ANGIODYNAMICS, INC. The following information should be read together with the consolidated financial statements and the notes thereto and other information included elsewhere in this quarterly report on Form 10-Q. Forward-Looking Statements This quarterly report on Form 10-Q, 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 regardingAngioDynamics' 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," 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 our expectations. Factors that may affect our actual results achieved include, without limitation, our ability to develop existing and new products, future actions by FDA or other regulatory agencies, results of pending or future clinical trials, the results of ongoing litigation, overall economic conditions, general market conditions, market acceptance, foreign currency exchange rate fluctuations, the effects on pricing from group purchasing organizations and competition, our ability to integrate purchased businesses and other factors including natural disasters and pandemics (such as the scope, scale and duration of the impact of the novel coronavirus, COVID-19). Other risks and uncertainties include, but are not limited to, the factors described from time to time in our reports filed with theSEC . Although we believe that the assumptions underlying the forward-looking statements contained herein are reasonable, any of the assumptions could be inaccurate and, therefore, there can be no assurance that the forward-looking statements included in this quarterly report on Form 10-Q will prove to be accurate. In light of the significant uncertainties inherent in the forward-looking statements included herein, the inclusion of such information should not be regarded as a representation by us or any other person that our objectives and plans will be achieved. Any forward-looking statements are made pursuant to the Private Securities Litigation Reform Act of 1995 and, as such, speak only as of the date made.AngioDynamics disclaims any obligation to update the forward-looking statements. Investors are cautioned not to place undue reliance on these forward-looking statements which speak only as of the date stated, or if no date is stated, as of the date of this document. Executive Overview 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 longer-term use. Our business operations cross a variety of markets. Our financial performance is impacted by changing market dynamics, which have included an emergence of value-based purchasing by healthcare providers, consolidation of healthcare providers, the increased role of the consumer in health care decision-making and an aging population, among others. In addition, our growth is impacted by changes within our sector, such as the merging of competitors to gain scale and influence; changes in the regulatory environment for medical device; and fluctuations in the global economy. Our sales and profitability growth also depends, in part, on the introduction of new and innovative products, together with ongoing enhancements to our existing products. Expansions to our product offerings are created through internal 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 business development opportunities and feel confident that our existing capital structure and free cash flow generation will allow us to properly fund those activities. We sell our products inthe United States primarily through a direct sales force, and outside theU.S. through a combination of a direct sales and distributor relationships. We expect our businesses to grow in both sales and profitability through geographic expansion, market penetration, new product introductions and increasing our direct presence internationally. The COVID-19 global pandemic may pose significant risks to our business. It is too early to quantify the impact this situation will have on fiscal year 2021 or beyond, but the public health actions being undertaken to reduce spread of the virus are causing and may continue to cause significant disruptions with respect to consumer demand, hospital operating procedures and workflow, our ability to continue to manufacture products and the reliability of our supply chain. Accordingly, management is evaluating the Company's liquidity position, communicating with and monitoring the actions of our customers and suppliers, 22 -------------------------------------------------------------------------------- Table of Contents and reviewing our near-term financial performance as we manage the Company through the uncertainty related to the coronavirus. As of the date of this report: •Our field based sales personnel have continued to re-enter the field in a safe and well orchestrated manner in order to once again provide unparalleled service to our physicians. •Our Latham headquarters opened at the beginning of the first quarter of fiscal year 2021 in accordance withNew York State guidelines. Our other office-based employees returned to the office during the first quarter of fiscal year 2021. •Our manufacturing facility inQueensbury, New York is operating under our business continuity plan with precautions including, without limitation, creating small "work pods", increasing distancing and regularly monitoring temperatures. As discussed in more detail below, we will closely monitor our liquidity and capital resources through the disruption caused by the COVID-19 pandemic. 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 three months endedAugust 31, 2020 compared to the three months endedAugust 31, 2019 are as follows: •Revenue increased by 6.3% to$70.2 million . •Gross margin decreased 700 bps to 50.9%. •Operating loss increased by$4.3 million to$5.1 million . •Loss per share increased by$0.08 to a loss of$0.11 . •Cash used in operations decreased by$1.1 million to$5.4 million . The ongoing recovery from the COVID-19 pandemic has had a varying impact on each of our three businesses. Our Vascular Interventions & Therapies and Vascular Access businesses performed the strongest of the businesses during the quarter. The number of procedures improved from the COVID-19 lows in the second half of last fiscal year, but remain below pre-COVID-19 levels. Our Oncology business continued to face pressure from COVID-19 related procedure headwinds and a challenging capital spending environment. We continued our commitment to supporting and progressing our key growth initiatives (AngioVac, Auryon and NanoKnife), managing operating expenses and managing our cash and balance sheet. New Accounting Pronouncements Information regarding new accounting pronouncements is included in Note 17 to our consolidated financial statements in this Quarterly Report on Form 10-Q. Results of Operations for the Three Months EndedAugust 31, 2020 andAugust 31, 2019 For the three months endedAugust 31, 2020 , the Company reported a net loss of$4.3 million , or a loss of$0.11 per diluted share, on net sales of$70.2 million , compared with a net loss of$1.3 million , or a loss of$0.03 per diluted share, on net sales of$66.0 million during the same quarter of the prior year.Net Sales
Net sales - Net sales are derived from the sale of products and related freight charges, less discounts and returns.
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Three Months Ended
(in thousands) Aug 31, 2020 Aug 31, 2019 % Growth
Vascular Interventions & Therapies $ 29,857 $ 28,913 3.3%
Vascular Access 28,105 23,159 21.4%
Oncology 12,254 13,970 (12.3)%
Total $ 70,216 $ 66,042 6.3%
Net Sales by Geography
United States $ 54,108 $ 52,937 2.2%
International 16,108 13,105 22.9%
Total $ 70,216 $ 66,042 6.3%
For the three months ended
•Total Vascular Interventions & Therapies sales increased$0.9 million primarily attributable to strong performance in the AngioVac business which grew$1.8 million . During the quarter, the Company continued to see strong case volumes in AngioVac, which increased 40% from the prior year. In addition, there was$1.1 million in sales of Auryon, which was acquired as part of the Eximo acquisition in the second quarter of fiscal year 2020. These increases were partially offset by lower volume in Venous products due to fewer elective procedures during the COVID-19 pandemic. •U.S. Vascular Interventions & Therapies sales increased$1.3 million due to increased case volume in AngioVac, increased Core Peripheral product sales and$1.1 million in sales of Auryon. These increases were partially offset by decreased sales volume in Venous. •International Vascular Interventions & Therapies sales decreased$0.4 million .
Vascular Access
•Total Vascular Access sales increased$4.9 million due to increased sales of PICCs and Midlines of$3.4 million and$2.2 million , respectively. These increases are the result of a large order in theUnited Kingdom related to the COVID-19 pandemic for$5.2 million along with the distribution agreement with MedComp. These increases were offset by decreased sales in Ports and Dialysis. BioFlo product lines comprise 59% of overall Vascular Access sales compared to 50% a year ago. •U.S. Vascular Access sales decreased$0.1 million . •International Vascular Access sales increased by$5.0 million primarily as a result of a large order in theUnited Kingdom related to the COVID-19 pandemic for$5.2 million Oncology •Total Oncology sales decreased$1.7 million year over year primarily due to lower NanoKnife capital sales of$1.0 million , decreased RadioFrequency Ablation sales of$0.6 million and decreased Balloon product sales of$0.5 million due to lower volumes. This was partially offset by increased Microwave sales of$0.3 million and BioSentry sales of$0.4 million . •U.S. Oncology sales decreased by$0.1 million primarily due to decreased Balloon product sales of$0.5 million due to lower volumes. This was partially offset by increased Microwave disposable sales of$0.4 million , BioSentry sales of$0.4 million and NanoKnife disposable sales of$0.1 million . •International Oncology sales decreased$1.6 million year over year as a result of decreased RadioFrequency Ablation and Microwave sales of$0.7 million and NanoKnife capital and disposable sales of$0.9 million . The Company has discussed the ongoing transformation from a company with a broad portfolio of largely undifferentiated products to a more focused medical technology company that delivers unique and innovative health care solutions. This transformation enables the Company to move away from the mature, lower-growth markets where we have 24 -------------------------------------------------------------------------------- Table of Contents competed in the past by carving out significant space in larger and faster growing markets. As such, the growth in the near to mid-term will be driven by our high technology platforms including AngioVac, Auryon and NanoKnife.
Gross Profit, Operating expenses, and Other income (expense)
Three Months Ended
(in thousands) Aug 31, 2020 Aug 31, 2019 % Change
Gross profit $ 35,764 $ 38,217 (6.4) %
Gross profit % of sales 50.9 % 57.9 %
Research and development $ 9,009 $ 6,292 43.2 %
% of sales 12.8 % 9.5 %
Selling and marketing $ 17,705 $ 19,380 (8.6) %
% of sales 25.2 % 29.3 %
General and administrative $ 8,557 $ 8,453 1.2 %
% of sales 12.2 % 12.8 %
Gross profit - Gross profit consists of net sales less the cost of goods sold,
which includes the costs of materials, products purchased from third parties and
sold by us, manufacturing personnel, royalties, freight, business insurance,
depreciation of property and equipment and other manufacturing overhead,
exclusive of intangible amortization.
Gross profit decreased by
•Sales volume positively impacted gross profit by$3.0 million year over year. •Net productivity negatively impacted gross profit by$3.0 million primarily as a result of under absorption of$2.2 million and costs associated with the COVID-19 pandemic of$0.4 million . The under absorption in manufacturing operations was due to the fact that the Company maintained staffing levels and continued producing product to provide flexibility during the uncertainty brought about by the COVID-19 pandemic. •Mix negatively impacted gross margin by$1.4 million as a result of the large order in theUnited Kingdom for lower gross margin products and decreased NanoKnife capital sales. This was partially offset by increased AngioVac sales. •A reserve for recalled products of$0.5 million and amortization of prior year capitalized variances of$0.4 million . Research and development expenses - Research and development ("R&D") expenses include internal and external costs to develop new products, enhance existing products, validate new and enhanced products, and manage clinical, regulatory and medical affairs.
R&D expense increased
•Research and development expenses related to AngioVac, NanoKnife and Tip
Location increased
Sales and marketing expenses - Sales and marketing ("S&M") expenses consist primarily of salaries, commissions, travel and related business expenses, attendance at medical society meetings, product promotions and marketing activities.
S&M expense decreased
•Travel expenses decreased$1.5 million due to less travel as a result of the COVID-19 pandemic. In addition, tradeshow and other expenses decreased$1.7 million due to the cancellation of events. •Compensation and benefits decreased approximately$0.4 million which is primarily the result of decreased commissions. •Expenses related to the build-out of the Auryon sales and marketing teams to prepare for full product launch of$2.1 million . General and administrative expenses - General and administrative ("G&A") expenses include executive management, finance, information technology, human resources, business development, legal, and the administrative and professional costs associated with those activities. 25 -------------------------------------------------------------------------------- Table of Contents G&A expense increased$0.1 million compared to the prior year. The increase is primarily attributable to the following: •Increased expenses related to the Auryon product to integrate the business of$0.2 million was partially offset by decreased travel and expenses of$0.1 million . Three Months Ended (in thousands) Aug 31, 2020 Aug 31, 2019 $ Change Amortization of intangibles$ 4,953 $ 3,868 $ 1,085 Change in fair value of contingent consideration$ (657) $ (448) $ (209) Acquisition, restructuring and other items, net$ 1,319 $ 1,500 $ (181) Other expense $ 309$ (563) $ 872
Amortization of intangibles - Represents the amount of amortization expense that was taken on intangibles assets held by the Company.
•Amortization expense increased$1.1 million compared to the prior year as a result of the Eximo Medical and C3 Wave tip location acquisitions, which increased intangible assets by$60.3 million and$9.4 million , respectively. These additions resulted in additional amortization expense of$1.2 million .
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 from the prior year is due to a decision to no longer pursue the final RadiaDyne technical milestone, which resulted in a reduction in the liability of$0.8 million . This reduction in the fair value was offset by normal amortization of the present value of the remaining Eximo contingent consideration of$14.9 million recorded in the second quarter of fiscal year 2020.
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
•Legal expense, related to litigation that is outside of the normal course of business, of$0.8 million was recorded in the first quarter of fiscal year 2021 compared to$0.7 million in the prior year. •There was no M&A expense incurred in the first quarter of fiscal year 2021 compared to$0.2 million in the prior year. •In the first quarter of fiscal year 2021, the Company incurred$0.3 million of expense to move manufacturing facilities as a result of the sale of the Fluid Management business compared to$0.8 million in the prior year. •As part of the sale of the Fluid Management business, the Company entered into a transition services agreement with Medline for certain legal, human resource, tax, accounting and information technology services from the Company for a period not to exceed 24 months. As a result of the transition services agreement, the Company invoiced Medline$0.4 million in the first quarter of fiscal year 2021. •Other expenses of$0.6 million in the first quarter of fiscal year 2021 consists of expenses to move the manufacturing of BioSentry products and severance associated with the sale of the Fluid Management business, compared to$0.5 million in the prior year.
Other expenses, net - Other expenses include interest expense, foreign currency impacts, bank fees, and amortization of deferred financing costs.
•The increase in other income from the prior year of$0.9 million is primarily due to foreign currency unrealized gains of$0.6 million and the prior year write-off of deferred financing fees associated with the old Credit Facility of$0.6 million . This was partially offset by increased interest expense of$0.1 million due on the$40.0 million outstanding on the Revolving Facility at the end of the first quarter of fiscal year 2021 compared to no debt outstanding in the prior year. In addition, interest income decreased by$0.2 million as a result of less cash on hand at the end of the first quarter of fiscal year 2021. 26
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Income Tax Provision (Benefit)
Three Months Ended
(in thousands) Aug 31, 2020 Aug 31, 2019
Income tax expense (benefit)$ (0.5) $
(0.1)
Effective tax rate including discrete items 11.3 %
8.3 %
Our effective tax rate including discrete items for the three month periods endedAugust 31, 2020 andAugust 31, 2019 was 11.3% and 8.3%, respectively. In fiscal year 2021, the Company's effective tax rate differs from theU.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 and non-deductible share based compensation). The estimated annual effective tax rate, however, prior to discrete items was 14.2% in the first quarter of fiscal year 2021, as compared to 8.3% for the same period in fiscal year 2020. Liquidity and Capital Resources We are continuously and critically reviewing our liquidity and anticipated capital requirements in light of the significant uncertainty created by the COVID-19 global pandemic. We believe that our current cash on hand and availability under our revolving credit facility provide sufficient liquidity to meet our anticipated needs for capital for at least the next 12 months. We are closely monitoring receivables and payables. In addition, we believe that our recently increased inventory levels provide additional risk mitigation in the event we incur a manufacturing disruption. Our cash and cash equivalents totaled$47.9 million as ofAugust 31, 2020 , compared with$54.4 million as ofMay 31, 2020 . As ofAugust 31, 2020 andMay 31, 2020 , total debt outstanding related to the Revolving Facility was$40.0 million . The fair value of contingent consideration liability as ofAugust 31, 2020 andMay 31, 2020 , was$15.0 million and$15.6 million , respectively. The table below summarizes our cash flows:
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