Medtronic Extravascular ICD meets global pivotal clinical trial's safety and effectiveness endpoints

Late-breaking data presented at ESC Congress 2022 and simultaneously published in The New England Journal of Medicine confirms implant procedure safety and defibrillation success

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that its investigational EV ICD™ System a first-of-its-kind defibrillator with the lead placed under the breastbone, outside of the heart and veins achieved a defibrillation success rate of 98.7% and met its safety endpoints in a global clinical trial. Findings from the Extravascular Implantable Cardioverter Defibrillator (EV ICD) Pivotal Study were presented as late-breaking science today at the European Society of Cardiology (ESC) Congress 2022 in Barcelona and simultaneously published in The New England Journal of Medicine. Worldwide, the EV ICD system is investigational and not yet approved for sale or distribution.

The Medtronic EV ICD system is designed to treat dangerously fast heart rhythms that can lead to sudden cardiac arrest (SCA), while avoiding certain risks of traditional, transvenous ICDs because its lead (thin wire) is placed outside the heart and veins, under the breastbone (sternum) using a minimally invasive approach. Placing the lead in this location is designed to help avoid long-term complications that may be associated with leads in the heart and veins, such as vessel occlusion (narrowing, blockage or compression of a vein) and risks for blood infections.

The lead is connected to a device that is implanted below the left armpit (in the left mid-axillary region). Clinical trial participants received the same therapies provided by traditional ICDs, including defibrillation, anti-tachycardia pacing (ATP), and back-up pacing therapies with this single implanted device that is similar in size, shape, and longevity to traditional ICDs.

"We are very encouraged by the high defibrillation effectiveness and strong safety profile of the EV ICD system seen in the study, as we look to deliver less-invasive treatment options for patients at risk of sudden cardiac arrest," said Ian Crozier, MB, CHB, M.D., Christchurch Hospital, Christchurch, New Zealand , who presented the results at ESC Congress 2022. "These results demonstrate the potential for this novel technology to be used as a safe, successful approach for patients with life-threatening arrhythmias."

Study Results: Effectiveness
In the study, the device's effectiveness in delivering defibrillation therapy at implant was 98.7% (298 of 302 patients), surpassing the prespecified performance goal of 88%. These results reflect a greater defibrillation efficacy for the EV ICD than historical transvenous ICD studies; ^1-4 comparable efficacy to the subcutaneous ICD despite EV ICD's smaller device size; ⁵ and a predicted increase in longevity compared to the subcutaneous ICD. Additionally, all discrete spontaneous arrhythmias were successfully treated (18 of 18, 100%).

Further, the efficacy of ATP – which paces the heart to interrupt and terminate a dangerous rhythm, potentially avoiding a defibrillation shock – in the EV ICD study was comparable to ATP efficacy in transvenous defibrillators. ^6,7 In total, 33 shocks were avoided by having ATP programmed "on."

Study Results: Safety
The study also exceeded its safety endpoint: at six months, 92.6% of patients (Kaplan-Meier estimate) were free from major system and/or procedure-related major complications such as hospitalization, system revision, or death (compared to the performance goal of 79%; p

At six months, 25 major complications were observed in 23 of 316 patients who underwent an implant attempt (7.3%). Twenty-nine patients experienced inappropriate shocks (9.7%, average 10.6 months follow up), most commonly due to P-wave oversensing, which was more frequent in patients implanted early in the study and less frequent among patients implanted later in the study.

"These pivotal data mark the start of a new era in ICD therapy for patients who are at significant risk of dangerously fast heart rhythms," said Alan Cheng , M.D., chief medical officer of the Cardiac Rhythm Management business, which is part of the Cardiovascular Portfolio at Medtronic. "Today's findings are an important clinical milestone toward our goal of delivering a one-system, one-procedure extravascular ICD solution that prevents sudden cardiac arrest while improving the patient experience with a smaller device and moving the lead out of the veins and placing it under the breastbone. The EV ICD system retains the benefits of a completely extravascular system while providing ATP, pause prevention pacing and low defibrillation energy."

The EV ICD Pivotal study is a prospective, multicenter, single-arm, non-randomized, pre-market clinical study that assessed the safety and effectiveness of the Medtronic EV ICD system for patients at risk of sudden cardiac death. The EV ICD Pivotal study enrolled 356 patients at 46 sites in 17 countries in North America , Europe , the Middle East , Asia , Australia and New Zealand . Medtronic has received FDA approval for a Continued Access Study while the agency reviews the company's EV ICD pre-market application.

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 all. 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 .

¹ Leong-Sit P, Gula LJ, Diamantouros P, et al. Effect of defibrillation testing on management during implantable cardioverter-defibrillator implantation. Am Heart J 2006;152:1104-8.

² Pires LA, Johnson KM. Intraoperative testing of the implantable cardioverter-defibrillator: how much is enough? J Cardiovasc Electrophysiol 2006;17:140-5.

³ Michowitz Y, Lellouche N, Contractor T, et al. Defibrillation threshold testing fails to show clinical benefit during long-term follow-up of patients undergoing cardiac resynchronization therapy defibrillator implantation. Europace 2011;13:683-8.

⁴ Healey JS, Hohnloser SH, Glikson M, et al. Cardioverter defibrillator implantation without induction of ventricular fibrillation: a single-blind, non-inferiority, randomised controlled trial (SIMPLE). Lancet 2015;385:785-91.

⁵ Weiss R, Knight BP, Gold MR, et al. Safety and efficacy of a totally subcutaneous implantable-cardioverter defibrillator. Circulation 2013;128:944-53.

⁶ Gasparini M, Lunati MG, Proclemer A, et al. Long Detection Programming in Single-Chamber Defibrillators Reduces Unnecessary Therapies and Mortality: The ADVANCE III Trial. JACC Clin Electrophysiol 2017;3:1275-82.

⁷ Moss AJ, Schuger C, Beck CA, et al. Reduction in inappropriate therapy and mortality through ICD programming. N Engl J Med 2012;367:2275-83.

Contacts :
Tracy McNulty	Ryan Weispfenning
Public Relations	Investor Relations
+1-763-526-2492	+1-763-505-4626

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SOURCE Medtronic plc

View original content to download multimedia: https://www.newswire.ca/en/releases/archive/August2022/28/c6976.html

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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

View original content to download multimedia: https://www.prnewswire.com/news-releases/medtronic-announces-fda-approval-of-minimally-invasive-device-to-treat-hypertension-301992645.html

SOURCE Medtronic plc

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	Three months ended									Nine months ended
(millions, except per share or as otherwise noted)	September 30 2023			June 30 2023			September 30 2022			September 30 2023			September 30 2022
FINANCIAL
Revenues	$	133.1		$	117.4		$	154.7		$	376.6		$	492.7

Funds from Operations		93.8			91.3			123.5			271.4			388.1
Per Share - basic and diluted ⁽¹⁾		0.39			0.38			0.52			1.14			1.63

Net Earnings		55.4			48.0			76.2			160.2			250.2
Per Share - basic and diluted ⁽¹⁾		0.23			0.20			0.32			0.67			1.05

Dividends declared ⁽²⁾		57.3			57.3			28.7			171.9			86. 0
Per Share		0.24			0.24			0.12			0.72			0.36

Acquisitions		15.6			15.2			2.5			36.2			24.4
Net debt at period end ⁽³⁾		253.7			275.9			364.2			253.7			364.2

Shares Outstanding
Shares outstanding at period end		239.0			238.9			238.8			239.0			238.8
Weighted average - basic		238.9			238.9			238.8			238.9			238.8
Weighted average - diluted		238.9			238.9			239.1			238.9			239.1

OPERATIONAL Royalty Production Volumes
Crude Oil (bbls/d)		12,084			12,607			11,376			12,300			11,595
NGL (bbls/d)		2,702			1,943			2,660			2,437			2,685
Natural Gas (MMcf/d)		64.1			53.8			65.7			59.2			64.1
Royalty Production (BOE/d) ⁽⁴⁾		25,469			23,517			24,986			24,604			24,963

Realized Pricing
Crude Oil ($/bbl)		92.53			78.05			102.80			82.25			108.02
NGL ($/bbl)		52.01			44.77			58.02			48.18			61.47
Natural Gas ($/Mcf)		1.97			2.23			4.00			2.74			4.80
Total ($/BOE) ⁽⁴⁾		54.37			50.65			63.51			52.49			69.10

Operating Netback per BOE ⁽⁵⁾		46.09			46.64			60.64			45.49			65.39

Funds from Operations per BOE		40.03			42.66			53.73			40.41			56.95

Oil Price Benchmarks
Western Texas Intermediate (WTI) (US$/bbl)		82.32			73.99			91.68			77.41			98.13
Edmonton Light Sweet ($/bbl)		107.87			95.32			116.88			100.68			123.44
Western Canadian Select (WCS) crude oil differential to WTI (US$/bbl)		(12.89	)		(15.07	)		(19.86	)		(17.57	)		(15.73	)

Natural Gas Price Benchmarks
AECO monthly index ($/Mcf)		2.39			2.35			5.81			3.03			5.56
AECO daily index ($/Mcf)		2.60			2.45			4.08			2.76			5.35

Foreign Exchange Rate (US$/CAD$)		0.7466			0.7454			0.7662			0.7436			0.7775
(1) Net Earnings and Funds from Operations per Share are calculated using the weighted average number of basic and diluted common shares outstanding.
(2) A dividend of $0.24 per common share was declared on September 11, 2023. The dividend was paid on October 16, 2023 to shareholders of record as at September 29, 2023.
(3) See Note 14 "Capital Management" in the interim condensed consolidated financial statements for the three and nine months ended September 30, 2023 and 2022 and the three and six months ended June 30, 2023.
(4) See "Conversions of Natural Gas to BOE".
(5) Operating Netback per BOE is defined under the Non-GAAP Measures and Ratios section of this press release.

	Three Months Ended									Nine Months Ended
($ millions)	September 30 2023			June 30 2023			September 30 2022			September 30 2023			September 30 2022
Cash from Operating Activities	$	78.1		$	95.6		$	178.3		$	190.9		$	424.8
Other Revenue		(5.7	)		(9.0	)		(8.7	)		(24.0	)		(21.8	)
Non-cash Revenue		0.5			-			-			0.5			0.2
Amortization of Debt Issuance Costs		-			(0.1	)		(0.2	)		(0.3	)		(0.5	)
Finance Expense		4.5			4.6			4.4			13.6			14.2
Current Tax Expense		14.9			13.0			20.4			44.4			65.4
Net Change in Non-cash Working Capital		15.7			(4.3	)		(54.8	)		80.5			(36.7	)
Operating Netback	$	108.0		$	99.8		$	139.4		$	305.6		$	445.6

	Three Months Ended						Nine Months Ended
($ millions)	September 30 2023		June 30 2023		September 30 2022		September 30 2023		September 30 2022
Royalty Production Revenue	$	127.4	$	108.4	$	146.0	$	352.6	$	470.9
Operating Netback	$	108.0	$	99.8	$	139.4	$	305.6	$	445.6
Operating Margin		85 %		92%		95%		87 %		95%

	Three Months Ended						Nine Months Ended
($ millions)	September 30 2023		June 30 2023		September 30 2022		September 30 2023		September 30 2022
Funds From Operations	$	93.8	$	91.3	$	123.5	$	271.4	$	388.1
Dividends Declared	$	57.3	$	57.3	$	28.7	$	171.9	$	86.0
Payout Ratio		61 %		63%		23%		63 %		22%

	Three Months Ended									Nine Months Ended
($ millions)	September 30 2023			June 30 2023			September 30 2022			September 30 2023			September 30 2022
Total Administrative Expenses	$	15.0		$	13.0		$	10.4		$	38.9		$	32.4
Share-Based Compensation Expense		(8.6	)		(7.2	)		(5.5	)		(20.4	)		(17.0	)
Cash Payments Made - Share Unit Plans		11.5			1.4			-			23.8			5.0
Cash Administrative Expenses	$	17.9		$	7.2		$	4.9		$	42.3		$	20.4

	Three months ended									Six months ended
(millions, except per share or as otherwise noted)	June 30, 2023			March 31, 2023			June 30, 2022			June 30, 2023			June 30, 2022
FINANCIAL
Revenues	$	117.4		$	126.1		$	198.1		$	243.5		$	338.0
Funds from Operations		91.3			86.3			159.6			177.6			264.6
Per Share - basic and diluted ⁽¹⁾		0.38			0.36			0.67			0.74			1.11
Net Earnings		48.0			56.8			110.1			104.8			174.0
Per Share - basic and diluted ⁽¹⁾		0.20			0.24			0.46			0.44			0.73
Dividends declared ⁽²⁾		57.3			57.3			28.7			114.6			57.4
Per Share		0.24			0.24			0.12			0.48			0.24

Acquisitions		15.2			5.4			15.6			20.6			21.9
Net debt at period end ⁽³⁾		275.9			292.4			453.9			275.9			453.9

Shares Outstanding
Shares outstanding at period end		238.9			238.9			238.8			238.9			238.8
Weighted average - basic		238.9			238.9			238.8			238.9			238.8
Weighted average - diluted		238.9			238.9			239.1			238.9			239.0

OPERATIONAL
Royalty Production Volumes
Crude Oil (bbls/d)		12,607			12,212			12,220			12,411			11,707
NGL (bbls/d)		1,943			2,664			2,772			2,302			2,697
Natural Gas (MMcf/d)		53.8			59.6			66.0			56.7			63.3
Royalty Production (BOE/d) ⁽⁴⁾		23,517			24,809			25,992			24,163			24,954

Realized Pricing
Crude Oil ($/bbl)		78.05			76.25			122.01			77.17			110.60
NGL ($/bbl)		44.77			46.71			70.25			45.89			63.20
Natural Gas ($/Mcf)		2.23			4.05			6.14			3.19			5.21
Total ($/BOE) ⁽⁴⁾		50.65			52.31			80.44			51.49			71.94

Operating Netback per BOE ⁽⁵⁾		46.64			43.80			77.69			45.18			67.80

Funds from Operations per BOE		42.66			38.65			67.48			40.61			58.58

Oil Price Benchmarks
Western Texas Intermediate (WTI) (US$/bbl)		73.99			76.13			108.57			75.06			101.43
Edmonton Light Sweet ($/bbl)		95.32			99.04			138.18			97.18			126.92
Western Canadian Select (WCS) crude oil differential to WTI (US$/bbl)		(15.07	)		(24.78	)		(12.80	)		(19.92	)		(13.67	)

Natural Gas Price Benchmarks
AECO monthly index ($/Mcf)		2.35			4.34			6.27			3.34			5.43
AECO daily index ($/Mcf)		2.45			3.22			7.24			2.83			5.99

Foreign Exchange Rate (US$/CAD$)		0.7454			0.7397			0.7820			0.7425			0.7831
_{(1) Net Earnings and Funds from Operations per Share are calculated using the weighted average number of basic and diluted common shares outstanding.}
_{(2) A dividend of $0.24 per common share was declared on June 6, 2023. The dividend was paid on July 17, 2023 to shareholders of record as at June 30, 2023.}
_{(3) See Note 14 "Capital Management" in the interim condensed consolidated financial statements for the three and six months ended June 30, 2023 and 2022.}
_{(4) See "Conversions of Natural Gas to BOE".}
_{(5) Operating Netback per BOE is defined under the Non-GAAP Measures and Ratios section of this press release.}

Andrew Phillips President & Chief Executive Officer PrairieSky Royalty Ltd. (587) 293-4005 Investor Relations (587) 293-4000 www.prairiesky.com		Pamela Kazeil Vice President, Finance & Chief Financial Officer PrairieSky Royalty Ltd. (587) 293-4089

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.

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

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


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.

Contacts:

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

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