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Cardiex June 2024 Quarter Update
Cardiex Limited (ASX:CDX) is pleased to present its June 2024 quarter update.
Highlights:
- Robust Q4 and record FY24 financial results.
- Expanded product capabilities to drive continued revenue growth with strong internal projections for FY25 and beyond. ● Initial CONNEQT Pulse units have arrived in the USA and Australia and are being distributed to strategic healthcare partners for pilot programs, including extensive user testing and evaluation.
- Pre-launch activities for Pulse have exceeded expectations leading to an increase in the first full production run from 3,000 to 8,000 units (Q1 FY25).
- Multiple new regulatory clearances being sought in new geographic markets.
- Targeted marketing initiatives for the Pulse are accelerating to build awareness and drive leads through key industry events, online marketing, and other digital and social channels.
- Strengthened financial position with funding commitments from C2 Ventures.
- Investor webinar details and closing CEO comments.
Dear Fellow Shareholders,
On behalf of the Company I’m pleased to present our final Quarterly Update for FY 2024. As we approach a pivotal moment in our journey, I’m thrilled to highlight our recent achievements and the exciting developments on the horizon. Our dedicated efforts across various sectors have led to impressive financial results and a growing interest in our innovative products. With a strong foundation in place, including significant advancements in our ATCOR division and successful product launches, we are well placed for continued success.
In the lead-up to the launch of the CONNEQT Pulse, we are now preparing to shift our focus towards a more targeted and strategic marketing approach. This will include leveraging a diverse array of industry, social, and digital channels to amplify our reach and drive both awareness and sales. With new partnerships, expanded product capabilities, and continuing strategic initiatives, we are confidently moving forward to meet the increasing demand and deliver transformative solutions to our market.
Click here for the full ASX Release
This article includes content from CardieX Limited, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
Cardiex Limited
Overview
Cardiex Limited (ASX:CDX) is an ASX-listed medical technology company leveraging its proprietary SphygmoCor® technology to develop and market vascular biomarker technologies and digital solutions focused on the world’s largest health disorders. The company’s groundbreaking technology – SphygmoCor® – set the benchmark for noninvasive measurement of central aortic pressures and related arterial health characteristics, collectively referred to as vascular biomarkers.
While measuring arterial health parameters had always been considered clinically beneficial, it was not considered for routine out-patient clinical use as it previously required an invasive catheterization procedure with a pressure sensor inserted into the aorta. Founded on 40 years of hemodynamics studies and backed by 20+ years of research, Cardiex’s SphygmoCor technology employs non-invasive techniques to assess "central aortic waveforms," offering valuable insights into various clinically significant arterial health parameters including arterial stiffness, central blood pressure (the pressure at the heart), pulse pressure, and crucial indicators of vascular health for major organs such as the heart, brain and kidneys.
Assessing central blood pressure directly at the heart is deemed superior to conventional blood pressure measurements taken at the arm, primarily owing to the heart's proximity to vital organs. Cardiex’s FDA-cleared devices replace traditional blood pressure technology for first-line screening and monitoring of arterial health status. The unique physiologic insights from the company’s devices provide clinically relevant information that helps guide treatment decisions and offer profound benefits for all members of the healthcare community:
For Healthcare Providers: Enable physicians to make more informed treatment decisions based on clinically relevant vascular health data.
For Patients: Give patients the tools to make better decisions about their own health.
For Pharmaceutical Companies: Generate reliable, real-world, clinically relevant data to accelerate drug development and commercialization.
For more than two decades, the company’s SphygmoCor technology has set the benchmark for vascular biomarker assessments, adopted by premier hospitals and pharmaceutical giants worldwide. SphygmoCor is the chosen technology for measuring central blood pressure in all of the "top 20 hospitals" in the US and has played a crucial role in the clinical trials of leading firms including Bayer, AstraZeneca, Roche, Novartis and GlaxoSmithKline.
Between 2002 and 2023, CDX received five FDA clearances, the latest for the CONNEQT Pulse, a first-of-its-kind connected vascular biometrics monitor.
Cardiex devices have previously been sold and used exclusively in clinical settings – principally by specialist clinicians, for research, and by pharmaceutical companies for drug assessment. The introduction of CONNEQT Pulse represents a significant shift for Cardiex, allowing the company to enter the connected care market and transition from niche segments to the mass healthcare market. Priced comparably to a home health monitor, the CONNEQT Pulse is positioned for widespread adoption and can be deployed at scale in general healthcare practices, homes, or any location where patients are present.
The CONNEQT Pulse will also bolster Cardiex's portfolio in clinical trial solutions with the introduction of a decentralized clinical trial (DCT) platform. The Cardiex DCT platform empowers clinical trial managers to remotely monitor thousands of patients in their homes, enabling pharmaceutical companies to more effectively evaluate potential vascular outcomes across various trial phases. This leads to increased efficiency and cost-effectiveness in trial outcomes.
Furthermore, in response to the growing demand for proactive health monitoring, Cardiex will be launching an innovative wrist-worn device that leverages the SphygmoCor technology to deliver a medical grade wearable with capabilities far beyond conventional health trackers. The CONNEQT Band will be a wearable “cuffless” device designed to monitor vascular health in patients as well as to provide general health insights to consumers.
Cardiex’s goal is to establish a holistic ecosystem that promotes cardiovascular well-being and empowers users to proactively manage their health as an integral part of individuals' health routines, contributing to a paradigm shift in preventive cardiovascular care.
The company’s first-mover advantage and exclusive technology FDA-cleared for noninvasive measurement of central pulse pressures and vascular biomarkers across all adult demographics grant it a distinctive market position. CDX recently secured AU$14 million in funding, which is enough to steer the company towards profitability.
With the entry into the connected care home market with the CONNEQT Pulse, CDX is transitioning towards a recurring revenue model based on monthly subscription fees. This should excite investors, given that the recurring revenue model will receive a higher multiple by the market, thereby boosting the company's valuation.
Company Highlights
- Cardiex Limited is an ASX-listed medical technology company that develops and markets vascular biomarker technologies and digital solutions for the world’s largest health disorders.
- The company’s offerings encompass FDA-cleared medical and home health devices alongside digital solutions tailored for managing health and wellness, delivering unique physiologic insights that inform clinical treatment decisions.
- The company’s groundbreaking technology – named SphygmoCor® – set the benchmark for measuring central aortic pressures and related arterial health characteristics, collectively referred to as vascular biomarkers.
- These biomarkers, extensively researched and detailed in numerous peer-reviewed journals, assess cardiovascular risk and guide disease management by predicting organ damage (such as the heart, brain, and kidneys) and outcomes (including heart failure, ischemic heart disease, and stroke), significantly influencing disease prognosis and clinical treatment.
- CDX received five FDA clearances from 2002 to 2023, the most recent for the CONNEQT Pulse, a world-first connected vascular biometric monitor. The CONNEQT Pulse targets new and significant healthcare channels and transitions the company towards a recurring revenue model based on monthly subscription fees.
- CDX's technology is uniquely FDA-cleared for noninvasive measurement of central pulse pressures and vascular biomarkers across all adult demographics – thereby granting it a distinctive competitive market position. With a significant funding round recently secured, CDX is poised for profitability ahead.
Products and Brands
The company’s solution is organised under two brands: ATCOR and CONNEQT.
ATCOR
ATCOR offers solutions for hospitals, research and pharma, and specialist clinician markets. ATCOR's solutions have been utilized in 46 pharmaceutical clinical trials thus far, across more than 1,700 study sites worldwide, and have been highlighted in over 2,400 peer-reviewed studies showcased in top-tier medical journals. It offers two devices – the company’s flagship device, the SphygmoCor XCEL, and the SunTech Oscar 2 with “SphygmoCor Inside”.
SphygmoCor XCEL: The SphygmoCor XCEL measures central and brachial blood pressures, providing insights into cardiovascular function. Additionally, it assesses numerous other clinically relevant vascular biomarkers, offering a comprehensive understanding of arterial stiffness and health. These advanced physiological measurements enable early detection of potential cardiovascular issues, guiding targeted interventions for maintaining or improving overall cardiovascular health.
SunTech Oscar 2 with “SphygmoCor Inside”: Jointly developed and marketed by SunTech Medical and Cardiex, the Oscar 2™ ABPM with “SphygmoCor Inside” produces a suite of unique vascular health features and health insights captured by the SphygmoCor technology over a continuous period. It provides valuable diagnostic information that traditional ambulatory blood pressure monitors are incapable of measuring.
CONNEQT
CONNEQT is focused on devices and solutions for home health, remote patient monitoring, and decentralized clinical trials. Cardiex offers two devices under the CONNEQT brand – the recently FDA-cleared CONNEQT Pulse and the upcoming CONNEQT Band wearable. The company estimates CONNEQT’s total addressable market opportunity to be nearly $283 billion across three markets – remote patient monitoring ($175 billion), health wearables ($104 billion), and decentralized clinical trials ($14 billion).
CONNEQT Pulse: The CONNEQT Pulse provides measurements of both central and brachial blood pressures, alongside vascular biomarkers reflecting arterial stiffness and overall vascular health—metrics once exclusively only available to specialist clinics, research, and pharmaceutical companies. As a Bluetooth-enabled device, it empowers patients and health enthusiasts to track their arterial health from home, employing the same advanced tools used by top cardiologists in research centers and clinics.
Physicians can prescribe the CONNEQT Pulse to patients requiring heart health monitoring. Patient data seamlessly integrates with the CONNEQT Patient Management Portal (CPMP), a HIPAA-compliant cloud-based tool that enables healthcare providers to remotely track patients' arterial health by way of a tablet. Furthermore, consumers and patients can access comprehensive arterial health insights, coaching, lifestyle programs, and additional health resources via the CONNEQT app.
CONNEQT Band: CONNEQT Band is a world's-first dual sensor arterial health wearable device featuring an innovative design with dual (wrist-and finger-based) photoplethysmography (PPG) optical sensors. The wrist-based sensor continuously captures physiological data such as heart rate, respiration, stress, activity, sleep, and pulse oximetry, while our patented on-demand finger-based side sensor uniquely derives clinically meaningful vascular biomarkers representing arterial stiffness and cardiovascular health.
By combining data from both sensors, the CONNEQT Band offers users a comprehensive view of their overall cardiovascular health which has never been available outside of a physician’s office. The CONNEQT Band is also supported by the CONNEQT app, available for both iOS and Android devices, which serves as a hub where users can easily access detailed reports, track their progress over time, explore content, and receive personalized health insights and recommendations.
The CONNEQT Band is currently in the process of FDA submission preparation. This innovative device is poised to extend the company's portfolio in connected health technology, offering users a new, user-friendly tool for monitoring their health metrics. With its cutting-edge features, the CONNEQT Band is expected to make a significant impact in the way individuals manage their wellness, bridging the gap between advanced health monitoring and everyday convenience.
A significant global market opportunity in wearable health devices is driven by nearly 1.3 billion hypertensive and other vascular disease patients. Some of the other wearable device firms have attracted significant funding at high valuations in recent times. For instance, Oura Health, a Finnish company that makes smart rings for tracking sleep and physical activity, was valued at $2.55 billion in April 2022.
Board of Directors & Management
Craig Cooper – Chief Executive Officer and Executive Director
Craig Cooper has established numerous prosperous health, digital media, technology and wellness ventures. Notably, he co-founded Boost Mobile, a prominent telecommunications company recognized as one of the leading mobile phone businesses in the USA. He is acknowledged as a distinguished authority and influential figure on a global scale in mobile and wireless technology, as well as businesses related to digital health and medical technology. His venture capital endeavors have secured over AU$3 billion, financing some of the most impactful global digital media technology companies. Cooper is also a principal of C2 Ventures, Cardiex’s largest shareholder.
Niall Cairns – Executive Chairman
Niall Cairns boasts a successful 25-year record of investing in both private and public companies. He has played a pivotal role in advancing the global expansion of more than 50 enterprises spanning various sectors, including digital media, agtech, medtech, consumer internet, and SaaS-based businesses. Cairns is also a principal of C2 Ventures, Cardiex’s largest shareholder.
King Nelson – Non-executive Director
King Nelson brings over 30 years of extensive experience in medical devices. He was previously the president and CEO at Uptake Medical Corporation, concentrating on treatments for emphysema and lung cancer. Before Uptake, he served as president and CEO of Kerberos Proximal Solutions, a company later acquired by FoxHollow Technologies. He was also president and CEO of VenPro, a heart valve business acquired by Medtronic. King also accumulated 19 years of experience with Baxter International and American Hospital Supply Corporation, progressing through various roles with increasing responsibilities. These roles included serving as division president for Dade Diagnostics, Bentley Labs, and Baxter’s Perfusion Services. Nelson is currently the CEO at Q’Apel Medical, a medical device company specializing in neurovascular disease.
Charlie Taylor – Non-executive Director
Charlie Taylor has over three decades of international advisory experience and recently concluded his tenure as senior partner at McKinsey, where he oversaw the health and public sector practice. Taylor has counseled numerous private and public sector healthcare organizations in Australia and globally, covering areas such as strategy, digitalization, operational enhancements, growth transformations, international expansion, supply chain management, mergers and acquisitions, and board governance. He is a non-executive director of Healius, a leading Australian health diagnostics company, and a part-time senior board advisor at McKinsey for the health and public sector practice.
Sanjeev Bhavnani, M.D. – Chief Clinical Officer
Dr. Sanjeev Bhavnani has served as a senior medical officer at the Digital Health Center of Excellence within the FDA's Center for Devices and Radiological Health (CDRH), overseeing clinical and scientific initiatives concerning digital health and medical devices incorporating artificial intelligence.
Bhavnani is also currently a senior cardiologist and principal investigator of digital health and machine learning at Scripps Clinic in San Diego, California, where he leads programs to develop and validate new technologies and to evaluate the safety and effectiveness of DHTs, nanosensors, cloud-based analytical platforms, handheld imaging technologies, AI/ML algorithms and software as a medical device. For over a decade, Bhavnani was the principal investigator of 90 clinical trials and patient care programs. These programs have enrolled over 30,000 patients in the US and in resource-limited areas. His team developed the SMART-FHIR integration interface for DHT data into EMRs for remote patient monitoring, remote therapeutic monitoring, and chronic care management, creating a real-world data platform to monitor the healthcare quality of DHT and ML devices in traditional and new consumer models of care delivery.
Catherine Liao – Chief Strategy Officer
Catherine Liao has served as our chief strategy officer since September 2022. Previously, Liao served as chief executive officer of Blumio, a pioneering medical device startup, from February 2016 to September 2022, where she led efforts in raising capital, formed a leadership and advisory board rich in knowledge spanning healthcare innovations, enterprise technology, and sensor technology. Her notable achievements include leading the commercialization of a groundbreaking medical radar sensor development platform, which garnered significant industry attention and was eventually acquired by Cardiex. Liao holds an MBA from Imperial College London and a Master of Science in Health Economics from the London School of Economics. These credentials underscore her deep and comprehensive insight into the intricacies of both the business world and the healthcare sector, demonstrating a balanced expertise critical for navigating and innovating within today’s complex healthcare economies.
Mark Gorelick, Ph.D. – Chief Product Officer
Dr. Mark Gorelick has served as Cardiex’s chief product officer since December 2020, bringing a wealth of experience from various leadership roles in the health and wellness technology sector. With an impressive tenure beginning in 2007, he has been at the helm as managing director of XPhys Technologies, a company at the forefront of developing innovative fitness, health, and wellness products. His strategic vision was further demonstrated through his role as vice-president of Digital Health, from 2018 to 2019, at Performance Lab Technologies, acclaimed for its software development prowess in the health sector. Further cementing his reputation in health technology, Gorelick served as the chief science officer at PAI Health (originally Mio Global) from 2015 to 2018, where he was instrumental in advancing health technology software solutions. Holding a BSc and MSc in kinesiology from Dalhousie University and a Ph.D. in biomedical science from University of Wollongong, Gorelick’s educational background underscores his deep-rooted understanding and innovative approach to biomedical science and kinesiology, reinforcing his invaluable contribution to our company and the broader health technology landscape.
This profile was written in collaboration with Couloir Capital.
CardieX June Quarterly Appendix 4C
Cardiex Limited (ASX:CDX) is pleased to present its quarterly cash flow report for entities subject to Listing Rule 4.7B.
This article includes content from CardieX Limited, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
CLEO Selects U.S. Clinical Trial Sites
MELBOURNE, AUSTRALIA, 31 July 2024: Ovarian cancer diagnostics company, Cleo Diagnostics Limited (ASX:COV) (CLEO, or the Company) is pleased to announce progress for its U.S. clinical trials in support of its FDA application for its ovarian cancer diagnostic blood test.
- Initial U.S. clinical trial sites contracted following Institutional Review Board (IRB) approval
- 7 sites selected across Texas, Arizona, Florida, Nevada, California, and New York
- First patients being recruited with trials to begin mid-August 2024
- Australian ethics approval also obtained with mirror trial to run at Monash Health.
U.S. Clinical Trial Sites Selected
CLEO is pursuing regulatory approval in the U.S. as the largest diagnostics market in the world. Prior to submission with the Food and Drug Administration (FDA), the Company will complete a study that will benchmark CLEO’s technology through a 500 patient clinical trial. CLEO’s U.S.-based clinical trials manager, Lindus Health, has now obtained Institutional Review Board (IRB) approval for, and formally contracted 7 clinical trial sites across the U.S.
This follows CLEO obtaining IRB approval for its clinical trial design last month. A wide geographic range of sites ensures that a diverse representation of the U.S. population is met. Initial sites that have been selected and contracted are located in Texas, Arizona, Florida (x2), Nevada, California, and New York. First patients are being recruited with the trials to begin mid-August 2024.
Commenting on the selection of U.S. trial sites, CLEO Chief Executive, Richard Allman, said:
“This marks the first visible activity by CLEO in the U.S. and effectively a large step in the įourney there to bring our ovarian cancer diagnostic blood test to the largest diagnostic market in the world.
We believe that we have a sound strategy and plan that has been supported by the FDA and IRB, and we now move to progress our clinical trials that will ultimately drive our market entry.
I look forward to announcing the start of trial activities in the coming weeks.”
Click here for the full ASX Release
This article includes content from CLEO Diagnostics, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
Surgeon for a Day! Medtronic Puts the Power of Healthcare Technology in the Hands of Teens With Jack and Jill of America, Inc.
Global healthcare technology leader Medtronic partnered with Jack and Jill of America, Inc., a nonprofit dedicated to nurturing future African American leaders, to give more than 150 teens hands-on experiences with healthcare tech at Jack and Jill's national convention. Students had the opportunity to use surgical tools in the Medtronic Mobile Lab, a truck built to mirror an operating room that's used to train healthcare providers.
See more here on Yahoo.com.
About Medtronic
Bold thinking. Bolder actions. We are Medtronic.
We lead global healthcare technology and boldly attack 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 90,000+ passionate people. 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.
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 the original press release on accesswire.com
News Provided by ACCESSWIRE via QuoteMedia
Thermo Fisher Scientific Reports Second Quarter 2024 Results
Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today reported its financial results for the second quarter ended June 29, 2024.
Second Quarter 2024 Highlights
- Second quarter revenue was $10.54 billion.
- Second quarter GAAP diluted earnings per share (EPS) increased 15% to $4.04.
- Second quarter adjusted EPS increased 4% to $5.37.
- Advanced our proven growth strategy, launching a range of high-impact, innovative new products during the quarter. This included a number of analytical instruments introduced at the American Society for Mass Spectrometry conference, including the Thermo Scientific™ Stellar™ mass spectrometer , which validates proteins of clinical interest discovered through our groundbreaking Thermo Scientific Orbitrap™ Astral™ mass spectrometer ; and three new built-for-purpose editions of the Thermo Scientific Orbitrap Ascend Tribrid™ mass spectrometer tailored to MultiOmics, Structural Biology and BioPharma applications. To help our customers meet their sustainability goals, we also launched: a first-of-its-kind biobased film for our bioprocessing containers, which uses plant-based materials to deliver lower-carbon solutions in the manufacturing of therapies; and a new line of ENERGY STAR-certified Thermo Scientific™ TSX™ Universal Series ULT Freezers , which deliver industry-leading performance and energy efficiency.
- Continued to strengthen our industry-leading commercial engine and deepen our trusted partner status with customers to accelerate their innovation and enhance their productivity. In the quarter, we expanded our leading clinical trial supply services with a new ultra-cold facility in Bleiswijk, the Netherlands and a new state-of-the-art innovation lab at our site in Center Valley, Pennsylvania , to enable our pharmaceutical and biotech customers to accelerate the development of therapies and medicines. Also in the quarter, to support Indonesia's growing investments in healthcare, scientific research, and renewable energy, we expanded our presence and capabilities in the country, further demonstrating our relevance to customers around the world.
- Shortly after the quarter ended, we completed our acquisition of Olink , a provider of differentiated next-generation proteomic solutions. The addition of Olink's technology extends our capabilities and further advances our leadership position in protein research, enabling our customers to meaningfully accelerate discovery and scientific breakthroughs while delivering on the promise of precision medicine.
"Our excellent execution enabled us to deliver another quarter of strong financial performance and share gain," said Marc N. Casper, chairman, president, and chief executive officer of Thermo Fisher Scientific. "We continue to see the benefit of our proven growth strategy and the impact of our PPI Business System in our performance. Shortly after the quarter ended, we were also pleased to welcome our Olink colleagues to Thermo Fisher and are excited about the power of this new combination to better serve our customers and advance science."
Casper added, "We have made very good progress through the halfway point of the year and are in a great position to deliver differentiated performance in 2024. We've further extended our industry leadership and positioned our company for an even brighter future."
Second Quarter 2024
Revenue for the quarter declined 1% to $10.54 billion in 2024, versus $10.69 billion in 2023. Organic revenue was 1% lower and Core organic revenue growth was flat.
GAAP Earnings Results
GAAP diluted EPS in the second quarter of 2024 increased 15% to $4.04, versus $3.51 in the same quarter last year. GAAP operating income for the second quarter of 2024 grew to $1.82 billion, compared with $1.58 billion in the year-ago quarter. GAAP operating margin increased to 17.3%, compared with 14.8% in the second quarter of 2023.
Non-GAAP Earnings Results
Adjusted EPS in the second quarter of 2024 increased 4% to $5.37, versus $5.15 in the second quarter of 2023. Adjusted operating income for the second quarter of 2024 was $2.35 billion, compared with $2.37 billion in the year-ago quarter. Adjusted operating margin increased to 22.3%, compared with 22.2% in the second quarter of 2023.
Annual Guidance for 2024
Thermo Fisher is raising its full-year revenue and adjusted EPS guidance. The company is raising its revenue guidance to a new range of $42.4 to $43.3 billion versus its previous guidance of $42.3 to $43.3 billion. The company is raising its adjusted EPS guidance to a new range of $21.29 to $22.07 versus its previous guidance of $21.14 to $22.02.
Use of Non-GAAP Financial Measures
Adjusted EPS, adjusted net income, adjusted operating income, adjusted operating margin, free cash flow, organic revenue growth and Core organic revenue growth are non-GAAP measures that exclude certain items detailed after the tables that accompany this press release, under the heading "Supplemental Information Regarding Non-GAAP Financial Measures." The reconciliations of GAAP to non-GAAP financial measures are provided in the tables that accompany this press release.
Note on Presentation
Certain amounts and percentages reported within this press release are presented and calculated based on underlying unrounded amounts. As a result, the sum of components may not equal corresponding totals due to rounding.
Conference Call
Thermo Fisher Scientific will hold its earnings conference call today, July 24, at 8:30 a.m. Eastern Daylight Time. During the call, the company will discuss its financial performance, as well as future expectations. To listen, call (833) 470-1428 within the U.S. or (404) 975-4839 outside the U.S. The access code is 023107. You may also listen to the call live on the "Investors" section of our website, www.thermofisher.com . The earnings press release and related information can also be found in that section of our website under the heading "Financials". A replay of the call will be available under "News, Events & Presentations" through Wednesday, August 7, 2024.
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. For more information, please visit www.thermofisher.com .
Safe Harbor Statement
The following constitutes a "Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995: This press release contains forward-looking statements that involve a number of risks and uncertainties. Important factors that could cause actual results to differ materially from those indicated by forward-looking statements include risks and uncertainties relating to: the COVID-19 pandemic; the need to develop new products and adapt to significant technological change; implementation of strategies for improving growth; general economic conditions and related uncertainties; dependence on customers' capital spending policies and government funding policies; the effect of economic and political conditions and exchange rate fluctuations on international operations; use and protection of intellectual property; the effect of changes in governmental regulations; any natural disaster, public health crisis or other catastrophic event; and the effect of laws and regulations governing government contracts, as well as the possibility that expected benefits related to recent or pending acquisitions, may not materialize as expected. Additional important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are set forth in our most recent annual report on Form 10-K, and subsequent quarterly report on Form 10-Q, which are on file with the SEC and available in the "Investors" section of our website under the heading "SEC Filings." While we may elect to update forward-looking statements at some point in the future, we specifically disclaim any obligation to do so, even if estimates change and, therefore, you should not rely on these forward-looking statements as representing our views as of any date subsequent to today.
Condensed Consolidated Statements of Income (unaudited) | ||||||||||||||
Three months ended | ||||||||||||||
June 29, | % of | July 1, | % of | |||||||||||
(Dollars in millions except per share amounts) | 2024 | Revenues | 2023 | Revenues | ||||||||||
Revenues | $ | 10,541 | $ | 10,687 | ||||||||||
Costs and operating expenses: | ||||||||||||||
Cost of revenues (a) | 6,106 | 57.9 | % | 6,323 | 59.2 | % | ||||||||
Selling, general and administrative expenses (b) | 1,687 | 16.0 | % | 1,673 | 15.7 | % | ||||||||
Amortization of acquisition-related intangible assets | 513 | 4.9 | % | 585 | 5.4 | % | ||||||||
Research and development expenses | 339 | 3.2 | % | 345 | 3.2 | % | ||||||||
Restructuring and other costs (c) | 77 | 0.7 | % | 183 | 1.7 | % | ||||||||
Total costs and operating expenses | 8,722 | 82.7 | % | 9,109 | 85.2 | % | ||||||||
Operating income | 1,820 | 17.3 | % | 1,578 | 14.8 | % | ||||||||
Interest income | 295 | 178 | ||||||||||||
Interest expense | (354 | ) | (326 | ) | ||||||||||
Other income/(expense) (d) | 5 | — | ||||||||||||
Income before income taxes | 1,765 | 1,430 | ||||||||||||
Provision for income taxes (e) | (128 | ) | (52 | ) | ||||||||||
Equity in earnings/(losses) of unconsolidated entities | (84 | ) | (16 | ) | ||||||||||
Net income | 1,553 | 1,362 | ||||||||||||
Less: net income/(losses) attributable to noncontrolling interests and redeemable noncontrolling interest | 6 | 1 | ||||||||||||
Net income attributable to Thermo Fisher Scientific Inc. | $ | 1,548 | 14.7 | % | $ | 1,361 | 12.7 | % | ||||||
Earnings per share attributable to Thermo Fisher Scientific Inc.: | ||||||||||||||
Basic | $ | 4.05 | $ | 3.53 | ||||||||||
Diluted | $ | 4.04 | $ | 3.51 | ||||||||||
Weighted average shares: | ||||||||||||||
Basic | 382 | 386 | ||||||||||||
Diluted | 383 | 388 | ||||||||||||
Reconciliation of adjusted operating income and adjusted operating margin | ||||||||||||||
GAAP operating income | $ | 1,820 | 17.3 | % | $ | 1,578 | 14.8 | % | ||||||
Cost of revenues adjustments (a) | 1 | 0.0 | % | 18 | 0.2 | % | ||||||||
Selling, general and administrative expenses adjustments (b) | (64 | ) | -0.6 | % | 6 | 0.1 | % | |||||||
Restructuring and other costs (c) | 77 | 0.7 | % | 183 | 1.7 | % | ||||||||
Amortization of acquisition-related intangible assets | 513 | 4.9 | % | 585 | 5.4 | % | ||||||||
Adjusted operating income (non-GAAP measure) | $ | 2,347 | 22.3 | % | $ | 2,370 | 22.2 | % | ||||||
Reconciliation of adjusted net income | ||||||||||||||
GAAP net income attributable to Thermo Fisher Scientific Inc. | $ | 1,548 | $ | 1,361 | ||||||||||
Cost of revenues adjustments (a) | 1 | 18 | ||||||||||||
Selling, general and administrative expenses adjustments (b) | (64 | ) | 6 | |||||||||||
Restructuring and other costs (c) | 77 | 183 | ||||||||||||
Amortization of acquisition-related intangible assets | 513 | 585 | ||||||||||||
Other income/expense adjustments (d) | — | (1 | ) | |||||||||||
Provision for income taxes adjustments (e) | (102 | ) | (171 | ) | ||||||||||
Equity in earnings/losses of unconsolidated entities | 84 | 16 | ||||||||||||
Noncontrolling interests adjustments (f) | (1 | ) | — | |||||||||||
Adjusted net income (non-GAAP measure) | $ | 2,057 | $ | 1,997 | ||||||||||
Reconciliation of adjusted earnings per share | ||||||||||||||
GAAP diluted EPS attributable to Thermo Fisher Scientific Inc. | $ | 4.04 | $ | 3.51 | ||||||||||
Cost of revenues adjustments (a) | 0.00 | 0.05 | ||||||||||||
Selling, general and administrative expenses adjustments (b) | (0.17 | ) | 0.01 | |||||||||||
Restructuring and other costs (c) | 0.20 | 0.47 | ||||||||||||
Amortization of acquisition-related intangible assets | 1.34 | 1.51 | ||||||||||||
Other income/expense adjustments (d) | 0.00 | 0.00 | ||||||||||||
Provision for income taxes adjustments (e) | (0.26 | ) | (0.44 | ) | ||||||||||
Equity in earnings/losses of unconsolidated entities | 0.22 | 0.04 | ||||||||||||
Noncontrolling interests adjustments (f) | 0.00 | 0.00 | ||||||||||||
Adjusted EPS (non-GAAP measure) | $ | 5.37 | $ | 5.15 | ||||||||||
Reconciliation of free cash flow | ||||||||||||||
GAAP net cash provided by operating activities | $ | 1,960 | $ | 1,540 | ||||||||||
Purchases of property, plant and equipment | (301 | ) | (284 | ) | ||||||||||
Proceeds from sale of property, plant and equipment | 15 | 4 | ||||||||||||
Free cash flow (non-GAAP measure) | $ | 1,674 | $ | 1,260 |
Business Segment Information | Three months ended | |||||||||||||
June 29, | % of | July 1, | % of | |||||||||||
(Dollars in millions) | 2024 | Revenues | 2023 | Revenues | ||||||||||
Revenues | ||||||||||||||
Life Sciences Solutions | $ | 2,355 | 22.3 | % | $ | 2,463 | 23.0 | % | ||||||
Analytical Instruments | 1,782 | 16.9 | % | 1,749 | 16.4 | % | ||||||||
Specialty Diagnostics | 1,117 | 10.6 | % | 1,109 | 10.4 | % | ||||||||
Laboratory Products and Biopharma Services | 5,758 | 54.6 | % | 5,831 | 54.6 | % | ||||||||
Eliminations | (470 | ) | -4.5 | % | (465 | ) | -4.4 | % | ||||||
Consolidated revenues | $ | 10,541 | 100.0 | % | $ | 10,687 | 100.0 | % | ||||||
Segment income and segment income margin | ||||||||||||||
Life Sciences Solutions | $ | 865 | 36.7 | % | $ | 817 | 33.2 | % | ||||||
Analytical Instruments | 439 | 24.6 | % | 432 | 24.7 | % | ||||||||
Specialty Diagnostics | 299 | 26.7 | % | 297 | 26.7 | % | ||||||||
Laboratory Products and Biopharma Services | 745 | 12.9 | % | 824 | 14.1 | % | ||||||||
Subtotal reportable segments | 2,347 | 22.3 | % | 2,370 | 22.2 | % | ||||||||
Cost of revenues adjustments (a) | (1 | ) | 0.0 | % | (18 | ) | -0.2 | % | ||||||
Selling, general and administrative expenses adjustments (b) | 64 | 0.6 | % | (6 | ) | -0.1 | % | |||||||
Restructuring and other costs (c) | (77 | ) | -0.7 | % | (183 | ) | -1.7 | % | ||||||
Amortization of acquisition-related intangible assets | (513 | ) | -4.9 | % | (585 | ) | -5.4 | % | ||||||
Consolidated GAAP operating income | $ | 1,820 | 17.3 | % | $ | 1,578 | 14.8 | % | ||||||
(a) Adjusted results in 2024 and 2023 exclude charges for inventory write-downs associated with large-scale abandonment of product lines. Adjusted results in 2023 exclude $11 of charges for the sale of inventory revalued at the date of acquisition and $5 of accelerated depreciation on manufacturing assets to be abandoned due to facility consolidations. | ||||||||||||||
(b) Adjusted results in 2024 and 2023 exclude certain third-party expenses, principally transaction/integration costs related to recent acquisitions, and charges/credits for changes in estimates of contingent acquisition consideration. | ||||||||||||||
(c) Adjusted results in 2024 and 2023 exclude restructuring and other costs consisting principally of severance, impairments of long-lived assets, net charges for pre-acquisition litigation and other matters, and abandoned facility and other expenses of headcount reductions and real estate consolidations. Adjusted results in 2023 also exclude $26 of contract termination costs associated with facility closures. | ||||||||||||||
(d) Adjusted results in 2024 and 2023 exclude net gains/losses on investments. | ||||||||||||||
(e) Adjusted results in 2024 and 2023 exclude incremental tax impacts for the reconciling items between GAAP and adjusted net income, incremental tax impacts as a result of tax rate/law changes, and the tax impacts from audit settlements. | ||||||||||||||
(f) Adjusted results exclude the incremental impacts for the reconciling items between GAAP and adjusted net income attributable to noncontrolling interests. | ||||||||||||||
Note: | ||||||||||||||
Consolidated depreciation expense is $276 and $270 in 2024 and 2023, respectively. |
Organic and Core organic revenue growth | Three months ended | ||
June 29, 2024 | |||
Revenue growth | -1 % | ||
Acquisitions | 0 % | ||
Currency translation | -1 % | ||
Organic revenue growth (non-GAAP measure) | -1 % | ||
COVID-19 testing revenue | -1 % | ||
Core organic revenue growth (non-GAAP measure) | 0 % | ||
Note: | |||
For more information related to non-GAAP financial measures, refer to the section titled "Supplemental Information Regarding Non-GAAP Financial Measures" of this release. |
Condensed Consolidated Statements of Income (unaudited) | ||||||||||||||
Six months ended | ||||||||||||||
June 29, | % of | July 1, | % of | |||||||||||
(Dollars in millions except per share amounts) | 2024 | Revenues | 2023 | Revenues | ||||||||||
Revenues | $ | 20,886 | $ | 21,397 | ||||||||||
Costs and operating expenses: | ||||||||||||||
Cost of revenues (a) | 12,146 | 58.2 | % | 12,760 | 59.6 | % | ||||||||
Selling, general and administrative expenses (b) | 3,417 | 16.4 | % | 3,319 | 15.5 | % | ||||||||
Amortization of acquisition-related intangible assets | 1,065 | 5.1 | % | 1,191 | 5.5 | % | ||||||||
Research and development expenses | 670 | 3.2 | % | 691 | 3.2 | % | ||||||||
Restructuring and other costs (c) | 106 | 0.5 | % | 295 | 1.4 | % | ||||||||
Total costs and operating expenses | 17,404 | 83.3 | % | 18,256 | 85.3 | % | ||||||||
Operating income | 3,483 | 16.7 | % | 3,141 | 14.7 | % | ||||||||
Interest income | 574 | 324 | ||||||||||||
Interest expense | (717 | ) | (626 | ) | ||||||||||
Other income/(expense) (d) | 14 | (46 | ) | |||||||||||
Income before income taxes | 3,354 | 2,793 | ||||||||||||
Provision for income taxes (e) | (408 | ) | (98 | ) | ||||||||||
Equity in earnings/(losses) of unconsolidated entities | (61 | ) | (41 | ) | ||||||||||
Net income | 2,885 | 2,654 | ||||||||||||
Less: net income/(losses) attributable to noncontrolling interests and redeemable noncontrolling interest | 9 | 4 | ||||||||||||
Net income attributable to Thermo Fisher Scientific Inc. | $ | 2,875 | 13.8 | % | $ | 2,650 | 12.4 | % | ||||||
Earnings per share attributable to Thermo Fisher Scientific Inc.: | ||||||||||||||
Basic | $ | 7.53 | $ | 6.86 | ||||||||||
Diluted | $ | 7.50 | $ | 6.83 | ||||||||||
Weighted average shares: | ||||||||||||||
Basic | 382 | 386 | ||||||||||||
Diluted | 383 | 388 | ||||||||||||
Reconciliation of adjusted operating income and adjusted operating margin | ||||||||||||||
GAAP operating income | $ | 3,483 | 16.7 | % | $ | 3,141 | 14.7 | % | ||||||
Cost of revenues adjustments (a) | 17 | 0.1 | % | 59 | 0.3 | % | ||||||||
Selling, general and administrative expenses adjustments (b) | (45 | ) | -0.2 | % | 14 | 0.1 | % | |||||||
Restructuring and other costs (c) | 106 | 0.5 | % | 295 | 1.4 | % | ||||||||
Amortization of acquisition-related intangible assets | 1,065 | 5.1 | % | 1,191 | 5.5 | % | ||||||||
Adjusted operating income (non-GAAP measure) | $ | 4,625 | 22.1 | % | $ | 4,700 | 22.0 | % | ||||||
Reconciliation of adjusted net income | ||||||||||||||
GAAP net income attributable to Thermo Fisher Scientific Inc. | $ | 2,875 | $ | 2,650 | ||||||||||
Cost of revenues adjustments (a) | 17 | 59 | ||||||||||||
Selling, general and administrative expenses adjustments (b) | (45 | ) | 14 | |||||||||||
Restructuring and other costs (c) | 106 | 295 | ||||||||||||
Amortization of acquisition-related intangible assets | 1,065 | 1,191 | ||||||||||||
Other income/expense adjustments (d) | (11 | ) | 45 | |||||||||||
Provision for income taxes adjustments (e) | (51 | ) | (342 | ) | ||||||||||
Equity in earnings/losses of unconsolidated entities | 61 | 41 | ||||||||||||
Noncontrolling interests adjustments (f) | (1 | ) | — | |||||||||||
Adjusted net income (non-GAAP measure) | $ | 4,016 | $ | 3,953 | ||||||||||
Reconciliation of adjusted earnings per share | ||||||||||||||
GAAP diluted EPS attributable to Thermo Fisher Scientific Inc. | $ | 7.50 | $ | 6.83 | ||||||||||
Cost of revenues adjustments (a) | 0.04 | 0.15 | ||||||||||||
Selling, general and administrative expenses adjustments (b) | (0.12 | ) | 0.03 | |||||||||||
Restructuring and other costs (c) | 0.28 | 0.76 | ||||||||||||
Amortization of acquisition-related intangible assets | 2.78 | 3.07 | ||||||||||||
Other income/expense adjustments (d) | (0.03 | ) | 0.11 | |||||||||||
Provision for income taxes adjustments (e) | (0.13 | ) | (0.88 | ) | ||||||||||
Equity in earnings/losses of unconsolidated entities | 0.16 | 0.11 | ||||||||||||
Noncontrolling interests adjustments (f) | 0.00 | 0.00 | ||||||||||||
Adjusted EPS (non-GAAP measure) | $ | 10.47 | $ | 10.18 | ||||||||||
Reconciliation of adjusted free cash flow | ||||||||||||||
GAAP net cash provided by operating activities | $ | 3,211 | $ | 2,269 | ||||||||||
Purchases of property, plant and equipment | (648 | ) | (742 | ) | ||||||||||
Proceeds from sale of property, plant and equipment | 20 | 10 | ||||||||||||
Free cash flow (non-GAAP measure) | $ | 2,583 | $ | 1,537 |
Business Segment Information | Six months ended | |||||||||||||
June 29, | % of | July 1, | % of | |||||||||||
(Dollars in millions) | 2024 | Revenues | 2023 | Revenues | ||||||||||
Revenues | ||||||||||||||
Life Sciences Solutions | $ | 4,640 | 22.2 | % | $ | 5,075 | 23.7 | % | ||||||
Analytical Instruments | 3,469 | 16.6 | % | 3,472 | 16.2 | % | ||||||||
Specialty Diagnostics | 2,227 | 10.7 | % | 2,217 | 10.4 | % | ||||||||
Laboratory Products and Biopharma Services | 11,480 | 55.0 | % | 11,594 | 54.2 | % | ||||||||
Eliminations | (930 | ) | -4.5 | % | (961 | ) | -4.5 | % | ||||||
Consolidated revenues | $ | 20,886 | 100.0 | % | $ | 21,397 | 100.0 | % | ||||||
Segment income and segment income margin | ||||||||||||||
Life Sciences Solutions | $ | 1,705 | 36.7 | % | $ | 1,653 | 32.6 | % | ||||||
Analytical Instruments | 838 | 24.2 | % | 853 | 24.6 | % | ||||||||
Specialty Diagnostics | 593 | 26.6 | % | 577 | 26.0 | % | ||||||||
Laboratory Products and Biopharma Services | 1,489 | 13.0 | % | 1,617 | 14.0 | % | ||||||||
Subtotal reportable segments | 4,625 | 22.1 | % | 4,700 | 22.0 | % | ||||||||
Cost of revenues adjustments (a) | (17 | ) | -0.1 | % | (59 | ) | -0.3 | % | ||||||
Selling, general and administrative expenses adjustments (b) | 45 | 0.2 | % | (14 | ) | -0.1 | % | |||||||
Restructuring and other costs (c) | (106 | ) | -0.5 | % | (295 | ) | -1.4 | % | ||||||
Amortization of acquisition-related intangible assets | (1,065 | ) | -5.1 | % | (1,191 | ) | -5.5 | % | ||||||
Consolidated GAAP operating income | $ | 3,483 | 16.7 | % | $ | 3,141 | 14.7 | % | ||||||
(a) Adjusted results in 2024 and 2023 exclude charges for inventory write-downs associated with large-scale abandonment of product lines and accelerated depreciation on manufacturing assets to be abandoned due to facility consolidations. Adjusted results in 2023 exclude $21 of charges for the sale of inventory revalued at the date of acquisition. | ||||||||||||||
(b) Adjusted results in 2024 and 2023 exclude certain third-party expenses, principally transaction/integration costs related to recent acquisitions, and charges/credits for changes in estimates of contingent acquisition consideration. | ||||||||||||||
(c) Adjusted results in 2024 and 2023 exclude restructuring and other costs consisting principally of severance, impairments of long-lived assets, net charges for pre-acquisition litigation and other matters, and abandoned facility and other expenses of headcount reductions and real estate consolidations. Adjusted results in 2023 also exclude $26 of contract termination costs associated with facility closures. | ||||||||||||||
(d) Adjusted results in 2024 and 2023 exclude net gains/losses on investments. | ||||||||||||||
(e) Adjusted results in 2024 and 2023 exclude incremental tax impacts for the reconciling items between GAAP and adjusted net income, incremental tax impacts as a result of tax rate/law changes and the tax impacts from audit settlements. | ||||||||||||||
(f) Adjusted results exclude the incremental impacts for the reconciling items between GAAP and adjusted net income attributable to noncontrolling interests. | ||||||||||||||
Notes: | ||||||||||||||
Consolidated depreciation expense is $562 and $523 in 2024 and 2023, respectively. | ||||||||||||||
For more information related to non-GAAP financial measures, refer to the section titled "Supplemental Information Regarding Non-GAAP Financial Measures" of this release. |
Condensed Consolidated Balance Sheets (unaudited) | ||||||
June 29, | December 31, | |||||
(In millions) | 2024 | 2023 | ||||
Assets | ||||||
Current assets: | ||||||
Cash and cash equivalents | $ | 7,073 | $ | 8,077 | ||
Short-term investments | 1,750 | 3 | ||||
Accounts receivable, net | 7,943 | 8,221 | ||||
Inventories | 5,198 | 5,088 | ||||
Other current assets | 3,512 | 3,200 | ||||
Total current assets | 25,476 | 24,589 | ||||
Property, plant and equipment, net | 9,282 | 9,448 | ||||
Acquisition-related intangible assets, net | 15,519 | 16,670 | ||||
Other assets | 4,377 | 3,999 | ||||
Goodwill | 43,843 | 44,020 | ||||
Total assets | $ | 98,496 | $ | 98,726 | ||
Liabilities, redeemable noncontrolling interest and equity | ||||||
Current liabilities: | ||||||
Short-term obligations and current maturities of long-term obligations | $ | 5,121 | $ | 3,609 | ||
Other current liabilities | 9,651 | 10,403 | ||||
Total current liabilities | 14,772 | 14,012 | ||||
Other long-term liabilities | 5,907 | 6,564 | ||||
Long-term obligations | 30,284 | 31,308 | ||||
Redeemable noncontrolling interest | 115 | 118 | ||||
Total equity | 47,419 | 46,724 | ||||
Total liabilities, redeemable noncontrolling interest and equity | $ | 98,496 | $ | 98,726 |
Condensed Consolidated Statements of Cash Flows (unaudited) | ||||||||
Six months ended | ||||||||
June 29, | July 1, | |||||||
(In millions) | 2024 | 2023 | ||||||
Operating activities | ||||||||
Net income | $ | 2,885 | $ | 2,654 | ||||
Adjustments to reconcile net income to net cash provided by operating activities: | ||||||||
Depreciation and amortization | 1,626 | 1,714 | ||||||
Change in deferred income taxes | (607 | ) | (328 | ) | ||||
Other non-cash expenses, net | 311 | 480 | ||||||
Changes in assets and liabilities, excluding the effects of acquisitions | (1,003 | ) | (2,251 | ) | ||||
Net cash provided by operating activities | 3,211 | 2,269 | ||||||
Investing activities | ||||||||
Purchases of property, plant and equipment | (648 | ) | (742 | ) | ||||
Proceeds from sale of property, plant and equipment | 20 | 10 | ||||||
Proceeds from cross-currency interest rate swap interest settlements | 111 | 35 | ||||||
Acquisitions, net of cash acquired | — | (2,751 | ) | |||||
Purchases of investments | (1,778 | ) | (188 | ) | ||||
Other investing activities, net | 12 | 51 | ||||||
Net cash used in investing activities | (2,283 | ) | (3,585 | ) | ||||
Financing activities | ||||||||
Net proceeds from issuance of debt | 1,204 | — | ||||||
Repayment of debt | — | (1,000 | ) | |||||
Net proceeds from issuance of commercial paper | — | 1,620 | ||||||
Repayment of commercial paper | — | (1,441 | ) | |||||
Purchases of company common stock | (3,000 | ) | (3,000 | ) | ||||
Dividends paid | (284 | ) | (252 | ) | ||||
Other financing activities, net | 145 | 24 | ||||||
Net cash used in financing activities | (1,936 | ) | (4,049 | ) | ||||
Exchange rate effect on cash | 7 | (19 | ) | |||||
Decrease in cash, cash equivalents and restricted cash | (1,000 | ) | (5,384 | ) | ||||
Cash, cash equivalents and restricted cash at beginning of period | 8,097 | 8,537 | ||||||
Cash, cash equivalents and restricted cash at end of period | $ | 7,097 | $ | 3,153 | ||||
Free cash flow (non-GAAP measure) | $ | 2,583 | $ | 1,537 | ||||
Note: | ||||||||
For more information related to non-GAAP financial measures, refer to the section titled "Supplemental Information Regarding Non-GAAP Financial Measures" of this release. |
Supplemental Information Regarding Non-GAAP Financial Measures
In addition to the financial measures prepared in accordance with generally accepted accounting principles (GAAP), we use certain non-GAAP financial measures such as organic revenue growth, which is reported revenue growth, excluding the impacts of acquisitions/divestitures and the effects of currency translation. We also report Core organic revenue growth, which is reported revenue growth, excluding the impacts of COVID-19 testing revenue, and excluding the impacts of acquisitions/divestitures and the effects of currency translation. We report these measures because Thermo Fisher management believes that in order to understand the company's short-term and long-term financial trends, investors may wish to consider the impact of acquisitions/divestitures, foreign currency translation and/or COVID-19 testing on revenues. Thermo Fisher management uses these measures to forecast and evaluate the operational performance of the company as well as to compare revenues of current periods to prior periods.
We report adjusted operating income, adjusted operating margin, adjusted net income, and adjusted EPS. We believe that the use of these non-GAAP financial measures, in addition to GAAP financial measures, helps investors to gain a better understanding of our core operating results and future prospects, consistent with how management measures and forecasts the company's core operating performance, especially when comparing such results to previous periods, forecasts, and to the performance of our competitors. Such measures are also used by management in their financial and operating decision-making and for compensation purposes. To calculate these measures we exclude, as applicable:
- Certain acquisition-related costs, including charges for the sale of inventories revalued at the date of acquisition, significant transaction/acquisition-related costs, including changes in estimates of contingent acquisition-related consideration, and other costs associated with obtaining short-term financing commitments for pending/recent acquisitions. We exclude these costs because we do not believe they are indicative of our normal operating costs.
- Costs/income associated with restructuring activities and large-scale abandonments of product lines, such as reducing overhead and consolidating facilities. We exclude these costs because we believe that the costs related to restructuring activities are not indicative of our normal operating costs.
- Equity in earnings/losses of unconsolidated entities; impairments of long-lived assets; and certain other gains and losses that are either isolated or cannot be expected to occur again with any predictability, including gains/losses on investments, the sale of businesses, product lines, and real estate, significant litigation-related matters, curtailments/settlements of pension plans, and the early retirement of debt. We exclude these items because they are outside of our normal operations and/or, in certain cases, are difficult to forecast accurately for future periods.
- The expense associated with the amortization of acquisition-related intangible assets because a significant portion of the purchase price for acquisitions may be allocated to intangible assets that have lives of up to 20 years. Exclusion of the amortization expense allows comparisons of operating results that are consistent over time for both our newly acquired and long-held businesses and with both acquisitive and non-acquisitive peer companies.
- The noncontrolling interest and tax impacts of the above items and the impact of significant tax audits or events (such as changes in deferred taxes from enacted tax rate/law changes), the latter of which we exclude because they are outside of our normal operations and difficult to forecast accurately for future periods.
We report free cash flow, which is operating cash flow excluding net capital expenditures, to provide a view of the continuing operations' ability to generate cash for use in acquisitions and other investing and financing activities. The company also uses this measure as an indication of the strength of the company. Free cash flow is not a measure of cash available for discretionary expenditures since we have certain non-discretionary obligations such as debt service that are not deducted from the measure.
Thermo Fisher Scientific does not provide GAAP financial measures on a forward-looking basis because we are unable to predict with reasonable certainty and without unreasonable effort items such as the timing and amount of future restructuring actions and acquisition-related charges as well as gains or losses from sales of real estate and businesses, the early retirement of debt and the outcome of legal proceedings. The timing and amount of these items are uncertain and could be material to Thermo Fisher Scientific's results computed in accordance with GAAP.
The non-GAAP financial measures of Thermo Fisher Scientific's results of operations and cash flows included in this press release are not meant to be considered superior to or a substitute for Thermo Fisher Scientific's results of operations prepared in accordance with GAAP. Reconciliations of such non-GAAP financial measures to the most directly comparable GAAP financial measures are set forth in the tables above.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240723465896/en/
Media Contact Information:
Sandy Pound
Thermo Fisher Scientific
Phone: 781-622-1223
E-mail: sandy.pound@thermofisher.com
Investor Contact Information:
Rafael Tejada
Thermo Fisher Scientific
Phone: 781-622-1356
E-mail: rafael.tejada@thermofisher.com
News Provided by Business Wire via QuoteMedia
June 2024 Quarterly Activities Report
Ovarian cancer diagnostics company, Cleo Diagnostics Limited (ASX:COV) (CLEO, or the Company) is pleased to provide the market with an update on activities in the June 2024 quarter as it develops its simple and accurate blood test for the early detection of ovarian cancer.
Highlights
- U.S. regulatory process commenced with FDA following initial pre-submission meeting held where CLEO outlined its submission framework and clinical plan
- A benchmarking study published in scientific journal “Cancers” demonstrated that CLEO’s ovarian cancer blood test outperforms current clinical benchmark
- FDA-enabling U.S. clinical trials commencing this quarter, targeting recruitment of 500 patients to verify CLEO’s pre-surgical ovarian cancer test
- CLEO’s U.S. market access and reimbursement program bolstered by appointment of New York- based healthcare industry consultancy HcFocus
- A$9.373M cash at bank at 30 June 2024
Commencement of U.S. Regulatory Process
CLEO completed an initial pre-submission meeting with the U.S. Food and Drug Administration (FDA) where the Company outlined its submission framework and clinical plan for its ovarian cancer detection blood test. The pre- submission meeting is designed to allow CLEO to receive early guidance from FDA review teams prior to an eventual application submission.
The meeting was interactive with the FDA providing constructive and positive feedback on CLEO’s approach to obtaining regulatory approval in the U.S. for its ovarian cancer detection blood test. This outcome provides confidence that CLEO's clinical trial designs and strategic direction are appropriately aligned with FDA requirements.
Early interaction with the FDA is important as a part of CLEO’s U.S. market access strategy for a number of reasons, as the guidance outcomes allow CLEO to:
- Refine its clinical trial design to maximise resourcing and quality of data;
- Reduce the possibility of rework;
- Shorten the potential timeframe to application submission; and
- Operate with an open and transparent approach.
CLEO is pursuing expedited FDA approval for its first ovarian cancer detection product - the pre-surgical Triage test - via the 510(k) application pathway. This approach provides the quickest pathway to achieve regulatory approval for devices that achieve "substantial equivalence" to an existing predicate.
Click here for the full ASX Release
This article includes content from Cleo Diagnostics, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
Bausch Health Welcomes Two New Members to the Executive Leadership Team
Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) today announced the appointment of two new members to its Executive Leadership Team (ELT
Jean-Jacques Charhon ("JJ") will join the Company as Chief Financial Officer on August 19, 2024. JJ has over 25 years of experience in financial leadership roles with public and private companies across healthcare, high tech and services, primarily at General Electric, Hewlett Packard, Novartis and Purdue Pharma. Upon JJ's arrival, John Barresi, the Company's Interim Chief Financial Officer, will resume his role as SVP, Controller.
Aimee Lenar joined the Company on July 15, 2024 as Executive Vice President, US Pharma. Aimee's new role includes leadership of Salix Pharmaceuticals, Bausch Health's gastroenterology (GI) business, as well as Neurology, Generics, Market Access and Commercial Operations. Aimee brings over 20 years of experience in the pharmaceutical industry, most recently as Head of US Prescription Medicine at Galderma.
"We are delighted to welcome JJ and Aimee to our ELT. They are both proven leaders bringing extensive experience and expertise to their respective roles that will drive our transformation and achieve our ambition to be a globally integrated and innovative healthcare company, trusted and valued by patients, HCPs, employees, and investors," said CEO, Thomas J. Appio. "I want to thank John Barresi for all his hard work and dedication as he stepped in as Interim Chief Financial Officer along with his other responsibilities. I am grateful to have John on the team; he is an integral part of our Financial Leadership Team."
About Jean-Jacques Charhon
On August 19, 2024, JJ will join the Company from Signant Health where he was Executive Vice President and Chief Financial Officer and was primarily responsible for financial planning and analysis, accounting & controllership, treasury, tax and procurement. JJ has over 25 years of experience in financial leadership roles with public and private companies such as General Electric, Hewlett Packard, Novartis and Purdue Pharma. JJ is passionate about driving business enablement through the finance function for both strategy shaping and operational execution. JJ holds a master's degree in business administration from the Solvay School of Management in Brussels, Belgium.
About Aimee Lenar
Aimee joined the Company from her most recent role as Head of US Prescription Medicine at Galderma. At Galderma, Aimee was responsible for sales, marketing, market access, and business analytics, overseeing both a portfolio of established prescription products and a new immunology asset. Prior to this role, Aimee held leadership roles with AbbVie and Allergan, where she served most recently as a VP and General Manager of CNS. Prior to this role, she was VP Gastroenterology at AbbVie for over 5 years. Aimee has a proven track record across several roles and brings a wealth of marketing and sales execution to Bausch Health. Aimee holds a master's degree in public health from Emory University.
About Bausch Health
Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) is a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling ownership of Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information, visit www.bauschhealth.comand connect with us on LinkedIn.
Forward-looking Statements
This news release may contain forward-looking statements about the future performance of Bausch Health, which may generally be identified by the use of the words "will," "anticipates," "hopes," This news release contains forward-looking information and statements, within the meaning of applicable securities laws (collectively, "forward-looking statements"), including, but not limited to, statements relating to the Company's succession plan for its chief financial officer position. Forward-looking statements may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "estimates," "potential," "target," or "continue" and variations or similar expressions, and phrases or statements that certain actions, events or results may, could, should or will be achieved, received or taken, or will occur or result, and similar such expressions also identify forward-looking information. These forward-looking statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in these forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in the Company's most recent annual and quarterly reports and detailed from time to time in the Company's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which risks and uncertainties are incorporated herein by reference. Additional information regarding certain of these material factors and assumptions may be found in the Company's filings described above. The Company believes that the material factors and assumptions reflected in these forward-looking statements are reasonable in the circumstances, but readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. The Company undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
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Investor Contact: | Media Contact: | |
Garen Sarafian | Katie Savastano | |
(877) 281-6642 (tollfree) | (908) 569-3692 |
SOURCE: Bausch Health Companies Inc
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