaining vascular access.
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:
•
SmartPort, SmartPort+, SmartPort Plastic: The SmartPort power-injectable port with Vortex technology offers the ability for a clinician to access a
vein for both the delivery of medications or fluids and for administering power-injected contrast to perform a CT scan. The ability to access a port
for power-injected contrast studies eliminates the need for additional needle sticks in the patient’s arm and wrist veins. Once implanted, repeated
access to the bloodstream can be accomplished with greater ease and less discomfort. Our SmartPort port line is available in standard, mini and
low-profile 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.
•
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, PASV and non-PASV valve technology and the ability to
administer contrast through a CT injection for purposes of imaging. The BioFlo port family is available in single or dual lumen configurations.
•
Xcela Plus: The Xcela Plus Port product family is Power-Injectable and part of a complete portfolio of vascular access products, and is fully
compatible with the LifeGuard Safety Infusion product family. It has easily identifiable critical information radiopaque “CT” lettering which helps
to confirm if port is power-injectable or flipped. The Xcela Plus port family is available in single lumen standard size in either a non-valved or
valved configuration.
6
Port Technologies
•
BioFlo Endexo: 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.
•
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.
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.
NeverTouch and NeverTouch Direct gold-tip laser fibers, is an integral part of AngioDynamics’ advanced varicose vein treatment and establishes a
new standard for patient comfort, visibility and ease of use. The innovation behind the NeverTouch tip is a glass weld at the distal tip. This glass weld tip
technology has less focal charring of the vein wall versus a bar-tip fiber. The NeverTouch procedure kit is available in 25cm, 45cm, 65cm, and 90cm lengths.
It is also available with an .018” access system, which eliminates the need for a 5F micro-access sheath and the need to exchange wires and size up, resulting
in few procedure steps, and may result in faster procedure time.
The 400 Micron Perforator & Accessory Vein Ablation kit (PVAK) is an AngioDynamics VenaCure EVLT endovenous laser vein treatment offering
that provides patients a minimally-invasive choice for treating the source of their varicose veins. The PVAK kit may also provide patients a potentially
quicker recovery and return to normal daily routines, as compared to surgical stripping. The PVAK kit allows for simple access and accurate positioning. The
smaller fiber aids in access and positioning for deep and saphenous veins. The 21G venous access needle ensures easy, atraumatic access and the .018”
guidewire navigates small, tortuous veins with a floppy tip and has a firm anchor to guide the sheath and hold it in place.
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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 patented dipole array and ceramic tip tuning
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. It is designed for open, laparoscopic and
percutaneous ablation of soft tissue masses.
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.
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.
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 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; Stryker Corporation; Penumbra, Inc.; Varian
Medical Systems; Abbott Laboratories and Total Vein Systems.
8
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 leased 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
•
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.
AngioDynamics entered into a supply agreement with Biomerics (previously Precision Concepts) in Alajuela, Costa Rica. Biomerics 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
other third party manufacturers for the manufacturing of certain products.
On January 5, 2024, the Company announced a restructuring to optimize its manufacturing efficiency, capabilities and footprint (the "Plan"). In the
second quarter of fiscal year 2025, the Company announced a modification to the Plan to maintain a presence in Queensbury, NY for the manufacturing of
select products, customer service, logistics, shipping, quality and regulatory operations. The restructuring activities associated with the modified Plan are
still expected to be completed in the third quarter of fiscal year 2026.
BACKLOG
We seek to maintain sufficient inventory on hand to ship product within 24-48 hours of order receipt to meet customer demand, and accordingly our
backlog is not significant. As we shift additional manufacturing to Costa Rica and/or other manufacturing partners, we have built sufficient safety stock to
reduce the risk of backlog during the transition.
9
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 (preamendment device); or (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. After a device receives 510(k) clearance, any modification that could significantly affect its safety or
effectiveness, or that would constitute a major change in its intended use, requires a new 510(k) clearance. The 510(k) clearance procedure including
questions and responses may take up to 12 months. In some cases, supporting clinical data may be required. The FDA may determine that a new or modified
device is not substantially equivalent to a predicate device or may require that additional information, including clinical data, be submitted before a
determination is made, either of which could significantly delay the introduction of 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 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.
10
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 most countries. The regulatory review process varies 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 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. All legacy devices have achieved the MDR CE Mark.
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
11
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 EU member country is subject to evolving regulation by the EU Medical Device Regulations, notified bodies and
comparable nation-specific bodies whether part of the EU or not, 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. Members of our healthcare economics team work 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.
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.
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EMPLOYEES
As of May 31, 2025, we had approximately 675 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 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.
Executive Officers of the Company
The following table sets forth certain information with respect to our executive officers.
Name
Age
Position
James C. Clemmer
60
President and Chief Executive Officer
Stephen A. Trowbridge
50
Executive Vice President and Chief Financial Officer
Lawrence T. Weiss
56
Senior Vice President, Chief Legal Officer & Corporate Secretary
Chad T. Campbell
54
Senior Vice President and General Manager, Oncology and Interventional Devices
Laura Piccinini
55
Senior Vice President and General Manager, Cardiovascular and International
Warren G. Nighan
56
Senior Vice President, Global Supply Chain, Quality and Regulatory Affairs
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 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
manages the Legal function. 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.
Lawrence T. Weiss was appointed Senior Vice President, Chief Legal Officer and Corporate Secretary in December 2024. Prior to joining
AngioDynamics, Mr. Weiss served as Executive Vice President and Chief Legal Officer of Butterfly Network, Inc., overseeing legal, compliance, quality
and regulatory functions. Prior roles include Chief Legal Officer of Emulate, Inc., and Senior Vice President, General Counsel, and Corporate Secretary for
Analog Devices, Inc. Mr. Weiss' career includes leadership positions at Medtronic, Covidien, and Tyco Healthcare, where he managed international legal
matters, mergers and acquisitions, intellectual property litigation, and global compliance initiatives. He began his career in the Corporate department of
Goodwin Procter & Hoar in Boston. Mr. Weiss holds a Juris Doctor from Boston University and a Bachelor’s degree from Tulane University. He serves on
the Boards of Directors for Greater Boston Legal Services and the Northeast Chapter of the Association for Corporate Counsel.
Chad T. Campbell joined AngioDynamics in May 2016 as the Senior Vice President and General Manager for Vascular Access (now Interventional
Devices). As of October 2021, Mr. Campbell assumed responsibility of the Oncology Global
13
Business Unit in addition to his role of General Manager for Vascular Access. In his role, Mr. Campbell oversees 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.
Laura Piccinini was appointed Senior Vice President and General Manager for Endovascular Therapies (now Cardiovascular) and International in
January 2024, after serving as Senior Vice President and General Manager for International since joining AngioDynamics 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.
Warren G. Nighan was appointed Senior Vice President, Global Supply Chain, Quality and Regulatory Affairs in March 2024, after serving as Senior
Vice President of Quality and Regulatory Affairs since joining AngioDynamics in April 2017. Before joining AngioDynamics, Mr. Nighan was a quality and
regulatory consultant to clients in FDA-regulated industries, specializing in execution and management of quality systems implementation and remediation.
Previously, Mr. Nighan served as the Executive Vice President of Global Clinical, Quality Affairs and Regulatory Affairs at Haemonetics Corporation, Vice
President of Quality/Regulatory/Clinical/Technical Services at St. Jude Medical’s Atrial Fibrillation Division, and Corporate Vice President of
Quality/Compliance at Tyco Healthcare/Covidien (Medtronic). Mr. Nighan earned a Bachelor and Master of Science in Nursing from Northeastern
University’s Bouvé College of Health Sciences.
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 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.
14
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 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.
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
15
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.
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 Ambition BTK clinical
study. 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 current Good Clinical Practices. The clinical trials are subject to oversight by the FDA, regulatory agencies in other jurisdictions, ethics
committees and institutional review boards at the medical institutions where the clinical trials are conducted. Clinical trial protocols may require a large
number of patients to be enrolled in the trials. Patient enrollment is a function of many factors, including the size of the patient population for the target
indication, the proximity of patients to clinical sites, the eligibility criteria for the trial, the existence of competing clinical trials and the availability of
alternative or new treatments. Clinical trials may be suspended by the FDA or by a regulatory agency in another jurisdiction at any time if the FDA or the
regulatory agency finds deficiencies in the conduct of these trials or it is believed that these trials expose patients to unacceptable health risks.
We, the FDA or regulatory agencies in other jurisdictions might delay or terminate our clinical trials for various reasons, including insufficient patient
enrollment, fatalities, unforeseen adverse side effects by enrolled patients or the development of new therapies that require us to revise or amend our clinical
trial protocols. Patients may be discouraged from enrolling in our clinical trials if the trial protocol requires them to undergo extensive follow-up to assess
safety and effectiveness, if they
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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.
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 historically have purchased and may purchase in the future 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 rely on third-party manufacturers to manufacture some of our products today, and we have announced a plan to move to a partially outsourced
model for manufacturing in various parts of the world, which exposes us to additional risks, including reduced control over manufacturing, delivery
timing, product quality issues, potential price fluctuations, regulatory, environmental, labor or other operational disruptions, which would result in a
loss of revenue or reduced profitability.
We currently rely on third-party manufacturers for a portion of our products. We also announced a plan to transfer certain product manufacturing
processes from Queensbury, NY to third-party manufacturers located in various parts of the world, including, but not limited to the United States, Costa
Rica, Latvia, Italy, Israel and China. The restructuring activities associated with this plan are expected to be completed in the third quarter of fiscal year
2026. If we are unable to effectively execute on this plan within the announced timeline it could have a material adverse effect on our business, financial
condition and/or results of operations.
Our manufacturing strategy may present certain 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, but not limited to:
•
the ability to effectively negotiate and enter into contracts with third party manufacturers;
•
if market demand for our products is less than our purchase obligations to our manufacturers, we may incur substantial penalties and substantial
inventory write-offs;
•
manufacturers of our products are subject to ongoing periodic inspections by the FDA and other regulatory authorities for compliance with strictly
enforced good manufacturing practices regulations and similar foreign standards, and we do not have control over our third-party manufacturers’
compliance with these regulations and standards;
•
we may have to share intellectual property rights, including any improvements in the manufacturing processes or new manufacturing processes for
our products;
•
our product costs may increase if our manufacturers pass their increasing costs onto us;
•
if our agreement with a third-party manufacturer expires, we may not be able to renegotiate a new agreement with that manufacturer on favorable
terms, if at all. If we cannot successfully complete such renegotiation, we may not be able to locate any necessary acceptable replacement
manufacturers or enter into favorable agreements with such replacement manufacturers in a timely manner, if at all; and
•
manufacturing could be curtailed or partially or completely shut down as the result of a number of circumstances, most of which are outside of our
control, such as unscheduled maintenance, an earthquake, hurricane, flood, tsunami or other natural disaster, significant labor strikes or work
stoppages, government implementation of export limitations or freezes, political unrest or pandemics.
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In addition, our business practices in international markets are subject to the requirements of the U.S. Foreign Corrupt Practices Act of 1977, as
amended, any violation of which could subject us to significant fines, criminal sanctions and other penalties. We expect all of our contracted manufacturing
facilities, to comply with all applicable laws, including labor, safety and environmental laws, and to otherwise meet our standards of conduct. Our ability to
find manufacturing facilities that uphold these standards is a challenge, especially with respect to facilities located outside the United States. We also are
subject to the risk that one or more of these manufacturing facilities will engage in business practices in violation of our standards or applicable laws, which
could damage our reputation, hurt our relationship with our customers and result in negative publicity, damage to our brand and a material and adverse effect
on our business, financial condition, results of operations and/or liquidity.
Recent changes in trade policy, treaties, government regulations and tariffs have created significant uncertainty about the future relationship between the
U.S. and various other countries where we have employees, customers, suppliers and operations. Changes in policy regarding international trade, including
import and export regulation and international trade agreements, could negatively impact our business. The implementation of new tariffs on imports from
Canada, Mexico, China or other countries for an extended period and without specific exemptions for our products, and any reciprocal tariffs or other
reactions by other countries thereto, could have a material adverse impact on our financial condition, results of operations and cash flows.
A portion of our component sourcing, supply chain and manufacturing activities are conducted in or partially sourced from China. As a result, our
business, financial condition, results of operations could be affected significantly by economic, political and legal developments in China as well as trade
disputes between China and the United States and the potential imposition of bilateral tariffs. The imposition of tariffs or export restrictions on products
imported by us from China could require us to (i) increase prices to our customers or (ii) locate suitable alternative manufacturing capacity or relocate our
operations from China to other countries. In the event we are unable to increase our prices or find alternative manufacturing capacity or relocate to an
alternative base of operation outside of China on favorable terms, we would likely experience higher manufacturing costs and lower gross margins, which
could have an adverse effect on our business and results of operations. The Chinese economy differs from the economies of most developed countries in
many respects, including the degree of government involvement, the level of development, the growth rate, the control of foreign exchange, access to
financing and the allocation of resources.
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, 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 74% of international revenues for the fiscal year ended May 31, 2025. International sales decreased 21% in fiscal year 2025 partially due to
the sale of the PICCs, Midline, dialysis and BioSentry businesses, along with the discontinuation of the RadioFrequency Ablation product line. 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.
We face currency and other risks associated with international sales.
We generate revenue from international sales which could expose us to risks including fluctuations in currency values, trade restrictions, tariff and trade
regulations, U.S. export controls, U.S. and non‑U.S. tax laws, shipping delays and economic and political instability, which could have a material adverse
effect on our business, results of operations, financial conditions and cash flows.
If we are unable to convince customers that our products can improve the cost structure of their business, or to secure adequate reimbursement for our
products our revenue growth and profitability may be materially and adversely impacted.
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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. 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. 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. 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.
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.
Pending or future product liability claims brought against us, especially if our product liability insurance coverage is inadequate, could adversely impact
our business, operations and financial results.
The design, manufacture and marketing of the types of medical devices we sell entail an inherent risk of product liability. Our products are used by
physicians to treat seriously ill patients. We are periodically subject to product liability claims, and patients or customers may in the future bring claims
against us in a number of circumstances and for a number of reasons, including if our products were misused, if a component of our product fails, if 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. For example, numerous product liability claims involving the Company's port products
which were previously pending in various state and federal court jurisdictions have been consolidated, together with additional product liability claims, in a
single multidistrict litigation in the U.S. District Court for the Southern District of California. We are unable to predict the outcome of these proceedings. See
Part I, Item 3 "Legal Proceedings" in this Annual Report on Form 10-K for additional information on these proceedings.
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In addition, individuals or groups seeking to represent a class may file suit against us in the future. Legal proceedings in general, class actions,
multidistrict litigation, governmental investigations and actions in particular, can be expensive and disruptive, and adverse publicity could harm our
reputation, regardless of validity of the allegations. The outcome of litigation, particularly class action and multidistrict litigation, 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.
The Company's recent divestitures of its PICCs and Midline businesses to Spectrum Vascular and dialysis product portfolio and BioSentry tract sealant
system biopsy business to Merit Medical Systems, Inc., 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 which may cause disruptions to our financial
controls, IT, administrative support, manufacturing or regulatory processes and 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, fluctuations in currency values, U.S. export controls, U.S. and non-U.S. tax laws, shipping
delays and economic and political instability, 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. 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.
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
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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 14% of our net sales during our fiscal year ended May 31, 2025. 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;
•
multiple non-U.S. regulatory requirements that are subject to change and could restrict our ability to manufacture and sell our products;
•
local product preferences and product requirements;
•
longer-term receivables than are typical in the U.S. and/or the ability to obtain payment;
•
trade protection measures, tariffs 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, tariffs, recession or interest rate fluctuations.
Geopolitical developments related to various global conflicts are sources of uncertainty and may cause disruptions to global or regional markets, supply
chains or operations in the regions. Russia’s invasion and military attacks on Ukraine have triggered significant sanctions from U.S. and European leaders.
The Israel/Hamas war has also disrupted operations of companies doing business in the Middle East. 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 and Israel, 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, Israel 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 global conflicts continue 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.
Further, trade disputes or tensions may adversely affect our sales, including as a result of the imposition of tariffs or other barriers or restrictions on
trade, or increase our costs. The institution of trade tariffs both globally and between the U.S. and China specifically could negatively impact the overall
economic condition in our markets, including China, which could pose a significant risk to our business and would affect our revenue and cost of goods sold.
The extent, focus and duration of any such tariffs and the resulting impact on general economic conditions and on our business are uncertain and depend on
various factors, such as negotiations between the U.S. and affected countries, the responses of other countries or regions, exemptions or exclusions that may
be granted, availability and cost of alternative sources of supply, and demand for our products in affected markets. Further, actions we take to adapt to new
tariffs or trade restrictions may cause us to modify our operations or forgo business opportunities, which could have a material adverse impact 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. 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.
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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 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 backlog we experienced in fiscal year 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 indebtedness which 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 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 indebtedness or draw amounts on 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, 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 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 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, a
rapid increase in inflation levels may negatively impact demand for our products and increase our costs and may lead to a rapid increase in market interest
rates. In addition, if rates increase, we may incur significant additional expense and adversely impact our ability to achieve our other strategic goals and
business plans.
Our intangible assets and fixed assets are subject to potential impairment; we have historically recorded significant impairment charges and may be
required to record additional charges to future earnings if our assets become impaired.
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A significant portion of our assets consist of 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.
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 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 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. If actual results differ from the assumptions and estimates used
in the 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, 2025 after considering IRC Section 382 limitations are $135.6 million. The expiration of the Federal
net operating loss carryforwards is as follows: $37.1 million between 2030 and 2032 and $98.5 million indefinitely. Our state net operating loss
carryforwards as of May 31, 2025 after considering remaining IRC Section 382 limitations are $23.9 million which expire in various years from 2030 to
2043. 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 9, "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, 2025 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 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.
Artificial intelligence based platforms present new risks and challenges to our business.
Artificial intelligence, or AI, based platforms are increasingly being used in the medical device and consumer health industries. We are committed to
providing a safe and secure environment for all of our personnel, our business partners and our
23
customers, including the responsible use of AI chatbots and generative AI data processor products (“AI Systems”). We have developed policies governing
the use of AI Systems to help reasonably ensure that such AI Systems are used in a trustworthy manner by our employees, contractors and authorized agents
and that AngioDynamics’ assets, including intellectual property, competitive information, personal information and customer information, are protected. The
failure by our personnel to adhere to the company’s established policies could violate confidentiality obligations or applicable laws and regulations,
jeopardize our intellectual property rights, cause or contribute to unlawful discrimination or result in the misuse of personally identifiable information or the
injection of malware into the company’s systems, any of which could have a material adverse effect on our business, results of operations and financial
condition.
The use of AI Systems by our business partners with access to our confidential information, including trade secrets, may continue to increase and could
lead to the release of such information, which could negatively impact our company, including our ability to realize the benefits of our intellectual property.
The use of AI Systems by our business partners may lead to novel and urgent cybersecurity risks, which could have a material adverse effect on our
operations and reputation as well as the operations of any of our business partners. We may also face increased competition from other companies that are
using AI Systems, some of whom may develop more effective methods than we and any of our business partners have, which could have a material adverse
effect on our business, results of operations and financial condition. In addition, uncertainties regarding developing legal and regulatory requirements and
standards may require significant resources to modify and maintain business practices to comply with U.S. and non-U.S. laws concerning the use of AI and
AI Systems, the nature of which cannot be determined at this time.
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.
Global health crises, pandemics, epidemics or other outbreaks could adversely impact our business, operations and financial results.
We are subject to risks associated with global health crises, pandemics, epidemics or other outbreaks beyond our control which could adversely affect
our business, operations and financial results. Such risks 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. For example, impacts from the COVID-19 pandemic
and measures taken in response thereto, such as constraints in the capacities of hospitals and other healthcare providers to perform non-COVID related
procedures, changes to our on-site operations, delays in product development efforts and related clinical trials and regulatory clearances and approvals, and
disruptions to global supply chains and labor markets, resulting in cost inflation and raw material supply constraints, adversely affected our business and
there can be no assurance that similar events will not occur in the future.
24
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 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.
25
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 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.
We have obtained Medical Device Regulation ("MDR") approvals for our principal products sold in the European Union ("EU") ahead of expiration
dates. Maintaining MDR approval requires annual random sampling of CE marked products including ensuring new and updated test standards are achieved,
post-market clinical data is collected and product performance expectations are achieved as demonstrated through post-market surveillance. For multiple
reasons, including but not limited to changing business strategies, labor shortages and contract resources, administrative delays, increased costs of obtaining
MDR certification and availability of necessary data, certain products will not continue to be CE marked under MDR. The additional time and resources
required to obtain MDR certification was a significant factor in, and the diligence required to maintain the CE mark under MDR 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.
26
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.
Medical devices are cleared or approved for one or more specific intended uses and promoting a device for an off-label use could result in government
enforcement action. If the FDA determines that our promotional materials, sales techniques, pricing programs or training constitutes promotion of an off-
label use or encourages over-utilization of our products or use of our products in combinations that are not indicated or appropriate, the FDA could request
that we modify materials, techniques, programs or training or subject us to 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, including the U.S. Department of
Justice ("DOJ"), might take similar actions, 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
certain countries, our revenue could be impacted.
The U.S. Department of the Treasury’s Office of Foreign Assets Control (OFAC), and the Bureau of Industry and Security at the U.S. Department of
Commerce (BIS), administer certain laws and regulations that restrict U.S. persons and, in some instances, non-U.S. persons, in conducting activities,
transacting business with or making investments in certain countries, governments, entities and individuals subject to U.S. economic sanctions.
Due to our international operations, we are subject to such laws and regulations, which are complex, restrict our business dealings with certain
countries and individuals, and are constantly changing. Further restrictions may be enacted, amended, enforced or interpreted in a manner that materially
impacts our operations.
In fiscal year 2025 we generated $0.6 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.
We have limited business dealings in certain other countries that are or may become 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
27
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 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;
28
•
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 1C. Cyber Security.
Risk Management and Strategy
We have designed and implemented a cybersecurity risk management program to help us identify, assess, and mitigate cybersecurity risks relevant to
our business, based on the National Institute of Standards and Technology (NIST) Cyber Security Framework 2.0.
Our cybersecurity risk management program includes:
•
dedicated third-party cybersecurity professionals who analyze cybersecurity threats, define cybersecurity policy and requirements, implement
protections, and monitor and respond to cybersecurity incidents;
•
cybersecurity regulatory based risk assessments for the Company’s systems and applications (where required);
•
a formal incident response plan, in which incidents are classified based upon the severity, impact, and the potential harm that can be caused by the
incident;
•
annual information security training program for all employees, including phishing awareness training;
•
working closely with application development and infrastructure & operation teams to embed security considerations into the foundation of
technology;
•
engagement of third-party service providers to conduct assessment of the Company’s cybersecurity risk management program, penetration testing,
and vulnerability testing; and
•
a third-party risk assessment process for service providers, suppliers, and vendors.
Risks from cybersecurity threats are integrated into AngioDynamics' enterprise risk management (ERM) program. The ERM program establishes a risk
management framework that seeks to identify, assess, and mitigate risks that could materially impact the Company’s business and operation.
To date, the Company is not aware of any cybersecurity incident that has had or is reasonably likely to have a material impact on the Company’s
business or operations. However, despite our security measures, there can be no assurance that the Company, or the third parties with which we interact, will
not experience a cybersecurity incident in the future that may materially affect us. See Item 1A. Risk Factors under, 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.
Governance
The cybersecurity risk management program is led by the Senior Vice President, Information Technology ("SVP of IT"). Our SVP of IT has over 28
years of experience assisting public and privately held companies in a variety of industries, leading several enterprise-wide transformation initiatives to adapt
to changing cybersecurity threats. Our SVP of IT reports to the Chief Executive Officer (CEO), who works closely with the Executive Committee to guide
strategic direction and IT decisions to drive business outcomes. Our SVP of IT also leads the Security & Risk Governance committee which provides
general oversight and assists in the Cybersecurity program when appropriate.
Our Board of Directors is engaged in the Company’s ERM program and receives briefings on the outcomes of the ERM program and the steps the
Company takes to mitigate risks that the program identifies. The Board oversees the Company’s cybersecurity strategies, systems, and controls to ensure
reliability and prevent unauthorized access. The Audit Committee discusses policies with respect to risk assessment and risk management, including risks
associated with the reliability and security of the Company’s information technology and security systems, and the steps management has undertaken to
monitor and control such exposures. The Board of Directors receives regular updates on the Company’s cybersecurity risk management program from the
SVP of IT.
Item 2. Properties.
During the year ended May 31, 2025, we operated in the following locations:
30
Location
Purpose
Approx.
Sq. Ft.
Property
Type
Latham, NY
Corporate headquarters
39,000
Lease
Glens Falls, NY
Manufacturing
21,000
Lease
Queensbury, NY
Manufacturing
135,000
Lease
Queensbury, NY
Distribution
58,000
Lease
Marlborough, MA
Research and development
8,400
Lease
Rehovot, IL
Research and development
4,300
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.
31
Part II
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
Market.
Sale Price
High
Low
Year ended May 31, 2025
Fourth Quarter
$
10.86
$
8.37
Third Quarter
$
12.94
$
7.00
Second Quarter
$
7.78
$
5.88
First Quarter
$
7.84
$
5.51
Sale Price
High
Low
Year ended May 31, 2024
Fourth Quarter
$
7.03
$
5.27
Third Quarter
$
8.04
$
5.49
Second Quarter
$
7.73
$
6.17
First Quarter
$
11.16
$
8.00
As of July 15, 2025, there were 163 holders of record of our common stock.
Dividends
We did not declare any cash dividends on our common stock during our last three fiscal years. We do not anticipate paying any cash dividends on our
common stock for the foreseeable future.
Performance Graph
The graph below matches AngioDynamics, Inc.’s cumulative 5-year total shareholder return on common stock with the cumulative total returns of the
NASDAQ Composite index, the RDG SmallCap Medical Devices index, and the S&P 500 Health Care 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, 2020 to May 31, 2025. The stock price
performance included in this graph is not necessarily indicative of future stock price performance.
32
Item 6. [Reserved]
33
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 dynamic, diversified medical technology company committed to expanding treatment options and improving patient outcomes
and quality of life by focusing on cardiovascular disease and cancer. Our execution strategy is built on innovative R&D, clinical and regulatory pathway
expansion and customer centric sales performance. 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. mainly through 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 current macroeconomic environment continues to impact our business and may continue to pose future risks. The Company's ability to
manufacture products, the reliability of our supply chain, labor shortages, backlog, inflation (including the cost and availability of raw materials, direct labor
and shipping) and tariffs 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.
On January 5, 2024, the Company announced a restructuring to optimize its manufacturing efficiency, capabilities and footprint (the "Plan"). In the
second quarter of fiscal year 2025, the Company announced a modification to the Plan to maintain a presence in Queensbury, NY for the manufacturing of
select products, customer service, logistics, shipping, quality and regulatory operations. The restructuring activities associated with the modified Plan are
still expected to be completed in the third quarter of fiscal year 2026. The modified Plan is still expected to generate $15.0 million in annual cost savings
starting in fiscal year 2027.
On July 16, 2024, the Board of Directors approved a share repurchase program (the "Repurchase Program") under which they authorized the Company
the option to repurchase up to $15.0 million of its outstanding common stock. The timing and amount of any share repurchases under the authorization will
be determined by management within certain parameters and based on market conditions and other considerations. During the year ended May 31, 2025, the
Company repurchased 243,847 shares of common stock in the open market at an aggregate cost of $1.7 million under the Repurchase Program. As of
May 31, 2025, $13.3 million remained available for repurchase under the Repurchase Program.
On December 24, 2024, the Company entered into an agreement to sell the manufacturing facilities in Queensbury, NY and Glens Falls, NY for a
purchase price of $5.5 million and $1.2 million, respectively, and net proceeds of $5.2 million and
34
$1.1 million, respectively. The Company simultaneously entered into lease agreements with future lease payments of $4.6 million over seven years for the
Queensbury, NY facility and $0.4 million over three years for the Glens Falls, NY facility.
On May 28, 2025, the Company entered into a new Credit Agreement (the “Credit Agreement”) with JPMorgan Chase Bank, N.A. The Credit
Agreement has a two-year maturity and provides for a $25.0 million secured revolving credit facility (the "Revolving Facility"), which is subject to a
borrowing base comprised of certain working capital assets of the Company. As of May 31, 2025, there is no outstanding balance on the Revolving Facility.
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, 2025 compared to the year ended May 31, 2024 follows:
Year ended May 31, 2025:
•
Revenue decreased by 3.8% to $292.5 million
•
Med Tech growth of 19.0% and Med Device declined by 16.0%
•
Gross margin increased by 300 bps to 53.9%
•
Net loss decreased by $150.4 million to $34.0 million
•
Loss per share decreased by $3.76 to a loss of $0.83
•
Cash flow from operations increased by $18.0 million resulting in cash used in operations of $10.1 million
For the year ended May 31, 2025, the decrease in revenue is due to the divestiture of the PICCs, Midline, dialysis and BioSentry businesses, along with
the discontinuation of the RadioFrequency Ablation and Syntrax product lines, the total of which impacted sales by $33.4 million compared to the year
ended May 31, 2024. Our Med Tech business, comprised of Auryon, the thrombus management platform and NanoKnife grew 19.0% in fiscal year 2025
was driven by growth in growth in Auryon and the thrombus management platform, while Nanoknife sales remained consistent year over year. Our Med
Device business decreased 16.0% in fiscal year 2025 driven mainly by the divestiture of the PICCs, Midlines, dialysis and BioSentry businesses along with
the discontinuation of the RadioFrequency Ablation product lines.
Strategic Initiatives to Drive Growth
The Company is focused on its Med Tech segment which is committed to expanding treatment options and improving patient outcomes and quality of
life by focusing on cardiovascular disease and cancer. Our execution strategy is built on innovative R&D, clinical and regulatory pathway expansion and
customer centric sales performance. Our investments in our high technology products including Auryon, Mechanical Thrombectomy (which includes
AngioVac and AlphaVac) and NanoKnife, will provide us access to larger and faster growing markets.
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:
•
Innovative R&D and Clinical and Regulatory Pathway Expansion. The Company continued its disciplined product development process which is
intended to improve the Company’s ability to bring new products to market and achieve clinical and regulatory pathway expansion. The Company:
◦
Received CE mark approval in Europe for Auryon;
◦
Received CPT Category I Codes for Irreversible Electroporation (IRE), the primary method of action for the NanoKnife System, for the
treatment of lesions in the prostate and liver, effective January 2026;
◦
Received FDA 510(k) clearance for NanoKnife Prostate Tissue Ablation;
◦
Received CPT Category I Codes for Irreversible Electroporation (IRE), the primary method of action for the NanoKnife System, for the
treatment of the pancreas, effective January 2027;
◦
Published APEX-AV trial results in the Journal of the Society for Cardiovascular Angiography & Interventions demonstrating the safety
and efficacy of the AlphaVac F1885 System;
◦
Initiated RECOVER-AV Clinical Trial in Europe for AlphaVac; and
◦
Initiated the AMBITION BTK RCT and Registry to generate definitive clinical evidence supporting the use of the Auryon Atherectomy
System in treating below the knee lesions in patients with critical limb ischemia.
•
Customer Centric Sales Performance. To create value and drive future growth, the Company is focused on ensuring that the sales team is
appropriately trained on how to market the products to our customers and that our customers are receiving the appropriate training and exposure to
our products. This included:
◦
Continued focus on training of the sales teams; and
35
◦
Conducted targeted physician trainings and symposiums both in the U.S. and internationally throughout the year.
•
Focused Resource Deployment. The Company continued its discipline on deploying resources. This included:
◦
The announcement to restructure the manufacturing footprint, which includes maintaining a presence in Queensbury, NY for select
products, customer service, logistics, shipping, quality and regulatory operations, and shifting all other products to an outsourced model
utilizing third-party manufacturers to allow the Company to more effectively compete in chosen markets and fundamentally change its
corporate gross margin profile. The restructuring activities are expected to be completed in the third quarter of fiscal year 2026 and are
expected to generate $15.0 million in annual cost savings starting in fiscal year 2027.
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 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 Company expects to receive in exchange for those goods or services. To determine revenue recognition for
arrangements, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the
contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue
when (or as) the entity satisfies a performance obligation.
The Company contracts with its customers based on customer purchase orders, which in 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 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 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 disposable revenue and lease revenue due to the insignificant value of the units in relation to the total
agreement value.
36
Sales, value add, and other taxes collected on behalf of third parties are excluded from revenue.
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, product returns, rebates and allowances that are offered within contracts between the Company and its
customers.
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. Discounts
and product returns are based on amounts earned or to be claimed on the related sales and are classified as a contra asset. During the years ended May 31,
2025, 2024 and 2023, such product returns were not material. 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 liabilities" 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.
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 as deferred revenue
in "Accrued liabilities" 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.
Intangible Assets
Intangible assets 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. 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.
Results of Operations for the years ended May 31, 2025 and 2024
For the fiscal year ended May 31, 2025, the Company reported a net loss of $34.0 million, or a loss of $0.83 per diluted share, on net sales of $292.5
million compared to a net loss of $184.3 million, or a loss of $4.59 per diluted share, on net sales of $303.9 million in fiscal year 2024.
Net Sales
Net sales - Net sales are derived from the sale of our products and related freight charges, less discounts, rebates and returns.
37
Year ended May 31,
(in thousands)
2025
2024
$ Change
Net Sales
Med Tech
$
126,653
$
106,403
$
20,250
Med Device
165,845
197,511
$
(31,666)
Total
$
292,498
$
303,914
$
(11,416)
Net Sales by Geography
United States
$
250,983
$
251,486
$
(503)
International
41,515
52,428
$
(10,913)
Total
$
292,498
$
303,914
$
(11,416)
For the year ended May 31, 2025, net sales decreased $11.4 million to $292.5 million compared to the year ended May 31, 2024. At May 31, 2025, the
Company had a backlog of $0.3 million compared to $1.3 million at the end of May 31, 2024.
The Med Tech business net sales increased $20.3 million for the year ended May 31, 2025 compared to the prior year. The change in sales from the prior
year was primarily driven by:
•
Increased Auryon sales of $9.8 million;
•
Decreased sales of Syntrax of $0.4 million due to the discontinuation of this product line as of February 29, 2024;
•
Increased sales of the thrombus management platform of $10.9 million, which was driven by increases in AngioVac, AlphaVac and thrombolytic
sales of $5.8 million, $4.0 million and $1.1 million, respectively; and
•
NanoKnife sales remained consistent year over year, and was comprised of increased NanoKnife disposable sales of $1.7 million offset by
decreased capital sales of $1.7 million.
The Med Device business net sales decreased $31.7 million for the year ended May 31, 2025 compared to the prior year. The backlog, which primarily
impacted sales of Core and Vascular Access products, was $0.3 million at May 31, 2025 compared to $1.3 million at May 31, 2024. The change in sales
from the prior year was primarily driven by:
•
Decreased sales of PICCs and Midline products of $30.1 million which was due to the divestiture of these businesses on February 15, 2024;
•
Decreased sales of dialysis and BioSentry products of $0.7 million which was due to the divestiture of these businesses on June 8, 2023;
•
Decreased sales of RadioFrequency Ablation of $2.2 million due to the discontinuation of this product line as of February 29, 2024; and
•
Increased sales of Core and Venous of $1.9 million and $0.9 million, respectively. This increase was partially offset by decreased sales of Ports,
Microwave and other Oncology products of $0.3 million, $0.8 million and $0.5 million, respectively.
38
Gross Margin
Year ended May 31,
(in thousands)
2025
2024
$ Change
Med Tech
$
78,515
$
67,198
$
11,317
Gross margin % of sales
62.0 %
63.2 %
Med Device
$
79,190
$
87,500
$
(8,310)
Gross margin % of sales
47.7 %
44.3 %
Total
$
157,705
$
154,698
$
3,007
Gross margin % of sales
53.9 %
50.9 %
Gross margin - Gross margin 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 margin increased by $3.0 million compared to the prior year. The change from the prior year was primarily driven by:
•
The divestiture of the PICCs, Midline, dialysis and BioSentry businesses, which negatively impacted gross margin by $9.2 million;
•
Sales volume, price and product mix, which positively impacted gross margin by $19.9 million;
•
Other incentives and a prior year supplier recall, which positively impacted gross profit by $1.7 million;
•
Production volume and other costs which negatively impacted gross margin by $1.5 million;
•
Tariffs, along with inflationary costs on raw materials, labor shortages, freight and other costs, which negatively impacted gross margin by $1.6
million and $3.6 million, respectively; and
•
Incremental depreciation on placement units of $2.6 million.
The Med Tech segment gross margin increased by $11.3 million compared to the prior year. The change from the prior year was primarily driven by:
•
Sales volume, price and product mix, which positively impacted gross margin by $17.2 million;
•
Production volume and other incentives which negatively impacted gross margin by $1.5 million;
•
Tariffs, along with inflationary costs on raw materials, labor shortages and freight costs, which negatively impacted gross margin by $1.1 million
and $0.4 million, respectively;
•
The abandonment of the Syntrax product line, which negatively impacted gross margin by $0.2 million; and
•
Incremental depreciation on placement units of $2.7 million.
The Med Device segment gross margin decreased by $8.3 million compared to the prior year. The change from the prior year was primarily driven by:
•
The divestiture of the PICCs, Midline, dialysis and BioSentry businesses, which negatively impacted gross margin by $9.0 million;
•
Price and product mix, which positively impacted gross margin by $3.6 million;
•
Other incentives and a prior year supplier recall, which positively impacted gross profit by $2.7 million;
•
Sales volume and production volume which negatively impacted gross margin by $1.4 million;
•
Tariffs, along with inflationary costs on raw materials, labor shortages and freight and other costs, which negatively impacted gross margin by $0.5
million and $3.7 million, respectively; and
•
Incremental depreciation on placement units of $0.1 million.
39
Operating Expenses and Other Income (expense)
Year ended May 31,
(in thousands)
2025
2024
$ Change
Research and development
$
26,222
$
31,512
$
(5,290)
% of sales
9.0 %
10.4 %
Selling and marketing
$
103,135
$
102,818
$
317
% of sales
35.3 %
33.8 %
General and administrative
$
42,092
$
41,164
$
928
% of sales
14.4 %
13.5 %
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 $5.3 million compared to the prior year. The change from the prior year was primarily driven by:
•
The timing of certain projects, clinical spend and other costs associated with the ongoing clinical trials, which decreased R&D expense by $5.1
million; and
•
Compensation and benefits expenses, which decreased $0.2 million.
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 $0.3 million compared to the prior year. The change from the prior year was primarily driven by:
•
Trade shows, subscriptions and other marketing expenses, which increased $1.5 million;
•
Consulting and other selling expenses, which increased $0.7 million; and
•
Compensation and benefits expense, which decreased by $2.0 million.
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 $0.9 million compared to the prior year. The change from the prior year was primarily driven by:
•
Compensation and benefits expense, which increased $2.1 million;
•
Other outside consultant spend, which increased $0.8 million; and
•
Depreciation and other corporate expenses, which decreased $2.0 million.
Year ended May 31,
(in thousands)
2025
2024
$ Change
Amortization of intangibles
$
10,318
$
13,048
$
(2,730)
Goodwill impairment
$
—
$
159,476
$
(159,476)
Change in fair value of contingent consideration
$
272
$
432
$
(160)
Acquisition, restructuring and other items, net
$
15,620
$
53,182
$
(37,562)
Other income
$
5,922
$
797
$
5,125
Amortization of intangibles - Represents the amount of amortization expense that was taken on intangible assets held by the Company.
•
Amortization expense decreased $2.7 million compared to the prior year. The decrease is due to assets being included in the sale of the dialysis,
BioSentry, PICCs and Midlines businesses and the abandonment of the Syntrax product line.
Goodwill impairment - Represents the impairment charge taken on goodwill.
•
The Company recorded a non-cash goodwill impairment charge of $159.5 million for the year ended May 31, 2024 as the fair value of the Med
Tech reporting unit was less than its carrying value.
40
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, 2025 is related to the Eximo contingent consideration and the increased probability of
achieving the revenue milestones. The final milestone associated with the contingent consideration was reached during the third quarter of fiscal
year 2025 and was paid during the fourth quarter of fiscal year 2025.
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 decreased by $37.6 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 decreased $34.2 million and was driven by the $19.3
million settlement between the Company and BD in the prior year;
•
Mergers and acquisitions expense, which increased $0.3 million;
•
Plant closure expense, related to the restructuring of our manufacturing footprint which was announced on January 5, 2024, which increased $4.3
million;
•
An impairment of $3.4 million on the Syntrax product technology intangible and fixed assets and an inventory write-off of $2.9 million was taken
in the third quarter of fiscal year 2024 related to the abandonment of the Syntrax and RF product lines;
•
Transaction services agreements that were entered into as a result of the divestiture of the PICCs, Midline, dialysis and BioSentry businesses. The
increase in the fees invoiced was $0.7 million;
•
Manufacturing relocation expense related to the move of certain manufacturing lines from Queensbury, New York to a third party, which decreased
$0.6 million; and
•
Other expenses, mainly severance associated with organizational changes, which decreased $0.4 million.
Other income (expense) - Other expense includes interest income and expense, foreign currency impacts and bank fees.
Other income, net increased by $5.1 million compared to the prior year. The change from the prior year was primarily driven by:
•
The Company achieved the $5.5 million sales milestone related to divested products in the third quarter of fiscal year 2025;
•
Unrealized foreign currency fluctuations, which increased $0.2 million; and
•
Interest income, which decreased $0.6 million compared to the prior year.
Income Tax Benefit
Year ended May 31,
(in thousands)
2025
2024
Income tax benefit
$
(39)
$
(7,289)
Effective tax rate
0.1 %
3.8 %
Our effective tax rate was a benefit of 0.1% for fiscal year 2025 compared with an effective tax rate benefit of 3.8% 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.
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. As a result of the full impairment of Goodwill and the reversal of the naked credit deferred
tax liability sourced income, the Company has recorded a full valuation allowance on its U.S. net deferred tax assets as of May 31, 2025. The Company will
continue to assess the level
41
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.
Liquidity and Capital Resources
We regularly review our liquidity and anticipated capital requirements and 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 $55.9 million as of May 31, 2025, compared with $76.1 million as of May 31, 2024. As of May 31, 2025 and
2024 the Company did not have any outstanding debt.
The table below summarizes our cash flows for the years ended May 31, 2025 and 2024:
Year ended May 31,
(in thousands)
2025
2024
Cash (used in) provided by:
Operating activities
$
(10,128)
$
(28,158)
Investing activities
(10,178)
123,717
Financing activities
(255)
(64,248)
Effect of exchange rate changes on cash and cash equivalents
398
125
Net change in cash and cash equivalents
$
(20,163)
$
31,436
During the years ended May 31, 2025 and 2024, cash flows consisted of the following:
Cash used in operating activities:
Years ended May 31, 2025 and 2024:
•
Net loss of $34.0 million and $184.3 million, respectively, plus the non-cash items, primarily driven by depreciation and amortization, gain on the
divestiture and related expenses, goodwill impairment and stock-based compensation, along with the changes in working capital below, contributed
to cash used in operations of $10.1 million and $28.2 million for the years ended May 31, 2025 and 2024, respectively;
•
For the year ended May 31, 2025, working capital was unfavorably impacted by decreased accounts payable and accrued liabilities and inventory
on hand of $15.9 million and $1.3 million, respectively. This was partially offset by decreased prepaid expenses of $3.1 million; and
•
For the year ended May 31, 2024, working capital was unfavorably impacted by increased prepaid expenses and inventory on hand of $11.6 million
and $9.4 million, respectively. This was partially offset by decreased accounts receivable and increased accounts payable and accrued liabilities of
$7.9 million and $27.5 million, respectively.
Cash (used in) provided by investing activities:
Years ended May 31, 2025 and 2024:
•
$4.5 million and $2.5 million, respectively, of cash was used for fixed asset additions;
•
$5.7 million and $5.0 million, respectively, of cash was used for Auryon placement and evaluation unit additions;
•
$134.5 million of cash was received for the divestiture of the PICCs, Midline, dialysis and BioSentry businesses in fiscal year 2024; and
•
$3.3 million of cash was used for the acquisition of exclusive licenses in fiscal year 2024.
Cash provided by (used in) financing activities:
Years ended May 31, 2025 and 2024:
•
$6.3 million of proceeds from financing arrangements offset with $0.1 million of principal payments on the financing arrangements in fiscal year
2025;
•
$1.7 million of cash was used for the repurchase of common shares in fiscal year 2025;
•
$5.0 million and $15.0 million, respectively, of contingent consideration payments;
•
$50.0 million repayment of the Credit Agreement in connection with the completion of the dialysis and BioSentry divestiture in fiscal year 2024;
and
42
•
$0.9 million and $0.8 million, respectively, of proceeds from stock option and ESPP activity.
On May 28, 2025, the Company entered into a new Credit Agreement (the “Credit Agreement”) with JPMorgan Chase Bank, N.A. The Credit
Agreement has a two-year maturity and provides for a $25.0 million secured revolving credit facility (the "Revolving Facility"), which is subject to a
borrowing base comprised of certain working capital assets of the Company. As of May 31, 2025, there is no outstanding balance on the Revolving Facility.
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.
Our contractual obligations as of May 31, 2025 are set forth in the table below (in thousands). We have no variable interest entities or other off-balance
sheet obligations.
Cash payments due by period as of May 31, 2025
(in thousands)
Total
Less than
One Year
1-3 Years
3-5 Years
After 5
Years
Contractual Obligations:
Operating leases
$
4,580
$
2,277
$
1,788
$
515
$
—
Finance leases
4,714
800
1,549
2,365
—
Royalties
32,380
3,620
7,240
7,240
14,280
$
41,674
$
6,697
$
10,577
$
10,120
$
14,280
(1) Operating leases include short-term leases that are not recorded on our Consolidated Balance Sheets under ASU No. 2016-02.
Results of Operations for the years ended May 31, 2024 and 2023
For management discussion and analysis of our 2024 financial results and liquidity compared with 2023, 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, 2024 filed on July 25, 2024.
Recent Accounting Pronouncements
Refer to Note 1 of the Notes to the consolidated financial statements for Recently Issued Accounting Pronouncements.
(1)
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 3.4% of our sales in
fiscal year 2025 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 margin 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
The risk associated with fluctuating interest rates is primarily limited to indebtedness. As of May 31, 2025, the Company does not have any
outstanding debt (see Note 11, "Long-Term Debt" set forth in the Notes in the consolidated financial statements included in this Annual Report on Form 10-
K).
Interest on the Revolving Facility will be based, at the Company's option, on a rate equal to (i) the Secured Overnight Financing Rate ("SOFR") plus
0.1% (subject to a floor of 0%) ("Adjusted Term SOFR"), or (ii) the alternate base rate (subject to a floor of 0%) ("ABR"), and in each case with a margin for
Adjusted Term SOFR loans of 2.0% and for ABR loans of 1.0%. The Revolving Facility will also carry a commitment fee of 0.2% per annum on the unused
portion. The Revolving Facility contains customary benchmark replacement and rate fallback provisions.
CONCENTRATION OF CREDIT RISK
Financial instruments, which potentially subject the Company to significant concentrations of credit risk, consist primarily of cash and cash equivalents
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.
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, 2025. 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, 2025.
The effectiveness of our internal control over financial reporting as of May 31, 2025 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, 2025 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, 2025, 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, 2025, 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, 2025, of the Company and our report dated July 18, 2025, 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
July 18, 2025
46
Item 9B. Other Information.
None.
Item 9C. Foreign Jurisdictions that Prevent Inspections.
Not applicable.
47
Part III
Certain information required by Part III is omitted from this Annual Report on Form 10-K because we will file a definitive proxy statement within 120
days after the end of our fiscal year end pursuant to Regulation 14A (the “Proxy Statement”) for our Annual Meeting of Stockholders, currently scheduled
for October 2025. The information included in the Proxy Statement under the respective headings noted below is incorporated herein by reference.
Item 10. Directors, Executive Officers and Corporate Governance.
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
Part IV
Item 15. Exhibits, Financial Statement Schedules.
(a)(1) Financial Statements
The following consolidated financial statements and supplementary data of Registrant and its subsidiaries required by Part II, Item 8, are included in
Part IV of this report:
Report of Independent Registered Public Accounting Firm (PCAOB ID 34)
50
Consolidated Statements of Operations—Year ended May 31, 2025, 2024 and 2023
52
Consolidated Statements of Comprehensive Loss - Year ended May 31, 2025, 2024 and 2023
53
Consolidated Balance Sheets—May 31, 2025 and May 31, 2024
54
Consolidated Statements of Stockholders’ Equity—Year ended May 31, 2025, 2024 and 2023
55
Consolidated Statements of Cash Flows—Year ended May 31, 2025, 2024 and 2023
56
Notes to Consolidated Financial Statements
58
(2) Financial Statement Schedules
The following consolidated financial statement schedule is included in Part IV of this report:
Schedule II—Valuation and qualifying accounts
81
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
82
49
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, 2025 and 2024, the
related consolidated statements of operations, comprehensive loss, stockholders' equity, and cash flows, for each of the three years in the period ended
May 31, 2025, 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, 2025 and 2024, and the results of its
operations and its cash flows for each of the three years in the period ended May 31, 2025, 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, 2025, based on criteria established in Internal Control — Integrated Framework (2013) issued by the
Committee of Sponsoring Organizations of the Treadway Commission and our report dated July 18, 2025, 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) relate 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 separate opinions on the critical
audit matters or on the accounts or disclosures to which they relate.
Inventories – Excess Quantities and Obsolescence — Refer to Notes 1 & 5
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, 2025, the Company has inventories of $62.0 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 and considered the Company's disclosures.
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.
/s/ Deloitte & Touche LLP
Boston, Massachusetts
July 18, 2025
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)
Year ended May 31,
2025
2024
2023
Net sales
$
292,498
$
303,914
$
338,752
Cost of sales (exclusive of intangible amortization)
134,793
149,216
164,506
Gross margin
157,705
154,698
174,246
Operating expenses
Research and development
26,222
31,512
29,883
Sales and marketing
103,135
102,818
104,249
General and administrative
42,092
41,164
40,003
Amortization of intangibles
10,318
13,048
18,790
Goodwill impairment
—
159,476
14,549
Change in fair value of contingent consideration
272
432
2,320
Acquisition, restructuring and other items, net
15,620
53,182
15,633
Total operating expenses
197,659
401,632
225,427
Gain on sale of assets
—
54,499
—
Operating loss
(39,954)
(192,435)
(51,181)
Other expenses
Interest income (expense), net
978
1,614
(2,702)
Other income (expense), net
4,944
(817)
(554)
Total other income (expense), net
5,922
797
(3,256)
Loss before income tax benefit
(34,032)
(191,638)
(54,437)
Income tax benefit
(39)
(7,289)
(1,995)
Net loss
$
(33,993)
$
(184,349)
$
(52,442)
Loss per share
Basic
$
(0.83)
$
(4.59)
$
(1.33)
Diluted
$
(0.83)
$
(4.59)
$
(1.33)
Weighted average shares outstanding
Basic
40,853
40,181
39,480
Diluted
40,853
40,181
39,480
The accompanying notes are an integral part of these consolidated financial statements.
52
AngioDynamics, Inc. and Subsidiaries
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(in thousands)
Year ended May 31,
2025
2024
2023
Net loss
$
(33,993)
$
(184,349)
$
(52,442)
Other comprehensive income (loss), before tax:
Foreign currency translation gain (loss)
2,342
358
(6,080)
Other comprehensive income (loss), before tax
2,342
358
(6,080)
Income tax benefit (expense) related to items of other comprehensive income (loss)
—
—
—
Other comprehensive income (loss), net of tax
2,342
358
(6,080)
Total comprehensive loss, net of tax
$
(31,651)
$
(183,991)
$
(58,522)
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, 2025
May 31, 2024
Assets
Current Assets
Cash and cash equivalents
$
55,893
$
76,056
Accounts receivable, net of allowances of $2,215 and $2,141 respectively
42,890
43,610
Inventories
62,006
60,616
Prepaid expenses and other
7,535
12,971
Total current assets
168,324
193,253
Property, plant and equipment, net
32,300
35,666
Intangible assets, net
69,116
77,383
Other assets
10,404
11,369
Total Assets
$
280,144
$
317,671
Liabilities and Stockholders' Equity
Current Liabilities
Accounts payable
$
33,291
$
37,751
Accrued liabilities
35,518
41,098
Current portion of contingent consideration
—
4,728
Other current liabilities
7,388
7,578
Total current liabilities
76,197
91,155
Deferred income taxes
4,073
4,852
Other long-term liabilities
16,904
16,078
Total Liabilities
97,174
112,085
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; 41,607,877 and 40,801,597 shares
issued and 40,994,030 and 40,431,597 shares outstanding at May 31, 2025 and 2024, respectively
385
385
Additional paid-in capital
621,186
610,484
Accumulated deficit
(429,197)
(395,204)
Treasury stock, 613,847 and 370,000 shares, at cost at May 31, 2025 and 2024, respectively
(7,381)
(5,714)
Accumulated other comprehensive loss
(2,023)
(4,365)
Total Stockholders' Equity
182,970
205,586
Total Liabilities and Stockholders' Equity
$
280,144
$
317,671
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)
Common Stock
Additional
paid in
capital
Accumulated
deficit
Accumulated
other
comprehensive
income (loss)
Treasury Stock
Total
Shares
Amount
Shares
Amount
Balance at May 31, 2022
39,541,173
$
380
$
586,879
$
(158,413)
$
1,357
(370,000)
$
(5,714)
424,489
Net loss
(52,442)
(52,442)
Exercise of stock options
21,617
1
155
156
Issuance/cancellation of restricted stock
units
239,028
(720)
(720)
Issuance of performance share units
29,826
(312)
(312)
Purchase of common stock under
Employee Stock Purchase Plan
149,778
1
2,046
2,047
Stock-based compensation
11,158
11,158
Other comprehensive loss, net of tax
(6,080)
(6,080)
Balance at May 31, 2023
39,981,422
$
382
$
599,206
$
(210,855)
$
(4,723)
(370,000)
$
(5,714)
$
378,296
Net loss
(184,349)
(184,349)
Issuance/cancellation of restricted stock
units
450,561
(305)
(305)
Issuance/cancellation of performance
share units
87,377
(546)
(546)
Purchase of common stock under
Employee Stock Purchase Plan
282,237
3
1,600
1,603
Stock-based compensation
10,529
10,529
Other comprehensive income, net of tax
358
358
Balance at May 31, 2024
40,801,597
$
385
$
610,484
$
(395,204)
$
(4,365)
(370,000)
$
(5,714)
$
205,586
Net loss
(33,993)
(33,993)
Exercise of stock options
25,000
—
248
248
Issuance/cancellation of restricted stock
units
464,525
(326)
(326)
Issuance/cancellation of performance
share units
60,731
(347)
(347)
Purchase of common stock under
Employee Stock Purchase Plan
256,024
3
1,355
1,358
Stock-based compensation
9,772
9,772
Common stock repurchased
(3)
(243,847)
(1,667)
(1,670)
Other comprehensive income, net of tax
2,342
2,342
Balance at May 31, 2025
41,607,877
$
385
$
621,186
$
(429,197)
$
(2,023)
(613,847)
$
(7,381)
$
182,970
The accompanying notes are an integral part of these consolidated financial statements.
55
AngioDynamics, Inc. and Subsidiaries
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
Year ended May 31,
2025
2024
2023
Cash flows from operating activities:
Net loss
$
(33,993)
$
(184,349)
$
(52,442)
Adjustments to reconcile net loss to net cash (used in) provided by operating activities:
Depreciation and amortization
25,800
27,712
30,873
Non-cash lease expense
1,958
1,931
2,484
Goodwill impairment
—
159,476
14,549
Stock based compensation
9,772
10,529
11,158
Gain on dispositions
—
(54,499)
—
Transaction costs for disposition
—
(5,084)
—
Change in fair value of contingent consideration
272
432
2,320
Deferred income tax provision
(988)
(7,968)
(2,311)
Changes in accounts receivable allowances
699
1,326
695
Asset impairments and disposals
173
7,108
291
Write-off of other assets
—
869
—
Other
291
(62)
(513)
Changes in operating assets and liabilities:
Accounts receivable
23
7,894
(1,299)
Inventories
(1,347)
(9,410)
(8,198)
Prepaid expenses and other
3,089
(11,594)
332
Accounts payable, accrued and other liabilities
(15,877)
27,531
2,139
Net cash (used in) provided by operating activities
(10,128)
(28,158)
78
Cash flows from investing activities:
Additions to property, plant and equipment
(4,464)
(2,518)
(3,812)
Additions to placement and evaluation units
(5,714)
(5,015)
(5,394)
Proceeds from sale of assets
—
134,500
—
Acquisition of intangibles
—
(3,250)
(540)
Net cash (used in) provided by investing activities
(10,178)
123,717
(9,746)
Cash flows from financing activities:
Proceeds from issuance of and borrowings on long-term debt
—
—
70,000
Repayment of long-term debt
—
(50,000)
(45,000)
Deferred financing costs on long-term debt
(680)
—
(751)
Principal payments on financing arrangement
(148)
—
—
Proceeds from financing arrangement
6,310
—
—
Payment of acquisition related contingent consideration
(5,000)
(15,000)
—
Repurchase of common stock
(1,670)
—
—
Proceeds from exercise of stock options and employee stock purchase plan
933
752
1,171
Net cash (used in) provided by financing activities
(255)
(64,248)
25,420
Effect of exchange rate changes on cash and cash equivalents
398
125
43
Increase (decrease) in cash and cash equivalents
(20,163)
31,436
15,795
Cash and cash equivalents at beginning of year
76,056
44,620
28,825
Cash and cash equivalents at end of year
$
55,893
$
76,056
$
44,620
The accompanying notes are an integral part of these consolidated financial statements.
56
AngioDynamics, Inc. and Subsidiaries
CONSOLIDATED STATEMENTS OF CASH FLOWS—(Continued)
(in thousands)
Year ended May 31,
2025
2024
2023
Supplemental disclosure of non-cash investing and financing activities:
Increase (decrease) in accounts payable for purchases of fixed assets
$
(49)
$
(78)
$
124
Cash paid during the year for:
Interest
$
185
$
—
$
2,577
Income taxes
800
455
342
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 dynamic, diversified medical technology company committed to expanding treatment options and improving patient outcomes and
quality of life by focusing on cardiovascular disease and cancer. Our execution strategy is built on innovative R&D, clinical and regulatory pathway
expansion and customer centric sales performance.
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. See Note 4, "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:
Estimated useful lives
Building and building improvements
3 to 39 years
Computer software and equipment
1 to 10 years
Machinery and equipment
3 to 11 years
Placement and evaluation units
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.
Intangible Assets
Intangible assets 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. 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.
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 3, “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
59
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 expense, net" in the Consolidated Statements of Operations as incurred.
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
Description
Effective Date
Effect on the Consolidated Financial Statements
ASU 2023-07, Segment
Reporting (Topic 280):
Improvements to Reportable
Segment Disclosures
This ASU improves the reportable segment
disclosure requirements, primarily through
enhanced disclosures about significant segment
expenses.
June 1, 2024
The Company adopted the new standard in fiscal
year 2025 and the related additional disclosures are
contained in Note 18 to the consolidated financial
statements in this Annual Report on Form 10-K.
60
Recently Issued Accounting Pronouncements - Not Yet Applicable or Adopted
Standard
Description
Effective Date
Effect on the Consolidated Financial Statements
ASU 2023-09, Income Taxes
(Topic 740): Improvements to
Income Tax Disclosures
This ASU improves the income tax disclosure
requirements on an annual basis by (1) disclose
specific categories in the rate reconciliation and (2)
provide additional information for reconciling items
that meet a quantitative threshold.
June 1, 2025
The Company plans to adopt the new standard in
the first quarter of fiscal year 2026 and is assessing
the impact to the consolidated financial statements.
ASU 2024-03, Income
Statement-Reporting
Comprehensive Income-
Expense Disaggregation
Disclosures (Subtopic 220-04):
Disaggregation of Income
Statement Expenses
This ASU improves the disclosures about a public
business entity's costs and expenses by requiring the
Company to disclose more detailed information
about the types of expenses (including purchases of
inventory, employee compensation, depreciation,
amortization and depletion) included in each
relevant income statement caption.
June 1, 2027
The Company plans to adopt the new standard for
the fiscal year 2028 and is assessing the impact to
the consolidated financial statements.
2. DIVESTITURES
PICCs and Midlines
Pursuant to an asset purchase agreement dated February 15, 2024 (the "Spectrum Asset Purchase Agreement"), the Company completed the divestiture
of its PICC and Midline businesses (the "Spectrum Divestiture") to Spectrum Vascular ("Spectrum"). Total consideration received by the Company for the
Spectrum Divestiture in the third quarter of fiscal year 2024 was $34.5 million in cash and resulted in a pre-tax book gain of $6.7 million. Included in the
agreement is a $5.5 million earn-out related to the sales of divested products over a two year period and a milestone payment of $5.0 million paid upon final
transfer of the manufacturing to a third-party that Spectrum will pay to the Company upon achievement. The Company achieved the sales milestone related
to the divested products in the third quarter of fiscal year 2025 and $5.5 million was paid to the Company in the fourth quarter of fiscal year 2025. The final
transfer of manufacturing has not been achieved as of May 31, 2025.
The Company and Spectrum entered into various agreements to facilitate the transition of the divested businesses to Spectrum, including a Transition
Services Agreement ("TSA") and Transition Manufacturing Agreement. The Company determined that the divestiture 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.
The following table summarizes the major classes of assets sold on the date of the sale:
(in thousands)
As of February 15, 2024
Current assets:
Inventories
$
4,203
Total current assets
$
4,203
Non-current assets:
Property, plant and equipment, net
$
158
Intangible assets, net
20,781
Other assets
40
Total non-current assets
$
20,979
Dialysis and BioSentry
Pursuant to an asset purchase agreement dated June 8, 2023 (the "Merit Asset Purchase Agreement"), the Company completed the divestiture of the
dialysis and BioSentry tract sealant system biopsy businesses (the "Merit Divestiture") to Merit Medical Systems, Inc. ("Merit"). Total consideration
received by the Company for the Merit Divestiture in the first quarter of fiscal year 2024 was $100.0 million in cash and resulted in a pre-tax book gain of
$47.8 million.
61
The Company and Merit entered into various agreements to facilitate the transition of the divested businesses to Merit, including a Transition Services
Agreement and Contract Manufacturing Agreement. The Company determined that the divestiture 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.
The following table summarizes the major classes of assets sold on the date of the sale:
(in thousands)
As of June 8, 2023
Current assets:
Inventories
$
4,068
Prepaid expenses and other
2,000
Total current assets
$
6,068
Non-current assets:
Property, plant and equipment, net
$
54
Intangible assets, net
17,629
Goodwill
25,980
Total non-current assets
$
43,663
3. REVENUE FROM CONTRACTS WITH CUSTOMERS
Revenue Recognition
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 Company expects to receive in exchange for those goods or services. To determine revenue recognition for
arrangements, 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:
Year ended May 31, 2025
Year ended May 31, 2024
(in thousands)
United States
International
Total
United States
International
Total
Net sales
Med Tech
$
109,254 $
17,399 $
126,653 $
90,361 $
16,042 $
106,403
Med Device
141,729
24,116
165,845
161,125
36,386
197,511
Total
$
250,983 $
41,515 $
292,498 $
251,486 $
52,428 $
303,914
Year ended May 31, 2023
(in thousands)
United States
International
Total
Net sales
Med Tech
$
84,332 $
12,355 $
96,687
Med Device
198,381
43,684
242,065
Total
$
282,713 $
56,039 $
338,752
Net Product Revenue
The Company's products consist of medical technology products focused on restoring healthy blood flow in the body's vascular system, expanding
cancer treatment options and improving quality of life for patients. 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.
62
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 disposable 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, product returns, rebates and allowances that are offered within contracts between the Company and its
customers. 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.
Discounts and product returns are based on amounts earned or to be claimed on the related sales and are classified as a contra asset. During the years ended
May 31, 2025, 2024 and 2023, such product returns were not material. 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 liabilities" 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.
63
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 as deferred revenue
in "Accrued liabilities" in the accompanying Consolidated Balance Sheets.
The following table presents changes in the Company’s receivables, contract assets and contract liabilities with customers:
(in thousands)
May 31, 2025
May 31, 2024
Receivables
$
42,890
$
43,610
Contract assets
$
—
$
—
Contract liabilities
$
277
$
391
During the years ended May 31, 2025 and 2024, the Company had additions to contract liabilities of $0.2 million and $0.6 million, respectively. This
was offset by $0.3 million and $0.7 million in revenue that was recognized during the years ended May 31, 2025 and 2024, 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.
4. 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.
•
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.
There were no assets or liabilities measured at fair value at May 31, 2025. The following table provides information by level for assets and liabilities
that are measured at fair value on a recurring basis at May 31, 2024:
64
Fair Value Measurements using inputs considered as:
(in thousands)
Level 1
Level 2
Level 3
Fair Value at May 31,
2024
Financial Liabilities
Contingent consideration for acquisition earn outs
$
—
$
—
$
4,728
$
4,728
Total Financial Liabilities
$
—
$
—
$
4,728
$
4,728
There were no transfers between Level 1, 2 and 3 for the years ended May 31, 2025 and 2024.
The following tables present the changes in fair value components of Level 3 instruments:
Financial Liabilities
(in thousands)
Fair Value Measurements
Using Significant
Unobservable Inputs
(Level 3)
Balance at May 31, 2024
$
4,728
Change in present value of contingent consideration (1)
272
Contingent consideration payments
(5,000)
Balance at May 31, 2025
$
—
(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.
Financial Liabilities
(in thousands)
Fair Value Measurements
Using Significant
Unobservable Inputs
(Level 3)
Balance at May 31, 2023
$
19,296
Change in fair value of contingent consideration (1)
432
Contingent consideration payments
(15,000)
Balance at May 31, 2024
$
4,728
(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.
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 final milestone associated with the contingent consideration was reached during the third quarter of fiscal year 2025 and was paid during the fourth
quarter of fiscal year 2025.
65
Items Measured at Fair Value on a Nonrecurring Basis
The Company recorded a goodwill impairment charge of $159.5 million for the quarter ended February 29, 2024 to write down the carrying value of
the Med Tech reporting unit to fair value. 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 third quarter of fiscal year 2024, the Company made the decision to abandon the Syntrax product technology which resulted in an
impairment charge of $3.3 million.
During the third quarter of fiscal year 2024, the Company received a purchase offer for the properties located at 603 Queensbury Avenue, Queensbury
NY and 8 Glens Falls Tech Park, Glens Falls, NY. This resulted in an impairment charge of $3.4 million to write the buildings down to fair value.
There were no other items measured at fair value on a nonrecurring basis during the year ended May 31, 2025 or 2024.
5. 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)
May 31, 2025
May 31, 2024
Raw materials
$
27,497
$
30,736
Work in process
7,509
6,772
Finished goods
27,000
23,108
Total
$
62,006
$
60,616
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, 2025 and 2024 was $4.4 million and $3.3 million, respectively.
6. PREPAID EXPENSES AND OTHER
Prepaid expenses and other consisted of the following:
(in thousands)
May 31, 2025
May 31, 2024
Deposits
$
1,372
$
913
Software licenses
1,801
1,643
TSA receivable
250
6,401
License fees
227
208
Trade shows
400
580
Rent
247
185
Other prepaid taxes
166
464
Other
3,072
2,577
Total
$
7,535
$
12,971
7. PROPERTY, PLANT AND EQUIPMENT, NET
66
Property, plant and equipment are summarized as follows:
(in thousands)
May 31, 2025
May 31, 2024
Building and building improvements
$
16,604
$
30,099
Computer software and equipment
29,038
28,407
Machinery and equipment
16,596
15,756
Placement and evaluation units
36,991
31,312
Construction in progress
3,794
2,638
103,023
108,212
Less accumulated depreciation
(71,116)
(69,675)
Less building impairment
—
(3,364)
31,907
35,173
Land and land improvements
393
493
$
32,300
$
35,666
Depreciation expense for fiscal years 2025, 2024 and 2023 was $13.5 million, $14.7 million and $11.9 million, respectively. Depreciation expense for
the year ended May 31, 2025 and 2024 includes accelerated depreciation of $3.4 million and $2.4 million, respectively, related to the plant closure
announced on January 5, 2024 (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). During the third quarter of fiscal year 2024, the Company received a purchase offer for the properties located at 603
Queensbury Avenue, Queensbury NY and 8 Glens Falls Tech Park, Glens Falls, NY. This resulted in an impairment charge of $3.4 million to write the
buildings down to fair value.
8. INTANGIBLE ASSETS
Definite Lived Intangible Assets
Intangible assets 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.
There were no impairment charges on definite lived intangible assets for the year ended May 31, 2025. During the third quarter of fiscal year 2024, the
Company made the decision to abandon the Syntrax product line. This resulted in an impairment charge of $3.3 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). There were no other impairment charges on
definite lived intangible assets for the year ended May 31, 2024.
Intangible assets consisted of the following:
May 31, 2025
(in thousands)
Gross carrying
value
Accumulated
amortization
Net carrying
value
Product technologies
$
178,673
$
(112,657)
$
66,016
Customer relationships
7,749
(4,802)
2,947
Trademarks
2,100
(2,081)
19
Licenses
3,837
(3,703)
134
$
192,359
$
(123,243)
$
69,116
67
May 31, 2024
(in thousands)
Gross carrying
value
Accumulated
amortization
Net carrying
value
Product technologies
$
176,227
$
(102,468)
$
73,759
Customer relationships
9,028
(5,628)
3,400
Trademarks
2,100
(2,024)
76
Licenses
3,837
(3,689)
148
$
191,192
$
(113,809)
$
77,383
Amortization expense was $10.3 million, $13.0 million and $18.8 million for fiscal years 2025, 2024 and 2023, respectively.
Expected future amortization expense related to the intangible assets for each of the following fiscal years is as follows:
(in thousands)
2026
$
10,302
2027
10,212
2028
10,163
2029
10,065
2030
10,052
2031 and thereafter
18,322
$
69,116
9. INCOME TAXES
The components of loss before income tax benefit are as follows:
Year ended May 31,
(in thousands)
2025
2024
2023
Loss before tax expense:
U.S.
$
(30,172)
$
(177,314)
$
(45,240)
Non-U.S.
(3,860)
(14,324)
(9,197)
$
(34,032)
$
(191,638)
$
(54,437)
Income tax benefit is comprised of the following:
Year ended May 31,
(in thousands)
2025
2024
2023
Current
U.S.
621
318
129
Non U.S.
328
361
187
949
679
316
Deferred
U.S.
—
(7,039)
(207)
Non U.S.
(988)
(929)
(2,104)
(988)
(7,968)
(2,311)
Income tax benefit
$
(39)
$
(7,289)
$
(1,995)
68
Temporary differences that give rise to deferred tax assets and liabilities are summarized as follows:
(in thousands)
May 31, 2025
May 31, 2024
Deferred tax assets
Net operating loss carryforward
$
34,388
$
28,243
Stock-based compensation
3,396
3,796
Federal and state R&D tax credit carryforward
8,275
7,777
Inventories
1,016
762
Expenses incurred not currently deductible
18,188
15,694
Accrued liabilities
34
39
Gross deferred tax asset
65,297
56,311
Deferred tax liabilities
Depreciation and amortization
10,915
8,443
10,915
8,443
Valuation allowance
(58,440)
(52,680)
Net deferred tax liability
$
(4,058)
$
(4,812)
The net deferred tax liability of $4.0 million as of May 31, 2025 relates 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 net deferred tax liability of $4.9 million as of May 31, 2024
relates 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, 2025 after considering IRC Section 382 limitations are $135.6 million.
The expiration of the Federal net operating loss carryforwards are as follows: $37.1 million between 2030 and 2032, and $98.5 million indefinitely.
The Company's state net operating loss carryforwards as of May 31, 2025 after considering remaining IRC Section 382 limitations are $23.9 million
which expire in various years from 2030 to 2043. The Company has Israel tax net operating losses of $19.2 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,
2025, as well as all subsequent earnings generated by all of our foreign subsidiaries. Determining the amount of unrecognized deferred tax liability related to
any additional outside basis difference in these entities is not practical.
The Company regularly assesses its ability to realize its deferred tax assets. Assessing the realization of deferred tax assets requires significant
management judgment. In determining whether its deferred tax assets are more likely than not realizable, the Company evaluated all available positive and
negative evidence, and weighted the evidence based on its objectivity.
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. As a result of the full impairment of Goodwill and the reversal of the naked credit deferred
tax liability sourced income, the Company has recorded a full valuation allowance on its US net deferred tax assets as of May 31, 2025. 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:
69
Year ended May 31,
(in thousands)
2025
2024
2023
Income tax benefit at federal statutory tax rate of 21.0%, 21.0% and 21.0%, respectively
$
(7,147)
$
(40,244)
$
(11,432)
State income taxes, net of Federal tax benefit
10
(3,016)
(353)
Impact of Non-U.S. operations
150
2,440
14
Research and development tax credit
(497)
(907)
(991)
Meals and entertainment
250
244
258
Goodwill impairment
—
4,867
3,055
Non-deductible executive compensation
294
201
366
Change in valuation allowance
5,760
26,921
5,556
Stock based compensation
1,325
1,357
505
Other
(184)
848
1,027
Income tax benefit
$
(39)
$
(7,289)
$
(1,995)
The following table provides a reconciliation of the beginning and ending amount of unrecognized tax benefits:
Year ended May 31,
(in thousands)
2025
2024
2023
Unrecognized tax benefits balance at June 1
$
—
$
464
$
464
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
—
(464)
—
Unrecognized tax benefits balance at May 31
$
—
$
—
$
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.
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, 2025 and 2024.
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 2022 through 2024 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.
70
10. ACCRUED LIABILITIES
Accrued liabilities consist of the following:
(in thousands)
May 31, 2025
May 31, 2024
Payroll and related expenses
$
20,397
$
15,640
Outside services
3,143
8,962
Research and development
1,459
1,255
Royalties
2,642
2,575
Sales and franchise taxes
531
520
Deferred warranties
374
—
Transaction service agreement payable
2,241
6,259
Rebates
446
412
Accrued freight
575
—
Accrued severance
800
1,486
Other
2,910
3,989
Total
$
35,518
$
41,098
11. LONG-TERM DEBT
On May 28, 2025, the Company entered into a new Credit Agreement (the “Credit Agreement”) with its subsidiary RITA Medical Systems, LLC
(“RITA” and, together with the Company, the “Loan Parties”), the lenders party thereto and JPMorgan Chase Bank, N.A., individually and as administrative
agent, issuing bank and swingline lender.
The Credit Agreement provides for a $25.0 million secured revolving credit facility (the "Revolving Facility"), which is subject to a borrowing base
comprised of certain working capital assets of the Company. Additionally, until such time as the Company has demonstrated a fixed charge coverage ratio
greater than 1.10 to 1.00, the Revolving Facility will be further reduced by $5,000,000 (such period, the “Availability Block Period”). To the extent
requested by the Company, and subject to certain customary limitations, the lenders will make revolving loan advances to the Company and the issuing bank
will issue letters of credit for the account of the Company, in each case in an aggregate amount not exceeding the availability under the Revolving Facility.
Issuances of letters of credit under the Revolving Facility shall further be limited by an issuance cap, which as at the closing date is set at $2,000,000. The
proceeds of the Revolving Facility may be used for working capital and for general corporate needs of AngioDynamics and its subsidiaries.
The Credit Agreement has a two-year maturity. Interest on the Revolving Facility will be based, at the Company's option, on a rate equal to (i) the
Secured Overnight Financing Rate ("SOFR") plus 0.1% (subject to a floor of 0%) ("Adjusted Term SOFR"), or (ii) the alternate base rate (subject to a floor
of 0%) ("ABR"), and in each case with a margin for Adjusted Term SOFR loans of 2.0% and for ABR loans of 1.0%. The Revolving Facility will also carry
a commitment fee of 0.2% per annum on the unused portion. The Revolving Facility contains customary benchmark replacement and rate fallback
provisions.
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”). The sole Guarantor as at the closing date is RITA. All obligations of the Company and the Guarantors
under the Revolving Facility are secured by first priority security interests in substantially all of the assets of the Loan Parties and the Guarantors.
The Credit Agreement includes customary representations, warranties and covenants, and acceleration, indemnity and events of default provisions,
including, among other things, a financial covenant which requires the Company to maintain, as of the end of each calendar month commencing after the end
of the Availability Block Period, a fixed charge coverage ratio of EBITDA* minus unfinanced 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 1.05 to 1.00.
* The definitions of total indebtedness, EBITDA, capital expenditures and interest expense are specifically defined in the Credit Agreement included as an
exhibit to Form 8-K filed on May 28, 2025.
As of May 31, 2025 there was no amounts outstanding on the Revolving Facility. As of May 31, 2025, the carrying value of long-term debt
approximated its fair market value.
71
12. 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 $4.5 million, $4.6 million and $4.2 million in 2025, 2024 and 2023, respectively. There are also various immaterial foreign
retirement plans.
13. 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 and November 14,
2023, the Company’s shareholders approved amendments to the 2020 Plan to increase the reserve of shares of common stock available for grants by
1.95 million shares and 1.5 million shares, respectively. On November 12, 2024, the Company's shareholders approved an additional amendment to the 2020
Plan to increase the reserve of shares of common stock available for future grants by 3.2 million shares. As of May 31, 2025, there remained approximately
4.0 million shares of common stock available for future grant 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.
72
The following table summarizes information about stock option activity for the fiscal year ended May 31, 2025:
Shares
Weighted average
exercise price
Weighted average
remaining contractual
life
Aggregate intrinsic
value (in thousands)
Outstanding at beginning of year - June 1, 2024
2,162,983
$
16.29
Granted
561,923
$
7.35
Exercised
(25,000)
$
9.92
Forfeited
(164,404)
$
16.56
Expired
—
$
—
Outstanding at end of year - May 31, 2025
2,535,502
$
14.36
6.35 $
2,219
Options exercisable at year-end
1,502,837
$
17.09
4.88 $
223
Options expected to vest in future periods
1,032,665
$
10.38
8.48 $
1,997
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.
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, 2025, 2024 and 2023 was $3.75, $4.30, and $9.27, respectively. The following
assumptions were used in arriving at the fair value of options granted during 2025, 2024 and 2023, respectively: risk-free interest rates of 4.06%, 3.96% and
3.20%; expected volatility of 52%, 49%, and 44%; and expected lives of 5.36 years, 5.23 years, and 5.14 years. The Company does not declare dividends
therefore a dividend yield of zero was used for the years ended May 31, 2025, 2024 and 2023. 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, 2025 and 2023 was $0.1 million and $0.2 million, respectively. There
were no options exercised during the year ended May 31, 2024. As of May 31, 2025, there was $3.2 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 2025 and 2023 was $0.2 million and $0.3 million, respectively. There were no options exercised during the
year ended May 31, 2024. Due to the valuation allowance there was no tax benefit realized from stock option exercises during the years ended May 31,
2025, 2024 and 2023.
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. In July 2023, the Board of Directors approved a change in terms of restricted stock units granted to non-employee directors to
provide for immediate vesting upon grant of the award. Unvested restricted stock unit awards will be forfeited if the recipient ceases to be employed by the
Company.
73
The following table summarizes information about restricted stock unit activity for the year ended May 31, 2025:
Restricted Stock Units
Weighted Average
Grant-Date Fair Value
Non-vested at beginning of year, June 1, 2024
1,080,898
$
12.44
Granted
1,066,865
$
7.47
Vested
(513,152)
$
7.14
Canceled
(126,372)
$
10.32
Non-vested at end of year, May 31, 2025
1,508,239
$
9.34
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, 2025, 2024 and 2023 was $7.47, $8.74 and $19.99, 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, 2025, 2024 and 2023 was $3.7 million,
$4.2 million, and $5.6 million, respectively. As of May 31, 2025, there was $9.5 million of total unrecognized compensation cost related to non-vested
restricted stock awards, which is expected to be recognized over a weighted average period of 3 years.
The Company grants performance share awards to certain employees under the 2020 Plan, and historically under the 2004 Plan, which gives the
recipients the right to receive shares of Company stock if certain criteria is met.
The following table summarizes information about performance unit award activity for the year ended May 31, 2025:
Performance Unit
Awards
Weighted Average
Grant-Date Fair Value
Non-vested at beginning of year, June 1, 2024
742,708
$
16.13
Granted
513,594
$
7.40
Vested
(107,560)
$
7.40
Canceled
(71,410)
$
20.81
Non-vested at end of year, May 31, 2025
1,077,332
$
10.81
During fiscal years 2025, 2024 and 2023, 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, 2025, 2024 and 2023, the weighted average grant date fair market value for new grants was $8.29, $9.53 and $23.71, respectively. Compensation
cost is recognized over the performance period which is typically three years. As of May 31, 2025, there was $1.6 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:
Year ended May 31,
(in thousands)
2025
2024
2023
Cost of sales
$
218
$
288
$
793
Research and development
1,413
1,400
1,459
Sales and marketing
2,554
3,243
2,922
General and administrative
5,479
5,595
5,984
Acquisition, restructuring and other items, net
108
3
—
$
9,772
$
10,529
$
11,158
74
The income tax benefit on the compensation expense recognized for all stock-based compensation arrangements was $2.2 million, $2.4 million and
$2.6 million for the years ended May 31, 2025, 2024 and 2023, respectively. The income tax benefit for 2025, 2024 and 2023 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 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. 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, 2025, 2024 and 2023, 256,024, 282,237
and 149,778 shares, respectively, were issued at an average price of $5.31, $5.68 and $13.67, respectively, under the Stock Purchase Plan. As of May 31,
2025, 2.6 million shares remained available for future purchases under the Stock Purchase Plan.
14. EQUITY
On July 16, 2024, the Board of Directors approved a share repurchase program (the "Repurchase Program") under which they authorized the Company
the option to repurchase up to $15.0 million of its outstanding common stock. The timing and amount of any share repurchases under the authorization will
be determined by management within certain parameters and based on market conditions and other considerations. During the year ended May 31, 2025, the
Company repurchased 243,847 shares of common stock in the open market at an aggregate cost of $1.7 million under the Repurchase Program. There were
no share repurchases during the year ended May 31, 2024. As of May 31, 2025, $13.3 million remained available for repurchase under the Repurchase
Program.
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:
Year ended May 31,
2025
2024
2023
Basic
40,852,564
40,180,925
39,480,367
Effect of dilutive securities
—
—
—
Diluted
40,852,564
40,180,925
39,480,367
Securities excluded as their inclusion would be anti-dilutive
5,121,073
3,973,382
3,491,099
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 and warehousing. The Company has financing arrangements for manufacturing and distribution.
75
Financing Arrangement
On December 24, 2024, the Company entered into an agreement to sell the manufacturing facilities in Queensbury, NY and Glens Falls, NY for a
purchase price of $5.5 million and $1.2 million, respectively, and net proceeds of $5.2 million and $1.1 million, respectively. The Company simultaneously
entered into lease agreements with future lease payments of $4.6 million over seven years for the Queensbury, NY facility and $0.4 million over three years
for the Glens Falls, NY facility.
Based on certain criteria, the transaction was accounted for as a financing arrangement, as it did not meet the criteria for a sale-leaseback. As a result,
the assets remain in "Property, plant and equipment, net" on the Consolidated Balance Sheets at their historical book value and are depreciated over the term
of the lease agreements. A financing arrangement was recorded in the amount of the net proceeds received. The Company will recognize monthly rent as a
reduction of the finance arrangement and interest expense, using the effective interest rate method. No gain or loss was recognized related to the financing
arrangement for the twelve months ended May 31, 2025.
As of May 31, 2025, the carrying value of the financing arrangement was $6.2 million, of which $0.4 million was classified as "Other current
liabilities" and $5.8 million was classified as "Other long-term liabilities" on the Consolidated Balance Sheets. Interest expense associated with the financing
arrangement was $0.2 million for the twelve months ending May 31, 2025.
Remaining future cash payments related to the financing arrangement as of May 31, 2025 for each of the following fiscal years is:
(in thousands)
May 31, 2025
2026
$
800
2027
804
2028
745
2029
660
2030 and thereafter
1,705
Total minimum liability payments
$
4,714
Less: imputed interest
(2,028)
Total
$
2,686
Operating Leases
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)
Balance Sheet Location
May 31, 2025
May 31, 2024
Assets
Operating lease ROU assets
Other assets
$
3,850
$
5,804
Liabilities
Current operating lease liabilities
Other current liabilities
1,840
1,975
Non-current operating lease liabilities
Other long-term liabilities
2,106
3,939
Total lease liabilities
$
3,946
$
5,914
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:
May 31, 2025
May 31, 2024
Weighted average remaining term (in years)
2.77
3.43
Weighted average discount rate
4.8 %
4.7 %
The maturities of the lease liabilities for each of the following fiscal years is:
(in thousands)
May 31, 2025
2026
$
1,982
2027
985
2028
729
2029
515
2030 and thereafter
—
Total lease payments
$
4,211
Less: Imputed Interest
265
Total lease obligations
$
3,946
Less: Current portion of lease obligations
1,840
Long-term lease obligations
$
2,106
During the years ended May 31, 2025, 2024 and 2023 the Company recognized operating lease expense, which includes immaterial short-term leases,
of $2.6 million, $2.5 million and $2.7 million, respectively. The expenses on the Consolidated Statement of Operations were classified as follows:
(in thousands)
May 31, 2025
May 31, 2024
May 31, 2023
Cost of sales
$
896 $
866 $
881
Research and development
372
195
193
Sales and marketing
167
161
162
General and administrative
1,155
1,327
1,458
Acquisition, restructuring and other items, net
42
—
—
$
2,632 $
2,549 $
2,694
The following table presents supplemental cash flow and other information related to leases:
(in thousands)
May 31, 2025
May 31, 2024
Cash paid for amounts included in the measurement of lease liabilities
Operating cash flows from operating leases
$
2,207 $
2,142
ROU assets obtained in exchange for lease liabilities
Operating leases
—
3,057
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, 2025:
(in thousands)
Total
2026
2027
2028
2029
2030 and
thereafter
Royalties
$
32,380
$
3,620
$
3,620
$
3,620
$
3,620
$
17,900
$
32,380
$
3,620
$
3,620
$
3,620
$
3,620
$
17,900
(1) 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")).
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 Court entered Judgement on June 1, 2023 in
favor of the Company.
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. The Company counterclaimed, alleging that certain of Bard’s catheter products infringe U.S.
Patent Nos. 8,377,011, 10,729,881, 8,454,574.
On March 31, 2024, the Company and Bard’s parent company Becton, Dickinson and Company (collectively, “BD”) entered into a settlement
agreement (the “Settlement Agreement”) to resolve the ongoing litigations. Under the terms of the Settlement Agreement, BD granted a license to the
Company under certain of BD’s port patents and AngioDynamics granted BD a license under certain of the Company’s catheter patents. The Company made
a one-time lump sum payment to BD in the amount of $7.0 million, $3.0 million which was paid within 5 business days of execution of the Settlement
Agreement, and the remainder is payable in installments during 12 month period ending March 31, 2025. The Company will also make six minimum annual
payments to BD of $2.5 million starting in fiscal year 2025, and potential additional payments if six percent (6%) of annual net sales of the Company’s port
products exceed the minimum payment. The Company made payments of $6.5 million related to the minimum annual payments to BD during the fiscal year
ended May 31, 2025. The parties will participate in the pending appeal before the Federal Circuit of the case that was filed March 10, 2015 and a contingent
payment of $3.0 million will be due from the Company to BD if the Federal Circuit reverses or vacates the District Court’s findings of invalidity with
respect to the patent claims at issue in the case. Appellate briefing is closed, but an argument date has not yet been set. Neither party admitted any liability
and the agreement contains mutual covenants not to sue and releases. As of May 31, 2025, there was $2.5 million payable to BD recorded in other current
liabilities and $9.0 million recorded in other long-term liabilities.
Port Product Claims
As of May 31, 2025, the Company is defending approximately 162 product liability claims involving the Company's port products (collectively, the
“Port Product Claims”). The Port Product Claims are consolidated for pretrial proceedings in the United States District Court for the Southern District of
California. The Port Product Claims generally seek damages for personal injury allegedly resulting from use of the products. The Company has limited
information regarding the nature and quantity of certain of the Port Product Claims. The Company continues to receive claims and lawsuits and may in
future periods learn additional information regarding other unfiled or unknown claims, or other lawsuits, which could materially impact the Company’s
estimate of the number of claims or lawsuits against the Company.
(1)
78
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"), to evaluate performance and allocate resources. The Company manages its operations through two operating segments, Med Tech and Med
Device. The CEO evaluates these two operating segments based on gross margin to, among other items, allocate resources and assess performance. The
CEO uses gross margin in the budgeting and forecasting process to assess profitability and enable decision making regarding strategic initiatives,
investments and personnel across the two operating segments. Executives reporting to the CEO include those responsible for commercial operations,
manufacturing operations, regulatory and quality and certain corporate functions.
The Med Tech segment is comprised of our technology portfolio including Auryon, the thrombus management platform and NanoKnife. The Med
Device segment is comprised of our Core, Venous, Ports and other Oncology products.
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.
The table below summarizes net sales, cost of sales and gross margin by Med Tech and Med Device:
Year ended May 31,
(in thousands)
2025
2024
2023
Med Tech Net Sales
$
126,653
$
106,403
$
96,687
Med Tech Cost of Sales (exclusive of intangible amortization)
$
48,138
$
39,205
$
34,721
Gross Margin
$
78,515
$
67,198
$
61,966
Gross Margin %
62.0 %
63.2 %
64.1 %
Med Device Net Sales
$
165,845
$
197,511
$
242,065
Med Device Cost of Sales (exclusive of intangible amortization)
$
86,655
$
110,011
$
129,785
Gross Margin
$
79,190
$
87,500
$
112,280
Gross Margin %
47.7 %
44.3 %
46.4 %
Total Net Sales
$
292,498
$
303,914
$
338,752
Total Cost of Sales (exclusive of intangible amortization)
$
134,793
$
149,216
$
164,506
Gross Margin
$
157,705
$
154,698
$
174,246
Gross Margin %
53.9 %
50.9 %
51.4 %
Operating expenses
$
197,659
$
401,632
$
225,427
Gain on sale of assets
—
54,499
—
Other income (expense), net
5,922
797
(3,256)
Loss before income tax benefit
$
(34,032)
$
(191,638)
$
(54,437)
(1) Operating expenses include Research and development, Sales and marketing, General and administrative, Amortization of intangibles, Goodwill impairment, Change in
fair value of contingent consideration and Acquisition, restructuring and other items, net.
(2) Gain on sale of assets includes the gain on the sale of divested products.
(3) Other income (expense), net includes interest income, interest expense, foreign currency impacts and bank fees.
Geographic information
The table below summarizes net sales by geographic area based on external customer location:
(1)
(2)
(3)
79
Year ended May 31,
(in thousands)
2025
2024
2023
Net sales by Geography
United States
$
250,983
$
251,486
$
282,713
International
41,515
52,428
56,039
Total
$
292,498
$
303,914
$
338,752
For fiscal years 2025, 2024 and 2023, international sales as a percentage of total net sales were 14%, 17% and 17%, 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. 65% of long-lived assets are located within the United States and 34% are
located within Israel.
19. ACQUISITION, RESTRUCTURING AND OTHER ITEMS, NET
Acquisition, restructuring and other items, net consisted of:
Year ended May 31,
(in thousands)
2025
2024
2023
Legal
$
715
$
34,942
$
9,998
Mergers and acquisitions
737
399
368
Transition service agreement
(1,838)
(1,092)
—
Plant Closure
13,761
9,481
—
Manufacturing Relocation
—
587
1,091
Intangible and other asset impairment
—
6,260
—
Israeli Innovation Authority prepayment
—
—
3,544
Other
2,245
2,605
632
Total
$
15,620
$
53,182
$
15,633
(1) Legal expenses related to litigation that is outside the normal course of business. For the year ended May 31, 2024, a $19.3 million settlement expense was recorded as a
result of the Settlement Agreement that was entered into between the Company and BD.
(2) Mergers and acquisitions expenses related to investment banking, legal and due diligence.
(3) Transition services agreement that were entered into with Merit and Spectrum.
(4) Plant closure expense, related to the restructuring of our manufacturing footprint which was announced on January 5, 2024.
(5) Expenses to relocate manufacturing lines out of Queensbury, NY.
(6) An impairment of $3.4 million on intangible and fixed assets and an inventory write-off of $2.9 million was taken in the third quarter of fiscal year 2024 relating to the
abandonment of the Syntrax and RF product lines.
(7) 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.
(8) Included in the $2.2 million and $2.6 million in other for the years ended May 31, 2025 and 2024 is $0.9 million and $1.4 million, respectively, of severance due to
restructurings outside of the plant closure. In addition, for the year ended May 31, 2024, $0.9 million of deferred financing fees that were written-off in conjunction with the
divestiture of the Dialysis and BioSentry businesses and concurrent extinguishment of the debt.
Restructuring
The Company evaluates its performance and looks for opportunities to improve the overall operations of the Company on an ongoing basis. As a result
of this evaluation, certain restructuring initiatives are taken to enhance the Company’s overall operations. On January 5, 2024, the Company announced a
restructuring to optimize its manufacturing efficiency, capabilities and footprint (the "Plan").
In the second quarter of fiscal year 2025, the Company announced a modification to the Plan to maintain a presence in Queensbury, NY for the
manufacturing of select products, customer service, logistics, shipping, quality and regulatory operations. The restructuring activities associated with the
modified Plan are still expected to be completed in the third quarter of fiscal year 2026.
The following table provides a summary of our estimated costs associated with the plan:
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
80
Type of cost (in thousands)
Total original estimated amount expected to be incurred
Total modified estimated amount expected to be incurred
Facilities closeout fees
$
14,500
to
$
15,250
$
16,000 to $
17,000
Termination benefits
9,000
to
10,000
6,200 to
7,200
Outside consultants
9,000
to
10,000
7,500 to
8,500
Validation expenses
4,500
to
5,500
3,400 to
4,400
Regulatory filings
750
to
1,250
150 to
650
Other
750
to
1,250
150 to
650
$
38,500
to
$
43,250
$
33,400 to $
38,400
(1) Included in the original and modified estimate is approximately $13.6 million and $13.3 million of non-cash charges for accelerated depreciation and building impairment.
The Company recorded restructuring charges related to the Plan during the years ended May 31, 2025 and 2024 of $13.8 million and $9.5 million,
respectively. Total restructuring charges recorded to date are $23.2 million. Termination benefits are only earned if an employee stays until their termination
date; therefore, the expenses related to termination benefits are being recorded ratably over the service period.
The table below presents the restructuring reserve for the twelve months ending May 31, 2025:
May 31, 2025
Termination
Benefits
Outside
Consultants
Validation
Expenses
Facilities
Closeout Fees
Regulatory
Filings
Other
Total
(in thousands)
Balance at May 31, 2024
$
568 $
1,153 $
373 $
—
$
6 $
20 $
2,120
Charges
$
1,555 $
5,646 $
1,769 $
3,381
$
72 $
1,338 $
13,761
Non-cash adjustments
$
— $
— $
— $
(3,381)
$
— $
— $
(3,381)
Cash payments
$
(1,494) $
(6,177) $
(2,056) $
—
$
(78) $
(1,192) $
(10,997)
Balance at May 31, 2025
$
629 $
622 $
86 $
—
$
— $
166 $
1,503
AngioDynamics, Inc. and Subsidiaries
(in thousands)
SCHEDULE II -VALUATION AND QUALIFYING ACCOUNTS
Description
Balance at Beginning
of Year
Additions - Charged to
costs and expenses
Deductions
Balance at
End of Period
Year Ended May 31, 2023
Allowance for deferred tax asset
$
20,203
$
5,556
$
—
$
25,759
Allowance for sales returns and doubtful accounts
$
1,939
$
457
$
(246)
$
2,150
Year Ended May 31, 2024
Allowance for deferred tax asset
$
25,759
$
26,921
$
—
$
52,680
Allowance for sales returns and doubtful accounts
$
2,150
$
1,073
$
(1,082)
$
2,141
Year Ended May 31, 2025
Allowance for deferred tax asset
$
52,680
$
5,760
$
—
$
58,440
Allowance for sales returns and doubtful accounts
$
2,141
$
886
$
(812)
$
2,215
(1)
81
EXHIBITS
Incorporated by Reference
Exhibit
Number
Description of Exhibits
Form
Exhibit
Filing Date
2.2
Asset Purchase Agreement dated as of June 8, 2023 by and between
AngioDynamics, Inc. and Merit Medical Systems, Inc.
8-K
2.4
June 14, 2023
3.1.1
Amended and Restated Certificate of Incorporation.
10-Q
3.1
October 7, 2005
3.1.2
Certificate of Amendment to the Amended and Restated Certificate of
Incorporation of AngioDynamics, Inc.
10-K
3.1.2
August 10, 2015
3.2
Second Amended and Restated By-Laws, effective October 16, 2015.
8-K
10.1
October 21, 2015
10.1
Credit Agreement, dated as of May 28, 2025, by and among
AngioDynamics, Inc., RITA Medical Systems, LLC, the lenders party
thereto, JPMorgan Chase Bank, N.A., individually and as administrative
agent, issuing bank and swingline lender.
8-K
10.1
May 28, 2025
10.1.3
AngioDynamics, Inc. 2004 Stock and Incentive Award Plan (as
amended).
DEF 14A
August 30, 2018
10.1.6
AngioDynamics 2017 Total Shareholder Return Performance Unit
Agreement Program.
10-Q
10.1
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
AngioDynamics 2019 Total Shareholder Return Performance Unit
Agreement Program.
10-Q
10.1.8
January 8, 2020
10.1.9
AngioDynamics, Inc. 2020 Stock and Incentive Award Plan (as
amended)
DEF 14A
September 28,
2023
10.2
AngioDynamics, Inc. Employee Stock Purchase Plan (as amended).
DEF 14A
September 3,
2020
10.3
Form of Non-Statutory Stock Option Agreement pursuant to the
AngioDynamics, Inc. Stock and Incentive Award Plan.
10-Q
10.1
October 12, 2004
10.3.1
Form of Non-Statutory Stock Option Agreement pursuant to the
AngioDynamics, Inc. Stock and Incentive Award Plan.
10-K
10.3.1
July 23, 2018
10.4.3
Form of 2016 Performance Share Award Agreement pursuant to the
AngioDynamics, Inc. 2004 Stock and Incentive Award Plan.
10-Q
10.2
October 5, 2016
10.4.4
Form of 2017 Performance Share Award Agreement pursuant to the
AngioDynamics, Inc. 2004 Stock and Incentive Award Plan.
10-Q
10.2
September 29,
2017
10.4.5
Form of 2018 Performance Share Award Agreement pursuant to the
AngioDynamics, Inc. 2004 Stock and Incentive Award Plan.
10-K
10.4.5
July 23, 2018
10.4.6
Form of 2020 Performance Share Award Agreement pursuant to the
AngioDynamics, Inc. 2004 Stock and Incentive Award Plan
10-Q
10.4.6
January 8, 2021
10.4.7
Form of Performance Share Award Agreement pursuant to the 2020
Stock and Incentive Award Plan
10-Q
10.4.7
September 30,
2021
10.5
Form of Restricted Stock Award Agreement pursuant to the
AngioDynamics, Inc. 2004 Stock and Incentive Award Plan.
8-K
10.3
May 12, 2005
10.6
Rita Medical Systems, Inc. 1994 Incentive Stock Plan.
S-1
10.2
May 3, 2000
10.7
Horizon Medical Products, Inc. 1998 Stock Incentive Plan.
S-1
10.11
February 13,
1998
10.8
Rita Medical Systems, Inc. 2000 Stock Plan.
S-1/A
10.3
June 14, 2000
10.9
Rita Medical Systems, Inc. 2000 Directors’ Stock Plan, as amended on
June 8, 2005.
S-8
99.2
July 8, 2005
82
Incorporated by Reference
Exhibit
Number
Description of Exhibits
Form
Exhibit
Filing Date
10.10
Rita Medical Systems, Inc. 2005 Stock and Incentive Plan.
S-8
99.1
July 8, 2005
10.11
Form of Indemnification Agreement of AngioDynamics, Inc.
8-K
10.1
May 12, 2006
10.11.1
Employment Agreement, dated April 1, 2016, between
AngioDynamics, Inc. and James C. Clemmer.
8-K
10.1
April 6, 2016
10.12
Change in Control Agreement, dated April 1, 2016, between
AngioDynamics, Inc. and James C. Clemmer.
8-K
10.2
April 6, 2016
10.12.2
Form of Severance Agreement of AngioDynamics, Inc.
10-K
10.12.2
August 10, 2020
10.13
Form of Change in Control Agreement.
10-K/A
10.13
January 12, 2015
10.14
Performance Share Award Agreement, with a grant date of April 4,
2016, between AngioDynamics, Inc. and James C. Clemmer.
8-K
10.3
April 6, 2016
10.15
AngioDynamics, Inc. Total Shareholder Return Performance Share
Award Program - Performance Period Ending July 2019.
8-K
10.4
April 6, 2016
10.16
Stock Option Award Agreement, with a grant date of April 4, 2016,
between AngioDynamics, Inc. and James C. Clemmer.
8-K
10.5
April 6, 2016
10.17
Restricted Stock Unit Award Agreement, with a grant date of April 4,
2016, between AngioDynamics, Inc. and James C. Clemmer.
8-K
10.6
April 6, 2016
10.18
Separation Agreement and General Release, dated April 22, 2016,
between AngioDynamics, Inc. and Joseph M. DeVivo.
8-K
10.1
April 27, 2016
10.19
Amended and Restated Change in Control Agreement, by and between
AngioDynamics, Inc. and James C. Clemmer.
8-K
10.1
February 3, 2021
10.2
Form of Amended and Restated Change in Control Agreement with
AngioDynamics, Inc.
8-K
10.2
February 3, 2021
10.21*
Settlement and License Agreement, dated March 31, 2024, by and
among Becton, Dickinson and Company, C.R. Bard, Inc., Bard
Peripheral Vascular, Inc. and AngioDynamics Inc.
10-K
10.21
July 25, 2024
14
Code of Ethics.
10-K
14
October 1, 2021
19
Insider Trading Policy
21
Subsidiaries
23
Consent of Deloitte & Touche LLP, an independent registered public accounting firm.
31.1
Certification by the Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2
Certification by the Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1
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.
32.2
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.
97
Clawback Policy
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
*Certain exhibits and schedules have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The registrant undertakes to furnish supplementally a copy
of any omitted exhibit or schedule upon request by the SEC.
83
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on
its behalf by the undersigned, thereunto duly authorized.
ANGIODYNAMICS, INC.
Date:
July 18, 2025
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:
July 18, 2025
/S/ HOWARD W. DONNELLY
Howard W. Donnelly,
Chairman of the Board, Director
Date:
July 18, 2025
/S/ JAMES C. CLEMMER
James C. Clemmer,
President, Chief Executive Officer
(Principal Executive Officer)
Date:
July 18, 2025
/S/ STEPHEN A. TROWBRIDGE
Stephen A. Trowbridge,
Executive Vice President, Chief Financial Officer,
(Principal Financial and Accounting Officer)
Date:
July 18, 2025
/S/ WESLEY E. JOHNSON, JR.
Wesley E. Johnson, Jr.,
Director
Date:
July 18, 2025
/S/ JAN S. REED
Jan S. Reed,
Director
Date:
July 18, 2025
/S/ EILEEN O. AUEN
Eileen O. Auen,
Director
Date:
July 18, 2025
/S/ KAREN A. LICITRA
Karen A. Licitra,
Director
Date:
July 18, 2025
/S/ MICHAEL E. TARNOFF
Michael E. Tarnoff,
Director
Date:
July 18, 2025
/S/ LORINDA A. BURGESS
Lorinda A. Burgess,
Director
84
Title: Insider Trading Policy
Function: Law
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Insider Trading Policy
Purpose
As a public company, AngioDynamics Inc. (the “Company”) is subject to various Federal and state laws and regulations
governing trading in its securities. The Company’s policy is to comply fully, and to assist its directors and employees in
complying fully, with these laws and regulations.
The Company has established this Insider Trading Policy (the “Policy”) to provide procedures and guidelines with respect to
transactions in the Company’s securities and the protection of material non- public information, to protect its directors and
employees from violating the law when buying or selling the Company’s securities and to prevent any appearance of impropriety.
It is important that all directors and employees read and understand this Policy to ensure compliance with the applicable laws.
The Company depends upon the conduct and diligence of its directors and employees, in both their professional and personal
capacities, to ensure full compliance with this Policy.
Scope
This Policy applies to all members of the Company’s Board of Directors (the “Board”), employees, consultants, and such other
people who gain access to material non-public information because of their relationship with the Company, as well as members
of such persons’ immediate families and households and certain other affiliated persons, as more fully described in the Who Is
Covered? section. This Policy applies to both domestic and international employees of the Company and its subsidiaries.
Company policy subjects its directors and certain covered employees to additional restrictions because of their access to
confidential information on a regular basis. All references in this Policy to employees of the Company should be read to include
all such persons listed in the Who Is Covered? section. It is the personal obligation and responsibility of each director, employee,
and consultant to act in a manner consistent with this Policy.
Definitions
Insider Trading
Insider trading generally involves (1) the purchase or sale of Company securities while in possession of material non-public
information; (2) disclosing or “tipping” material non-public information to others or recommending the purchase or sale of
securities based on such information; or (3) assisting someone who is engaged in any of the above activities. Additionally, the
prohibition on insider trading is not limited to trading in Company securities, and includes trading in the securities of other
companies, such as the Company’s customers, suppliers, strategic partners, and competitors.
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Non-Public Information
Information about the Company is non-public if it is generally not known to the public or if it has not been disseminated in a
manner making it available to investors generally. To show that information is “public”, there must be evidence that it is widely
disseminated and absorbed by the marketplace.
Generally, information should not be considered fully absorbed by the marketplace until after the second business day
following public release of such information. Examples of public dissemination include, without limitation, a press release or
filing of a reporting document, such as Form 8-K, 10-Q, or 10-K, with the U.S. Securities and Exchange Commission (the
“SEC”). During the period that material information relating to the business or affairs of the Company is unavailable to the
general public, it must be kept in strict confidence. Accordingly, such information should be discussed with persons who have
a “need to know,” and should be confined to as small a group as possible.
Material Information
Information is material if there is a substantial likelihood that a reasonable investor would consider it important in deciding
whether to buy or sell securities. While information that would affect the market price of the Company’s stock or value of the
Company is material in all cases, information that does not have any direct or quantifiable effect on stock price or value may also
be material. As a practical matter, materiality often is determined after the fact, when it is known that someone has traded on the
information and after the information itself has been made public and its effects upon the market are more certain. Examples of
information that might be “material” include without limitation:
(a) financial results, reports or projections, including without limitation sales, earnings, unusual write-offs, write-downs,
impairment charges, profit and losses;
(b) information about current, proposed or contemplated transactions, business plans, financial restructuring;
(c) proposed or contemplated issuance, redemption or repurchase of Company stock as well as tender offers,
recapitalizations, dividends, stock splits and reverse splits;
(d) significant expansions or contractions of operations and facilities;
(e) pending research, development and discoveries relating to new products or potential products;
(f) significant increases or decreases in business or information relating to major contracts;
(g) institution of, or developments in, major litigation, investigations or other regulatory actions or proceedings;
(h) developments regarding senior management or the Board;
(i) material defaults under agreements or actions by creditors, clients or suppliers;
(j) extraordinary borrowings or liquidity problems;
(k) discussions, negotiations or agreements regarding potential mergers, acquisitions, divestitures, sale or purchase of
substantial assets, major license and distribution agreements;
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(l) execution, amendment or termination (other than in accordance with its terms) of a material definitive agreement not
made in the ordinary course of the Company’s business;
(m) creation of, or triggering events that accelerate or increase, a material direct financial obligation or a material obligation
under an off-balance sheet arrangement, whether or not the Company is party to the agreement;
(n) the Board (or officers where Board approval is not required) definitively committing the Company to an exit or
disposal plan under which material charges will be incurred under Generally Accepted Accounting Principles
(“GAAP”);
(o) determination by the Board (or officers where Board approval is not required) that the Company is required to record a
material impairment charge under GAAP;
(p) determination by the Board (or officers where Board approval is not required) that investors should no longer rely
on previously issued financial statements or a related audit report or completed interim review by independent
accounts or changes in auditors;
(q) notice from a national securities exchange or Nasdaq that the Company or its securities do not satisfy its listing
standards or have been delisted;
(r) actual or potential cybersecurity risks, incidents or events that affect the Company or third-party providers that support
the Company’s business operations, including computer system or network compromises, viruses or other destructive
software and data breach incidents that may disclose personal, business, or other confidential information; and
(s) commencement, termination, or results of any pending or future clinical trials and the status of any regulatory
clearances.
By including the list above, the Company does not mean to imply that each of these items above is per se material. The
information and events on this list still require determinations as to their materiality (although some determinations will be
reached more easily than others). There is no clear definition of what information is deemed to be “material”. Assessment of
materiality involves a fact specific inquiry. For this reason, if employees have any questions about whether a particular piece of
information is “material” or whether it is “public”, they should ask the General Counsel before they buy or sell Company stock.
References
The Securities Exchange Act of 1934 (“1934 Act”) was enacted, in part, in response to the insider trading abuses believed to
have contributed to the stock market crash of 1929. The 1934 Act addressed insider trading directly through Section 16(b) and
indirectly through Section 10(b) and Rule 10b-5 thereunder. Criminal prosecutions for insider trading are commonplace and
may result in fines and/or imprisonment.
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Responsibilities
Executive Leadership Team and Vice Presidents (“Management”)
On an ongoing basis, Management is responsible for:
(a) Identifying individuals within their areas of responsibility who will be entrusted with material non-public information.
(b) Notifying the General Counsel of the list of individuals and updating this list as needed.
(c) Notifying all individuals to the extent they become a Covered Persons (i.e., insider) due to the material non-public
information that they are entrusted with.
(d) Instructing all Covered Persons that they cannot discuss this material non-public information with anyone, including
immediate family or friends, under penalty of violation of Section 10(b) of the 1934 Act and Rule 10b-5 thereunder.
These individuals could face jail time as well as fines of up to three times the profit that they or the person they tipped
made on the transaction.
Window Period Notices
On an ongoing basis, the General Counsel or his/her designee shall notify all Covered Persons as to when trading windows
are open and closed and instruct all Covered Person to buy and sell Company stock only during such open windows.
Notwithstanding any open window period, trading when in possession of material non-public information is prohibited and
illegal (see the General Prohibition on “Insider Trading” section).
Human Resources
On an ongoing basis, Human Resources will ensure all newly hired employees are trained on this Policy as part of their new
hire orientation, and that such employees acknowledge receipt of this Policy in accordance with the Company’s policies and
procedures and that such acknowledgment is maintained in their employee files.
Policy
General Prohibition on “Insider Trading”
Federal securities laws prohibit the trading of securities while in possession of “material non-public” information. If a director or
employee is in possession of material non-public information, such person may not buy or sell Company stock (including
common stock, preferred stock, convertible debentures, warrants, exchange-traded options or other derivative securities),
other than pursuant to a pre- approved trading plan that complies with SEC Rule 10b5-1, and may not recommend the
Company’s stock to a third party. In addition, directors and employees of the Company who, while working for the
Title: Insider Trading Policy
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Company, learn of material non-public information provided by a third party to the Company, including any customer or supplier
of the Company, may not buy or sell such third-party security.
Who is Covered?
The prohibition on insider trading applies to all directors and employees of the Company, both officers and non-officers, family
members or other persons who reside in their households, family members who do not live in their households but whose
securities transactions are directed by them or are subject to their influence or control, and all trusts, family partnerships, and
other types of entities formed for their benefit or for the benefit of a member of their family and all investment funds, trusts,
retirement plans, partnerships, corporations and other types of entities in each case over which they have the ability to
influence or direct investment decisions concerning securities, as well as anyone who receives such information from an
employee of the Company, including consultants and advisors. An employee is prohibited from disclosing or disseminating to
anyone, even immediate family members or close friends, any material non-public information obtained while working for the
Company, whether relating to the Company or another third party.
Transactions under Company Plans
Generally, this Policy does not apply to the exercise of an employee stock option, or to the exercise of a tax withholding right
pursuant to which you elect to have the Company withhold shares subject to an option to satisfy tax-withholding requirements.
This Policy does apply, however, to any sale of stock as part of a broker-assisted cashless exercise of an option, or any other
market sale for the purpose of generating the cash needed to pay the exercise price of an option.
This Policy does not apply to purchases of Company stock in the employee stock purchase plan resulting from your periodic
contribution of money to the plan pursuant to the election you made at the time of your enrollment in the plan. This Policy does
apply to your election to participate in the employee stock purchase plan for any enrollment period, and to your sales of
Company stock purchased pursuant to such plan.
Gifts
Generally, bona fide gifts of securities are not deemed to be transactions for the purposes of this Policy. Whether a gift is truly
bona fide will depend on the circumstances surrounding a specific gift. The more unrelated the donee is to the donor, the more
likely the gift would be considered “bona fide” and not a “transaction.” For example, gifts to charities, churches or non-profit
organizations would not be deemed to be “transactions.” However, gifts to dependent children followed by a sale of the “gifted
securities” near the time of the gift may imply some economic benefit to the donor and, therefore, may be deemed to be a
“transaction” and not a “bona fide gift.”
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Additional Prohibited Transactions by Definition
The Company considers it improper and inappropriate for any director, officer, or other employee of the Company to engage in
short-term or speculative transactions in the Company’s securities. Under this Policy, directors, officers, and other employees
may not engage in any of the following transactions.
Short Sales
Short sales of the Company’s securities evidence an expectation on the part of the seller that the securities will decline in
value, and therefore signal to the market that the seller has no confidence in the Company or its short-term prospects. In
addition, short sales may reduce the seller’s incentive to improve the Company’s performance. For these reasons, short sales
of the Company’s securities are prohibited by this Policy. In addition, Section 16(c) of the 1934 Act prohibits officers and
directors from engaging in short sales.
Publicly Traded Options
A transaction in options is, in effect, a bet on the short-term movement of the Company’s stock and therefore creates the
appearance that the director or employee is trading based on inside information. Transactions in options also may focus the
director or employee’s attention on short-term performance at the expense of the Company’s long-term objectives.
Accordingly, transactions in puts, calls, or other derivative securities, on an exchange or in any other organized market, are
prohibited by this Policy.
Hedging Transactions
Certain forms of hedging or monetization transactions, such as zero-cost dollars and forward sale contracts, allow an individual
to lock in much of the value of their stock holdings, often in exchange for all or part of the potential for upside appreciation in
the stock. These transactions allow the director or employee to continue to own the covered securities, but without the full risks
and rewards of ownership. When that occurs, the director of employee may no longer have the same objectives as the
Company’s other shareholders. Therefore, directors and employees are prohibited from engaging in any such transactions.
Margin Accounts and Pledges
Securities held in a margin account may be sold by the broker without the holder’s consent if the holder fails to meet a margin
call. Similarly, securities pledged (or hypothecated) as collateral for a loan may be sold in foreclosure if the borrower defaults
on the loan. Because a margin sale or foreclosure sale may occur at a time when the pledgor is aware of material non-public
information or otherwise is not permitted to trade in Company securities, directors, officers, and other employees are prohibited
from holding Company securities in a margin account or pledging Company securities as collateral for a loan. An exception to
this prohibition may be granted where a person wishes to pledge Company securities as collateral for a loan (not including
margin debt) and clearly demonstrates the financial capacity to repay the loan without resort to the pledged securities. Any
person who wishes to pledge Company securities as collateral for a loan must submit a request for approval to the General
Counsel at least two weeks prior to the proposed execution of documents evidencing the proposed pledge.
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No Tipping
No director or employee shall disclose (“tip”) material non-public information to any other person where such information could
potentially be used by such person to their benefit by trading in the securities of the Company to which such information
relates, nor shall any director or employee make any recommendations or express any opinions as to trading in the
Company’s securities, or the securities of any other third party, to any other person based on material non-public information.
What are the Penalties for Violating this Policy?
The consequences of violating this Policy and the Federal securities laws are likely to be severe. Both the SEC and the
national securities exchanges, through the Financial Industry Regulatory Authority, investigate and are very effective at
detecting insider trading. The SEC, together with the U.S. Attorneys, pursue insider trading violations vigorously. For instance,
cases have been successfully prosecuted against trading by employees in foreign accounts, trading by family members and
friends, and trading involving only a small number of shares. In addition to possible termination of your employment, persons
found to have violated the law and bought or sold securities while in possession of material
non-public information, or passed such information on to others, are subject to both civil action and criminal prosecution. Civil
penalties may include cease and desist orders, disgorgement of profits and fines of up to three times the profit gained or loss
avoided as a result of the unlawful sale or purchase. Criminal sanctions may include fines of up to $5 million for individuals
and/or imprisonment of up to 20 years, or both.
Pre-Clearance Procedures
To help prevent inadvertent violations of the Federal securities laws and to avoid even the appearance of trading on inside
information, directors, Management, and certain designated employees and consultants of the Company and its subsidiaries
(collectively “Covered Persons”) who have access to material non-public information about the Company, together with their
family members and other members of their household, may not engage in any transaction involving the Company’s securities
(including a stock plan transaction such as an option exercise, a gift, a contribution to a trust or any other transfer) without first
obtaining pre-clearance of the transaction from the Company’s General Counsel. A request for pre-clearance should be
submitted to the General Counsel on the day of the proposed transaction. The General Counsel is under no obligation to
approve a trade submitted for pre- clearance and may determine not to permit the trade. The General Counsel may not trade
in Company securities unless the Chief Executive Officer has approved the trade(s) in accordance with the procedures set
forth in this Policy. Any Covered Person who wishes to implement a trading plan under SEC Rule 10b5-1 must first pre-clear
the plan with the General Counsel. Any pre-clearance approval granted by the General Counsel is only good for the specific
day it is given. If the trade does not take place on the specific day approval is given, then the request must be resubmitted for
approval. Any transactions in the Company’s securities by a Covered Person must be reported to the General Counsel on the
same day in which such a transaction occurs.
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Additionally, officers and directors of the Company must continue to comply with the other SEC reporting requirements and
procedures associated with such transactions.
Blackout Procedures
All directors, executive officers, and Covered Persons are subject to the following blackout procedures.
Quarterly Blackout Periods
The Company’s announcement of its quarterly or year-end financial results has the potential to have a material effect on the
market for the Company’s securities. Therefore, to avoid even the appearance of trading based on material non-public
information, you may only trade during open window periods upon notice and subject to pre-clearance (see Window Period
Notices and Pre-Clearance Procedures sections), which will generally begin on the second business day following the
Company’s announcement of quarterly or year-end financial results and end on the last day of the second month following the
end of the then current quarter or fiscal year end. All other periods shall be blackout periods and you may not trade in the
Company’s securities. Persons subject to these quarterly blackout periods include the Board, Management, and all other
persons who are informed by the General Counsel that they are Covered Persons and subject to the quarterly blackout
periods. The trading window may be opened or closed in the Company’s sole discretion.
Interim Earnings Guidance and Event-Specific Blackouts
The Company may on occasion issue interim earnings guidance or other potentially material information by means of a press
release, SEC filing on Form 8-K or other means designed to achieve widespread dissemination of the information. You should
anticipate that trading will be blacked out while the Company is in the process of assembling the information to be released
and until the information has been released and fully absorbed by the market. Please contact the General Counsel to the
extent there is any doubt as to whether a blackout is currently in effect.
Other Material Events
From time to time, an event may occur that is material to the Company and is known by only a few directors or executives. So
long as the event remains material and non-public, the persons who are aware of the event, as well as other persons covered
by the quarterly earnings blackout procedures, may not trade in the Company’s securities. The existence of an event-specific
blackout may not be announced, other than to those who are aware of the event giving rise to the blackout. If, however, a
person whose trades are subject to pre-clearance requests permission to trade in the Company’s securities during an event-
specific blackout, the General Counsel may inform the requesting person of the existence of a blackout period, without
disclosing the reason for the blackout. Any person made aware of the existence of an event-specific blackout is prohibited
from disclosing the existence of the blackout to any other person. The failure of the General Counsel to designate a person as
being subject to an event-specific blackout will not relieve that person of the obligation not to trade while aware of material
non-public information. Please contact the General Counsel to the extent there is any doubt as to whether an event-specific
blackout is currently in effect.
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Directors and executive officers may also be subject to event-specific blackouts pursuant to the SEC’s Regulation Blackout
Trading Restriction, which prohibits certain sales and other transfers by insiders during certain pension plan blackout periods.
Hardship Exceptions
A Covered Person who is subject to a quarterly earnings blackout period and who has an unexpected and urgent need to sell
Company stock to generate cash may, in appropriate circumstances, be permitted to sell Company stock even during the
quarterly blackout period. Hardship exceptions may be granted only by the General Counsel and must be requested at least
two days in advance of the proposed trade. A hardship exception may be granted only if the General Counsel concludes that
the Company’s earnings information for the applicable quarter does not constitute material non-public information. Under no
circumstance will a hardship exception be granted during an event-specific blackout period or to a director or executive officer.
Unless approved by the General Counsel, a hardship exception shall not justify your noncompliance with this Policy. As a
general rule, transactions that may be necessary or justifiable for independent reasons (such as the need to raise money for an
emergency expenditure) are not exceptions to this Policy. The federal securities laws do not recognize such mitigating
circumstances, and, in any event, even the appearance of an improper transaction must be avoided to preserve the
Company’s reputation for adhering to the highest standards of conduct. Even in the event the General Counsel grants a
hardship exception, no person shall be permitted to buy or sell the Company’s securities to the extent such person is in
possession of material non-public information.
Exception for Approved 10b5-1 Plans
Trades by Covered Persons in the Company’s securities that are executed pursuant to an approved 10b5-1 plan are not
subject to the prohibition on trading based on material non-public information contained in this Policy or to the restrictions
set forth above relating to Pre-Clearance Procedures and blackout periods.
Rule 10b5-1 provides an affirmative defense from insider trading liability under the federal securities laws for trading plans that
meet certain requirements. In general, a 10b5-1 plan must be entered into during an open window and when you are not
aware of material non-public information. Once the plan is adopted, you must not exercise any influence over the amount of
securities to be traded, the price at which they are to be traded or the date of the trade. The plan must either specify (including
by formula) the amount, pricing, and timing of transactions in advance or delegate discretion on those matters to an
independent third party.
The Company requires that all 10b5-1 plans be approved in writing in advance by the General Counsel. The General Counsel
may refuse to approve a 10b5-1 plan and may require amendments to any pre- approved 10b5-1 plan in his or her sole
discretion, including in response to any changes in Federal securities laws. Any modification to a previously approved 10b5-1
plan must be approved in writing in advance by the General Counsel and must occur during a trading window and while a
person is not aware of any material non-public information.
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Post-Termination Transactions
If you are aware of material non-public information when you terminate employment or services, you may not trade in the
Company’s securities until that information has become public or is no longer material. In all other respects, the procedures set
forth in this Policy will cease to apply to your transactions in Company securities upon the expiration of any “blackout period”
that is applicable to your transactions at the time of your termination of employment or services.
Acknowledgement; Amendment
This Policy will be delivered to all directors and employees who must acknowledge receipt and agree to comply with the terms
of this Policy. You acknowledge that you may be required upon the Company’s request to re-acknowledge and agree to
comply with this Policy (including any amendments or modifications). For such purpose, an individual will be deemed to have
acknowledged and agreed to comply with this Policy, as amended from time to time, when copies of such items have been
delivered by regular or electronic mail (or other delivery option used by the Company) or otherwise provided to you by the
General Counsel or his or her designee.
The Company may at any time change this Policy or adopt such other policies or procedures which it considers appropriate to
carry out the purposes of its policies regarding insider trading and the disclosure of material, non-public information.
Questions/Reporting Concerns
If you have questions or concerns about our Insider Trading Policy, we offer the following resources:
•
The Compliance Team (compliance@angiodynamics.com) or Law Department
(legal@angiodynamics.com)
•
People you can talk to: Managers, Supervisors, or the Human Resources Team
•
Compliance Hotline, 24 hours a day, 7 days a week at 1-877-325-3781 or online at
angiodynamics.ethicspoint.com
AngioDynamics will not tolerate any kind of retaliation against anyone who asks questions or reports a concern in good faith.
Anyone who engages in retaliation against someone who asks questions or voices a concern will face discipline.
Exhibit 21
Subsidiaries of AngioDynamics, Inc.
Subsidiary
State of Incorporation or Organization
AngioDynamics UK Limited
United Kingdom
AngioDynamics Netherlands B. V.
Netherlands
RITA Medical Systems, LLC
Delaware
AngioDynamics France, SARL
France
AngioDynamics Canada Inc.
Canada
AngioDynamics Medical Brasil Servicos de Marketing Ltda.
Brazil
Eximo Medical, Ltd.
Israel
AngioDynamics Italy S.r.l
Italy
Exhibit 23
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We consent to the incorporation by reference in Registration Statement Nos. 333-120053, 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 July 18, 2025, 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, 2025.
/s/ Deloitte & Touche LLP
Boston, Massachusetts
July 18, 2025
Exhibit 31.1
CERTIFICATION
I, James C. Clemmer, certify that:
1.
I have reviewed this annual report on Form 10-K of AngioDynamics, Inc.;
2.
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;
3.
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;
4.
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:
(a)
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;
(b)
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;
(c)
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
(d)
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
5.
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):
(a)
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
(b)
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: July 18, 2025
/ S / JAMES C. CLEMMER
James C. Clemmer, President,
Chief Executive Officer
Exhibit 31.2
CERTIFICATION
I, Stephen A. Trowbridge, certify that:
1.
I have reviewed this annual report on Form 10-K of AngioDynamics, Inc.;
2.
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;
3.
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;
4.
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:
(a)
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;
(b)
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;
(c)
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
(d)
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
5.
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):
(a)
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
(b)
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: July 18, 2025
/ S / STEPHEN A. TROWBRIDGE
Stephen A. Trowbridge, Executive Vice President,
Chief Financial Officer
Exhibit 32.1
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
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, 2025 (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: July 18, 2025
/S/ JAMES C. CLEMMER
James C. Clemmer, President,
Chief Executive Officer
Exhibit 32.2
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
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, 2025 (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: July 18, 2025
/S/ STEPHEN A. TROWBRIDGE
Stephen A. Trowbridge, Executive Vice President,
Chief Financial Officer
Privileged and Confidential
AngioDynamics, Inc.
Executive Compensation Recoupment Policy
(Effective October 2, 2023)
This policy (“Policy”) sets forth the conditions under which AngioDynamics, Inc. (the “Company”) will seek reimbursement of certain
compensation paid or payable to current or former executive officers of the Company who are subject to recoupment pursuant to this Policy
(“Grantees”). Except to the extent otherwise expressly provided below, the Policy as set forth herein shall become effective October 2, 2023
(the “Effective Date”). This Policy applies in addition to any other compensation recoupment policy that the Company may maintain from
time to time and shall control in the event of any inconsistency with any other such policy.
A. In General
Clause (vii) below defines certain capitalized terms that are used but not otherwise defined in this Policy.
(i) Except as provided below in this Policy, the Company will recover reasonably promptly the amount of erroneously awarded Incentive-
Based Compensation (“Erroneously Awarded Compensation”) in the event that the Company is required to prepare an accounting restatement
due to the material noncompliance of the Company with any financial reporting requirement under the United States securities laws, including
any required accounting restatement to correct an error in previously issued financial statements that is material to the previously issued
financial statements, or that would result in a material misstatement if the error were corrected in the current period or left uncorrected in the
current period.
(ii) This Policy applies only to Incentive-Based Compensation that is Received by an individual: (a) after beginning service as an
Executive Officer; (b) who served as an Executive Officer at any time during the performance period for the applicable Incentive-Based
Compensation; and (c) during the three completed fiscal years immediately preceding the date that the Company is required to prepare an
accounting restatement described in clause (i) above (together with any transition period resulting from a change in the Company’s fiscal year
within or immediately following those three completed fiscal years, provided that any transition period between the last day of the Company’s
previous fiscal year end and the first day of its new fiscal year that comprises a period of nine to 12 months shall be deemed a completed fiscal
year), regardless whether or when the restated financial statements are filed.
(iii) For purposes of this Policy, Erroneously Awarded Compensation is the amount of Incentive-Based Compensation that is Received
that exceeds the amount of Incentive-Based Compensation that otherwise would have been Received had it been determined based on the
restated amounts, computed without regard to any taxes paid. For Incentive-Based Compensation based on stock price or total shareholder
return, where the amount of Erroneously Awarded Compensation is not subject to mathematical recalculation directly from the information in
an accounting restatement, the amount shall be based on a reasonable estimate of the effect of the accounting restatement on the stock price or
total shareholder return upon which the Incentive-Based Compensation was Received, and the Company shall maintain documentation of that
reasonable estimate and provide such documentation to The Nasdaq Stock Market LLC (the “Exchange”).
(iv) For purposes of this Policy, the date that the Company is required to prepare an accounting restatement as described in clause (i)
above is the earlier to occur of: (a) the date the Board of Directors of the Company (the “Board”), a committee of the Board, or the officer or
officers of the Company authorized to take such action if Board action is not required, concludes, or reasonably should have concluded, that
the Company is required to prepare an accounting restatement as described in clause (i) above; or (b) the date a court, regulator, or other
legally authorized body directs the Company to prepare an accounting restatement as described in clause (i) above.
(v) The requirements of clause (i) above shall not apply if the Compensation Committee of the Board (the “Compensation Committee”) or
a majority of the independent directors serving on the Board determine that recovery would be impracticable in any of the following
circumstances: (a) the direct expense paid to a third party to assist in enforcing this Policy would exceed the amount to be recovered, provided
the Company has made a reasonable attempt to recover such Erroneously Awarded Compensation, has documented such reasonable attempt(s)
to recover, and has provided that documentation to the Exchange; (b) recovery would violate home country law where that law was adopted
prior to November 28, 2022, provided that the Company has obtained an opinion of home country counsel, acceptable to the Exchange, that
recovery would result in such a violation and has provided such opinion to the Exchange; or (c) recovery would likely cause an otherwise tax-
qualified retirement plan, under which benefits are broadly available to employees of the Company or its subsidiaries, to fail to meet the
requirements of 26 U.S.C. Section 401(a)(13) or 26 U.S.C. Section 411(a) and regulations thereunder.
(vi) This Policy shall apply to all Incentive-Based Compensation that is Received by Executive Officers on or after the Effective Date that
results from attainment of a Financial Reporting Measure based on or derived from financial information for any fiscal period ending on or
after the Effective Date.
(vii) For purposes of this Policy, the following italicized terms shall have the meaning indicated:
“Executive Officer” means (a) the Company’s president, principal financial officer, principal accounting officer (or if there is no
such accounting officer, the controller), any vice-president in charge of a principal business unit, division, or function (such as sales,
administration, or finance), any other officer of the Company or its subsidiaries who performs a significant policy-making function for
the Company, or any other person who performs significant policy-making functions for the Company and in any event (b) any
individual identified as an executive officer of the Company pursuant to 17 C.F.R. Section 229.401(b).
“Financial Reporting Measures” means measures that are determined and presented in accordance with the accounting principles
used in preparing the Company’s financial statements, any measures that are derived wholly or in part from such measures, and stock
price and total shareholder return, regardless whether such measures are presented within the Company’s financial statements or
included in a filing with the Securities and Exchange Commission.
“Incentive-Based Compensation” means any compensation that is granted, earned, or vested based wholly or in part upon the
attainment of a Financial Reporting Measure.
Incentive-Based Compensation is deemed “Received” in the Company’s fiscal period during which the Financial Reporting
Measure specified in the Incentive-Based Compensation award is attained, even if the payment or grant of Incentive-Based
Compensation occurs after the end of that period.
(viii) This Policy shall be applied in a manner that is consistent with and does not cause a violation of, and shall be deemed to incorporate
any provisions required to make it compliant with, applicable Exchange listing standards.
B. Miscellaneous
(i) The Company may, to the extent permitted by law, enforce all or part of a Grantee’s repayment obligation under this Policy by any
available means.
(ii) Except as provided in Part A(v) of this Policy, this Policy shall be administered and enforced by the Compensation Committee, except
to the extent the Board shall designate another committee comprising exclusively independent directors or itself shall act (the Compensation
Committee, such other committee or the Board, as applicable, the “Administrator”). The Administrator shall have full and final authority to
make all determinations required under this Policy, and its decision as to all questions of interpretation and application of the Policy shall be
final, binding and conclusive on all persons, provided that the Administrator shall make no determination as to whether an accounting
restatement is required in the first instance, and any such determination shall be reviewed with the Audit Committee of the Board.
(iii) The recoupment of Incentive-Based Compensation under this Policy is in addition to any other right or remedy available to the
Company. Without limiting the preceding sentence, this Policy is separate from and in addition to the requirements of Section 304 of the
Sarbanes-Oxley Act of 2002 (“Section 304”) that are applicable to the Company’s Chief Executive Officer and Chief Financial Officer, and
the Administrator shall consider any amounts paid to the Company by the Chief Executive Officer and Chief Financial Officer pursuant to
Section 304 in determining any amount of Incentive-Based Compensation to recoup under this Policy.
(iv) The Company shall not indemnify any Grantee against the loss of Incentive-Based Compensation recouped pursuant to this Policy.
(v) This Policy may be amended at any time by the Administrator.