Beckman Coulter SARS-CoV-2 IgM Antibody Test Receives FDA Emergency Use Authorization

Beckman Coulter, a clinical diagnostics leader, today announced its Access SARS-CoV-2 Immunoglobulin M (IgM) assay has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). The assay detects antibodies that recognize the receptor binding domain (RBD) of the spike protein which the SARS-CoV-2 virus uses to enter the human host cells. The assay, which demonstrates 99.9% specificity and 98.3% sensitivity, is part of a suite of diagnostic solutions being developed by Beckman Coulter in response to the ongoing COVID-19 pandemic to guide physicians and patients in their healthcare decision making.

Beckman Coulter's Access SARS-CoV-2 IgM antibody assay receives Emergency Use Authorization from the U.S. FDA

"Since March, the Beckman Coulter team has worked around the clock to develop a suite of assays that play a critical role in the ongoing global fight against COVID-19," said Julie Sawyer Montgomery , president of Beckman Coulter. "As a science-driven company, we continue in our commitment to deliver rigorously validated diagnostics of the highest quality that provide meaningful information, so doctors and patients alike can trust the results for urgent, care decisions."

Beckman Coulter's suite of COVID-19 testing solutions includes the Access SARS-CoV-2 IgM assay and the Access SARS CoV-2 IgG assay, which received EUA in June. The company also recently received FDA Emergency Use Authorization for its interleukin 6 (IL-6) assay, which can be used to assist in identifying severe inflammatory response in patients with confirmed COVID 19 illness to aid in determining the risk of intubation with mechanical ventilation, in conjunction with clinical findings and the results of other laboratory testing. Beckman Coulter is also currently developing a SARS CoV-2 antigen assay as well as a quantitative IgG assay anticipated to be launched later this year.

All of the Beckman Coulter assays to address COVID-19 can be performed in automated or high-throughput immunoassay formats, as well as Beckman Coulter's Access 2 analyzer, a compact, table-top analyzer enabling high-quality serology testing to be carried out in small hospitals and clinics. Additionally, all of the assays seamlessly integrate into laboratory workflows making it easy to add these tests to routine blood tests performed during inpatient and wellness testing.

For more information on Beckman Coulter's suite of testing solutions or its commitment to the fight against COVID-19, visit: www.BeckmanCoulter.com/Coronavirus .

About the Access SARS-CoV-2 IgM Assay

The Access SARS-CoV-2 IgM Assay is a qualitative immunoassay that detects IgM antibodies. The test has confirmed 98.3% positive percent agreement (sensitivity) at 15-30 days post symptom onset and 99.9% negative percent agreement (specificity). The assay utilizes an immunocapture format to bind patient IgM antibodies on the magnetic particle solid phase and a recombinant SARS-CoV-2 protein - enzyme conjugate to detect anti-SARS-CoV-2 IgM. The Access SARS-CoV-2 IgM assay can be used in Random Access Mode (RAM), which means that the antibody tests can be run along with other immunoassay tests. The assay can also be used with a variety of Beckman Coulter analyzers, including the high-throughput DxI 800 designed for large labs, to the DxI 600 for mid-sized labs and the DxC 600i and Access 2 analyzers for smaller labs and healthcare clinics.

About Beckman Coulter

Beckman Coulter is committed to advancing healthcare for every person by applying the power of science, technology and the passion and creativity of our teams to enhance the diagnostic laboratory's role in improving healthcare outcomes. Our diagnostic systems are used in complex biomedical testing, and are found in hospitals, reference laboratories and physician office settings around the globe. Beckman Coulter offers a unique combination of people, processes and solutions designed to elevate the performance of clinical laboratories and healthcare networks. We do this by accelerating care with a menu that matters, bringing the benefit of automation to all, delivering greater insights through clinical informatics and unlocking hidden value through performance partnership. An operating company of Danaher Corporation (NYSE: DHR) since 2011, Beckman Coulter is headquartered in Brea, Calif. , and has more than 11,000 global associates working diligently to make the world a healthier place.

© 2020 Beckman Coulter. All rights reserved. Beckman Coulter, the stylized logo, and the Beckman Coulter product and service marks mentioned herein are trademarks or registered trademarks of Beckman Coulter, Inc. in the United States and other countries.

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SOURCE Beckman Coulter Diagnostics

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Condensed Consolidated Statements of Income (unaudited)
	Three months ended
	September 28,			% of		September 30,			% of
(Dollars in millions except per share amounts)	2024			Revenues		2023			Revenues
Revenues	$	10,598				$	10,574
Costs and operating expenses:
Cost of revenues (a)		6,180		58.3	%		6,145		58.1	%
Selling, general and administrative expenses (b)		1,739		16.4	%		1,578		14.9	%
Amortization of acquisition-related intangible assets		450		4.2	%		584		5.6	%
Research and development expenses		346		3.3	%		319		3.0	%
Restructuring and other costs (c)		45		0.4	%		84		0.8	%
Total costs and operating expenses		8,759		82.7	%		8,710		82.4	%
Operating income		1,838		17.3	%		1,864		17.6	%
Interest income		277					246
Interest expense		(356	)				(359	)
Other income/(expense) (d)		(16	)				14
Income before income taxes		1,742					1,765
Provision for income taxes (e)		(99	)				(53	)
Equity in earnings/(losses) of unconsolidated entities		(14	)				(17	)
Net income		1,629					1,695
Less: net income/(losses) attributable to noncontrolling interests and redeemable noncontrolling interest (f)		—					(20	)
Net income attributable to Thermo Fisher Scientific Inc.	$	1,630		15.4	%	$	1,715		16.2	%

Earnings per share attributable to Thermo Fisher Scientific Inc.:
Basic	$	4.26				$	4.44
Diluted	$	4.25				$	4.42
Weighted average shares:
Basic		382					386
Diluted		384					388

Reconciliation of adjusted operating income and adjusted operating margin
GAAP operating income	$	1,838		17.3	%	$	1,864		17.6	%
Cost of revenues adjustments (a)		9		0.1	%		14		0.1	%
Selling, general and administrative expenses adjustments (b)		21		0.2	%		14		0.1	%
Restructuring and other costs (c)		45		0.4	%		84		0.8	%
Amortization of acquisition-related intangible assets		450		4.2	%		584		5.6	%
Adjusted operating income (non-GAAP measure)	$	2,362		22.3	%	$	2,560		24.2	%

Reconciliation of adjusted net income
GAAP net income attributable to Thermo Fisher Scientific Inc.	$	1,630				$	1,715
Cost of revenues adjustments (a)		9					14
Selling, general and administrative expenses adjustments (b)		21					14
Restructuring and other costs (c)		45					84
Amortization of acquisition-related intangible assets		450					584
Other income/expense adjustments (d)		3					(9	)
Provision for income taxes adjustments (e)		(139	)				(192	)
Equity in earnings/losses of unconsolidated entities		14					17
Noncontrolling interests adjustments (f)		(6	)				(19	)
Adjusted net income (non-GAAP measure)	$	2,026				$	2,208

Reconciliation of adjusted earnings per share
GAAP diluted EPS attributable to Thermo Fisher Scientific Inc.	$	4.25				$	4.42
Cost of revenues adjustments (a)		0.02					0.04
Selling, general and administrative expenses adjustments (b)		0.05					0.03
Restructuring and other costs (c)		0.12					0.22
Amortization of acquisition-related intangible assets		1.17					1.50
Other income/expense adjustments (d)		0.01					(0.02	)
Provision for income taxes adjustments (e)		(0.36	)				(0.49	)
Equity in earnings/losses of unconsolidated entities		0.04					0.04
Noncontrolling interests adjustments (f)		(0.02	)				(0.05	)
Adjusted EPS (non-GAAP measure)	$	5.28				$	5.69

Reconciliation of free cash flow
GAAP net cash provided by operating activities	$	2,167				$	2,414
Purchases of property, plant and equipment		(271	)				(332	)
Proceeds from sale of property, plant and equipment		20					66
Free cash flow (non-GAAP measure)	$	1,915				$	2,148

Business Segment Information	Three months ended
	September 28,			% of		September 30,			% of
(Dollars in millions)		2024		Revenues			2023		Revenues

Revenues
Life Sciences Solutions	$	2,387		22.5	%	$	2,433		23.0	%
Analytical Instruments		1,808		17.1	%		1,754		16.6	%
Specialty Diagnostics		1,129		10.7	%		1,083		10.2	%
Laboratory Products and Biopharma Services		5,740		54.2	%		5,728		54.2	%
Eliminations		(467	)	-4.4	%		(424	)	-4.0	%
Consolidated revenues	$	10,598		100.0	%	$	10,574		100.0	%

Segment income and segment income margin
Life Sciences Solutions	$	845		35.4	%	$	872		35.9	%
Analytical Instruments		451		24.9	%		468		26.7	%
Specialty Diagnostics		293		25.9	%		283		26.1	%
Laboratory Products and Biopharma Services		773		13.5	%		937		16.4	%
Subtotal reportable segments		2,362		22.3	%		2,560		24.2	%
Cost of revenues adjustments (a)		(9	)	-0.1	%		(14	)	-0.1	%
Selling, general and administrative expenses adjustments (b)		(21	)	-0.2	%		(14	)	-0.1	%
Restructuring and other costs (c)		(45	)	-0.4	%		(84	)	-0.8	%
Amortization of acquisition-related intangible assets		(450	)	-4.2	%		(584	)	-5.6	%
Consolidated GAAP operating income	$	1,838		17.3	%	$	1,864		17.6	%


(a) Adjusted results in 2024 and 2023 exclude charges for the sale of inventory revalued at the date of acquisition and 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, charges/credits for changes in estimates of contingent acquisition consideration, and charges associated with product liability litigation. Adjusted results in 2024 also exclude $5 of accelerated depreciation on fixed assets to be abandoned due to facility consolidations.
(c) Adjusted results in 2024 and 2023 exclude restructuring and other costs consisting principally of severance, impairments of long-lived assets, net charges/credits for pre-acquisition litigation and other matters, net gains on the sale of real estate, and abandoned facility and other expenses of headcount reductions and real estate consolidations.
(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 $291 and $269 in 2024 and 2023, respectively.

Organic and Core organic revenue growth		Three months ended
		September 28, 2024
Revenue growth		0%
Acquisitions		1%
Currency translation		0%
Organic revenue growth (non-GAAP measure)		0%
COVID-19 testing revenue		0%
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)
	Nine months ended
	September 28,			% of		September 30,			% of
(Dollars in millions except per share amounts)		2024		Revenues			2023		Revenues
Revenues	$	31,484				$	31,971
Costs and operating expenses:
Cost of revenues (a)		18,326		58.2	%		18,905		59.1	%
Selling, general and administrative expenses (b)		5,156		16.4	%		4,897		15.3	%
Amortization of acquisition-related intangible assets		1,514		4.8	%		1,775		5.5	%
Research and development expenses		1,016		3.2	%		1,010		3.2	%
Restructuring and other costs (c)		151		0.5	%		379		1.2	%
Total costs and operating expenses		26,163		83.1	%		26,966		84.3	%
Operating income		5,321		16.9	%		5,005		15.7	%
Interest income		851					570
Interest expense		(1,073	)				(985	)
Other income/(expense) (d)		(2	)				(32	)
Income before income taxes		5,096					4,558
Provision for income taxes (e)		(507	)				(151	)
Equity in earnings/(losses) of unconsolidated entities		(75	)				(58	)
Net income		4,514					4,349
Less: net income/(losses) attributable to noncontrolling interests and redeemable noncontrolling interest (f)		9					(16	)
Net income attributable to Thermo Fisher Scientific Inc.	$	4,505		14.3	%	$	4,365		13.7	%

Earnings per share attributable to Thermo Fisher Scientific Inc.:
Basic	$	11.79				$	11.31
Diluted	$	11.75				$	11.25
Weighted average shares:
Basic		382					386
Diluted		383					388

Reconciliation of adjusted operating income and adjusted operating margin
GAAP operating income	$	5,321		16.9	%	$	5,005		15.7	%
Cost of revenues adjustments (a)		25		0.1	%		73		0.2	%
Selling, general and administrative expenses adjustments (b)		(24	)	-0.1	%		28		0.1	%
Restructuring and other costs (c)		151		0.5	%		379		1.2	%
Amortization of acquisition-related intangible assets		1,514		4.8	%		1,775		5.5	%
Adjusted operating income (non-GAAP measure)	$	6,987		22.2	%	$	7,260		22.7	%

Reconciliation of adjusted net income
GAAP net income attributable to Thermo Fisher Scientific Inc.	$	4,505				$	4,365
Cost of revenues adjustments (a)		25					73
Selling, general and administrative expenses adjustments (b)		(24	)				28
Restructuring and other costs (c)		151					379
Amortization of acquisition-related intangible assets		1,514					1,775
Other income/expense adjustments (d)		(8	)				36
Provision for income taxes adjustments (e)		(190	)				(534	)
Equity in earnings/losses of unconsolidated entities		75					58
Noncontrolling interests adjustments (f)		(6	)				(19	)
Adjusted net income (non-GAAP measure)	$	6,042				$	6,161

Reconciliation of adjusted earnings per share
GAAP diluted EPS attributable to Thermo Fisher Scientific Inc.	$	11.75				$	11.25
Cost of revenues adjustments (a)		0.07					0.19
Selling, general and administrative expenses adjustments (b)		(0.06	)				0.07
Restructuring and other costs (c)		0.39					0.98
Amortization of acquisition-related intangible assets		3.95					4.57
Other income/expense adjustments (d)		(0.02	)				0.09
Provision for income taxes adjustments (e)		(0.50	)				(1.38	)
Equity in earnings/losses of unconsolidated entities		0.20					0.15
Noncontrolling interests adjustments (f)		(0.02	)				(0.05	)
Adjusted EPS (non-GAAP measure)	$	15.76				$	15.87

Reconciliation of free cash flow
GAAP net cash provided by operating activities	$	5,377				$	4,683
Purchases of property, plant and equipment		(920	)				(1,074	)
Proceeds from sale of property, plant and equipment		40					76
Free cash flow (non-GAAP measure)	$	4,498				$	3,685

Business Segment Information	Nine months ended
	September 28,			% of		September 30,			% of
(Dollars in millions)		2024		Revenues			2023		Revenues

Revenues
Life Sciences Solutions	$	7,027		22.3	%	$	7,508		23.5	%
Analytical Instruments		5,277		16.8	%		5,226		16.3	%
Specialty Diagnostics		3,355		10.7	%		3,300		10.3	%
Laboratory Products and Biopharma Services		17,221		54.7	%		17,322		54.2	%
Eliminations		(1,397	)	-4.4	%		(1,385	)	-4.3	%
Consolidated revenues	$	31,484		100.0	%	$	31,971		100.0	%

Segment income and segment income margin
Life Sciences Solutions	$	2,551		36.3	%	$	2,525		33.6	%
Analytical Instruments		1,289		24.4	%		1,321		25.3	%
Specialty Diagnostics		886		26.4	%		860		26.1	%
Laboratory Products and Biopharma Services		2,262		13.1	%		2,554		14.7	%
Subtotal reportable segments		6,987		22.2	%		7,260		22.7	%
Cost of revenues adjustments (a)		(25	)	-0.1	%		(73	)	-0.2	%
Selling, general and administrative expenses adjustments (b)		24		0.1	%		(28	)	-0.1	%
Restructuring and other costs (c)		(151	)	-0.5	%		(379	)	-1.2	%
Amortization of acquisition-related intangible assets		(1,514	)	-4.8	%		(1,775	)	-5.5	%
Consolidated GAAP operating income	$	5,321		16.9	%	$	5,005		15.7	%


(a) Adjusted results in 2024 and 2023 exclude charges for inventory write-downs associated with large-scale abandonment of product lines, accelerated depreciation on manufacturing assets to be abandoned due to facility consolidations, and 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, charges/credits for changes in estimates of contingent acquisition consideration, and charges associated with product liability litigation. Adjusted results in 2024 also exclude $5 of accelerated depreciation on fixed assets to be abandoned due to facility consolidations.
(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, net gains on the sale of real estate, 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 $852 and $792 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)

	September 28,		December 31,
(In millions)	2024		2023

Assets
Current assets:
Cash and cash equivalents	$	4,645	$	8,077
Short-term investments		2,000		3
Accounts receivable, net		8,255		8,221
Inventories		5,430		5,088
Other current assets		3,453		3,200
Total current assets		23,783		24,589
Property, plant and equipment, net		9,412		9,448
Acquisition-related intangible assets, net		16,262		16,670
Other assets		4,180		3,999
Goodwill		46,726		44,020
Total assets	$	100,364	$	98,726

Liabilities, redeemable noncontrolling interest and equity
Current liabilities:
Short-term obligations and current maturities of long-term obligations	$	4,116	$	3,609
Other current liabilities		10,485		10,403
Total current liabilities		14,601		14,012
Other long-term liabilities		5,466		6,564
Long-term obligations		31,197		31,308
Redeemable noncontrolling interest		127		118
Total equity		48,972		46,724
Total liabilities, redeemable noncontrolling interest and equity	$	100,364	$	98,726

Condensed Consolidated Statements of Cash Flows (unaudited)

	Nine months ended
	September 28,			September 30,
(In millions)		2024			2023

Operating activities
Net income	$	4,514		$	4,349
Adjustments to reconcile net income to net cash provided by operating activities:
Depreciation and amortization		2,367			2,567
Change in deferred income taxes		(1,007	)		(631	)
Other non-cash expenses, net		477			658
Changes in assets and liabilities, excluding the effects of acquisitions		(973	)		(2,260	)
Net cash provided by operating activities		5,377			4,683

Investing activities
Purchases of property, plant and equipment		(920	)		(1,074	)
Proceeds from sale of property, plant and equipment		40			76
Proceeds from cross-currency interest rate swap interest settlements		203			36
Acquisitions, net of cash acquired		(3,132	)		(3,660	)
Purchases of investments		(2,065	)		(200	)
Other investing activities, net		14			56
Net cash used in investing activities		(5,861	)		(4,766	)

Financing activities
Net proceeds from issuance of debt		1,204			3,466
Repayment of debt		(1,107	)		(2,000	)
Net proceeds from issuance of commercial paper		—			1,620
Repayment of commercial paper		—			(1,935	)
Purchases of company common stock		(3,000	)		(3,000	)
Dividends paid		(434	)		(387	)
Other financing activities, net		212			42
Net cash used in financing activities		(3,126	)		(2,194	)

Exchange rate effect on cash		182			(92	)
Decrease in cash, cash equivalents and restricted cash		(3,427	)		(2,369	)
Cash, cash equivalents and restricted cash at beginning of period		8,097			8,537
Cash, cash equivalents and restricted cash at end of period	$	4,670		$	6,168


Free cash flow (non-GAAP measure)	$	4,498		$	3,685

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.

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

Contacts:
Leslie Williamson	Ryan Weispfenning
Public Relations	Investor Relations
+1-612-227-5099	+1-763-505-4626

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