Life Science News

  • Sales growth of 10.1 percent; organic sales growth of 14.3 percent
  • GAAP diluted EPS growth of 72.7 percent; adjusted diluted EPS growth of 22.2 percent
  • Global COVID-19 testing-related sales of $2.3 billion in the second quarter
  • Continues to strengthen portfolio with new product approvals

Abbott (NYSE: ABT) today announced financial results for the second quarter ended June 30, 2022 .

  • Second-quarter sales of $11.3 billion increased 10.1 percent on a reported basis and 14.3 percent on an organic basis, which excludes the impact of foreign exchange.
  • GAAP diluted EPS 1 was $1.14 in the second quarter. Excluding specified items, adjusted diluted EPS was $1.43 , which reflects growth of 22.2 percent compared to the prior year.
  • Global COVID-19 testing-related sales were $2.3 billion in the second quarter.
  • Abbott is raising its full-year 2022 EPS guidance. Abbott projects full-year diluted EPS on a GAAP basis of at least $3.50 and projected adjusted diluted EPS of at least $4.90 .
  • 2022 guidance includes projected COVID-19 testing-related sales of $6.1 billion , which includes sales of $5.6 billion through June 2022 and projected sales of $500 million over the next few months.
  • In April, Abbott announced U.S. Food and Drug Administration (FDA) approval of its Aveir™ single-chamber (VR) leadless pacemaker for the treatment of patients with slow heart rhythms. Aveir VR is the world's only leadless pacemaker with a unique mapping capability to assess correct positioning prior to placement and was specifically designed to be expandable and retrievable when therapy needs evolve or the device needs to be replaced.
  • In May, Abbott announced U.S. FDA clearance of its FreeStyle Libre ® 3 system, which automatically delivers up-to-the-minute glucose readings and unsurpassed 14-day accuracy 2 in the world's smallest and thinnest 3 wearable sensor.
  • In June, Abbott announced breakthrough device designation from the U.S. FDA for its first-of-its-kind glucose-ketone biowearable sensor development program, which will enable people with diabetes to continuously monitor glucose and ketones in one sensor, helping those at risk for developing a life-threatening complication called diabetic ketoacidosis.

"We achieved another quarter of strong growth and are raising our full-year EPS guidance," said Robert B. Ford , chairman and chief executive officer, Abbott. "Our new product pipeline has remained highly productive, and our diversified business has continued to be resilient in a challenging macro environment."

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 2022:

Total Company
($ in millions)










% Change vs. 2Q21



Sales 2Q22


Reported


Organic



U.S.


Int'l


Total


U.S.


Int'l


Total


U.S.


Int'l


Total

Total *


4,892


6,365


11,257


36.6


(4.2)


10.1


36.6


2.3


14.3

Nutrition


761


1,192


1,953


(12.9)


(3.5)


(7.4)


(12.9)


1.5


(4.5)

Diagnostics


2,469


1,853


4,322


113.8


(11.4)


33.1


113.8


(5.6)


36.9

Established Pharmaceuticals


--


1,223


1,223


n/a


3.7


3.7


n/a


9.2


9.2

Medical Devices


1,660


2,097


3,757


7.9


(1.5)


2.5


7.9


7.1


7.5


* Total Q2 2022 Abbott sales include Other Sales of approximately $2 million.









% Change vs. 1H21



Sales 1H22


Reported


Organic



U.S.


Int'l


Total


U.S.


Int'l


Total


U.S.


Int'l


Total

Total *


9,829


13,323


23,152


32.5


0.5


12.0


32.5


6.7


15.9

Nutrition


1,438


2,409


3,847


(15.9)


(1.1)


(7.2)


(15.9)


3.6


(4.4)

Diagnostics


5,210


4,398


9,608


86.4


(1.5)


32.3


86.4


4.3


35.9

Established Pharmaceuticals


--


2,370


2,370


n/a


5.3


5.3


n/a


11.2


11.2

Medical Devices


3,176


4,146


7,322


9.9


1.2


4.8


9.9


9.0


9.4


* Total 1H 2022 Abbott sales include Other Sales of approximately $5 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 2022 worldwide sales of $11.3 billion increased 10.1 percent on a reported basis and 14.3 percent on an organic basis.

Worldwide sales, excluding COVID-19 testing-related sales, decreased 0.3 percent on a reported basis and increased 4.1 percent on an organic basis in the quarter. 4 Worldwide sales were negatively impacted by a voluntary recall and manufacturing shutdown initiated in February of certain infant formula products manufactured at one of Abbott's U.S. plants. Excluding COVID-19 testing-related sales and the U.S. sales associated with the recalled products in the current and prior years, total worldwide sales increased 1.6 percent on a reported basis and 6.2 percent on an organic basis in the second quarter. 5

Nutrition
($ in millions)










% Change vs. 2Q21



Sales 2Q22


Reported


Organic



U.S.


Int'l


Total


U.S.


Int'l


Total


U.S.


Int'l


Total

Total


761


1,192


1,953


(12.9)


(3.5)


(7.4)


(12.9)


1.5


(4.5)

Pediatric


413


512


925


(21.6)


(9.5)


(15.3)


(21.6)


(5.8)


(13.4)

Adult


348


680


1,028


0.5


1.6


1.2


0.5


7.6


5.2









% Change vs. 1H21



Sales 1H22


Reported


Organic



U.S.


Int'l


Total


U.S.


Int'l


Total


U.S.


Int'l


Total

Total


1,438


2,409


3,847


(15.9)


(1.1)


(7.2)


(15.9)


3.6


(4.4)

Pediatric


751


1,021


1,772


(27.5)


(9.1)


(17.9)


(27.5)


(5.6)


(16.1)

Adult


687


1,388


2,075


2.1


5.8


4.6


2.1


11.5


8.3

Worldwide Nutrition sales decreased 7.4 percent on a reported basis and 4.5 percent on an organic basis in the second quarter. Total worldwide Nutrition and Pediatric Nutrition sales were negatively impacted by a voluntary recall and manufacturing shutdown initiated in February of certain infant formula products manufactured at one of Abbott's U.S. plants. On July 1 , Abbott restarted partial production at the facility. Excluding the U.S. sales associated with these products in the current and prior years, total worldwide Nutrition sales increased 0.5 percent on a reported basis and 3.8 percent on an organic basis in the second quarter. 6

In Adult Nutrition, Ensure ® , Abbott's market-leading complete and balanced nutrition brand, and Glucerna ® , Abbott's market-leading diabetes nutrition brand, led to global sales growth of 1.2 percent on a reported basis and 5.2 percent on an organic basis.

Diagnostics
($ in millions)










% Change vs. 2Q21



Sales 2Q22


Reported


Organic



U.S.


Int'l


Total


U.S.


Int'l


Total


U.S.


Int'l


Total

Total


2,469


1,853


4,322


113.8


(11.4)


33.1


113.8


(5.6)


36.9

Core Laboratory


287


934


1,221


1.3


(8.6)


(6.5)


1.3


(2.0)


(1.3)

Molecular


71


141


212


(23.7)


(28.4)


(26.9)


(23.7)


(24.4)


(24.2)

Point of Care


101


38


139


3.2


(3.7)


1.2


3.2


0.3


2.4

Rapid Diagnostics


2,010


740


2,750


195.4


(11.2)


81.7


195.4


(5.8)


84.6









% Change vs. 1H21



Sales 1H22


Reported


Organic



U.S.


Int'l


Total


U.S.


Int'l


Total


U.S.


Int'l


Total

Total


5,210


4,398


9,608


86.4


(1.5)


32.3


86.4


4.3


35.9

Core Laboratory


555


1,850


2,405


0.1


(4.3)


(3.4)


0.1


1.7


1.3

Molecular


243


389


632


(9.4)


(16.9)


(14.2)


(9.4)


(12.4)


(11.3)

Point of Care


192


75


267


1.2


(1.7)


0.4


1.2


2.0


1.4

Rapid Diagnostics


4,220


2,084


6,304


136.6


4.9


67.2


136.6


10.9


70.4

Worldwide Diagnostics sales increased 33.1 percent on a reported basis and 36.9 percent on an organic basis in the second quarter. Global COVID-19 testing-related sales were $2.3 billion in the quarter, led by sales of testing products in Rapid Diagnostics.

Sales in Core Laboratory and Molecular Diagnostics were impacted by year-over-year declines in COVID-19 testing-related sales in these businesses. Excluding COVID-19 testing-related sales, Core Laboratory Diagnostics sales decreased 3.1 percent on a reported basis and increased 2.3 percent on an organic basis and Molecular Diagnostics sales increased 17.9 percent on a reported basis and 22.3 percent on an organic basis in the second quarter. 7

Established Pharmaceuticals
($ in millions)










% Change vs. 2Q21



Sales 2Q22


Reported


Organic



U.S.


Int'l


Total


U.S.


Int'l


Total


U.S.


Int'l


Total

Total


--


1,223


1,223


n/a


3.7


3.7


n/a


9.2


9.2

Key Emerging Markets


--


931


931


n/a


1.8


1.8


n/a


7.1


7.1

Other


--


292


292


n/a


10.3


10.3


n/a


16.7


16.7









% Change vs. 1H21



Sales 1H22


Reported


Organic



U.S.


Int'l


Total


U.S.


Int'l


Total


U.S.


Int'l


Total

Total


--


2,370


2,370


n/a


5.3


5.3


n/a


11.2


11.2

Key Emerging Markets


--


1,833


1,833


n/a


5.6


5.6


n/a


11.8


11.8

Other


--


537


537


n/a


4.5


4.5


n/a


9.2


9.2

Established Pharmaceuticals sales increased 3.7 percent on a reported basis and 9.2 percent on an organic basis in the second 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 1.8 percent on a reported basis and 7.1 percent on an organic basis, led by double-digit growth on a reported and organic basis in several geographies and therapeutic areas, including cardiometabolic, respiratory and central nervous system/pain management.

Other sales increased 10.3 percent on a reported basis and 16.7 percent on an organic basis in the quarter.

Medical Devices
($ in millions)










% Change vs. 2Q21



Sales 2Q22


Reported


Organic



U.S.


Int'l


Total


U.S.


Int'l


Total


U.S.


Int'l


Total

Total


1,660


2,097


3,757


7.9


(1.5)


2.5


7.9


7.1


7.5

Rhythm Management


264


284


548


(2.3)


(4.4)


(3.4)


(2.3)


3.7


0.9

Electrophysiology


226


260


486


8.6


(6.8)


(0.2)


8.6


2.2


5.0

Heart Failure


179


62


241


6.5


4.2


5.9


6.5


13.6


8.3

Vascular


228


425


653


(6.7)


(5.8)


(6.1)


(6.7)


1.2


(1.6)

Structural Heart


207


233


440


8.1


0.9


4.2


8.1


11.4


9.9

Neuromodulation


157


40


197


(5.2)


(8.7)


(6.0)


(5.2)


0.2


(4.1)

Diabetes Care


399


793


1,192


37.8


3.4


12.8


37.8


12.4


19.4









% Change vs. 1H21



Sales 1H22


Reported


Organic



U.S.


Int'l


Total


U.S.


Int'l


Total


U.S.


Int'l


Total

Total


3,176


4,146


7,322


9.9


1.2


4.8


9.9


9.0


9.4

Rhythm Management


512


560


1,072


0.3


(2.7)


(1.3)


0.3


4.4


2.5

Electrophysiology


442


529


971


14.0


(0.1)


5.8


14.0


8.0


10.5

Heart Failure


346


116


462


10.6


7.3


9.7


10.6


15.9


11.9

Vascular


437


835


1,272


(6.0)


(3.7)


(4.5)


(6.0)


2.6


(0.4)

Structural Heart


397


454


851


10.4


3.4


6.5


10.4


12.8


11.7

Neuromodulation


300


76


376


(3.4)


(9.1)


(4.6)


(3.4)


(0.9)


(2.9)

Diabetes Care


742


1,576


2,318


36.8


5.5


13.8


36.8


13.7


19.8

Worldwide Medical Devices sales increased 2.5 percent on a reported basis and 7.5 percent on an organic basis in the second quarter. Sales growth was negatively impacted by reduced cardiovascular and neuromodulation procedure volumes as a result of recent surges of COVID-19 in several geographies, healthcare staffing challenges and lockdowns in China that were implemented to control the spread of the virus.

In Diabetes Care, FreeStyle Libre sales were approximately $1.1 billion in the quarter, which represents sales growth of 18.7 percent on a reported basis and 25.6 percent on an organic basis.

ABBOTT'S EARNINGS-PER-SHARE GUIDANCE
Abbott is raising its projected full-year 2022 diluted earnings per share under GAAP to at least $3.50 . Abbott forecasts specified items for the full-year 2022 of $1.40 per share primarily related to intangible amortization, costs related to a voluntary recall, expenses associated with acquisitions, restructurings and cost reduction initiatives and other net expenses. Excluding specified items, Abbott is raising its projected adjusted diluted earnings per share to at least $4.90 for the full-year 2022.

ABBOTT DECLARES 394 TH CONSECUTIVE QUARTERLY DIVIDEND
On June 10, 2022 , the board of directors of Abbott declared the company's quarterly dividend of $0.47 per share. Abbott's cash dividend is payable Aug. 15, 2022 , to shareholders of record at the close of business on July 15, 2022 .

Abbott has increased its dividend payout for 50 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 113,000 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 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, 2021 , 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

All reported amounts relate to continuing operations only as there are no discontinued operations in the periods presented.

2

Data on file, Abbott Diabetes Care. Comparison based on publicly available information.

3

Among patient-applied sensors. Data on file, Abbott Diabetes Care.

4

In the second quarter of 2022, COVID-19 testing-related sales were $2.324 billion. In the second quarter of 2021, total worldwide sales were $10.223 billion, which included COVID-19 testing-related sales of $1.267 billion.

5

In the second quarter of 2022, U.S. sales of certain infant formula products were $116 million. In the second quarter of 2021, U.S. sales of certain infant formula products were $280 million.

6

In the second quarter of 2021, worldwide Nutrition sales were $2.108 billion, which included $280 million of U.S. sales of certain infant formula products.

7

In the second quarter of 2022, Core Laboratory and Molecular Diagnostics COVID-19 testing-related sales were $12 million and $75 million, respectively. In the second quarter of 2021, worldwide Core Laboratory and Molecular Diagnostics sales were $1.306 billion and $290 million, respectively. Core Laboratory and Molecular Diagnostics COVID-19 testing-related sales in the second quarter of 2021 were $58 million and $173 million, respectively.

Abbott Laboratories and Subsidiaries
Condensed Consolidated Statement of Earnings
Second Quarter Ended June 30, 2022 and 2021
(in millions, except per share data)
(unaudited)





2Q22


2Q21


% Change


Net Sales


$11,257


$10,223


10.1










Cost of products sold, excluding amortization expense


4,933


4,947


(0.3)

1)

Amortization of intangible assets


507


504


0.7


Research and development


684


654


4.8


Selling, general, and administrative


2,757


2,726


1.1


Total Operating Cost and Expenses


8,881


8,831


0.6










Operating Earnings


2,376


1,392


70.6










Interest expense, net


106


123


(14.1)


Other (income) expense, net


(82)


(79)


3.6


Earnings before taxes


2,352


1,348


74.4


Taxes on earnings


334


159


109.2










Net Earnings


$2,018


$1,189


69.7










Net Earnings Excluding Specified Items, as described below


$2,542


$2,115


20.2

2)









Diluted Earnings per Common Share


$1.14


$0.66


72.7










Diluted Earnings per Common Share,








excluding Specified Items, as described below


$1.43


$1.17


22.2

2)









Average Number of Common Shares Outstanding








Plus Dilutive Common Stock Options


1,765


1,793




















NOTES:


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

See footnotes on the following 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)

2022 Net Earnings and Diluted Earnings per Common Share, excluding Specified Items, excludes net after-tax charges of $524 million, or $0.29 per share, for intangible amortization, charges related to a voluntary recall and other net expenses primarily associated with acquisitions.




2021 Net Earnings and Diluted Earnings per Common Share, 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.

Abbott Laboratories and Subsidiaries
Condensed Consolidated Statement of Earnings
First Half Ended June 30, 2022 and 2021
(in millions, except per share data)
(unaudited)





1H22


1H21


% Change










Net Sales


$23,152


$20,679


12.0


























Cost of products sold, excluding amortization expense


9,920


9,348


6.1

1)









Amortization of intangible assets


1,019


1,013


0.6










Research and development


1,381


1,308


5.6










Selling, general, and administrative


5,544


5,509


0.6










Total Operating Cost and Expenses


17,864


17,178


4.0


























Operating Earnings


5,288


3,501


51.0


























Interest expense, net


223


247


(9.9)










Net foreign exchange (gain) loss


(3)


3


n/m










Other (income) expense, net


(160)


(140)


14.5










Earnings before taxes


5,228


3,391


54.2










Taxes on earnings


763


409


86.5

2)

























Net Earnings


$4,465


$2,982


49.7


























Net Earnings Excluding Specified Items, as described below


$5,619


$4,483


25.3

3)

























Diluted Earnings per Common Share


$2.51


$1.66


51.2


























Diluted Earnings per Common Share,
















excluding Specified Items, as described below


$3.16


$2.49


26.9

3)

























Average Number of Common Shares Outstanding
















Plus Dilutive Common Stock Options


1,770


1,792












NOTES:


See 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 on the following 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)

2022 Taxes on Earnings includes the recognition of approximately $27 million of net tax expense as a result of the resolution of various tax positions related to prior years and approximately $32 million in excess tax benefits associated with share-based compensation.




2021 Taxes on Earnings includes the recognition of approximately $90 million in excess tax benefits associated with share-based compensation.



3)

2022 Net Earnings and Diluted Earnings per Common Share, excluding Specified Items, excludes net after-tax charges of $1.154 billion, or $0.65 per share, for intangible amortization, charges related to a voluntary recall and other net expenses primarily associated with acquisitions.




2021 Net Earnings and Diluted Earnings per Common Share, 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.

Abbott Laboratories and Subsidiaries
Non-GAAP Reconciliation of Financial Information
Second Quarter Ended June 30, 2022 and 2021
(in millions, except per share data)
(unaudited)





2Q22



As
Reported
(GAAP)


Specified
Items


As
Adjusted


% to
Sales










Intangible Amortization


$           507


$     (507)


$         --



Gross Margin


5,817


563


6,380


56.7 %

R&D


684


(32)


652


5.8 %

SG&A


2,757


(14)


2,743


24.4 %

Other (income) expense, net


(82)


(12)


(94)



Earnings before taxes


2,352


621


2,973



Taxes on Earnings


334


97


431



Net Earnings


2,018


524


2,542



Diluted Earnings per Share


$1.14


$0.29


$1.43




Specified items reflect intangible amortization expense of $507 million and other net expenses of $114 million that includes costs associated with a product recall, acquisitions, and other net expenses. See tables titled "Details of Specified Items" for additional details regarding specified items.



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 before taxes


1,348


1,121


2,469



Taxes on Earnings


159


195


354



Net Earnings


1,189


926


2,115



Diluted Earnings per Share


$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.

Abbott Laboratories and Subsidiaries
Non-GAAP Reconciliation of Financial Information
First Half Ended June 30, 2022 and 2021
(in millions, except per share data)
(unaudited)





1H22



As
Reported
(GAAP)


Specified
Items


As
Adjusted


% to
Sales










Intangible Amortization


$         1,019


$  (1,019)


$         --



Gross Margin


12,213


1,199


13,412


57.9 %

R&D


1,381


(65)


1,316


5.7 %

SG&A


5,544


(53)


5,491


23.7 %

Other (income) expense, net


(160)


(27)


(187)



Earnings before taxes


5,228


1,344


6,572



Taxes on Earnings


763


190


953



Net Earnings


4,465


1,154


5,619



Diluted Earnings per Share


$2.51


$0.65


$3.16












Specified items reflect intangible amortization expense of $1.019 billion and other net expenses of $325 million that includes costs associated with a product recall, acquisitions, and other net expenses. See tables titled "Details of Specified Items" for additional details regarding specified items.



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 before taxes


3,391


1,864


5,255



Taxes on Earnings


409


363


772



Net Earnings


2,982


1,501


4,483



Diluted Earnings per Share


$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.

A reconciliation of the second-quarter tax rates for 2022 and 2021 is shown below:





2Q22

($ in millions)


Pre-Tax
Income


Taxes on
Earnings


Tax
Rate

As reported (GAAP)


$2,352


$        334


14.2 %

Specified items


621


97



Excluding specified items


$2,973


$431


14.5 %












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 %

A reconciliation of the year-to-date tax rates for 2022 and 2021 is shown below:





1H22


($ in millions)


Pre-Tax
Income


Taxes on
Earnings


Tax
Rate


As reported (GAAP)


$5,228


$        763


14.6 %

1)

Specified items


1,344


190




Excluding specified items


$6,572


$953


14.5 %














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 %











1)

2022 Taxes on Earnings includes the recognition of approximately $27 million of net tax expense as a result of the resolution of various tax positions related to prior years and approximately $32 million in excess tax benefits associated with share-based compensation.



2)

2021 Taxes on Earnings includes the recognition of approximately $90 million in excess tax benefits associated with share-based compensation.

Abbott Laboratories and Subsidiaries
Details of Specified Items
Second Quarter Ended June 30, 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

$              20


$              (6)


$          507


$       42


$       563

R&D

(5)


--


--


(27)


(32)

SG&A

(7)


--


--


(7)


(14)

Other (income) expense, net

(4)


--


--


(8)


(12)

Earnings before taxes

$              36


$              (6)


$          507


$       84


621

Taxes on Earnings (d)









97

Net Earnings









$       524

Diluted Earnings per Share









$      0.29


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 costs 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 and 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 before taxes


$              45


$            507


$          504


$       65


1,121

Taxes on Earnings (d)










195

Net Earnings










$       926

Diluted Earnings per Share










$      0.51


The table above provides additional details regarding the specified items 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. 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
First Half Ended June 30, 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


$              41


$             (12)


$        1,019


$      151


$    1,199

R&D


(7)


(1)


--


(57)


(65)

SG&A


(18)


--


--


(35)


(53)

Other (income) expense, net


(11)


--


--


(16)


(27)

Earnings before taxes


$              77


$             (11)


$        1,019


$      259


1,344

Taxes on Earnings (d)










190

Net Earnings










$    1,154

Diluted Earnings per Share










$      0.65












The table above provides additional details regarding the specified items 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.

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 before taxes


$              79


$            526


$        1,013


$      246


1,864

Taxes on Earnings (d)










363

Net Earnings










$    1,501

Diluted Earnings per Share










$      0.83


The table above provides additional details regarding the specified items 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. 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.

Cision View original content: https://www.prnewswire.com/news-releases/abbott-reports-second-quarter-2022-results-and-raises-full-year-eps-guidance-301590017.html

SOURCE Abbott

News Provided by PR Newswire via QuoteMedia

ABT
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.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Avisa Diagnostics Begins Trading on the Canadian Securities Exchange

Avisa Diagnostics Begins Trading on the Canadian Securities Exchange

  • Public Listing offers Access to CAD 52 Million from Share Subscription and Drawdown Agreement, Sufficient Funding to Complete Development and Launch Avisa BreathTest™
  • Pivotal Trials Planned in Post-COVID-19 Long Haulers and Ventilator-Associated Pneumonia

Avisa Diagnostics Inc. (Avisa) is pleased to announce that the Company has begun trading on the Canadian Securites Exchange (CSE:AVBT) through the previously announced merger completion with Fogchain Corp. Avisa has developed the Avisa BreathTest™ (ABT), an ultra-rapid, point-of-care biomarker breath test for the detection and monitoring of bacterial load in Post-COVID-19 “long haulers,” who can develop acute respiratory disease, and ventilator-associated pneumonia (VAP), an indication with high morbidity and mortality.

The public listing enables Avisa to draw down over the period of three years CAD 52 million (~USD 41 million) from a share subscription and drawdown agreement put in place in 2020 with GEM GLOBAL YIELD LLC SCS (GEM), a $3.4 billion alternative investment group with offices in Paris, New York, and Los Angeles.

Keep reading...Show less
abt stock

Avisa Diagnostics Begins Trading on the Canadian Securities Exchange

  • Public Listing offers Access to CAD 52 Million from Share Subscription and Drawdown Agreement, Sufficient Funding to Complete Development and Launch Avisa BreathTest™
  • Pivotal Trials Planned in Post-COVID-19 Long Haulers and Ventilator-Associated Pneumonia

Avisa Diagnostics Inc. (Avisa) is pleased to announce that the Company has begun trading on the Canadian Securites Exchange (CSE:AVBT) through the previously announced merger completion with Fogchain Corp. Avisa has developed the Avisa BreathTest™ (ABT), an ultra-rapid, point-of-care biomarker breath test for the detection and monitoring of bacterial load in Post-COVID-19 "long haulers," who can develop acute respiratory disease, and ventilator-associated pneumonia (VAP), an indication with high morbidity and mortality.

The public listing enables Avisa to draw down over the period of three years CAD 52 million (~USD 41 million) from a share subscription and drawdown agreement put in place in 2020 with GEM GLOBAL YIELD LLC SCS (GEM), a $3.4 billion alternative investment group with offices in Paris, New York, and Los Angeles.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

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:

Keep reading...Show less

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.

Keep reading...Show less

Johnson & Johnson Ends Global Sales of Cancer-Causing Baby Powder Amid Increased Scrutiny from Consumer Litigation, Science

Courts continue to scrutinize J&J's controversial bankruptcy ploy to avoid liability

Legal experts say the decision by Johnson & Johnson (NYSE: JNJ) to halt future sales and distribution of talc-based products worldwide, including its iconic Johnson's Baby Powder, points to mounting pressure on the company to resolve tens of thousands of legal claims brought by ovarian cancer and mesothelioma victims.

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
Medical Device Stocks: 5 Biggest Companies in 2022

Medical Device Stocks: 5 Biggest Companies in 2022

The top medical device companies are a vital component of the overarching life science industry, as well as a major force in treating many diseases and conditions.

The global medical device market was valued at US$434.2 billion in 2021, and is expected to grow at a compound annual growth rate of 6.3 percent to reach US$625.3 billion in 2027.

Growth in the global medical device industry is tied to the rapid rise of an aging population, increased infectious and chronic diseases, as well as technological advancements in both the field of life science and in emerging technologies such as 3D printing, robotics and the internet of things.

Keep reading...Show less

New Study Shows Abbott's Blood Test for Concussion Could Predict Outcomes from Brain Injury and Inform Treatment Interventions

  • The study concluded that elevated levels of two proteins help predict how a person will recover from a traumatic brain injury (TBI), providing important information to determine appropriate care
  • Researchers used Abbott's i-STAT™ TBI Plasma test – the only FDA-cleared rapid test on a portable analyzer for concussion – and Abbott's core laboratory ARCHITECT instrument to measure two biomarkers in blood plasma associated with brain injury

A new study published in The Lancet Neurology demonstrates the ability of two blood-based biomarkers to predict how someone will recover from traumatic brain injury (TBI). Testing for these two biomarkers in the immediate aftermath of an injury can help health care providers determine the best way to treat and care for patients.

This research shows that when a clinician conducts a blood test for these brain proteins soon after a possible injury, they quickly get a more accurate picture of how severe the injury is, the expected course of recovery and the longer-term implications of the TBI. The markers were measured using Abbott's i-STAT™ TBI Plasma test , as well as on the company's ARCHITECT core laboratory instrument using research prototype assays, both of which helped predict recovery.

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

Knight Therapeutics Reports Second Quarter 2022 Results

-- Achieves Record Quarterly Revenues and EBITDA 1 --

Knight Therapeutics Inc. (TSX: GUD) ("Knight" or "the Company"), a leading pan-American (ex-US) specialty pharmaceutical company, today reported financial results for its second quarter ended June 30, 2022. All currency amounts are in thousands except for share and per share amounts. All currencies are Canadian unless otherwise specified.

Q2 2022 Highlights

Financials

  • Revenues were $75,820, an increase of $10,024 or 15% over the same period in prior year.
  • Gross margin of $38,295 or 51% compared to $28,871 or 44% in the same period in prior year.
  • Adjusted EBITDA 1 was $17,890, an increase of $8,494 or 90% over the same period in prior year.
  • Net loss on financial assets measured at fair value through profit or loss of $7,692.
  • Net income was $2,516, compared to net income of $29,004 in the same period in prior year.
  • Cash inflow from operations was $11,521, compared to a cash inflow from operations of $12,409 in the same period in prior year.

Corporate Developments

  • Purchased 1,460,684 common shares through Knight's normal course issuer bid ("NCIB") at an average price of $5.30 for an aggregate cash consideration of $7,739.
  • Shareholders re-elected Jonathan Ross Goodman, Samira Sakhia, James C. Gale, Robert N. Lande, Michael J. Tremblay, Nicolás Sujoy and Janice Murray on the Board of Directors.

Products

  • Entered into an exclusive license, distribution and supply agreement with Helsinn Healthcare SA ("Helsinn") for AKYNZEO® oral/IV (netupitant/palonosetron/fosnetupitant/palonosetron) in Canada, Brazil and select LATAM countries and ALOXI® oral/IV (palonosetron) in Canada.
  • Entered into exclusive license and supply agreements with Rigel Pharmaceuticals ("Rigel") to commercialize fostamatinib in LATAM.
  • Obtained marketing authorization transfer of Exelon® from Novartis to Knight in Colombia, Brazil, and Mexico, and transferred Exelon®'s commercial activities from Novartis to Knight's affiliate in Colombia.

Subsequent Events

  • Relaunched AKYNZEO® in Brazil in July 2022.
  • Transferred marketing authorization of Exelon® from Novartis to Knight's affiliate in Chile.
  • Executed a settlement agreement with former controlling shareholders of GBT and will receive US$4.6 million.
  • Launched a NCIB in July 2022 to purchase up to 7,988,986 common shares of the Company over the next 12 months.

"I am excited to announce that Knight achieved record quarterly revenues this quarter and see continuous growth in each of our key therapeutic categories primarily driven by the lifting of COVID-19 restrictions as well as the impact of the acquisition of Exelon®. Almost one year after closing that transaction, we have completed the Exelon® marketing authorization transfers to Knight in our key LATAM territories and have assumed Exelon® commercial activities in Colombia. We also continued to execute on the business development front and entered into exclusive license, distribution and supply agreements with Helsinn and Rigel in our key territories,", said Samira Sakhia, President and Chief Executive Officer of Knight Therapeutics Inc.

__________
1 EBITDA and Adjusted EBITDA are a non-GAAP measures, refer to section "Non-GAAP measures" and "Reconciliation to adjusted EBITDA" for additional details


SELECT FINANCIAL RESULTS
[In thousands of Canadian dollars]

Change Change
Q2-22 Q2-21 $ 1 % 2 YTD-22 YTD-21 $ 1 % 2
Revenues 75,820 65,796 10,024 15% 139,627 111,865 27,762 25%
Gross margin 38,295 28,871 9,424 33% 70,772 49,451 21,321 43%
Gross margin % 51 % 44% 51% 44%
Operating expenses 4 35,959 28,855 7,104 25% 68,752 51,670 17,082 33%
Net income (loss) 2,516 29,004 (26,488 ) 91% (16,295 ) 32,562 (48,857 ) 150%
EBITDA 3 17,890 9,271 8,619 93% 31,202 14,431 16,771 116%
Adjusted EBITDA 3 17,890 9,396 8,494 90% 31,202 14,975 16,227 108%
  1. A positive variance represents a positive impact to net income (loss) and a negative variance represents a negative impact to net income (loss)
  2. Percentage change is presented in absolute values
  3. EBITDA and adjusted EBITDA are non-GAAP measures, refer to the definitions in section "Non-GAAP measures" for additional details
  4. Operating expenses include selling and marketing expenses, general and administrative expenses, research and development expenses, amortization and impairment of intangible assets


SELECT BALANCE SHEET ITEMS
[In thousands of Canadian dollars]

Change
06-30-22 12-31-21 $ % 1
Cash, cash equivalents and marketable securities 136,235 149,502 (13,267 ) 9 %
Trade and other receivables 131,570 103,875 27,695 27 %
Inventory 76,400 72,397 4,003 6 %
Financial assets 162,306 192,443 (30,137 ) 16 %
Accounts payable and accrued liabilities 82,635 65,590 17,045 26 %
Bank loans 32,483 35,927 (3,444 ) 10 %
  1. Percentage change is presented in absolute values

Revenues: For the quarter ended June 30, 2022 revenues increased by $10,024 or 15% compared to the same period in prior year. The growth in revenues excluding the impact of hyperinflation was $9,836 or 15% and is explained by the following:

  • Knight recognized revenues of $12,390 for Exelon®, an increase of $8,202 or 200% driven by the following factors:
    • The timing of the acquisition of Exelon® executed on May 26, 2021
    • Estimated increase in revenues between $4,000 to $4,500 driven by the purchasing pattern of certain customers as well as higher sales in Brazil in anticipation of the transfer of commercial activities from Novartis to Knight
  • An increase in revenues of $1,634 driven by the growth of recently launched products including the Q1-22 launches of Lenvima®, Rembre® and Halaven® in Colombia, an increase in patient treatments as our markets reduce COVID-19 restrictions and buying patterns offset by a decrease in revenues of certain of our oncology branded generics products due to market entrance of new competitors. In addition, revenues decreased by approximately $4,500 to $6,000 due to lower demand of certain of our infectious diseases products associated with COVID-19.

Gross margin: For the quarter ended June 30, 2022, gross margin increased from 44% to 51% explained by a change in product mix as well as the acquisition of Exelon®. The revenues of Exelon® is recorded as a net profit transfer from Novartis with the exception of revenues generated in Colombia upon the transfer of commercial activities to Knight in June 2022. The gross margin would have been 54% versus 51% (YTD-21: 44% to 46%) after excluding the adjustment of hyperinflation accounting in accordance with IAS 29.

Knight expects gross margin as a % of revenues to decline over the next quarters as the commercial activities of Exelon® are transferred to Knight on a country-by-country basis and the Company records revenues with related cost of sales instead of a net profit transfer.

Selling and marketing: For the quarter ended June 30, 2022, S&M expenses were $10,926, an increase of $1,742 or 19%, compared to the same period in prior year due to an increase in compensation expenses, certain variable costs such as logistics fees as well as an increase in selling and marketing activities related to key promoted products and Exelon®.

General and administrative: For the quarter ended June 30, 2022, G&A expenses were $10,566, an increased of $1,115 or 12%, compared to the same period in prior year due to an increase in compensation expense, certain consulting and professional fees partially offset by the lower costs of related to stock options

Research and development: For the quarter ended June 30, 2022, R&D expenses were $3,412, an increase of $827 or 32%, compared to the same period in prior year. The variance is not significant.

Amortization of intangible assets: For the quarter ended June 30, 2022, amortization of intangible assets was $11,055, an increase of $3,420 or 45%, compared to the same period in prior year driven by acquisition of Exelon®.

Interest income: Interest income is the sum of interest income on financial instruments measured at amortized cost and other interest income. For the quarter ended June 30, 2022, interest income was $2,427, an increase of 36% or $641, compared to the same period in prior year due to higher interest rates.

Interest expense: For the quarter ended June 30, 2022, interest expense was $1,717, an increase of $1,049 or 157%, compared to the same period in prior year due to higher interest rates partially offset by a lower average bank loan balance.

Adjusted EBITDA: For the quarter ended June 30, 2022, adjusted EBITDA increased by $8,494 or 90%. The growth in adjusted EBITDA is driven by an increase in gross margin of $9,424, offset by an increase in operating expenses.

Net loss or income: For the quarter ended June 30, 2022, net income was $2,516 compared to net income of $29,004 for the same period in prior year. The variance mainly resulted from the above-mentioned items and (1) a net loss on the revaluation of financial assets measured at fair value through profit or loss of $7,692 versus a net gain of $28,472 in the same period in prior year, mainly due to unrealized revaluations of the strategic fund investments, offset by (2) a foreign exchange gain of $4,507 mainly due to the unrealized gains on intercompany balances driven by the appreciation of the USD compared to a foreign exchange loss of $3,194 in the same period in prior year mainly due to depreciation of the USD.

Cash, cash equivalents and marketable securities : As at June 30, 2022, Knight had $136,235 in cash, cash equivalents and marketable securities, a decrease of $13,267 or 9% as compared to December 31, 2021. The variance is primarily due to outflows related to due to upfront payments and certain milestones mainly related to in-licensing of AKYNZEO® and ALOXI® from Helsinn as well as fostamatinib from Rigel, shares repurchased through NCIB, partially offset by cash inflows from operating activities.

Financial assets: As at June 30, 2022, financial assets were at $162,306, a decrease of $30,137 or 16%, as compared to the prior year, mainly due to negative mark-to-market adjustments of $23,520 driven by the decline in the share prices of the publicly-traded equities of our strategic fund investments due to general market conditions and distributions of $4,336. Given the nature of the fund investments there could be significant fluctuations in the fair value of the underlying assets.

Bank Loans: As at June 30, 2022, bank loans were at $32,483, a decrease of $3,444 or 10% as compared to the prior period, due to loan repayments of $5,391, partially offset by the appreciation of BRL and accrued interest.

Product Updates

The marketing authorizations of Exelon® for Colombia, Mexico, Chile and Brazil were transferred to Knight. The Company expects that remaining marketing authorizations will be transferred in the second half of 2022. Furthermore, Knight has assumed the commercial activities of Exelon® in Colombia and expects to assume commercial activities in Brazil, Mexico and Chile in Q3-22.

Knight entered into an exclusive license, distribution and supply agreement with Helsinn for AKYNZEO® oral/IV (netupitant/palonosetron / fosnetupitant/palonosetron) in Canada, Brazil and select LATAM countries and ALOXI® oral/IV (palonosetron) in Canada. AKYNZEO ® oral is approved and marketed in Canada for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cancer chemotherapy and the prevention of acute nausea and vomiting associated with moderately emetogenic cancer therapy that is uncontrolled by a 5-HT3 receptor antagonist alone in adults. AKYNZEO ® oral is also approved and marketed in Argentina and Brazil for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy and prevention of acute and delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults. ALOXI® solution for injection is approved and marketed in Canada for the prevention of acute and delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy and highly emetogenic cancer chemotherapy, including high dose cisplatin in adults. In Canada, the product is also indicated in pediatric patients aged 2 to 17 years for the prevention of acute nausea and vomiting associated with moderately and highly emetogenic cancer chemotherapy. ALOXI® oral is approved in Canada for use in adults for the prevention of acute nausea and vomiting associated with moderately emetogenic cancer chemotherapy. According to IQVIA, sales of AKYNZEO® in Canada and Brazil were approximately $7 million in 2021. Knight assumed commercial activities of AKYNZEO® in Brazil and Argentina in July 2022 and will begin commercial activities following a transition period from Helsinn's current licensees in Canada.

Knight entered into exclusive license and supply agreements with Rigel Pharmaceuticals for the exclusive rights to commercialize fostamatinib, an oral spleen tyrosine kinase (SYK) inhibitor, in Latin America. Fostamatinib is commercially available in the United States under the brand name TAVALISSE® and in Europe under the brand name TAVLESSE® for the treatment of chronic immune thrombocytopenia. On June 8, 2022, Rigel announced topline efficacy and safety data from the Phase 3 clinical trial of fostamatinib in patients with warm autoimmune hemolytic anemia (wAIHA). The trial did not demonstrate statistical significance in the primary efficacy endpoint of durable hemoglobin response in the overall study population. The safety profile was consistent with prior clinical experience, and no new safety issues were identified. Rigel is conducting an in-depth analysis of this data to better understand differences in patient characteristics and outcomes and expects to discuss these findings with the FDA to determine the path forward in wAIHA. Fostamatinib is also in Phase 3 clinical trials for the treatment of hospitalized patients with COVID-19 1,2 .

_______________

1 Clinicaltrials.gov: NCT04629703
2 Clinicaltrials.gov: NCT04924660


Corporate Updates

NCIB

On July 12, 2022, the Company announced that the Toronto Stock Exchange approved its notice of intention to launch a NCIB ("2022 NCIB"). Under the terms of the 2022 NCIB, Knight may purchase for cancellation up to 7,988,986 common shares of the Company which represented 10% of its public float as at June 30, 2022. The 2022 NCIB commenced on July 14, 2022 and will end on the earlier of July 13, 2023 or when the Company completes its maximum purchases under the NCIB. Furthermore, Knight entered into an agreement with a broker to facilitate purchases of its common shares under the NCIB. Under Knight's automatic share purchase plan, the broker may purchase common shares which would ordinarily not be permitted due to regulatory restrictions or self-imposed blackout periods.

For the three-month period ended June 30, 2022, the Company purchased 1,460,684 common shares at an average price of $5.30 for an aggregate cash consideration of $7,739. The Company did not acquire any common shares subsequent to the quarter ended June 30, 2022.

Settlement Agreement

Knight executed a settlement agreement and general release ("Settlement Agreement") with the former shareholders of GBT. The Company made certain claims ("Claims") with respect to its indemnification rights under the purchase agreement for the acquisition of GBT. Under the Settlement Agreement, Knight will receive $5.9 million (US$4.6 million) as settlement for the Claims, which will be recorded in the Statement of Income.

Conference Call Notice

Knight will host a conference call and audio webcast to discuss its second quarter ended June 30, 2022, today at 8:30 am ET. Knight cordially invites all interested parties to participate in this call.

Date: Thursday, August 11, 2022
Time: 8:30 a.m. ET
Telephone : Toll Free: 1-855-669-9657 or International 1-412-317-0790
Webcast: www.gud-knight.com or Webcast
This is a listen-only audio webcast. Media Player is required to listen to the broadcast.

Replay: An archived replay will be available for 30 days at www.gud-knight.com

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Bausch Health to Appeal XIFAXAN® Patent Decision to U.S. Court of Appeals for the Federal Circuit

Bausch Health Companies Inc. (NYSETSX: BHC), and its gastroenterology business Salix Pharmaceuticals, today announced that, consistent with the company's July 28, 2022 press release, the U.S. District Court of Delaware has issued a decision in the matter of Salix Pharmaceuticals, Ltd. et al v. Norwich Pharmaceuticals, Inc. finding certain XIFAXAN® (rifaximin) 550 mg HE patents valid and infringed and certain XIFAXAN composition and IBS-D patents invalid.  As previously stated, the Company will appeal this decision to the U.S. Court of Appeals for the Federal Circuit and it expects an appeal decision to issue within 12 to 18 months.

To date, Norwich has not received tentative or final approval of its ANDA from the FDA.  Unless and until FDA approves a revised Norwich ANDA that omits the XIFAXAN HE indication, and any injunction issued by the Court is modified, Norwich is not permitted to launch a generic equivalent of XIFAXIN.

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

Medtronic to announce financial results for its first quarter of fiscal year 2023

Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced that it will report financial results for its first quarter of fiscal year 2023 on Tuesday, August 23, 2022 . 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 first quarter of fiscal year 2023, which ended on Friday, July 29, 2022 .

Medtronic will host a video webcast at 7:00 a.m. CDT on Tuesday, August 23, 2022 , to discuss results for its first quarter of fiscal year 2023. The webcast can be accessed at https://investorrelations.medtronic.com .

News Provided by Canada Newswire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×