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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
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Cleo Diagnostics
Overview
A medical technology company based in Australia, Cleo Diagnostics (ASX:COV) is revolutionising women's healthcare with its disruptive cancer detection platform technology, through a simple blood test that can accurately detect ovarian cancer early – the leading cause of cancer-related deaths among women.
Approximately 50 percent of women will die within five years of an ovarian cancer diagnosis. The chances of survival beyond five years, however, increase with early detection. According to the American Cancer Society, only about 20 percent of ovarian cancers are diagnosed at an early stage, and more than 90 percent of women live beyond five years when the cancer is detected early.
With early diagnosis being key to a higher survival rate, ovarian cancer has become a target for biomarker research. And one particular biomarker holds promise.
Cleo’s technology is underpinned by the CXCL10 novel and patented biomarker, which was first identified as a small inflammatory molecule in ovarian cancer tissue sections. Subsequent research demonstrated that CXCL10 was overexpressed in ovarian cancers, but importantly not expressed in benign disease, and remains throughout the lifetime of the cancer. The biomarker effectively provides a robust indicator at all stages of cancer. Recognizing that early detection is a significantly unmet need in the clinical diagnostics market, Cleo Diagnostics is focused on bringing to market a simple blood test to accurately detect ovarian cancer early.
Cleo’s first clinical validation study for its ovarian cancer triage test has been published in the peer-reviewed international journal Cancers. The article concluded that Cleo’s ovarian cancer test was highly accurate with 95 percent sensitivity and 95 percent specificity, correctly discriminated malignant from benign samples, and has outperformed and was superior to current clinical methods. The second peer-reviewed dataset has also been published in the medical journal Diagnostics, which concluded that CLEO’s test has correctly identified most cancer cases that were missed by the standard marker CA125. It also eliminated the majority of “false positive” results caused by CA125 use, and it correctly identified the majority of patients with early-stage ovarian cancers.
CLEO has appointed New York-based healthcare industry consultancy, HcFocus, to support the commencement of its US market access program. HcFocus will provide specialised and strategic expertise to assist CLEO in navigating the complexities of the US health system and regulatory environment.
The addressable market for a technology like this is compelling, and with a management team that brings to the table decades of leadership experience in the medical technology space, Cleo is well-positioned to leverage this market opportunity.
Cleo chief executive and executive director Dr. Richard Allman has over 30 years of experience in commercially focused scientific research and innovation. Throughout his career, Allman has overseen and expedited a product development pipeline covering no less than six major cancers, cardiovascular disease, type-2 diabetes and a commercially available COVID-19 test.
Chief scientific officer Dr. Andrew Stephens boasts an equally impressive resume. A career research scientist with two decades of experience in molecular and cellular biology, Stephens is named in over 60 academic publications and holds numerous patents in the cancer therapy and diagnostic space. Cleo’s blood test looks for a novel and patented biomarker in the blood called CXCL10, which was discovered by Stephens, the product of over ten years of scientific work at Monash Medical Centre's Hudson Institute of Medical Research.
There's also Professor Tom Jobling, Cleo's non-executive director and lead medical advisor. As the head of gynaecological oncology at Monash Health and visiting medical officer at the Peter MacCallum Cancer Centre, Jobling has been treating ovarian cancer for over thirty years. He was also the founding chairman of the Ovarian Cancer Research Foundation (OCRF)
Non-executive director Lucinda Nolan, meanwhile, brings significant business and strategic expertise to the table. Most recently, she served as the CEO of the Ovarian Cancer Research Foundation.
These experienced professionals, together with the other members of Cleo’s management and board, have developed a staged execution strategy focused on de-risking the pathway to the international screening market — ensuring that, although Cleo is still in its advanced R&D stage, its prospects for commercialisation remain incredibly promising.
Company Highlights
- Backed by medical professionals and cancer specialists with decades of experience, Cleo Diagnostics has developed a disruptive, accurate and early-stage ovarian cancer detection blood test.
- Cleo targets the CXCL10 novel biomarker, which is now known to be overexpressed in all stages of ovarian cancer.
- Cleo is the result of more than a decade of research at the Hudson Institute of Medical Research, where chief scientist Dr. Andrew Stephens received more than $5 million OCRF & NHMRC funding for development and clinical studies.
- The test is also supported by Professor Tom Jobling, founder of the Ovarian Cancer Foundation and Lucinda Nolan, the foundation's former CEO.
- Cleo has developed a staged execution strategy focused on an achievable path to market. This ensures the project, which is currently in its advanced R&D stage, can maximise commercial value for all stakeholders.
Key Projects
Cleo Diagnostics
Developed over a decade by Dr. Andrew Stephens, Cleo’s blood test is underpinned by the CXCL10 novel and patented protein biomarker known to be present in all stages of ovarian cancer. By combining CXCL10 with several other biomarkers in a custom algorithm, Cleo can not only be used in triage, but also for screening and recurrence testing. The project is currently in the advanced R&D stage and has so far conducted two clinical studies, analysing more than 700 patient samples in the process.
Highlights:
- Readily Accessible: Cleo requires no additional or specialised equipment and can be conducted in any standard pathology lab either on its own or as part of a standard panel of tests ordered by a physician.
- AI-based Risk Assessment: Once the sample has been collected and tested, Cleo leverages a proprietary algorithm to perform a risk evaluation on the patient, determining the likelihood of a cancer diagnosis.
- Intuitive Results: Cleo generates an easy-to-understand post-assessment report which can then be sent to the patient's primary care provider or surgeon for triage.
- High Performance: The Cleo prototype outperforms FDA-cleared predicates and clinical guideline tests in terms of accuracy and specificity.
- Current Roadmap: Cleo plans for the test to be ready for clinical use in a surgical triage setting by 2025, where it will be available initially to one million patients. Target launch dates for recurrence, high-risk screening and mass screening are still to be determined. Additionally, the company has numerous inflection points planned over the next two years:
- Kit Development:
- Internal trial antibody optimisation
- Finalisation of antibody selection for the Cleo test-kit
- Complete re-agent development
- Pre-IDE strategic development
- Manufacturing:
- Establishment and accreditation of ISO13485 quality system
- Manufacturing establishment of Cleo key biomarker
- Manufacturing establishment of Cleo Ovarian Cancer Kit
- Clinical Studies:
- Sign key opinion leaders and trial sites
- Perform and finalise verification of the Cleo kit through clinical studies
- Regulatory Approval:
- FDA Pre-IDE submission
- CE regulatory submissions and approval
- TGA regulatory submission and approval
- FDA submission and approval
- Kit Development:
Cleo is bringing to market three testsfor ovarian cancer diagnosis, monitoring and screening.
Management Team
Dr. Richard Allman — Chief Executive Officer and Executive Director
Dr. Richard Allman has over 30 years of scientific research leadership and innovation with a clear focus on commercialisation. He has wide experience in research leadership, innovation management, and intellectual property strategy, covering oncology, diagnostics, and product development.
Previously, Allman was chief scientific officer at Genetic Technologies (ASX:GTG). Recent successes include the strategic design and management of a second-generation breast cancer risk assessment test from concept to commercial launch and a similar test for colorectal cancer. These tests have now been NATA-accredited and comprise the first commercially available polygenic risk tests in Australia.
More recently, Allman supervised the underlying R&D, translation, regulatory approval, patent filing and commercial launch of a COVID-19 disease severity test within 12 months. This strategy has been utilised to expedite a product development pipeline covering six major cancers, cardiovascular disease and type-2 diabetes which were commercially launched in March 2022.
Dr. Andrew Stephens — Chief Scientific Officer and Executive Director
Dr. Andrew Stephens is a career research scientist with 20 years of experience in molecular and cellular biology research. He has broad experience in academic and pre-clinical research and a strong focus on translation and the commercialisation of research findings. He established and leads an independent academic research group at the Hudson Institute of Medical Research, investigating mechanisms that contribute to the formation, progression and dissemination of high-grade, serous epithelial ovarian cancers. Since 2010, his research has focused on biomarker identification and development in ovarian cancer and the development of therapeutic strategies to improve patient outcomes. He is also actively involved across the biotech sector, with appointments to the scientific advisory for Invion and AMTBio.
Stephens has more than 60 academic publications and numerous patents (pending and provisional) in the cancer therapeutic and diagnostic space.
Professor Tom Jobling — Lead Medical Advisor and Non-executive Director
Professor Thomas Jobling is director of gynaecologic oncology at Monash Medical Centre. He graduated from Monash University in 1980 and did his postgraduate sub-specialist training in gynaecologic oncology in London at the Royal Marsden and St Bartholomew's hospitals. Jobling has subsequently been elected as a member of the Society of Pelvic Surgeons and is also founder of the Ovarian Cancer Research Foundation (1999). He was the chairman of the Ovarian Cancer Research Foundation Board. His major interests are in radical surgery for ovarian cancer and the application of robotic surgery for gynaecological malignancy.
Jobling is an active member of a research team in biomarker detection and proteomics in ovarian cancer. He is involved as a collaborative investigator on a number of international clinical trials and is a member of the Australia and New Zealand Gynaecologic Oncology Group, the Australian Society of Gynaecologic Oncology, the Victorian Cooperative Oncology Group and the International Society of Gynaecological Cancer.
Lucinda Nolan — Non-executive Director
Lucinda Nolan is a non-executive director and was most recently the CEO of the Ovarian Cancer Research Foundation. She has a wealth of knowledge and experience across the public sector and not-for-profit environments. Before joining the Ovarian Cancer Research Foundation, she was selected as the first female CEO of the Country Fire Authority, one of the world’s largest volunteer-based emergency services organisations. She also spent 32 years with Victoria Police, reaching the rank of deputy commissioner. She was awarded the Australian Police Medal in 2009.
Nolan is also the chair of BankVic and a director on the boards of Alkira Box Hill and the Melbourne Archdiocese of Catholic Schools. She has a Master of Arts and a Bachelor of Arts (Honours) from Melbourne University and is an alum of the Advanced Management Programme at Harvard University.
Adrien Wing — Non-executive Chair
Adrien Wing began his professional career practising in the audit and corporate advisory divisions of a chartered accounting firm. He has over 25 years of experience in the corporate sector with a large portion of this experience in ASX small caps, lead in IPO transactions and post listing reverse takeovers and acquisitions across a range of industry sectors and jurisdictions. He also has a strong pedigree in the life sciences industry being the founder of Rhythm Biosciences and bringing that entity to the ASX in 2017.
Wing currently serves as an officer/director on the following company boards: New Age Exploration (ASX: NAE), director and joint company secretary; Red Sky Energy (ASX:ROG), director and joint company secretary; Sparc Technologies (ASX:SPN), company secretary; and Osmond Resources (ASX:OSM), company secretary.
Thermo Fisher Scientific Reports Second Quarter 2024 Results
- 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
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Medtronic Recognized for Disability Inclusion in U.S., U.K.
For the seventh consecutive year in the U.S., and for the first time in the U.K., Medtronic is recognized as a "Best Place to Work for Disability Inclusion" by Disability:IN and the American Association of People with Disabilities
For the seventh consecutive year in the U.S., and for the first time in the U.K., Medtronic is recognized as a "Best Place to Work for Disability Inclusion" by Disability:IN and the American Association of People with Disabilities (AAPD). This honor is the result of Medtronic earning a top score of 100 on the 2024 Disability Equality Index®, which is the world's most comprehensive benchmarking tool for measuring disability workplace inclusion
Medtronic is committed to employees with disabilities and their allies, and to ensuring they have the tools and resources they need to thrive in the workplace, and in life. Today's recognition - along with ranking among DiversityInc's 2024 Top Companies for People with Disabilities - validates our work and provides momentum to keep advancing our efforts.
The company's unwavering commitment to inclusion, diversity, and equity (ID&E) means zero barriers to opportunity within Medtronic and a culture where all employees belong, are respected, and feel valued for who they are and the life experiences they contribute. Anchored in our Mission, we continue to drive ID&E forward both to enhance the well-being of Medtronic employees and to accelerate innovation that brings our lifesaving technologies to more people in more places 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 more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic, visit www.Medtronic.com and follow Medtronic on LinkedIn
View additional multimedia and more ESG storytelling from Medtronic on 3blmedia.com.
Contact Info:
Spokesperson: Medtronic
Website: https://www.3blmedia.com/profiles/medtronic
Email: info@3blmedia.com
SOURCE: Medtronic
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Thermo Fisher Scientific Declares Quarterly Dividend
Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today announced that its Board of Directors authorized a quarterly cash dividend of $0.39 per common share, payable on October 15, 2024, to shareholders of record as of September 13, 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 .
View source version on businesswire.com: https://www.businesswire.com/news/home/20240711114348/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
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Thermo Fisher Scientific to Help Advance Myeloid Cancer Clinical Research and Treatment Utilizing Next Generation Sequencing Technology
myeloMATCH Precision Medicine Clinical Trial Leverages Next-Day Genomic Testing to Quickly Match Patients with Appropriate Trials Across North America
To help accelerate research into new treatments for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, is partnering with the National Cancer Institute (NCI) part of the National Institutes of Health on the myeloMATCH (Molecular Analysis for Therapy Choice) precision medicine umbrella trial. By testing patients' bone marrow and blood for certain genetic biomarkers using Thermo Fisher's next-generation sequencing (NGS) technology, clinical sites can more quickly match patients with an appropriate clinical trial that tests a treatment designed to target specific mutations present in the samples.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240711570854/en/
myeloMATCH Precision Medicine Clinical Trial Leverages Next-Day Genomic Testing to Quickly Match Patients with Appropriate Trials Across North America (Photo: Business Wire)
AML is an aggressive cancer of the bone marrow and blood and is one of the most common types of leukemia. Because it can advance quickly with a five-year survival rate of only 30-40% for people under age 60, rapid detection and effective treatment are essential to improve patient outcomes. Further, clinical practice guidelines note the importance of rapid genetic analysis to identify biomarkers that may help match patients with optimal treatments based on their unique cancer profile.
"myeloMATCH breaks new ground in many ways, not least by assembling a portfolio of sub-studies to treat patients with specific subtypes of AML and MDS through all stages of their treatment journey," said Dr. Harry P. Erba, chair of the Southwest Oncology Group (SWOG) Leukemia Committee and co-chair of the myeloMATCH Senior Science Council. "Many more treatment options are available for people with AML and MDS than just 5-10 years ago, and many more targeted therapies are being developed. However, to choose the best treatment option for our patients requires knowledge of the genetic changes that underly the disease, which vary between patients. This information is needed quickly in order to begin effective therapy for very aggressive cancers. Our partnership with Thermo Fisher allows us to obtain the required genomic profiling rapidly and begin therapies specific for each subtype of the disease. Through this personalized approach to treatment, we believe we will increase the number of people who are leukemia survivors."
The study aims to complete genomic testing and deliver complete results within a few days across testing modalities to help quickly enroll patients into specific sub-studies based on their biomarker profile at time of diagnosis. As the first turnkey NGS solution that automates the specimen-to-report workflow designed to deliver results in a single day with just two user touchpoints, the Ion Torrent ™ Genexus ™ System * will help accelerate the process of matching patients with appropriate clinical trials.
myeloMATCH will be open in the U.S. and Canadian sites of the NCI National Clinical Trials Network, which includes more than 2,200 sites. Further, the NCI's Division of Cancer Treatment and Diagnosis has developed cooperative research and development agreements with many pharmaceutical companies that will provide different drugs to support myeloMATCH. By conducting multiple treatment sub-studies specific to genomic types, myeloMATCH may help fuel the development of promising new therapies.
"myeloMATCH is an immense step forward for patients with aggressive and rapidly advancing cancers who need better treatment options," said John Sos, senior vice president and president, life sciences solutions at Thermo Fisher Scientific. "Using the Genexus System, clinical teams across sites can quickly match eligible patients with the right trials to ultimately better understand the clinical impact of these therapies. By helping to expedite this process, we can ensure that more patients have access to appropriate precision oncology treatments."
Patient samples will be sequenced in the myeloMATCH Molecular Diagnostics Laboratory Network (MDNet) using the Genexus System and reagents along with the Oncomine-based NCI Myeloid Assay as part of an approved Investigational Device Exemption (IDE) to assign participants to myeloMATCH treatment studies and has received Investigational New Drug authorization by the U.S. Federal Drug Administration. The MDNet sites at the Molecular Characterization Laboratory, part of the Frederick National Laboratory for Cancer Research, and the Fred Hutchinson Cancer Center in Seattle, Wash., are funded by NCI for this activity. As presented during the 2023 American Society of Hematology (ASH) annual meeting , the assay demonstrated high sensitivity and reproducibility between sites.
To learn more about myeloMATCH, please visit https://clinicaltrials.gov/study/NCT05564390
* Available for research use only in the United States. Not for use in diagnostic procedures.
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 .
View source version on businesswire.com: https://www.businesswire.com/news/home/20240711570854/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: 781-622-1256
Email: rafael.tejada@thermofisher.com
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Knight Announces Normal Course Issuer Bid
Knight Therapeutics Inc. (TSX:GUD) (" Knight " or the " Company "), a leading pan-American (ex-US) specialty pharmaceutical company, announced today acceptance by the Toronto Stock Exchange (the "TSX") of the Company's Notice of Intention to Make a Normal Course Issuer Bid ("NCIB"). Pursuant to the NCIB, the Company proposes to purchase, from time to time over the next 12 months, if considered advisable, up to 5,312,846 common shares of the Company, being approximately 10% of its public float of 53,128,463 common shares, as of June 30, 2024. As of June 30, 2024, there were a total of 101,327,297 common shares issued and outstanding. Purchases may commence on July 15, 2024 and will conclude on the earlier of the date on which purchases under the bid have been completed and July 14, 2025. The Company may purchase up to a daily maximum of 16,855 common shares (being 25% of the average daily trading volume of 67,421 common shares, for the last six calendar months). The common shares may be purchased for cancellation through the facilities of the TSX or through alternative Canadian trading systems at times and in numbers to be determined by the Company. The Company had previously sought and obtained approval from the TSX to purchase up to 5,999,524 common shares under an NCIB and the Company has, in the twelve months preceding this announcement, purchased such 5,999,524 common shares through the facilities of the TSX and alternative Canadian trading systems at a weighted average price per share of $4.87.
Knight also entered into an automatic share purchase plan with a broker in order to facilitate purchases of its common shares under the NCIB. Under Knight's automatic share purchase plan, Knight's broker may repurchase common shares which it would ordinarily not be permitted to due to regulatory restrictions or self-imposed blackout periods. Purchases will be made by Knight's broker based upon the parameters prescribed by the TSX and applicable Canadian securities laws and the terms of the parties' written agreement. The automatic share purchase plan has been pre-cleared by the TSX and will be implemented effective as of July 15, 2024.
The Company believes that the market price of Knight's common shares, from time to time, may not reflect the inherent value of the Company and purchases of common shares pursuant to the bid may represent an appropriate and desirable use of the Company's funds. The price that Knight will pay for Common Shares in open market transactions will be the market price at the time of purchase.
About Knight Therapeutics Inc .
Knight Therapeutics Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing and commercializing pharmaceutical products for Canada and Latin America. Knight's Latin American subsidiaries operate under United Medical, Biotoscana Farma and Laboratorio LKM. Knight Therapeutics Inc.'s shares trade on TSX under the symbol GUD. For more information about Knight Therapeutics Inc., please visit the company's web site at www.knighttx.com or www.sedarplus.ca .
Forward-Looking Statement
This document contains forward-looking statements for Knight Therapeutics Inc. and its subsidiaries. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Knight Therapeutics Inc. considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared but cautions the reader that these assumptions regarding future events, many of which are beyond the control of Knight Therapeutics Inc. and its subsidiaries, may ultimately prove to be incorrect. Factors and risks which could cause actual results to differ materially from current expectations are discussed in Knight Therapeutics Inc.'s Annual Report and in Knight Therapeutics Inc.'s Annual Information Form for the year ended December 31, 2023, as filed on www.sedarplus.ca . Knight Therapeutics Inc. disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information or future events, except as required by law.
CONTACT INFORMATION:
| Investor Contact: | |
| Knight Therapeutics Inc. | |
| Samira Sakhia | Arvind Utchanah |
| President & Chief Executive Officer | Chief Financial Officer |
| T: 514.484.4483 | T. +598.2626.2344 |
| F: 514.481.4116 | |
| Email: IR@knighttx.com | Email: IR@knighttx.com |
| Website: www.knighttx.com | Website: www.knighttx.com |
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