Abbott Reports Second-Quarter 2021 Results

Abbott (NYSE: ABT) today announced financial results for the second quarter ended June 30, 2021 .

Second-quarter sales of $10.2 billion increased 39.5 percent on a reported basis and 35.0 percent on an organic basis, which excludes the impact of foreign exchange.
Second-quarter GAAP diluted EPS was $0.66 and adjusted diluted EPS, which excludes specified items, was $1.17 , reflecting 105.3 percent growth versus the prior year. ¹
Abbott continues to project full-year 2021 diluted EPS from continuing operations on a GAAP basis of $2.75 to $2.95 and full-year adjusted diluted EPS from continuing operations of $4.30 to $4.50 , reflecting strong, double-digit growth versus the prior year.
Diagnostics sales increased 62.8 percent on a reported basis and 57.2 percent on an organic basis in the second quarter. Global COVID-19 testing-related sales were $1.3 billion in the second quarter.
Nutrition sales increased 11.9 percent on a reported basis and 9.5 percent on an organic basis in the second quarter. Sales performance was led by double-digit growth in Adult Nutrition globally.
Established Pharmaceuticals sales increased 16.4 percent on a reported basis and 14.5 percent on an organic basis in the second quarter. Sales performance was led by double-digit growth in several countries, including India , China , Russia , and several countries across Latin America .
Medical Devices sales increased 51.3 percent on a reported basis and 45.1 percent on an organic basis in the second quarter. Compared to pre-pandemic sales in 2019, Medical Devices sales increased 19.2 percent on a reported basis and 15.6 percent on an organic basis in the second quarter, led by double-digit growth in Electrophysiology, Heart Failure, Structural Heart and Diabetes Care. ²

"We're achieving very strong growth across our portfolio," said Robert B. Ford , president and chief executive officer, Abbott. "Perhaps most impressively, excluding COVID testing-related sales, our sales grew more than 11 percent on an organic basis compared to pre-pandemic levels in the second quarter of 2019, which demonstrates the fundamental strength of our performance."

SECOND-QUARTER BUSINESS OVERVIEW
Note: Management believes that measuring sales growth rates on an organic basis is an appropriate way for investors to best understand the underlying performance of the business. Organic sales growth excludes the impact of foreign exchange.

Following are sales by business segment and commentary for the second quarter 2021:

Total Company
($ in millions)

				% Change vs. 2Q20
	Sales 2Q21			Reported			Organic
	U.S.	Int'l	Total	U.S.	Int'l	Total	U.S.	Int'l	Total
Total *	3,581	6,642	10,223	35.8	41.6	39.5	35.8	34.6	35.0
Nutrition	873	1,235	2,108	8.0	14.9	11.9	8.0	10.6	9.5
Diagnostics	1,155	2,092	3,247	34.8	83.9	62.8	34.8	74.0	57.2
Established Pharmaceuticals	--	1,180	1,180	n/a	16.4	16.4	n/a	14.5	14.5
Medical Devices	1,538	2,128	3,666	59.3	46.0	51.3	59.3	35.6	45.1

* Total Q2 2021 Abbott sales from continuing operations include Other Sales of approximately $22 million.

				% Change vs. 1H20
	Sales 1H21			Reported			Organic
	U.S.	Int'l	Total	U.S.	Int'l	Total	U.S.	Int'l	Total
Total *	7,419	13,260	20,679	35.0	38.7	37.4	35.0	33.3	33.9
Nutrition	1,709	2,435	4,144	5.5	12.3	9.4	5.5	9.8	8.0
Diagnostics	2,796	4,465	7,261	68.5	106.6	90.0	68.5	97.1	84.7
Established Pharmaceuticals	--	2,250	2,250	n/a	9.4	9.4	n/a	10.3	10.3
Medical Devices	2,889	4,097	6,986	31.4	29.6	30.3	31.4	20.8	25.2

* Total 1H 2021 Abbott sales from continuing operations include Other Sales of approximately $38 million.

n/a = Not Applicable.

Note: In order to compute results excluding the impact of exchange rates, current year U.S. dollar sales are multiplied or divided, as appropriate, by the current year average foreign exchange rates and then those amounts are multiplied or divided, as appropriate, by the prior year average foreign exchange rates.

Second-quarter 2021 worldwide sales of $10.2 billion increased 39.5 percent on a reported basis and 35.0 percent on an organic basis.

Compared to pre-pandemic sales in 2019, worldwide sales increased 12.3 percent on a reported basis and 11.3 percent on an organic basis in the second quarter, excluding COVID-19 testing-related sales. ³

Nutrition
($ in millions)

				% Change vs. 2Q20
	Sales 2Q21			Reported			Organic
	U.S.	Int'l	Total	U.S.	Int'l	Total	U.S.	Int'l	Total
Total	873	1,235	2,108	8.0	14.9	11.9	8.0	10.6	9.5
Pediatric	528	565	1,093	8.9	4.7	6.7	8.9	0.3	4.4
Adult	345	670	1,015	6.6	25.2	18.2	6.6	21.1	15.6

				% Change vs. 1H20
	Sales 1H21			Reported			Organic
	U.S.	Int'l	Total	U.S.	Int'l	Total	U.S.	Int'l	Total
Total	1,709	2,435	4,144	5.5	12.3	9.4	5.5	9.8	8.0
Pediatric	1,036	1,123	2,159	3.4	1.1	2.2	3.4	(1.4)	0.8
Adult	673	1,312	1,985	8.9	24.2	18.5	8.9	21.6	16.9

Worldwide Nutrition sales increased 11.9 percent on a reported basis and 9.5 percent on an organic basis in the second quarter. Strong performance of Ensure ^® , Abbott's market-leading complete and balanced nutrition brand, and Glucerna ^® , Abbott's market-leading diabetes nutrition brand, led to global Adult Nutrition sales growth of 18.2 percent on a reported basis and 15.6 percent on an organic basis.

Worldwide Pediatric Nutrition sales increased 6.7 percent on a reported basis and 4.4 percent on an organic basis. Strong performance of Abbott's market-leading toddler brands, Pedialyte ^® and PediaSure ^® , and continued share growth in infant nutrition led to U.S. Pediatric Nutrition growth of 8.9 percent.

Diagnostics
($ in millions)

				% Change vs. 2Q20
	Sales 2Q21			Reported			Organic
	U.S.	Int'l	Total	U.S.	Int'l	Total	U.S.	Int'l	Total
Total	1,155	2,092	3,247	34.8	83.9	62.8	34.8	74.0	57.2
Core Laboratory	283	1,023	1,306	(2.2)	46.6	32.3	(2.2)	38.7	26.7
Molecular	94	196	290	(34.8)	(8.7)	(19.1)	(34.8)	(15.2)	(23.1)
Point of Care	97	40	137	24.2	(1.2)	15.7	24.2	(5.9)	14.1
Rapid Diagnostics	681	833	1,514	97.2	349.4	185.4	97.2	327.1	177.6

				% Change vs. 1H20
	Sales 1H21			Reported			Organic
	U.S.	Int'l	Total	U.S.	Int'l	Total	U.S.	Int'l	Total
Total	2,796	4,465	7,261	68.5	106.6	90.0	68.5	97.1	84.7
Core Laboratory	554	1,934	2,488	(0.2)	36.2	25.9	(0.2)	29.8	21.4
Molecular	269	468	737	28.8	61.9	48.0	28.8	52.8	42.7
Point of Care	189	77	266	4.0	3.0	3.7	4.0	(1.4)	2.4
Rapid Diagnostics	1,784	1,986	3,770	150.1	426.3	245.7	150.1	403.7	237.9

Worldwide Diagnostics sales increased 62.8 percent on a reported basis in the second quarter and increased 57.2 percent on an organic basis. Global COVID-19 testing-related sales were $1.3 billion in the second quarter, led by combined sales of $1.0 billion from Abbott's BinaxNOW ^® , Panbio ^® and ID NOW ^® rapid testing platforms. Excluding COVID-19 testing-related sales, worldwide diagnostics sales increased 42.5 percent on a reported basis in the second quarter and 37.2 percent on an organic basis. ⁴ Compared to 2019, sales in Core Laboratory and Molecular Diagnostics, excluding COVID-19 testing-related sales, grew 6.8 percent and 8.3 percent, respectively, on a reported basis in the second quarter and grew 4.2 percent and 6.5 percent, respectively, on an organic basis. ⁵

Established Pharmaceuticals
($ in millions)

				% Change vs. 2Q20
	Sales 2Q21			Reported			Organic
	U.S.	Int'l	Total	U.S.	Int'l	Total	U.S.	Int'l	Total
Total	--	1,180	1,180	n/a	16.4	16.4	n/a	14.5	14.5
Key Emerging Markets	--	915	915	n/a	19.7	19.7	n/a	18.4	18.4
Other	--	265	265	n/a	6.5	6.5	n/a	2.6	2.6

				% Change vs. 1H20
	Sales 1H21			Reported			Organic
	U.S.	Int'l	Total	U.S.	Int'l	Total	U.S.	Int'l	Total
Total	--	2,250	2,250	n/a	9.4	9.4	n/a	10.3	10.3
Key Emerging Markets	--	1,736	1,736	n/a	10.1	10.1	n/a	12.4	12.4
Other	--	514	514	n/a	7.1	7.1	n/a	3.4	3.4

Established Pharmaceuticals sales increased 16.4 percent on a reported basis in the second quarter and increased 14.5 percent on an organic basis.

Key Emerging Markets include India , Brazil , Russia and China along with several additional emerging countries that represent the most attractive long-term growth opportunities for Abbott's branded generics product portfolio. Sales in these geographies increased 19.7 percent on a reported basis in the quarter and increased 18.4 percent on an organic basis. Organic sales growth was led by strong growth across several geographies, including India , China , Russia , and several countries across Latin America .

Other sales increased 6.5 percent on a reported basis in the quarter and increased 2.6 percent on an organic basis.

Medical Devices
($ in millions)

				% Change vs. 2Q20
	Sales 2Q21			Reported			Organic
	U.S.	Int'l	Total	U.S.	Int'l	Total	U.S.	Int'l	Total
Total	1,538	2,128	3,666	59.3	46.0	51.3	59.3	35.6	45.1
Rhythm Management	269	298	567	46.0	37.2	41.2	46.0	27.7	36.1
Electrophysiology	209	278	487	74.6	55.6	63.2	74.6	47.2	58.2
Heart Failure	168	59	227	46.8	35.7	43.8	46.8	25.8	41.0
Vascular	246	451	697	45.4	44.2	44.6	45.4	35.1	38.7
Structural Heart	191	231	422	109.4	75.1	89.2	109.4	63.3	82.2
Neuromodulation	166	44	210	95.1	110.4	98.1	95.1	92.7	94.7
Diabetes Care	289	767	1,056	43.4	38.7	40.0	43.4	27.3	31.6

				% Change vs. 1H20
	Sales 1H21			Reported			Organic
	U.S.	Int'l	Total	U.S.	Int'l	Total	U.S.	Int'l	Total
Total	2,889	4,097	6,986	31.4	29.6	30.3	31.4	20.8	25.2
Rhythm Management	510	576	1,086	23.7	24.5	24.1	23.7	16.2	19.7
Electrophysiology	388	530	918	36.7	31.5	33.7	36.7	24.0	29.3
Heart Failure	313	108	421	17.5	14.2	16.6	17.5	6.2	14.5
Vascular	465	867	1,332	16.5	22.6	20.4	16.5	15.3	15.7
Structural Heart	360	439	799	58.6	39.8	47.7	58.6	30.4	42.2
Neuromodulation	311	83	394	40.3	36.9	39.5	40.3	26.3	37.3
Diabetes Care	542	1,494	2,036	39.7	33.5	35.1	39.7	23.4	27.6

Worldwide Medical Devices sales increased 51.3 percent on a reported basis in the second quarter and increased 45.1 percent on an organic basis. Strong growth in the quarter was driven by continued strong recovery from the COVID-19 pandemic.

Compared to pre-pandemic sales in 2019, Medical Devices sales increased 19.2 percent on a reported basis and 15.6 percent on an organic basis in the second quarter, led by double-digit growth in Electrophysiology, Heart Failure, Structural Heart and Diabetes Care. ²

In Structural Heart, MitraClip ^® sales increased 88.0 percent on a reported basis and 82.1 percent on an organic basis in the second quarter compared to the prior year, driven by the highest-ever number of MitraClip procedures in the second quarter.

In Diabetes Care, sales of FreeStyle Libre ^® and Libre Sense ^® were $904 million in the quarter, which represents 52.5 percent reported sales growth and 42.9 percent organic sales growth compared to the prior year.

ABBOTT'S EARNINGS-PER-SHARE GUIDANCE
Abbott projects 2021 diluted earnings per share from continuing operations under GAAP of $2.75 to $2.95 . Abbott forecasts specified items for the full-year 2021 of $1.55 per share primarily related to intangible amortization, restructuring and cost reduction initiatives, including expenses to align its COVID-19 testing-related business with current and projected demand, expenses associated with acquisitions and other net expenses. Excluding specified items, projected adjusted diluted earnings per share from continuing operations would be $4.30 to $4.50 for full-year 2021.

ABBOTT DECLARES 390 ^TH CONSECUTIVE QUARTERLY DIVIDEND
On June 11, 2021 , the board of directors of Abbott declared the company's quarterly dividend of $0.45 per share. Abbott's cash dividend is payable Aug. 16, 2021 to shareholders of record at the close of business on July 15, 2021 .

Abbott has increased its dividend payout for 49 consecutive years and is a member of the S&P 500 Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years.

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 www.facebook.com/Abbott and on Twitter @AbbottNews .

Abbott will live-webcast its second-quarter earnings conference call through its Investor Relations website at www.abbottinvestor.com at 8 a.m. Central time today. An archived edition of the webcast will be available later that day.

— Private Securities Litigation Reform Act of 1995 —
A Caution Concerning Forward-Looking Statements

Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. Abbott cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Economic, competitive, governmental, technological and other factors that may affect Abbott's operations are discussed in Item 1A, "Risk Factors" in our Annual Report on Form 10-K for the year ended Dec. 31, 2020 , and are incorporated herein by reference. Abbott undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.


¹	Second-quarter 2021 diluted EPS from continuing operations on a GAAP basis reflects 120.0 percent growth.
²	In the second quarter of 2019, Medical Devices sales were $3.075 billion.
³	In the second quarter of 2019, worldwide sales were $7.979 billion. In the second quarter of 2021, COVID-19 testing-related sales were $1.267 billion.
⁴	In the second quarter of 2020, Diagnostics sales were $1.99 billion, which included COVID-19 testing-related sales of $0.6 billion.
⁵	In the second quarter of 2019, Core Laboratory and Molecular Diagnostics sales were $1.169 billion and $107 million, respectively. In the second quarter of 2021, COVID-19 testing-related sales for Core Laboratory and Molecular Diagnostics were $58 million and $173 million, respectively.

Abbott Laboratories and Subsidiaries
Condensed Consolidated Statement of Earnings
Second Quarter Ended June 30, 2021 and 2020
(in millions, except per share data)
(unaudited)

	2Q21	2Q20	% Change
Net Sales	$10,223	$7,328	39.5

Cost of products sold, excluding amortization expense	4,947	3,263	51.7	1)
Amortization of intangible assets	504	553	(9.0)
Research and development	654	564	15.7
Selling, general, and administrative	2,726	2,276	19.8
Total Operating Cost and Expenses	8,831	6,656	32.7

Operating Earnings	1,392	672	107.4

Interest expense, net	123	125	(1.0)
Net foreign exchange (gain) loss	--	(1)	n/m
Other (income) expense, net	(79)	22	n/m
Earnings from Continuing Operations before taxes	1,348	526	156.5

Tax expense on Earnings from Continuing Operations	159	(11)	n/m	2)
Earnings from Continuing Operations	1,189	537	121.5

Earnings from Discontinued Operations, net of taxes	--	--	n/m

Net Earnings	$1,189	$537	121.5

Earnings from Continuing Operations, excluding
Specified Items, as described below	$2,115	$1,018	107.7	3)

Diluted Earnings per Common Share from:
Continuing Operations	$0.66	$0.30	120.0
Discontinued Operations	--	--	n/m
Total	$0.66	$0.30	120.0

Diluted Earnings per Common Share from Continuing
Operations, excluding Specified Items, as described below	$1.17	$0.57	105.3	3)

Average Number of Common Shares Outstanding
Plus Dilutive Common Stock Options	1,793	1,785

NOTES:

See tables titled "Non-GAAP Reconciliation of Financial Information From Continuing Operations" for an explanation of certain non-GAAP financial information.

n/m = Percent change is not meaningful.

See footnotes below.


1)	2021 Cost of products sold, excluding amortization expense includes approximately $500 million of charges associated with a restructuring plan to align Abbott's manufacturing network for COVID-19 diagnostic tests with changes during the second quarter in projected testing demand.

2)	2020 Tax expense on Earnings from Continuing Operations includes the recognition of approximately $80 million of net tax benefits as a result of the resolution of various tax positions related to prior years and approximately $20 million in excess tax benefits associated with share-based compensation.

3)	2021 Net Earnings and Diluted Earnings per Common Share from Continuing Operations, excluding Specified Items, excludes net after-tax charges of $926 million, or $0.51 per share, for intangible amortization and other net expenses primarily associated with restructuring actions, certain litigation and acquisitions.

	2020 Net Earnings and Diluted Earnings per Common Share from Continuing Operations, excluding Specified Items, excludes net after-tax charges of $481 million, or $0.27 per share, for intangible amortization expense, other expenses primarily associated with acquisitions and restructuring actions and charges for equity investment impairments.

Abbott Laboratories and Subsidiaries
Condensed Consolidated Statement of Earnings
First Half Ended June 30, 2021 and 2020
(in millions, except per share data)
(unaudited)

	1H21	1H20	% Change
Net Sales	$20,679	$15,054	37.4

Cost of products sold, excluding amortization expense	9,348	6,544	42.9	1)
Amortization of intangible assets	1,013	1,114	(9.1)
Research and development	1,308	1,142	14.5
Selling, general, and administrative	5,509	4,824	14.2
Total Operating Cost and Expenses	17,178	13,624	26.1

Operating Earnings	3,501	1,430	144.9

Interest expense, net	247	246	0.6
Net foreign exchange (gain) loss	3	4	(46.1)
Other (income) expense, net	(140)	21	n/m
Earnings from Continuing Operations before taxes	3,391	1,159	192.6

Tax expense on Earnings from Continuing Operations	409	78	n/m	2)
Earnings from Continuing Operations	2,982	1,081	175.9

Earnings from Discontinued Operations, net of taxes	--	20	n/m

Net Earnings	$2,982	$1,101	170.9

Earnings from Continuing Operations, excluding
Specified Items, as described below	$4,483	$2,180	105.6	3)

Diluted Earnings per Common Share from:
Continuing Operations	$1.66	$0.60	176.7
Discontinued Operations	--	0.01	n/m
Total	$1.66	$0.61	172.1

Diluted Earnings per Common Share from Continuing
Operations, excluding Specified Items, as described below	$2.49	$1.22	104.1	3)

Average Number of Common Shares Outstanding
Plus Dilutive Common Stock Options	1,792	1,783

NOTES:

See tables titled "Non-GAAP Reconciliation of Financial Information From Continuing Operations" for an explanation of certain non-GAAP financial information.

n/m = Percent change is not meaningful.

See footnotes below.


1)	2021 Cost of products sold, excluding amortization expense includes approximately $500 million of charges associated with a restructuring plan to align Abbott's manufacturing network for COVID-19 diagnostic tests with changes during the second quarter in projected testing demand.

2)	2021 Tax expense on Earnings from Continuing Operations includes the recognition of approximately $90 million in excess tax benefits associated with share-based compensation.

	2020 Tax expense on Earnings from Continuing Operations includes the recognition of approximately $80 million of net tax benefits as a result of the resolution of various tax positions related to prior years and approximately $70 million in excess tax benefits associated with share-based compensation.

3)	2021 Net Earnings and Diluted Earnings per Common Share from Continuing Operations, excluding Specified Items, excludes net after-tax charges of $1.501 billion, or $0.83 per share, for intangible amortization and other net expenses primarily associated with restructuring actions, certain litigation and acquisitions.

	2020 Net Earnings and Diluted Earnings per Common Share from Continuing Operations, excluding Specified Items, excludes net after-tax charges of $1.099 billion, or $0.62 per share, for intangible amortization expense and other expenses primarily associated with acquisitions and restructuring actions.

Abbott Laboratories and Subsidiaries
Non-GAAP Reconciliation of Financial Information From Continuing Operations
Second Quarter Ended June 30, 2021 and 2020
(in millions, except per share data)
(unaudited)

	2Q21
	As Reported (GAAP)	Specified Items	As Adjusted	% to Sales

Intangible Amortization	$ 504	$ (504)	$ --
Gross Margin	4,772	1,048	5,820	56.9%
R&D	654	(18)	636	6.2%
SG&A	2,726	(90)	2,636	25.8%
Other (income) expense, net	(79)	35	(44)
Earnings from Continuing Operations before taxes	1,348	1,121	2,469
Tax expense on Earnings from Continuing Operations	159	195	354
Earnings from Continuing Operations	1,189	926	2,115
Diluted Earnings per Share from Continuing Operations	$0.66	$0.51	$1.17

Specified items reflect intangible amortization expense of $504 million and other net expenses of $617 million, primarily associated with restructuring actions, certain litigation, acquisitions and other expenses. See tables titled "Details of Specified Items" for additional details regarding specified items.

	2Q20
	As Reported (GAAP)	Specified Items	As Adjusted	% to Sales

Intangible Amortization	$ 553	$ (553)	$ --
Gross Margin	3,512	591	4,103	56.0%
R&D	564	(28)	536	7.3%
SG&A	2,276	(24)	2,252	30.7%
Other (income) expense, net	22	(68)	(46)
Earnings from Continuing Operations before taxes	526	711	1,237
Tax expense on Earnings from Continuing Operations	(11)	230	219
Earnings from Continuing Operations	537	481	1,018
Diluted Earnings per Share from Continuing Operations	$0.30	$0.27	$0.57

Specified items reflect intangible amortization expense of $553 million and other expenses of $158 million, primarily associated with acquisitions, restructuring actions and other expenses. See tables titled "Details of Specified Items" for additional details regarding specified items.

Abbott Laboratories and Subsidiaries
Non-GAAP Reconciliation of Financial Information From Continuing Operations
First Half Ended June 30, 2021 and 2020
(in millions, except per share data)
(unaudited)

	1H21
	As Reported (GAAP)	Specified Items	As Adjusted	% to Sales

Intangible Amortization	$ 1,013	$ (1,013)	$ --
Gross Margin	10,318	1,597	11,915	57.6%
R&D	1,308	(46)	1,262	6.1%
SG&A	5,509	(244)	5,265	25.5%
Other (income) expense, net	(140)	23	(117)
Earnings from Continuing Operations before taxes	3,391	1,864	5,255
Tax expense on Earnings from Continuing Operations	409	363	772
Earnings from Continuing Operations	2,982	1,501	4,483
Diluted Earnings per Share from Continuing Operations	$1.66	$0.83	$2.49

Specified items reflect intangible amortization expense of $1.013 billion and other net expenses of $851 million, primarily associated with restructuring actions, certain litigation, acquisitions and other expenses. See tables titled "Details of Specified Items" for additional details regarding specified items.

	1H20
	As Reported (GAAP)	Specified Items	As Adjusted	% to Sales

Intangible Amortization	$ 1,114	$ (1,114)	$ --
Gross Margin	7,396	1,190	8,586	57.0%
R&D	1,142	(43)	1,099	7.3%
SG&A	4,824	(82)	4,742	31.5%
Other (income) expense, net	21	(110)	(89)
Earnings from Continuing Operations before taxes	1,159	1,425	2,584
Tax expense on Earnings from Continuing Operations	78	326	404
Earnings from Continuing Operations	1,081	1,099	2,180
Diluted Earnings per Share from Continuing Operations	$0.60	$0.62	$1.22

Specified items reflect intangible amortization expense of $1.114 billion and other expenses of $311 million, primarily associated with acquisitions, restructuring actions and other expenses. See tables titled "Details of Specified Items" for additional details regarding specified items.

A reconciliation of the second-quarter tax rates for continuing operations for 2021 and 2020 is shown below:

	2Q21
($ in millions)	Pre-Tax Income	Taxes on Earnings	Tax Rate
As reported (GAAP)	$1,348	$ 159	11.9%
Specified items	1,121	195
Excluding specified items	$2,469	$354	14.4%

	2Q20
($ in millions)	Pre-Tax Income	Taxes on Earnings	Tax Rate
As reported (GAAP)	$526	(11)	(2.1%)	1)
Specified items	711	230
Excluding specified items	$1,237	$219	17.7%


1)	2020 Tax expense on Earnings from Continuing Operations includes the recognition of approximately $80 million of net tax benefits as a result of the resolution of various tax positions related to prior years and approximately $20 million in excess tax benefits associated with share-based compensation.

A reconciliation of the year-to-date tax rates for continuing operations for 2021 and 2020 is shown below:

	1H21
($ in millions)	Pre-Tax Income	Taxes on Earnings	Tax Rate
As reported (GAAP)	$3,391	$ 409	12.1%	2)
Specified items	1,864	363
Excluding specified items	$5,255	$772	14.7%

	1H20
($ in millions)	Pre-Tax Income	Taxes on Earnings	Tax Rate
As reported (GAAP)	$1,159	$78	6.7%	3)
Specified items	1,425	326
Excluding specified items	$2,584	$404	15.6%


2)	2021 Tax expense on Earnings from Continuing Operations includes the recognition of approximately $90 million in excess tax benefits associated with share-based compensation.

3)	2020 Tax expense on Earnings from Continuing Operations includes the recognition of approximately $80 million of net tax benefits as a result of the resolution of various tax positions related to prior years and approximately $70 million in excess tax benefits associated with share-based compensation.

Abbott Laboratories and Subsidiaries
Details of Specified Items
Second Quarter Ended June 30, 2021
(in millions, except per share data)
(unaudited)

	Acquisition or Divestiture- related (a)	Restructuring and Cost Reduction Initiatives (b)	Intangible Amortization	Other (c)	Total Specifieds
Gross Margin	$ 21	$ 510	$ 504	13	$ 1,048
R&D	(3)	1	--	(16)	(18)
SG&A	(18)	2	--	(74)	(90)
Other (income) expense, net	(3)	--	--	38	35
Earnings from Continuing Operations before taxes	$ 45	$ 507	$ 504	$ 65	1,121
Tax expense on Earnings from Continuing Operations (d)					195
Earnings from Continuing Operations					$ 926
Diluted Earnings per Share from Continuing Operations					$ 0.51

The table above provides additional details regarding the specified items described on table titled "Non-GAAP Reconciliation of Financial Information From Continuing Operations."


a)	Acquisition-related expenses include integration costs, which represent incremental costs directly related to integrating the acquired businesses and include expenditures for the integration of systems, processes and business activities.
b)	Restructuring and cost reduction initiative expenses include severance, outplacement, and other direct costs associated with specific restructuring plans and cost reduction initiatives. Restructuring and cost reduction plans consist of distinct initiatives to streamline operations including the consolidation and rationalization of business activities and facilities, workforce reductions, the transfer of product lines between manufacturing facilities, and the transfer of other business activities between sites. The Gross Margin amount includes charges associated with a restructuring plan to align Abbott's manufacturing network for COVID-19 diagnostic tests with changes during the second quarter in projected testing demand.
c)	Other includes costs related to certain litigation and the impairment of an intangible asset, as well as a gain on the disposition of an equity method investment.
d)	Reflects the net tax benefit associated with the specified items and excess tax benefits associated with share-based compensation.

Abbott Laboratories and Subsidiaries
Details of Specified Items
Second Quarter Ended June 30, 2020
(in millions, except per share data)
(unaudited)

	Acquisition or Divestiture- related (a)	Restructuring and Cost Reduction Initiatives (b)	Intangible Amortization	Other (c)	Total Specifieds
Gross Margin	$ 22	$ 15	$ 553	$ 1	$ 591
R&D	(3)	(2)	--	(23)	(28)
SG&A	(27)	3	--	--	(24)
Other (income) expense, net	(3)	--	--	(65)	(68)
Earnings from Continuing Operations before taxes	$ 55	$ 14	$ 553	$ 89	711
Tax expense on Earnings from Continuing Operations (d)					230
Earnings from Continuing Operations					$ 481
Diluted Earnings per Share from Continuing Operations					$ 0.27

The table above provides additional details regarding the specified items described on table titled "Non-GAAP Reconciliation of Financial Information From Continuing Operations."


a)	Acquisition-related expenses include integration costs, which represent incremental costs directly related to integrating the acquired businesses and include expenditures for retention, severance, and the integration of systems, processes and business activities.
b)	Restructuring and cost reduction initiative expenses include severance, outplacement, and other direct costs associated with specific restructuring plans and cost reduction initiatives. Restructuring and cost reduction plans consist of distinct initiatives to streamline operations including the consolidation and rationalization of business activities and facilities, workforce reductions, the transfer of product lines between manufacturing facilities, and the transfer of other business activities between sites.
c)	Other primarily relates to the impairment of equity investments and the costs to acquire research and development assets.
d)	Reflects the net tax benefit associated with the specified items, the resolution of prior years' tax positions and excess tax benefits associated with share-based compensation.

Abbott Laboratories and Subsidiaries
Details of Specified Items
First Half Ended June 30, 2021
(in millions, except per share data)
(unaudited)

	Acquisition or Divestiture- related (a)	Restructuring and Cost Reduction Initiatives (b)	Intangible Amortization	Other (c)	Total Specifieds
Gross Margin	$ 40	$ 529	$ 1,013	15	$ 1,597
R&D	(5)	1	--	(42)	(46)
SG&A	(31)	1	--	(214)	(244)
Other (income) expense, net	(3)	1	--	25	23
Earnings from Continuing Operations before taxes	$ 79	$ 526	$ 1,013	$ 246	1,864
Tax expense on Earnings from Continuing Operations (d)					363
Earnings from Continuing Operations					$ 1,501
Diluted Earnings per Share from Continuing Operations					$ 0.83

The table above provides additional details regarding the specified items described on table titled "Non-GAAP Reconciliation of Financial Information From Continuing Operations."


a)	Acquisition-related expenses include integration costs, which represent incremental costs directly related to integrating the acquired businesses and include expenditures for the integration of systems, processes and business activities.
b)	Restructuring and cost reduction initiative expenses include severance, outplacement, and other direct costs associated with specific restructuring plans and cost reduction initiatives. Restructuring and cost reduction plans consist of distinct initiatives to streamline operations including the consolidation and rationalization of business activities and facilities, workforce reductions, the transfer of product lines between manufacturing facilities, and the transfer of other business activities between sites. The Gross Margin amount includes charges associated with a restructuring plan to align Abbott's manufacturing network for COVID-19 diagnostic tests with changes during the second quarter in projected testing demand.
c)	Other primarily relates to the costs related to certain litigation, the acquisition of a research and development asset, the impairments of an equity investment and an intangible asset, and the gain on the disposition of an equity method investment.
d)	Reflects the net tax benefit associated with the specified items and excess tax benefits associated with share-based compensation.

Abbott Laboratories and Subsidiaries
Details of Specified Items
First Half Ended June 30, 2020
(in millions, except per share data)
(unaudited)

	Acquisition or Divestiture- related (a)	Restructuring and Cost Reduction Initiatives (b)	Intangible Amortization	Other (c)	Total Specifieds
Gross Margin	$ 45	$ 30	$ 1,114	$ 1	$ 1,190
R&D	(7)	(8)	--	(28)	(43)
SG&A	(55)	(27)	--	--	(82)
Other (income) expense, net	(1)	--	--	(109)	(110)
Earnings from Continuing Operations before taxes	$ 108	$ 65	$ 1,114	$ 138	1,425
Tax expense on Earnings from Continuing Operations (d)					326
Earnings from Continuing Operations					$ 1,099
Diluted Earnings per Share from Continuing Operations					$ 0.62

The table above provides additional details regarding the specified items described on table titled "Non-GAAP Reconciliation of Financial Information From Continuing Operations."


a)	Acquisition-related expenses include integration costs, which represent incremental costs directly related to integrating the acquired businesses and include expenditures for retention, severance, and the integration of systems, processes and business activities.
b)	Restructuring and cost reduction initiative expenses include severance, outplacement, and other direct costs associated with specific restructuring plans and cost reduction initiatives. Restructuring and cost reduction plans consist of distinct initiatives to streamline operations including the consolidation and rationalization of business activities and facilities, workforce reductions, the transfer of product lines between manufacturing facilities, and the transfer of other business activities between sites.
c)	Other primarily relates to the impairment of equity investments and the costs to acquire research and development assets.
d)	Reflects the net tax benefit associated with the specified items, the resolution of prior years' tax positions and excess tax benefits associated with share-based compensation.

View original content: https://www.prnewswire.com/news-releases/abbott-reports-second-quarter-2021-results-301339347.html

SOURCE Abbott

News Provided by PR Newswire via QuoteMedia

medical device investing Medical Device Investing

Orchestra BioMed Reports First Quarter 2025 Financial Results and Highlights Recent Regulatory and Clinical Milestones

FDA Breakthrough Device Designation Awarded to AVIM Therapy
FDA IDE Approved for Virtue SAB U.S. Pivotal Trial for Launch

Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, "Orchestra BioMed" or the "Company"), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced financial results for the first quarter ended March 31, 2025, and provided a business update highlighting continued regulatory momentum, disciplined operational execution, and a strengthening clinical development pipeline.

Q1 2025 Highlights:

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Medtronic to announce financial results for its fourth quarter and full fiscal year 2025

- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that it will report financial results for its fourth quarter and full fiscal year 2025 on Wednesday, May 21, 2025 . A news release will be issued at approximately 5:45 a.m. Central Daylight Time (CDT) and will be available at https:news.medtronic.com . The news release will include summary financial information for the company's fourth quarter and full fiscal year 2025, which ended on Friday, April 25, 2025 .

Medtronic will host a video webcast at 7:00 a.m. CDT on May 21, 2025 , to discuss results for its fourth quarter and full fiscal year 2025. The webcast can be accessed at https://investorrelations.medtronic.com .

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New survey: 1 in 3 women have not talked to their doctor about heart health, the #1 killer of women

Star Jones , award winning television personality & women's heart health advocate, helps kick off heart health conversations this Mother's Day with the Medtronic 'Letter to My Mother' campaign

A new Medtronic-sponsored survey of women ages 30-50 reveals a significant gap in awareness and discussion around heart health among women and their mother-figures. Despite cardiovascular disease being the #1 killer of women in the U.S. many women are still unaware of the risk and the importance of heart health.

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Medtronic Affera pulsed field ablation technologies continue to demonstrate promising evidence for atrial fibrillation patients

One-year clinical trial data for the next-generation, investigational, Sphere-360™ single-shot PFA catheter show impressive safety, performance, and efficiency results for paroxysmal Afib
Dual-energy (RF/PF), focal Sphere-9™ catheter demonstrates efficacy for linear ablation in persistent AFib
Medtronic continues legacy of leadership in innovation, showcasing arrhythmia management portfolio at Heart Rhythm Society annual meeting

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced positive clinical outcomes from two studies in atrial fibrillation (AFib) patients treated with the Affera™ family of technologies, including the next-generation Sphere-360™ single-shot pulsed field ablation (PFA) catheter and the groundbreaking Sphere-9™ combination mapping and dual-energy focal PFA catheter. Data were presented in High Impact Science Sessions at the Heart Rhythm Society 2025 Annual Meeting in San Diego ; the Sphere-360 study was simultaneously published in the Heart Rhythm Journal .

Sphere-360 Study Safety and Performance

Sphere-360 is an investigational, first-of-its-kind, single-shot PFA mapping and ablation catheter for treatment of paroxysmal atrial fibrillation (PAF). Results for Sphere-360 at one year, in a prospective, single-arm, multi-center trial performed in European centers, demonstrated freedom from arrhythmia recurrence in 88% of patients, with chronically durable pulmonary vein isolation (PVI) in 98% of targeted veins and no reported safety events in a sub-group treated with the most optimized waveform. The Sphere-360 catheter has a large, conformable lattice design that can be modified into various shapes, is seamlessly integrated with the Affera Mapping and Ablation System and utilizes an 8.5 Fr sheath – the smallest in any single-shot PFA technology.

"The Affera technology is a sophisticated ecosystem, including an advanced, intuitive mapping system and catheters that are seamlessly integrated to offer treatment options for different cardiac arrhythmias. It is encouraging to see the promising results for Sphere-360, which can easily create circumferential lesions without the need for catheter rotation," said Vivek Reddy , M.D., Director of Cardiac Arrhythmia Services for the Mount Sinai Health System in New York City . "The study results showed Sphere-360 has a promising safety and performance profile with zero serious adverse events observed. Upon approval, Sphere-360 will be a valuable addition to Medtronic's Affera system, which has been a game changer for Afib treatment and physician workflow."

Medtronic intends to begin its U.S. pivotal trial for the Sphere-360 catheter later this calendar year. Worldwide, Sphere-360 is currently investigational and not approved for sale or distribution.

Sphere-9 for Linear Ablation

Additionally, in a sub-analysis from the Sphere Per-AF IDE study , results demonstrated that the Sphere-9 catheter can be used safely and effectively to create linear lesions in persistent AF patients. Linear ablation is often used in conjunction with PVI to improve the chances of restoring a normal heart rhythm without recurrence in persistent AF patients. The Sphere Per-AF IDE study evaluated the safety, efficacy and efficiency of Affera and Sphere-9 in persistent AF and led to the FDA approval of Affera in October 2024 .

"True to our Medtronic mission for patients and legacy of innovation, we are delivering our best-in-class technologies to physicians and improving care for AFib patients, and we are not slowing down," said Rebecca Seidel , president of the Cardiac Ablation Solutions business at Medtronic, which is part of the Cardiovascular portfolio. "These results signify another step forward and energize us as we continue to earn and build our leadership position in electrophysiology every day."

Medtronic is the only company with two PFA offerings for physicians and patients. The PulseSelect™ Pulsed Field Ablation System offers physicians a safe, single-shot solution for pulmonary vein isolation (PVI) and is now available in more than 30 countries. The Affera system together with the Sphere-9 catheter enables physician treatment flexibility with its wide area focal design and 9mm lattice tip that can used with an 8.5Fr sheath. Affera is available in Europe , Australia and New Zealand , with global expansion ongoing.

AFib is one of the most common and undertreated heart rhythm disorders, affecting more than 60 million people worldwide. ¹ Afib is a progressive disease, often beginning as paroxysmal AFib (presents intermittently) and progressing to persistent (lasts for more than 7+ days without stopping). As the disease progresses, the risk of serious complications including heart failure, stroke and risk of death increases ^2-5 .

For more information on the Affera PFA system and the Sphere-9 catheter, visit Medtronic.com.

About Medtronic

Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway , 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 more than 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 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.

References

Roth GA, Mensah GA, Johnson CO et al. Global Burden of Cardiovascular Diseases and Risk Factors, 1990-2019: Update From the GBD 2019 Study. J Am Coll Cardiol 2020;76:2982-3021.
Miyasaka Y, Barnes ME, Bailey KR, et al. Mortality trends in patients diagnosed with first atrial fibrillation: a 21-year community-based study. J Am Coll Cardiol 2007;49:986-92.
Hindricks G, Potpara T, Dagres N, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS). Eur Heart J 2020.
Wolf PA , Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991;22:983-8.
Lubitz SA, Moser C, Sullivan L, et al. Atrial fibrillation patterns and risks of subsequent stroke, heart failure, or death in the community. J Am Heart Assoc 2013;2:e000126

Dr. Reddy is a paid consultant for Medtronic.

Contacts:
Leslie Williamson
Public Relations
+1-612-227-5099

Ryan Weispfenning
Investor Relations
+1-763-505-4626

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SOURCE Medtronic plc

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Medtronic Expand URO U.S. clinical trial meets safety and effectiveness primary endpoints for Hugo robotic-assisted surgery system

Largest multi-center prospective Investigational Device Exemption (IDE) study for multi-port robotic-assisted urologic surgery in the U.S. presented as a late-breaker at the American Urologic Association annual meeting

Company confirms Hugo RAS system submission to the U.S. Food and Drug Administration

Medtronic (NYSE: MDT), a global leader in healthcare technology, today announced that the Expand URO Investigational Device Exemption (IDE) clinical study, the largest such study for robotic-assisted urologic surgery ever conducted, met both primary safety and effectiveness endpoints. The prospective, multi-center, single-arm IDE study included 137 patients who underwent urologic procedures using the Hugo™ robotic-assisted surgery (RAS) system.

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ORCHESTRA BIOMED HOLDINGS, INC. Condensed Consolidated Balance Sheets (in thousands, except share and per share data) (Unaudited)

	March 31,			December 31,
	2025			2024
ASSETS
CURRENT ASSETS:
Cash and cash equivalents	$	18,348		$	22,261
Marketable securities		31,536			44,551
Accounts receivable, net		89			92
Inventory		135			173
Prepaid expenses and other current assets		1,795			2,094
Total current assets		51,903			69,171
Property and equipment, net		1,413			1,384
Right-of-use assets		1,956			2,103
Strategic investments, less current portion		2,495			2,495
Deposits and other assets		1,284			1,020
TOTAL ASSETS	$	59,051		$	76,173

LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable	$	5,563		$	5,134
Accrued expenses and other liabilities		5,392			6,084
Operating lease liability, current portion		590			550
Deferred revenue, current portion		3,944			4,439
Total current liabilities		15,489			16,207
Deferred revenue, less current portion		10,752			10,989
Loan payable		14,338			14,292
Operating lease liability, less current portion		1,516			1,687
Other long-term liabilities		99			40
TOTAL LIABILITIES		42,194			43,215

STOCKHOLDERS' EQUITY
Preferred stock, $0.0001 par value per share; 10,000,000 shares authorized; none issued or outstanding at March 31, 2025 and December 31, 2024.		—			—
Common stock, $0.0001 par value per share; 340,000,000 shares authorized; 38,312,512 and 38,194,442 shares issued and outstanding as of March 31, 2025 and December 31, 2024, respectively.		4			4
Additional paid-in capital		345,449			342,780
Accumulated other comprehensive income		37			52
Accumulated deficit		(328,633	)		(309,878	)
TOTAL STOCKHOLDERS' EQUITY		16,857			32,958
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY	$	59,051		$	76,173

ORCHESTRA BIOMED HOLDINGS, INC. Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands, except share and per share data) (Unaudited)
	Three Months Ended March 31,
	2025			2024
Revenue:
Partnership revenue	$	732		$	497
Product revenue		136			123
Total revenue		868			620
Expenses:
Cost of product revenues		44			34
Research and development		13,482			9,112
Selling, general and administrative		6,263			5,897
Total expenses		19,789			15,043
Loss from operations		(18,921	)		(14,423	)
Other income (expense):
Interest income, net		166			1,016
Loss on fair value of strategic investments		—			(45	)
Other expense		—			(11	)
Total other income		166			960
Net loss	$	(18,755	)	$	(13,463	)
Net loss per share
Basic and diluted	$	(0.49	)	$	(0.38	)
Weighted-average shares used in computing net loss per share, basic and diluted		38,235,409			35,777,877
Comprehensive loss
Net loss	$	(18,755	)	$	(13,463	)
Unrealized (loss) gain on marketable securities		(15	)		2
Comprehensive loss	$	(18,770	)	$	(13,461	)

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