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- 1 Apr 24 Entry into a Material Definitive Agreement
- 13 Feb 24 Departure of Directors or Certain Officers
- 22 Jan 24 Departure of Directors or Certain Officers
- 11 Jan 24 Regulation FD Disclosure
- 5 Jan 24 AngioDynamics Reports Fiscal Year 2024 Second Quarter
- 15 Nov 23 Departure of Directors or Certain Officers
- 4 Oct 23 Results of Operations and Financial Condition
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Exhibit 99.1
J.P. Morgan Healthcare Conference January 11, 2024 Jim Clemmer, President & CEO
A medical technology platform company focused on a select group of large, high growth markets where meaningful treatment gaps exist in current standard of care. We are transforming our portfolio to be a company focused on investing our resources on innovative technologies backed by science and clinical data. Our technologies positively impact treatment options and patients' quality of life. AngioDynamics
AngioDynamics Cardiovascular disease and cancer have the highest morbidity and mortality worldwide Global Cardiovascular Disease Burden1 523M diagnosed in 2020 ~19 million deaths Cardiovascular Disease causes 1 in 3 deaths globally Global Cancer Burden2 Cancer causes 1 in 6 deaths globally 19.3M diagnosed in 2020 ~10 million deaths 3 https://professional.heart.org/-/media/PHD-Files-2/Science-News/2/2022-Heart-and-Stroke-Stat-Update/2022-Stat-Update-factsheet-GIobal-Burden-of-Disease.pdf; https://www.cdc.gov/pcd/issues/2022/22_0347.htm https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21660#:~:text=Worldwide%2C%20an%20estimated%2019.3%20million,skin%20cancer)%20occurred%20in%202020.
MedTech Markets 4 Targeted segments have attractive underpenetrated addressable markets Cardiac Thrombus & Emboli $825M TAM Pulmonary Embolism $2.9B TAM Prostate Cancer $2B TAM Deep Vein Thrombosis $3B TAM Peripheral Arterial Disease $1.1B TAM *AlphaVac PE, Auryon Venous Thrombectomy/DVT, AngioVac Left Heart and Infective Endocarditis are not cleared by the US Food and Drug Administration (FDA) for these indications 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 The NanoKnife System has not been cleared for the treatment or therapy of a specific disease or condition.
5 AngioDynamics Investments in our Med Tech platforms are funded by operating cash flows from our Med Device portfolio Med Tech: Invest for Growth Disease State Latest Investment Updates Peripheral Arterial Disease Radial length catheter launch Jan 2024 Pathfinder 12 month & 24 month publications Feb & July 2024 Below the knee study publication March 2024 CE Mark expected May 2024 6 additional new product extensions/upgrades scheduled throughout 2024 Coronary Atherectomy pre-submission (PMA) & pilot trial planned to begin in 2024 Venous Thromboembolism APEX complete, PE indication expected by June 2024 CE Mark for PE expected by June 2024 2 additional new product extensions/upgrades scheduled throughout 2024 IDE clinical trial for Auryon DVT to begin in late 2024 Cardiac Thrombus & Emboli Begin study for Infective Endocarditis indication in 2024 Prostate PRESERVE Study enrolled, expected Prostate indication by December 2024 Med Device: Maintain Positioning PICCs, Midlines & Accessories Microwave & Radiofrequency Ablation Diagnostic Catheters, Guidewires & Kits Implantable Ports Endovenous Laser Treatment Radiation Treatment Stabilization Balloons *AlphaVac PE, Auryon Venous Thrombectomy/DVT, Auryon Coronary Atherectomy, AngioVac Left Heart and Infective Endocarditis are not cleared by the US Food and Drug Administration (FDA) for these indications 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. The NanoKnife System has not been cleared for the treatment or therapy of a specific disease or condition. The planned portfolio additions and new indications are based on management estimates and industry sources as of July 2022 and are not guarantees of future performance and are subject to risks and uncertainties including FDA clearance. Investors are cautioned that actual events or results may differ from AngioDynamics’ expectations.
PAD As of November 2023, the Auryon Atherectomy System has treated over 50,000 patients and reached $100M cumulative sales since its September 2020 launch 6 T H E M A R K E T O U R S O L U T I O N Peripheral Atherectomy Protective of vessel wall c-e Targeted biological reactions to address risk of perforations Built-in aspiration to address risk of embolization† †Built-in aspiration available with the 2.0-and 2.35-mm catheters. W H Y I T M A T T E R S Treat all levels of calcification a-c Indicated for in-stent restenosis* Treats above and below the knee (inc. below the ankle) *2.0mm and 2.35mm catheters are indicated for ISR. Designed for hospital and lab a-c, f Portable, 110V outlet, low noise, touch screen Debulk in fewer passes 2022 TAM $1.1B a-f See reference page “We’ve always known that Auryon’s technology is one-of-a-kind and unmatched. With the new [hydrophilic coating], we should be able to prove this – case after case after case” – Dr. Curtis Anderson, Vascular & Interventional Radiologist Europe APAC US $760M $210M $100M Source: Management estimate & industry sources as of July 2022.
Thrombus Management Our differentiated technology platforms offer potential treatment solutions across multiple disease states T H E M A R K E T O U R S O L U T I O N W H Y I T M A T T E R S Only solution on the market with continuous aspiration and simultaneous reinfusion of filtered blood Aspirates large clot burden Controlled aspiration Aspirates large clot burden APEX-AV study for PE Right Heart and Left Heart* removal of cardiac thrombus Large Vessel Venous Thrombectomy/DVT Pulmonary Embolism* Small Vessel Venous Thrombectomy/DVT* 7 2022 TAM $6.7B M $3.9 $ 1B $210M $1B Auryon’s low profile + laser + aspiration, make it a compelling and simple technology to effectively ablate & remove thrombus with the legs VTE PE Pulmonary Embolism DVT Deep Vein Thrombosis Cardiac TVIE Tricuspid Valve Infective Endocarditis LV Lead Vegetation RA Right Atrial Thrombus + Europe APAC US Europe US Cardiac $3.9B $1B VTE $1B $535M $290M Source: Management estimate & industry sources as of July 2022. *AlphaVac PE, Auryon Venous Thrombectomy/DVT, and AngioVac Left Heart and Infective Endocarditis are not cleared by the US FDA for these indications.
Thrombus Management All-purpose technology platforms targeted at peripheral and cardiovascular thrombolytic events, including small and large vessels POWERFUL 355 nm laser is designed to deliver an optimized wavelength, pulse width, and amplitude to restore flow in occluded vesselsc, d, g Small Vessel The AngioVac System allows for the continuous aspiration of embolic material such as thrombi and emboli from the venous system while simultaneously reinfusing the patient’s own filtered blood to limit procedural blood loss MULTIPLE TIP ANGLES 200, 850, 1800 PROPRIETARY FUNNEL DESIGN Allows for Significant Clot Removal RADIOPAQUE MARKERS Better Tip Visibility LARGE END HOLE ASPIRATION 42FR & 30FR Opening The AlphaVac System allows for the controlled aspiration of embolic material such as thrombi and emboli from the venous system Large Vessel PRECISE Protective of vessel wallc-e ADAPTABLE Potential to treat all types of small vessel DVT* c-g See reference page *Auryon Venous Thrombectomy/DVT is not cleared by the US FDA for this indication.
NanoKnife Prostate Initiative* Over 505,000 men with prostate cancer could be treated with this technology 9 USA EMEA APAC LAM CAN *IDE Study in progress; enrollment completed 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. The NanoKnife System has not been cleared for the treatment or therapy of a specific disease or condition. Market Source: Management estimate & industry sources as of July 2022. Focal Therapy O U R S O L U T I O N W H Y I T M A T T E R S T H E M A R K E T 2023 Global TAM $2B Targeted: Short electric pulses destroy cells without relying on extreme heat or cold and spare vital structures within the ablation zone Quality of Life: Better preserves urinary control and erectile function Versatile: Can be used in all segments of the prostate for primary and recurrent disease Fast: Minimally invasive treatment that is delivered in a single session Preserves future treatment options $702M $728M $521M $30M $60M
International Expansion Plan Expanding our business reach in targeted regions, markets & countries 10 Aligning our Go-to-Market strategy to the different regions, markets & countries, utilizing new partnerships where appropriate to maximize growth Preparing for CE Mark and other selected international launches of both the Auryon System and the AlphaVac F1885 System Auryon CE Mark expected 1H of calendar 2024 AlphaVac F1885 System CE Mark expected 1H of calendar 2024 Continue to increase our global presence through our series of life symposiums which has attracted interest from global key opinion leaders who are gaining more access to our technologies
IDE Clinical Studies and Pathway Expansion Corporate Developments – Q2 and YTD FY24 Initiated restructuring of manufacturing footprint to a fully outsourced model Continued portfolio optimization initiatives Full-year adjusted EPS profitability expected in FY27 Cumulative Auryon sales of over $100.0 million achieved in November Q2 Highlights and Operational Developments PRESERVE study for the treatment of prostate cancer with NanoKnife completed enrollment in July 2023 APEX AV study for the treatment of pulmonary embolism with AlphaVac F1885 System Completed enrollment in December 2023 Submission to the FDA planned in early calendar 2024 Continued focused investment in our 3 key Med Tech platforms: Auryon, Thrombus Management & NanoKnife NanoKnife disposables down 3.6% YOY Q2 FY24 Revenue $79.1 mil Pro Forma Revenue Growth* 2.7% Med Tech up 3.5% Med Device up 2.3%* $11.4 million in Auryon sales; growth of 12.9% YOY Mechanical Thrombectomy down 4.7% YOY $1.9 million in AlphaVac sales AngioVac sales declined 10.8% YOY * On a pro forma basis, excluding the sale of Dialysis and BioSentry 11 AngioDynamics Second Quarter FY2024 Earnings 12.9% YOY growth in NanoKnife disposables YTD FY24 Pro Forma Revenue* $157.1 mil Pro Forma Revenue Growth* 4.2% Med Tech up 8.3% Med Device up 2.3%* $22.5 million in Auryon sales; growth of 18.9% YOY Mechanical Thrombectomy down 5.3% YOY $3.7 million in AlphaVac sales AngioVac sales declined 9.2% YOY
FY24 Revised Guidance * FY23 pro forma results excluding the divested assets were $306.3 million for revenue, 50.5% for gross margin and adjusted loss per share of $0.43. 12 AngioDynamics Second Quarter FY2024 Earnings Guidance* Revised Guidance* Revenue $328 - $333 million $320 - $325 million Gross Margin Med Tech Med Device 50.0% - 52.0% 63.0% – 65.0% 43.0% - 45.0% 49.0% - 51.0% 61.0% – 63.0% 43.0% - 45.0% Adjusted EPS ($0.28) – ($0.34) ($0.35) – ($0.42)
J.P. Morgan Healthcare Conference January 11, 2024 Jim Clemmer, President & CEO
Auryon References Rundback J, Chandra P, Brodmann M, Weinstock B, Sedillo G, Cawich I, et al. Novel laser-based catheter for peripheral atherectomy: 6-month results from the Eximo Medical B-Laser™ IDE study. Catheter Cardiovasc Interv. 2019;1-8. Shammas NW, Chandra P, Brodmann M, Weinstock B, Sedillo G, Cawich I, et al. Acute and 30-day safety and effectiveness evaluation of Eximo Medical’s B-Laser™, a novel atherectomy device, in subjects affected with infrainguinal peripheral arterial disease: Results of the EX-PAD-03 trial. Cardiovas Revasc Med. 2020;21(1):86-92. Auryon. Instructions for use. AngioDynamics; 2019. Herzog A, Bogdan S, Glikson M, Ishaaya AA, Love C. Selective tissue ablation using laser radiation at 355 nm in lead extraction by a hybrid catheter; a preliminary report. Lasers Surg Med. 2016;48(3):281-287. Herzog A, Steinberg I, Gaisenberg E, Nomberg R, Ishaaya AA. A route to laser angioplasty in the presence of fluoroscopy contrast media, using a nanosecond-pulsed 355- nm laser. IEEE J Sel Top Quantum Electron. 2016;22(3):342-347. Kuczmik W, Kruszyna L, Stanisic MG, Dzieciuchowicz L, Ziaja K, Zelawski W, et al. Laser atherectomy using the novel B-Laser™ catheter, for the treatment of femoropopliteal lesions: twelve-month results from the EX-PAD-01 study. Not yet published. Vogel A, Venugopalan V. Mechanisms of pulsed laser ablation of biological tissues. Chem Rev. 2003;103(2):577-644. 14