Cepheid Receives Emergency Use Authorization For SARS-CoV-2, Flu A, Flu B and RSV Combination Test

Cepheid today announced it has received Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration (FDA) for Xpert ® Xpress SARS-CoV-2FluRSV a rapid molecular diagnostic test for qualitative detection of the viruses causing COVID-19, Flu A, Flu B, and RSV infections from a single patient sample. The four-in-one test is designed for use on any of Cepheid's over 26,000 GeneXpert ® Systems placed worldwide, with results delivered in approximately 36 minutes.

"Things may get complicated this respiratory season as clinicians encounter a range of viral infections with symptoms overlapping with COVID-19, including Flu A, Flu B, and respiratory syncytial virus," said Dr. David Persing, MD, Ph.D., Chief Medical and Technology Officer at Cepheid. "The ability to run a single, highly sensitive test that detects all four viruses in a syndromic panel provides actionable results and helps to alleviate pressure on our healthcare system."

Cepheid's previously announced capacity expansion program, supported by parent company Danaher Corporation, was designed in part to address anticipated demand for Xpert Xpress SARS-CoV-2/Flu/RSV. Cepheid expects the first impact of the program in the fourth quarter of 2020 with additional capacity ramping through 2021.

"The dramatic impact of SARS-CoV-2 has been felt by us all, and we understand that a reliable supply of SARS-CoV-2 tests is critical to the communities our healthcare institutions serve — for the coming Flu season and beyond," said Cepheid President Warren Kocmond . "Another goal of the capacity expansion program is to ensure supply continuity of not only our 4-Plex combination test for SARS-CoV-2, Flu A&B and RSV, but the entire portfolio of critical tests Cepheid supplies — including tests for tuberculosis, MRSA, C. difficile , CT/NG, Strep A, and many more."

The new EUA combination test is expected to begin shipping to US customers this week, with expected CE-IVD availability in November.

Visit www.cepheid.com/coronavirus for more information, videos, package inserts and more.

GeneXpert System – Reference Lab Quality Tests Anywhere They Are Needed

The GeneXpert System was built for simple, reference lab quality PCR testing – on location at medical centers and hospitals or closer to patient in health clinics and nursing homes. At the core of every GeneXpert System is the module (or testing bay) where a test cartridge is loaded onto the machine. Our GeneXpert Systems are configured with a varying number of modules, or test bays, to meet the volume requirements of any setting. Smaller GeneXpert Systems are configured with 2 or 4 modules — meaning up to four different tests can be run at one time. Our largest GeneXpert System is configured with up to 80 modules — meaning as many as 80 tests can operate independently at any given time with a capacity of about 2,000 tests per day*.

About Cepheid
Based in Sunnyvale, Calif. , Cepheid is a leading molecular diagnostics company that is an operating company within Danaher Corporation's (NYSE: DHR) Diagnostics platform. Cepheid is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated molecular diagnostic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. For more information, visit https://www.cepheid.com .

About Emergency Use Authorization Status
This test has not been FDA cleared or approved. It has been authorized by the FDA under an EUA for use by authorized laboratories. The test has been authorized only for the simultaneous qualitative detection and differentiation of nucleic acid from SARS-CoV-2, influenza A virus, influenza B virus, and RSV and not for any other viruses or pathogens. The test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

*Cepheid internal study based on 30 minute test results.

For Cepheid Media Inquiries:
Darwa Peterson
darwa.peterson@cepheid.com

Media Contacts:
Jason Spark , CanaleComm, jason@canalecomm.com
Cammy Duong , CanaleComm, cammy@canalecomm.com

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SOURCE Cepheid

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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.

Investor Contact:		Media Contact:
Garen Sarafian		Katie Savastano
ir@bauschhealth.com		corporate.communications@bauschhealth.com
(877) 281-6642 (tollfree)		(908) 569-3692

Cepheid Receives Emergency Use Authorization For SARS-CoV-2, Flu A, Flu B and RSV Combination Test

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