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
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 December 2023 quarter as it develops its simple and accurate blood test for the early detection of ovarian cancer.
Highlights
Cleo’s first clinical validation study for its ovarian cancer triage test has been published in the peer- reviewed international journal ‘Cancers’. The results confirm the high accuracy of the CleoDX Triage Test, which was independent of menopausal status, and showed that it out-performed the two most widely used clinical scoring systems (the “Risk of Malignancy Index” and “Risk of Malignancy Algorithm”) for discriminating benign from malignant ovarian disease.
A copy of the publication is available here: https://www.mdpi.com/2072-6694/15/21/5267
Moreover, the CleoDX surgical triage test correctly identified 81% of early-stage cancer patients in the cohort.
The next step in development will confirm functionality of the commercially available kits in an independent clinical trial, the results of which will be submitted to the FDA for regulatory approval. Cleo anticipates commencement of this trial early in CY2024.
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.
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.
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.
Cleo is bringing to market three testsfor ovarian cancer diagnosis, monitoring and screening.
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 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 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 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 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 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
"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:
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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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
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:
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 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.
###
Investor Contact: | Media Contact: | |
Garen Sarafian | Katie Savastano | |
(877) 281-6642 (tollfree) | (908) 569-3692 |
SOURCE: Bausch Health Companies Inc
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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
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SOURCE: Medtronic
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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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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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