Australia
The Conversation (0)
Medtronic
Medtronic LABS makes its digital health platform open source
Cleo Diagnostics Investor Kit
- Corporate info
- Insights
- Growth strategies
- Upcoming projects
GET YOUR FREE INVESTOR KIT
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.
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. Over the course of 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 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 Technology
Cleo Diagnostics
Developed over the course of 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 the purposes of 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:
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 a 12-month period. 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. Prior to 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.Medtronic LABS: Opening Up Software To Expand Access to Healthcare
Medtronic LABS accelerates access to healthcare in underserved communities around the world through technology. And now, the code behind its digital health platform SPICE is open source - making it available to anyone.
Since Medtronic LABS launched in 2013, the independent nonprofit with Medtronic funding has enrolled over 217,000 people in one million patients healthcare and trained over 8,000 community health workers in Kenya, Tanzania, Rwanda, Ghana, Sierra Leone, Bangladesh, Bhutan, and the United States.
SPICE is a digital health platform embedded directly within health systems and government digital ecosystems. Making its code available to health system partners and governments is just one way LABS approaches global health collaboratively.
And it's that spirit of collaboration that accelerates access in low-and middle-income communities.
How it works
At any given moment, community health workers are visiting patients in their homes and at community events, often in hard-to-reach places. Equipped with screening tools and SPICE, they screen patients for a range of conditions including hypertension, diabetes, malaria, and TB.
If needed, they refer patients to the nearest health facility where they are immediately connected to care. Medical staff confirm the diagnosis, and enroll the patient in LABS' programs, where they receive a personalized care plan.
The community health worker continues to follow up with patients directly based on their care plan.
This approach - pairing health tech with strong partnerships and community care - is working. LABS has screened half a million people for non-communicable diseases since 2014.
And open-source technology means more organizations, health systems, and governments can access LABS' health tech - connecting even more people to care.
"We offer a fundamentally new take on risk-based, data-driven community health, and we hope that by open sourcing our platform, our approach might be widely adopted," said LABS' Chief Strategy and Product Officer, Anne Stake.
Becoming open source also allowed LABS to receive the designation as a Digital Public Good by a multi-stakeholder United Nations-endorsed initiative that works to reduce barriers to the digitization of health systems.
"We made SPICE open source and applied to be a Digital Public Good to enable any health system innovator to use the technology and ultimately improve population health outcomes," said Stake.
Learn more about how Medtronic LABS is reimagining healthcare for communities around the world.
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
View source version on accesswire.com:
https://www.accesswire.com/810825/medtronic-labs-opening-up-software-to-expand-access-to-healthcare
News Provided by ACCESSWIRE via QuoteMedia
Thermo Fisher Scientific & Flagship Pioneering Expand Ongoing Strategic Partnership to Jointly Create New Platform Companies with First-in-Class Enabling Technologies for Life Sciences
Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, and Flagship Pioneering, the bioplatform innovation company, today announced the formation of a strategic partnership to develop and commercially scale multiproduct platforms on an accelerated basis.
Through this collaboration, Thermo Fisher and Flagship will work together to create new platform companies focusing on novel tools and capabilities that seek to power the biotech ecosystem and accelerate the development of first-in-class therapies. The newly formed strategic partnership is an expansion of the long-standing supply relationship between Thermo Fisher and Flagship, which extends to Flagship's ecosystem of companies and leverages the expertise of both organizations including the areas of life science tools, diagnostics, and services.
"As the trusted partner in our industry, collaborating on innovation is an important evolution of the long-standing relationship between our companies," said Michel Lagarde, executive vice president and chief operating officer, Thermo Fisher Scientific. "We look forward to seeing the accelerating effect of Thermo Fisher's deep technical expertise and extensive commercial capabilities on the future innovations Flagship and its companies will bring to market."
"Pioneering new modalities for human health and environmental health require complementary capabilities and ecosystem elements to realize the full potential," said Justine Levin-Allerhand, Ph.D., Flagship Pioneering Senior Partner. "Our partnership will couple Flagship's innovative company formation process with Thermo Fisher's deep understanding of the life sciences industry, as we collaborate to develop transformative capabilities for the ecosystem. We are pleased to expand our relationship with Thermo Fisher and together take bigger leaps in life sciences capabilities, while further empowering our industry."
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. 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.
About Flagship Pioneering
Flagship Pioneering is a biotechnology company that invents and builds platform companies, each with the potential for multiple products that transform human health or sustainability. Since its launch in 2000, Flagship has originated and fostered more than 100 scientific ventures, resulting in more than $90 billion in aggregate value. To date, Flagship has deployed over $3.4 billion in capital toward the founding and growth of its pioneering companies alongside more than $26 billion of follow-on investments from other institutions. The current Flagship ecosystem comprises 40 companies, including Denali Therapeutics (NASDAQ: DNLI), Foghorn Therapeutics (NASDAQ: FHTX), Generate:Biomedicines , Inari , Indigo Agriculture , Moderna (NASDAQ: MRNA), Omega Therapeutics (NASDAQ: OMGA), Sana Biotechnology (NASDAQ: SANA), Seres Therapeutics (NASDAQ: MCRB) and Tessera Therapeutics .
View source version on businesswire.com: https://www.businesswire.com/news/home/20231128400906/en/
Media Contact Information:
Sandy Pound
Phone: 781-622-1223
E-mail: sandy.pound@thermofisher.com
Investor Contact Information:
Rafael Tejada
Phone: 781-622-1356
E-mail: rafael.tejada@thermofisher.com
Flagship Pioneering:
press@flagshippioneering.com
News Provided by Business Wire via QuoteMedia
Medtronic reports second quarter fiscal 2024 financial results
Solid execution results in mid-single digit revenue growth, driven by broad-based strength across multiple businesses and geographies; Major innovative product approvals; Raises fiscal year guidance
Medtronic plc (NYSE:MDT) today announced financial results for its second quarter of fiscal year 2024 (FY24), which ended October 27, 2023 .
Key Highlights
- Revenue of $8.0 billion increased 5.3% as reported and 5.0% organic
- GAAP diluted earnings per share (EPS) of $0.68 ; non-GAAP diluted EPS of $1.25
- Underlying business fundamentals are strong with broad-based, diversified growth coming from multiple businesses and geographies
- Company increases FY24 organic revenue growth and EPS guidance
- Received U.S. FDA approval for Aurora EV-ICD™ system and Symplicity Spyral™ renal denervation (RDN) system; CE Mark for Evolut™ FX TAVR system, Simplera™ standalone CGM, and PulseSelect™ pulsed field ablation (PFA) system
Financial Results
Medtronic reported Q2 worldwide revenue of $7.984 billion , an increase of 5.3% as reported and 5.0% on an organic basis. The company's organic revenue results reflect continued broad strength across businesses and geographies benefiting from durable fundamentals. The organic revenue growth comparison excludes:
- Revenue and the associated impact from foreign currency translation reported as Other, stemming from business separations, including Renal Care Solutions and ongoing manufacturing agreements with Cardinal Health from the divestiture of Patient Care, Deep Vein Thrombosis, and Nutritional Insufficiency; and
- The favorable impact from foreign currency translation of $86 million on the remaining segments.
As reported, Q2 GAAP net income and diluted EPS were $909 million and $0.68 , respectively, both representing increases of 113%. As detailed in the financial schedules included at the end of this release, Q2 non-GAAP net income of $1.667 billion decreased 3% and non-GAAP diluted EPS of $1.25 decreased 4%. Included in non-GAAP diluted EPS was an 8 cent , or 6%, unfavorable impact from foreign currency translation.
"We're delivering a track record of durable, mid-single digit revenue growth. The underlying fundamentals are strong, and our solid results were broad-based across our businesses and geographies," said Geoff Martha , Medtronic chairman and chief executive officer. "We're bringing game changing innovation to market, with numerous recent regulatory approvals and major product launches, which give us confidence in our ability to continue delivering dependable growth."
Cardiovascular Portfolio
The Cardiovascular Portfolio includes the Cardiac Rhythm & Heart Failure (CRHF), Structural Heart & Aortic (SHA), and Coronary & Peripheral Vascular (CPV) divisions. Revenue of $2.923 billion increased 5.9% as reported and 4.8% organic, with a high-single digit organic increase in SHA and mid-single digit organic increases in CRHF and CPV.
- CRHF results driven by high-single digit growth in Cardiac Pacing Therapies, including low-double digit growth in Micra™ transcatheter pacing systems; Cardiovascular Diagnostics grew high-single digits and Cardiac Ablation Solutions grew mid-single digits
- SHA drove high-single digit growth in Aortic and Cardiac Surgery; Structural Heart (TAVR) grew mid-single digits on the continued adoption of Evolut™ FX in the U.S. & Japan
- CPV results driven by mid-single digit growth in Coronary on the continued strength of the Onyx Frontier™ drug-eluting stent and low-single digit growth in Peripheral Vascular Health on mid-teens growth in drug-coated balloons
- Received U.S. FDA approval for Aurora EV-ICD™ system and Symplicity Spyral™ RDN system; CE Mark for Evolut™ FX transcatheter aortic valve implantation system and PulseSelect™ pulsed field ablation (PFA) system
- Presented four-year results from Evolut Low Risk Trial at the 2023 TCT conference showing the Evolut™ TAVR system demonstrated exceptional outcomes with sustained valve performance, proven by significantly better hemodynamics, low thrombosis rates, and lower and diverging rates of all-cause mortality or disabling stroke than surgical aortic valve replacement (SAVR) at four years
Neuroscience Portfolio
The Neuroscience Portfolio includes the Cranial & Spinal Technologies (CST), Specialty Therapies, and Neuromodulation divisions. Revenue of $2.288 billion increased 4.7% as reported and 4.2% organic, with a high-single digit organic increase in CST and low-single digit organic increases in Specialty Therapies and Neuromodulation.
- CST delivered high-single digit Core Spine growth on implant pull-through fueled by continued adoption of the AiBLE™ ecosystem; Neurosurgery grew mid-single digits on strong sales of StealthStation™ navigation and O-arm™ imaging systems
- Specialty Therapies results driven by mid-single digit growth in Neurovascular on strength in flow diversion and low-single digit growth in ENT and Pelvic Health; excluding a product line divestiture, Pelvic Health grew mid-single digits
- Neuromodulation drove mid-single digit growth in Targeted Drug Delivery and low-single digit growth in Pain Stim
Medical Surgical Portfolio
The Medical Surgical Portfolio includes the Surgical & Endoscopy (SE) and the Patient Monitoring & Respiratory Interventions (PMRI) divisions. Revenue of $2.142 billion increased 7.0% as reported and 5.6% organic, with a high-single digit organic increase in SE and low-single digit organic increase in PMRI.
- SE results driven by low-double digit growth in General Surgical Technologies, mid-single digit growth in Advanced Surgical Technologies, and low-double digit growth in Endoscopy
- SE also drove installed base growth of the Hugo™ robotic-assisted surgery (RAS) system; received Investigational Device Exemption (IDE) from U.S. FDA to begin the U.S. clinical trial for Hugo™ RAS system for Hernia procedures
- PMRI results driven by low-single digit growth in Patient Monitoring, with double-digit growth in Nellcor™ pulse oximetry monitor sales; Respiratory Interventions results were flat, with high-single digit growth in Airways offset by decreases in Ventilator sales
Diabetes
Diabetes revenue of $610 million increased 9.7% as reported and 6.7% organic.
- Non-U.S. Developed Markets grew mid-teens on continued MiniMed™ 780G system adoption and increased CGM attachment rates on the strength of the Guardian™ 4 sensor
- First full quarter of the U.S. launch of MiniMed™ 780G system resulted in low-thirties sequential growth in U.S. Diabetes pump revenue; overall, U.S. Diabetes declined mid-single digits year-over-year on customer attrition versus the prior year; customer base increased sequentially
- Received CE Mark and began phased launch for Simplera™ standalone CGM
Guidance
The company today raised its FY24 revenue growth and EPS guidance.
The company increased its FY24 organic revenue growth guidance to 4.75% versus the prior 4.5%. The organic revenue growth guidance excludes the impact of foreign currency and revenue related to certain businesses reported as Other. Including Other revenue and the impact of foreign currency, if foreign currency exchange rates as of the beginning of November hold, FY24 revenue growth on a reported basis would be approximately 2.6%.
The company increased its FY24 diluted non-GAAP EPS guidance from the prior range of $5.08 to $5.16 to the new range of $5.13 to $5.19 , a 4 cent increase at the midpoint. Given the change in foreign currency exchange rates over the past quarter, the foreign exchange impact on FY24 diluted non-GAAP EPS is now estimated to be 2 cents more unfavorable in the second half and is estimated to be a 6% unfavorable impact for the full year.
"Overall, it was another good quarter as we delivered revenue, margins, and earnings ahead of expectations. Combining our second quarter outperformance with our updated tax and foreign currency estimates, we're raising our full year organic revenue growth and EPS guidance," said Karen Parkhill , Medtronic EVP & chief financial officer. "Based on the changes we've made to our operating model, incentives, and capital allocation, among other drivers, we've positioned the company to deliver consistent mid-single digit growth on the top line. As we move ahead, translating this durable revenue growth into durable earnings power remains a top priority."
Video Webcast Information
Medtronic will host a video webcast today, November 21 , 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 FY24 third and fourth quarter results on Tuesday, February 20, 2024 , and Thursday, May 23, 2024 , respectively. Confirmation and additional details will be provided closer to the specific event.
Financial Schedules
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 second quarter earnings presentation, click here .
MEDTRONIC PLC | ||||||||||||||||||||||||||||
WORLD WIDE REVENUE (1) | ||||||||||||||||||||||||||||
(Unaudited) | ||||||||||||||||||||||||||||
SECOND QUARTER | YEAR-TO-DATE | |||||||||||||||||||||||||||
REPORTED | ORGANIC | REPORTED | ORGANIC | |||||||||||||||||||||||||
(in millions) | FY24 | FY23 | Growth | Currency | Adjusted | Adjusted | Growth | FY24 | FY23 | Growth | Currency | Adjusted | Adjusted | Growth | ||||||||||||||
Cardiovascular | $ 2,923 | $ 2,759 | 5.9 % | $ 31 | $ 2,892 | $ 2,759 | 4.8 % | $ 5,773 | $ 5,459 | 5.8 % | $ 12 | $ 5,761 | $ 5,459 | 5.5 % | ||||||||||||||
Cardiac Rhythm & Heart Failure | 1,492 | 1,417 | 5.3 | 18 | 1,474 | 1,417 | 4.0 | 2,938 | 2,798 | 5.0 | 11 | 2,927 | 2,798 | 4.6 | ||||||||||||||
Structural Heart & Aortic | 819 | 757 | 8.2 | 11 | 808 | 757 | 6.7 | 1,633 | 1,499 | 8.9 | 6 | 1,627 | 1,499 | 8.5 | ||||||||||||||
Coronary & Peripheral Vascular | 613 | 584 | 5.0 | 2 | 611 | 584 | 4.6 | 1,202 | 1,163 | 3.4 | (5) | 1,207 | 1,163 | 3.8 | ||||||||||||||
Neuroscience | 2,288 | 2,186 | 4.7 | 10 | 2,278 | 2,186 | 4.2 | 4,506 | 4,301 | 4.8 | (5) | 4,511 | 4,301 | 4.9 | ||||||||||||||
Cranial & Spinal Technologies | 1,157 | 1,081 | 7.0 | 4 | 1,153 | 1,081 | 6.7 | 2,260 | 2,124 | 6.4 | (3) | 2,263 | 2,124 | 6.5 | ||||||||||||||
Specialty Therapies | 705 | 686 | 2.8 | 1 | 704 | 686 | 2.6 | 1,400 | 1,353 | 3.5 | (7) | 1,407 | 1,353 | 4.0 | ||||||||||||||
Neuromodulation | 426 | 419 | 1.7 | 5 | 421 | 419 | 0.5 | 846 | 824 | 2.7 | 5 | 841 | 824 | 2.1 | ||||||||||||||
Medical Surgical | 2,142 | 2,002 | 7.0 | 27 | 2,115 | 2,002 | 5.6 | 4,181 | 3,935 | 6.3 | 16 | 4,165 | 3,935 | 5.8 | ||||||||||||||
Surgical & Endoscopy | 1,641 | 1,513 | 8.5 | 25 | 1,616 | 1,513 | 6.8 | 3,187 | 2,968 | 7.4 | 17 | 3,170 | 2,968 | 6.8 | ||||||||||||||
Patient Monitoring & Respiratory Interventions | 501 | 489 | 2.5 | 3 | 498 | 489 | 1.8 | 994 | 967 | 2.8 | (2) | 996 | 967 | 3.0 | ||||||||||||||
Diabetes | 610 | 556 | 9.7 | 17 | 593 | 556 | 6.7 | 1,189 | 1,098 | 8.3 | 20 | 1,169 | 1,098 | 6.5 | ||||||||||||||
Other (3) | 22 | 82 | (73.2) | (1) | — | — | — | 37 | 162 | (77.2) | (5) | — | — | — | ||||||||||||||
TOTAL | $ 7,984 | $ 7,585 | 5.3 % | $ 85 | $ 7,876 | $ 7,503 | 5.0 % | $ 15,686 | $ 14,955 | 4.9 % | $ 38 | $ 15,605 | $ 14,793 | 5.5 % | ||||||||||||||
(1) | The data in this schedule has been intentionally rounded to the nearest million and, therefore, may not sum. |
(2) | The currency impact to revenue measures the change in revenue between current and prior year periods using constant exchange rates. |
(3) | Includes inorganic revenue from the divested Renal Care Solutions business and Transition Manufacturing Agreements from previously divested businesses. |
MEDTRONIC PLC | ||||||||||||||||||||||||
U.S. (1)(2) REVENUE | ||||||||||||||||||||||||
(Unaudited) | ||||||||||||||||||||||||
SECOND QUARTER | YEAR-TO-DATE | |||||||||||||||||||||||
REPORTED | ORGANIC | REPORTED | ORGANIC | |||||||||||||||||||||
(in millions) | FY24 | FY23 | Growth | Adjusted | Adjusted | Growth | FY24 | FY23 | Growth | Adjusted | Adjusted | Growth | ||||||||||||
Cardiovascular | $ 1,427 | $ 1,410 | 1.2 % | $ 1,427 | $ 1,410 | 1.2 % | $ 2,776 | $ 2,696 | 3.0 % | $ 2,776 | $ 2,696 | 3.0 % | ||||||||||||
Cardiac Rhythm & Heart Failure | 782 | 776 | 0.8 | 782 | 776 | 0.8 | 1,502 | 1,481 | 1.4 | 1,502 | 1,481 | 1.4 | ||||||||||||
Structural Heart & Aortic | 367 | 348 | 5.5 | 367 | 348 | 5.5 | 724 | 660 | 9.7 | 724 | 660 | 9.7 | ||||||||||||
Coronary & Peripheral Vascular | 278 | 286 | (2.8) | 278 | 286 | (2.8) | 550 | 555 | (0.9) | 550 | 555 | (0.9) | ||||||||||||
Neuroscience | 1,560 | 1,512 | 3.2 | 1,560 | 1,512 | 3.2 | 3,057 | 2,931 | 4.3 | 3,057 | 2,931 | 4.3 | ||||||||||||
Cranial & Spinal Technologies | 863 | 817 | 5.6 | 863 | 817 | 5.6 | 1,685 | 1,580 | 6.6 | 1,685 | 1,580 | 6.6 | ||||||||||||
Specialty Therapies | 403 | 403 | — | 403 | 403 | — | 795 | 784 | 1.4 | 795 | 784 | 1.4 | ||||||||||||
Neuromodulation | 293 | 291 | 0.7 | 293 | 291 | 0.7 | 577 | 567 | 1.8 | 577 | 567 | 1.8 | ||||||||||||
Medical Surgical | 963 | 895 | 7.6 | 963 | 895 | 7.6 | 1,845 | 1,726 | 6.9 | 1,845 | 1,726 | 6.9 | ||||||||||||
Surgical & Endoscopy | 688 | 633 | 8.7 | 688 | 633 | 8.7 | 1,308 | 1,214 | 7.7 | 1,308 | 1,214 | 7.7 | ||||||||||||
Patient Monitoring & Respiratory Interventions | 275 | 262 | 5.0 | 275 | 262 | 5.0 | 537 | 512 | 4.9 | 537 | 512 | 4.9 | ||||||||||||
Diabetes | 217 | 228 | (4.8) | 217 | 228 | (4.8) | 405 | 434 | (6.7) | 405 | 434 | (6.7) | ||||||||||||
Other (3) | 8 | 23 | (65.2) | — | — | — | 16 | 49 | (67.3) | — | — | — | ||||||||||||
TOTAL | $ 4,175 | $ 4,069 | 2.6 % | $ 4,167 | $ 4,046 | 3.0 % | $ 8,099 | $ 7,835 | 3.4 % | $ 8,083 | $ 7,787 | 3.8 % | ||||||||||||
(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. |
(3) | Includes inorganic revenue from the divested Renal Care Solutions business and Transition Manufacturing Agreements from previously divested businesses. |
MEDTRONIC PLC | ||||||||||||||||||||||||||||
WORLD WIDE REVENUE: GEOGRAPHIC (1)(2) | ||||||||||||||||||||||||||||
(Unaudited) | ||||||||||||||||||||||||||||
SECOND QUARTER | YEAR-TO-DATE | |||||||||||||||||||||||||||
REPORTED | ORGANIC | REPORTED | ORGANIC | |||||||||||||||||||||||||
(in millions) | FY24 | FY23 | Growth | Currency | Adjusted | Adjusted | Growth | FY24 | FY23 | Growth | Currency | Adjusted | Adjusted | Growth | ||||||||||||||
U.S. | $ 1,427 | $ 1,410 | 1.2 % | $ — | $ 1,427 | $ 1,410 | 1.2 % | $ 2,776 | $ 2,696 | 3.0 % | $ — | $ 2,776 | $ 2,696 | 3.0 % | ||||||||||||||
Non-U.S. Developed | 912 | 802 | 13.7 | 43 | 869 | 802 | 8.4 | 1,869 | 1,694 | 10.3 | 45 | 1,824 | 1,694 | 7.7 | ||||||||||||||
Emerging Markets | 584 | 546 | 7.0 | (12) | 596 | 546 | 9.2 | 1,128 | 1,070 | 5.4 | (33) | 1,161 | 1,070 | 8.5 | ||||||||||||||
Cardiovascular | 2,923 | 2,759 | 5.9 | 31 | 2,892 | 2,759 | 4.8 | 5,773 | 5,459 | 5.8 | 12 | 5,761 | 5,459 | 5.5 | ||||||||||||||
U.S. | 1,560 | 1,512 | 3.2 | — | 1,560 | 1,512 | 3.2 | 3,057 | 2,931 | 4.3 | — | 3,057 | 2,931 | 4.3 | ||||||||||||||
Non-U.S. Developed | 399 | 382 | 4.5 | 14 | 385 | 382 | 0.8 | 815 | 788 | 3.4 | 10 | 805 | 788 | 2.2 | ||||||||||||||
Emerging Markets | 329 | 292 | 12.7 | (4) | 333 | 292 | 14.0 | 634 | 582 | 8.9 | (15) | 649 | 582 | 11.5 | ||||||||||||||
Neuroscience | 2,288 | 2,186 | 4.7 | 10 | 2,278 | 2,186 | 4.2 | 4,506 | 4,301 | 4.8 | (5) | 4,511 | 4,301 | 4.9 | ||||||||||||||
U.S. | 963 | 895 | 7.6 | — | 963 | 895 | 7.6 | 1,845 | 1,726 | 6.9 | — | 1,845 | 1,726 | 6.9 | ||||||||||||||
Non-U.S. Developed | 740 | 685 | 8.0 | 27 | 713 | 685 | 4.1 | 1,512 | 1,420 | 6.5 | 21 | 1,491 | 1,420 | 5.0 | ||||||||||||||
Emerging Markets | 438 | 421 | 4.0 | 1 | 437 | 421 | 3.8 | 824 | 789 | 4.4 | (5) | 829 | 789 | 5.1 | ||||||||||||||
Medical Surgical | 2,142 | 2,002 | 7.0 | 27 | 2,115 | 2,002 | 5.6 | 4,181 | 3,935 | 6.3 | 16 | 4,165 | 3,935 | 5.8 | ||||||||||||||
U.S. | 217 | 228 | (4.8) | — | 217 | 228 | (4.8) | 405 | 434 | (6.7) | — | 405 | 434 | (6.7) | ||||||||||||||
Non-U.S. Developed | 310 | 254 | 22.0 | 18 | 292 | 254 | 15.0 | 625 | 518 | 20.7 | 22 | 603 | 518 | 16.4 | ||||||||||||||
Emerging Markets | 84 | 74 | 13.5 | (1) | 85 | 74 | 14.9 | 159 | 145 | 9.7 | (3) | 162 | 145 | 11.7 | ||||||||||||||
Diabetes | 610 | 556 | 9.7 | 17 | 593 | 556 | 6.7 | 1,189 | 1,098 | 8.3 | 20 | 1,169 | 1,098 | 6.5 | ||||||||||||||
U.S. | 8 | 23 | (65.2) | — | — | — | — | 16 | 49 | (67.3) | — | — | — | — | ||||||||||||||
Non-U.S. Developed | 7 | 33 | (78.8) | (1) | — | — | — | 12 | 65 | (81.5) | (2) | — | — | — | ||||||||||||||
Emerging Markets | 7 | 25 | (72.0) | (1) | — | — | — | 10 | 48 | (79.2) | (2) | — | — | — | ||||||||||||||
Other (4) | 22 | 82 | (73.2) | (1) | — | — | — | 37 | 162 | (77.2) | (5) | — | — | — | ||||||||||||||
U.S. | 4,175 | 4,069 | 2.6 | — | 4,167 | 4,046 | 3.0 | 8,099 | 7,835 | 3.4 | — | 8,083 | 7,787 | 3.8 | ||||||||||||||
Non-U.S. Developed | 2,368 | 2,157 | 9.8 | 101 | 2,259 | 2,123 | 6.4 | 4,831 | 4,485 | 7.7 | 96 | 4,722 | 4,420 | 6.8 | ||||||||||||||
Emerging Markets | 1,441 | 1,359 | 6.0 | (17) | 1,451 | 1,334 | 8.8 | 2,755 | 2,635 | 4.6 | (57) | 2,800 | 2,586 | 8.3 | ||||||||||||||
TOTAL | $ 7,984 | $ 7,585 | 5.3 % | $ 85 | $ 7,876 | $ 7,503 | 5.0 % | $ 15,686 | $ 14,955 | 4.9 % | $ 38 | $ 15,605 | $ 14,793 | 5.5 % | ||||||||||||||
(1) | U.S. includes the United States and U.S. territories. Non-U.S. developed markets include Japan, Australia, New Zealand, Korea, Canada, and the countries within Western Europe. Emerging Markets include the countries of the Middle East, Africa, Latin America, Eastern Europe, and the countries of Asia that are not included in the non-U.S. developed markets, as previously defined. |
(2) | The data in this schedule has been intentionally rounded to the nearest million and, therefore, may not sum. |
(3) | The currency impact to revenue measures the change in revenue between current and prior year periods using constant exchange rates. |
(4) | Includes inorganic revenue from the divested Renal Care Solutions business and Transition Manufacturing Agreements from previously divested businesses. |
MEDTRONIC PLC | |||||||
CONSOLIDATED STATEMENTS OF INCOME | |||||||
(Unaudited) | |||||||
Three months ended | Six months ended | ||||||
(in millions, except per share data) | October 27, | October 28, | October 27, | October 28, | |||
Net sales | $ 7,984 | $ 7,585 | $ 15,686 | $ 14,955 | |||
Costs and expenses: | |||||||
Cost of products sold, excluding amortization of intangible assets | 2,761 | 2,535 | 5,390 | 5,051 | |||
Research and development expense | 698 | 676 | 1,365 | 1,368 | |||
Selling, general, and administrative expense | 2,686 | 2,617 | 5,299 | 5,184 | |||
Amortization of intangible assets | 425 | 421 | 855 | 844 | |||
Restructuring charges, net | 40 | 30 | 94 | 44 | |||
Certain litigation charges | 65 | — | 105 | — | |||
Other operating income, net | (31) | (97) | (30) | (62) | |||
Operating profit | 1,340 | 1,404 | 2,608 | 2,528 | |||
Other non-operating income, net | (154) | (109) | (230) | (192) | |||
Interest expense, net | 180 | 118 | 329 | 282 | |||
Income before income taxes | 1,313 | 1,395 | 2,510 | 2,438 | |||
Income tax provision | 402 | 959 | 802 | 1,072 | |||
Net income | 911 | 435 | 1,708 | 1,367 | |||
Net income attributable to noncontrolling interests | (2) | (8) | (8) | (10) | |||
Net income attributable to Medtronic | $ 909 | $ 427 | $ 1,700 | $ 1,356 | |||
Basic earnings per share | $ 0.68 | $ 0.32 | $ 1.28 | $ 1.02 | |||
Diluted earnings per share | $ 0.68 | $ 0.32 | $ 1.28 | $ 1.02 | |||
Basic weighted average shares outstanding | 1,330.2 | 1,329.4 | 1,330.3 | 1,329.4 | |||
Diluted weighted average shares outstanding | 1,331.9 | 1,332.0 | 1,332.8 | 1,333.3 | |||
The data in the schedule above has been intentionally rounded to the nearest million, and therefore, the quarterly amounts may not sum to the fiscal year-to-date amounts. |
MEDTRONIC PLC | |||||||||||||||||
GAAP TO NON-GAAP RECONCILIATIONS (1) | |||||||||||||||||
(Unaudited) | |||||||||||||||||
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 | — | — | — | 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 % | ||||||||
Currency impact | (85) | (65) | 0.5 | 121 | 1.8 | 0.08 | |||||||||||
Currency Adjusted | $ 7,899 | $ 2,655 | 66.4 % | $ 2,130 | 27.0 % | $ 1.33 | |||||||||||
Three months ended October 28, 2022 | |||||||||||||||||
(in millions, except per share data) | Net | Cost of | Gross | Operating | Operating | Income | Net Income | Diluted | Effective | ||||||||
GAAP | $ 7,585 | $ 2,535 | 66.6 % | $ 1,404 | 18.5 % | $ 1,395 | $ 427 | $ 0.32 | 68.7 % | ||||||||
Non-GAAP Adjustments: | |||||||||||||||||
Amortization of intangible assets | — | — | — | 421 | 5.6 | 421 | 356 | 0.27 | 15.4 | ||||||||
Restructuring and associated costs (2) | — | (21) | 0.3 | 95 | 1.3 | 95 | 76 | 0.06 | 20.0 | ||||||||
Acquisition and divestiture-related items (3) | — | (39) | 0.5 | 63 | 0.8 | 63 | 55 | 0.05 | 404.2 | ||||||||
(Gain)/loss on minority investments (4) | — | — | — | — | — | (11) | (11) | (0.01) | — | ||||||||
Medical device regulations (5) | — | (22) | 0.3 | 37 | 0.5 | 37 | 30 | 0.02 | 18.9 | ||||||||
Certain tax adjustments, net (7) | — | — | — | — | — | — | 793 | 0.60 | — | ||||||||
Non-GAAP | $ 7,585 | $ 2,454 | 67.6 % | $ 2,020 | 26.6 % | $ 1,999 | $ 1,725 | $ 1.30 | 13.3 % | ||||||||
See description of non-GAAP financial measures contained in the press release dated November 21, 2023. | |
(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 include costs incurred as a direct result of the restructuring program, such as salaries for employees supporting the program, consulting expenses, and asset write-offs. |
(3) | The charges primarily include business combination costs, changes in fair value of contingent consideration, and charges related to the impending separation of the Patient Monitoring and Respiratory Interventions businesses within our Medical Surgical Portfolio. |
(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, and a withholding tax cost related to the impending separation of the Patient Monitoring and Respiratory Interventions businesses within our Medical Surgical Portfolio. |
(7) | The charge primarily relates to a $764 million reserve adjustment that was a direct result of the U.S. Tax Court opinion, issued on August 18, 2022, on the previously disclosed litigation regarding the allocation of income between Medtronic, Inc. and its wholly owned subsidiary operating in Puerto Rico. |
MEDTRONIC PLC | |||||||||||||||||
GAAP TO NON-GAAP RECONCILIATIONS (1) | |||||||||||||||||
(Unaudited) | |||||||||||||||||
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) | — | 107 | — | 107 | 97 | 0.07 | 9.3 | ||||||||
Certain litigation charges | — | — | — | 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 (6) | — | — | — | — | — | — | 375 | 0.28 | — | ||||||||
Non-GAAP | $ 15,686 | $ 5,306 | 66.2 % | $ 3,919 | 25.0 % | $ 3,910 | $ 3,262 | $ 2.45 | 16.4 % | ||||||||
Currency impact | (38) | (66) | 0.3 | 243 | 1.6 | 0.16 | |||||||||||
Currency Adjusted | $ 15,648 | $ 5,240 | 66.5 % | $ 4,162 | 26.6 % | $ 2.61 | |||||||||||
Six month ended October 28, 2022 | |||||||||||||||||
(in millions, except per share data) | Net | Cost of | Gross | Operating | Operating | Income | Net Income | Diluted | Effective | ||||||||
GAAP | $ 14,955 | $ 5,051 | 66.2 % | $ 2,528 | 16.9 % | $ 2,438 | $ 1,356 | $ 1.02 | 44.0 % | ||||||||
Non-GAAP Adjustments: | |||||||||||||||||
Amortization of intangible assets | — | — | — | 844 | 5.6 | 844 | 715 | 0.54 | 15.3 | ||||||||
Restructuring and associated costs (2) | — | (41) | 0.3 | 171 | 1.1 | 171 | 136 | 0.10 | 20.5 | ||||||||
Acquisition and divestiture-related items (3) | — | (50) | 0.3 | 174 | 1.2 | 174 | 157 | 0.12 | 38.8 | ||||||||
(Gain)/loss on minority investments (4) | — | — | — | — | — | (15) | (15) | (0.01) | — | ||||||||
Medical device regulations (5) | — | (40) | 0.3 | 70 | 0.5 | 70 | 56 | 0.04 | 20.0 | ||||||||
Debt redemption premium and other charges (7) | — | — | — | — | — | 53 | 42 | 0.03 | 20.8 | ||||||||
Certain tax adjustments, net (8) | — | — | — | — | — | — | 780 | 0.59 | — | ||||||||
Non-GAAP | $ 14,955 | $ 4,921 | 67.1 % | $ 3,785 | 25.3 % | $ 3,733 | $ 3,226 | $ 2.42 | 13.3 % | ||||||||
See description of non-GAAP financial measures contained in the press release dated November 21, 2023. | |
(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 include costs incurred as a direct result of the restructuring program, such as salaries for employees supporting the program, consulting expenses, and asset write-offs. |
(3) | The charges primarily include business combination costs, changes in fair value of contingent consideration, and charges related to the impending separation of the Patient Monitoring and Respiratory Interventions businesses within our Medical Surgical Portfolio. The prior year included non-cash pre-tax impairments, primarily related to goodwill and other associated costs, as a result of the April 1, 2023, sale of half of the Company's Renal Care Solutions (RCS) business. |
(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 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 period. |
(6) | The charge relates to an income tax reserve adjustment associated with the June 1, 2023, Israeli Central-Lod District Court decision, the establishment of a valuation allowance against certain net operating losses, a withholding tax cost related to the impending separation of the Patient Monitoring and Respiratory Interventions businesses, and amortization of previously established deferred tax assets from intercompany intellectual property transactions. |
(7) | The charges relate to the early redemption of approximately $2.3 billion of debt and were recorded within interest expense, net within the consolidated statements of income. |
(8) | The charge primarily relates to a $764 million reserve adjustment that was a direct result of the U.S. Tax Court opinion, issued on August 18, 2022, on the previously disclosed litigation regarding the allocation of income between Medtronic, Inc. and its wholly owned subsidiary operating in Puerto Rico. |
MEDTRONIC PLC | |||||||||||||||
GAAP TO NON-GAAP RECONCILIATIONS (1) | |||||||||||||||
(Unaudited) | |||||||||||||||
Three months ended October 27, 2023 | |||||||||||||||
(in millions) | Net Sales | SG&A | SG&A | R&D | R&D | Other | Other | Other Non- | |||||||
GAAP | $ 7,984 | $ 2,686 | 33.6 % | $ 698 | 8.7 % | $ (31) | (0.4) % | $ (154) | |||||||
Non-GAAP Adjustments: | |||||||||||||||
Restructuring and associated costs (2) | — | (36) | (0.5) | — | — | — | — | — | |||||||
Acquisition and divestiture-related items (3) | — | (26) | (0.3) | — | — | (26) | (0.3) | — | |||||||
Medical device regulations (4) | — | — | — | (9) | (0.1) | — | — | — | |||||||
(Gain)/loss on minority investments (5) | — | — | — | — | — | — | — | (25) | |||||||
Non-GAAP | $ 7,984 | $ 2,623 | 32.9 % | $ 688 | 8.6 % | $ (57) | (0.7) % | $ (179) | |||||||
Currency impact | (85) | (36) | (0.1) | (1) | 0.1 | (104) | (1.3) | 4 | |||||||
Currency Adjusted | $ 7,899 | $ 2,587 | 32.8 % | $ 687 | 8.7 % | $ (161) | (2.0) % | $ (175) | |||||||
Six months ended October 27, 2023 | |||||||||||||||
(in millions) | Net Sales | SG&A | SG&A | R&D | R&D | Other | Other Operating | Other Non- | |||||||
GAAP | $ 15,686 | $ 5,299 | 33.8 % | $ 1,365 | 8.7 % | $ (30) | (0.2) % | $ (230) | |||||||
Non-GAAP Adjustments: | |||||||||||||||
Restructuring and associated costs (2) | — | (57) | (0.4) | — | — | 1 | — | — | |||||||
Acquisition and divestiture-related items (3) | — | (42) | (0.3) | — | — | (53) | (0.3) | — | |||||||
Medical device regulations (4) | — | (1) | — | (19) | (0.1) | — | — | — | |||||||
(Gain)/loss on minority investments (5) | — | — | — | — | — | — | — | (89) | |||||||
Non-GAAP | $ 15,686 | $ 5,199 | 33.1 % | $ 1,346 | 8.6 % | $ (83) | (0.5) % | $ (320) | |||||||
Currency impact | (38) | (31) | (0.1) | 2 | — | (186) | (1.2) | 5 | |||||||
Currency Adjusted | $ 15,648 | $ 5,168 | 33.0 % | $ 1,348 | 8.6 % | $ (269) | (1.7) % | $ (315) | |||||||
See description of non-GAAP financial measures contained in the press release dated November 21, 2023. | |
(1) | The data in this schedule has been intentionally rounded to the nearest million, and, therefore, may not sum. |
(2) | Associated costs include costs incurred as a direct result of the restructuring program, such as salaries for employees supporting the program, consulting expenses, and asset write-offs. |
(3) | The charges primarily include business combination costs, changes in fair value of contingent consideration, and charges related to the impending separation of the Patient Monitoring and Respiratory Interventions businesses within our Medical Surgical Portfolio. |
(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. |
MEDTRONIC PLC | |||
GAAP TO NON-GAAP RECONCILIATIONS (1) | |||
(Unaudited) | |||
Six months ended | |||
(in millions) | October 27, 2023 | October 28, 2022 | |
Net cash provided by operating activities | $ 1,536 | $ 2,005 | |
Additions to property, plant, and equipment | (815) | (749) | |
Free Cash Flow (2) | $ 721 | $ 1,256 | |
See description of non-GAAP financial measures contained in the press release dated November 21, 2023. | |
(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 27, 2023 | April 28, 2023 | ||
ASSETS | ||||
Current assets: | ||||
Cash and cash equivalents | $ 1,311 | $ 1,543 | ||
Investments | 6,423 | 6,416 | ||
Accounts receivable, less allowances and credit losses of $177 and $176, respectively | 5,934 | 5,998 | ||
Inventories, net | 5,754 | 5,293 | ||
Other current assets | 2,658 | 2,425 | ||
Total current assets | 22,081 | 21,675 | ||
Property, plant, and equipment, net | 5,735 | 5,569 | ||
Goodwill | 40,821 | 41,425 | ||
Other intangible assets, net | 14,060 | 14,844 | ||
Tax assets | 3,428 | 3,477 | ||
Other assets | 3,962 | 3,959 | ||
Total assets | $ 90,087 | $ 90,948 | ||
LIABILITIES AND EQUITY | ||||
Current liabilities: | ||||
Current debt obligations | $ 1,339 | $ 20 | ||
Accounts payable | 2,174 | 2,662 | ||
Accrued compensation | 1,758 | 1,949 | ||
Accrued income taxes | 1,088 | 840 | ||
Other accrued expenses | 3,299 | 3,581 | ||
Total current liabilities | 9,659 | 9,051 | ||
Long-term debt | 23,741 | 24,344 | ||
Accrued compensation and retirement benefits | 1,020 | 1,093 | ||
Accrued income taxes | 1,777 | 2,360 | ||
Deferred tax liabilities | 686 | 708 | ||
Other liabilities | 1,556 | 1,727 | ||
Total liabilities | 38,440 | 39,283 | ||
Commitments and contingencies | ||||
Shareholders' equity: | ||||
Ordinary shares— par value $0.0001, 2.6 billion shares authorized, | — | — | ||
Additional paid-in capital | 24,580 | 24,590 | ||
Retained earnings | 30,256 | 30,392 | ||
Accumulated other comprehensive loss | (3,377) | (3,499) | ||
Total shareholders' equity | 51,460 | 51,483 | ||
Noncontrolling interests | 187 | 182 | ||
Total equity | 51,647 | 51,665 | ||
Total liabilities and equity | $ 90,087 | $ 90,948 | ||
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 27, 2023 | October 28, 2022 | |
Operating Activities: | |||
Net income | $ 1,708 | $ 1,367 | |
Adjustments to reconcile net income to net cash provided by operating activities: | |||
Depreciation and amortization | 1,344 | 1,339 | |
Provision for credit losses | 37 | 41 | |
Deferred income taxes | (36) | (92) | |
Stock-based compensation | 219 | 199 | |
Loss on debt extinguishment | — | 53 | |
Other, net | 182 | 148 | |
Change in operating assets and liabilities, net of acquisitions and divestitures: | |||
Accounts receivable, net | (117) | (346) | |
Inventories, net | (616) | (784) | |
Accounts payable and accrued liabilities | (699) | (14) | |
Other operating assets and liabilities | (486) | 94 | |
Net cash provided by operating activities | 1,536 | 2,005 | |
Investing Activities: | |||
Acquisitions, net of cash acquired | (22) | (1,867) | |
Additions to property, plant, and equipment | (815) | (749) | |
Purchases of investments | (3,403) | (3,743) | |
Sales and maturities of investments | 3,336 | 3,609 | |
Other investing activities, net | (59) | 19 | |
Net cash used in investing activities | (963) | (2,731) | |
Financing Activities: | |||
Change in current debt obligations, net | 1,321 | 349 | |
Proceeds from short-term borrowings (maturities greater than 90 days) | — | 2,284 | |
Issuance of long-term debt | — | 3,430 | |
Payments on long-term debt | — | (2,311) | |
Dividends to shareholders | (1,836) | (1,807) | |
Issuance of ordinary shares | 149 | 153 | |
Repurchase of ordinary shares | (378) | (477) | |
Other financing activities | 153 | 443 | |
Net cash (used in) provided by financing activities | (591) | 2,064 | |
Effect of exchange rate changes on cash and cash equivalents | (214) | (223) | |
Net change in cash and cash equivalents | (232) | 1,114 | |
Cash and cash equivalents at beginning of period | 1,543 | 3,714 | |
Cash and cash equivalents at end of period | $ 1,311 | $ 4,828 | |
Supplemental Cash Flow Information | |||
Cash paid for: | |||
Income taxes | $ 1,110 | $ 821 | |
Interest | 476 | 234 | |
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 Dublin, 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 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 X (formerly Twitter) and 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 2023.
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.
Contacts: | |
Erika Winkels | Ryan Weispfenning |
Public Relations | Investor Relations |
+1-763-526-8478 | +1-763-505-4626 |
View original content to download multimedia: https://www.prnewswire.com/news-releases/medtronic-reports-second-quarter-fiscal-2024-financial-results-301994289.html
SOURCE Medtronic plc
News Provided by PR Newswire via QuoteMedia
Medtronic announces FDA approval of minimally invasive device to treat hypertension
The Symplicity ™ blood pressure procedure offers patients a new adjunct approach to lowering blood pressure
Approval is the culmination of ten years of clinical research and development of the Medtronic renal denervation technology
- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that the United States Food and Drug Administration (FDA) has approved the Symplicity Spyral ™ renal denervation (RDN) system, also known as the Symplicity ™ blood pressure procedure, for the treatment of hypertension. With this approval, Medtronic will immediately begin commercialization.
Hypertension, or high blood pressure, is the leading modifiable cause of heart attack, stroke, and death, and its prevalence is notably worse in underserved U.S. populations. Despite available medications and lifestyle interventions, control rates remain low. These challenges speak to the possibility that patients may benefit from an adjunctive treatment option to better manage their blood pressure.
"Medtronic has always believed in the potential of this therapy. We partnered closely with leading experts in our clinical community who could help us in our journey to get this technology to the people who need it most," said Jason Weidman , senior vice president and president of the Coronary and Renal Denervation business within the Cardiovascular Portfolio at Medtronic. "It was the promise of this therapy that enabled Medtronic to keep going, even when others exited the renal denervation space. High blood pressure is a global health issue, and patients need more options to manage their blood pressure. The approval of the Symplicity blood pressure procedure represents a significant milestone for physicians and patients in the treatment of hypertension."
The Medtronic Symplicity blood pressure procedure is an innovative, minimally invasive procedure that delivers radiofrequency energy to nerves near the kidneys that can become overactive and contribute to high blood pressure. After sedation, the doctor inserts a single thin tube (known as a catheter) into the artery leading to the kidney. Once the tube is in place, the doctor administers energy to the system to calm the excessive activity of the nerves connected to the kidney. The tube is removed, leaving no implant behind.
"The Symplicity blood pressure procedure is safe and effective, providing significant 'always on' blood pressure reductions for patients," said David Kandzari , M.D., chief, Piedmont Heart Institute and Cardiovascular Service and co-principal investigator of the SPYRAL clinical program. "This landmark approval is the culmination of rigorous scientific study and clinical trials, including long-term, sham-controlled studies in the presence and absence of medication, and the largest real-world study."
Patient preference and shared decision making have been identified as critical components of developing a hypertension care plan including the Symplicity blood pressure procedure. According to results from a Medtronic-led patient preference study, when presented with an interventional treatment with blood pressure reduction and potential risks in line with those of the Symplicity blood pressure procedure, approximately one third of patients were likely to choose the interventional treatment.
"This approval paves the way for a transformation in hypertension treatment, offering a solution that complements medication and lifestyle changes," said Raymond Townsend , M.D., from the Hypertension Section, Department of Internal Medicine / Renal, University of Pennsylvania School of Medicine and co-principal investigator of the SPYRAL clinical program. "The Symplicity blood pressure procedure is a promising treatment option for clinicians and patients alike and offers opportunity to fulfill a significant unmet need in hypertension care, especially for those patients who are desperately seeking additional approaches to get their blood pressure down."
The Medtronic SPYRAL HTN Global Clinical Program is the most comprehensive clinical program studying RDN and is backed by experience in more than 25,000 patients treated globally, studied in the presence and absence of medication, and in patients with high baseline cardiovascular risk. Although currently limited for investigational use in Japan , China and Canada , the Symplicity Spyral Renal Denervation System is approved for commercial use in more than 70 countries around the world.
About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Dublin, 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 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 Twitter and 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: | |||
Krystin Hayward Leong | Ryan Weispfenning | ||
Public Relations | Investor Relations | ||
+1-508-261-6512 | +1-763-505-4626 | ||
View original content to download multimedia: https://www.prnewswire.com/news-releases/medtronic-announces-fda-approval-of-minimally-invasive-device-to-treat-hypertension-301992645.html
SOURCE Medtronic plc
News Provided by PR Newswire via QuoteMedia
Medtronic: A Majority of Americans Are Optimistic That AI Will Improve Healthcare in 2024
According to a new survey from Medtronic and Morning Consult, respondents recognize potential of AI to enable earlier diagnosis and improve access to care
Medtronic More than half (51%) of U.S. adults are optimistic new applications of artificial intelligence (AI) will lead to major advancements and breakthroughs in healthcare in the year ahead, according to a new survey from Medtronic, a global healthcare technology leader, and Morning Consult
Some of the highest levels of optimism for AI in healthcare are around diagnoses and improving healthcare access. In fact, roughly six in ten adults (61%) agree one of the main benefits of using AI in healthcare is to diagnose and detect health conditions. Further, approximately two-thirds (65%) of adults agree technology can help break down barriers to healthcare with more than half (56%) saying AI (specifically) can be beneficial in improving healthcare access.
"Disruptive technologies like AI alter the trajectories of our daily lives, changing how we shop, how we communicate, and how we receive healthcare," shares Ken Washington, chief technology and innovation officer at Medtronic. "While skepticism is natural, the survey found strong optimism around the potential of AI in healthcare. And the reality is, the way we engage with AI will likely look radically different five to 10 years from now. That said, there is one thing I'm certain of - the responsible, ethical use of AI has the power to radically improve healthcare for both patients and doctors."
Addressing perceived barriers to AI adoption is key to increasing consumer confidence
While more than half of Americans are optimistic about AI, there are still barriers to overcome. Among survey respondents who are skeptical about the technology, they report having more proof around AI's potential could help them be more confident in the technology.
- 83% of consumers view the potential for AI to make mistakes as one of the largest barriers.
- 80% say lack of basic understanding and evidence that AI improves health outcomes are risks to using AI.
- However, nearly half (47%) say they would feel more confident if these barriers were addressed.
Americans want to know their doctor is calling the shots - not AI
Consumers have a favorable opinion of using AI to manage their health - but report they aren't ready for their physician to use it extensively, with the survey showing that:
- 62% of adults have a favorable opinion of symptom trackers and health related apps that depend on AI technology.
- Despite this, only roughly one-third (36%) say they would prefer to work with a physician who uses AI, and only one-in-five (20%) would want their doctor to use AI extensively.
- However, when presented with specific ways a physician might use AI, Americans are more open. Two-thirds (67%) say they'd be likely to work with a physician who uses AI to analyze tests, x-rays and CT scans. More than half say the same for detecting cancer (62%).
- Health status also might influence their openness, with more than half (53%) of adults who consider themselves to be in excellent health preferring to work with a doctor using AI, compared to just 29% who rate their health as fair.
"Here's the bottom line - AI can't be a substitute for human judgement and experience. To this end, I cannot imagine a future where AI will replace doctors. But I can envision a future where AI is ubiquitous in healthcare, creating better experiences and outcomes that patients will prefer," adds Washington.
Medtronic has been pioneering the research and development of AI-based technology for more insights-driven care, from diagnosis to treatment to monitoring. Here are few examples of AI in action at Medtronic today.
Washington will be sharing more of his perspective on AI in healthcare and these survey findings during this week's Techonomy23 conference taking place in Orlando, FL.
For more information on Medtronic's commitment to advancing healthcare through technology and examples of the impact of their AI-based solutions, visit Medtronic.com.
About the Consumer Perceptions of AI Survey
The survey was conducted by decision intelligence company Morning Consult among a nationally representative sample of 2,213 adults in the U.S. from September 27-30, 2023, with an unweighted margin of error of +/- 2 percentage points.
About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Dublin, 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 Twitter and 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 | Ryan Weispfenning |
| Public Relations | Investor Relations |
| +1-763-526-8472 | +1-736-505-4626 |
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
View source version on accesswire.com:
https://www.accesswire.com/803481/medtronic-a-majority-of-americans-are-optimistic-that-ai-will-improve-healthcare-in-2024
News Provided by ACCESSWIRE via QuoteMedia
Cleo Diagnostics Investor Kit
- Corporate info
- Insights
- Growth strategies
- Upcoming projects