Angiodynamics Inc 8-K/A, filed Jan 7, 2021
Angiodynamics Inc (ANGO)
8-K/A
2021-01-07
For: 2021-01-07
View Original
Added on
April 10, 2026
About this 8-K/A
Angiodynamics Inc filed this 8-K/A on January 7, 2021.
Items reported
- Item 7.01: Regulation FD disclosure
- Item 9.01: Financial statements and exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
__________
FORM 8-K/A
(Amendment No. 1)
(Amendment No. 1)
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 7, 2021
(Exact Name of Registrant as Specified in Charter)
|
|
|
|
|
(State or Other Jurisdiction of Incorporation)
|
(Commission File
Number)
|
(IRS Employer
Identification No.)
|
|
|
|
(Address of Principal Executive Offices) (Zip Code)
|
|
(
|
|
(Registrant’s telephone number, including area code)
|
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the
registrant under any of the following provisions:
|
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
|
|
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
|
|
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2 (b))
|
|
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4 (c))
|
Securities registered pursuant to Section 12(b) of the Act:
|
Title of each class
|
Trading Symbol(s)
|
Name of each exchange on which
registered |
|
|
|
|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act
of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition
period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Explanatory Note
This Amendment No. 1 on Form 8-K/A (this “Amendment”) amends the Current Report on Form 8-K furnished by AngioDynamics, Inc.
(“AngioDynamics”) to the Securities and Exchange Commission on January 7, 2021 (the “Original Report”). The sole purpose of this Amendment is to correct a typographical error on slide 4 of the presentation slides furnished with the Original Report
regarding the Product Family Sales Growth for Venous Insufficiency. No other changes have been made to the Original Report or the presentation slides furnished therewith.
Item 7.01 – Regulation FD Disclosure.
Presentation slides discussing AngioDynamics and its fiscal second quarter ended November 30, 2020 that were originally furnished as
part of the Original Report have been amended as described in the Explanatory Note above and are furnished herewith as Exhibit 99.2.
The presentation slides furnished pursuant to Item 7.01 of this Form 8-K (including Exhibit 99.2) shall not be deemed “filed” for
purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities under that Section. Furthermore, the presentation slides shall not be deemed to be incorporated by reference into any filing under the Securities Act or the Exchange
Act.
Forward-Looking Statements
This document and its attachments contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of
1995. All statements regarding AngioDynamics’ expected future financial position, results of operations, cash flows, business strategy, budgets, projected costs, capital expenditures, products, competitive positions, growth opportunities, plans and
objectives of management for future operations, as well as statements that include the words such as “expects,” “reaffirms,” “intends,” “anticipates,” “plans,” “believes,” “seeks,” “estimates,” “optimistic,” or variations of such words and similar
expressions, are forward-looking statements. These forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties. Investors are cautioned that actual events or results may differ from AngioDynamics’
expectations. Factors that may affect the actual results achieved by AngioDynamics include, without limitation, the scale and scope of the COVID-19 global pandemic, the ability of AngioDynamics to develop its existing and new products, technological
advances and patents attained by competitors, infringement of AngioDynamics’ technology or assertions that AngioDynamics’ technology infringes the technology of third parties, the ability of AngioDynamics to effectively compete against competitors
that have substantially greater resources, future actions by the FDA or other regulatory agencies, domestic and foreign health care reforms and government regulations, results of pending or future clinical trials, overall economic conditions, the
results of on-going litigation, challenges with respect to third-party distributors or joint venture partners or collaborators, the results of sales efforts, the effects of product recalls and product liability claims, changes in key personnel, the
ability of AngioDynamics to execute on strategic initiatives, the effects of economic, credit and capital market conditions, general market conditions, market acceptance, foreign currency exchange rate fluctuations, the effects on pricing from group
purchasing organizations and competition, the ability of AngioDynamics to integrate purchased businesses, as well as the risk factors listed from time to time in AngioDynamics’ SEC filings, including but not limited to its Annual Report on Form 10-K
for the year ended May 31, 2020 and its Quarterly Report on Form 10-Q for the fiscal period ended August 31, 2020. AngioDynamics does not assume any obligation to publicly update or revise any forward-looking statements for any reason.
Item 9.01 – Financial Statements and Exhibits.
(d) Exhibits.
|
Exhibit No.
|
Description
|
|
|
Presentation, dated January 7, 2021.
|
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed
on its behalf by the undersigned hereunto duly authorized.
| ANGIODYNAMICS, INC. | ||||
| (Registrant) |
||||
|
Date: January 7, 2021
|
By:
|
/s/ Stephen A. Trowbridge | ||
| Name: |
Stephen A. Trowbridge |
|||
| Title: |
Executive Vice President and | |||
| |
Chief Financial Officer | |||
Exhibit 99.2
ANGIODYNAMICS Second Quarter 2021 Earnings PresentationJanuary 7, 2021 1
2 Forward-Looking Statement Notice Regarding Forward-Looking StatementsThis presentation contains
forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements regarding AngioDynamics’ expected future financial position, results of operations, cash flows, business strategy, budgets,
projected costs, capital expenditures, products, competitive positions, growth opportunities, plans and objectives of management for future operations, as well as statements that include the words such as “expects,” “reaffirms,” “intends,”
“anticipates,” “plans,” “believes,” “seeks,” “estimates,” “optimistic,” or variations of such words and similar expressions, are forward-looking statements. These forward-looking statements are not guarantees of future performance and are
subject to risks and uncertainties. Investors are cautioned that actual events or results may differ from AngioDynamics’ expectations. Factors that may affect the actual results achieved by AngioDynamics include, without limitation, the scale
and scope of the COVID-19 global pandemic, the ability of AngioDynamics to develop its existing and new products, technological advances and patents attained by competitors, infringement of AngioDynamics’ technology or assertions that
AngioDynamics’ technology infringes the technology of third parties, the ability of AngioDynamics to effectively compete against competitors that have substantially greater resources, future actions by the FDA or other regulatory agencies,
domestic and foreign health care reforms and government regulations, results of pending or future clinical trials, overall economic conditions, the results of on-going litigation, challenges with respect to third-party distributors or joint
venture partners or collaborators, the results of sales efforts, the effects of product recalls and product liability claims, changes in key personnel, the ability of AngioDynamics to execute on strategic initiatives, the effects of economic,
credit and capital market conditions, general market conditions, market acceptance, foreign currency exchange rate fluctuations, the effects on pricing from group purchasing organizations and competition, the ability of AngioDynamics to
integrate acquired businesses, as well as the risk factors listed from time to time in AngioDynamics’ SEC filings, including but not limited to its Annual Report on Form 10-K for the year ended May 31, 2020. AngioDynamics does not assume any
obligation to publicly update or revise any forward-looking statements for any reason.In the United States, the NanoKnife System has received a 510(k) clearance by the Food and Drug Administration for use in the surgical ablation of soft
tissue, and is similarly approved for commercialization in Canada, the European Union and Australia. The NanoKnife System has not been cleared for the treatment or therapy of a specific disease or condition.Notice Regarding Non-GAAP Financial
MeasuresManagement uses non-GAAP measures to establish operational goals and believes that non-GAAP measures may assist investors in analyzing the underlying trends in AngioDynamics’ business over time. Investors should consider these non-GAAP
measures in addition to, not as a substitute for or as superior to, financial reporting measures prepared in accordance with GAAP. In this presentation, AngioDynamics has reported adjusted EBITDA (income before interest, taxes, depreciation and
amortization and stock-based compensation); adjusted net income; adjusted earnings per share and free cash flow. Management uses these measures in its internal analysis and review of operational performance. Management believes that these
measures provide investors with useful information in comparing AngioDynamics’ performance over different periods. By using these non-GAAP measures, management believes that investors get a better picture of the performance of AngioDynamics’
underlying business. Management encourages investors to review AngioDynamics’ financial results prepared in accordance with GAAP to understand AngioDynamics’ performance taking into account all relevant factors, including those that may only
occur from time to time but have a material impact on AngioDynamics’ financial results. Please see the tables that follow for a reconciliation of non-GAAP measures to measures prepared in accordance with GAAP.
Corporate Developments FY2021 Guidance 3 NanoKnife disposable growth was 76% in the
U.S. and 30% worldwide. Growth in AngioVac was 24%, and we achieved $2.1 million in Auryon sales. Procedural volumes continued to rebound in the second quarter and reflect less severe declines than the 10-15% decline discussed in the first
quarter. We expect that the third quarter is likely to see a more pronounced impact from COVID related headwinds along with typical third quarter seasonality. We continued our focused investment in our three key technology platforms:
NanoKnife, AngioVac and Auryon. Within our Thrombus Management portfolio we are progressing toward the planned launch of a multi-purpose mechanical aspiration thrombectomy device in calendar 2021. NanoKnife DIRECT study: 26 sites have secured
IRB approval, up from 23 at the end of the first quarter. Reaffirm FY2021 Guidance Revenue$278 - $284 million Adjusted EPS$0.00 - $0.05 $10 million was paid down on the revolver in December 2020. Pathfinder study: 9 sites have been
initiated and are enrolling subjects. As of today, we are approximately 75% of the way toward our enrollment target and expect enrollment to be completed by the end of the 3rd quarter.
Second Quarter FY2021 Highlights $ in thousands (except per share data) Q2 FY2021 Q2 FY2020 YOY
Change Revenue $72,770 $70,003 4.0% Gross Margin 55.2% 59.3% (410 bps) Adjusted EPS $0.01 $0.06 ($0.05) Adjusted EBITDA $5,158 $6,410 ($1,252) Cash Provided by Operations $11,448 $5,937 $5,511 Free Cash
Flow $10,087 $3,314 $6,773 Financial Performance Vascular Interventions and Therapies Q2 FY2021 YTD FY2021 AngioVac® 24% 34% Auryon NA NA Thrombolytic 4% (2%) Core Peripheral 4% 2% Venous Insufficiency (11%) (13%) Product
Family Sales Growth Vascular Access Q2 FY2021 YTD FY2021 Midlines 17% 53% C3 NA NA PICCs 2% 24% Ports 3% (1%) Dialysis 6% 2% Oncology Q2 FY2021 YTD FY2021 NanoKnife® Capital (50%) (56%) NanoKnife®
Disposables 30% 12% Solero® Microwave 7% 7% BioSentry 28% 28% Alatus and IsoLoc Balloons (22%) (27%) RadioFrequency Ablation (19%) (24%)
Second Quarter FY2021 Results (unaudited) $ in thousands (except per share data) Q2 FY2021 Q2
FY2020 Change YTD FY2021 YTD FY2020 Change Revenue Vascular Interventions and Therapies Vascular Access Oncology United States
International $72,770$33,900$23,930$14,940$60,684$12,086 $70,003$31,150$22,784$16,069$55,555$14,448 4.0%8.8%5.0%(7.0%)9.2%(16.3%) $142,986$63,757$52,035$27,194$114,792$28,194 $136,045$60,063$45,943$30,039$108,492$27,553 5.1%6.2%13.3%(9.5%)5.8%2.3% Net
LossNon-GAAP Adjusted Net Income ($4,268)$564 ($2,736)$2,151 ($1,532)($1,587) ($8,536)$1,181 ($4,011)$5,325 ($4,525)($4,144) GAAP EPSNon-GAAP Adjusted
EPS ($0.11)$0.01 ($0.07)$0.06 ($0.04)($0.05) ($0.22)$0.03 ($0.11)$0.14 ($0.11)($0.11) Gross Margin 55.2% 59.3% 410 bps 53.1% 58.6% 550 bps Adjusted EBITDA $5,158 $6,410 ($1,252) $9,625 $13,690 ($4,065) Free Cash
Flow $10,087 $3,314 $6,773 $2,838 ($4,611) $7,449 $ in thousands (except per share data) Q2 FY2021 Q4 FY2020 Change Cash $58,025 $54,435 $3,590 Debt $40,000 $40,000 $0 5
GAAP to Non-GAAP Reconciliation 6
Reconciliation of GAAP to Non-GAAP Net Income (Loss) and EPS Reconciliation of Net Loss to Adjusted
EBITDA Includes costs related to merger and acquisition activities, restructurings, and unusual items, including asset impairments and write-offs, certain litigation, and other items.Deferred financing fees related to the old credit agreement
were written off during the second quarter of fiscal year 2020.Adjustment to reflect the income tax provision on a non-GAAP basis has been calculated assuming no valuation allowance on the Company's U.S. deferred tax assets and an effective tax
rate of 23% for November 30, 2020 and 2019. 7
ANGIODYNAMICS Thrombus Management Portfolio Update 8
9 Deep Vein ThrombosisDVT + Pulmonary EmbolismPE = Venous ThromboembolismVTE A blood clot that
forms in a deep vein, usually the leg, groin or arm A DVT breaks free from a vein wall and travels to the lungs blocking some or all of the blood supply DVT and PE are collectively referred to as VTE 208,000 Iliofemoral Cases1 171,000
High-risk & intermediate-risk PE Cases1 100,000 – 300,000 VTE-Related Deaths in the USA Annually2 Stages of Clot Clot in Transit (traveling through the heart) Clot in Pulmonary Arteries (PE) 1. Plovanic, W. J., &
Furlong, C. (2020, June). Inari Medical Biomedical Devices and Services. Canaccord Genuity Capital Markets.2. “Venous Thromboembolism (VTE).” World Thrombosis Day, www.worldthrombosisday.org/issue/vte. Illustrations and Images not Produced by
AngioDynamics Include:https://www.vascularmedcure.com/disease-backgroundDVT (Blood Clot In the Leg): 7 Warning Signs and Symptoms (emedicinehealth.com)
THROMBUS
MANAGEMENTPurpose Built Portfolio & Technology 10 Right Heart AngioVac’s use is currently focused on the Right Heart, which is a $77M addressable market. Pulmonary Embolism Deep Vein Thrombosis A multi-purpose mechanical aspiration
device will allow us to compete in the broader DVT & PE addressable markets with a first-line treatment option without the need for perfusion. C U R R E N T P O R T F O L I O F U T U R E P O R T F O L I O DVT & PE Uni-Fuse+
catheter directed thrombolysis now has the additional indication for placement in the pulmonary artery. C U R R E N T P O R T F O L I O SIMPLE COMPLEX MODERATE $3B $77M2 $1.3B1 $1.6B1 PULMONARYEMBOLISM RIGHT HEART DEEP VEIN
THROMBOSIS Plovanic, W. J., & Furlong, C. (2020, June). Inari Medical Biomedical Devices and Services. Canaccord Genuity Capital Markets. Fletcher Spaght, Inc. AngioVac market assessment March 2018, Angiodynamics funded Planned Launch
Calendar 2021
The Difference The AngioVac System allows for the continuous aspiration of embolic material such as
fresh, soft thrombi or vegetation from the venous systemUtilizing a self-expanding, nitinol reinforced funnel tipSimultaneously reinfusing the patient’s own filtered blood to limit procedural blood loss Centrifugal Pump Console Waste
Collection System Filter Saline AngioVac Cannula Reinfusion Cannula AngioVac Circuit Individual experience may not be indicative of all procedure results. 11
THROMBUS MANAGEMENTPlanned Portfolio Additions & U.S. Addressable Markets
Expansion 12 $1.3B $1.6B FY 2021 FY 2022 FY 2023 FY 2025 FY 2024 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 $140M $700M $3.6B $1.5B 1 2 The planned portfolio additions are not guarantees of
future performance and are subject to risks and uncertainties. Investors are cautioned that actual events or results may differ from AngioDynamics’ expectations. Controlled Powerful Versatile Gen 3Right Heart, Illio-caval
DVT Multi-Purpose Mechanical Aspiration Gen 1Entry into Ilio-femoral DVT Multi-Purpose Mechanical Aspiration Gen 2Access to full Ilio-femoral DVT market Gen 4 Smaller size should drive further adoption in addressable market Multi-Purpose
Mechanical AspirationPE Indication THE NEXT PORTFOLIO INNOVATION A purpose-built, innovative product leveraging the strengths of the AngioVac cannula technology with off-circuit manual aspiration control Proven, funnel tip design allows
efficient aspiration and compression of large clot burden Designed to allow the end-user command and control of the mechanical aspiration Broadens our Thrombus Management portfolio and designed to provide an intuitive, first-line treatment
option without the need for lytics and advanced procedural support
ANGIODYNAMICS Second Quarter 2021 Earnings PresentationJanuary 7, 2021 13