Abbott Reports First-Quarter 2023 Results; Increases Outlook For Underlying Base Business

  • Sales of $9.7 billion driven by strong underlying base business performance
  • Reported sales decreased 18.1 percent due to anticipated decline in COVID-19 testing-related sales versus prior year
  • Organic sales growth for underlying base business of 10.0 percent, led by Medical Devices, Established Pharmaceuticals and Nutrition

Abbott (NYSE: ABT) today announced financial results for the first quarter ended March 31, 2023 .

  • First-quarter GAAP diluted EPS of $0.75 and adjusted diluted EPS of $1.03 , which excludes specified items.
  • Projected full-year 2023 diluted EPS from continuing operations on a GAAP basis of $3.05 to $3.25 remains unchanged.
  • Projected full-year adjusted EPS from continuing operations of $4.30 to $4.50 remains unchanged and now reflects an increased outlook for the underlying base business offset by a lower forecasted earnings contribution from COVID-19 testing-related sales.
  • Abbott now projects full-year 2023 organic sales growth, excluding COVID-19 testing-related sales 1 , of at least high single-digits 2 and COVID-19 testing-related sales of approximately $1.5 billion .
  • In January, Abbott announced U.S. Food and Drug Administration (FDA) approval of Navitor ® , its second-generation transcatheter aortic valve implantation system, for people with severe aortic stenosis who are at high risk for surgery.
  • In March, data was presented at the American College of Cardiology Scientific Sessions showing Abbott's TriClip ® system was superior to current medical therapy in treating patients with severe tricuspid regurgitation, or a leaky tricuspid heart valve.
  • In March, Abbott's market-leading FreeStyle Libre ® continuous glucose monitoring system received U.S. FDA clearance for integration with automated insulin delivery systems. Abbott is partnering with leading insulin pump manufacturers to integrate their systems with FreeStyle Libre 2 and FreeStyle Libre 3 as soon as possible.

"Our first-quarter results reflect a very strong start to the year," said Robert B. Ford , chairman and chief executive officer, Abbott. "Growth in our underlying base businesses accelerated, including particularly strong results in Medical Devices, Established Pharmaceuticals and Nutrition."

FIRST-QUARTER BUSINESS OVERVIEW
Management believes that measuring sales growth rates on an organic basis, which excludes the impact of foreign exchange, as well as the impact of exiting the pediatric nutrition business in China , is an appropriate way for investors to best understand the core underlying performance of the business.

Management further believes that measuring sales growth rates on an organic basis excluding COVID-19 tests is an appropriate way for investors to best understand underlying base business performance as the COVID-19 pandemic shifts to an endemic state, resulting in significantly lower expected demand for COVID-19 tests.

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.

Total Company


Reported Sales


Sales 1Q23 ($ in millions)

Total Company


Nutrition


Diagnostics


Established
Pharmaceuticals


Medical Devices

U.S.

3,928


812


1,335



1,778

International

5,819


1,155


1,353


1,189


2,122

Total reported

9,747


1,967


2,688


1,189


3,900


% Change vs. 1Q22










U.S.

(20.4)


19.9


(50.8)


n/a


15.1

International

(16.4)


(5.1)


(46.9)


3.7


3.5

Total reported

(18.1)


3.8


(48.9)


3.7


8.5



Organic Sales


% Change vs. 1Q22

Total Company


Nutrition


Diagnostics


Established
Pharmaceuticals


Medical Devices

Reported

(18.1)


3.8


(48.9)


3.7


8.5

Impact of foreign exchange

(3.3)


(3.9)


(1.8)


(7.4)


(3.9)

Impact of business exit

(0.3)


(2.6)




Organic

(14.5)


10.3


(47.1)


11.1


12.4

Impact of COVID-19 testing sales 3

(24.5)



(51.5)



Organic excluding COVID-19 tests

10.0


10.3


4.4


11.1


12.4











U.S.

12.6


19.9


0.3


n/a


15.1

International

8.6


4.8


6.8


11.1


10.4

n/a = Not Applicable.

Refer to table titled "Non-GAAP Revenue Reconciliation" for a reconciliation of adjusted historical revenue to reported revenue.

Nutrition


Reported Sales


Sales 1Q23 ($ in millions)



Total


Pediatric


Adult

U.S.



812


459


353

International



1,155


465


690

Total reported



1,967


924


1,043


% Change vs. 1Q22








U.S.



19.9


36.1


3.9

International



(5.1)


(8.6)


(2.6)

Total reported



3.8


9.2


(0.5)



Organic Sales


% Change vs. 1Q22



Total


Pediatric


Adult

Reported



3.8


9.2


(0.5)

Impact of foreign exchange



(3.9)


(2.8)


(4.7)

Impact of business exit



(2.6)


(6.4)


Organic



10.3


18.4


4.2









U.S.



19.9


36.1


3.9

International



4.8


5.3


4.4

Worldwide Nutrition sales increased 3.8 percent on a reported basis and 10.3 percent on an organic basis in the first quarter. Refer to table titled "Non-GAAP Revenue Reconciliation" for a reconciliation of adjusted historical revenue to reported revenue.

In Pediatric Nutrition, global sales increased 9.2 percent on a reported basis and 18.4 percent on an organic basis. In the U.S., sales growth of 36.1 percent includes the impact of lower sales in the first quarter of the prior year due to a voluntary recall of certain infant formula products. Following a temporary manufacturing stoppage of these products, Abbott subsequently restarted production last year and continues to make good progress recovering market share in this business.

In Adult Nutrition, global sales decreased 0.5 percent on a reported basis and increased 4.2 percent on an organic basis, which was led by strong global growth of Ensure ® , Abbott's market-leading complete and balanced nutrition brand.

Diagnostics


Reported Sales


Sales 1Q23 ($ in millions)

Total


Core Laboratory


Molecular


Point of Care


Rapid
Diagnostics *

U.S.

1,335


289


47


93


906

International

1,353


893


100


41


319

Total reported

2,688


1,182


147


134


1,225


% Change vs. 1Q22










U.S.

(50.8)


7.7


(72.7)


2.9


(58.4)

International

(46.9)


(2.5)


(59.7)


9.2


(76.3)

Total reported

(48.9)


(0.2)


(65.0)


4.7


(65.3)



Organic Sales


% Change vs. 1Q22

Total


Core Laboratory


Molecular


Point of Care


Rapid
Diagnostics *

Reported

(48.9)


(0.2)


(65.0)


4.7


(65.3)

Impact of foreign exchange

(1.8)


(5.3)


(1.0)


(1.0)


(0.8)

Organic

(47.1)


5.1


(64.0)


5.7


(64.5)

Impact of COVID-19 testing sales 3

(51.5)


(2.0)


(39.2)



(72.5)

Organic excluding COVID-19 tests

4.4


7.1


(24.8)


5.7


8.0











U.S.

0.3


9.0


(36.7)


2.9


(0.9)

International

6.8


6.5


(18.9)


12.7


23.2


*The Acelis Connected Health business was internally transferred from Rapid Diagnostics to Heart Failure on January 1, 2023. As a result, $29 million of sales for the first quarter of 2022 were moved from Rapid Diagnostics to Heart Failure.

As expected, Diagnostics sales growth in the first quarter was negatively impacted by year-over-year declines in COVID-19 testing-related sales 3 . Worldwide COVID-19 testing sales were $730 million in the first quarter of 2023 compared to $3.304 billion in the first quarter of the prior year.

Excluding COVID-19 testing-related sales, global Diagnostics sales increased 0.2 percent on a reported basis and increased 4.4 percent on an organic basis. Organic sales growth, excluding COVID-19 testing-related sales, was led by Core Laboratory, Point of Care and Rapid Diagnostics. In Molecular Diagnostics, growth was negatively impacted by lower demand for seasonal respiratory testing compared to significantly higher-than-usual demand in the first quarter of the prior year.

Established Pharmaceuticals


Reported Sales


Sales 1Q23 ($ in millions)




Total


Key Emerging
Markets


Other

U.S.






International




1,189


912


277

Total reported




1,189


912


277


% Change vs. 1Q22









U.S.




n/a


n/a


n/a

International




3.7


0.7


15.0

Total reported




3.7


0.7


15.0



Organic Sales


% Change vs. 1Q22




Total


Key Emerging
Markets


Other

Reported




3.7


0.7


15.0

Impact of foreign exchange




(7.4)


(7.6)


(6.8)

Organic




11.1


8.3


21.8










U.S.




n/a


n/a


n/a

International




11.1


8.3


21.8

Established Pharmaceuticals sales increased 3.7 percent on a reported basis and 11.1 percent on an organic basis in the first quarter.

Key Emerging Markets include several emerging countries that represent the most attractive long-term growth opportunities for Abbott's branded generics product portfolio. Sales in these geographies increased 0.7 percent on a reported basis and 8.3 percent on an organic basis, led by growth in Brazil , China and Southeast Asia , and across several therapeutic areas, including cardiometabolic, respiratory and central nervous system/pain management.

Medical Devices


Reported Sales


Sales 1Q23 ($ in millions)

Total


Rhythm
Management


Electro-

physiology


Heart
Failure *


Vascular


Structural
Heart


Neuro-
modulation


Diabetes
Care

U.S.

1,778


260


238


218


218


210


155


479

International

2,122


267


267


63


399


251


41


834

Total reported

3,900


527


505


281


617


461


196


1,313

















% Change vs. 1Q22
















U.S.

15.1


4.4


10.0


11.3


4.8


10.5


8.4


39.7

International

3.5


(3.2)


(1.0)


16.6


(2.7)


13.7


13.5


6.5

Total reported

8.5


0.4


3.9


12.4


(0.2)


12.2


9.4


16.6



Organic Sales

% Change vs. 1Q22

Total


Rhythm
Management


Electro-

physiology


Heart
Failure *


Vascular


Structural
Heart


Neuro-
modulation


Diabetes
Care

Reported

8.5


0.4


3.9


12.4


(0.2)


12.2


9.4


16.6

Impact of foreign exchange

(3.9)


(3.6)


(4.9)


(1.2)


(4.1)


(4.2)


(1.8)


(4.4)

Organic

12.4


4.0


8.8


13.6


3.9


16.4


11.2


21.0

















U.S.

15.1


4.4


10.0


11.3


4.8


10.5


8.4


39.7

International

10.4


3.7


7.8


22.3


3.4


21.4


22.5


12.9


*The Acelis Connected Health business was internally transferred from Rapid Diagnostics to Heart Failure on January 1, 2023. As a result, $29 million of sales for the first quarter of 2022 were moved from Rapid Diagnostics to Heart Failure.

Worldwide Medical Devices sales increased 8.5 percent on a reported basis and 12.4 percent on an organic basis in the first quarter, including double-digit organic sales growth in both the U.S. and internationally.

Sales growth was led by double-digit organic growth in Diabetes Care, Structural Heart, Heart Failure and Neuromodulation. Several recently launched products and new indications contributed to the strong performance, including Amplatzer ® Amulet ® , Navitor, TriClip, Aveir ® and CardioMEMS ® .

In Electrophysiology, internationally, sales grew double-digits on a reported basis and high-teens on an organic basis in Europe , which was partially offset by soft market conditions in China during the first several weeks of the first quarter.

In Diabetes Care, FreeStyle Libre sales were $1.2 billion , which included U.S. growth of approximately 50 percent.

ABBOTT'S EARNINGS-PER-SHARE GUIDANCE
Abbott projects full-year 2023 diluted earnings per share from continuing operations under GAAP of $3.05 to $3.25 . Abbott forecasts specified items for the full-year 2023 of $1.25 per share primarily related to intangible amortization, restructuring and cost reduction initiatives and other net expenses. Excluding specified items, projected adjusted diluted earnings per share from continuing operations would be $4.30 to $4.50 for the full-year 2023.

ABBOTT DECLARES 397 TH CONSECUTIVE QUARTERLY DIVIDEND
On February 17, 2023, the board of directors of Abbott declared the company's quarterly dividend of $0.51 per share. Abbott's cash dividend is payable May 15, 2023 , to shareholders of record at the close of business on April 14, 2023 .

Abbott has increased its dividend payout for 51 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 115,000 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 first-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 in the 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, 2022 , 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

For the full-year 2022, COVID-19 testing-related sales were $8.368 billion and total worldwide sales were $43.653 billion.



2

Abbott has not provided the related GAAP financial measure for organic sales growth, excluding COVID-19 testing-related sales, on a forward-looking basis because the company is unable to predict the impact of foreign exchange due to the unpredictability of future changes in foreign exchange rates, which could significantly impact reported sales growth.



3

Diagnostic sales and COVID-19 testing-related sales in 2023 and 2022 are summarized below:








Sales 1Q23



COVID Tests Sales 1Q23

($ in millions)







U.S.


Int'l


Total



U.S.


Int'l


Total

Total Diagnostics







1,335


1,353


2,688



608


122


730

Core Laboratory







289


893


1,182



2


4


6

Molecular







47


100


147



10


10


20

Rapid Diagnostics







906


319


1,225



596


108


704









Sales 1Q22



COVID Tests Sales 1Q22

($ in millions)







U.S.


Int'l


Total



U.S.


Int'l


Total

Total Diagnostics







2,712


2,545


5,257



1,988


1,316


3,304

Core Laboratory







268


916


1,184



5


23


28

Molecular







172


248


420



114


132


246

Rapid Diagnostics







2,181


1,344


3,525



1,869


1,161


3,030

Abbott Laboratories and Subsidiaries

Condensed Consolidated Statement of Earnings

First Quarter Ended March 31, 2023 and 2022

(in millions, except per share data)

(unaudited)



1Q23


1Q22


% Change


Net Sales

$9,747


$11,895


(18.1)









Cost of products sold, excluding amortization expense

4,331


4,987


(13.2)


Amortization of intangible assets

491


512


(4.0)


Research and development

654


697


(6.2)


Selling, general, and administrative

2,762


2,787


(0.9)


Total Operating Cost and Expenses

8,238


8,983


(8.3)









Operating Earnings

1,509


2,912


(48.2)









Interest expense, net

52


117


(56.1)


Net foreign exchange (gain) loss

6


(3)


n/m


Other (income) expense, net

(111)


(78)


41.5


Earnings before taxes

1,562


2,876


(45.7)


Taxes on earnings

244


429


(43.0)

1)








Net Earnings

$1,318


$2,447


(46.1)









Net Earnings excluding Specified Items, as described below

$1,815


$3,077


(41.0)

2)








Diluted Earnings per Common Share

$0.75


$1.37


(45.3)









Diluted Earnings per Common Share,

excluding Specified Items, as described below

$1.03


$1.73


(40.5)

2)








Average Number of Common Shares Outstanding

Plus Dilutive Common Stock Options

1,752


1,775





NOTES:

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

n/m = Percent change is not meaningful.

See footnotes below.



1)

2023 Taxes on Earnings includes the recognition of approximately $22 million of net tax expense as a result of the resolution of various tax positions related to prior years.




2022 Taxes on Earnings includes the recognition of approximately $30 million of net tax expense as a result of the resolution of various tax positions related to prior years and approximately $30 million in excess tax benefits associated with share-based compensation.



2)

2023 Net Earnings and Diluted Earnings per Common Share, excluding Specified Items, excludes net after-tax charges of $497 million, or $0.28 per share, for intangible amortization, charges related to restructuring and cost reduction initiatives, expenses associated with acquisitions and other net expenses.




2022 Net Earnings and Diluted Earnings per Common Share, excluding Specified Items, excludes net after-tax charges of $630 million, or $0.36 per share, for intangible amortization, charges related to a voluntary recall and other net expenses primarily associated with acquisitions.

Abbott Laboratories and Subsidiaries

Non-GAAP Reconciliation of Financial Information

First Quarter Ended March 31, 2023 and 2022

(in millions, except per share data)

(unaudited)






1Q23





As

Reported
(GAAP)


Specified
Items


As

Adjusted










Intangible Amortization




$            491


$          (491)


$              —

Gross Margin




4,925


520


5,445

R&D




654


(26)


628

SG&A




2,762


(2)


2,760

Earnings before taxes




1,562


548


2,110

Taxes on Earnings




244


51


295

Net Earnings




1,318


497


1,815

Diluted Earnings per Share




$           0.75


$           0.28


$           1.03


Specified items reflect intangible amortization expense of $491 million and other net expenses of $57 million associated with restructuring actions, costs associated with acquisitions and other expenses. See table titled " Details of Specified Items First Quarter Ended March 31, 2023" for additional details regarding specified items.





1Q22





As

Reported
(GAAP)


Specified
Items


As

Adjusted










Intangible Amortization




$            512


$          (512)


$              —

Gross Margin




6,396


636


7,032

R&D




697


(33)


664

SG&A




2,787


(39)


2,748

Other (income) expense, net




(78)


(15)


(93)

Earnings before taxes




2,876


723


3,599

Taxes on Earnings




429


93


522

Net Earnings




2,447


630


3,077

Diluted Earnings per Share




$           1.37


$           0.36


$           1.73


Specified items reflect intangible amortization expense of $512 million and other net expenses of $211 million that includes costs associated with a product recall, acquisitions and other net expenses. See table titled "Details of Specified Items First Quarter Ended March 31, 2022" for additional details regarding specified items.

A reconciliation of the first-quarter tax rates for 2023 and 2022 is shown below:







1Q23


($ in millions)





Pre-Tax

Income


Taxes on

Earnings


Tax

Rate


As reported (GAAP)





$         1,562


$            244


15.6 %

1)

Specified items





548


51




Excluding specified items





$         2,110


$            295


14.0 %









1Q22


($ in millions)





Pre-Tax

Income


Taxes on

Earnings


Tax

Rate


As reported (GAAP)





$         2,876


$            429


14.9 %

2)

Specified items





723


93




Excluding specified items





$         3,599


$            522


14.5 %




1)

2023 Taxes on Earnings includes the recognition of approximately $22 million of net tax expense as a result of the resolution of various tax positions related to prior years.



2)

2022 Taxes on Earnings includes the recognition of approximately $30 million of net tax expense as a result of the resolution of various tax positions related to prior years and approximately $30 million in excess tax benefits associated with share-based compensation.

Abbott Laboratories and Subsidiaries

Non-GAAP Revenue Reconciliation

First Quarter Ended March 31, 2023 and 2022

($ in millions)

(unaudited)




1Q23


1Q22


% Change vs. 1Q22













Non-GAAP



Abbott
Reported

Impact from
business exit (a)

Adjusted
Revenue


Abbott
Reported

Impact from
business exit (a)

Adjusted
Revenue


Reported


Adjusted

Organic

Total Company


9,747

(8)

9,739


11,895

(52)

11,843


(18.1)


(17.8)

(14.5)

U.S.


3,928

3,928


4,937

4,937


(20.4)


(20.4)

(20.4)

Intl


5,819

(8)

5,811


6,958

(52)

6,906


(16.4)


(15.9)

(10.2)















Total Nutrition


1,967

(8)

1,959


1,894

(52)

1,842


3.8


6.4

10.3

U.S.


812

812


677

677


19.9


19.9

19.9

Intl


1,155

(8)

1,147


1,217

(52)

1,165


(5.1)


(1.5)

4.8















Pediatric Nutrition


924

(8)

916


847

(52)

795


9.2


15.4

18.4

U.S.


459

459


338

338


36.1


36.1

36.1

Intl


465

(8)

457


509

(52)

457


(8.6)


0.2

5.3



(a)

Reflects the impact of exiting the pediatric nutrition business in China. This action was initiated in December 2022.

Abbott Laboratories and Subsidiaries

Details of Specified Items

First Quarter Ended March 31, 2023

(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

$                    5


$                  21


$                491


$                    3


$                520

R&D

(4)


1



(23)


(26)

SG&A

(4)


(4)



6


(2)

Other (income) expense, net

(6)




6


Earnings before taxes

$                  19


$                  24


$                491


$                  14


548

Taxes on Earnings (d)









51

Net Earnings









$                497

Diluted Earnings per Share









$               0.28



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



a)

Acquisition-related expenses include legal and other costs related to business acquisitions as well as integration costs, which represent incremental costs directly related to integrating acquired businesses.

b)

Restructuring and cost reduction initiative expenses include severance, outplacement and other direct costs associated with specific restructuring plans and cost reduction initiatives.

c)

Other includes incremental costs to comply with the European Union's Medical Device Regulations (MDR) and In Vitro Diagnostics Medical Device Regulations (IVDR) requirements for previously approved products.

d)

Reflects the net tax benefit associated with the specified items.

Abbott Laboratories and Subsidiaries

Details of Specified Items

First Quarter Ended March 31, 2022

(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


$                  (6)


$                512


$                109


$                636

R&D

(2)


(1)



(30)


(33)

SG&A

(11)




(28)


(39)

Other (income) expense, net

(7)




(8)


(15)

Earnings before taxes

$                  41


$                  (5)


$                512


$                175


723

Taxes on Earnings (d)









93

Net Earnings









$                630

Diluted Earnings per Share









$               0.36



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

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. The Gross Margin amount includes a credit associated with the charges taken in the second quarter of 2021 for a restructuring plan related to Abbott's manufacturing network for COVID-19 diagnostic tests.

c)

Other includes charges related to a voluntary recall within the Nutrition segment and incremental costs to comply with the European Union's Medical Device (MDR) and In Vitro Diagnostics Medical Device (IVDR) Regulations for previously approved products.

d)

Reflects the net tax benefit associated with the specified items, excess tax benefits associated with share-based compensation and net tax expense as a result of the resolution of various tax positions related to prior years.

Cision View original content: https://www.prnewswire.com/news-releases/abbott-reports-first-quarter-2023-results-increases-outlook-for-underlying-base-business-301801684.html

SOURCE Abbott

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Abbott Announces New Partnerships and Programs to Advance its Diversity in Clinical Trials Initiative

Abbott Announces New Partnerships and Programs to Advance its Diversity in Clinical Trials Initiative

  • New efforts focus on research infrastructure, continued training of diverse clinical research personnel and improved diversity within Abbott's own clinical trials
  • Abbott's Diversity in Clinical Trials initiative aligns with the company's continued focus for greater health equity, expanded access, affordability and removing barriers to life-saving technology and innovation
  • The new programs build on a successful first year of the multi-million-dollar corporate initiative

Abbott (NYSE: ABT) today announced a series of new programs within its multi-million-dollar initiative to increase diversity in clinical trials and improve care among under-represented populations. The new additions to Abbott's Diversity in Clinical Trials initiative build on the partnerships, scholarships, and the focus on diversified participants in the company's own clinical trials during the initiative's first year.

The latest programs include the launch of a new initiative with the Norton Healthcare Foundation to build and implement new models of sustainable clinical research alongside the Institute for Health Equity, a Part of Norton Healthcare in Louisville, Ky. ; a new training program for clinical research coordinators in partnership with Barnett International; and a newly-created Diversity in Research Office at Abbott focused on ensuring diverse representation in clinical trials.

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richard murray md

Avisa Diagnostics Appoints Dr. Richard Murray as Chief Medical Officer

Avisa Diagnostics Inc. (CSE:AVBT) (Avisa), a clinical-stage medical device company developing an ultra-rapid, point-of-care biomarker breath test for the detection and monitoring of virulent bacterial lung infections, is pleased to announce that the Company has hired Richard K. Murray, M.D., to the newly created position of Chief Medical Officer (CMO).

Dr. Murray has over 25 years of industry experience. He worked at Merck & Co. for many years in positions of increasing responsibility, in a variety of business, medical and scientific areas. His most recent position was Vice President and Deputy Chief Patient Officer. Dr. Murray was also a Fellow at the Advanced Leadership Initiative at Harvard University. He has managed all areas of medical affairs, including outcomes research, medical information, professional and academic affairs, field-based medical physicians, and investigator-initiated trials globally. Prior to his industry career, he was a practicing physician in cardiovascular-pulmonary medicine and an asthma researcher at the Hospital of the University of Pennsylvania. Dr. Murray has an M.D. from Howard University and an M.A. in Chemistry and A.B. in Psychology from Clark University. Dr. Murray currently is Board Chair of the Asthma and Allergy Foundation of America.

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Aehr Test Systems Receives Orders of Over $2.3 million

Aehr Test Systems (NASDAQ:AEHR) has over 2,500 systems installed over the world that test optical and memory integrated circuits, semiconductors and reliability qualification equipment announced that it received over $2.3 million in orders for test and burn-in services. These orders came from a major manufacturer where Aehr’s services would be implemented for automotive products.

As quoted in the press release:

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Cyclacel Reports Fourth Quarter And 2016 Financial Results

Cyclacel Pharmaceuticals (NASDAQ:CYCC) posted its financial results for the fourth quarter and full year 2016.
As quoted in the press release:

The Company’s net loss applicable to common shareholders for the three months and year ended December 31, 2016 was $2.9 million and $12.0 million, respectively. As of December 31, 2016, cash and cash equivalents totaled $16.5 million.

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Enanta Pharmaceuticals Announces AbbVie’s Investigational Regimen of Glecaprevir/Pibrentasvir Shows High SVR Rates

Enanta Pharmaceuticals, Inc., (NASDAQ:ENTA), a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced 98 percent (n=102/104) of chronic hepatitis C virus (HCV) infected patients with severe chronic kidney disease (CKD) achieved sustained virologic response following 12 weeks of treatment (SVR12) with AbbVie’s investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) in the primary intent-to-treat (ITT) analysis. In a modified intent-to-treat (mITT) analysis, SVR12 was achieved in 100 percent (n=102/102) of severe CKD patients. The mITT analysis excludes patients who did not achieve SVR for reasons other than virologic failure. These new data from the Phase 3 EXPEDITION-4 study, evaluating patients with chronic HCV infection across all major genotypes (GT1-6) and severe CKD, will be presented as a late-breaker today at The Liver Meeting®, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston.
The EXPEDITION-4 results are the latest to be released from
registrational studies in AbbVie’s G/P clinical development program,
designed to investigate a faster path to virologic cure* for all major
HCV genotypes (GT1-6) and with the goal of addressing areas of continued
unmet need.
Glecaprevir (GLE), an NS3/4A protease inhibitor, is Enanta’s second
protease inhibitor being developed through its collaboration with
AbbVie. G/P is a once-daily regimen that combines two distinct antiviral
agents. G/P is a fixed-dose combination of glecaprevir (300mg) and
pibrentasvir (120mg), an NS5A inhibitor, dosed once-daily as three oral
tablets.
HCV is common among people with severe CKD, reaching prevalence of up to
80 percent in some regions of the world.1 In the U.S., it is
estimated that over 500,000 people have both chronic HCV and CKD2.
Some chronic HCV infected patients with severe CKD, particularly those
with GT2 and GT3 HCV infection, currently don’t have access to
direct-acting antivirals (DAAs). The development of new, safe and
effective regimens to treat HCV in these patients remains a critical
unmet medical need.3
The EXPEDITION-4 study enrolled 104 patients with severe chronic kidney
disease, including 85 patients (82 percent) who were receiving dialysis
at enrollment and 20 patients (19 percent) who had compensated
cirrhosis. The study also included those who were not cured with
previous treatment with sofosbuvir (SOF) plus ribavirin (RBV) or with
interferon (IFN) plus RBV, with or without SOF (44 patients, 42 percent).
The majority of treatment related adverse events (AEs) were mild or
moderate. The most commonly reported AEs included pruritus, fatigue and
nausea. Of the 24 percent of patients who experienced serious AEs, none
were considered related to G/P. Four AEs (4 percent) led to the
discontinuation of G/P and one patient died after achieving SVR4
due to a serious AE (intracerebral hemorrhage) considered not-related to
G/P.
*Patients who achieve a sustained virologic response at 12 weeks post
treatment (SVR
12) are considered cured of
hepatitis C

About the EXPEDITION-4 Study
EXPEDITION-4 is a single-arm,
open-label, Phase 3 study evaluating the safety and efficacy of 12 weeks
of G/P in patients with GT1-6 chronic HCV infection and chronic kidney
disease, including those on dialysis. The primary endpoint is SVR12.
Patients in the study had severe or end stage kidney disease (stage 4
and 5 CKD), with an eGFR < 30 mL/min/1.73 m2 required at screening.
Prior treatment in the study is defined as treatment with interferon
(IFN)/pegIFN ± RBV, or sofosbuvir (SOF) + RBV ± pegIFN therapy.
Additional information on the clinical trials for G/P is available at www.clinicaltrials.gov/.
About Enanta
Enanta Pharmaceuticals is a research and
development-focused biotechnology company that uses its robust
chemistry-driven approach and drug discovery capabilities to create
small molecule drugs for viral infections and liver diseases. Enanta’s
research and development efforts are currently focused on four disease
targets: Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), Non-alcoholic
Steatohepatitis (NASH) and Respiratory Syncytial Virus (RSV).
Enanta has discovered novel protease inhibitors that are members of the
direct-acting-antiviral (DAA) inhibitor classes designed for use against
the hepatitis C virus (HCV). These protease inhibitors, developed
through Enanta’s collaboration with AbbVie, include paritaprevir, which
is contained in AbbVie’s marketed DAA regimens for HCV, and glecaprevir
(ABT-493), Enanta’s second protease inhibitor product, which AbbVie has
developed in Phase 3 studies in a fixed-dose combination (G/P) with
pibrentasvir (ABT-530), AbbVie’s second NS5A inhibitor, and is preparing
for regulatory approval filings in the U.S., Europe and Japan.
Enanta has also discovered EDP-305, an FXR agonist product candidate for
NASH, currently in Phase 1 clinical development, as well as a
cyclophilin inhibitor, EDP-494, a novel host-targeting mechanism for
HCV, which is also in Phase 1 clinical development. In addition, Enanta
has early lead candidates for HBV and RSV in preclinical development.
Please visit www.enanta.com
for more information on Enanta’s programs and pipeline.
Forward Looking Statements Disclaimer
This press release contains forward-looking statements, including
statements with respect to the prospects for AbbVie’s investigational
HCV treatment regimen containing glecaprevir (ABT-493). Statements that
are not historical facts are based on management’s current expectations,
estimates, forecasts and projections about Enanta’s business and the
industry in which it operates and management’s beliefs and assumptions.
The statements contained in this release are not guarantees of future
performance and involve certain risks, uncertainties and assumptions,
which are difficult to predict. Therefore, actual outcomes and results
may differ materially from what is expressed in such forward-looking
statements. Important factors and risks that may affect actual results
include: the efforts of AbbVie (our collaborator developing glecaprevir)
to develop its glecaprevir/pibrentasvir(G/P) combination and
successfully obtain regulatory approval and commercialize it; the
regulatory and marketing efforts of others with respect to competitive
treatment regimens for HCV; regulatory and reimbursement actions
affecting G/P, any competitive regimen, or both; the need to obtain and
maintain patent protection for glecaprevir and avoid potential
infringement of the intellectual property rights of others; and other
risk factors described or referred to in “Risk Factors” in Enanta’s most
recent Form 10-K for the fiscal year ended September 30, 2015 and other
periodic reports filed more recently with the Securities and Exchange
Commission. Enanta cautions investors not to place undue reliance on the
forward-looking statements contained in this release. These statements
speak only as of the date of this release, and Enanta undertakes no
obligation to update or revise these statements, except as may be
required by law.
________________________________________________
1 Fabrizi F, Poordad FF, Martin P. Hepatitis C infection in
the patient with end stage renal disease. Hepatology. 2002;36(1):3-10.
2 IMS Health, July 2016. Parsippany, NJ; Medivo, July 2016.
New York, NY (Estimate based on IMS Health Dx Medical Claims
12/2013-4/2016; IMS Health Life Link Patient Level Data 12/2013-4/2016;
Medivo Lab Data 12/2013-4/2016).
3 American Association for the Study of Liver Diseases.
Recommendations for Testing, Managing, and Treating Hepatitis C,
February 24, 2016, https://www.hcvguidelines.org/full-report/monitoring-patients-who-are-starting-hepatitis-c-treatment-are-treatment-or-have.
Accessed March 15, 2016.

Healing People and Planet: 3 Things You Need to Know About This Shared Innovation Challenge

By Ken Washington, Chief Technology and Innovation Officer, and Raman Venkatesh, Chief Sustainability Officer, Medtronic

When you think about healthcare technology, you may imagine the pacemaker assisting your dad's ailing heart, the sutures your child received after a bike accident, or the pulse oximeter placed on your finger during your annual physical exam. You probably don't think about the energy or resources required to manufacture those products, nor the resulting emissions and waste.

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Healing People and Planet: New Impact Report Outlines How Medtronic Is Shaping the Future of Health

Medtronic

Medtronic releases 2024 Impact Report highlighting success in healthcare equity with new data from the Healthy Neighbor program, in addition to community engagement and environmental sustainability progress

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Artificial Intelligence Reshaping Healthcare Industry with Unimaginable Potential

FN Media Group News Commentary - The Healthcare Artificial Intelligence (AI) market exhibits a high degree of innovation, characterized by ongoing advancements in technology. Rapid developments in ML, deep learning, NLP, and computer vision are driving the evolution of AI-powered healthcare solutions. One primary factor driving market growth is the increasing demand in the healthcare sector for enhanced efficiency, accuracy, and better patient outcomes. According to a March 2024 Microsoft-IDC study, 79% of healthcare organizations are presently utilizing AI technology. In addition, the return on investment (ROI) is realized within 14 months, generating USD 3.20 for every USD 1 invested in artificial intelligence (AI). AI technologies hold transformative potential in various areas including medical imaging analysis, predictive analytics, personalized treatment planning, and drug discovery, potentially transforming conventional healthcare practices. A report from Grand View Research said the global AI in healthcare market size, which was estimated at USD 19.27 billion in 2023, is expected to grow at a CAGR of 38.5% from 2024 to 2030. The report said: "Mergers & acquisitions (M&As) play a significant role in shaping the healthcare AI market landscape. Companies [that] engage in M&A activities to expand their AI software and services increase their market reach or acquire specialized technology and expertise. End-users are becoming increasingly aware of the potential benefits of AI in improving patient care, operational efficiency, and healthcare outcomes. Education initiatives and industry events helped raise awareness about the capabilities and applications of AI in healthcare." A.I. companies active in the markets include: Avant Technologies Inc. (OTCQB: AVAI), Teladoc Health, Inc. (NYSE: TDOC), Tempus AI, Inc. (NASDAQ: TEM), Medtronic plc (NYSE: MDT), Clover Health Investments, Corp. (NASDAQ: CLOV).

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Medtronic receives FDA clearance for new InPen app, paving the way for its Smart MDI system launch with Simplera CGM

New Smart MDI system will be the first system to deliver real-time, personalized insights on when and how much to dose including for missed or inaccurate mealtime doses.

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced U.S. Food and Drug Administration (FDA) clearance for its new InPen™ app featuring missed meal dose detection, paving the way for the launch of its Smart MDI system with the Simplera™ continuous glucose monitor (CGM). The company's Smart MDI system combines its InPen™ smart insulin pen with its newest Simplera™ CGM — the company's first disposable, all-in-one CGM that's half the size of previous Medtronic CGMs.

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Medtronic reports second quarter fiscal 2025 financial results

Delivering on commitments, executing ahead of expectations, and raising guidance

Innovation driving sustained growth across many franchises:  TAVR, PFA, Leadless Pacemakers, Diabetes, Spine, and Neuromodulation

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Knight Therapeutics Announces Health Canada Approval for JORNAY PM to Treat Attention-Deficit Hyperactivity Disorder

Knight Therapeutics Inc. (TSX: GUD) ("Knight"), a pan-American (ex-USA) specialty pharmaceutical company, announced today that Health Canada has approved JORNAY PM ™, an extended-release formulation of methylphenidate, a stimulant medication for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in children.

JORNAY PM ™ is the first and only evening-dosed methylphenidate product commercially available in Canada to treat ADHD in patients from 6 to 12 years of age. JORNAY PM ™ consists of microbeads with a delayed-release layer and an extended-release layer. The first layer delays the release of the active ingredient until morning while the extended-release layer controls the release of the active ingredient starting in the morning and continuing throughout the day. This unique formulation provides a pharmacokinetic profile that allows ADHD symptom control from the time patients wake up until the evening.

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