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Medtronic releases 2024 Impact Report highlighting success in healthcare equity with new data from the Healthy Neighbor program, in addition to community engagement and environmental sustainability progress
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Cleo Diagnostics
Overview
A medical technology company based in Australia, Cleo Diagnostics (ASX:COV) is revolutionising women's healthcare with its disruptive cancer detection platform technology, through a simple blood test that can accurately detect ovarian cancer early – the leading cause of cancer-related deaths among women.
Approximately 50 percent of women will die within five years of an ovarian cancer diagnosis. The chances of survival beyond five years, however, increase with early detection. According to the American Cancer Society, only about 20 percent of ovarian cancers are diagnosed at an early stage, and more than 90 percent of women live beyond five years when the cancer is detected early.
With early diagnosis being key to a higher survival rate, ovarian cancer has become a target for biomarker research. And one particular biomarker holds promise.
Cleo’s technology is underpinned by the CXCL10 novel and patented biomarker, which was first identified as a small inflammatory molecule in ovarian cancer tissue sections. Subsequent research demonstrated that CXCL10 was overexpressed in ovarian cancers, but importantly not expressed in benign disease, and remains throughout the lifetime of the cancer. The biomarker effectively provides a robust indicator at all stages of cancer. Recognizing that early detection is a significantly unmet need in the clinical diagnostics market, Cleo Diagnostics is focused on bringing to market a simple blood test to accurately detect ovarian cancer early.
Cleo’s first clinical validation study for its ovarian cancer triage test has been published in the peer-reviewed international journal Cancers. The article concluded that Cleo’s ovarian cancer test was highly accurate with 95 percent sensitivity and 95 percent specificity, correctly discriminated malignant from benign samples, and has outperformed and was superior to current clinical methods. The second peer-reviewed dataset has also been published in the medical journal Diagnostics, which concluded that CLEO’s test has correctly identified most cancer cases that were missed by the standard marker CA125. It also eliminated the majority of “false positive” results caused by CA125 use, and it correctly identified the majority of patients with early-stage ovarian cancers.
CLEO has appointed New York-based healthcare industry consultancy, HcFocus, to support the commencement of its US market access program. HcFocus will provide specialised and strategic expertise to assist CLEO in navigating the complexities of the US health system and regulatory environment.
The addressable market for a technology like this is compelling, and with a management team that brings to the table decades of leadership experience in the medical technology space, Cleo is well-positioned to leverage this market opportunity.
Cleo chief executive and executive director Dr. Richard Allman has over 30 years of experience in commercially focused scientific research and innovation. Throughout his career, Allman has overseen and expedited a product development pipeline covering no less than six major cancers, cardiovascular disease, type-2 diabetes and a commercially available COVID-19 test.
Chief scientific officer Dr. Andrew Stephens boasts an equally impressive resume. A career research scientist with two decades of experience in molecular and cellular biology, Stephens is named in over 60 academic publications and holds numerous patents in the cancer therapy and diagnostic space. Cleo’s blood test looks for a novel and patented biomarker in the blood called CXCL10, which was discovered by Stephens, the product of over ten years of scientific work at Monash Medical Centre's Hudson Institute of Medical Research.
There's also Professor Tom Jobling, Cleo's non-executive director and lead medical advisor. As the head of gynaecological oncology at Monash Health and visiting medical officer at the Peter MacCallum Cancer Centre, Jobling has been treating ovarian cancer for over thirty years. He was also the founding chairman of the Ovarian Cancer Research Foundation (OCRF)
Non-executive director Lucinda Nolan, meanwhile, brings significant business and strategic expertise to the table. Most recently, she served as the CEO of the Ovarian Cancer Research Foundation.
These experienced professionals, together with the other members of Cleo’s management and board, have developed a staged execution strategy focused on de-risking the pathway to the international screening market — ensuring that, although Cleo is still in its advanced R&D stage, its prospects for commercialisation remain incredibly promising.
Company Highlights
- Backed by medical professionals and cancer specialists with decades of experience, Cleo Diagnostics has developed a disruptive, accurate and early-stage ovarian cancer detection blood test.
- Cleo targets the CXCL10 novel biomarker, which is now known to be overexpressed in all stages of ovarian cancer.
- Cleo is the result of more than a decade of research at the Hudson Institute of Medical Research, where chief scientist Dr. Andrew Stephens received more than $5 million OCRF & NHMRC funding for development and clinical studies.
- The test is also supported by Professor Tom Jobling, founder of the Ovarian Cancer Foundation and Lucinda Nolan, the foundation's former CEO.
- Cleo has developed a staged execution strategy focused on an achievable path to market. This ensures the project, which is currently in its advanced R&D stage, can maximise commercial value for all stakeholders.
Key Projects
Cleo Diagnostics
Developed over a decade by Dr. Andrew Stephens, Cleo’s blood test is underpinned by the CXCL10 novel and patented protein biomarker known to be present in all stages of ovarian cancer. By combining CXCL10 with several other biomarkers in a custom algorithm, Cleo can not only be used in triage, but also for screening and recurrence testing. The project is currently in the advanced R&D stage and has so far conducted two clinical studies, analysing more than 700 patient samples in the process.
Highlights:
- Readily Accessible: Cleo requires no additional or specialised equipment and can be conducted in any standard pathology lab either on its own or as part of a standard panel of tests ordered by a physician.
- AI-based Risk Assessment: Once the sample has been collected and tested, Cleo leverages a proprietary algorithm to perform a risk evaluation on the patient, determining the likelihood of a cancer diagnosis.
- Intuitive Results: Cleo generates an easy-to-understand post-assessment report which can then be sent to the patient's primary care provider or surgeon for triage.
- High Performance: The Cleo prototype outperforms FDA-cleared predicates and clinical guideline tests in terms of accuracy and specificity.
- Current Roadmap: Cleo plans for the test to be ready for clinical use in a surgical triage setting by 2025, where it will be available initially to one million patients. Target launch dates for recurrence, high-risk screening and mass screening are still to be determined. Additionally, the company has numerous inflection points planned over the next two years:
- Kit Development:
- Internal trial antibody optimisation
- Finalisation of antibody selection for the Cleo test-kit
- Complete re-agent development
- Pre-IDE strategic development
- Manufacturing:
- Establishment and accreditation of ISO13485 quality system
- Manufacturing establishment of Cleo key biomarker
- Manufacturing establishment of Cleo Ovarian Cancer Kit
- Clinical Studies:
- Sign key opinion leaders and trial sites
- Perform and finalise verification of the Cleo kit through clinical studies
- Regulatory Approval:
- FDA Pre-IDE submission
- CE regulatory submissions and approval
- TGA regulatory submission and approval
- FDA submission and approval
- Kit Development:
Cleo is bringing to market three testsfor ovarian cancer diagnosis, monitoring and screening.
Management Team
Dr. Richard Allman — Chief Executive Officer and Executive Director
Dr. Richard Allman has over 30 years of scientific research leadership and innovation with a clear focus on commercialisation. He has wide experience in research leadership, innovation management, and intellectual property strategy, covering oncology, diagnostics, and product development.
Previously, Allman was chief scientific officer at Genetic Technologies (ASX:GTG). Recent successes include the strategic design and management of a second-generation breast cancer risk assessment test from concept to commercial launch and a similar test for colorectal cancer. These tests have now been NATA-accredited and comprise the first commercially available polygenic risk tests in Australia.
More recently, Allman supervised the underlying R&D, translation, regulatory approval, patent filing and commercial launch of a COVID-19 disease severity test within 12 months. This strategy has been utilised to expedite a product development pipeline covering six major cancers, cardiovascular disease and type-2 diabetes which were commercially launched in March 2022.
Dr. Andrew Stephens — Chief Scientific Officer and Executive Director
Dr. Andrew Stephens is a career research scientist with 20 years of experience in molecular and cellular biology research. He has broad experience in academic and pre-clinical research and a strong focus on translation and the commercialisation of research findings. He established and leads an independent academic research group at the Hudson Institute of Medical Research, investigating mechanisms that contribute to the formation, progression and dissemination of high-grade, serous epithelial ovarian cancers. Since 2010, his research has focused on biomarker identification and development in ovarian cancer and the development of therapeutic strategies to improve patient outcomes. He is also actively involved across the biotech sector, with appointments to the scientific advisory for Invion and AMTBio.
Stephens has more than 60 academic publications and numerous patents (pending and provisional) in the cancer therapeutic and diagnostic space.
Professor Tom Jobling — Lead Medical Advisor and Non-executive Director
Professor Thomas Jobling is director of gynaecologic oncology at Monash Medical Centre. He graduated from Monash University in 1980 and did his postgraduate sub-specialist training in gynaecologic oncology in London at the Royal Marsden and St Bartholomew's hospitals. Jobling has subsequently been elected as a member of the Society of Pelvic Surgeons and is also founder of the Ovarian Cancer Research Foundation (1999). He was the chairman of the Ovarian Cancer Research Foundation Board. His major interests are in radical surgery for ovarian cancer and the application of robotic surgery for gynaecological malignancy.
Jobling is an active member of a research team in biomarker detection and proteomics in ovarian cancer. He is involved as a collaborative investigator on a number of international clinical trials and is a member of the Australia and New Zealand Gynaecologic Oncology Group, the Australian Society of Gynaecologic Oncology, the Victorian Cooperative Oncology Group and the International Society of Gynaecological Cancer.
Lucinda Nolan — Non-executive Director
Lucinda Nolan is a non-executive director and was most recently the CEO of the Ovarian Cancer Research Foundation. She has a wealth of knowledge and experience across the public sector and not-for-profit environments. Before joining the Ovarian Cancer Research Foundation, she was selected as the first female CEO of the Country Fire Authority, one of the world’s largest volunteer-based emergency services organisations. She also spent 32 years with Victoria Police, reaching the rank of deputy commissioner. She was awarded the Australian Police Medal in 2009.
Nolan is also the chair of BankVic and a director on the boards of Alkira Box Hill and the Melbourne Archdiocese of Catholic Schools. She has a Master of Arts and a Bachelor of Arts (Honours) from Melbourne University and is an alum of the Advanced Management Programme at Harvard University.
Adrien Wing — Non-executive Chair
Adrien Wing began his professional career practising in the audit and corporate advisory divisions of a chartered accounting firm. He has over 25 years of experience in the corporate sector with a large portion of this experience in ASX small caps, lead in IPO transactions and post listing reverse takeovers and acquisitions across a range of industry sectors and jurisdictions. He also has a strong pedigree in the life sciences industry being the founder of Rhythm Biosciences and bringing that entity to the ASX in 2017.
Wing currently serves as an officer/director on the following company boards: New Age Exploration (ASX: NAE), director and joint company secretary; Red Sky Energy (ASX:ROG), director and joint company secretary; Sparc Technologies (ASX:SPN), company secretary; and Osmond Resources (ASX:OSM), company secretary.
Healing People and Planet: New Impact Report Outlines How Medtronic Is Shaping the Future of Health
November 20, 2024 /3BL/ - Medtronic plc, a global leader in healthcare technology, has today released its fiscal year 2024 (FY24) Impact Report. The report highlights the company's continued commitment to advancing health equity, increasing representation and inclusion, and reducing its environmental footprint. One of the highlights in this year's report is the early success of the Healthy Neighbor program, a transformative initiative addressing health inequities in chronic disease care.
Established in collaboration with Virtua Health, a 15,000-person academic health system, Healthy Neighbor extends access to integrated clinical and social care for hypertension and diabetes management within Camden, New Jersey. Launched in 2023, Healthy Neighbor trained a team of dedicated community health workers and a registered nurse to provide tailored support, combining SPICE, the Medtronic LABS open-source digital health platform, with social resource navigation.
Early results1 show that 71% of enrolled patients with high blood pressure and 63% of patients with previously uncontrolled diabetes achieved meaningful progress in blood pressure and blood glucose control.
"We are incredibly proud of the Healthy Neighbor program," said Geoff Martha, Medtronic chairman and CEO. "Our partnership with Virtua Health underscores our belief that to drive true impact, healthcare must be accessible, localized, and powered by technology and partnerships. We aim to develop a replicable model for community-based care that can improve outcomes for millions across the world."
The Medtronic 2024 Impact Report reveals broader commitments to patients, people, and planet. Key FY24 accomplishments include:
Patients - Putting patients first:
Medtronic places patient centricity at the forefront of its Mission through clinical research and targeted programs. In FY24, the company:
Shared data from the 87% women-enrolled global SMART Trial, led by Dr. Roxana Mehran and Dr. Howard Herrmann. Women are commonly under-represented in clinical trials. This trial addresses gender disparities in heart disease detection and treatment, setting a new standard for inclusive healthcare research.
Achieved a 33% reduction in product complaint rate for key product families. Complaint rates are an important indicator of patient experience and product quality. The company exceeded its 10% reduction target in aggregate product complaints by FY25 for key product families.
Invested $2.7 billion in research and development directed toward pioneering medical innovations for millions globally.
Supported over 550,000 healthcare professionals with over $121 million invested in medical education, participation in Medtronic Academy, in-person events at training centers, and Medtronic Mobile Labs.
Improved healthcare access for more than 78 million patients through increased access initiatives, putting the company on track to reach its target of 79 million patients annually by FY25.
Flowed 20.7% of revenue from products and therapies released in the prior 36 months (vitality index), exceeding its goal of 20% by FY25.
People - Striving for zero barriers:
Medtronic strives for zero barriers to health, opportunity, and well-being for its employees and the communities it serves. In FY24, the company:
Visited Alabama A&M University, a historically Black college, with the Medtronic Mobile Lab, offering students hands-on experience with cutting-edge technology and supporting diversity in science and engineering.
Reached 51% womenin Medtronic's global workforce, and 41% U.S. employees from diverse backgrounds. The company is on track to achieve 45% women in manager-and-above roles globally (currently at 44%) and 30% representation of ethnically diverse groups in manager-and-above roles in the U.S. (currently at 28%) by FY26.
Drove positive health outcomes for populations outside of the reach of its product portfolio by impacting 166,400 lives through Medtronic LABS.
Planet - Reducing impact for a healthier planet:
Medtronic is committed to reducing its environmental impact through science-based targets, focusing on emissions reduction and sustainable practices. In FY24, the company:
Secured energy expected to meet 50% of its electricity needs across its five Irish sites, reinforcing Medtronic's commitment to a healthier planet through a recent Power Purchase Agreement.2
Achieved a 52% reduction in emissionsintensity compared to FY20, surpassing its FY25 target of a 50% reduction in greenhouse gas (GHG) emissions intensity.
Met 42% of operational energy needswith renewables and are on track to achieve its target of sourcing 50% of energy from renewable and alternative sources by FY25.
Reduced operational waste by 19% and water use intensity by 28% since FY20. The company is also 90% of the way to achieving its goal to reduce packaging waste by 25% for four targeted, high-volume product families compared to FY21.
The Medtronic 2024 Impact Report reflects the company's key environmental, social, and governance (ESG) topics in alignment with leading reporting frameworks and standards, including the Global Sustainability Standards Board's (GSSB) Global Reporting Initiative (GRI); the International Sustainability Standards Board's (ISSB) Sustainability Accounting Standards Board (SASB) Standards; the Financial Stability Board's (FSB) Task Force on Climate-related Financial Disclosures (TCFD); and the World Economic Forum's (WEF) Stakeholder Capitalism Metrics.
View the full report here.
About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic, visit www.Medtronic.com and follow on LinkedIn.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
Contacts:
Erika Winkels
Public Relations
+1-763-526-8478
Ryan Weispfenning
Investor Relations
+1-763-505-4626
Editor notes
1. Outcomes are within a cohort of patients enrolled in Healthy Neighbor between August 1, 2023, and August 26, 2024, who had both a baseline and follow-up reading. A significant improvement in blood pressure is defined as achieving blood pressure control (
2. FY45 Decarbonization Roadmap: Recognizing the risks that climate change poses to human health and long-term global financial stability, Medtronic has set an ambition to achieve net-zero emissions across Scope 1, 2, and 3 by FY45. To achieve our ambition, we will pursue setting targets through the Science-Based Targets initiative (SBTi), a multiyear process which provides companies with a clearly defined path to reduce GHG emissions in line with the Paris Agreement. Signed by 191 countries, plus the European Union, the Paris Agreement aspires to limit global warming to 1.5 degrees Celsius compared to pre-industrial levels.
2024 Impact Report Cover Page
View additional multimedia and more ESG storytelling from Medtronic on 3blmedia.com.
Contact Info:
Spokesperson: Medtronic
Website: https://www.3blmedia.com/profiles/medtronic
Email: info@3blmedia.com
SOURCE: Medtronic
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Artificial Intelligence Reshaping Healthcare Industry with Unimaginable Potential
FN Media Group News Commentary - The Healthcare Artificial Intelligence (AI) market exhibits a high degree of innovation, characterized by ongoing advancements in technology. Rapid developments in ML, deep learning, NLP, and computer vision are driving the evolution of AI-powered healthcare solutions. One primary factor driving market growth is the increasing demand in the healthcare sector for enhanced efficiency, accuracy, and better patient outcomes. According to a March 2024 Microsoft-IDC study, 79% of healthcare organizations are presently utilizing AI technology. In addition, the return on investment (ROI) is realized within 14 months, generating USD 3.20 for every USD 1 invested in artificial intelligence (AI). AI technologies hold transformative potential in various areas including medical imaging analysis, predictive analytics, personalized treatment planning, and drug discovery, potentially transforming conventional healthcare practices. A report from Grand View Research said the global AI in healthcare market size, which was estimated at USD 19.27 billion in 2023, is expected to grow at a CAGR of 38.5% from 2024 to 2030. The report said: "Mergers & acquisitions (M&As) play a significant role in shaping the healthcare AI market landscape. Companies [that] engage in M&A activities to expand their AI software and services increase their market reach or acquire specialized technology and expertise. End-users are becoming increasingly aware of the potential benefits of AI in improving patient care, operational efficiency, and healthcare outcomes. Education initiatives and industry events helped raise awareness about the capabilities and applications of AI in healthcare." A.I. companies active in the markets include: Avant Technologies Inc. (OTCQB: AVAI), Teladoc Health, Inc. (NYSE: TDOC), Tempus AI, Inc. (NASDAQ: TEM), Medtronic plc (NYSE: MDT), Clover Health Investments, Corp. (NASDAQ: CLOV).
Grand View Research continued: "The software solution component segment is anticipated to grow at the fastest CAGR of 38.7% over the forecast period. The segment growth is attributed to the rapidly growing adoption of AI-based software solutions among healthcare providers, payers, and patients… The services component segment is anticipated to witness significant growth from 2024 to 2030. The growth of this segment can be attributable to the rising penetration of AI-based technologies in several healthcare applications, such as clinical trials , virtual assistants, robot-assisted surgeries, dosage error reduction, and fraud detection. The healthcare providers (hospitals, outpatient facilities, and others) segment is expected to grow significantly over the forecast period. AI-powered medical imaging analysis tools aid healthcare providers in interpreting medical images like X-rays, MRIs, and CT scans. These tools improve diagnostic accuracy, shorten interpretation time, and facilitate early disease detection, resulting in prompt interventions and enhanced patient care. In addition, hospitals are leveraging AI-driven predictive analytics to anticipate patient admission rates, pinpoint at-risk populations, and allocate resources effectively. These factors are driving the segment growth."
Avant Technologies, Inc. (OTCQB: AVAI) and Ainnova Advancing Proprietary Retinal Camera to Market with Vision AI Software - Avant Technologies, Inc. ("Avant" or the "Company"), and its partner Ainnova Tech, Inc. (Ainnova), a leading healthcare technology company focused on revolutionizing early disease detection using artificial intelligence (AI), today announced the companies will advance Ainnova's proprietary low-cost retinal camera, which will be used for fundus photography, and seamlessly packaged together with Ainnova's Vision AI software platform for commercialization. By combining the two technologies, Ainnova's versatile camera will provide precise retinal scans to its AI software leading to even more accurate data.
Vision AI is a powerful cutting-edge, AI-driven platform that can quickly and accurately detect the early markers of a host of diseases by applying AI models to examine imaging data from the eye to expedite earlier detection and allow patients to better manage their disease. The diseases that Vision AI can detect include diabetic retinopathy and other retinopathies, such as glaucoma, macular edema, age-related macular degeneration and other anomalies, as well as other diseases that do not require retinal images, and instead use other datapoints that Ainnova will integrate into the software like the detection of kidney disease, liver fat, cardiovascular risk, and pre-diabetes.
Currently, Ainnova's Vision AI software works well with any fundus camera on the market; however, Ainnova and Avant are aiming for exclusivity by developing a lower-cost, easier-to-use camera that captures retinal images automatically and then uploads those images to the Vision AI software platform, which then produces a "risk report" in mere seconds. Ai-nova Acquisition Corp. (AAC), the company formed by the partnership between Avant and Ainnova, will develop the retinal cameras as part of the joint venture and licensing deal to facilitate the development of Ainnova's technology portfolio. AAC owns the licensing rights to develop, maintain, and market Ainnova's technology portfolio in both North America (United States and Canada) and throughout Europe.
Vinicio Vargas, Chief Executive Officer of Ainnova and member of AAC's Board of Directors, said, "The cost of a fundus camera has always been a barrier to entry into ... this market, so our low-cost camera should allow us to not only enter the market but to capture a large share of the market. To that end, I will be meeting with a leading U.S. provider of digital healthcare solutions to discuss a potential distribution agreement, investment, and regulatory support."
AAC will market the two technologies as a Software as a Service (SaaS) + retinal camera package with the hope of making retinal scans a part of routine healthcare. The business model is a pay-per-use platform, per patient, monthly, aimed at primary care clinics, insurance companies, opticians, pharmacies, occupational health companies that provide the service to employees of many companies, and pharmaceutical companies that sell the treatments or therapies.
Vinicio Vargas added, "Our vision is that the retina will be a new standard in primary care, as basic as taking a patient's blood pressure, and together with other datapoints, such as demographic data or laboratory results, to generate a complete report of preventive medicine." CONTINUED… Read this and more news for Avant Technologies at: https://www.financialnewsmedia.com/news-avai/
In other Artificial Intelligence industry developments and happenings in the market recently include:
Teladoc Health, Inc. (NYSE: TDOC), the global leader in whole-person virtual care, this year released new data today from two studies, presented at the American Diabetes Association's 84th Scientific Sessions, that illustrate the company's unmatched predictive modeling capabilities to help members with type 2 diabetes control their blood sugar through participation in Teladoc Health's diabetes management program.
The new data shows a 3X increase in engagement leading to an additional 0.4 reduction in A1c (8.2 to 7.8) for members targeted with personalized health nudges (notifications that are sent to mobile or cellular connected devices) after being identified as at-risk for uncontrolled diabetes through artificial intelligence (AI). Additionally, diabetes members who received personalized next-best actions, powered by predictive modeling, in their weekly email were 50% more likely to engage with a health coach.
Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, recently announced the collaboration with Flatiron Health, a leading healthtech company dedicated to expanding the possibilities of point of care solutions in oncology, to integrate its comprehensive genomic testing directly into Flatiron's cloud-based Electronic Medical Record (EMR) platform, OncoEMR ® through the Molecular Profiling Integration (MPI). This integration will provide oncologists with seamless access to Tempus' suite of testing options, enhancing their ability to deliver personalized cancer care.
Flatiron's MPI—a two-way integration between laboratories and OncoEMR—will allow the 4,200 providers at more than 800 community-based cancer care locations across the U.S. in Flatiron's network to order and receive results from Tempus directly in the OncoEMR workflow. The integration will enable electronic ordering, order tracking, and the receipt of Tempus test results directly within the OncoEMR platform, significantly reducing administrative burden and improving the experience for care providers.
Medtronic plc (NYSE:MDT), a global leader in healthcare technology, announced recently at the North American Spine Society (NASS) 39th Annual Meeting in Chicago the commercial launch of several software, hardware, and imaging innovations. These enhancements are designed to advance AiBLE™, the Medtronic smart ecosystem of innovative navigation, robotics, data and AI imaging software, and implants that enable more predictable outcomes in spine and cranial procedures. In line with its commitment to increasing the quality of care for patients with spinal conditions, Medtronic also announced a partnership with Siemens Healthineers to explore opportunities to further expand access to advanced pre- and post-operative imaging technologies for spine care.
New advancements in the AiBLE™ ecosystem build upon the company's commitment to procedural innovation and execution, and include the following: O-arm™ 4.3 software, which introduces advanced navigation volumes, dose reduction, and enhanced image confirmation. With this release, Medtronic now offers the industry's longest 3D scan length for cone-beam CT images, which allows surgeons to capture additional spine levels in one scan and streamline their workflow. O-arm™ is the first and only intraoperative imager that uses AI, with 70% less radiation dose compared to the standard protocol, while maintaining image quality. Medtronic Implant Resolution (MIR) further enhances decision-making by reducing metal artifacts around select screws, enabling confident final screw placement.
Clover Health Investments, Corp. (NASDAQ: CLOV ) A.I. News - Counterpart Health, Inc. ("Counterpart"), a leading AI-powered physician enablement platform, recently announced a multi-year agreement with The Iowa Clinic, P.C., one of the most highly regarded multispecialty healthcare groups in the United States. This deal positions The Iowa Clinic as one of Counterpart's anchor customers in the Midwest, as Counterpart drives a broader strategic expansion across the country. Counterpart is a subsidiary of Clover Health Investments, Corp. ("Clover Health").
Founded in 1994, The Iowa Clinic is a benchmark for excellence in American healthcare, recognized as one of America's Top 100 Healthcare Providers by Becker's Hospital Review and a recipient of multiple Press Ganey Guardian of Excellence Awards for patient satisfaction. As the largest physician-owned multispecialty group in its community, with over 250 providers across more than 40 specialties, The Iowa Clinic is celebrated for its pioneering physician-governed, patient-centered model. It also has been recognized for its leadership in patient safety by the Leapfrog Group and quality care by the NCQA. The clinic is a frequent collaborator in national research and an early adopter of advanced diagnostic technologies, with its physicians regularly featured in Castle Connolly's list of America's Top Doctors. Renowned for its clinical expertise and commitment to innovation, The Iowa Clinic consistently delivers world-class, patient-centered care.
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Medtronic receives FDA clearance for new InPen app, paving the way for its Smart MDI system launch with Simplera CGM
New Smart MDI system will be the first system to deliver real-time, personalized insights on when and how much to dose including for missed or inaccurate mealtime doses.
Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced U.S. Food and Drug Administration (FDA) clearance for its new InPen™ app featuring missed meal dose detection, paving the way for the launch of its Smart MDI system with the Simplera™ continuous glucose monitor (CGM). The company's Smart MDI system combines its InPen™ smart insulin pen with its newest Simplera™ CGM — the company's first disposable, all-in-one CGM that's half the size of previous Medtronic CGMs.
With this clearance, the system will be the first in the market to recommend corrections for missed or inaccurate insulin doses, providing real-time, personalized insights for individuals on multiple daily injection (MDI) therapy.
For people with diabetes who need daily insulin injections, bolusing before a meal is essential as it helps regulate glucose levels and prevent blood sugar spikes after eating. Minimizing the frequency of these glucose highs reduces the risk of both short- and long-term complications and supports better overall health. However, it's estimated that individuals living with diabetes regularly miss 1 out of 3 doses. The Missed Dose alert function helps to minimize the frequency of these glucose highs. 1 The Medtronic Smart MDI system reduces the guesswork out of diabetes management, helping to address a significant unmet need for MDI users who struggle with juggling numerous decisions related to insulin dosing on a daily basis.
"I'm thrilled about the launch of the Medtronic Smart MDI system with the InPen™ app and Simplera™ CGM. This is a significant leap forward for those on multiple daily injections, offering intelligent dosing insights and simplifying diabetes management," said Diana Isaacs , PharmD, BCPS, BCACP, BC-ADM, CDCES, FADCES, FCCP. "By reducing the guesswork out of insulin dosing, this tool helps maintain stable blood sugars, optimize long-term health, and reduce complications from hyperglycemia." 2,3
Medtronic will initiate a limited market release beginning with existing standalone CGM and InPen™ customers followed by a broad commercial launch.
1. MacLeod, J, Heungyong Im, G, Smith, M, Vigersky, RA. Shining the Spotlight on Multiple Daily Insulin Therapy: Real-World Evidence of the InPen Smart Insulin Pen. Diabetes Technology & Therapeutics. 2024. 26:1, 33-39. |
2. Vigersky et al., Impact Of InPen Smart Insulin Pen Use on Real-World Glycemic and Insulin Dosing Outcomes in Individuals with Poorly Controlled Diabetes. Presented at: American Diabetes Association; 81st Scientific Sessions; 2021 Jun 25-29. |
3. Chien A, Thanasekaran S, Gaetano A, Im G, Wherry K, MacLeod J, Vigersky RA. Potential cost savings in the United States from a reduction in sensor-detected severe hypoglycemia among users of the InPen smart insulin pen system. J Manag Care Spec Pharm. 2023 Mar;29(3):285-292. |
About the Diabetes Business at Medtronic ( www.medtronicdiabetes.com )
Medtronic Diabetes is on a mission to alleviate the burden of diabetes by empowering individuals to live life on their terms, with the most advanced diabetes technology and always-on support when and how they need it. We've pioneered first-of-its-kind innovations for over 40 years and are committed to designing the future of diabetes management through next-generation sensors (CGM), intelligent dosing systems, and the power of data science and AI while always putting the customer experience at the forefront.
About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE: MDT), visit www.Medtronic.com and follow Medtronic on LinkedIn .
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
Contacts: | ||
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Medtronic reports second quarter fiscal 2025 financial results
Delivering on commitments, executing ahead of expectations, and raising guidance
Innovation driving sustained growth across many franchises: TAVR, PFA, Leadless Pacemakers, Diabetes, Spine, and Neuromodulation
- Medtronic plc (NYSE: MDT) today announced financial results for its second quarter (Q2) of fiscal year 2025 (FY25), which ended October 25, 2024 .
Key Highlights
- Revenue of $8.4 billion increased 5.3% as reported and 5.0% organic
- GAAP diluted earnings per share (EPS) of $0.99 ; non-GAAP diluted EPS of $1.26
- Company raises FY25 organic revenue growth and EPS guidance
Financial Results
Medtronic reported Q2 worldwide revenue of $8.403 billion , an increase of 5.3% as reported and 5.0% on an organic basis. Organic revenue growth comparison excludes:
- Other revenue of $37 million in the current year and $61 million in the prior year; and
- Foreign currency translation benefit of $45 million on the remaining segments.
As reported, Q2 GAAP net income and diluted earnings per share (EPS) were $1.270 billion and $0.99 , respectively, representing increases of 40% and 46%, respectively. As detailed in the financial schedules included at the end of this release, Q2 non-GAAP net income and non-GAAP diluted EPS were $1.620 billion and $1.26 , respectively, representing a decrease of 3% and an increase of 1%, respectively. Included in Q2 non-GAAP diluted EPS was a -9 cent impact from foreign currency translation. Non-GAAP adjusted diluted EPS grew 8% on a constant currency basis.
"Our momentum is building as we keep executing on our commitments, delivering yet another consecutive quarter of strong results that came in ahead of expectations," said Geoff Martha , Medtronic chairman and chief executive officer. "Innovation matters, and innovation is really driving our growth today. As we look ahead, we're confident that this diversified growth will keep going, especially given the strength of our pipeline in high-impact markets that will allow us to benefit even more patients around the world."
Cardiovascular Portfolio
The Cardiovascular Portfolio includes the Cardiac Rhythm & Heart Failure (CRHF), Structural Heart & Aortic (SHA), and Coronary & Peripheral Vascular (CPV) divisions. Revenue of $3.102 billion increased 6.1% as reported and 5.6% organic, with a high-single digit increase in SHA and mid-single digit increases in CRHF and CPV, all on an organic basis.
- CRHF results included mid-single digit growth in Cardiac Rhythm Management, driven by high-single digit growth in Defibrillation Solutions and Cardiac Pacing Therapies, including high-teens growth in Micra™ transcatheter pacing systems; Cardiac Ablation Solutions had flat results as strong growth of the PulseSelect™ pulsed field ablation (PFA) system offset declines in cryoablation
- SHA results driven by high-single digit growth in Structural Heart, on the U.S. launch of the Evolut™ FX+ TAVR system, and low-double digit growth in Cardiac Surgery
- CPV delivered mid-single digit growth in both Coronary, with strength in guide catheters and balloons, and Peripheral Vascular Health
- Ramping commercial availability of the Affera™ Mapping and Ablation System and Sphere-9™ catheter following late October U.S. Food and Drug Administration (FDA) approval
- Received CE Mark for Evolut™ FX+ TAVR system in late October; started commercial launch across Europe this month
- Launched Avalus Ultra™ surgical valve in Western Europe and VitalFlow™ Extracorporeal Membrane Oxygenation (ECMO) system in the U.S.
- In September, Symplicity™ blood pressure procedure named to FORTUNE 2024 'Change the World' list
- Earlier this month, granted transitional pass-through (TPT) payment under the U.S. Medicare Hospital Outpatient Prospective Payment System beginning January 1, 2025 , for Symplicity Spyral™ renal denervation (RDN) catheter, used in the Symplicity™ blood pressure procedure
Neuroscience Portfolio
The Neuroscience Portfolio includes the Cranial & Spinal Technologies (CST), Specialty Therapies, and Neuromodulation divisions. Revenue of $2.451 billion increased 7.1% as reported and 6.7% organic, with a low-double digits increase in Neuromodulation and mid-single digit increases in both CST and Specialty Therapies, all on an organic basis.
- CST above market performance driven by continued adoption of the AiBLE™ ecosystem of spine implants and enabling technology, with mid-single digit growth in Core Spine and high-single digit growth in Biologics and Neurosurgery
- Specialty Therapies results driven by mid-single digit growth in both Neurovascular, with continued strength in hemorrhagic stroke products, and Pelvic Health, on continued adoption of the InterStim X™ system; ENT grew low-single digits on strength in capital placements
- Neuromodulation drove above market performance, with high-teens growth in Brain Modulation on the continued launch of the Percept™ RC deep brain stimulator (DBS) with BrainSense™ technology; Pain Therapies grew low-double digits, including low-double digit growth in U.S. Pain Stim on the continued launch of the Inceptiv™ spinal cord stimulator
- Medtronic pioneering ADAPT-PD clinical trial methods and preliminary data studying adaptive deep brain stimulation (aDBS) published in September in npj Parkinson's Disease , part of the prestigious Nature Portfolio of journals
- In September, expanded AiBLE™ spine surgery ecosystem with new technologies and announced partnership with Siemens Healthineers to co-market and integrate the Siemens Healthineers Multitom Rax™ imaging system
Medical Surgical Portfolio
The Medical Surgical Portfolio includes the Surgical & Endoscopy (SE) and the Acute Care & Monitoring (ACM) divisions. Revenue of $2.128 billion increased 1.2% as reported and increased 0.7% organic, with low-single digit organic increase in ACM and flat organic result in SE. SE year-over-year results were affected by a difficult comparison from prior year supply recovery in Surgical and increased high-single digits sequentially.
- SE results included flat results in both Advanced Surgical Technologies, with strength in Advanced Energy, driven by continued adoption of the LigaSure™ Maryland XP vessel sealer, offsetting declines in Advanced Stapling; General Surgical Technologies grew low-single digits, with strength in Hernia and Wound Management products
- ACM performance included high-single digit growth in Nellcor™ Blood Oxygen Management products
Diabetes
Revenue of $686 million increased 12.4% as reported and 11.0% organic.
- U.S. revenue grew high-single digits on the continued adoption of the MiniMed™ 780G automated insulin delivery (AID) system
- International revenue grew low-double digits on increasing CGM attachment rates and the continued roll-out of Simplera Sync™ sensor
- In September, meta-analysis of 28 randomized control trials published in Diabetes/Metabolism Research and Reviews concluded MiniMed™ 780G achieved highest time-in-range among seven commercial AID systems
Guidance
The company today raised its FY25 revenue growth and EPS guidance.
The company raised its FY25 organic revenue growth guidance to 4.75% to 5% versus the prior range of 4.5% to 5%. The organic revenue growth guidance excludes the impact of foreign currency and revenue reported as Other. Including Other revenue and the impact of foreign currency exchange, if recent foreign currency exchange rates hold, FY25 revenue growth on an adjusted basis would be in the range of 3.4% to 3.9%.
The company raised its FY25 diluted non-GAAP EPS guidance to the new range of $5.44 to $5.50 versus the prior $5.42 to $5.50 . This includes an estimated -5% impact from foreign currency exchange based on recent rates, unchanged from the prior guidance. The company's guidance represents FY25 diluted non-GAAP EPS growth in the range of 4.6% to 5.8%.
"We're restoring our earnings power through our focus on underlying margin improvement, delivering another quarter of high-single digit constant currency adjusted EPS growth," said Gary Corona , Medtronic interim chief financial officer. "And now, as the impact from foreign currency abates, we expect to report high-single digit adjusted EPS growth in the back half of our fiscal year, in line with our long-term commitment to deliver durable, mid-single digit organic revenue growth with EPS leverage."
FY24 Impact Report
Today, Medtronic released its FY24 Impact Report demonstrating the company's sustainability progress. Medtronic also launched a new Impact webpage and FY24 Highlights Report featuring notable key performance indicators and stories, as well as an online Data Hub that shows the company's commitment to transparent disclosure and reporting:
- Achieved 2025 goal to reduce greenhouse gas intensity by 50% a year early, with a 52% reduction in FY24
- Exceeded goal to reduce aggregate product complaint rate by 10% for identified product families, with a 33% reduction in FY24
- More than 78 million patients served through expanded access strategies
- $2.7B spent in R&D investments to drive innovation
Video Webcast Information
Medtronic will host a video webcast today, November 19 , at 8:00 a.m. EST ( 7:00 a.m. CST ) to provide information about its businesses for the public, investors, analysts, and news media. This webcast can be accessed by clicking on the Events icon at investorrelations.medtronic.com , and this earnings release will be archived at news.medtronic.com . Within 24 hours of the webcast, a replay of the webcast and transcript of the company's prepared remarks will be available by clicking on the Events icon at investorrelations.medtronic.com .
Medtronic plans to report its FY25 third and fourth quarter results on Tuesday, February 18, 2025 , and Wednesday, May 21, 2025 , respectively. Confirmation and additional details will be provided closer to the specific event.
Financial Schedules and Earnings Presentation
The second quarter financial schedules and non-GAAP reconciliations can be viewed by clicking on the Investor Events link at investorrelations.medtronic.com . To view a printable PDF of the financial schedules and non-GAAP reconciliations, click here . To view the first quarter earnings presentation, click here .
MEDTRONIC PLC WORLD WIDE REVENUE (1) (Unaudited) | ||||||||||||||||||||||||||||
SECOND QUARTER | YEAR-TO-DATE | |||||||||||||||||||||||||||
REPORTED | ORGANIC | REPORTED | ORGANIC | |||||||||||||||||||||||||
(in millions) | FY25 | FY24 | Growth | Currency | Adjusted | Adjusted | Growth | FY25 | FY24 | Growth | Currency | Adjusted | Adjusted | Growth | ||||||||||||||
Cardiovascular | $ 3,102 | $ 2,923 | 6.1 % | $ 16 | $ 3,086 | $ 2,923 | 5.6 % | $ 6,108 | $ 5,773 | 5.8 % | $ (23) | $ 6,132 | $ 5,773 | 6.2 % | ||||||||||||||
Cardiac Rhythm & Heart Failure | 1,578 | 1,492 | 5.8 | 11 | 1,567 | 1,492 | 5.0 | 3,114 | 2,938 | 6.0 | (8) | 3,122 | 2,938 | 6.2 | ||||||||||||||
Structural Heart & Aortic | 881 | 819 | 7.6 | 4 | 877 | 819 | 7.1 | 1,736 | 1,633 | 6.3 | (8) | 1,744 | 1,633 | 6.8 | ||||||||||||||
Coronary & Peripheral Vascular | 643 | 613 | 4.9 | 1 | 642 | 613 | 4.8 | 1,259 | 1,202 | 4.7 | (7) | 1,266 | 1,202 | 5.3 | ||||||||||||||
Neuroscience | 2,451 | 2,288 | 7.1 | 10 | 2,441 | 2,288 | 6.7 | 4,768 | 4,506 | 5.8 | (8) | 4,776 | 4,506 | 6.0 | ||||||||||||||
Cranial & Spinal Technologies | 1,234 | 1,157 | 6.7 | 3 | 1,231 | 1,157 | 6.4 | 2,382 | 2,260 | 5.4 | (6) | 2,387 | 2,260 | 5.6 | ||||||||||||||
Specialty Therapies | 737 | 705 | 4.6 | 5 | 732 | 705 | 3.9 | 1,450 | 1,400 | 3.5 | (2) | 1,452 | 1,400 | 3.7 | ||||||||||||||
Neuromodulation | 480 | 426 | 12.6 | 2 | 478 | 426 | 12.1 | 937 | 846 | 10.8 | (1) | 938 | 846 | 10.9 | ||||||||||||||
Medical Surgical | 2,128 | 2,103 | 1.2 | 10 | 2,117 | 2,103 | 0.7 | 4,123 | 4,107 | 0.4 | (18) | 4,142 | 4,107 | 0.8 | ||||||||||||||
Surgical & Endoscopy | 1,649 | 1,641 | 0.5 | 9 | 1,641 | 1,641 | — | 3,193 | 3,187 | 0.2 | (13) | 3,207 | 3,187 | 0.6 | ||||||||||||||
Acute Care & Monitoring | 478 | 462 | 3.6 | 1 | 477 | 462 | 3.3 | 930 | 921 | 1.0 | (5) | 935 | 921 | 1.6 | ||||||||||||||
Diabetes | 686 | 610 | 12.4 | 9 | 678 | 610 | 11.0 | 1,333 | 1,189 | 12.1 | 5 | 1,329 | 1,189 | 11.8 | ||||||||||||||
Total Reportable Segments | 8,366 | 7,923 | 5.6 | 45 | 8,322 | 7,923 | 5.0 | 16,333 | 15,575 | 4.9 | (46) | 16,379 | 15,575 | 5.2 | ||||||||||||||
Other (2) | 37 | 61 | (38.9) | — | — | — | — | (15) | 111 | (113.5) | (2) | — | — | — | ||||||||||||||
TOTAL | $ 8,403 | $ 7,984 | 5.3 % | $ 45 | $ 8,322 | $ 7,923 | 5.0 % | $ 16,318 | $ 15,686 | 4.0 % | $ (48) | $ 16,379 | $ 15,575 | 5.2 % | ||||||||||||||
(1) | The data in this schedule has been intentionally rounded to the nearest million and, therefore, may not sum. Percentages have been calculated using actual, non-rounded figures and, therefore, may not recalculate precisely. |
(2) | Includes historical operations and ongoing transition agreements from businesses the Company has exited or divested, and specifically for the three months ended July 26, 2024, impacting year-to-date figures, $90 million of incremental Italian payback accruals resulting from the two July 22, 2024 rulings by the Constitutional Court of Italy relating to certain prior years since 2015. |
(3) | The currency impact to revenue measures the change in revenue between current and prior year periods using constant exchange rates. |
(4) | The three months ended October 25, 2024 includes $82 million of revenue adjustments related to $37 million of inorganic revenue for the transition activity noted in (2) and $45 million of favorable currency impact on the remaining segments. The three months ended October 27, 2023 excludes $61 million of inorganic revenue related to the transition activity noted in (2). |
(5) | The six months ended October 25, 2024 excludes $61 million of revenue adjustments related to $90 million of incremental Italian payback accruals further described in note (2), $75 million of inorganic revenue related to the transition activity noted in (2), and $46 million of unfavorable currency impact on the remaining segments. The six months ended October 27, 2023 excludes $111 million of inorganic revenue related to the transition activity noted in (2). |
MEDTRONIC PLC U.S. (1)(2) REVENUE (Unaudited) | ||||||||||||||||||||||||
SECOND QUARTER | YEAR-TO-DATE | |||||||||||||||||||||||
REPORTED | ORGANIC | REPORTED | ORGANIC | |||||||||||||||||||||
(in millions) | FY25 | FY24 | Growth | Adjusted | Adjusted | Growth | FY25 | FY24 | Growth | Adjusted | Adjusted | Growth | ||||||||||||
Cardiovascular | $ 1,434 | $ 1,427 | 0.5 % | $ 1,434 | $ 1,427 | 0.5 % | $ 2,836 | $ 2,776 | 2.2 % | $ 2,836 | $ 2,776 | 2.2 % | ||||||||||||
Cardiac Rhythm & Heart Failure | 768 | 782 | (1.8) | 768 | 782 | (1.8) | 1,534 | 1,502 | 2.1 | 1,534 | 1,502 | 2.1 | ||||||||||||
Structural Heart & Aortic | 388 | 367 | 5.7 | 388 | 367 | 5.7 | 757 | 724 | 4.5 | 757 | 724 | 4.5 | ||||||||||||
Coronary & Peripheral Vascular | 278 | 278 | 0.1 | 278 | 278 | 0.1 | 546 | 550 | (0.8) | 546 | 550 | (0.8) | ||||||||||||
Neuroscience | 1,677 | 1,560 | 7.5 | 1,677 | 1,560 | 7.5 | 3,242 | 3,057 | 6.0 | 3,242 | 3,057 | 6.0 | ||||||||||||
Cranial & Spinal Technologies | 926 | 863 | 7.2 | 926 | 863 | 7.2 | 1,781 | 1,685 | 5.7 | 1,781 | 1,685 | 5.7 | ||||||||||||
Specialty Therapies | 418 | 403 | 3.6 | 418 | 403 | 3.6 | 816 | 795 | 2.6 | 816 | 795 | 2.6 | ||||||||||||
Neuromodulation | 333 | 293 | 13.7 | 333 | 293 | 13.7 | 645 | 577 | 11.8 | 645 | 577 | 11.8 | ||||||||||||
Medical Surgical | 944 | 948 | (0.4) | 944 | 948 | (0.4) | 1,825 | 1,815 | 0.5 | 1,825 | 1,815 | 0.5 | ||||||||||||
Surgical & Endoscopy | 675 | 688 | (1.9) | 675 | 688 | (1.9) | 1,304 | 1,308 | (0.2) | 1,304 | 1,308 | (0.2) | ||||||||||||
Acute Care & Monitoring | 269 | 260 | 3.6 | 269 | 260 | 3.6 | 521 | 508 | 2.6 | 521 | 508 | 2.6 | ||||||||||||
Diabetes | 232 | 217 | 6.9 | 232 | 217 | 6.9 | 447 | 405 | 10.4 | 447 | 405 | 10.4 | ||||||||||||
Total Reportable Segments | 4,286 | 4,151 | 3.3 | 4,286 | 4,151 | 3.3 | 8,350 | 8,054 | 3.7 | 8,350 | 8,054 | 3.7 | ||||||||||||
Other (3) | 18 | 23 | (22.2) | — | — | — | 37 | 45 | (19.0) | — | — | — | ||||||||||||
TOTAL | $ 4,304 | $ 4,175 | 3.1 % | $ 4,286 | $ 4,151 | 3.3 % | $ 8,387 | $ 8,099 | 3.6 % | $ 8,350 | $ 8,054 | 3.7 % | ||||||||||||
(1) | U.S. includes the United States and U.S. territories. |
(2) | The data in this schedule has been intentionally rounded to the nearest million and, therefore, may not sum. Percentages have been calculated using actual, non-rounded figures and, therefore, may not recalculate precisely. |
(3) | Includes historical operations and ongoing transition agreements from businesses the Company has exited or divested. |
MEDTRONIC PLC INTERNATIONAL REVENUE (1) (Unaudited) | ||||||||||||||||||||||||||||
SECOND QUARTER | YEAR-TO-DATE | |||||||||||||||||||||||||||
REPORTED | ORGANIC | REPORTED | ORGANIC | |||||||||||||||||||||||||
(in millions) | FY25 | FY24 | Growth | Currency | Adjusted | Adjusted | Growth | FY25 | FY24 | Growth | Currency | Adjusted | Adjusted | Growth | ||||||||||||||
Cardiovascular | $ 1,668 | $ 1,496 | 11.5 % | $ 16 | $ 1,652 | $ 1,496 | 10.4 % | $ 3,272 | $ 2,996 | 9.2 % | $ (23) | $ 3,295 | $ 2,996 | 10.0 % | ||||||||||||||
Cardiac Rhythm & Heart Failure | 811 | 710 | 14.2 | 11 | 799 | 710 | 12.6 | 1,580 | 1,436 | 10.0 | (8) | 1,588 | 1,436 | 10.6 | ||||||||||||||
Structural Heart & Aortic | 492 | 451 | 9.1 | 4 | 488 | 451 | 8.3 | 980 | 909 | 7.8 | (8) | 988 | 909 | 8.7 | ||||||||||||||
Coronary & Peripheral Vascular | 365 | 335 | 8.9 | 1 | 364 | 335 | 8.7 | 713 | 652 | 9.3 | (7) | 720 | 652 | 10.4 | ||||||||||||||
Neuroscience | 774 | 728 | 6.3 | 10 | 764 | 728 | 5.0 | 1,526 | 1,449 | 5.3 | (8) | 1,535 | 1,449 | 5.9 | ||||||||||||||
Cranial & Spinal Technologies | 308 | 293 | 5.0 | 3 | 305 | 293 | 3.9 | 600 | 576 | 4.2 | (6) | 606 | 576 | 5.2 | ||||||||||||||
Specialty Therapies | 319 | 302 | 5.8 | 5 | 315 | 302 | 4.3 | 634 | 605 | 4.8 | (2) | 636 | 605 | 5.1 | ||||||||||||||
Neuromodulation | 146 | 133 | 10.4 | 2 | 144 | 133 | 8.8 | 292 | 269 | 8.8 | (1) | 293 | 269 | 9.1 | ||||||||||||||
Medical Surgical | 1,183 | 1,155 | 2.5 | 10 | 1,173 | 1,155 | 1.6 | 2,298 | 2,292 | 0.3 | (18) | 2,317 | 2,292 | 1.1 | ||||||||||||||
Surgical & Endoscopy | 974 | 953 | 2.3 | 9 | 966 | 953 | 1.4 | 1,889 | 1,879 | 0.5 | (13) | 1,902 | 1,879 | 1.2 | ||||||||||||||
Acute Care & Monitoring | 209 | 202 | 3.5 | 1 | 208 | 202 | 2.8 | 409 | 413 | (0.9) | (5) | 414 | 413 | 0.4 | ||||||||||||||
Diabetes | 455 | 394 | 15.5 | 9 | 446 | 394 | 13.2 | 886 | 784 | 13.1 | 5 | 882 | 784 | 12.5 | ||||||||||||||
Total Reportable Segments | 4,080 | 3,772 | 8.2 | 45 | 4,035 | 3,772 | 7.0 | 7,983 | 7,521 | 6.1 | (46) | 8,028 | 7,521 | 6.7 | ||||||||||||||
Other (2) | 19 | 37 | (49.4) | — | — | — | — | (51) | 66 | (178.3) | (2) | — | — | — | ||||||||||||||
TOTAL | $ 4,099 | $ 3,809 | 7.6 % | $ 45 | $ 4,035 | $ 3,772 | 7.0 % | $ 7,931 | $ 7,587 | 4.5 % | $ (48) | $ 8,028 | $ 7,521 | 6.7 % | ||||||||||||||
(1) | The data in this schedule has been intentionally rounded to the nearest million and, therefore, may not sum. Percentages have been calculated using actual, non-rounded figures and, therefore, may not recalculate precisely. |
(2) | Includes historical operations and ongoing transition agreements from businesses the Company has exited or divested, and specifically for the three months ended July 26, 2024, impacting year-to-date figures, $90 million of incremental Italian payback accruals resulting from the two July 22, 2024 rulings by the Constitutional Court of Italy relating to certain prior years since 2015. |
(3) | The currency impact to revenue measures the change in revenue between current and prior year periods using constant exchange rates. |
(4) | The three months ended October 25, 2024 includes $64 million of revenue adjustments related to $19 million of inorganic revenue for the transition activity noted in (2), and $45 million of favorable currency impact on the remaining segments. The three months ended October 27, 2023 excludes $37 million of inorganic revenue related to the transition activity noted in (2). |
(5) | The six months ended October 25, 2024 excludes $97 million of revenue adjustments related to $90 million of incremental Italian payback accruals further described in note (2), $38 million of inorganic revenue related to the transition activity noted in (2), and $46 million of unfavorable currency impact on the remaining segments. The six months ended October 27, 2023 excludes $66 million of inorganic revenue related to the transition activity noted in (2). |
MEDTRONIC PLC CONSOLIDATED STATEMENTS OF INCOME (Unaudited) | |||||||
Three months ended | Six months ended | ||||||
(in millions, except per share data) | October 25, 2024 | October 27, 2023 | October 25, 2024 | October 27, 2023 | |||
Net sales | $ 8,403 | $ 7,984 | $ 16,318 | $ 15,686 | |||
Costs and expenses: | |||||||
Cost of products sold, excluding amortization of intangible assets | 2,946 | 2,761 | 5,707 | 5,390 | |||
Research and development expense | 697 | 698 | 1,373 | 1,365 | |||
Selling, general, and administrative expense | 2,757 | 2,686 | 5,412 | 5,299 | |||
Amortization of intangible assets | 413 | 425 | 827 | 855 | |||
Restructuring charges, net | 30 | 40 | 77 | 94 | |||
Certain litigation charges, net | — | 65 | 81 | 105 | |||
Other operating income, net | (34) | (31) | (33) | (30) | |||
Operating profit | 1,595 | 1,340 | 2,873 | 2,608 | |||
Other non-operating income, net | (173) | (154) | (330) | (230) | |||
Interest expense, net | 209 | 180 | 376 | 329 | |||
Income before income taxes | 1,559 | 1,313 | 2,827 | 2,510 | |||
Income tax provision | 281 | 402 | 500 | 802 | |||
Net income | 1,278 | 911 | 2,327 | 1,708 | |||
Net income attributable to noncontrolling interests | (9) | (2) | (15) | (8) | |||
Net income attributable to Medtronic | $ 1,270 | $ 909 | $ 2,312 | $ 1,700 | |||
Basic earnings per share | $ 0.99 | $ 0.68 | $ 1.79 | $ 1.28 | |||
Diluted earnings per share | $ 0.99 | $ 0.68 | $ 1.79 | $ 1.28 | |||
Basic weighted average shares outstanding | 1,282.4 | 1,330.2 | 1,288.6 | 1,330.3 | |||
Diluted weighted average shares outstanding | 1,286.9 | 1,331.9 | 1,292.5 | 1,332.8 | |||
The data in the schedule above has been intentionally rounded to the nearest million. |
MEDTRONIC PLC GAAP TO NON-GAAP RECONCILIATIONS (1) (Unaudited) | |||||||||||||||||
Three months ended October 25, 2024 | |||||||||||||||||
(in millions, except per share data) | Net | Cost of | Gross | Operating | Operating | Income | Net Income | Diluted | Effective | ||||||||
GAAP | $ 8,403 | $ 2,946 | 64.9 % | $ 1,595 | 19.0 % | $ 1,559 | $ 1,270 | $ 0.99 | 18.0 % | ||||||||
Non-GAAP Adjustments: | |||||||||||||||||
Amortization of intangible assets | — | — | — | 413 | 4.9 | 413 | 338 | 0.26 | 18.2 | ||||||||
Restructuring and associated costs (2) | — | (11) | 0.1 | 46 | 0.5 | 46 | 37 | 0.03 | 19.6 | ||||||||
Acquisition and divestiture-related items (3) | — | (5) | 0.1 | (25) | (0.3) | (25) | (30) | (0.02) | (20.0) | ||||||||
(Gain)/loss on minority investments (4) | — | — | — | — | — | (10) | (21) | (0.02) | (100.0) | ||||||||
Medical device regulations (5) | — | (9) | 0.1 | 12 | 0.1 | 12 | 10 | 0.01 | 16.7 | ||||||||
Certain tax adjustments, net | — | — | — | — | — | — | 16 | 0.01 | — | ||||||||
Non-GAAP | $ 8,403 | $ 2,921 | 65.2 % | $ 2,041 | 24.3 % | $ 1,995 | $ 1,620 | $ 1.26 | 18.3 % | ||||||||
Currency impact | (45) | (103) | 1.1 | 145 | 1.9 | 0.09 | |||||||||||
Currency Adjusted | $ 8,358 | $ 2,818 | 66.3 % | $ 2,186 | 26.2 % | $ 1.35 | |||||||||||
Three months ended October 27, 2023 | |||||||||||||||||
(in millions, except per share data) | Net | Cost of | Gross | Operating | Operating | Income | Net Income | Diluted | Effective | ||||||||
GAAP | $ 7,984 | $ 2,761 | 65.4 % | $ 1,340 | 16.8 % | $ 1,313 | $ 909 | $ 0.68 | 30.6 % | ||||||||
Non-GAAP Adjustments: | |||||||||||||||||
Amortization of intangible assets | — | — | — | 425 | 5.3 | 425 | 360 | 0.27 | 15.3 | ||||||||
Restructuring and associated costs (2) | — | (15) | 0.2 | 91 | 1.1 | 91 | 76 | 0.06 | 17.6 | ||||||||
Acquisition and divestiture-related items (3) | — | (6) | 0.1 | 58 | 0.7 | 58 | 51 | 0.04 | 12.1 | ||||||||
Certain litigation charges, net | — | — | — | 65 | 0.8 | 65 | 50 | 0.04 | 23.1 | ||||||||
(Gain)/loss on minority investments (4) | — | — | — | — | — | 25 | 21 | 0.02 | 20.0 | ||||||||
Medical device regulations (5) | — | (21) | 0.3 | 30 | 0.4 | 30 | 24 | 0.02 | 20.0 | ||||||||
Certain tax adjustments, net (6) | — | — | — | — | — | — | 176 | 0.13 | — | ||||||||
Non-GAAP | $ 7,984 | $ 2,720 | 65.9 % | $ 2,009 | 25.2 % | $ 2,008 | $ 1,667 | $ 1.25 | 16.9 % | ||||||||
See description of non-GAAP financial measures contained in the press release dated November 19, 2024. | |
(1) | The data in this schedule has been intentionally rounded to the nearest million or $0.01 for EPS figures, and, therefore, may not sum. |
(2) | Associated costs primarily include salaries and wages for employees supporting the restructuring activities, consulting expenses, and asset write-offs. |
(3) | The charges primarily include business combination costs, changes in fair value of contingent consideration, and exit of business-related charges. The three months ended October 25, 2024, also include gains related to certain business or asset sales. |
(4) | We exclude unrealized and realized gains and losses on our minority investments as we do not believe that these components of income or expense have a direct correlation to our ongoing or future business operations. |
(5) | The charges represent incremental costs of complying with the new European Union (E.U.) medical device regulations for previously registered products and primarily include charges for contractors supporting the project and other direct third-party expenses. We consider these costs to be duplicative of previously incurred costs and/or one-time costs, which are limited to a specific time period. |
(6) | The charge primarily relates to the establishment of a valuation allowance against certain net operating losses. |
MEDTRONIC PLC GAAP TO NON-GAAP RECONCILIATIONS (1) (Unaudited) | |||||||||||||||||
Six months ended October 25, 2024 | |||||||||||||||||
(in millions, except per share data) | Net | Cost of | Gross | Operating | Operating | Income | Net Income | Diluted | Effective | ||||||||
GAAP | $ 16,318 | $ 5,707 | 65.0 % | $ 2,873 | 17.6 % | $ 2,827 | $ 2,312 | $ 1.79 | 17.7 % | ||||||||
Non-GAAP Adjustments: | |||||||||||||||||
Amortization of intangible assets | — | — | — | 827 | 4.9 | 827 | 678 | 0.52 | 18.0 | ||||||||
Restructuring and associated costs (2) | — | (20) | 0.1 | 108 | 0.6 | 108 | 87 | 0.07 | 19.4 | ||||||||
Acquisition and divestiture-related items (3) | — | (16) | 0.1 | (13) | (0.1) | (13) | (19) | (0.01) | (46.2) | ||||||||
Certain litigation charges, net | — | — | — | 81 | 0.5 | 81 | 68 | 0.05 | 16.0 | ||||||||
(Gain)/loss on minority investments (4) | — | — | — | — | — | (27) | (38) | (0.03) | (37.0) | ||||||||
Medical device regulations (5) | — | (20) | 0.1 | 27 | 0.2 | 27 | 22 | 0.02 | 18.5 | ||||||||
Other (6) | 90 | — | 0.4 | 90 | 0.5 | 90 | 70 | 0.05 | 22.2 | ||||||||
Certain tax adjustments, net | — | — | — | — | — | — | 33 | 0.03 | — | ||||||||
Non-GAAP | $ 16,408 | $ 5,651 | 65.6 % | $ 3,993 | 24.3 % | $ 3,921 | $ 3,213 | $ 2.49 | 17.7 % | ||||||||
Currency impact | 46 | (134) | 0.9 | 246 | 1.5 | 0.16 | |||||||||||
Currency Adjusted | $ 16,454 | $ 5,517 | 66.5 % | $ 4,239 | 25.8 % | $ 2.65 | |||||||||||
Six months ended October 27, 2023 | |||||||||||||||||
(in millions, except per share data) | Net | Cost of | Gross | Operating | Operating | Income | Net Income | Diluted | Effective | ||||||||
GAAP | $ 15,686 | $ 5,390 | 65.6 % | $ 2,608 | 16.6 % | $ 2,510 | $ 1,700 | $ 1.28 | 32.0 % | ||||||||
Non-GAAP Adjustments: | |||||||||||||||||
Amortization of intangible assets | — | — | — | 855 | 5.5 | 855 | 724 | 0.54 | 15.2 | ||||||||
Restructuring and associated costs (2) | — | (30) | 0.2 | 182 | 1.2 | 182 | 152 | 0.11 | 16.5 | ||||||||
Acquisition and divestiture-related items (3) | — | (12) | 0.1 | 107 | 0.7 | 107 | 97 | 0.07 | 9.3 | ||||||||
Certain litigation charges, net | — | — | — | 105 | 0.7 | 105 | 81 | 0.06 | 22.9 | ||||||||
(Gain)/loss on minority investments (4) | — | — | — | — | — | 89 | 85 | 0.06 | 5.6 | ||||||||
Medical device regulations (5) | — | (42) | 0.3 | 62 | 0.4 | 62 | 49 | 0.04 | 21.0 | ||||||||
Certain tax adjustments, net (7) | — | — | — | — | — | — | 375 | 0.28 | — | ||||||||
Non-GAAP | $ 15,686 | $ 5,306 | 66.2 % | $ 3,919 | 25.0 % | $ 3,910 | $ 3,262 | $ 2.45 | 16.4 % | ||||||||
See description of non-GAAP financial measures contained in the press release dated November 19, 2024. | |
(1) | The data in this schedule has been intentionally rounded to the nearest million or $0.01 for EPS figures, and, therefore, may not sum. |
(2) | Associated costs primarily include salaries and wages for employees supporting the restructuring activities, consulting expenses, and asset write-offs. |
(3) | The charges primarily include business combination costs, changes in fair value of contingent consideration, and exit of business-related charges. The six months ended October 25, 2024, also include gains related to certain business or asset sales. |
(4) | We exclude unrealized and realized gains and losses on our minority investments as we do not believe that these components of income or expense have a direct correlation to our ongoing or future business operations. |
(5) | The charges represent incremental costs of complying with the new European Union (E.U.) medical device regulations for previously registered products and primarily include charges for contractors supporting the project and other direct third-party expenses. We consider these costs to be duplicative of previously incurred costs and/or one-time costs, which are limited to a specific time period. |
(6) | Reflects the recognition of incremental Italian payback accruals resulting from the two July 22, 2024 rulings by the Constitutional Court of Italy relating to certain prior years since 2015. |
(7) | The charge relates to an income tax reserve adjustment associated with the June 2023, Israeli Central-Lod District Court decision, the establishment of a valuation allowance against certain net operating losses and amortization of previously established deferred tax assets from intercompany intellectual property transactions. |
MEDTRONIC PLC GAAP TO NON-GAAP RECONCILIATIONS (1) (Unaudited) | |||||||||||||||
Three months ended October 25, 2024 | |||||||||||||||
(in millions) | Net | SG&A | SG&A | R&D | R&D | Other | Other | Other Non- | |||||||
GAAP | $ 8,403 | $ 2,757 | 32.8 % | $ 697 | 8.3 % | $ (34) | (0.4) % | $ (173) | |||||||
Non-GAAP Adjustments: | |||||||||||||||
Restructuring and associated costs (2) | — | (6) | (0.1) | — | — | — | — | — | |||||||
Acquisition and divestiture-related items (3) | — | (19) | (0.2) | — | — | 50 | 0.6 | — | |||||||
Medical device regulations (4) | — | — | — | (4) | — | — | — | — | |||||||
(Gain)/loss on minority investments (5) | — | — | — | — | — | — | — | 10 | |||||||
Non-GAAP | $ 8,403 | $ 2,732 | 32.5 % | $ 693 | 8.2 % | $ 16 | 0.2 % | $ (163) | |||||||
Six months ended October 25, 2024 | |||||||||||||||
(in millions) | Net | SG&A | SG&A | R&D | R&D | Other | Other | Other Non- | |||||||
GAAP | $ 16,318 | $ 5,412 | 33.2 % | $ 1,373 | 8.4 % | $ (33) | (0.2) % | $ (330) | |||||||
Non-GAAP Adjustments: | |||||||||||||||
Restructuring and associated costs (2) | — | (11) | (0.1) | — | — | — | — | — | |||||||
Acquisition and divestiture-related items (3) | — | (27) | (0.3) | — | — | 55 | 0.3 | — | |||||||
Medical device regulations (4) | — | — | — | (7) | (0.1) | — | — | — | |||||||
Other (6) | 90 | — | — | — | — | — | — | — | |||||||
(Gain)/loss on minority investments (5) | — | — | — | — | — | — | — | 27 | |||||||
Non-GAAP | $ 16,408 | $ 5,374 | 32.8 % | $ 1,366 | 8.3 % | $ 23 | 0.1 % | $ (303) | |||||||
See description of non-GAAP financial measures contained in the press release dated November 19, 2024. | |
(1) | The data in this schedule has been intentionally rounded to the nearest million, and, therefore, may not sum. |
(2) | Associated costs primarily include salaries and wages for employees supporting the restructuring activities, consulting expenses, and asset write-offs. |
(3) | The charges primarily include business combination costs, changes in fair value of contingent consideration, exit of business-related charges, and gains related to certain business or asset sales. |
(4) | The charges represent incremental costs of complying with the new European Union medical device regulations for previously registered products and primarily include charges for contractors supporting the project and other direct third-party expenses. We consider these costs to be duplicative of previously incurred costs and/or one-time costs, which are limited to a specific time period. |
(5) | We exclude unrealized and realized gains and losses on our minority investments as we do not believe that these components of income or expense have a direct correlation to our ongoing or future business operations. |
(6) | Reflects the recognition of incremental Italian payback accruals resulting from the two July 22, 2024 rulings by the Constitutional Court of Italy relating to certain prior years since 2015. |
MEDTRONIC PLC GAAP TO NON-GAAP RECONCILIATIONS (1) (Unaudited) | |||
Six months ended | |||
(in millions) | October 25, 2024 | October 27, 2023 | |
Net cash provided by operating activities | $ 1,944 | $ 1,536 | |
Additions to property, plant, and equipment | (924) | (815) | |
Free Cash Flow (2) | $ 1,020 | $ 721 | |
See description of non-GAAP financial measures contained in the press release dated November 19, 2024. | |
(1) | The data in this schedule has been intentionally rounded to the nearest million, and, therefore, may not sum. |
(2) | Free cash flow represents operating cash flows less property, plant, and equipment additions. |
MEDTRONIC PLC CONSOLIDATED BALANCE SHEETS (Unaudited) | ||||
(in millions) | October 25, 2024 | April 26, 2024 | ||
ASSETS | ||||
Current assets: | ||||
Cash and cash equivalents | $ 1,394 | $ 1,284 | ||
Investments | 6,595 | 6,721 | ||
Accounts receivable, less allowances and credit losses of $195 and $173, respectively | 6,260 | 6,128 | ||
Inventories | 5,479 | 5,217 | ||
Other current assets | 2,710 | 2,584 | ||
Total current assets | 22,438 | 21,935 | ||
Property, plant, and equipment, net | 6,438 | 6,131 | ||
Goodwill | 41,161 | 40,986 | ||
Other intangible assets, net | 12,423 | 13,225 | ||
Tax assets | 3,572 | 3,657 | ||
Other assets | 4,009 | 4,047 | ||
Total assets | $ 90,042 | $ 89,981 | ||
LIABILITIES AND EQUITY | ||||
Current liabilities: | ||||
Current debt obligations | $ 3,719 | $ 1,092 | ||
Accounts payable | 2,376 | 2,410 | ||
Accrued compensation | 1,893 | 2,375 | ||
Accrued income taxes | 947 | 1,330 | ||
Other accrued expenses | 3,260 | 3,582 | ||
Total current liabilities | 12,195 | 10,789 | ||
Long-term debt | 24,607 | 23,932 | ||
Accrued compensation and retirement benefits | 1,084 | 1,101 | ||
Accrued income taxes | 1,432 | 1,859 | ||
Deferred tax liabilities | 473 | 515 | ||
Other liabilities | 1,534 | 1,365 | ||
Total liabilities | 41,326 | 39,561 | ||
Commitments and contingencies | ||||
Shareholders' equity: | ||||
Ordinary shares— par value $0.0001, 2.6 billion shares authorized, 1,282,553,150 and | — | — | ||
Additional paid-in capital | 20,824 | 23,129 | ||
Retained earnings | 30,919 | 30,403 | ||
Accumulated other comprehensive loss | (3,250) | (3,318) | ||
Total shareholders' equity | 48,494 | 50,214 | ||
Noncontrolling interests | 222 | 206 | ||
Total equity | 48,716 | 50,420 | ||
Total liabilities and equity | $ 90,042 | $ 89,981 | ||
The data in this schedule has been intentionally rounded to the nearest million, and, therefore, may not sum. |
MEDTRONIC PLC CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) | |||
Six months ended | |||
(in millions) | October 25, 2024 | October 27, 2023 | |
Operating Activities: | |||
Net income | $ 2,327 | $ 1,708 | |
Adjustments to reconcile net income to net cash provided by operating activities: | |||
Depreciation and amortization | 1,337 | 1,344 | |
Provision for credit losses | 45 | 37 | |
Deferred income taxes | 57 | (36) | |
Stock-based compensation | 242 | 219 | |
Other, net | (98) | 182 | |
Change in operating assets and liabilities, net of acquisitions and divestitures: | |||
Accounts receivable, net | (181) | (117) | |
Inventories | (278) | (616) | |
Accounts payable and accrued liabilities | (707) | (699) | |
Other operating assets and liabilities | (800) | (486) | |
Net cash provided by operating activities | 1,944 | 1,536 | |
Investing Activities: | |||
Acquisitions, net of cash acquired | — | (22) | |
Additions to property, plant, and equipment | (924) | (815) | |
Purchases of investments | (4,019) | (3,403) | |
Sales and maturities of investments | 4,338 | 3,336 | |
Other investing activities, net | 1 | (59) | |
Net cash used in investing activities | (604) | (963) | |
Financing Activities: | |||
Change in current debt obligations, net | (67) | 1,321 | |
Issuance of long-term debt | 3,209 | — | |
Dividends to shareholders | (1,795) | (1,836) | |
Issuance of ordinary shares | 232 | 149 | |
Repurchase of ordinary shares | (2,780) | (378) | |
Other financing activities, net | (64) | 153 | |
Net cash used in financing activities | (1,265) | (591) | |
Effect of exchange rate changes on cash and cash equivalents | 35 | (214) | |
Net change in cash and cash equivalents | 110 | (232) | |
Cash and cash equivalents at beginning of period | 1,284 | 1,543 | |
Cash and cash equivalents at end of period | $ 1,394 | $ 1,311 | |
Supplemental Cash Flow Information | |||
Cash paid for: | |||
Income taxes | $ 1,335 | $ 1,110 | |
Interest | 513 | 476 | |
The data in this schedule has been intentionally rounded to the nearest million, and, therefore, may not sum. |
About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE:MDT), visit www.Medtronic.com and follow on LinkedIn .
FORWARD LOOKING STATEMENTS
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties, including risks related to competitive factors, difficulties and delays inherent in the development, manufacturing, marketing and sale of medical products, government regulation, geopolitical conflicts, general economic conditions, and other risks and uncertainties described in the company's periodic reports on file with the U.S. Securities and Exchange Commission including the most recent Annual Report on Form 10-K of the company. In some cases, you can identify these statements by forward-looking words or expressions, such as "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "looking ahead," "may," "plan," "possible," "potential," "project," "should," "going to," "will," and similar words or expressions, the negative or plural of such words or expressions and other comparable terminology. Actual results may differ materially from anticipated results. Medtronic does not undertake to update its forward-looking statements or any of the information contained in this press release, including to reflect future events or circumstances.
NON-GAAP FINANCIAL MEASURES
This press release contains financial measures, including adjusted net income, adjusted diluted EPS, and organic revenue, which are considered "non-GAAP" financial measures under applicable SEC rules and regulations. References to quarterly or annual figures increasing, decreasing or remaining flat are in comparison to fiscal year 2024, and references to sequential changes are in comparison to the prior fiscal quarter.
Medtronic management believes that non-GAAP financial measures provide information useful to investors in understanding the company's underlying operational performance and trends and to facilitate comparisons with the performance of other companies in the med tech industry. Non-GAAP net income and diluted EPS exclude the effect of certain charges or gains that contribute to or reduce earnings but that result from transactions or events that management believes may or may not recur with similar materiality or impact to operations in future periods (Non-GAAP Adjustments). Medtronic generally uses non-GAAP financial measures to facilitate management's review of the operational performance of the company and as a basis for strategic planning. Non-GAAP financial measures should be considered supplemental to and not a substitute for financial information prepared in accordance with U.S. generally accepted accounting principles (GAAP), and investors are cautioned that Medtronic may calculate non-GAAP financial measures in a way that is different from other companies. Management strongly encourages investors to review the company's consolidated financial statements and publicly filed reports in their entirety. Reconciliations of the non-GAAP financial measures to the most directly comparable GAAP financial measures are included in the financial schedules accompanying this press release.
Medtronic calculates forward-looking non-GAAP financial measures based on internal forecasts that omit certain amounts that would be included in GAAP financial measures. For instance, forward-looking organic revenue growth guidance excludes the impact of foreign currency fluctuations, as well as significant acquisitions or divestitures. Forward-looking diluted non-GAAP EPS guidance also excludes other potential charges or gains that would be recorded as Non-GAAP Adjustments to earnings during the fiscal year. Medtronic does not attempt to provide reconciliations of forward-looking non-GAAP EPS guidance to projected GAAP EPS guidance because the combined impact and timing of recognition of these potential charges or gains is inherently uncertain and difficult to predict and is unavailable without unreasonable efforts. In addition, the company believes such reconciliations would imply a degree of precision and certainty that could be confusing to investors. Such items could have a substantial impact on GAAP measures of financial performance.
Multitom Rax™ is a trademark of Siemens Healthcare GmbH.
Contacts: | |
Erika Winkels | Ryan Weispfenning |
Public Relations | Investor Relations |
+1-763-526-8478 | +1-763-505-4626 |
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SOURCE Medtronic plc
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Knight Therapeutics Announces Health Canada Approval for JORNAY PM to Treat Attention-Deficit Hyperactivity Disorder
Knight Therapeutics Inc. (TSX: GUD) ("Knight"), a pan-American (ex-USA) specialty pharmaceutical company, announced today that Health Canada has approved JORNAY PM ™, an extended-release formulation of methylphenidate, a stimulant medication for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in children.
JORNAY PM ™ is the first and only evening-dosed methylphenidate product commercially available in Canada to treat ADHD in patients from 6 to 12 years of age. JORNAY PM ™ consists of microbeads with a delayed-release layer and an extended-release layer. The first layer delays the release of the active ingredient until morning while the extended-release layer controls the release of the active ingredient starting in the morning and continuing throughout the day. This unique formulation provides a pharmacokinetic profile that allows ADHD symptom control from the time patients wake up until the evening.
"As a psychiatrist who treats ADHD, I find the introduction of JORNAY PM ™ particularly exciting because its distinct mechanism of delivery addresses one of the most difficult aspects of ADHD management—early morning functioning. JORNAY PM ™ offers an effective treatment that assists in better morning routines. This new treatment is a welcome addition to the growing options available for ADHD management in Canada", said Dr. Doron Almagor (MD, FRCPC) Child, Adolescent, and Adult Psychiatrist.
JORNAY PM ™ was studied in two multicenter, randomized, double-blind, placebo-controlled, phase 3 clinical trials 1,2 . Both studies met their primary and key secondary endpoints demonstrating a statistically significant and clinically meaningful improvement in ADHD symptom control upon awakening, through the afternoon, and into the early evening .
"I am proud to announce the approval of JORNAY PM ™ in Canada. This exciting new launch, expected in the second half of 2025, represents a significant advancement for our Canadian business as we continue to expand our offerings for ADHD treatment," said Samira Sakhia, President and CEO of Knight. "Following this approval, we are building a well-rounded ADHD portfolio with a range of complementary therapies that address diverse patient needs and offer greater support for their families."
In May 2024, Knight entered into an agreement with Ironshore Pharmaceuticals & Development, Inc., a wholly owned subsidiary of Ironshore Therapeutics, Inc. (now part of Collegium Pharmaceutical, Inc.; Nasdaq: COLL), for the exclusive rights to distribute JORNAY PM ™ in Canada and Latin America.
According to IQVIA Canada, the total Canadian market of extended-release methylphenidate products was $469 million in 2023, with an 8.1% increase in prescriptions compared to 2022 and a 16% compound annual growth rate (CAGR) over the past four years.
About ADHD 3
ADHD is a chronic, often lifelong neurodevelopmental disorder that affects both children and adults. The estimated prevalence of ADHD is 5-9% in children and adolescents and 3-5% in adults. 3 The disorder is characterized by symptoms of inattention, hyperactivity, and impulsivity that can significantly impact an individual's ability to function in daily life. Although patients' symptoms of ADHD can change over time, they will generally require continued monitoring and treatment over their lifetime. Current first-line pharmacotherapies for ADHD include long-acting methylphenidate or amphetamine-based psychostimulants and non-stimulants. Individual products for both differ in their delivery systems and release profiles to provide distinct durations of effect. However, not all patients derive adequate symptom coverage with currently available therapies. As a result, there remains a significant medical need for additional treatment options for patients with ADHD.
About Knight Therapeutics Inc.
Knight Therapeutics Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing and commercializing pharmaceutical products for Canada and Latin America. Knight's Latin American subsidiaries operate under United Medical, Biotoscana Farma and Laboratorio LKM. Knight Therapeutics Inc.'s shares trade on TSX under the symbol GUD. For more information about Knight Therapeutics Inc., please visit the company's web site at www.knighttx.com or www.sedarplus.ca .
Forward-Looking Statements for Knight
This document contains forward-looking statements for Knight Therapeutics Inc. and its subsidiaries. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Knight Therapeutics Inc. considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared but cautions the reader that these assumptions regarding future events, many of which are beyond the control of Knight Therapeutics Inc. and its subsidiaries, may ultimately prove to be incorrect. Factors and risks which could cause actual results to differ materially from current expectations are discussed in Knight Therapeutics Inc.'s Annual Report and in Knight Therapeutics Inc.'s Annual Information Form for the year ended December 31, 2023, as filed on www.sedarplus.ca . Knight Therapeutics Inc. disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information or future events, except as required by law.
References:
- Childress, A. C., Cutler, A. J., Marraffino, A., McDonnell, M. A., Turnbow, J. M., Brams, M., DeSousa, N. J., Incledon, B., Sallee, F. R., & Wigal, S. B. (2020). A randomized, double-blind, placebo-controlled study of HLD200, a delayed-release and extended-release methylphenidate, in children with attention-deficit/hyperactivity disorder: An evaluation of safety and efficacy throughout the day and across settings. Journal of Child and Adolescent Psychopharmacology, 30(1), 2–14. https://doi.org/10.1089/cap.2019.0070
- Pliszka, S. R., Wilens, T. E., Bostrom, S., Arnold, V. K., Marraffino, A., Cutler, A. J., López, F. A., DeSousa, N. J., Sallee, F. R., Incledon, B., & Newcorn, J. H. (2017). Efficacy and safety of HLD200, delayed-release and extended-release methylphenidate, in children with attention-deficit/hyperactivity disorder. Journal of Child and Adolescent Psychopharmacology, 27(6), 474–482. https://doi.org/10.1089/cap.2017.0084
- CADDRA - Canadian ADHD Resource Alliance. (2020). Canadian ADHD Practice Guidelines, 4.1 Edition. https://adhdlearn.caddra.ca/wp-content/uploads/2022/08/Canadian-ADHD-Practice-Guidelines-4.1-January-6-2021.pdf
CONTACT INFORMATION FOR KNIGHT:
| Investor Contact: | |
| Knight Therapeutics Inc. | |
| Samira Sakhia | Arvind Utchanah |
| President & Chief Executive Officer | Chief Financial Officer |
| T: 514.484.4483 | T. +598.2626.2344 |
| F: 514.481.4116 | |
| Email: IR@knighttx.com | Email: IR@knighttx.com |
| Website: www.knighttx.com | Website: www.knighttx.com |
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Mainz Biomed and Thermo Fisher Scientific Sign a Collaboration Agreement for the Development of Next Generation Colorectal Cancer Screening Product for Global Markets
Mainz Biomed N.V. (NASDAQ:MYNZ) ("Mainz Biomed" or the "Company"), a molecular genetics diagnostic company specializing in the early detection of cancer, today announced a collaborative agreement with Thermo Fisher Scientific Inc. (NYSE: TMO), through its subsidiary Life Technologies Corporation ("Thermo Fisher"), a world leader in supplying life sciences solutions and services.
The collaboration agreement will enable Mainz Biomed and Thermo Fisher to jointly develop and potentially commercialize Mainz Biomed's Next Generation colorectal cancer screening product. The collaboration will harness Thermo Fisher's powerful technologies, instrumentation and information translation systems to enable Mainz Biomed to develop the proprietary assays for its mRNA-based next-generation CRC screening tests which are redefining standards in early cancer detection. Mainz Biomed's flagship non-invasive test not only targets the early detection of colorectal cancer but also focuses on precancerous lesions, particularly advanced adenomas, demonstrating significant clinical success in both US and European trials.
The collaboration will leverage combined capabilities to deliver testing solutions being developed at Mainz Biomed's laboratories in Mainz, Germany.
Guido Baechler, CEO of Mainz Biomed, said: "This collaboration with Thermo Fisher will be instrumental to our goal to bring to market a home collection colorectal screening tool with highly effective detection of adenomas. Our product development will be greatly enhanced by Thermo Fisher's knowledge and scalable, class-leading technologies, providing both partners with a means to accelerate the availability of an innovative new test for colorectal cancer screening around the world."
Peter Jacobs, Director, EMEA Clinical Business Development, Thermo Fisher Scientific, said: "We are excited at the prospect of working with Mainz Biomed on their next generation screening test and are confident that together we will be able to achieve rapid progress and deliver innovative new assays for the global clinical marketplace."
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About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with annual revenue over $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com .
About Mainz Biomed NV
Mainz Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening conditions. The Company's flagship product is ColoAlert ® , an accurate, non-invasive and easy-to-use, early-detection diagnostic test for colorectal cancer. ColoAlert ® is marketed across Europe. The Company is currently running a pivotal FDA clinical study for US regulatory approval. Mainz Biomed's product candidate portfolio also includes PancAlert, an early-stage pancreatic cancer screening test based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples. To learn more, visit mainzbiomed.com or follow us on LinkedIn , Twitter and Facebook .
For media inquiries
MC Services AG
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For investor inquiries, please contact info@mainzbiomed.com
Forward-Looking Statements
Certain statements made in this press release are "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as "anticipate", "believe", "expect", "estimate", "plan", "outlook", and "project" and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties. As a result, caution must be exercised in relying on forward-looking statements. Due to known and unknown risks, actual results may differ materially from the Company's expectations or projections. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: (i) the failure to meet projected development and related targets; (ii) changes in applicable laws or regulations; (iii) the effect of the COVID-19 pandemic on the Company and its current or intended markets; and (iv) other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the Securities and Exchange Commission (the "SEC") by the Company. Additional information concerning these and other factors that may impact the Company's expectations and projections can be found in its initial filings with the SEC, including its annual report on Form 20-F filed on April 9, 2024. The Company's SEC filings are available publicly on the SEC's website at www.sec.gov. Any forward-looking statement made by us in this press release is based only on information currently available to Mainz Biomed and speaks only as of the date on which it is made. Mainz Biomed undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, except as required by law.
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