Financial Data and Key Metrics Changes - The company reported revenue of $78.3 million for Q2 FY 2022, representing a year-over-year growth of 7.6% [8][24] - Adjusted EPS was negative $0.02, compared to adjusted net income of $0.01 in the same quarter last year [31] - Gross margin for Q2 FY 2022 was 51.8%, a decrease of 340 basis points year-over-year due to rising labor and manufacturing costs [28][29] Business Line Data and Key Metrics Changes - Med Tech revenue was $18.9 million, a 36% increase year-over-year, driven by strong performance in Auryon and Thrombectomy platforms [8][24] - The Med Device business grew approximately 1% year-over-year, impacted by a $4 million backlog due to supply chain disruptions [8][20] - Auryon generated $6.3 million in revenue, with an estimated 5% market share, and is expected to continue robust growth [14][15] Market Data and Key Metrics Changes - Endovascular therapies revenue increased 17% year-over-year to $39.7 million, benefiting from the adoption of Auryon [25] - Mechanical Thrombectomy revenue grew 29% year-over-year, with a 21% increase when including unit usage [26] - Oncology business revenue declined 9.3% due to fewer capital sales and procedural pressures related to COVID [27] Company Strategy and Development Direction - The company is focused on transforming into a high-growth med tech company, with ongoing investments in manufacturing capacity and supply chain improvements [7][11] - Strategic initiatives include increasing manufacturing capacity in Costa Rica and pursuing targeted projects to enhance efficiency [11][12] - The company continues to explore strategic tuck-in M&A opportunities as part of its long-term growth strategy [21] Management's Comments on Operating Environment and Future Outlook - Management acknowledged ongoing challenges from COVID-19, including staffing shortages and supply chain disruptions, but remains optimistic about demand for products [9][39] - The company expects potential headwinds to persist in Q3, with a recovery anticipated as internal initiatives take hold [32][46] - Management reiterated revenue guidance for FY 2022 in the range of $310 million to $315 million, despite current challenges [32][68] Other Important Information - The company has 22 active sites in its DIRECT study, with plans to expand clinical research efforts [22] - The PRESERVE study for the NanoKnife system is expected to begin patient enrollment in Q3, aiming to expand the target market significantly [23] Q&A Session Summary Question: How is the current wave of COVID different from previous ones and its impact on business? - Management noted increased pressure on healthcare networks due to staffing challenges, leading to cancellations of elective procedures [38][39] Question: What is the status of the $4 million backlog? - The backlog has increased slightly and is expected to plateau, with efforts underway to address labor shortages and supply chain issues [43][60] Question: How does the company view the impact of Omicron on revenue guidance? - Management expects some impact on the February quarter but believes demand remains strong overall [44][46] Question: What is the penetration rate of Auryon in the market? - Auryon currently holds about 5% market share, with room for growth as the company continues to place new lasers [47][50] Question: What is the timeline for the AlphaVac commercial release? - The full commercial release is not expected to be significantly impacted by Omicron, with plans to launch the 18 French device in the first half of the calendar year [52][70]

Revenue and Sales Performance - Revenue increased by 7.6% to $78.3 million for the three months ended November 30, 2021, compared to $72.8 million in the same period of the prior year[113]. - For the six months ended November 30, 2021, revenue increased by 8.6% to $155.3 million, compared to $142.986 million in the same period of the prior year[114]. - Med Tech segment experienced growth of 36.4% to $18.9 million for the three months ended November 30, 2021, while Med Device segment grew by 0.8% to $59.4 million[118]. - Auryon sales increased by $4.2 million for the three months ended November 30, 2021, compared to the same period in the prior year[120]. - The Oncology segment faced a decline of 9.3% in net sales for the three months ended November 30, 2021, totaling $13.6 million[119]. - The Med Device business net sales increased by $0.5 million for the three months ended November 30, 2021, compared to the same period in the prior year[121]. - International sales decreased by 9.8% for the six months ended November 30, 2021, totaling $25.4 million compared to $28.2 million in the prior year[119]. Financial Loss and Profitability - Net loss for the three months ended November 30, 2021, increased by $4.1 million to $8.4 million, resulting in a loss per share of $0.21[115]. - The company reported a net loss of $15.3 million for the six months ended November 30, 2021, compared to a net loss of $8.5 million for the same period in 2020[140]. - Gross profit for the three months ended November 30, 2021, increased by $0.4 million to $40.555 million, a 0.9% increase year-over-year[125]. - For the six months ended November 30, 2021, gross profit increased by $4.8 million to $80.694 million, representing a 6.3% increase year-over-year[126]. Expenses - Research and development (R&D) expenses decreased by $1.5 million for the three months ended November 30, 2021, totaling $8.199 million, a 15.6% decrease year-over-year[127]. - Sales and marketing expenses increased by $3.4 million for the three months ended November 30, 2021, totaling $23.606 million, a 17.0% increase year-over-year[129]. - General and administrative expenses increased by $0.5 million for the three months ended November 30, 2021, totaling $9.678 million, a 5.0% increase year-over-year[130]. Cash Flow and Liquidity - Cash used in operations increased by $13.0 million to $7.0 million for the six months ended November 30, 2021[114]. - Cash and cash equivalents totaled $34.3 million as of November 30, 2021, down from $48.2 million as of May 31, 2021[137]. - Cash used in investing activities for the six months ended November 30, 2021, was $12.941 million, compared to $3.185 million for the same period in 2020[138]. - The Company believes its current cash balance, along with cash generated from operations and access to the Revolving Facility, will provide sufficient liquidity for at least the next 12 months[143]. Debt and Credit Facilities - Total debt outstanding related to the Revolving Facility increased to $25.0 million as of November 30, 2021, from $20.0 million as of May 31, 2021[137]. - The Credit Agreement provides for a $125.0 million secured Revolving Facility, with an uncommitted expansion feature allowing an increase of up to $75.0 million in total revolving commitments[142]. - As of November 30, 2021, the interest rate on the Revolving Facility was 1.34%, with $25.0 million outstanding[149]. - In the first quarter of fiscal year 2022, the Company made a $5.0 million draw on the Revolving Facility for the QX Medical asset acquisition[143]. Risk Factors - Approximately 7% of the Company's sales for the six months ended November 30, 2021, were denominated in foreign currencies, exposing profitability to currency fluctuations[148]. - The Company is required to maintain a fixed charge coverage ratio of not less than 1.25 to 1.00 and a total leverage ratio of not greater than 3.00 to 1.00[142]. - The Company is exposed to interest rate fluctuations on its credit facility, which could impact its financial position[147]. - No single customer represents more than 10% of total sales, limiting concentration of credit risk[151]. - The Company has structured its Credit Agreement across five above investment grade banks to limit concentration of credit risk[150]. Internal Controls - There were no changes in internal control over financial reporting that materially affected the Company for the fiscal quarter ended November 30, 2021[154].

Financial Data and Key Metrics Changes - The company reported revenue of $77 million for the first quarter, representing a year-over-year growth of 9.6% [9][20] - Adjusted net loss for the quarter was $0.9 million, or a loss of $0.02 per share, compared to adjusted net income of $0.6 million, or earnings per share of $0.02 in the same quarter last year [27] - Gross margin for the quarter was 52.1%, an increase of 120 basis points compared to the previous year [23] Business Line Data and Key Metrics Changes - Revenue from the Med Tech business was $17.6 million, a 68% increase year-over-year, while the Med Device business revenue was approximately flat year-over-year at $59.4 million [20] - Auryon revenue was $5.9 million, up from $4.6 million in the previous quarter, with expectations for FY 2022 revenue now projected between $24 million to $26 million [10][20] - AngioVac revenue grew 12% year-over-year, while Vascular Access revenue declined 11.2% compared to the prior year [21][22] Market Data and Key Metrics Changes - The endovascular therapies business saw a revenue increase of 27.5% year-over-year to $38.1 million, driven by Auryon growth [20] - NanoKnife sales grew 34% year-over-year globally and 63% in the U.S., supported by increased procedural volumes [14][22] Company Strategy and Development Direction - The company is transforming into a high-growth Med Tech company, focusing on innovative technologies to drive growth in larger markets [8][29] - Strategic and tuck-in M&A remains a part of the long-term growth strategy, with ongoing monitoring of the landscape for opportunities [15][16] Management's Comments on Operating Environment and Future Outlook - Management noted that the ongoing COVID-19 pandemic, particularly the Delta variant, impacted case volumes but observed improving trends in September [8][18] - The company anticipates continued headwinds from COVID-related challenges but remains confident in its growth trajectory [19][55] Other Important Information - The company is investing in R&D and sales and marketing to drive sustainable growth, with R&D expenses at $7.4 million for the quarter [26] - The company has a disciplined approach to capital allocation and expense management, with expectations for FY 2022 net sales in the range of $310 million to $315 million [28][29] Q&A Session Summary Question: Can you summarize the COVID commentary? - Management confirmed that the Delta variant negatively impacted the fiscal first quarter but noted improving trends in September [31][32] Question: What drove the jump in the installed base of Auryon lasers? - The increase was attributed to strong customer demand and a secure supply chain [33][34] Question: What is the timing for the 18 French AlphaVac device? - The launch is expected in the first half of calendar year 2022 [39] Question: What is the growth expectation for the thrombectomy platform? - The 30% growth target is focused on mechanical thrombectomy products, primarily from the AngioVac and AlphaVac platforms [40] Question: How is the company addressing nursing staff shortages? - Management is closely monitoring the situation and noted that hospitals are under pressure but have learned to balance care delivery better than before [58][59]

Product Offerings - AngioDynamics reported a comprehensive range of medical devices for minimally invasive procedures, focusing on peripheral vascular disease and oncology [11]. - The company has expanded its product lines through multiple acquisitions, including RITA Medical Systems and Eximo Medical, enhancing its offerings in ablation and vascular access products [13][15]. - The Auryon Atherectomy System is designed for treating Peripheral Artery Disease, utilizing a proprietary 355nm laser technology [20]. - AngioDynamics' thrombolytic catheters, such as the Uni-Fuse system, provide a 12-fold advantage in fluid distribution compared to standard catheters [22]. - The VenaCure EVLT system utilizes a 1470 nanometer wavelength laser for treating varicose veins, allowing for minimally invasive procedures with reduced pain and bruising [29]. - The NanoKnife Ablation System offers a non-thermal approach to soft tissue ablation, utilizing low energy direct current to induce cell death [31]. - The Solero Microwave Tissue Ablation System can deliver up to 140W for optimized power delivery, completing a 5 cm ablation in six minutes [33]. - The BioSentry Tract Sealant System significantly reduces the risk of pneumothoraxes during lung biopsies by creating an airtight seal [36]. - The IsoLoc Endorectal Balloon is designed to enhance patient comfort and improve radiation therapy outcomes for prostate treatment [37]. - The Alatus Vaginal Balloon Packing System improves patient comfort during radiation therapy by replacing traditional gauze packing [39]. - AngioDynamics offers a broad portfolio of Vascular Access products, including peripherally inserted central catheters (PICCs), midline catheters, implantable ports, and dialysis catheters [40]. - The BioFlo catheter, featuring Endexo Technology, is designed to resist thrombus accumulation and is available across various product lines, enhancing patient safety and outcomes [41]. - The BioFlo PICC line is the only power injectable PICC that supports contrast-enhanced CT scans compatible with up to 325 psi CT injections [43]. - AngioDynamics' ports can be utilized for approximately 2,000 accesses once implanted, primarily for cancer treatment protocols requiring frequent infusions [45]. - The BioFlo DuraMax dialysis catheter is the only dialysis catheter with Endexo Technology, designed for long-term patency and improved patient outcomes [46]. Research and Development - The company emphasizes continuous investment in research and development to introduce innovative products and enhance existing offerings [48]. - The company is engaged in product development and improvement programs to maintain its competitive position, which involves significant planning and investment in research and development [101]. - The company expects to continue engaging in business development activities, including the acquisition of complementary businesses and technologies, although competition for targets may be significant [103]. Competition and Market Dynamics - AngioDynamics faces significant competition from major manufacturers like Boston Scientific and Medtronic, requiring a focus on quality, clinical outcomes, and cost-effectiveness [49]. - The company faces intense competition in the medical device industry, which is characterized by rapid technological change and frequent product introductions [98]. - The company’s growth is dependent on maintaining a positive reputation with interventional physicians and critical care nurses, as their purchasing decisions significantly influence sales [106]. - The company’s ability to generate satisfactory clinical results and enhance existing products is crucial for achieving growth goals [105]. - The company may face challenges in retaining contracts with major group purchasing organizations (GPOs) and integrated health delivery networks (IDNs), which could adversely impact profitability [100]. Financial Performance - Revenue for the year ended May 31, 2021, increased by 10.2% to $291.0 million compared to the previous year [205]. - Gross margin as a percentage of sales decreased by 300 basis points to 53.9% for the year ended May 31, 2021 [205]. - Operating loss decreased by $131.8 million to $35.3 million for the year ended May 31, 2021 [205]. - Cash flow from operations increased by $38.6 million to $24.1 million for the year ended May 31, 2021 [205]. - The company recorded a benefit of $1.9 million from the employee retention credit under the CARES Act in the third quarter of fiscal year 2021 [204]. - The Endovascular Therapies and Vascular Access businesses performed the strongest during the year, while the Oncology business faced pressure due to reduced procedure volumes [206]. Regulatory Environment - Manufacturing facilities are registered with the FDA and certified to ISO 13485 standards, ensuring compliance with regulatory requirements [53]. - The company operates under a stringent regulatory environment, requiring FDA clearance for new medical devices, which can lead to delays and increased costs [60]. - The company is subject to the FDA's Quality System Regulation (QSR), which mandates extensive testing and quality assurance procedures throughout production [66]. - The company relies on international distributors to obtain regulatory approvals and complete product registrations in various countries [68]. - The company faces potential product recalls mandated by the FDA, which could harm its reputation and divert resources [167]. - The company is subject to fines and penalties if found promoting products for unapproved uses, which could adversely affect financial condition [169]. Operational Challenges - The company may experience significant cost overruns and difficulties managing contract research organizations (CROs) involved in clinical trials, which could adversely affect its financial condition [112]. - The company is heavily reliant on single and limited source suppliers, which poses risks of business interruptions and potential delays in product manufacturing [114]. - The company faces challenges in securing adequate reimbursement for its products, which is critical for revenue growth and profitability [119]. - Economic conditions, including inflation and trade protection measures, could adversely affect consumer spending and the company's financial performance [127]. - The company is implementing operational excellence initiatives aimed at restructuring and cost reduction, but the benefits may not materialize as anticipated [134]. Human Resources and Corporate Governance - The company has approximately 800 full-time employees as of May 31, 2021, with no labor union representation and no history of work stoppages [76]. - The company’s Chief Executive Officer, James C. Clemmer, has a background in managing a $1.8 billion medical supplies segment at Covidien plc [80]. - The company’s Chief Financial Officer, Stephen A. Trowbridge, has been with the company since June 2008 and previously served as Corporate Counsel [81]. - The company has a diverse and inclusive culture aimed at attracting and retaining talent in various operational roles [76]. Impact of COVID-19 - The COVID-19 pandemic has significantly decreased elective procedures that use the company's products, impacting sales and operations [153]. - The company anticipates ongoing negative impacts from COVID-19, including potential disruptions in logistics and supply chain [155]. - The company has faced challenges in sales efforts due to restrictions on sales representatives entering hospitals and clinics during the pandemic [154]. Financial Liabilities and Risks - The company’s product liability insurance coverage is limited to a maximum of $10 million per claim, with an annual aggregate limit of $10 million [74]. - The company carries a product liability policy with a limit of $10.0 million per claim, which may not be sufficient to cover potential liabilities [126]. - The company may require additional capital for expansion, which could lead to increased indebtedness and operational restrictions [135]. - The potential for increased interest expenses due to floating rates on borrowings could impact financial stability [136]. - The company relies on information technology systems that are vulnerable to cyber-attacks, which could adversely affect operations and financial condition [142]. - The company may face increased scrutiny and compliance costs due to new legislation affecting interactions with healthcare providers [159]. Stock and Market Considerations - The company’s stock price may be volatile, influenced by various external factors, which could lead to significant fluctuations [182]. - The company’s future operating results are difficult to predict and may vary significantly, impacting stock price and investor expectations [179]. - The company does not anticipate paying any cash dividends on its common stock for the foreseeable future [191].

Financial Data and Key Metrics Changes - For FY '21, the company reported full year revenue of $291 million, representing a growth of 10.2% year-over-year [10] - The fourth quarter revenue was $76.8 million, reflecting a sequential growth of 8% over the third quarter [10] - Adjusted EPS for FY '21 was $0.05, compared to an adjusted net loss of $2.1 million or $0.06 per share in the fourth quarter of the previous year [25] - Gross margin for the fourth quarter was 55.1%, an increase of 330 basis points year-over-year [21] Business Line Data and Key Metrics Changes - Auryon revenue for the fourth quarter was $4.6 million, with total FY '21 revenue at $11.1 million, and expected to grow to $18 million to $22 million in FY '22 [12][19] - AngioVac platform revenue increased 14% sequentially in the fourth quarter, with year-over-year growth of 47% in FY '21 [12] - NanoKnife probe sales grew 14% sequentially in the fourth quarter and 19% in the U.S., with FY '21 growth of 13% worldwide and 38% in the U.S. [15] Market Data and Key Metrics Changes - The total endovascular therapies business increased 72.3% year-over-year to $38.1 million, driven by strong performance from AngioVac and Auryon [19] - Vascular Access revenue increased 3.2% year-over-year, while Oncology business revenue increased 14.2% during the quarter [20][21] Company Strategy and Development Direction - The company is focused on transforming into a customer-focused, technology-driven, growth-oriented entity, with strategic investments in R&D and sales and marketing [7][9] - The company plans to continue investing in its Med Tech platforms, including Auryon, Mechanical Thrombectomy, and NanoKnife, while maintaining a disciplined approach to capital allocation [16][27] - M&A remains a long-term growth strategy, although it was deprioritized in the short term due to COVID-related challenges [16] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the normalization of procedural volumes as the COVID-19 pandemic subsides, indicating a positive trend in end markets [10][11] - The company anticipates FY '22 net sales in the range of $305 million to $310 million, reflecting a growth of 5% to 7% over FY '21 [27] - Management acknowledged external pressures such as staffing challenges and inflationary costs impacting gross margins, but expects gradual improvement over time [22][23] Other Important Information - The company generated free cash flow of $3.1 million during the fourth quarter and ended with $48.2 million in cash and cash equivalents [26] - The company received FDA approval for its 100 patient NanoKnife prostate IDE study, PRESERVE, which is expected to enhance its clinical offerings [17] Q&A Session Summary Question: Can you provide insight into the types of procedures Auryon is growing in? - Management noted a blend of above and below the knee procedures, with increasing confidence in the technology leading to more complex cases being performed [31][32] Question: How is the growth in AngioVac being driven? - Growth is attributed to new users and existing users increasing their usage as they gain confidence in the product's outcomes [39] Question: What are the trends in April and May? - Management indicated that while there is improvement, the operating environment is not yet fully normalized, particularly in regions like Latin America and Asia Pacific [44][62] Question: What is the expected growth for the different business segments in FY '22? - Guidance includes $18 million to $22 million from Auryon, 30% growth for the Mechanical Thrombectomy platform, and 20% growth for NanoKnife probes [46] Question: What is the expected gross margin for FY '22? - The company expects gross margin to be approximately 55%, with potential for improvement as sales mix shifts towards higher-margin products [23][56]