Abbott's FreeStyle® Libre 2 iOS App Cleared in U.S., Providing a Seamless Digital Experience to Simplify Diabetes Management

- Abbott announced today that the U.S. Food and Drug Administration (FDA) has cleared the FreeStyle ® Libre 2 iOS application for use with compatible iPhones 1 providing a comprehensive digital offering for its FreeStyle Libre 2 integrated continuous glucose monitoring (iCGM) system . Providing breakthrough technology that is accessible and affordable 4 the FreeStyle Libre portfolio is the number one continuous glucose monitoring (CGM) system worldwide 5 and most prescribed in the U.S. 6 changing the lives of nearly 3.5 million people across more than 50 countries including 1 million users in the U.S.

Approved for adults and children (4 and older) with diabetes, the new FreeStyle Libre 2 app creates a seamless experience for users and healthcare professionals. The app enables users to get glucose readings directly on their iPhones without the use of a reader. A key benefit of the app is the ability for caregivers to remotely monitor their loved one's glucose readings and get real-time alarms via the LibreLinkUp app . ⁷

" The demands of living with diabetes can be overwhelming, and there's a critical need to improve the way people with diabetes manage their condition – easily, affordably, accurately – and in a way that seamlessly fits into their everyday lives," said Jared Watkin, senior vice president, Diabetes Care, Abbott. "The FreeStyle Libre 2 iOS app streamlines how people manage their diabetes on their iPhones – empowering users with the information they need 24/7 while improving their health on the go."

According to a recent Gallup poll, 1 in 5 Americans currently tracks health statistics using a mobile app. ⁸ Free to download on the iOS App Store soon, the FreeStyle Libre 2 app will offer personalized, up-to-the-minute glucose data for people with diabetes who are using FreeStyle Libre 2 glucose sensors. By scanning the sensor with the FreeStyle Libre 2 app, users will get their current glucose reading and trend arrow which can help them determine how food, exercise and other lifestyle factors impact diabetes management.

With a 14-day wear time, FreeStyle Libre 2 is the longest-lasting iCGM sensor currently on the market. ⁹ Available at pharmacies at a fraction of the cost of other CGM systems, ¹⁰ the FreeStyle Libre 2 system is widely accessible to people with diabetes. Integrated features include:

Optional real-time glucose alarms ² that automatically alert users when glucose is high or low
Unsurpassed 14-day accuracy ¹¹ with readings every minute and an eight-hour glucose history, including comprehensive view of trends
Seamless integration with Abbott's connected digital health tools – the LibreLinkUp app and LibreView ¹² , a secure cloud-based data management platform – allowing users to easily share their glucose readings with healthcare professionals and caregivers. Accessible remotely, use of LibreView increased about 70% over the past year. ¹³

"The pandemic taught us the importance of connected devices in managing chronic conditions remotely, and we continue to see the benefit from the latest advances in digital health," said Kurt Midyett , M.D., pediatric endocrinologist and medical director at Midwest Pediatric Specialists. "Continuous glucose monitoring is one of the most significant health tech innovations in the last decade, and I see the life-changing benefits first-hand from my patients every day. As a doctor, it's invaluable to receive my patients' glucose data remotely via systems like LibreView – enabling more meaningful conversations with my patients, and ultimately, improving treatment decisions and their long-term health."

Abbott has secured partial or full reimbursement for the FreeStyle Libre system in 38 countries, including Canada , France , Germany , Japan , the United Kingdom , and the U.S.

The FreeStyle Libre 2 iOS app will be available soon in the U.S. to download on the App Store.

Indications and Important Safety Information

FreeStyle Libre 2 system : Failure to use FreeStyle Libre 2 system as instructed in labeling may result in missing a severe low or high glucose event and/or making a treatment decision, resulting in injury. If glucose alarms and readings do not match symptoms or expectations, use a fingerstick value from a blood glucose meter for treatment decisions. Seek medical attention when appropriate or contact Abbott at 855-632-8658 or https://www.FreeStyle.abbott/us-en/safety-information for safety info.

About Abbott:

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.

Connect with us at www.abbott.com , on LinkedIn at www.linkedin.com/company/abbott-/ , on Facebook at https://www.facebook.com/Abbott and on Twitter @AbbottNews

¹ The FreeStyle Libre 2 app is only compatible with certain mobile devices and operating systems. Please check our website for more information about device compatibility before using the app. Use of the FreeStyle Libre 2 app requires registration with LibreView.
² The High Glucose alarm level can be set between 120-400 mg/dL and the Low Glucose alarm level can be set between 60 – 100 mg/dL Notifications will only be received when alarms are turned on and the sensor is within 20 feet of the reading device. Critical Alerts must be enabled to receive alarms and alerts on the smartphone.
³ The LibreLinkUp app is only compatible with certain mobile device and operating systems. Please check www.librelinkup.com for more information about device compatibility before using the app. Use of FreeStyle Libre-compatible apps and LibreLinkUp may require registration with LibreView. The LibreLinkUp mobile app is not intended to be a primary glucose monitor: users must consult their primary device(s) and consult a healthcare professional before making any medical interpretation and therapy adjustments from the information provided by the app.
⁴ Based on a comparison of list prices of the FreeStyle Libre portfolio versus competitor CGM systems. The actual cost to patients may or may not be lower than other CGM systems, depending on the amount covered by insurance, if any.
⁵ Data on file, Abbott Diabetes Care. Data based on the number of users worldwide for the FreeStyle Libre system compared to the number of users for other leading personal-use, sensor-based glucose monitoring systems
⁶ Data based on the number of patients assigned to each manufacturer based on last filled prescription in US Retail Pharmacy and DME.
⁷ The LibreLinkUp app is only compatible with certain mobile devices and operating systems. Please check www.LibreLinkUp.com for more information about device compatibility before using the app. Use of the LibreLinkUp app requires registration with LibreView.
⁸ Gallup News Service; Gallup Poll Social Series Health and Healthcare, Nov. 1 – 4, 2019
⁹ Data on file, Abbott Diabetes Care.
¹⁰ Based on a comparison of list prices of the FreeStyle Libre portfolio versus competitor CGM systems. The actual cost to patients may or may not be lower than other CGM systems, depending on the amount covered by insurance, if any.
¹¹ Based on FDA iCGM special controls.
¹² The LibreView data management software is intended for use by both patients and healthcare professionals to assist people with diabetes and their healthcare professionals in the review, analysis and evaluation of historical glucose meter data to support effective diabetes management. The LibreView software is not intended to provide treatment decisions or to be used as a substitute for professional healthcare advice.
¹³ Data on file, Abbott Diabetes Care. (Percent of PAT Accounts – percent of Patient LibreView Accounts that enabled remote monitoring)

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Condensed Consolidated Statements of Income (unaudited)
	Three months ended
	March 30,			% of		April 1,			% of
(Dollars in millions except per share amounts)	2024			Revenues		2023			Revenues
Revenues	$	10,345				$	10,710
Costs and operating expenses:
Cost of revenues (a)		6,040		58.4	%		6,437		60.1	%
Selling, general and administrative expenses (b)		1,731		16.7	%		1,646		15.4	%
Amortization of acquisition-related intangible assets		551		5.3	%		606		5.7	%
Research and development expenses		331		3.2	%		346		3.2	%
Restructuring and other costs (c)		29		0.3	%		112		1.0	%
Total costs and operating expenses		8,682		83.9	%		9,147		85.4	%
Operating income		1,663		16.1	%		1,563		14.6	%
Interest income		279					146
Interest expense		(363	)				(300	)
Other income/(expense) (d)		10					(46	)
Income before income taxes		1,589					1,363
Provision for income taxes (e)		(281	)				(46	)
Equity in earnings/(losses) of unconsolidated entities		23					(25	)
Net income		1,331					1,292
Less: net income/(losses) attributable to noncontrolling interests and redeemable noncontrolling interest		4					3
Net income attributable to Thermo Fisher Scientific Inc.	$	1,328		12.8	%	$	1,289		12.0	%

Earnings per share attributable to Thermo Fisher Scientific Inc.:
Basic	$	3.47				$	3.34
Diluted	$	3.46				$	3.32
Weighted average shares:
Basic		382					386
Diluted		384					388

Reconciliation of adjusted operating income and adjusted operating margin
GAAP operating income	$	1,663		16.1	%	$	1,563		14.6	%
Cost of revenues adjustments (a)		15		0.1	%		41		0.4	%
Selling, general and administrative expenses adjustments (b)		19		0.2	%		8		0.1	%
Restructuring and other costs (c)		29		0.3	%		112		1.0	%
Amortization of acquisition-related intangible assets		551		5.3	%		606		5.7	%
Adjusted operating income (non-GAAP measure)	$	2,278		22.0	%	$	2,330		21.8	%

Reconciliation of adjusted net income
GAAP net income attributable to Thermo Fisher Scientific Inc.	$	1,328				$	1,289
Cost of revenues adjustments (a)		15					41
Selling, general and administrative expenses adjustments (b)		19					8
Restructuring and other costs (c)		29					112
Amortization of acquisition-related intangible assets		551					606
Other income/expense adjustments (d)		(11	)				46
Provision for income taxes adjustments (e)		50					(171	)
Equity in earnings/losses of unconsolidated entities		(23	)				25
Adjusted net income (non-GAAP measure)	$	1,959				$	1,956

Reconciliation of adjusted earnings per share
GAAP diluted EPS attributable to Thermo Fisher Scientific Inc.	$	3.46				$	3.32
Cost of revenues adjustments (a)		0.04					0.10
Selling, general and administrative expenses adjustments (b)		0.05					0.02
Restructuring and other costs (c)		0.08					0.29
Amortization of acquisition-related intangible assets		1.44					1.56
Other income/expense adjustments (d)		(0.03	)				0.12
Provision for income taxes adjustments (e)		0.13					(0.44	)
Equity in earnings/losses of unconsolidated entities		(0.06	)				0.06
Adjusted EPS (non-GAAP measure)	$	5.11				$	5.03

Reconciliation of free cash flow
GAAP net cash provided by operating activities	$	1,251				$	729
Purchases of property, plant and equipment		(347	)				(458	)
Proceeds from sale of property, plant and equipment		4					6
Free cash flow (non-GAAP measure)	$	908				$	277

Business Segment Information	Three months ended
	March 30,			% of		April 1,			% of
(Dollars in millions)	2024			Revenues		2023			Revenues

Revenues
Life Sciences Solutions	$	2,285		22.1	%	$	2,612		24.4	%
Analytical Instruments		1,687		16.3	%		1,723		16.1	%
Specialty Diagnostics		1,109		10.7	%		1,108		10.3	%
Laboratory Products and Biopharma Services		5,723		55.3	%		5,763		53.8	%
Eliminations		(460	)	-4.4	%		(496	)	-4.6	%
Consolidated revenues	$	10,345		100.0	%	$	10,710		100.0	%

Segment income and segment income margin
Life Sciences Solutions	$	840		36.8	%	$	836		32.0	%
Analytical Instruments		400		23.7	%		421		24.4	%
Specialty Diagnostics		294		26.5	%		280		25.3	%
Laboratory Products and Biopharma Services		744		13.0	%		793		13.8	%
Subtotal reportable segments		2,278		22.0	%		2,330		21.8	%
Cost of revenues adjustments (a)		(15	)	-0.1	%		(41	)	-0.4	%
Selling, general and administrative expenses adjustments (b)		(19	)	-0.2	%		(8	)	-0.1	%
Restructuring and other costs (c)		(29	)	-0.3	%		(112	)	-1.0	%
Amortization of acquisition-related intangible assets		(551	)	-5.3	%		(606	)	-5.7	%
Consolidated GAAP operating income	$	1,663		16.1	%	$	1,563		14.6	%


(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 $10 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, abandoned facility, and other expenses of headcount reductions and real estate consolidations. Adjusted results in 2023 also exclude $18 of net charges for pre-acquisition litigation and other matters.
(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.
Note:
Consolidated depreciation expense is $285 and $253 in 2024 and 2023, respectively.

Organic and Core organic revenue growth		Three months ended
		March 30, 2024
Revenue growth		-3%
Acquisitions		0%
Currency translation		0%
Organic revenue growth (non-GAAP measure)		-4%
COVID-19 testing revenue		-1%
Core organic revenue growth (non-GAAP measure)		-3%

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 Balance Sheets (unaudited)

	March 30,		December 31,
(In millions)	2024		2023

Assets
Current assets:
Cash and cash equivalents	$	5,499	$	8,077
Short-term investments		1,751		3
Accounts receivable, net		7,931		8,221
Inventories		5,133		5,088
Other current assets		3,326		3,200
Total current assets		23,640		24,589
Property, plant and equipment, net		9,324		9,448
Acquisition-related intangible assets, net		16,048		16,670
Other assets		4,241		3,999
Goodwill		43,843		44,020
Total assets	$	97,095	$	98,726

Liabilities, redeemable noncontrolling interest and equity
Current liabilities:
Short-term obligations and current maturities of long-term obligations	$	4,451	$	3,609
Other current liabilities		9,486		10,403
Total current liabilities		13,937		14,012
Other long-term liabilities		6,378		6,564
Long-term obligations		31,157		31,308
Redeemable noncontrolling interest		119		118
Total equity		45,504		46,724
Total liabilities, redeemable noncontrolling interest and equity	$	97,095	$	98,726

Condensed Consolidated Statements of Cash Flows (unaudited)

	Three months ended
	March 30,			April 1,
(In millions)	2024			2023

Operating activities
Net income	$	1,331		$	1,292
Adjustments to reconcile net income to net cash provided by operating activities:
Depreciation and amortization		837			859
Change in deferred income taxes		(253	)		(146	)
Other non-cash expenses, net		123			257
Changes in assets and liabilities, excluding the effects of acquisitions		(787	)		(1,533	)
Net cash provided by operating activities		1,251			729

Investing activities
Purchases of property, plant and equipment		(347	)		(458	)
Proceeds from sale of property, plant and equipment		4			6
Proceeds from cross-currency interest rate swap interest settlements		64			2
Acquisitions, net of cash acquired		—			(2,704	)
Purchases of investments		(1,758	)		(2	)
Other investing activities, net		7			14
Net cash used in investing activities		(2,030	)		(3,142	)

Financing activities
Net proceeds from issuance of debt		1,205			—
Net proceeds from issuance of commercial paper		—			1,027
Repayment of commercial paper		—			(523	)
Purchases of company common stock		(3,000	)		(3,000	)
Dividends paid		(135	)		(117	)
Other financing activities, net		110			20
Net cash used in financing activities		(1,821	)		(2,593	)

Exchange rate effect on cash		22			(31	)
Decrease in cash, cash equivalents and restricted cash		(2,578	)		(5,037	)
Cash, cash equivalents and restricted cash at beginning of period		8,097			8,537
Cash, cash equivalents and restricted cash at end of period	$	5,519		$	3,500

Free cash flow (non-GAAP measure)	$	908		$	277



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.

Contacts:
Erika Winkels	Ryan Weispfenning
Public Relations	Investor Relations
+1-763-526-8472	+1-763-505-4626

Abbott's FreeStyle® Libre 2 iOS App Cleared in U.S., Providing a Seamless Digital Experience to Simplify Diabetes Management

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