Beckman Coulter's SARS-CoV-2 IgG II antibody test receives Emergency Use Authorization from the FDA

Beckman Coulter, a clinical diagnostics leader, today announced that its Access SARS-CoV-2 IgG II antibody assay received U.S. Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration. The semi-quantitative assay measures a patient's level of antibodies in response to a previous SARS-CoV-2 infection and provides a qualitative and numerical result of antibodies in arbitrary units (AU).

Lenco Diagnostic Laboratories , one of New York City's largest privately-owned, full-service reference labs, is among the first to offer the test in its facilities across Brooklyn , NYC, and the tri-state metropolitan area. Lenco conducted an independent verification of the assay's performance and is highly satisfied with the quality of the results.

"To help in the fight against COVID-19, it is important that we partner with a company that has the reputation, quality, and testing accuracy like Beckman Coulter in meeting the needs of the people of New York ," said Robert Boorstein , M.D., Ph.D., medical director, Lenco Diagnostics Laboratories. "This next step in COVID-19 antibody testing creates a pathway in helping us establish a quantitative baseline of different antibody levels and determine how a patient's immune response to COVID-19 is affected over time. We expect that clinicians will find this assay useful for monitoring the progress of a patient's COVID-19 recovery and assessing the immune response over time."

The Access SARS-CoV-2 IgG II assay measures IgG antibodies directed to the receptor-binding domain of the spike protein of the coronavirus. The test has a confirmed 99.9% negative percent agreement (specificity) and a 98.9% positive percent agreement (sensitivity) at 15-60 days post symptom onset. The Access SARS-CoV-2 IgG II assay can be used in Random Access Mode (RAM) and seamlessly integrates into existing workflows without batch processing.

"Effective and high-quality diagnostic solutions are essential in the fight against COVID-19," said Shamiram R. Feinglass , MD, M.P.H, chief medical officer at Beckman Coulter. "Antibody assays like our Access SARS-CoV-2 IgG II test can help researchers quantitatively determine the levels of IgG antibodies and enable them to assess the relative changes of an individual's immune response to the SARS-CoV-2 virus over time. This information is essential because it helps continually inform therapeutics and vaccine development."

The Access SARS-CoV-2 IgG II antibody assay is now available in the U.S. and countries accepting the CE Mark. Results of the new test are delivered on Beckman Coulter's award-winning immunoassay analyzers, including the DxI 800 high-throughput analyzer, capable of processing up to 4,800 samples per day.

The IgG II antibody assay is the latest addition to Beckman Coulter's full suite of testing solutions that provide clinicians valuable information in their fight against COVID-19. Beckman Coulter also recently launched an automated SARS-CoV-2 antigen test in the U.S. under Policy C of the FDA's emergency use authorization (EUA) program. For more information on Beckman Coulter's antibody assays, as well as its full suite of COVID-19 diagnostic solutions, visit www.BeckmanCoulter.com/Coronavirus .

For more information about Lenco Diagnostic Laboratories, and its commitment to being part of the solution for COVID-19, visit: https://www.lencolab.com/covid19-antibody/ .

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, California , and has more than 11,000 global associates working diligently to make the world a healthier place.

References:

¹ At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity.

© 2021 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.
2021-8737

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SOURCE Beckman Coulter Diagnostics

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Danaher DHR Medical Device Investing

Thermo Fisher Scientific & Flagship Pioneering Expand Ongoing Strategic Partnership to Jointly Create New Platform Companies with First-in-Class Enabling Technologies for Life Sciences

Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, and Flagship Pioneering, the bioplatform innovation company, today announced the formation of a strategic partnership to develop and commercially scale multiproduct platforms on an accelerated basis.

Through this collaboration, Thermo Fisher and Flagship will work together to create new platform companies focusing on novel tools and capabilities that seek to power the biotech ecosystem and accelerate the development of first-in-class therapies. The newly formed strategic partnership is an expansion of the long-standing supply relationship between Thermo Fisher and Flagship, which extends to Flagship's ecosystem of companies and leverages the expertise of both organizations including the areas of life science tools, diagnostics, and services.

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Medtronic announces FDA approval of minimally invasive device to treat hypertension

The Symplicity ^™ blood pressure procedure offers patients a new adjunct approach to lowering blood pressure

Approval is the culmination of ten years of clinical research and development of the Medtronic renal denervation technology

- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that the United States Food and Drug Administration (FDA) has approved the Symplicity Spyral ™ renal denervation (RDN) system, also known as the Symplicity ™ blood pressure procedure, for the treatment of hypertension. With this approval, Medtronic will immediately begin commercialization.

Hypertension, or high blood pressure, is the leading modifiable cause of heart attack, stroke, and death, and its prevalence is notably worse in underserved U.S. populations. Despite available medications and lifestyle interventions, control rates remain low. These challenges speak to the possibility that patients may benefit from an adjunctive treatment option to better manage their blood pressure.

"Medtronic has always believed in the potential of this therapy. We partnered closely with leading experts in our clinical community who could help us in our journey to get this technology to the people who need it most," said Jason Weidman , senior vice president and president of the Coronary and Renal Denervation business within the Cardiovascular Portfolio at Medtronic. "It was the promise of this therapy that enabled Medtronic to keep going, even when others exited the renal denervation space. High blood pressure is a global health issue, and patients need more options to manage their blood pressure. The approval of the Symplicity blood pressure procedure represents a significant milestone for physicians and patients in the treatment of hypertension."

The Medtronic Symplicity blood pressure procedure is an innovative, minimally invasive procedure that delivers radiofrequency energy to nerves near the kidneys that can become overactive and contribute to high blood pressure. After sedation, the doctor inserts a single thin tube (known as a catheter) into the artery leading to the kidney. Once the tube is in place, the doctor administers energy to the system to calm the excessive activity of the nerves connected to the kidney. The tube is removed, leaving no implant behind.

"The Symplicity blood pressure procedure is safe and effective, providing significant 'always on' blood pressure reductions for patients," said David Kandzari , M.D., chief, Piedmont Heart Institute and Cardiovascular Service and co-principal investigator of the SPYRAL clinical program. "This landmark approval is the culmination of rigorous scientific study and clinical trials, including long-term, sham-controlled studies in the presence and absence of medication, and the largest real-world study."

Patient preference and shared decision making have been identified as critical components of developing a hypertension care plan including the Symplicity blood pressure procedure. According to results from a Medtronic-led patient preference study, when presented with an interventional treatment with blood pressure reduction and potential risks in line with those of the Symplicity blood pressure procedure, approximately one third of patients were likely to choose the interventional treatment.

"This approval paves the way for a transformation in hypertension treatment, offering a solution that complements medication and lifestyle changes," said Raymond Townsend , M.D., from the Hypertension Section, Department of Internal Medicine / Renal, University of Pennsylvania School of Medicine and co-principal investigator of the SPYRAL clinical program. "The Symplicity blood pressure procedure is a promising treatment option for clinicians and patients alike and offers opportunity to fulfill a significant unmet need in hypertension care, especially for those patients who are desperately seeking additional approaches to get their blood pressure down."

The Medtronic SPYRAL HTN Global Clinical Program is the most comprehensive clinical program studying RDN and is backed by experience in more than 25,000 patients treated globally, studied in the presence and absence of medication, and in patients with high baseline cardiovascular risk. Although currently limited for investigational use in Japan , China and Canada , the Symplicity Spyral Renal Denervation System is approved for commercial use in more than 70 countries 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 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 (NYSE:MDT), visit www.Medtronic.com , and follow @Medtronic on Twitter and LinkedIn.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

Contacts:
Krystin Hayward Leong			Ryan Weispfenning
Public Relations			Investor Relations
+1-508-261-6512			+1-763-505-4626

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Ocumetics Announces Private Placement

Ocumetics Technology Corp. (“ Ocumetics ” or the “ Corporation ”) ( TSXV:OTC) (OTC:OTCFF) (FRA:2QBO) announces that it proposes to complete a non-brokered private placement of up to 3,125,000 units of the Corporation (“ Units ”) at a price of $0.32 per Unit for gross proceeds of up to $1,000,000. There will be no minimum subscription level for this offering. Each Unit will consist of one common share in the share capital of the Corporation (“ Common Share ”) and one-half of one common share purchase warrant. Each whole warrant (“ Warrant ”) will entitle the holder to purchase one additional Common Share at an exercise price of $0.64 for a period of two years from the date of issuance of the Warrant.

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MEDTRONIC PLC
WORLD WIDE REVENUE ⁽¹⁾
(Unaudited)

	SECOND QUARTER							YEAR-TO-DATE
	REPORTED				ORGANIC			REPORTED				ORGANIC
(in millions)	FY24	FY23	Growth	Currency Impact ⁽²⁾	Adjusted FY24	Adjusted FY23	Growth	FY24	FY23	Growth	Currency Impact ⁽²⁾	Adjusted FY24	Adjusted FY23	Growth
Cardiovascular	$ 2,923	$ 2,759	5.9 %	$ 31	$ 2,892	$ 2,759	4.8 %	$ 5,773	$ 5,459	5.8 %	$ 12	$ 5,761	$ 5,459	5.5 %
Cardiac Rhythm & Heart Failure	1,492	1,417	5.3	18	1,474	1,417	4.0	2,938	2,798	5.0	11	2,927	2,798	4.6
Structural Heart & Aortic	819	757	8.2	11	808	757	6.7	1,633	1,499	8.9	6	1,627	1,499	8.5
Coronary & Peripheral Vascular	613	584	5.0	2	611	584	4.6	1,202	1,163	3.4	(5)	1,207	1,163	3.8
Neuroscience	2,288	2,186	4.7	10	2,278	2,186	4.2	4,506	4,301	4.8	(5)	4,511	4,301	4.9
Cranial & Spinal Technologies	1,157	1,081	7.0	4	1,153	1,081	6.7	2,260	2,124	6.4	(3)	2,263	2,124	6.5
Specialty Therapies	705	686	2.8	1	704	686	2.6	1,400	1,353	3.5	(7)	1,407	1,353	4.0
Neuromodulation	426	419	1.7	5	421	419	0.5	846	824	2.7	5	841	824	2.1
Medical Surgical	2,142	2,002	7.0	27	2,115	2,002	5.6	4,181	3,935	6.3	16	4,165	3,935	5.8
Surgical & Endoscopy	1,641	1,513	8.5	25	1,616	1,513	6.8	3,187	2,968	7.4	17	3,170	2,968	6.8
Patient Monitoring & Respiratory Interventions	501	489	2.5	3	498	489	1.8	994	967	2.8	(2)	996	967	3.0
Diabetes	610	556	9.7	17	593	556	6.7	1,189	1,098	8.3	20	1,169	1,098	6.5
Other ⁽³⁾	22	82	(73.2)	(1)	—	—	—	37	162	(77.2)	(5)	—	—	—
TOTAL	$ 7,984	$ 7,585	5.3 %	$ 85	$ 7,876	$ 7,503	5.0 %	$ 15,686	$ 14,955	4.9 %	$ 38	$ 15,605	$ 14,793	5.5 %


(1)	The data in this schedule has been intentionally rounded to the nearest million and, therefore, may not sum.
(2)	The currency impact to revenue measures the change in revenue between current and prior year periods using constant exchange rates.
(3)	Includes inorganic revenue from the divested Renal Care Solutions business and Transition Manufacturing Agreements from previously divested businesses.

MEDTRONIC PLC
U.S. ⁽¹⁾⁽²⁾ REVENUE
(Unaudited)

	SECOND QUARTER						YEAR-TO-DATE
	REPORTED			ORGANIC			REPORTED			ORGANIC
(in millions)	FY24	FY23	Growth	Adjusted FY24	Adjusted FY23	Growth	FY24	FY23	Growth	Adjusted FY24	Adjusted FY23	Growth
Cardiovascular	$ 1,427	$ 1,410	1.2 %	$ 1,427	$ 1,410	1.2 %	$ 2,776	$ 2,696	3.0 %	$ 2,776	$ 2,696	3.0 %
Cardiac Rhythm & Heart Failure	782	776	0.8	782	776	0.8	1,502	1,481	1.4	1,502	1,481	1.4
Structural Heart & Aortic	367	348	5.5	367	348	5.5	724	660	9.7	724	660	9.7
Coronary & Peripheral Vascular	278	286	(2.8)	278	286	(2.8)	550	555	(0.9)	550	555	(0.9)
Neuroscience	1,560	1,512	3.2	1,560	1,512	3.2	3,057	2,931	4.3	3,057	2,931	4.3
Cranial & Spinal Technologies	863	817	5.6	863	817	5.6	1,685	1,580	6.6	1,685	1,580	6.6
Specialty Therapies	403	403	—	403	403	—	795	784	1.4	795	784	1.4
Neuromodulation	293	291	0.7	293	291	0.7	577	567	1.8	577	567	1.8
Medical Surgical	963	895	7.6	963	895	7.6	1,845	1,726	6.9	1,845	1,726	6.9
Surgical & Endoscopy	688	633	8.7	688	633	8.7	1,308	1,214	7.7	1,308	1,214	7.7
Patient Monitoring & Respiratory Interventions	275	262	5.0	275	262	5.0	537	512	4.9	537	512	4.9
Diabetes	217	228	(4.8)	217	228	(4.8)	405	434	(6.7)	405	434	(6.7)
Other ⁽³⁾	8	23	(65.2)	—	—	—	16	49	(67.3)	—	—	—
TOTAL	$ 4,175	$ 4,069	2.6 %	$ 4,167	$ 4,046	3.0 %	$ 8,099	$ 7,835	3.4 %	$ 8,083	$ 7,787	3.8 %


(1)	U.S. includes the United States and U.S. territories.
(2)	The data in this schedule has been intentionally rounded to the nearest million and, therefore, may not sum.
(3)	Includes inorganic revenue from the divested Renal Care Solutions business and Transition Manufacturing Agreements from previously divested businesses.

MEDTRONIC PLC
WORLD WIDE REVENUE: GEOGRAPHIC ⁽¹⁾⁽²⁾
(Unaudited)

	SECOND QUARTER							YEAR-TO-DATE
	REPORTED				ORGANIC			REPORTED				ORGANIC
(in millions)	FY24	FY23	Growth	Currency Impact ⁽³⁾	Adjusted FY24	Adjusted FY23	Growth	FY24	FY23	Growth	Currency Impact ⁽³⁾	Adjusted FY24	Adjusted FY23	Growth
U.S.	$ 1,427	$ 1,410	1.2 %	$ —	$ 1,427	$ 1,410	1.2 %	$ 2,776	$ 2,696	3.0 %	$ —	$ 2,776	$ 2,696	3.0 %
Non-U.S. Developed	912	802	13.7	43	869	802	8.4	1,869	1,694	10.3	45	1,824	1,694	7.7
Emerging Markets	584	546	7.0	(12)	596	546	9.2	1,128	1,070	5.4	(33)	1,161	1,070	8.5
Cardiovascular	2,923	2,759	5.9	31	2,892	2,759	4.8	5,773	5,459	5.8	12	5,761	5,459	5.5
U.S.	1,560	1,512	3.2	—	1,560	1,512	3.2	3,057	2,931	4.3	—	3,057	2,931	4.3
Non-U.S. Developed	399	382	4.5	14	385	382	0.8	815	788	3.4	10	805	788	2.2
Emerging Markets	329	292	12.7	(4)	333	292	14.0	634	582	8.9	(15)	649	582	11.5
Neuroscience	2,288	2,186	4.7	10	2,278	2,186	4.2	4,506	4,301	4.8	(5)	4,511	4,301	4.9
U.S.	963	895	7.6	—	963	895	7.6	1,845	1,726	6.9	—	1,845	1,726	6.9
Non-U.S. Developed	740	685	8.0	27	713	685	4.1	1,512	1,420	6.5	21	1,491	1,420	5.0
Emerging Markets	438	421	4.0	1	437	421	3.8	824	789	4.4	(5)	829	789	5.1
Medical Surgical	2,142	2,002	7.0	27	2,115	2,002	5.6	4,181	3,935	6.3	16	4,165	3,935	5.8
U.S.	217	228	(4.8)	—	217	228	(4.8)	405	434	(6.7)	—	405	434	(6.7)
Non-U.S. Developed	310	254	22.0	18	292	254	15.0	625	518	20.7	22	603	518	16.4
Emerging Markets	84	74	13.5	(1)	85	74	14.9	159	145	9.7	(3)	162	145	11.7
Diabetes	610	556	9.7	17	593	556	6.7	1,189	1,098	8.3	20	1,169	1,098	6.5
U.S.	8	23	(65.2)	—	—	—	—	16	49	(67.3)	—	—	—	—
Non-U.S. Developed	7	33	(78.8)	(1)	—	—	—	12	65	(81.5)	(2)	—	—	—
Emerging Markets	7	25	(72.0)	(1)	—	—	—	10	48	(79.2)	(2)	—	—	—
Other ⁽⁴⁾	22	82	(73.2)	(1)	—	—	—	37	162	(77.2)	(5)	—	—	—
U.S.	4,175	4,069	2.6	—	4,167	4,046	3.0	8,099	7,835	3.4	—	8,083	7,787	3.8
Non-U.S. Developed	2,368	2,157	9.8	101	2,259	2,123	6.4	4,831	4,485	7.7	96	4,722	4,420	6.8
Emerging Markets	1,441	1,359	6.0	(17)	1,451	1,334	8.8	2,755	2,635	4.6	(57)	2,800	2,586	8.3
TOTAL	$ 7,984	$ 7,585	5.3 %	$ 85	$ 7,876	$ 7,503	5.0 %	$ 15,686	$ 14,955	4.9 %	$ 38	$ 15,605	$ 14,793	5.5 %

MEDTRONIC PLC
CONSOLIDATED STATEMENTS OF INCOME
(Unaudited)

	Three months ended		Six months ended
(in millions, except per share data)	October 27, 2023	October 28, 2022	October 27, 2023	October 28, 2022
Net sales	$ 7,984	$ 7,585	$ 15,686	$ 14,955
Costs and expenses:
Cost of products sold, excluding amortization of intangible assets	2,761	2,535	5,390	5,051
Research and development expense	698	676	1,365	1,368
Selling, general, and administrative expense	2,686	2,617	5,299	5,184
Amortization of intangible assets	425	421	855	844
Restructuring charges, net	40	30	94	44
Certain litigation charges	65	—	105	—
Other operating income, net	(31)	(97)	(30)	(62)
Operating profit	1,340	1,404	2,608	2,528
Other non-operating income, net	(154)	(109)	(230)	(192)
Interest expense, net	180	118	329	282
Income before income taxes	1,313	1,395	2,510	2,438
Income tax provision	402	959	802	1,072
Net income	911	435	1,708	1,367
Net income attributable to noncontrolling interests	(2)	(8)	(8)	(10)
Net income attributable to Medtronic	$ 909	$ 427	$ 1,700	$ 1,356
Basic earnings per share	$ 0.68	$ 0.32	$ 1.28	$ 1.02
Diluted earnings per share	$ 0.68	$ 0.32	$ 1.28	$ 1.02
Basic weighted average shares outstanding	1,330.2	1,329.4	1,330.3	1,329.4
Diluted weighted average shares outstanding	1,331.9	1,332.0	1,332.8	1,333.3

MEDTRONIC PLC
GAAP TO NON-GAAP RECONCILIATIONS ⁽¹⁾
(Unaudited)

	Three months ended October 27, 2023
(in millions, except per share data)	Net Sales	Cost of Products Sold	Gross Margin Percent	Operating Profit	Operating Profit Percent	Income Before Income Taxes	Net Income attributable to Medtronic	Diluted EPS	Effective Tax Rate
GAAP	$ 7,984	$ 2,761	65.4 %	$ 1,340	16.8 %	$ 1,313	$ 909	$ 0.68	30.6 %
Non-GAAP Adjustments:
Amortization of intangible assets	—	—	—	425	5.3	425	360	0.27	15.3
Restructuring and associated costs (2)	—	(15)	0.2	91	1.1	91	76	0.06	17.6
Acquisition and divestiture-related items (3)	—	(6)	0.1	58	0.7	58	51	0.04	12.1
Certain litigation charges	—	—	—	65	0.8	65	50	0.04	23.1
(Gain)/loss on minority investments (4)	—	—	—	—	—	25	21	0.02	20.0
Medical device regulations (5)	—	(21)	0.3	30	0.4	30	24	0.02	20.0
Certain tax adjustments, net (6)	—	—	—	—	—	—	176	0.13	—
Non-GAAP	$ 7,984	$ 2,720	65.9 %	$ 2,009	25.2 %	$ 2,008	$ 1,667	$ 1.25	16.9 %
Currency impact	(85)	(65)	0.5	121	1.8			0.08
Currency Adjusted	$ 7,899	$ 2,655	66.4 %	$ 2,130	27.0 %			$ 1.33

	Three months ended October 28, 2022
(in millions, except per share data)	Net Sales	Cost of Products Sold	Gross Margin Percent	Operating Profit	Operating Profit Percent	Income Before Income Taxes	Net Income attributable to Medtronic	Diluted EPS	Effective Tax Rate
GAAP	$ 7,585	$ 2,535	66.6 %	$ 1,404	18.5 %	$ 1,395	$ 427	$ 0.32	68.7 %
Non-GAAP Adjustments:
Amortization of intangible assets	—	—	—	421	5.6	421	356	0.27	15.4
Restructuring and associated costs (2)	—	(21)	0.3	95	1.3	95	76	0.06	20.0
Acquisition and divestiture-related items (3)	—	(39)	0.5	63	0.8	63	55	0.05	404.2
(Gain)/loss on minority investments (4)	—	—	—	—	—	(11)	(11)	(0.01)	—
Medical device regulations (5)	—	(22)	0.3	37	0.5	37	30	0.02	18.9
Certain tax adjustments, net (7)	—	—	—	—	—	—	793	0.60	—
Non-GAAP	$ 7,585	$ 2,454	67.6 %	$ 2,020	26.6 %	$ 1,999	$ 1,725	$ 1.30	13.3 %


See description of non-GAAP financial measures contained in the press release dated November 21, 2023.
(1)	The data in this schedule has been intentionally rounded to the nearest million or $0.01 for EPS figures, and, therefore, may not sum.
(2)	Associated costs include costs incurred as a direct result of the restructuring program, such as salaries for employees supporting the program, consulting expenses, and asset write-offs.
(3)	The charges primarily include business combination costs, changes in fair value of contingent consideration, and charges related to the impending separation of the Patient Monitoring and Respiratory Interventions businesses within our Medical Surgical Portfolio.
(4)	We exclude unrealized and realized gains and losses on our minority investments as we do not believe that these components of income or expense have a direct correlation to our ongoing or future business operations.
(5)	The charges represent incremental costs of complying with the new European Union (E.U.) medical device regulations for previously registered products and primarily include charges for contractors supporting the project and other direct third-party expenses. We consider these costs to be duplicative of previously incurred costs and/or one-time costs, which are limited to a specific time period.
(6)	The charge primarily relates to the establishment of a valuation allowance against certain net operating losses, and a withholding tax cost related to the impending separation of the Patient Monitoring and Respiratory Interventions businesses within our Medical Surgical Portfolio.
(7)	The charge primarily relates to a $764 million reserve adjustment that was a direct result of the U.S. Tax Court opinion, issued on August 18, 2022, on the previously disclosed litigation regarding the allocation of income between Medtronic, Inc. and its wholly owned subsidiary operating in Puerto Rico.


See description of non-GAAP financial measures contained in the press release dated November 21, 2023.
(1)	The data in this schedule has been intentionally rounded to the nearest million, and, therefore, may not sum.
(2)	Free cash flow represents operating cash flows less property, plant, and equipment additions.

MEDTRONIC PLC
CONSOLIDATED BALANCE SHEETS
(Unaudited)

(in millions)	October 27, 2023	April 28, 2023
ASSETS
Current assets:
Cash and cash equivalents	$ 1,311	$ 1,543
Investments	6,423	6,416
Accounts receivable, less allowances and credit losses of $177 and $176, respectively	5,934	5,998
Inventories, net	5,754	5,293
Other current assets	2,658	2,425
Total current assets	22,081	21,675
Property, plant, and equipment, net	5,735	5,569
Goodwill	40,821	41,425
Other intangible assets, net	14,060	14,844
Tax assets	3,428	3,477
Other assets	3,962	3,959
Total assets	$ 90,087	$ 90,948
LIABILITIES AND EQUITY
Current liabilities:
Current debt obligations	$ 1,339	$ 20
Accounts payable	2,174	2,662
Accrued compensation	1,758	1,949
Accrued income taxes	1,088	840
Other accrued expenses	3,299	3,581
Total current liabilities	9,659	9,051
Long-term debt	23,741	24,344
Accrued compensation and retirement benefits	1,020	1,093
Accrued income taxes	1,777	2,360
Deferred tax liabilities	686	708
Other liabilities	1,556	1,727
Total liabilities	38,440	39,283
Commitments and contingencies
Shareholders' equity:
Ordinary shares— par value $0.0001, 2.6 billion shares authorized, 1,330,173,450 and 1,330,809,036 shares issued and outstanding, respectively	—	—
Additional paid-in capital	24,580	24,590
Retained earnings	30,256	30,392
Accumulated other comprehensive loss	(3,377)	(3,499)
Total shareholders' equity	51,460	51,483
Noncontrolling interests	187	182
Total equity	51,647	51,665
Total liabilities and equity	$ 90,087	$ 90,948

MEDTRONIC PLC
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)

	Six months ended
(in millions)	October 27, 2023	October 28, 2022
Operating Activities:
Net income	$ 1,708	$ 1,367
Adjustments to reconcile net income to net cash provided by operating activities:
Depreciation and amortization	1,344	1,339
Provision for credit losses	37	41
Deferred income taxes	(36)	(92)
Stock-based compensation	219	199
Loss on debt extinguishment	—	53
Other, net	182	148
Change in operating assets and liabilities, net of acquisitions and divestitures:
Accounts receivable, net	(117)	(346)
Inventories, net	(616)	(784)
Accounts payable and accrued liabilities	(699)	(14)
Other operating assets and liabilities	(486)	94
Net cash provided by operating activities	1,536	2,005
Investing Activities:
Acquisitions, net of cash acquired	(22)	(1,867)
Additions to property, plant, and equipment	(815)	(749)
Purchases of investments	(3,403)	(3,743)
Sales and maturities of investments	3,336	3,609
Other investing activities, net	(59)	19
Net cash used in investing activities	(963)	(2,731)
Financing Activities:
Change in current debt obligations, net	1,321	349
Proceeds from short-term borrowings (maturities greater than 90 days)	—	2,284
Issuance of long-term debt	—	3,430
Payments on long-term debt	—	(2,311)
Dividends to shareholders	(1,836)	(1,807)
Issuance of ordinary shares	149	153
Repurchase of ordinary shares	(378)	(477)
Other financing activities	153	443
Net cash (used in) provided by financing activities	(591)	2,064
Effect of exchange rate changes on cash and cash equivalents	(214)	(223)
Net change in cash and cash equivalents	(232)	1,114
Cash and cash equivalents at beginning of period	1,543	3,714
Cash and cash equivalents at end of period	$ 1,311	$ 4,828
Supplemental Cash Flow Information
Cash paid for:
Income taxes	$ 1,110	$ 821
Interest	476	234

Contacts:

Erika Winkels	Ryan Weispfenning
Public Relations	Investor Relations
+1-763-526-8478	+1-763-505-4626

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