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. The following discussion should be read in conjunction with the Company's 2022 Annual Report on Form 10-K, and the consolidated financial statements and notes thereto included elsewhere in the Form 10-Q.
Disclosure Regarding 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," "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 fromAngioDynamics' expectations, expressed or implied. Factors that may affect the actual results achieved byAngioDynamics include, without limitation, the scale and scope of the COVID-19 global pandemic, the ability ofAngioDynamics to develop its existing and new products, technological advances and patents attained by competitors, infringement ofAngioDynamics' technology or assertions thatAngioDynamics' technology infringes the technology of third parties, the ability ofAngioDynamics to effectively compete against competitors that have substantially greater resources, future actions by the FDA or other regulatory agencies, domestic and foreign health care reforms and government regulations, results of pending or future clinical trials, overall economic conditions (including inflation, labor shortages and supply chain challenges including the cost and availability of raw materials), the results of on-going litigation, challenges with respect to third-party distributors or joint venture partners or collaborators, the results of sales efforts, the effects of product recalls and product liability claims, changes in key personnel, the ability ofAngioDynamics 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 ofAngioDynamics 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 theSecurities and Exchange Commission (the "SEC"). Although we believe that the assumptions underlying the forward-looking statements contained herein are reasonable, any of the assumptions could be inaccurate and, therefore, there can be no assurance that the forward-looking statements included in this quarterly report on Form 10-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, investors are cautioned not to place undue reliance on these forward-looking statements which speak only as of the date stated, or if no date is stated, as of the date of this report.AngioDynamics disclaims any obligation to update the forward-looking statements.
Disclosure Regarding Trademarks
This report includes trademarks, tradenames and service marks that are our property or the property of other third parties. Solely for convenience, such trademarks and tradenames sometimes appear without any "™" or "®" symbol. However, failure to include such symbols is not intended to suggest, in any way, that we will not assert our rights or the rights of any applicable licensor, to these trademarks and tradenames. For a complete listing of all our trademarks, tradenames and service marks please visit www.angiodynamics.com/IP. Information on our website or connected to our website is not incorporated by reference into this Quarterly Report on Form 10-Q.
Executive Overview
AngioDynamics is a leading and transformative medical technology company focused on restoring healthy blood flow in the body's vascular system, expanding cancer treatment options and improving quality of life for patients. 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. 24 -------------------------------------------------------------------------------- Table of Contents 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 devices; 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 inthe United States primarily through a direct sales force, and outside theU.S. through a combination of direct sales and distributor relationships. Our end users include interventional radiologists, interventional cardiologists, vascular surgeons, urologists, interventional and surgical oncologists and critical care nurses. We expect our businesses to grow in both sales and profitability by expanding geographically, penetrating new markets, introducing new products and increasing our presence internationally. The COVID-19 global pandemic has impacted our business and may continue to pose future risks with the emergence of new variants. Even with the public health actions that have been taken to reduce the spread of the virus, the market continues to experience disruptions with respect to consumer demand, hospital operating procedures and workflow, trends that may continue. The Company's ability to manufacture products, the reliability of our supply chain, labor shortages, backlog and inflation (including the cost and availability of raw materials, direct labor and shipping) have impacted our business, trends that may continue. Accordingly, management continues to evaluate the Company's liquidity position, communicate with and monitor the actions of our customers and suppliers, and review our near-term financial performance. OnAugust 30, 2022 , the Company repaid all amounts outstanding under its then existing credit agreement and entered into a new Credit Agreement. The new Credit Agreement provides for a$75.0 million Revolving Facility and a$30.0 million Delayed Draw Term Loan as ofNovember 30, 2022 ,$25.0 million was drawn on the Revolving Facility and$25.0 million was drawn on the Delayed Draw Term Loan. See Note 7 "Long-Term Debt" set forth in the Notes to the consolidated financial statements.
Commencing with the first quarter of fiscal year 2023, the Company began to manage its operations through two segments, Med Tech and Med Device to align with the transformation from a company with a broad portfolio of largely undifferentiated products to a more focused medical technology company.
In evaluating the operating performance of our business, management focuses on company-wide and segment revenue and gross margin and company-wide operating income, earnings per share and cash flow from operations. A summary of these key financial metrics for the three and six months endedNovember 30, 2022 compared to the three and six months endedNovember 30, 2021 are as follows:
Three months ended
•Revenue increased by 9.1% to$85.4 million . •Med Tech growth of 29.7% and Med Device growth of 2.6%. •Gross profit increased 100 bps to 52.8%. •Med Tech gross profit decreased 290 bps to 63.7% and Med Device gross profit increased 130 bps to 48.4%. •Net loss increased by$0.1 million to$8.5 million . •Loss per share was consistent at a loss of$0.21 .
Six months ended
•Revenue increased by 7.5% to$167.0 million . •Med Tech growth of 29.7% and Med Device growth of 0.7%. •Gross profit increased 30 bps to 52.3%. •Med Tech gross profit decreased 250 bps to 63.5% and Med Device gross profit increased 20 bps to 47.9%. •Net loss increased by$6.2 million to$21.5 million . •Loss per share increased by$0.16 to a loss of$0.55 . Our Med Tech revenue, comprised of Auryon, the thrombus management platform and NanoKnife, grew 29.7% in the second quarter of fiscal year 2023. The growth in Auryon and NanoKnife capital and disposables was partially offset by decreased thrombus management platform sales. Our Med Device revenue grew 2.6% in the second quarter of fiscal year 2023 25 -------------------------------------------------------------------------------- Table of Contents driven by growth in Core, Dialysis, Ports and Microwave products, partially offset by the backlog in Vascular Access products and continued pressures from reductions in Oncology procedure volumes due to challenges resulting from the COVID-19 pandemic, a trend that may continue.
Results of Operations
For the three months endedNovember 30, 2022 , the Company reported a net loss of$8.5 million , or a loss of$0.21 per diluted share, on net sales of$85.4 million , compared with a net loss of$8.4 million , or a loss of$0.21 per diluted share, on net sales of$78.3 million during the same quarter of the prior year. For the six months endedNovember 30, 2022 , the Company reported a net loss of$21.5 million , or a loss of$0.55 per diluted share, on net sales of$167.0 million , compared with a net loss of$15.3 million , or a loss of$0.39 per diluted share, on net sales of$155.3 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, rebates and returns.
Three Months Ended Six Months Ended
(in thousands) Nov 30, 2022 Nov 30, 2021 % Change Nov 30, 2022 Nov 30, 2021 % Change
Net Sales
Med Tech $ 24,502 $ 18,886 29.7% $ 47,318 $ 36,493 29.7%
Med Device 60,927 59,394 2.6% 119,648 118,758 0.7%
Total $ 85,429 $ 78,280 9.1% $ 166,966 $ 155,251 7.5%
Three Months Ended Six Months Ended
(in thousands) Nov 30, 2022 Nov 30, 2021 % Change Nov 30, 2022 Nov 30, 2021 % Change
United States $ 71,631 $ 65,350 9.6% $ 140,655 $ 129,814 8.4%
International 13,798 12,930 6.7% 26,311 25,437 3.4%
Total $ 85,429 $ 78,280 9.1% $ 166,966 $ 155,251 7.5%
For the three months ended November 30, 2022 , net sales increased $7.1 million
to $85.4 million compared to the same period in the prior year. For the six
months ended November 30, 2022 , net sales increased $11.7 million to $167.0
million compared to the same period in the prior year. At November 30, 2022 , the
Company had a backlog of $5.0 million , a decrease of $2.1 million from August
31, 2022 .
The Med Tech segment net sales increased $5.6 million and $10.8 million for the
three and six months ended November 30, 2022 compared to the same periods in the
prior year, respectively. The change in sales for both periods was primarily
driven by:
•Increased Auryon sales of $3.8 million and $6.7 million compared to the same
periods in the prior year, respectively;
•Growth in the thrombus management platform of $2.4 million for the six months
ended November 30, 2022 compared to the same period in the prior year, while the
thrombus management platform was flat for the three months ended November 30,
2022 compared to the same period in the prior year. Increased sales in the
mechanical thrombectomy platform of $2.2 million for the six months ended
November 30, 2022 compared to the same period in the prior year, was driven by
the AlphaVac product; and
•Increased NanoKnife sales of $1.8 million and $1.7 million compared to the same
periods in the prior year, respectively, which was primarily driven by increased
probe sales domestically and internationally.
The Med Device segment net sales increased $1.5 million and $0.9 million for the
three and six months ended November 30, 2022 compared to the same periods in the
prior year, respectively. The change in sales for both periods was primarily
driven by:
•The backlog of $5.0 million at November 30, 2022 , which primarily impacted
sales of Core and Vascular Access products; and
•Increased sales of Core, Dialysis and Ports, despite the impact of the backlog,
along with increased Microwave sales for the three months ended November 30,
2022 compared to the same period in the prior year of $1.9 million , $1.6
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million, $0.6 million and $0.3 million , respectively. These increases were
partially offset by decreased Venous, PICCs and other Oncology sales for the
three months ended November 30, 2022 compared to the same period in the prior
year of $1.2 million , $0.8 million and $0.7 million , respectively; and
•Increased sales of Core and Dialysis, despite the impact of the backlog, along
with increased Microwave sales for the six months ended November 30, 2022
compared to the same period in the prior year of $2.8 million , $2.8 million and
$0.6 million , respectively. These increases were partially offset by decreased
Venous, PICCs, Midlines and other Oncology and Vascular Access sales for the six
months ended November 30, 2022 compared to the same period in the prior year of
$1.7 million , $1.4 million , $0.4 million and $1.5 million , respectively.
Gross Profit
Three Months Ended Six Months Ended
(in thousands) Nov 30, 2022 Nov 30, 2021 % Change Nov 30, 2022 Nov 30, 2021 $ Change
Med Tech $ 15,614 $ 12,578 24.1 % $ 30,043 $ 24,095 24.7 %
Gross profit % of sales 63.7 % 66.6 % 63.5 % 66.0 %
Med Device $ 29,464 $ 27,977 5.3 % $ 57,340 $ 56,599 1.3 %
Gross profit % of sales 48.4 % 47.1 % 47.9 % 47.7 %
Total $ 45,078 $ 40,555 11.2 % $ 87,383 $ 80,694 8.3 %
Gross profit % of sales 52.8 % 51.8 % 52.3 % 52.0 %
Gross profit - Gross profit consists of net sales less the cost of goods sold,
which includes the costs of materials, products purchased from third parties and
sold by us, manufacturing personnel, royalties, freight, business insurance,
depreciation of property and equipment and other manufacturing overhead,
exclusive of intangible amortization.
Total Company gross profit increased by $4.5 million and $6.7 million for the
three months and six months ended November 30, 2022 compared to the same periods
in the prior year. The change for both periods was primarily driven by:
•Sales volume, which positively impacted gross profit by $4.2 million and $6.9
million , respectively;
•Production volume, mix and other incentives which positively impacted gross
profit by $2.8 million and $5.5 million , respectively;
•Pricing, which negatively impacted gross profit by $1.9 million and $3.3
million , respectively;
•Inflationary costs on raw materials, labor shortages and freight costs, which
negatively impacted gross profit by $1.1 million for the six months ended
November 30, 2022 ; and
•Depreciation on placement units of $0.5 million and $1.2 million , respectively.
The Med Tech segment gross profit increased by $3.0 million and $5.9 million for
the three and six months ended November 30, 2022 compared to the same periods in
the prior year. The change for both periods was primarily driven by:
•Sales volume, which positively impacted gross profit by $4.6 million and $8.6
million , respectively;
•Production volume, overhead, manufacturing and other incentives which
positively impacted gross profit by $1.1 million and $1.9 million , respectively;
•Pricing pressures and mix, which negatively impacted gross profit by $2.4
million and $3.8 million , respectively; and
•Depreciation on placement units of $0.3 million and $0.7 million , respectively.
The Med Device segment gross profit increased by
•Sales volume, which positively impacted gross profit by$0.5 million and$0.1 million , respectively; •Production volume, manufacturing and other incentives which positively impacted gross profit by$2.5 million and$3.7 million , respectively; •Pricing pressures and mix, which negatively impacted gross profit by$0.5 million and$0.8 million , respectively; •Inflationary costs on raw materials, labor shortages and freight costs, which negatively impacted gross profit by$1.0 and$2.1 million , respectively; and •Depreciation on placement units of$0.1 million and$0.2 million , respectively. 27 -------------------------------------------------------------------------------- Table of Contents Operating Expenses, and Other Income (expense) Three Months Ended Six Months Ended (in thousands) Nov 30, 2022 Nov 30, 2021 % Change Nov 30, 2022 Nov 30, 2021 % Change Research and development$ 6,838 $ 8,199 (16.6) %$ 15,171 $ 15,593 (2.7) % % of sales 8.0 % 10.5 % 9.1 % 10.0 % Selling and marketing$ 26,007 $ 23,606 10.2 %$ 52,550 $ 48,052 9.4 % % of sales 30.4 % 30.2 % 31.5 % 31.0 % General and administrative$ 10,835 $ 9,678 12.0 %$ 20,936 $ 18,621 12.4 % % of sales 12.7 % 12.4 % 12.5 % 12.0 % 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, and manage clinical, regulatory and medical affairs.
R&D expense decreased
•The timing of certain projects and clinical spend associated with the ongoing clinical trials, which decreased R&D expense by$1.4 million and$0.5 million , respectively.
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
•Additional headcount from the build-out of the Auryon and mechanical
thrombectomy sales and marketing teams, which increased compensation and
benefits expense by
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
•Compensation and benefits and travel expenses, which increased$0.6 million for the six months endedNovember 30, 2022 and decreased$0.2 million for the three months endedNovember 30, 2022 ; and •Other outside consultant spend for legal and IT which increased$1.2 million and$1.6 million , respectively. Three Months Ended Six Months Ended (in thousands) Nov 30, 2022 Nov 30, 2021 $ Change Nov 30, 2022 Nov 30, 2021 $ Change
Amortization of intangibles
(81)
1,037
806 $ 8,640 $ 4,693 $ 3,947
and other items, net
Other expense, net $ (936) $ (184) $ (752) $ (1,492) $ (692) $ (800) Amortization of intangibles - Represents the amount of amortization expense that was taken on intangibles assets held by the Company.
•Amortization expense remained consistent with the prior year.
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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 three and six months ended
Acquisition, restructuring and other items, net - Represents costs associated with mergers and acquisitions, restructuring expenses, legal costs that are related to litigation that is not in the ordinary course of business, legal settlements and other one-time items.
Acquisition, restructuring and other items, net, increased by$0.8 million and$3.9 million for the three and six months endedNovember 30, 2022 , compared to the same periods in the prior year, respectively. The change for both periods was primarily driven by: •Manufacturing relocation expense related to the move of certain manufacturing lines toCosta Rica , which increased$0.5 million and$0.7 million , respectively; •Legal expense, related to litigation that is outside of the normal course of business, which increased$0.4 million and$0.1 million , respectively; •Other expenses (mainly severance associated with organizational changes), which decreased$0.3 million for the six months endedNovember 30, 2022 ; and •The payment to theIsraeli Innovation Authority of$3.5 million related to grant funds that were provided to Eximo to develop the Auryon laser prior to the acquisition in the second quarter of fiscal year 2020. These grant funds were fully repaid in the first quarter of fiscal year 2023 to satisfy the obligation which was otherwise being paid as a royalty based on a percentage of sales.
Other expense, net - Other expenses include interest expense, foreign currency impacts, bank fees, and amortization of deferred financing costs.
•The change in other expense of$0.8 million for both the three and six months endedNovember 30, 2022 compared to the same periods in the prior year, is primarily due to increased interest expense of$0.5 million and$0.7 million , respectively and unrealized foreign currency fluctuations of$0.3 million and$0.1 million , respectively.
Income Tax Benefit
Three Months Ended Six Months Ended
(in thousands) Nov 30, 2022 Nov 30, 2021 Nov 30, 2022 Nov 30, 2021
Income tax benefit $ (0.6) $ (0.5) $ (1.4) $ (2.1)
Effective tax rate including discrete
items 6.2 % 5.8 % 6.2 % 12.3 %
Our effective tax rate including discrete items for the three months ended
November 30, 2022 and 2021 was 6.2% and 5.8%, respectively. Our effective tax
rate including discrete items for the six months ended November 30, 2022 and
2021 was 6.2% and 12.3%, respectively. In fiscal year 2023, the Company's
effective tax rate differs 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 and non-deductible share-based compensation).
Liquidity and Capital Resources
We regularly review our liquidity and anticipated capital requirements in light of the significant uncertainty created by the COVID-19 global pandemic. We believe that our current cash on hand and availability under our Credit Agreement provides sufficient liquidity to meet our anticipated needs for capital for at least the next 12 months. We are closely monitoring receivables and payables. Our cash and cash equivalents totaled$29.9 million as ofNovember 30, 2022 , compared with$28.8 million as ofMay 31, 2022 . As ofNovember 30, 2022 andMay 31, 2022 , total debt outstanding related to the Credit Agreement was$50.0 million ($25.0 million on the Revolving Facility and$25.0 million on the Delayed Draw Term Loan) and$25.0 million , respectively. The fair value of contingent consideration liability as ofNovember 30, 2022 andMay 31, 2022 , was$18.8 million and$16.9 million , respectively. 29
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