Asahi Kasei Corp.

NANTES, France--(BUSINESS WIRE)-- Regulatory News: OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) presented the first Phase 1/2 positive clinical results with high affinity anti-PD1 monoclonal antibody OSE-279 in advanced solid tumors at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, held in Boston, MA (October 11 – 15, 2023 - Abstract number 35371, Poster C063). Silvia Comis, Head of Clinical Development and Regulatory Affairs of OSE Immunotherapeutics, comments: “These first efficacy and safety positive results from clinical Phase 1/2 assessing the therapeutic potential of our proprietary anti-PD1 monoclonal antibody OSE-279 in advanced solid tumors are very promising. These results encourage further clinical development of OSE-279 in the future as a monotherapy treatment in pre-identified cancer niche indications, with still high unmet medical needs. This product will also be available for combination with other OSE drug candidates or with external assets opening new potential partnerships.” The communication reported on the first positive results from the Phase 1/2 clinical trial evaluating OSE-279 monotherapy in patients with advanced solid tumors, with no therapeutic option available. These data have shown a manageable safety pro preliminary signs of efficacy in the first 13 patients included with 8 tumor types and treated by a dose of 100 and 300 mg every 3 weeks (q3w) or 600 mg every 6 weeks (q6w). One confirmed partial response in a hepatocellular carcinoma patient (-81% tumor shrinkage) after a single dose of OSE-279 300 mg and 2 yet unconfirmed partial responses in anal squamous cell carcinoma (-46% tumor shrinkage) and undifferentiated pleomorphic sarcoma (-33% tumor shrinkage) with OSE-279 600 mg, were reported out of 11 patients with at least one post baseline tumor assessment. Furthermore, stable disease longer than 16 weeks was observed in 3 patients (Disease Control Rate: 55%). Pharmacokinetic pro good exposure and dose-proportionality and both pharmacokinetic and pharmacodynamic profiles were consistent with modelling. Receptor occupancy was maintained and within the boundaries of simulation. A Phase 2 dose (RP2D) of 300 mg was recommended every 3 weeks and 600 mg appears to be a good candidate for the RP2D every 6 weeks. OSE-279 is a high affinity humanized anti-PD1 monoclonal antibody blocking both PD-L1 and PD-L2, the ligands of PD1 overexpressed by tumor cells and tumor microenvironment. OSE-279 is also the key anti-PD1 backbone component of OSE’s bifunctional checkpoint inhibitor BiCKI® platform that is targeting PD1 and other new immune targets. The first-in-human open label Phase 1/2 dose escalation and expansion study aims to determine the Maximum Tolerated Dose (MTD) and/or the RP2D of OSE-279 as a monotherapy in advanced solid tumors with two possible administration rates. Secondary objectives include assessment of OSE-279’s antitumor activity, evaluation of the safety profile, pharmacokinetic and receptor occupancy or pharmacodynamic profile (NCT05751798). ABOUT OSE Immunotherapeutics OSE Immunotherapeutics is a biotech company dedicated to developing first-in-class assets in immuno-oncology and immuno-inflammation. The Company’s current well-balanced first-in-class clinical pipeline includes: Tedopi® (immunotherapy activating tumor specific T-cells, off-the-shelf, neoepitope-based): this cancer vaccine is the Company’s most advanced product; positive results from the Phase 3 trial (Atalante 1) in Non-Small Cell Lung Cancer patients in secondary resistance after checkpoint inhibitor failure. Other Phase 2 trials, sponsored by clinical oncology groups, of Tedopi® in combination are ongoing in solid tumors. OSE-279 (anti-PD1): first positive results in the ongoing Phase 1/2 in solid tumors. OSE-279 is the backbone therapy of the BiCKI® platform. OSE-127 - lusvertikimab (humanized monoclonal antibody antagonist of IL-7 receptor); ongoing Phase 2 in Ulcerative Colitis (sponsor OSE Immunotherapeutics); ongoing preclinical research in leukemia (OSE Immunotherapeutics). FR-104/VEL-101 (anti-CD28 monoclonal antibody): developed in partnership with Veloxis Pharmaceuticals, Inc. in transplantation; ongoing Phase 1/2 in renal transplant (sponsor Nantes University Hospital); Phase 1 ongoing in the US (sponsor Veloxis Pharmaceuticals, Inc.). OSE-172/BI 765063 (anti-SIRPα monoclonal antibody on CD47/SIRPα pathway) developed in partnership with Boehringer Ingelheim in advanced solid tumors; positive Phase 1 dose escalation results in monotherapy and in combination, in particular with anti-PD-1 antibody ezabenlimab; international Phase 1b ongoing clinical trial in combination with ezabenlimab alone or with other drugs in patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) and hepatocellular carcinoma (HCC). OSE Immunotherapeutics expects to generate further significant value from its two proprietary drug discovery platforms, which are central to its ambitious goal to deliver next-generation first-in-class immunotherapies: BiCKI® platform focused on immuno-oncology (IO) is a bispecific fusion protein platform built on the key backbone component of anti-PD1 combined with a new immunotherapy target to increase anti-tumor efficacy. BiCKI-IL-7 is the most advanced BiCKI® candidate targeting anti-PD1xIL-7. Myeloid platform focused on optimizing the therapeutic potential of myeloid cells in IO and immuno-inflammation (I&I). OSE-230 (ChemR23 agonist mAb) is the most advanced candidate generated by the platform, with the potential to resolve chronic inflammation by driving affected tissues to tissue integrity. Additional information about OSE Immunotherapeutics assets is available on the Company’s website: Click and follow us on Twitter and LinkedIn Forward-looking statements This press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management in light of its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate. These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Universal Registration Document filed with the AMF on May 2, 2023, including the annual financial report for the fiscal year 2022, available on the OSE Immunotherapeutics’ website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements. View source version on businesswire.com: Contacts OSE Immunotherapeutics Sylvie Détry sylvie.detry@ose-immuno.com Nicolas Poirier Chief Executive Officer nicolas.poirier@ose-immuno.com French Media: FP2COM Florence Portejoie fportejoie@fp2com.fr +33 6 07 768 283 Source: OSE Immunotherapeutics SA View this news release online at:

CHICAGO, Oct. 13, 2023 /PRNewswire/ -- The ventilators industry is poised for significant advancements in the near future, driven by rapid technological innovation and the increasing demand for critical care equipment. With a growing emphasis on portable and compact ventilators, manufacturers are expected to develop more efficient and user-friendly devices, making them accessible for a broader range of healthcare settings. Additionally, the integration of artificial intelligence and telemedicine capabilities into ventilator systems promises to enhance patient monitoring and remote control. This industry's future is marked by a commitment to improving patient outcomes and streamlining healthcare delivery, ultimately ensuring a higher level of care for those in need of respiratory support. Ventilators Market in terms of revenue was estimated to be worth $4.2 Billion in 2023 and is poised to reach $5.7 Billion by 2028, growing at a CAGR of 6.4% from 2023 to 2028 according to a new report by MarketsandMarkets™. The growth of the global ventilators market is driven by the rising burden of respiratory diseases, such as COPD and asthma. COPD and asthma result in the narrowing of respiratory paths, making breathing difficults. Therefore, many patirnts with COPD and asthma require external ventilation and airway management which will dive growth for ventilators market. However, skilled workforce shortages have been exacerbated during the pandemic and can hamper the growth of the ventilators market in the coming years. Download an Illustrative overview: Browse in-depth TOC on "Ventilators Market" 259 - Tables 57 - Figures 290 - Pages Ventilators Market Scope: Based on mobility, intensive care ventilators segment holds the largest share ventilators market In 2022, the intensive care ventilators segment holds the largest share of the ventilators market. The growth of the intensive care ventilators segment is due to the susceptibility of geriatric individuals to develop severe health problems, the volume of patients being treated in critical care units is increasing, which in turn is driving the demand for intensive care beds. Based on type, the adult/pediatric ventilators segment accounted of the ventilators market In 2022, the adult/pediatric ventilators segment accounted of the ventilators market. The large share of the adult/pediatric ventilators segment can be attributed to the chronic diseases such as COPD & asthma, growing tobacco consumption, and the increasing geriatric population.These patients usually exhibit acute respiratory failure signs and are not candidates for less invasive respiratoy support methods. For adults, there are invasive and non-invasive techniques of mechanical ventilation. Based on end user, the hospitals and clinics segment accounted of the ventilators market In 2021, the hospitals and clinics segment accounted of the ventilators market. The hospitals and clinics segment will continue to dominate the market during the forecast period. The large share of this segment can be attributed to the increasing number of patients with complex medical conditions, such as multiple organ failure and severe sepsis, and growing awareness of the benefits of mechanical ventilation, such as improved patient outcomes and reduced mortality. The Asia Pacific market is expected to grow at a higher rate during the forecast period the APAC market is expected to grow at the highest rate during the forecast period, the growing prevalence of lifestyle related diseases such as obesity, a decreasing mortality rate, and the rising demand for home healthcare, is also driving the demand for ventilators. Moreover, improvements in the standard of living, coupled with incaresed access to healthcare, will aid market growth. Request Sample Pages: Ventilators Market Dynamics: Drivers: 1. Rising burden of respiratory diseases a. Increasing incidence of COPD and asthma b. High prevalence of tobacco smoking 2. Urbanization and rising pollution levels 3. Rising obesity cases due to sedentary lifestyles 4. Rapid growth in geriatric population worldwide 5. Growing preference for home care settings 6. Rising number of preterm births 7. Outbreak of infectious respiratory diseases Restraints: 1. Shortage of skilled medical workers 2. Excessive purchase of ventilators during COVID-19 3. Reimbursement concerns Opportunities: 1. Cost efficiency of home care services 2. Growth opportunities in emerging economies Challenge: 1. Low awareness and unavailability of adequate resources in emerging economies 2. Harmful effects of certain respiratory devices on neonates Key Market Players of Ventilators Industry : The prominent players in the ventilators market are Koninklijke Philips N.V. (Netherlands), ResMed (US), Medtronic (Ireland), Vyaire Medical, Inc. (US), Getinge AB (Sweden), Drägerwerk AG & CO. KGAA (Germany), ICU Medical, Inc. (US), Hamilton Medical (Switzerland), GE Healthcare (US), Air Liquide (France), Asahi Kasei Corporation (Japan), Allied Healthcare Products, Inc. (US), Nihon Kohden Corporation (Japan), Shenzhen Mindray Bio-Medical Electronics Co., Ltd, (China), Skanray Technologies (India), Baxter International Inc, (US), aXcent Medical GmbH (Germany), Metran Co., Ltd (Japan), MAGNAMED (Brazil), Leistung Ingeniería SRL(Argentina), Avasarala Technologies Limited (India), Airon Corporation (Florida), TRITON Electronic Systems Ltd. (Russia), Bio-Med Devices, Inc. (US), and HEYER Medical AG (Germany). Recent Developments: In January 2022, ICU Medical acquired Smiths Group plc, aims to support the expansion of ICU Medical's product line, including infusion therapy and ventilators, thus expanding ICU Medical's presence in critical care markets. In October 2021, GE Healthcare partnered with Apprise Health Insights. The companies together launched Oregon's Statewide Capacity System to track 7,368 beds and approximately 800 ventilators across 60 hospitals. In June 2021, Vyaire Medical, Inc. partnered with GenWorks Healthcare Limited. The partnership in India expands the company's footprint and provides greater accessibility to high-quality pulmonary screening, testing, and treatment. Get 10% Free Customization on this Report: Ventilators Market Advantages: Life-Saving Support: Ventilators are critical in providing life-saving respiratory support for patients with severe respiratory conditions, such as those suffering from acute respiratory distress syndrome (ARDS), pneumonia, or the effects of COVID-19, helping them breathe when their own respiratory system is compromised. Diverse Applications: Ventilators have a broad range of applications across various healthcare settings, from intensive care units (ICUs) in hospitals to ambulances and even home care, ensuring that patients receive appropriate care wherever they are. Technological Advancements: Ongoing technological advancements have led to the development of more efficient and user-friendly ventilators with features like advanced modes of ventilation, better patient monitoring, and improved alarm systems, enhancing patient care and safety. Patient-Centric Care: Ventilators allow for personalized treatment plans and fine-tuned respiratory support, contributing to better patient outcomes and reducing the risk of ventilator-associated complications. Telemedicine Integration: With the integration of telemedicine capabilities, ventilators enable remote monitoring and adjustments, enhancing patient care, and reducing the need for constant physical presence by medical staff, especially during pandemics or in remote areas. Global Health Preparedness: The COVID-19 pandemic highlighted the importance of ventilators in global health crises, prompting increased investment and manufacturing capabilities to ensure adequate supply and readiness for future emergencies. Economic Opportunities: The ventilators market represents a significant economic opportunity, fostering growth in research, development, and manufacturing, as well as creating jobs and stimulating innovation in medical technology. Improved Quality of Life: Ventilators not only save lives but also help improve the quality of life for patients with chronic respiratory conditions by providing ongoing respiratory support and reducing the strain on the respiratory system. Enhanced Education and Training: The presence of ventilators in healthcare settings allows for continuous medical education and training, enabling healthcare professionals to enhance their skills in critical care and life support. Global Health Equity: The availability and accessibility of ventilators contribute to global health equity, ensuring that patients around the world, regardless of their location or socioeconomic status, have access to life-saving respiratory support. Related Reports: Respiratory Care Devices Market - Global Forecasts To 2028 Sleep Apnea Devices Market - Global Forecasts to 2028 Pulse Oximeter Market - Global Forecasts to 2027 Patient Monitoring Devices Market - Global Forecasts to 2027 Top 10 Medical Device Technologies Market - Global Forecasts to 2027 About MarketsandMarkets™: MarketsandMarkets™ has been recognized as one of America's best management consulting firms by Forbes, as per their recent report. MarketsandMarkets™ is a blue ocean alternative in growth consulting and program management, leveraging a man-machine offering to drive supernormal growth for progressive organizations in the B2B space. We have the widest lens on emerging technologies, making us proficient in co-creating supernormal growth for clients. Earlier this year, we made a formal transformation into one of America's best management consulting firms as per a survey conducted by Forbes. The B2B economy is witnessing the emergence of $25 trillion of new revenue streams that are substituting existing revenue streams in this decade alone. We work with clients on growth programs, helping them monetize this $25 trillion opportunity through our service lines - TAM Expansion, Go-to-Market (GTM) Strategy to Execution, Market Share Gain, Account Enablement, and Thought Leadership Marketing. Built on the 'GIVE Growth' principle, we work with several Forbes Global 2000 B2B companies - helping them stay relevant in a disruptive ecosystem. Our insights and strategies are molded by our industry experts, cutting-edge AI-powered Market Intelligence Cloud, and years of research. The KnowledgeStore™ (our Market Intelligence Cloud) integrates our research, facilitates an analysis of interconnections through a set of applications, helping clients look at the entire ecosystem and understand the revenue shifts happening in their industry. To find out more, visit ™.com or follow us on Twitter, LinkedIn and Facebook. Contact: Mr. Aashish Mehra MarketsandMarkets™ INC. 630 Dundee Road Suite 430 Northbrook, IL 60062 USA: +1-888-600-6441 Email: [email protected] Research Insight: Visit Our Website: Content Source: Logo: SOURCE MarketsandMarkets

Fiscal Year 2024 First Quarter Highlights Net sales of $78.7 million as reported Includes $0.7 million of Dialysis and BioSentry Biopsy Tract Sealant System sales Net sales increased 5.7% on a pro-forma basis when excluding Dialysis and BioSentry, compared to the prior-year quarter Med Tech net sales of $25.9 million increased 13.3% Med Device net sales of $52.8 million as reported Med Device net sales increased 2.3% on a pro-forma basis Gross margin of 50.9% Declined 20 basis points on a pro-forma basis year over year Completed the sale of the Dialysis and BioSentry Biopsy Tract Sealant System businesses to Merit Medical Systems, Inc. for $100.0 million in cash GAAP earnings per share of $1.15 As reported adjusted loss per share of $0.12 Cash and cash equivalents at August 31, 2023 were $57.6 million Completed enrollment in the PRESERVE study for the use NanoKnife to treat prostate tissue LATHAM, N.Y.--(BUSINESS WIRE)-- AngioDynamics, Inc. (NASDAQ: ANGO), 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, today announced financial results for the first quarter of fiscal year 2024, which ended August 31, 2023. “We started Fiscal Year 2024 with strong performance across both businesses, driven by continued strength from NanoKnife and our International markets,” commented Jim Clemmer, President and Chief Executive Officer of AngioDynamics, Inc. “We remain focused on bringing innovative new products to market, expanding the approved indications for our existing products, and continuing to build a body of compelling clinical evidence in support of these indications and products.” First Quarter 2024 Financial Results Net sales for the first quarter of fiscal year 2024 were $78.7 million, including $0.7 million of Dialysis and BioSentry Tract Sealant System sales. On a pro forma basis, excluding sales of Dialysis and BioSentry, net sales increased 5.7% compared to the prior-year quarter. Foreign currency translation did not have a significant impact on the Company's net sales in the quarter. Med Tech net sales were $25.9 million, a 13.3% increase from $22.8 million in the prior- year period. Med Tech includes the Auryon peripheral atherectomy platform, the thrombus management platform and the NanoKnife irreversible electroporation platform. Year-over-year growth was driven by Auryon sales during the quarter of $11.1 million, which increased 25.7%, NanoKnife disposable sales of $4.3 million, which grew 34.5%, and AlphaVac sales of $1.8 million, which grew 1.8%. AngioVac sales were $6.3 million in the quarter, a decline of 7.7% year over year and up 3.6% sequentially from the fourth fiscal quarter of FY23. Med Device net sales were $52.8 million. When excluding sales of Dialysis and BioSentry, Med Device net sales increased 2.3% compared to $51.0 million in the prior-year period. U.S. net sales in the first quarter of fiscal 2024 were $64.4 million. When excluding sales of Dialysis and BioSentry, U.S. net sales increased 2.1% from $62.4 million a year ago. International net sales were $14.3 million. When excluding sales of Dialysis and BioSentry, International net sales increased 25.7%, compared to $11.3 million a year ago. Gross margin for the first quarter of fiscal 2024 was 50.9%. On a pro forma basis, excluding Dialysis and BioSentry, gross margin of 50.8% decreased 20 basis points compared to the first quarter of fiscal 2023. Gross margin for the Med Tech business was 64.7%, an increase of 150 basis points from the first quarter of fiscal 2023. Gross margin for the Med Device business was 44.2%. On a pro forma basis, excluding Dialysis and BioSentry, Med Device gross margin of 43.9% decreased 170 basis points compared to the first quarter of fiscal 2023. Gross margin continued to be impacted by inflationary pressures including increased costs for labor and raw materials as well as geographic mix. The Company recorded net income of $45.9 million, or earnings per share of $1.15, in the first quarter of fiscal 2024. This includes a gain on the sale of the Company’s Dialysis and BioSentry Tract Sealant System products of $47.8 million in connection with the transaction announced on June 8, 2023. Excluding the items shown in the non-GAAP reconciliation table below, adjusted net loss for the first quarter of fiscal 2024 was $4.8 million, and adjusted loss per share was $0.12. When excluding Dialysis and BioSentry, on a pro-forma basis, adjusted net loss in the first quarter of fiscal 2024 was $5.2 million, or an adjusted net loss of $0.13 per share, compared to adjusted net loss of $6.0 million, or an adjusted net loss of $0.15 per share compared to the prior-year period. During the first quarter of fiscal 2024, the Company revised its annual equity grant practice for non-employee directors, moving from granting shares with a one-year vesting term to granting immediately vested shares. The target grant value was not changed from the prior year. This change resulted in cumulative expense totaling approximately $0.02 shifting into the first quarter instead of being ratably expensed over the remainder of fiscal year 2024. Adjusted EBITDA in the first quarter of fiscal 2024, excluding the items shown in the reconciliation table below, was $0.8 million. When excluding Dialysis and BioSentry, on a pro-forma basis, adjusted EBITDA was $0.4 million compared to negative adjusted EBITDA of $1.6 million in the first quarter of fiscal 2023. In the first quarter of fiscal 2024, the Company used $25.9 million in operating cash, had capital expenditures of $0.8 million and $0.8 million in Auryon placement and evaluation units. As stated in July, the Company expects to finish fiscal year 2024 with cash balances in the range of $65.0 to $70.0 million. At August 31, 2023, the Company had $57.6 million in cash and cash equivalents compared to $44.6 million in cash and cash equivalents at May 31, 2023. During the first quarter, the Company used the proceeds from the divestiture of its Dialysis and BioSentry Tract Sealant System Biopsy businesses to extinguish its debt. Fiscal Year 2024 Financial Guidance The Company continues to expect its fiscal year 2024 net sales to be in the range of $328 to $333 million, gross margin to be approximately 50% to 52% and adjusted loss per share in the range of $0.28 to $0.34. For comparison, pro forma revenue, gross margin, and adjusted loss per share for FY23 when excluding the assets divested to Merit Medical were $306.3 million, 50.5%, and $0.43, respectively. Conference Call The Company's management will host a conference call today at 8:00 a.m. ET to discuss its first quarter 2024 results. To participate in the conference call, dial 1-877-407-0784 (domestic) or +1- 201-689-8560 (international) and refer to the passcode 13741149. This conference call will also be webcast and can be accessed from the “Investors” section of the AngioDynamics website at . The webcast replay of the call will be available at the same site approximately one hour after the end of the call. A recording of the call will also be available from 11:00 a.m. ET on Wednesday, October 4, 2023, until 11:59 p.m. ET on Wednesday, October 11, 2023. To hear this recording, dial 1-844-512-2921 (domestic) or +1-412-317-6671 (international) and enter the passcode 13741149. Use of Non-GAAP Measures Management 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 news release, AngioDynamics has reported pro-forma results, adjusted EBITDA, adjusted net income and adjusted earnings per share. 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. About AngioDynamics, Inc. 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. The Company’s innovative technologies and devices are chosen by talented physicians in fast-growing healthcare markets to treat unmet patient needs. For more information, visit . Safe Harbor This release 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 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 (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 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, 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, 2023. 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. ANGIODYNAMICS, INC. AND SUBSIDIARIES CONSOLIDATED INCOME STATEMENTS (in thousands, except per share data) Three Months Ended Three Months Ended Actual (1) Pro Forma Adjustments (2) Pro Forma As Reported (1) Pro Forma Adjustments (2) Pro Forma Aug 31, 2023 Aug 31, 2023 Aug 31, 2023 Aug 31, 2022 Aug 31, 2022 Aug 31, 2022 (unaudited) (unaudited) Net sales $ 78,679 (671) $ 78,008 $ 81,537 $ (7,746) $ 73,791 Cost of sales (exclusive of intangible amortization) 38,619 (218) 38,401 39,232 (3,108) 36,124 Gross profit 40,060 (453) 39,607 42,305 (4,638) 37,667 % of net sales 50.9 % 50.8 % 51.9 % 51.0 % Operating expenses Research and development 7,941 (29) 7,912 8,333 (62) 8,271 Sales and marketing 27,368 — 27,368 26,543 (19) 26,524 General and administrative 10,856 (2) 10,854 10,101 (1) 10,100 Amortization of intangibles 3,625 — 3,625 4,837 (483) 4,354 Change in fair value of contingent consideration (130) — (130) 211 — 211 Acquisition, restructuring and other items, net 3,212 — 3,212 5,581 (17) 5,564 Total operating expenses 52,872 (31) 52,841 55,606 (582) 55,024 Gain on sale of assets 47,842 — 47,842 — — — Operating income (loss) 35,030 (422) 34,608 (13,301) (4,056) (17,357) Interest income (expense), net 119 — 119 (381) — (381) Other expense, net (288) — (288) (175) — (175) Total other expense, net (169) — (169) (556) — (556) Income (loss) before income tax benefit 34,861 (422) 34,439 (13,857) (4,056) (17,913) Income tax benefit (11,023) — (11,023) (853) — (853) Net income (loss) $ 45,884 $ (422) $ 45,462 $ (13,004) $ (4,056) $ (17,060) Earnings (loss) per share Basic $ 1.15 $ 1.14 $ (0.33) $ (0.43) Diluted $ 1.15 $ 1.14 $ (0.33) $ (0.43) Weighted average shares outstanding Basic 39,842 39,842 39,302 39,302 Diluted 39,968 39,968 39,302 39,302 (1) Reflects the Company's US GAAP consolidated financial statements before pro forma adjustments related to the sale of the Dialysis and BioSentry Businesses ("the Businesses") for the three months ended August 31, 2023 and 2022. (2) Reflects the elimination of revenues and expenses representing the operating results from the sale of the Businesses. ANGIODYNAMICS, INC. AND SUBSIDIARIES GAAP TO NON-GAAP RECONCILIATION (in thousands, except per share data) Reconciliation of Net Income (Loss) to non-GAAP Adjusted Net Loss: Three Months Ended Aug 31, 2023 Aug 31, 2022 (unaudited) Net income (loss) from continuing operations $ 45,884 $ (13,004) Amortization of intangibles 3,625 4,837 Change in fair value of contingent consideration (130) 211 Acquisition, restructuring and other items, net (1) 3,212 5,581 Gain on sale of assets (47,842) — Tax effect of non-GAAP items (2) (9,580) (111) Adjusted net loss $ (4,831) $ (2,486) Reconciliation of Diluted Earnings (Loss) Per Share to non-GAAP Adjusted Diluted Loss Per Share: Three Months Ended Aug 31, 2023 Aug 31, 2022 (unaudited) Diluted earnings (loss) per share $ 1.15 $ (0.33) Amortization of intangibles 0.09 0.12 Change in fair value of contingent consideration — 0.01 Acquisition, restructuring and other items, net (1) 0.08 0.14 Gain on sale of assets (1.20) — Tax effect of non-GAAP items (2) (0.24) — Adjusted diluted loss per share $ (0.12) $ (0.06) Adjusted diluted sharecount (3) 39,842 39,302 (1) Includes costs related to merger and acquisition activities, restructuring, and unusual items, including asset impairments and write-offs, certain litigation, and other items. (2) 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 the periods ended August 31, 2023 and 2022. (3) Diluted shares may differ for non-GAAP measures as compared to GAAP due to a GAAP loss. ANGIODYNAMICS, INC. AND SUBSIDIARIES GAAP TO NON-GAAP RECONCILIATION (Continued) (in thousands, except per share data) Reconciliation of Net Income (Loss) to Adjusted EBITDA: Three Months Ended Aug 31, 2023 Aug 31, 2022 (unaudited) Net income (loss) from continuing operations $ 45,884 $ (13,004) Income tax benefit (11,023) (853) Interest expense, net (119) 381 Depreciation and amortization 6,688 7,621 Change in fair value of contingent consideration (130) 211 Stock based compensation 4,144 3,024 Acquisition, restructuring and other items, net (1) 3,212 5,581 Gain on sale of assets (47,842) — Adjusted EBITDA $ 814 $ 2,961 Per diluted share: Adjusted EBITDA $ 0.02 $ 0.08 (1) Includes costs related to merger and acquisition activities, restructuring, and unusual items, including asset impairments and write-offs, certain litigation, and other items. ANGIODYNAMICS, INC. AND SUBSIDIARIES GAAP TO NON-GAAP RECONCILIATION (in thousands, except per share data) Reconciliation of Pro Forma Net Income (Loss) to Pro Forma Adjusted Net Loss: Pro Forma Three Months Ended Aug 31, 2023 Aug 31, 2022 (unaudited) Pro forma net income (loss) from continuing operations $ 45,462 $ (17,060) Amortization of intangibles 3,625 4,354 Change in fair value of contingent consideration (130) 211 Acquisition, restructuring and other items, net (1) 3,212 5,564 Gain on sale of assets (47,842) — Tax effect of non-GAAP items (2) (9,483) 937 Adjusted pro forma net loss $ (5,156) $ (5,994) Reconciliation of Pro Forma Diluted Earnings (Loss) Per Share to Pro Forma Adjusted Diluted Loss Per Share: Pro Forma Three Months Ended Aug 31, 2023 Aug 31, 2022 (unaudited) Pro forma diluted earnings (loss) per share $ 1.14 $ (0.43) Amortization of intangibles 0.09 0.11 Change in fair value of contingent consideration — 0.01 Acquisition, restructuring and other items, net (1) 0.08 0.14 Gain on sale of assets (1.20) — Tax effect of non-GAAP items (2) (0.24) 0.02 Adjusted pro forma diluted loss per share $ (0.13) $ (0.15) Adjusted diluted sharecount (3) 39,842 39,302 (1) Includes costs related to merger and acquisition activities, restructuring, and unusual items, including asset impairments and write-offs, certain litigation, and other items. (2) 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 the periods ended August 31, 2023 and 2022. (3) Diluted shares may differ for non-GAAP measures as compared to GAAP due to a GAAP loss. ANGIODYNAMICS, INC. AND SUBSIDIARIES GAAP TO NON-GAAP RECONCILIATION (Continued) (in thousands, except per share data) Reconciliation of Pro Forma Net Income (Loss) to Pro Forma Adjusted EBITDA: Pro Forma Three Months Ended Aug 31, 2023 Aug 31, 2022 (unaudited) Pro forma net income (loss) from continuing operations $ 45,462 $ (17,060) Income tax benefit (11,023) (853) Interest expense, net (119) 381 Depreciation and amortization 6,688 7,131 Change in fair value of contingent consideration (130) 211 Stock based compensation 4,144 3,024 Acquisition, restructuring and other items, net (1) 3,212 5,564 Gain on sale of assets (47,842) — Pro forma adjusted EBITDA $ 392 $ (1,602) Per diluted share: Adjusted EBITDA $ 0.01 $ (0.04) (1) Includes costs related to merger and acquisition activities, restructuring, and unusual items, including asset impairments and write-offs, certain litigation, and other items. ANGIODYNAMICS, INC. AND SUBSIDIARIES NET SALES BY PRODUCT CATEGORY AND BY GEOGRAPHY (in thousands) Three Months Ended Three Months Ended Actual (1) Pro Forma Adj. (2) Pro Forma As Reported (1) Pro Forma Adj. (2) Pro Forma Actual Pro Forma Aug 31, 2023 Aug 31, 2023 Aug 31, 2023 Aug 31, 2022 Aug 31, 2022 Aug 31, 2022 % Growth Currency Impact Constant Currency Growth % Growth Currency Impact Constant Currency Growth (unaudited) (unaudited) Net Sales Med Tech $ 25,860 $ — $ 25,860 $ 22,817 $ — $ 22,817 13.3% 13.3% Med Device 52,819 (671) 52,148 58,720 (7,746) 50,974 (10.0)% 2.3% $ 78,679 $ (671) $ 78,008 $ 81,537 $ (7,746) $ 73,791 (3.5)% 0.0% (3.5)% 5.7% 0.1% 5.8% Net Sales United States $ 64,399 $ (650) $ 63,749 $ 69,023 $ (6,576) $ 62,447 (6.7)% 2.1% International 14,280 (21) 14,259 12,514 (1,170) 11,344 14.1% 0.3% 14.4% 25.7% $ 78,679 $ (671) $ 78,008 $ 81,537 $ (7,746) $ 73,791 (3.5)% 0.0% (3.5)% 5.7% 0.1% 5.8% (1) Reflects the Company's US GAAP consolidated financial statements before pro forma adjustments related to the sale of the Dialysis and BioSentry Businesses ("the Businesses") for the three months ended August 31, 2023 and 2022. (2) Reflects the elimination of revenues and expenses representing the operating results from the sale of the Businesses. GROSS PROFIT BY PRODUCT CATEGORY (in thousands) Three Months Ended Three Months Ended Actual (1) Pro Forma Adj. (2) Pro Forma As Reported (1) Pro Forma Adj. (2) Pro Forma Actual Pro Forma Aug 31, 2023 Aug 31, 2023 Aug 31, 2023 Aug 31, 2022 Aug 31, 2022 Aug 31, 2022 % Change % Change (unaudited) (unaudited) Med Tech $ 16,727 $ — $ 16,727 $ 14,429 $ — $ 14,429 15.9 % 15.9 % Gross profit % of sales 64.7 % 64.7 % 63.2 % 63.2 % Med Device $ 23,333 $ (453) $ 22,880 $ 27,876 $ (4,638) $ 23,238 (16.3) % (1.5) % Gross profit % of sales 44.2 % 43.9 % 47.5 % 45.6 % Total $ 40,060 $ (453) $ 39,607 $ 42,305 $ (4,638) $ 37,667 (5.3) % 5.2 % Gross profit % of sales 50.9 % 50.8 % 51.9 % 51.0 % (1) Reflects the Company's US GAAP consolidated financial statements before pro forma adjustments related to the sale of the Dialysis and BioSentry Businesses ("the Businesses") for the three months ended August 31, 2023 and 2022. (2) Reflects the elimination of revenues and expenses representing the operating results from the sale of the Businesses. ANGIODYNAMICS, INC. AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS (in thousands) Aug 31, 2023 May 31, 2023 (unaudited) (audited) Assets Current assets: Cash and cash equivalents $ 57,586 $ 44,620 Accounts receivable, net 49,755 52,826 Inventories 59,972 55,325 Prepaid expenses and other 8,162 4,617 Current assets held for sale — 6,154 Total current assets 175,475 163,542 Property, plant and equipment, net 43,356 44,384 Other assets 9,430 10,676 Intangible assets, net 106,671 111,144 Goodwill 159,017 159,238 Non-current assets held for sale — 43,653 Total assets $ 493,949 $ 532,637 Liabilities and stockholders' equity Current liabilities: Accounts payable $ 24,807 $ 40,445 Accrued liabilities 26,079 26,617 Current portion of contingent consideration 4,729 14,761 Other current liabilities 1,837 2,002 Total current liabilities 57,452 83,825 Long-term debt — 49,818 Deferred income taxes 1,279 12,813 Contingent consideration 4,438 4,535 Other long-term liabilities 2,976 3,350 Total liabilities 66,145 154,341 Stockholders' equity 427,804 378,296 Total Liabilities and Stockholders' Equity $ 493,949 $ 532,637 ANGIODYNAMICS, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF CASH FLOWS (in thousands) Three Months Ended Aug 31, 2023 Aug 31, 2022 (unaudited) Cash flows from operating activities: Net income (loss) $ 45,884 $ (13,004) Adjustments to reconcile net income (loss) to net cash used in operating activities: Depreciation and amortization 6,688 7,660 Non-cash lease expense 476 621 Stock based compensation 4,144 3,024 Gain on disposal of assets (47,842) — Transaction costs for disposition (2,427) — Change in fair value of contingent consideration (130) 211 Deferred income taxes (11,415) (907) Change in accounts receivable allowances (78) 45 Fixed and intangible asset impairments and disposals 65 87 Write-off of other assets 869 — Other (9) (96) Changes in operating assets and liabilities: Accounts receivable 3,157 (1,425) Inventories (4,574) (6,238) Prepaid expenses and other (4,168) (5,733) Accounts payable, accrued and other liabilities (16,539) (8,990) Net cash used in operating activities (25,899) (24,745) Cash flows from investing activities: Additions to property, plant and equipment (791) (809) Additions to placement and evaluation units (767) (2,227) Acquisition of intangibles — (540) Proceeds from sale of assets 100,000 — Net cash provided by (used in) investing activities 98,442 (3,576) Cash flows from financing activities: Repayment of long-term debt (50,000) (45,000) Proceeds from borrowings on long-term debt — 70,000 Deferred financing costs on long-term debt — (706) Payment of acquisition related contingent consideration (10,000) — Proceeds from exercise of stock options and employee stock purchase plan 410 82 Net cash (used in) provided by financing activities (59,590) 24,376 Effect of exchange rate changes on cash and cash equivalents 13 (316) Increase (decrease) in cash and cash equivalents 12,966 (4,261) Cash and cash equivalents at beginning of period 44,620 28,825 Cash and cash equivalents at end of period $ 57,586 $ 24,564