U.S. Patent Office Completes Review of Medtronic Patents, Rejects More Axonics Challenges

Medtronic (NYSE:MDT), the global leader in medical technology, today announced that the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office has affirmed an additional three patents in a dispute with Axonics over intellectual property for its sacral neuromodulation (SNM) device family, the InterStim™ systems. Today's decisions complete the review process initiated by Axonics to challenge the validity of the seven total patents involved in the IP infringement case brought by Medtronic. Cumulatively, the PTAB has now affirmed claims in all seven of the Medtronic patents.

The PTAB's latest decisions today affirmed all claims at issue in Medtronic's U.S. Patent Nos. 8,457,758 ('758) and 8,738,148 ('148); and affirmed claims 1-7, 16-18 and 22 of Medtronic's U.S. Patent No. 9,821,112 ('112), while invalidating claims 9-13 and 20. These patents relate to recharging technology. Medtronic is weighing its legal options with regard to the handful of invalidated patent claims in the '112 patent. The '758 patent and the '148 patent expire in April 2025 , the '112 patent expires in April 2024 .

Now that the IPR is complete — including the PTAB's decision in September 2020 to reject without hearing the challenge to Medtronic U.S. patent No. 9,463,324 ('324) — Medtronic will request that the U.S. District Court in the Central District of California lift the stay on the IP infringement case and resume proceedings. The decision on the '324 patent is final and not appealable. The '324 patent expires in April 2024 .

All Medtronic patents affirmed by the PTAB have been in force for every sale Axonics has made to-date.

"Medtronic appreciates the Patent Trial and Appeal Board's efforts in this matter," said Brett Wall , executive vice president and president of the Neuroscience Portfolio at Medtronic. "We are pleased with the outcome of the review process and look forward to our day in court to protect the proprietary technology that brings SNM therapy to patients around the world."

About the IP Infringement Case Against Axonics
Medtronic filed suit against Axonics in November 2019 , asserting claims for infringement of seven patents related to Medtronic's minimally invasive sacral neuromodulation lead placement procedure and implant recharging technologies. In response, Axonics filed Inter Partes Review (IPR) in March 2020 on all seven patents and the litigation was stayed pending the outcome at the PTAB.

In September 2020 , the PTAB rejected without hearing the challenge to Medtronic's U.S. Patent No. 9,463,324 and found that Axonics' arguments lacked merit. That decision by the PTAB is final and not appealable.

Last week, the PTAB affirmed the additional Medtronic U.S. Patent Nos. 8,036,756 and 8,626,314, which protects technology related to its tined leads; and it upheld claim 7 in Medtronic's U.S. Patent No. 7,774,069 ('069 patent), which protects technology related to its recharge power control. The PTAB's decision on the '069 patent also found claims 5, 6, 8 and 9 invalid, while claims 1-4 and 10-13 were not challenged by Axonics. These decisions are subject to appeal, and Medtronic is weighing its legal options in regard to the invalidated claims of the '069 patent.

About Medtronic InterStim™ Systems
Medtronic has the world's smallest rechargeable bladder/bowel control system and the fastest battery recharge available and is the only company that offers patients the choice of a rechargeable or recharge-free sacral neuromodulation device. With 25-years' experience of innovation, investment and pioneering therapy, Medtronic is the only company with five-year data demonstrating the safety and efficacy of its sacral neuromodulation systems.

About Medtronic
Medtronic plc ( www.medtronic.com ), headquartered in Dublin, Ireland , is among the world's largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 90,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

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:

Katie Genereux	Ryan Weispfenning
Public Relations	Investor Relations
+1-763-514-0162	+1-763-505-4626

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MEDTRONIC PLC WORLD WIDE REVENUE ⁽¹⁾ (Unaudited)

	SECOND QUARTER							YEAR-TO-DATE
	REPORTED				ORGANIC			REPORTED				ORGANIC
(in millions)	FY25	FY24	Growth	Currency Impact ⁽³⁾	Adjusted FY25 ⁽⁴⁾	Adjusted FY24 ⁽⁴⁾	Growth	FY25	FY24	Growth	Currency Impact ⁽³⁾	Adjusted FY25 ⁽⁵⁾	Adjusted FY24 ⁽⁵⁾	Growth
Cardiovascular	$ 3,102	$ 2,923	6.1 %	$ 16	$ 3,086	$ 2,923	5.6 %	$ 6,108	$ 5,773	5.8 %	$ (23)	$ 6,132	$ 5,773	6.2 %
Cardiac Rhythm & Heart Failure	1,578	1,492	5.8	11	1,567	1,492	5.0	3,114	2,938	6.0	(8)	3,122	2,938	6.2
Structural Heart & Aortic	881	819	7.6	4	877	819	7.1	1,736	1,633	6.3	(8)	1,744	1,633	6.8
Coronary & Peripheral Vascular	643	613	4.9	1	642	613	4.8	1,259	1,202	4.7	(7)	1,266	1,202	5.3
Neuroscience	2,451	2,288	7.1	10	2,441	2,288	6.7	4,768	4,506	5.8	(8)	4,776	4,506	6.0
Cranial & Spinal Technologies	1,234	1,157	6.7	3	1,231	1,157	6.4	2,382	2,260	5.4	(6)	2,387	2,260	5.6
Specialty Therapies	737	705	4.6	5	732	705	3.9	1,450	1,400	3.5	(2)	1,452	1,400	3.7
Neuromodulation	480	426	12.6	2	478	426	12.1	937	846	10.8	(1)	938	846	10.9
Medical Surgical	2,128	2,103	1.2	10	2,117	2,103	0.7	4,123	4,107	0.4	(18)	4,142	4,107	0.8
Surgical & Endoscopy	1,649	1,641	0.5	9	1,641	1,641	—	3,193	3,187	0.2	(13)	3,207	3,187	0.6
Acute Care & Monitoring	478	462	3.6	1	477	462	3.3	930	921	1.0	(5)	935	921	1.6
Diabetes	686	610	12.4	9	678	610	11.0	1,333	1,189	12.1	5	1,329	1,189	11.8
Total Reportable Segments	8,366	7,923	5.6	45	8,322	7,923	5.0	16,333	15,575	4.9	(46)	16,379	15,575	5.2
Other ⁽²⁾	37	61	(38.9)	—	—	—	—	(15)	111	(113.5)	(2)	—	—	—
TOTAL	$ 8,403	$ 7,984	5.3 %	$ 45	$ 8,322	$ 7,923	5.0 %	$ 16,318	$ 15,686	4.0 %	$ (48)	$ 16,379	$ 15,575	5.2 %


(1)	The data in this schedule has been intentionally rounded to the nearest million and, therefore, may not sum. Percentages have been calculated using actual, non-rounded figures and, therefore, may not recalculate precisely.
(2)	Includes historical operations and ongoing transition agreements from businesses the Company has exited or divested, and specifically for the three months ended July 26, 2024, impacting year-to-date figures, $90 million of incremental Italian payback accruals resulting from the two July 22, 2024 rulings by the Constitutional Court of Italy relating to certain prior years since 2015.
(3)	The currency impact to revenue measures the change in revenue between current and prior year periods using constant exchange rates.
(4)	The three months ended October 25, 2024 includes $82 million of revenue adjustments related to $37 million of inorganic revenue for the transition activity noted in (2) and $45 million of favorable currency impact on the remaining segments. The three months ended October 27, 2023 excludes $61 million of inorganic revenue related to the transition activity noted in (2).
(5)	The six months ended October 25, 2024 excludes $61 million of revenue adjustments related to $90 million of incremental Italian payback accruals further described in note (2), $75 million of inorganic revenue related to the transition activity noted in (2), and $46 million of unfavorable currency impact on the remaining segments. The six months ended October 27, 2023 excludes $111 million of inorganic revenue related to the transition activity noted in (2).

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

	SECOND QUARTER						YEAR-TO-DATE
	REPORTED			ORGANIC			REPORTED			ORGANIC
(in millions)	FY25	FY24	Growth	Adjusted FY25	Adjusted FY24	Growth	FY25	FY24	Growth	Adjusted FY25	Adjusted FY24	Growth
Cardiovascular	$ 1,434	$ 1,427	0.5 %	$ 1,434	$ 1,427	0.5 %	$ 2,836	$ 2,776	2.2 %	$ 2,836	$ 2,776	2.2 %
Cardiac Rhythm & Heart Failure	768	782	(1.8)	768	782	(1.8)	1,534	1,502	2.1	1,534	1,502	2.1
Structural Heart & Aortic	388	367	5.7	388	367	5.7	757	724	4.5	757	724	4.5
Coronary & Peripheral Vascular	278	278	0.1	278	278	0.1	546	550	(0.8)	546	550	(0.8)
Neuroscience	1,677	1,560	7.5	1,677	1,560	7.5	3,242	3,057	6.0	3,242	3,057	6.0
Cranial & Spinal Technologies	926	863	7.2	926	863	7.2	1,781	1,685	5.7	1,781	1,685	5.7
Specialty Therapies	418	403	3.6	418	403	3.6	816	795	2.6	816	795	2.6
Neuromodulation	333	293	13.7	333	293	13.7	645	577	11.8	645	577	11.8
Medical Surgical	944	948	(0.4)	944	948	(0.4)	1,825	1,815	0.5	1,825	1,815	0.5
Surgical & Endoscopy	675	688	(1.9)	675	688	(1.9)	1,304	1,308	(0.2)	1,304	1,308	(0.2)
Acute Care & Monitoring	269	260	3.6	269	260	3.6	521	508	2.6	521	508	2.6
Diabetes	232	217	6.9	232	217	6.9	447	405	10.4	447	405	10.4
Total Reportable Segments	4,286	4,151	3.3	4,286	4,151	3.3	8,350	8,054	3.7	8,350	8,054	3.7
Other ⁽³⁾	18	23	(22.2)	—	—	—	37	45	(19.0)	—	—	—
TOTAL	$ 4,304	$ 4,175	3.1 %	$ 4,286	$ 4,151	3.3 %	$ 8,387	$ 8,099	3.6 %	$ 8,350	$ 8,054	3.7 %


(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. Percentages have been calculated using actual, non-rounded figures and, therefore, may not recalculate precisely.
(3)	Includes historical operations and ongoing transition agreements from businesses the Company has exited or divested.

MEDTRONIC PLC INTERNATIONAL REVENUE ⁽¹⁾ (Unaudited)

	SECOND QUARTER							YEAR-TO-DATE
	REPORTED				ORGANIC			REPORTED				ORGANIC
(in millions)	FY25	FY24	Growth	Currency Impact ⁽³⁾	Adjusted FY25 ⁽⁴⁾	Adjusted FY24 ⁽⁴⁾	Growth	FY25	FY24	Growth	Currency Impact ⁽³⁾	Adjusted FY25 ⁽⁵⁾	Adjusted FY24 ⁽⁵⁾	Growth
Cardiovascular	$ 1,668	$ 1,496	11.5 %	$ 16	$ 1,652	$ 1,496	10.4 %	$ 3,272	$ 2,996	9.2 %	$ (23)	$ 3,295	$ 2,996	10.0 %
Cardiac Rhythm & Heart Failure	811	710	14.2	11	799	710	12.6	1,580	1,436	10.0	(8)	1,588	1,436	10.6
Structural Heart & Aortic	492	451	9.1	4	488	451	8.3	980	909	7.8	(8)	988	909	8.7
Coronary & Peripheral Vascular	365	335	8.9	1	364	335	8.7	713	652	9.3	(7)	720	652	10.4
Neuroscience	774	728	6.3	10	764	728	5.0	1,526	1,449	5.3	(8)	1,535	1,449	5.9
Cranial & Spinal Technologies	308	293	5.0	3	305	293	3.9	600	576	4.2	(6)	606	576	5.2
Specialty Therapies	319	302	5.8	5	315	302	4.3	634	605	4.8	(2)	636	605	5.1
Neuromodulation	146	133	10.4	2	144	133	8.8	292	269	8.8	(1)	293	269	9.1
Medical Surgical	1,183	1,155	2.5	10	1,173	1,155	1.6	2,298	2,292	0.3	(18)	2,317	2,292	1.1
Surgical & Endoscopy	974	953	2.3	9	966	953	1.4	1,889	1,879	0.5	(13)	1,902	1,879	1.2
Acute Care & Monitoring	209	202	3.5	1	208	202	2.8	409	413	(0.9)	(5)	414	413	0.4
Diabetes	455	394	15.5	9	446	394	13.2	886	784	13.1	5	882	784	12.5
Total Reportable Segments	4,080	3,772	8.2	45	4,035	3,772	7.0	7,983	7,521	6.1	(46)	8,028	7,521	6.7
Other ⁽²⁾	19	37	(49.4)	—	—	—	—	(51)	66	(178.3)	(2)	—	—	—
TOTAL	$ 4,099	$ 3,809	7.6 %	$ 45	$ 4,035	$ 3,772	7.0 %	$ 7,931	$ 7,587	4.5 %	$ (48)	$ 8,028	$ 7,521	6.7 %

Contacts:
Janet Cho	Ryan Weispfenning
Public Relations	Investor Relations
+1-818-403-7028	+1-763-505-4626

MEDTRONIC PLC CONSOLIDATED STATEMENTS OF INCOME (Unaudited)

	Three months ended		Six months ended
(in millions, except per share data)	October 25, 2024	October 27, 2023	October 25, 2024	October 27, 2023
Net sales	$ 8,403	$ 7,984	$ 16,318	$ 15,686
Costs and expenses:
Cost of products sold, excluding amortization of intangible assets	2,946	2,761	5,707	5,390
Research and development expense	697	698	1,373	1,365
Selling, general, and administrative expense	2,757	2,686	5,412	5,299
Amortization of intangible assets	413	425	827	855
Restructuring charges, net	30	40	77	94
Certain litigation charges, net	—	65	81	105
Other operating income, net	(34)	(31)	(33)	(30)
Operating profit	1,595	1,340	2,873	2,608
Other non-operating income, net	(173)	(154)	(330)	(230)
Interest expense, net	209	180	376	329
Income before income taxes	1,559	1,313	2,827	2,510
Income tax provision	281	402	500	802
Net income	1,278	911	2,327	1,708
Net income attributable to noncontrolling interests	(9)	(2)	(15)	(8)
Net income attributable to Medtronic	$ 1,270	$ 909	$ 2,312	$ 1,700
Basic earnings per share	$ 0.99	$ 0.68	$ 1.79	$ 1.28
Diluted earnings per share	$ 0.99	$ 0.68	$ 1.79	$ 1.28
Basic weighted average shares outstanding	1,282.4	1,330.2	1,288.6	1,330.3

Diluted weighted average shares outstanding	1,286.9	1,331.9	1,292.5	1,332.8

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

	Three months ended October 25, 2024
(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	$ 8,403	$ 2,946	64.9 %	$ 1,595	19.0 %	$ 1,559	$ 1,270	$ 0.99	18.0 %
Non-GAAP Adjustments:
Amortization of intangible assets	—	—	—	413	4.9	413	338	0.26	18.2
Restructuring and associated costs ⁽²⁾	—	(11)	0.1	46	0.5	46	37	0.03	19.6
Acquisition and divestiture-related items ⁽³⁾	—	(5)	0.1	(25)	(0.3)	(25)	(30)	(0.02)	(20.0)
(Gain)/loss on minority investments ⁽⁴⁾	—	—	—	—	—	(10)	(21)	(0.02)	(100.0)
Medical device regulations ⁽⁵⁾	—	(9)	0.1	12	0.1	12	10	0.01	16.7
Certain tax adjustments, net	—	—	—	—	—	—	16	0.01	—
Non-GAAP	$ 8,403	$ 2,921	65.2 %	$ 2,041	24.3 %	$ 1,995	$ 1,620	$ 1.26	18.3 %
Currency impact	(45)	(103)	1.1	145	1.9			0.09
Currency Adjusted	$ 8,358	$ 2,818	66.3 %	$ 2,186	26.2 %			$ 1.35

	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, net	—	—	—	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 %


See description of non-GAAP financial measures contained in the press release dated November 19, 2024.
(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 primarily include salaries and wages for employees supporting the restructuring activities, consulting expenses, and asset write-offs.
(3)	The charges primarily include business combination costs, changes in fair value of contingent consideration, and exit of business-related charges. The three months ended October 25, 2024, also include gains related to certain business or asset sales.
(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.

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

	Six months ended October 25, 2024
(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	$ 16,318	$ 5,707	65.0 %	$ 2,873	17.6 %	$ 2,827	$ 2,312	$ 1.79	17.7 %
Non-GAAP Adjustments:
Amortization of intangible assets	—	—	—	827	4.9	827	678	0.52	18.0
Restructuring and associated costs ⁽²⁾	—	(20)	0.1	108	0.6	108	87	0.07	19.4
Acquisition and divestiture-related items ⁽³⁾	—	(16)	0.1	(13)	(0.1)	(13)	(19)	(0.01)	(46.2)
Certain litigation charges, net	—	—	—	81	0.5	81	68	0.05	16.0
(Gain)/loss on minority investments ⁽⁴⁾	—	—	—	—	—	(27)	(38)	(0.03)	(37.0)
Medical device regulations ⁽⁵⁾	—	(20)	0.1	27	0.2	27	22	0.02	18.5
Other ⁽⁶⁾	90	—	0.4	90	0.5	90	70	0.05	22.2
Certain tax adjustments, net	—	—	—	—	—	—	33	0.03	—
Non-GAAP	$ 16,408	$ 5,651	65.6 %	$ 3,993	24.3 %	$ 3,921	$ 3,213	$ 2.49	17.7 %
Currency impact	46	(134)	0.9	246	1.5			0.16
Currency Adjusted	$ 16,454	$ 5,517	66.5 %	$ 4,239	25.8 %			$ 2.65

	Six 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	$ 15,686	$ 5,390	65.6 %	$ 2,608	16.6 %	$ 2,510	$ 1,700	$ 1.28	32.0 %
Non-GAAP Adjustments:
Amortization of intangible assets	—	—	—	855	5.5	855	724	0.54	15.2
Restructuring and associated costs ⁽²⁾	—	(30)	0.2	182	1.2	182	152	0.11	16.5
Acquisition and divestiture-related items ⁽³⁾	—	(12)	0.1	107	0.7	107	97	0.07	9.3
Certain litigation charges, net	—	—	—	105	0.7	105	81	0.06	22.9
(Gain)/loss on minority investments ⁽⁴⁾	—	—	—	—	—	89	85	0.06	5.6
Medical device regulations ⁽⁵⁾	—	(42)	0.3	62	0.4	62	49	0.04	21.0
Certain tax adjustments, net ⁽⁷⁾	—	—	—	—	—	—	375	0.28	—
Non-GAAP	$ 15,686	$ 5,306	66.2 %	$ 3,919	25.0 %	$ 3,910	$ 3,262	$ 2.45	16.4 %


See description of non-GAAP financial measures contained in the press release dated November 19, 2024.
(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 25, 2024	April 26, 2024
ASSETS
Current assets:
Cash and cash equivalents	$ 1,394	$ 1,284
Investments	6,595	6,721
Accounts receivable, less allowances and credit losses of $195 and $173, respectively	6,260	6,128
Inventories	5,479	5,217
Other current assets	2,710	2,584
Total current assets	22,438	21,935
Property, plant, and equipment, net	6,438	6,131
Goodwill	41,161	40,986
Other intangible assets, net	12,423	13,225
Tax assets	3,572	3,657
Other assets	4,009	4,047
Total assets	$ 90,042	$ 89,981
LIABILITIES AND EQUITY
Current liabilities:
Current debt obligations	$ 3,719	$ 1,092
Accounts payable	2,376	2,410
Accrued compensation	1,893	2,375
Accrued income taxes	947	1,330
Other accrued expenses	3,260	3,582
Total current liabilities	12,195	10,789
Long-term debt	24,607	23,932
Accrued compensation and retirement benefits	1,084	1,101
Accrued income taxes	1,432	1,859
Deferred tax liabilities	473	515
Other liabilities	1,534	1,365
Total liabilities	41,326	39,561
Commitments and contingencies
Shareholders' equity:
Ordinary shares— par value $0.0001, 2.6 billion shares authorized, 1,282,553,150 and 1,311,337,531 shares issued and outstanding, respectively	—	—
Additional paid-in capital	20,824	23,129
Retained earnings	30,919	30,403
Accumulated other comprehensive loss	(3,250)	(3,318)
Total shareholders' equity	48,494	50,214
Noncontrolling interests	222	206
Total equity	48,716	50,420
Total liabilities and equity	$ 90,042	$ 89,981

Contacts:

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

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