AbbVie Reports Third-Quarter 2022 Financial Results

  • Reports Third-Quarter Diluted EPS of $2.21 on a GAAP Basis, an Increase of 24.2 Percent; Adjusted Diluted EPS of $3.66 , an Increase of 29.3 Percent; These Results Include an Unfavorable Impact of $0.02 Per Share related to Acquired IPR&D and Milestones Expense   1
  • Delivers Third-Quarter Net Revenues of $14.812 Billion , an Increase of 3.3 Percent on a Reported Basis and 5.4 Percent Operationally
  • Third   -Quarter Global Net Revenues from the Immunology Portfolio Were $7.651 Billion , an Increase of 14.6 Percent on a Reported Basis, or 16.4 Percent on an Operational Basis; U.S. Humira Net Revenues Were $4.956 Billion , an Increase of 7.4 Percent; Internationally, Humira Net Revenues Were $603 Million , a Decrease of 25.9 Percent on a Reported Basis, or 16.8 Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $1.397 Billion ; Global Rinvoq Net Revenues Were $695 Million
  • Third   -Quarter Global Net Revenues from the Hematologic Oncology Portfolio Were $1.650 Billion , a Decrease of 11.7 Percent on a Reported Basis, or 9.9 Percent on an Operational Basis; Global Imbruvica Net Revenues Were $1.135 Billion , a Decrease of 17.4 Percent , with U.S. Net Revenues of $849 Million and International Profit Sharing of $286 Million ; Global Venclexta Net Revenues Were $515 Million
  • Third   -Quarter Global Net Revenues from the Neuroscience Portfolio Were $1.672 Billion , an Increase of 6.7 Percent on a Reported Basis, or 8.3 Percent on an Operational Basis; Global Botox Therapeutic Net Revenues Were $699 Million ; Vraylar Net Revenues Were $554 Million
  • Third   -Quarter Global Net Revenues from the Aesthetics Portfolio Were $1.301 Billion , an Increase of 4.0 Percent on a Reported Basis, or 8.1 Percent on an Operational Basis; Global Botox Cosmetic Net Revenues Were $637 Million ; Global Juvederm Net Revenues Were $352 Million
  • Confirms Midpoint of 2022 Adjusted Diluted EPS Guidance Range and Narrows Range from $13.76 - $13.96 to $13.84 - $13.88 , which Includes an Unfavorable Impact of $0.25 Per Share Related to Acquired IPR&D and Milestones Expense Incurred Year-To-Date Through the Third Quarter 2022
  • Announces 2023 Dividend Increase of 5.0 Percent, Beginning with Dividend Payable in February 2023

ABBVie (NYSE:ABBV) announced financial results for the third quarter ended September 30, 2022 .

"We continue to see strong momentum from our key immunology assets, Skyrizi and Rinvoq, and this performance – combined with strength from other growth drivers within our diverse portfolio – has mitigated the impact of temporary economic headwinds on our aesthetics products to deliver another quarter of strong results," said Richard A. Gonzalez , chairman and chief executive officer, AbbVie. "Based upon our performance and confidence in AbbVie's long-term outlook, we are once again meaningfully raising our dividend."

Note: "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year's foreign exchange rates.

1 Beginning in the first quarter 2022, AbbVie includes the impact of upfront and milestone payments related to collaborations, licensing agreements and other asset acquisitions in its reported non-GAAP financial measures.

Third   -Quarter Results

  • Worldwide net revenues were $14.812 billion , an increase of 3.3 percent on a GAAP basis, or 5.4 percent on an operational basis.

  • Global net revenues from the immunology portfolio were $7.651 billion , an increase of 14.6 percent on a reported basis, or 16.4 percent on an operational basis.
    • Global Humira net revenues of $5.559 billion increased 2.5 percent on a reported basis, or 3.9 percent on an operational basis. U.S. Humira net revenues were $4.956 billion , an increase of 7.4 percent. Internationally, Humira net revenues were $603 million , a decrease of 25.9 percent on a reported basis, or 16.8 percent on an operational basis, due to biosimilar competition.
    • Global Skyrizi net revenues were $1.397 billion , an increase of 75.4 percent on a reported basis, or 78.3 percent on an operational basis.
    • Global Rinvoq net revenues were $695 million , an increase of 53.5 percent on a reported basis, or 59.3 percent on an operational basis.
  • Global net revenues from the hematologic oncology portfolio were $1.650 billion , a decrease of 11.7 percent on a reported basis, or 9.9 percent on an operational basis.
    • Global Imbruvica net revenues were $1.135 billion , a decrease of 17.4 percent, with U.S. net revenues of $849 million and international profit sharing of $286 million .
    • Global Venclexta net revenues were $515 million , an increase of 4.5 percent on a reported basis, or 11.3 percent on an operational basis.
  • Global net revenues from the neuroscience portfolio were $1.672 billion , an increase of 6.7 percent on a reported basis, or 8.3 percent on an operational basis.
    • Global Botox Therapeutic net revenues were $699 million , an increase of 8.2 percent on a reported basis, or 10.0 percent on an operational basis.
    • Vraylar net revenues were $554 million , an increase of 20.2 percent.
    • Global Ubrelvy net revenues were $160 million .
  • Global net revenues from the aesthetics portfolio were $1.301 billion , an increase of 4.0 percent on a reported basis, or 8.1 percent on an operational basis.
    • Global Botox Cosmetic net revenues were $637 million , an increase of 16.9 percent on a reported basis, or 21.6 percent on an operational basis.
    • Global Juvederm net revenues were $352 million , a decrease of 0.6 percent on a reported basis, or an increase of 5.3 percent on an operational basis.
  • On a GAAP basis, the gross margin ratio in the third quarter was 66.1 percent. The adjusted gross margin ratio was 85.4 percent.
  • On a GAAP basis, selling, general and administrative (SG&A) expense was 22.3 percent of net revenues. The adjusted SG&A expense was 20.9 percent of net revenues.
  • On a GAAP basis, research and development (R&D) expense was 10.9 percent of net revenues. The adjusted R&D expense was 10.8 percent of net revenues.
  • Acquired IPR&D and milestones expense was 0.3 percent of net revenues.
  • On a GAAP basis, the operating margin in the third quarter was 31.1 percent. The adjusted operating margin was 53.4 percent.
  • Net interest expense was $497 million .
  • On a GAAP basis, the tax rate in the quarter was 10.2 percent. The adjusted tax rate was 12.9 percent.
  • Diluted EPS in the third quarter was $2.21 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $3.66 . These results include an unfavorable impact of $0.02 per share related to acquired IPR&D and milestones expense.

Note: "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year's foreign exchange rates.

Recent Events

  • AbbVie announced the U.S. Food and Drug Administration (FDA) approved Rinvoq (upadacitinib, 15 mg, once daily) for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation who have had an inadequate response or intolerance to tumor necrosis factor (TNF) blocker therapy. The approval is supported by data from the SELECT-AXIS 2 clinical trial, in which Rinvoq delivered rapid and meaningful disease control as well as significant improvement in signs and symptoms of nr-axSpA. This approval marks the sixth FDA approved indication for Rinvoq in chronic immune-mediated diseases.
  • AbbVie announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of Skyrizi (risankizumab) for the treatment of adults with moderately to severely active Crohn's disease (CD) who have had inadequate response, lost response or were intolerant to conventional or biologic therapy. The positive opinion is based on results from three Phase 3 studies in which Skyrizi demonstrated significant improvements in clinical remission and endoscopic response, compared to placebo, as both induction and maintenance therapy. If the CHMP recommendation is accepted by the European Commission (EC), this would mark the third indication for Skyrizi in the European Union. Skyrizi is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.
  • At the United European Gastroenterology (UEG) Week 2022, AbbVie shared 17 abstracts, including seven oral presentations, from a broad range of studies in inflammatory bowel disease (IBD). Highlights included final analyses from the U-ACHIEVE Phase 3 maintenance study of Rinvoq in moderately to severely active ulcerative colitis (UC), data from the U-EXCEL Phase 3 study evaluating the efficacy and safety of Rinvoq as induction therapy for use in adults with moderately to severely active CD as well as data evaluating Skyrizi for use in patients with moderate to severe CD.
  • At the American College of Gastroenterology (ACG) Annual Scientific Meeting, AbbVie presented 26 abstracts that illustrate AbbVie's commitment to providing research and innovative solutions that support patients with high disease burden and unmet need. Key presentations focused on the treatment of moderate to severe CD, including late-breaking Phase 3 data from the Rinvoq 52 week maintenance trial, as well as efficacy and safety outcomes from the Skyrizi pivotal clinical program.
  • At the European Academy of Dermatology and Venereology (EADV) Congress, AbbVie presented 23 abstracts from across its dermatology portfolio that underscore AbbVie's commitment to advancing research in dermatology for people living with immune-mediated skin diseases such as psoriasis (PsO), psoriatic arthritis (PsA), atopic dermatitis (AD) and vitiligo. Presentations included long-term efficacy and safety results, including real-world data, from studies of Skyrizi in moderate to severe PsO and active PsA as well as data from the largest-of-its-kind study that demonstrate the real-world burden of AD.
  • AbbVie announced that the FDA approved the use of Imbruvica (ibrutinib) for the treatment of pediatric patients one year and older with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy. The approval marks the first approved treatment option for children with cGVHD under 12 years of age and the only Bruton's tyrosine kinase inhibitor (BTKi) treatment for a pediatric patient population. Imbruvica is jointly developed and commercialized with Janssen Biotech, Inc.
  • At the International Parkinson and Movement Disorder Society's (MDS) International Congress, ABBVie presented 13 abstracts across multiple disease states that highlighted ABBVie's continued commitment to advancing the management of movement disorders. Highlights included results from the Phase 3 M15-736 trial evaluating the continuous subcutaneous infusion of ABBV-951 (foslevodopa/foscarbidopa) in people with advanced Parkinson's disease (PD) as well as data on the real-world efficacy of Botox (onabotulinumtoxinA) for the treatment of spasticity and treatment of cervical dystonia.
  • At the Migraine Trust International Symposium (MTIS), AbbVie shared 13 abstracts, including 4 oral presentations, from a wide range of studies across its migraine portfolio that underscore AbbVie's leadership and commitment to people living with migraine. Highlights included Phase 3 PROGRESS study results evaluating Qulipta (atogepant) for the preventive treatment of chronic migraine as well as data from studies evaluating Botox and Ubrelvy (ubrogepant) in the treatment of migraine.
  • Allergan Aesthetics announced that the FDA approved Juvederm Volux XC for the improvement of jawline definition in adults over the age of 21 with moderate to severe loss of jawline definition. Juvederm Volux XC is the first and only hyaluronic acid (HA) filler to receive FDA approval for jawline definition.
  • At the American Society for Dermatologic Surgery (ASDS), Allergan Aesthetics shared data from across its facial injectables, body contouring and skincare portfolio that highlighted Allergan Aesthetics' continued commitment to advancing aesthetic medicine. Highlights included analyses of 15 years of post-marketing surveillance data that demonstrated the global reported rate of delayed-onset nodules associated with dermal fillers on the Vycross technology platform is low, as well as results from three clinical studies showcasing a customizable platform with patent-pending LTN Complex, to address the appearance of facial hyperpigmentation.
  • AbbVie announced the acquisition of DJS Antibodies (DJS), a biotechnology company dedicated to discovering and developing antibody medicines that target difficult-to-drug disease-causing proteins. The acquisition includes DJS' lead program DJS-002, a potential first-in-class LPAR1 antagonist antibody in preclinical studies for the treatment of Idiopathic Pulmonary Fibrosis (IPF) and other fibrotic diseases as well as the company's proprietary HEPTAD platform.

Full-Year 2022 Outlook

AbbVie is confirming the midpoint of its full-year 2022 adjusted diluted EPS guidance range and narrowing the range from $13.76 - $13.96 to $13.84 - $13.88 , which includes an unfavorable impact of $0.25 per share related to acquired IPR&D and milestones expense incurred year-to-date through the third quarter 2022. The company's 2022 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred beyond the third quarter of 2022, as both cannot be reliably forecasted.

Company Declares Dividend Increase of 5.0 Percent

AbbVie is announcing today that its board of directors declared an increase in the company's quarterly cash dividend from $1.41 per share to $1.48 per share beginning with the dividend payable on February 15, 2023 to shareholders of record as of January 13, 2023 . This reflects an increase of approximately 5.0 percent, continuing AbbVie's strong commitment to returning cash to shareholders through a growing dividend. Since the company's inception in 2013, AbbVie has increased its quarterly dividend by 270 percent. AbbVie is a member of the S&P Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years.

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology and gastroenterology, in addition to products and services across our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook or LinkedIn .

Conference Call

AbbVie will host an investor conference call today at 8:00 a.m. Central time to discuss our third-quarter performance. The call will be webcast through AbbVie's Investor Relations website at investors.abbvie.com . An archived edition of the call will be available after 11:00 a.m. Central time .

Non-GAAP Financial Results

Financial results for 2022 and 2021 are presented on both a reported and a non-GAAP basis. Reported results were prepared in accordance with GAAP and include all revenue and expenses recognized during the period. Non-GAAP results adjust for certain non-cash items and for factors that are unusual or unpredictable, and exclude those costs, expenses, and other specified items presented in the reconciliation tables later in this release. Beginning in the first quarter of 2022, the company includes the impact of upfront and milestone payments related to collaborations, licensing agreements, and other asset acquisitions in its reported non-GAAP financial measures. Prior periods have been revised to conform to the current period presentation. AbbVie's management believes non-GAAP financial measures provide useful information to investors regarding AbbVie's results of operations and assist management, analysts, and investors in evaluating the performance of the business. Non-GAAP financial measures should be considered in addition to, and not as a substitute for, measures of financial performance prepared in accordance with GAAP.

Forward-Looking Statements

Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie 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. Such risks and uncertainties include, but are not limited to, the failure to realize the expected benefits of AbbVie's acquisition of Allergan or to promptly and effectively integrate Allergan's business, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2021 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie 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.

AbbVie Inc.  
Key Product Revenues  
Quarter Ended September 30, 2022  
(Unaudited)








% Change vs. 3Q21


Net Revenues (in millions)


Reported


Operational a


U.S.


Int'l.


Total


U.S.


Int'l.


Total


Int'l.


Total

NET REVENUES

$11,763


$3,049


$14,812


4.3 %


(0.4) %


3.3 %


9.6 %


5.4 %

















Immunology

6,682


969


7,651


18.5


(6.3)


14.6


5.6


16.4

Humira

4,956


603


5,559


7.4


(25.9)


2.5


(16.8)


3.9

Skyrizi

1,221


176


1,397


79.8


50.1


75.4


70.0


78.3

Rinvoq

505


190


695


44.7


82.9


53.5


>100.0


59.3

















Hematologic Oncology

1,108


542


1,650


(17.7)


3.9


(11.7)


10.3


(9.9)

Imbruvica b

849


286


1,135


(23.5)


7.6


(17.4)


7.6


(17.4)

Venclexta

259


256


515


9.2


0.1


4.5


13.2


11.3

















Aesthetics

760


541


1,301


(7.4)


25.6


4.0


37.4


8.1

Botox Cosmetic

370


267


637


4.1


41.0


16.9


54.5


21.6

Juvederm Collection

125


227


352


(21.9)


16.9


(0.6)


27.7


5.3

Other Aesthetics

265


47


312


(13.1)


(0.8)


(11.4)


8.3


(10.2)

















Neuroscience

1,464


208


1,672


8.6


(5.0)


6.7


6.3


8.3

Botox Therapeutic

584


115


699


9.2


3.6


8.2


14.2


10.0

Vraylar

554



554


20.1


n/a


20.2


n/a


20.2

Duodopa

22


88


110


(4.9)


(15.0)


(13.1)


(2.6)


(3.0)

Ubrelvy

160



160


(1.4)


n/a


(1.4)


n/a


(1.4)

Qulipta

62



62


n/m


n/a


n/m


n/a


n/m

Other Neuroscience

82


5


87


(50.5)


10.2


(49.0)


14.1


(48.9)

















Eye Care

362


261


623


(38.1)


(9.1)


(28.6)


1.3


(25.2)

Lumigan/Ganfort

59


62


121


(4.4)


(18.7)


(12.2)


(8.7)


(6.7)

Alphagan/Combigan

37


36


73


(58.2)


(8.9)


(43.0)


2.9


(39.4)

Restasis

132


10


142


(56.7)


(30.7)


(55.6)


(37.7)


(55.9)

Other Eye Care

134


153


287


3.7


(2.7)


0.1


9.1


6.6

















Other Key Products

788


202


990


5.5


(19.4)


(0.7)


(9.1)


1.9

Mavyret

190


193


383


3.5


(20.6)


(10.2)


(10.3)


(4.4)

Creon

336



336


8.5


n/a


8.5


n/a


8.5

Linzess/Constella

262


9


271


3.4


16.0


3.8


25.8


4.1



a

"Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year's foreign exchange rates.

b

Reflects profit sharing for Imbruvica international revenues.

n/a = not applicable

n/m = not meaningful

AbbVie Inc.

Key Product Revenues

Nine Months Ended September 30, 2022

(Unaudited)









% Change vs. 9M21


Net Revenues (in millions)


Reported


Operational a


U.S.


Int'l.


Total


U.S.


Int'l.


Total


Int'l.


Total

NET REVENUES

$33,521


$9,412


$42,933


5.3 %


(0.7) %


3.9 %


6.7 %


5.6 %

















Immunology

17,922


3,077


20,999


16.4


(2.2)


13.3


6.6


14.8

Humira

13,613


2,045


15,658


6.5


(20.9)


1.9


(14.3)


3.0

Skyrizi

3,081


508


3,589


78.6


59.3


75.6


75.1


78.1

Rinvoq

1,228


524


1,752


38.0


>100.0


54.5


>100.0


59.3

















Hematologic Oncology

3,325


1,621


4,946


(14.5)


10.7


(7.6)


15.6


(6.3)

Imbruvica b

2,585


868


3,453


(19.4)


6.3


(14.2)


6.3


(14.2)

Venclexta

740


753


1,493


8.1


16.2


12.1


27.3


17.5

















Aesthetics

2,489


1,557


4,046


0.6


15.1


5.8


23.1


8.6

Botox Cosmetic

1,232


741


1,973


20.0


27.9


22.8


36.8


26.0

Juvederm Collection

420


686


1,106


(12.3)


9.9


0.3


17.6


4.6

Other Aesthetics

837


130


967


(13.4)


(12.8)


(13.4)


(7.2)


(12.7)

















Neuroscience

4,175


643


4,818


15.2


(1.1)


12.8


7.9


14.2

Botox Therapeutic

1,641


350


1,991


13.1


6.5


11.9


15.0


13.5

Vraylar

1,473



1,473


18.9


n/a


18.9


n/a


18.9

Duodopa

72


279


351


(2.4)


(9.8)


(8.4)



(0.5)

Ubrelvy

483



483


31.0


n/a


31.0


n/a


31.0

Qulipta

106



106


n/m


n/a


n/m


n/a


n/m

Other Neuroscience

400


14


414


(18.3)


10.3


(17.6)


13.1


(17.5)

















Eye Care

1,265


846


2,111


(26.9)


(3.5)


(19.0)


5.4


(16.0)

Lumigan/Ganfort

186


205


391


(7.1)


(10.8)


(9.0)


(2.9)


(4.8)

Alphagan/Combigan

161


111


272


(40.8)


(5.1)


(30.0)


4.9


(27.0)

Restasis

518


38


556


(41.3)


(10.1)


(39.9)


(2.8)


(39.6)

Other Eye Care

400


492


892


6.3


0.9


3.3


10.1


8.5

















Other Key Products

2,245


623


2,868


4.5


(16.9)


(1.0)


(8.6)


1.2

Mavyret

562


599


1,161


0.9


(17.5)


(9.5)


(9.1)


(4.7)

Creon

941



941


9.0


n/a


9.0


n/a


9.0

Linzess/Constella

742


24


766


2.0


3.2


2.0


9.6


2.2



a

"Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year's foreign exchange rates.

b

Reflects profit sharing for Imbruvica international revenues.

n/a = not applicable

n/m = not meaningful

AbbVie Inc.

Consolidated Statements of Earnings

(Unaudited)


(in millions, except per share data)

Third Quarter

Ended September 30


Nine Months

Ended September 30


2022


2021


2022


2021

Net revenues

$       14,812


$       14,342


$       42,933


$        41,311

Cost of products sold

5,022


4,390


13,244


13,126

Selling, general and administrative

3,304


3,083


11,843


9,089

Research and development a

1,614


1,661


4,720


5,095

Acquired IPR&D and milestones a

40


402


454


719

Other operating expense, net

229


500


57


432

Total operating costs and expenses

10,209


10,036


30,318


28,461









Operating earnings

4,603


4,306


12,615


12,850









Interest expense, net

497


585


1,568


1,813

Net foreign exchange loss

36


12


108


35

Other expense (income), net

(330)


21


427


2,284

Earnings before income tax expense

4,400


3,688


10,512


8,718

Income tax expense

448


508


1,139


1,214

Net earnings

3,952


3,180


9,373


7,504

Net earnings attributable to noncontrolling interest

3


1


10


6

Net earnings attributable to AbbVie Inc.

$          3,949


$          3,179


$          9,363


$          7,498









Diluted earnings per share attributable to AbbVie Inc.

$            2.21


$            1.78


$            5.24


$            4.19









Adjusted diluted earnings per share b

$            3.66


$            2.83


$          10.18


$            8.75









Weighted-average diluted shares outstanding

1,776


1,777


1,777


1,776



a

During the three months ended March 31, 2022, AbbVie changed its classification of development milestone expense associated with licensing and collaboration arrangements in the consolidated statement of earnings. Milestone payments incurred prior to regulatory approval, which were previously included in research and development expense, are now presented as acquired IPR&D and milestones expense. The reclassification decreased research and development expense and increased acquired IPR&D and milestones expense by $12 million for the three months and $162 million for the nine months ended September 30, 2021. The company believes this presentation assists users of the financial statements to better understand the total upfront and subsequent development milestone payments incurred to acquire in-process research and development projects. Prior periods have been revised to conform to the current period presentation. The reclassification had no impact on total operating costs and expenses, operating earnings, net earnings, net earnings attributable to AbbVie, Inc., earnings per share, or total equity.



b

Refer to the Reconciliation of GAAP Reported to Non-GAAP Adjusted Information for further details.

AbbVie Inc.

Reconciliation of GAAP Reported to Non-GAAP Adjusted Information

(Unaudited)


1.     Specified items impacted results as follows:







Quarter Ended September 30, 2022

(in millions, except per share data)





Earnings


Diluted






Pre-tax


After-tax a


EPS

As reported (GAAP)





$              4,400


$              3,949


$                2.21

Adjusted for specified items:










Intangible asset amortization





2,024


1,673


0.94

Intangible asset impairment





770


604


0.34

Acquisition and integration costs





348


348


0.20

Change in fair value of contingent consideration





(214)


(218)


(0.12)

Litigation matters





110


94


0.05

Other





58


78


0.04

As adjusted (non-GAAP)





$              7,496


$              6,528


$                3.66


a Represents net earnings attributable to AbbVie Inc.


Acquisition and integration costs include costs related to the Allergan acquisition. Other primarily includes restructuring charges associated with streamlining global operations.


Beginning in the first quarter of 2022, the company includes acquired IPR&D and milestones expense in its reported non-GAAP financial measures. Reported GAAP earnings and adjusted non-GAAP earnings for the three months ended September 30, 2022 included acquired IPR&D and milestones expense of $40 million on a pre-tax and after-tax basis, representing an unfavorable impact of $0.02 to both diluted EPS and adjusted diluted EPS.


2.     The impact of the specified items by line item was as follows:



Quarter Ended September 30, 2022

(in millions)

Cost of
products
sold


SG&A


R&D


Other
operating
expense,
net


Other
expense
(income),
net

As reported (GAAP)

$         5,022


$        3,304


$              1,614


$                 229


$                (330)

Adjusted for specified items:










Intangible asset amortization

(2,024)





Intangible asset impairment

(770)





Acquisition and integration costs

(22)


(91)


(6)


(229)


Change in fair value of contingent consideration





214

Litigation matters


(110)




Other

(39)


(14)


(1)



(4)

As adjusted   (non-GAAP)

$          2,167


$        3,089


$              1,607


$                    —


$                (120)











3.     The adjusted tax rate for the third quarter of 2022 was 12.9 percent, as detailed below:











Quarter Ended September 30, 2022

(dollars in millions)





Pre-tax
earnings


Income taxes


Tax rate

As reported (GAAP)





$              4,400


$                  448


10.2 %

Specified items





3,096


517


16.7 %

As adjusted   (non-GAAP)





$              7,496


$                  965


12.9 %

AbbVie Inc.

Reconciliation of GAAP Reported to Non-GAAP Adjusted Information

(Unaudited)


1.     Specified items impacted results as follows:





Quarter Ended September 30, 2021

(in millions, except per share data)



Earnings


Diluted




Pre-tax


After-tax a


EPS

As reported (GAAP)



$              3,688


$              3,179


$                1.78

Adjusted for specified items:








Intangible asset amortization



1,904


1,585


0.88

Acquisition and integration costs



176


166


0.09

Change in fair value of contingent consideration



98


98


0.06

Other



48


29


0.02

As adjusted (non-GAAP)



$              5,914


$              5,057


$                2.83


a Represents net earnings attributable to AbbVie Inc.


Acquisition and integration costs reflect Allergan-related integration costs. Other primarily includes restructuring charges associated with streamlining global operations and COVID-19 related expenses.


Beginning in the first quarter of 2022, the company includes acquired IPR&D and milestones expense in its reported non-GAAP financial measures. Reported GAAP earnings and adjusted non-GAAP earnings for the three months ended September 30, 2021 included acquired IPR&D and milestones expense of $402 million on a pre-tax and $396 million on an after-tax basis, as well as other operating expense related to the Calico collaboration of $500 million on a pre-tax and after-tax basis, representing an unfavorable impact of $0.50 to both diluted EPS and adjusted diluted EPS.


2.     The impact of the specified items by line item was as follows:



Quarter Ended September 30, 2021

(in millions)

Cost of
products
sold


SG&A


R&D


Other
expense
(income),
net

As reported (GAAP)

$        4,390


$              3,083


$              1,661


$                   21

Adjusted for specified items:








Intangible asset amortization

(1,904)




Acquisition and integration costs

(49)


(105)


(22)


Change in fair value of contingent consideration




(98)

Other

(24)


(17)


(7)


As adjusted   (non-GAAP)

$        2,413


$              2,961


$              1,632


$                  (77)


3.     The adjusted tax rate for the third quarter of 2021 was 14.5 percent, as detailed below:





Quarter Ended September 30, 2021

(dollars in millions)



Pre-tax
earnings


Income taxes


Tax rate

As reported (GAAP)



$              3,688


$                 508


13.8 %

Specified items



2,226


348


15.6 %

As adjusted   (non-GAAP)



$              5,914


$                 856


14.5 %

AbbVie Inc.

Reconciliation of GAAP Reported to Non-GAAP Adjusted Information

(Unaudited)


1.     Specified items impacted results as follows:







Nine Months Ended September 30, 2022

(in millions, except per share data)





Earnings


Diluted






Pre-tax


After-tax a


EPS

As reported (GAAP)





$           10,512


$              9,363


$                5.24

Adjusted for specified items:










Intangible asset amortization





5,728


4,794


2.69

Intangible asset impairment





770


604


0.34

Acquisition and integration costs





595


567


0.32

Change in fair value of contingent consideration





647


657


0.37

Pylera divestiture





(172)


(126)


(0.07)

Litigation matters





2,497


2,021


1.13

Other





281


295


0.16

As adjusted (non-GAAP)





$           20,858


$           18,175


$              10.18


a Represents net earnings attributable to AbbVie Inc.


Acquisition and integration costs include costs related to the Allergan acquisition. Litigation matters primarily include a charge related to a potential settlement of litigation involving Allergan's past sales of opioid products. Other primarily includes restructuring charges associated with streamlining global operations.


Beginning in the first quarter of 2022, the company includes acquired IPR&D and milestones expense in its reported non-GAAP financial measures. Reported GAAP earnings and adjusted non-GAAP earnings for the nine months ended September 30, 2022 included acquired IPR&D and milestones expense of $454 million on a pre-tax and $439 million on an after-tax basis, representing an unfavorable impact of $0.25 to both diluted EPS and adjusted diluted EPS.


2.     The impact of the specified items by line item was as follows:



Nine Months Ended September 30, 2022

(in millions)

Cost of
products
sold


SG&A


R&D


Other
operating
expense,
net


Other
expense
(income),
net

As reported (GAAP)

$        13,244


$      11,843


$            4,720


$                   57


$                427

Adjusted for specified items:










Intangible asset amortization

(5,728)





Intangible asset impairment

(770)





Acquisition and integration costs

(84)


(263)


(19)


(229)


Change in fair value of contingent consideration





(647)

Pylera divestiture




172


Litigation matters


(2,497)




Other

(160)


(107)


(7)



(7)

As adjusted   (non-GAAP)

$          6,502


$        8,976


$             4,694


$                    —


$                (227)


3.     The adjusted tax rate for the first nine months of 2022 was 12.8 percent, as detailed below:







Nine Months Ended September 30, 2022

(dollars in millions)





Pre-tax
earnings


Income taxes


Tax rate

As reported (GAAP)





$           10,512


$              1,139


10.8 %

Specified items





10,346


1,534


14.8 %

As adjusted   (non-GAAP)





$           20,858


$              2,673


12.8 %

AbbVie Inc.

Reconciliation of GAAP Reported to Non-GAAP Adjusted Information

(Unaudited)


1.     Specified items impacted results as follows:







Nine Months Ended September 30, 2021

(in millions, except per share data)





Earnings


Diluted






Pre-tax


After-tax a


EPS

As reported (GAAP)





$              8,718


$              7,498


$                4.19

Adjusted for specified items:










Intangible asset amortization





5,912


4,929


2.77

Acquisition and integration costs





535


427


0.23

Change in fair value of contingent consideration





2,447


2,445


1.38

Litigation matters





107


86


0.05

Other





319


255


0.13

As adjusted (non-GAAP)





$           18,038


$           15,640


$                8.75


a Represents net earnings attributable to AbbVie Inc.


Acquisition and integration costs reflect integration costs as well as amortization of the acquisition date fair value step-up for inventory related to the Allergan acquisition. Other primarily includes the purchase of FDA priority review vouchers from third parties, restructuring charges associated with streamlining global operations and COVID-19 related expenses.


Beginning in the first quarter of 2022, the company includes acquired IPR&D and milestones expense in its reported non-GAAP financial measures. Reported GAAP earnings and adjusted non-GAAP earnings for the nine months ended September 30, 2021 included acquired IPR&D and milestones expense of $719 million on a pre-tax and $696 million on an after-tax basis, as well as other operating expense related to the Calico collaboration of $500 million on a pre-tax and after-tax basis, representing an unfavorable impact of $0.67 to both diluted EPS and adjusted diluted EPS.


2.     The impact of the specified items by line item was as follows:



Nine Months Ended September 30, 2021

(in millions)

Cost of
products
sold


SG&A


R&D


Other
operating
expense,
net


Other
expense
(income),
net

As reported (GAAP)

$       13,126


$         9,089


$            5,095


$                 432


$            2,284

Adjusted for specified items:










Intangible asset amortization

(5,912)





Acquisition and integration costs

(172)


(275)


(88)



Change in fair value of contingent consideration





(2,447)

Litigation matters


(107)




Other

(65)


(50)


(287)


68


15

As adjusted   (non-GAAP)

$         6,977


$         8,657


$             4,720


$                 500


$              (148)


3.     The adjusted tax rate for the first nine months of 2021 was 13.3 percent, as detailed below:







Nine Months Ended September 30, 2021

(dollars in millions)





Pre-tax
earnings


Income taxes


Tax rate

As reported (GAAP)





$              8,718


$              1,214


13.9 %

Specified items





9,320


1,178


12.6 %

As adjusted   (non-GAAP)





$            18,038


$              2,392


13.3 %

Cision View original content: https://www.prnewswire.com/news-releases/abbvie-reports-third-quarter-2022-financial-results-301661927.html

SOURCE AbbVie

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Health Canada Approves AbbVie's RINVOQ®  for the Treatment of Adults with Active Non-Radiographic Axial Spondyloarthritis

Health Canada Approves AbbVie's RINVOQ® for the Treatment of Adults with Active Non-Radiographic Axial Spondyloarthritis

- Approval is based on results from the Phase 3 SELECT-AXIS 2 pivotal clinical trial in which RINVOQ delivered rapid and meaningful disease control, meeting the primary endpoint of ASAS40 response at week 14 versus placebo 1
- RINVOQ is the first and only Janus Kinase (JAK) inhibitor approved to treat patients across the spectrum of axial spondyloarthritis (nr-axSpA and ankylosing spondylitis) in Canada 1, 2, 3

AbbVie (NYSE: ABBV), today announced that Health Canada has approved RINVOQ ® (upadacitinib, 15 mg), the first oral, once-daily selective and reversible JAK inhibitor for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation who have had an inadequate response to a biologic disease modifying anti-rheumatic drug (DMARD) or when use of those therapies is inadvisable.

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AbbVie Releases New Data Demonstrating Breadth of Its Gastroenterology Portfolio at 2023 Digestive Disease Week®

AbbVie Releases New Data Demonstrating Breadth of Its Gastroenterology Portfolio at 2023 Digestive Disease Week®

- Oral presentations highlight efficacy and safety outcomes from the upadacitinib (RINVOQ ® ) clinical trial program in adults with moderately to severely active Crohn's disease, and investigational use of linaclotide (LINZESS ® ) in treating functional constipation in pediatric patients aged 6 to 17 years

- Twenty-nine abstracts showcase AbbVie's   vast portfolio and continued commitment to changing the way patients living with gastrointestinal disorders manage their condition

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Sirona Biochem Announces Exclusive Global Licensing Agreement with Allergan Aesthetics

Sirona Biochem Announces Exclusive Global Licensing Agreement with Allergan Aesthetics

Sirona Biochem Corp . (TSX-V: SBM) (FSE: ZSB) (OTC: SRBCF) (" Sirona ") is pleased to announce it has entered into a global exclusive licensing agreement with Allergan Aesthetics, an AbbVie company (NYSE: ABBV), pursuant to which Allergan Aesthetics will develop and commercialize topical skin care treatments based on active ingredients derived from certain of Sirona's patents for TFC-1067 and related family of compounds.

"We are very pleased to have finalized terms with a global leader in medical aesthetics and the innovator behind SkinMedica™, a leader in the science of skin rejuvenation," said Dr. Howard Verrico, CEO of Sirona Biochem. "Our most recent clinical trial of TFC-1067 was a collaborative effort with Allergan Aesthetics to demonstrate the clinical potential in topical skin care treatments. This further validates our platform technology as viable for additional commercial products which we are actively pursuing. We would like to thank Dr. Linda Pullan of Pullan Consulting who assisted with our current success."

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Biogen and AbbVie Receive Positive Opinion from the CHMP on ZINBRYTA™ (Daclizumab) for Treatment of Multiple Sclerosis

CAMBRIDGE, Mass. & NORTH CHICAGO, Ill.–(BUSINESS WIRE)–The Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) has adopted a positive opinion
recommending the granting of a marketing authorization for ZINBRYTA™
(daclizumab) intended for the treatment of relapsing forms of multiple
sclerosis (RMS), Biogen
(NASDAQ: BIIB) and AbbVie (NYSE:
ABBV) announced today. ZINBRYTA is a once-monthly, self-administered,
subcutaneous investigational treatment for RMS. ZINBRYTA is also
currently under regulatory review in the United States, Switzerland,
Canada and Australia.
For people with relapsing forms of MS (RMS) and active disease,
ZINBRYTA has the potential to offer robust efficacy, a manageable safety
profile through patient monitoring, and once-monthly subcutaneous
dosing,” said Alfred Sandrock, M.D., Ph.D., executive vice president and
chief medical officer at Biogen. “ZINBRYTA may offer another option for
people with multiple sclerosis (MS) with its targeted mechanism of
action (MOA) which did not cause broad and prolonged immune cell
depletion.”
The CHMP positive opinion is now referred to the European Commission
(EC), which grants marketing authorizations for centrally authorized
medicines in the European Union. A decision from the EC is expected
within the coming months.
Together with Biogen, AbbVie is committed to meeting the needs of
patients with MS, and the positive opinion issued by the CHMP is a
critical step that moves us closer to bringing ZINBRYTA to patients in
Europe,” said Michael Severino, M.D., executive vice president, research
and development and chief scientific officer, AbbVie.
According to the CHMP opinion, the benefits of ZINBRYTA are its ability
to reduce the annualized relapse rate (ARR), as well as the risk of
24-week confirmed disability progression. The opinion is based on
results from two clinical trials, DECIDE and SELECT, in which ZINBRYTA
150 mg, administered subcutaneously every four weeks improved results on
key measures of MS disease activity in patients with RMS compared to
AVONEX 30 mcg intramuscular injection administered weekly and placebo,
respectively.
In the DECIDE study, the overall incidence of adverse events was similar
in the ZINBRYTA and AVONEX groups. In patients treated with ZINBRYTA
compared to AVONEX, there was an increased incidence of serious
infections (4% versus 2%), serious cutaneous reactions (2% versus <1%),
elevations of liver transaminases greater than five times the upper
limit of normal (6% versus 3%), gastrointestinal disorders (31% versus
24%), and depression (8% versus 6%).
About ZINBRYTA™ (daclizumab)
ZINBRYTA (daclizumab) is an investigational compound being developed for
the treatment of relapsing forms of MS. ZINBRYTA is a new form of a
humanized monoclonal antibody that selectively binds to the
high-affinity interleukin-2 (IL-2) receptor subunit (CD25) that is
expressed at high levels on T-cells that become activated in people with
MS. ZINBRYTA modulates IL-2 signaling without general immune cell
depletion.
Biogen and AbbVie are jointly developing ZINBRYTA.
About Biogen
Through cutting-edge science and medicine, Biogen discovers, develops
and delivers worldwide innovative therapies for people living with
serious neurological, autoimmune and rare diseases. Founded in 1978,
Biogen is one of the world’s oldest independent biotechnology companies
and patients worldwide benefit from its leading multiple sclerosis and
innovative hemophilia therapies. For more information, please visit www.biogen.com.
Follow us on Twitter.
Biogen Safe Harbor
This press release contains forward-looking statements, including
statements about the anticipated timing of the EC’s decision on the
marketing authorization for ZINBRYTA, and potential impact of ZINBRYTA,
if approved. These statements may be identified by words such as
“believe,” “expect,” “may,” “potential,” “will” and similar expressions,
and are based on our current beliefs and expectations. You should not
place undue reliance on these statements. Drug development and
commercialization involve a high degree of risk. Factors which could
cause actual results to differ materially from our current expectations
include the risk that the EC may fail to approve or may delay approval
of ZINBRYTA or may not follow the recommendation of the CHMP,
uncertainty of success in commercialization of ZINBRYTA For more
detailed information on the risks and uncertainties associated with our
drug development and commercialization activities and risks relating to
our collaborations with third parties, please review the Risk Factors
section of our most recent annual or quarterly report filed with the
Securities and Exchange Commission. Any forward-looking statements speak
only as of the date of this press release and we assume no obligation to
update any forward-looking statements, whether as a result of new
information, future events or otherwise.
About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in
2013 following separation from Abbott Laboratories. The company’s
mission is to use its expertise, dedicated people and unique approach to
innovation to develop and market advanced therapies that address some of
the world’s most complex and serious diseases. Together with its
wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000
people worldwide and markets medicines in more than 170 countries. For
further information on the company and its people, portfolio and
commitments, please visit www.abbvie.com.
Follow @abbvie on
Twitter or view careers on our Facebook or LinkedIn
page.
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.
The words “believe,” “expect,” “anticipate,” “project” and similar
expressions, among others, generally identify forward-looking
statements. AbbVie 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. Such risks and uncertainties include, but are not limited
to, challenges to intellectual property, competition from other
products, difficulties inherent in the research and development process,
adverse litigation or government action, and changes to laws and
regulations applicable to our industry.
Additional information about the economic, competitive, governmental,
technological and other factors that may affect AbbVie’s operations is
set forth in Item 1A, “Risk Factors,” in AbbVie’s 2014 Annual Report on
Form 10-K, which has been filed with the Securities and Exchange
Commission. AbbVie 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.

Enbrel Biosimilar Marks Victory for Merck and Samsung

The biosimilar alliance between Merck (NYSE:MRK) and Samsung Bioepis appears to have paid off, as the companies have won South Korean approval for their copy of Amgen’s (NASDAQ:AMGN) blockbuster drug Enbrel.
According to Fierce Biotech:

Korea’s Ministry of Food and Drug Safety signed off on the injection, to be marketed as Brenzys, to treat rheumatoid arthritis, psoriatic arthritis, spondyloarthritis and psoriasis in adults. The biosimilar, developed as SB4, proved itself equivalent to Amgen’s cash cow in a 596-patient study disclosed this year, reducing symptoms of rheumatoid arthritis on pace with its reference product, according to Merck and Samsung.
Brenzys’ approval marks the first marketing victory for the two companies, a milestone Merck hopes will be a harbinger of future success in biosimilars.
The approval could also have major implications for Samsung Bioepis, long rumored to be considering a U.S. IPO. Details of the company’s Wall Street plans have been tricking out for months, and The Wall Street Journal reported in August that Samsung is planning a $1 billion debut offering for its biologics division, valuing the company at about $7 billion.
Samsung Bioepis, a joint venture with Biogen ($BIIB) that is 85% owned by the South Korean company, joined forces with Merck in 2013 in a wide-ranging deal designed to crack the growing market for off-patent biological treatments. Beyond Enbrel, the pair are working on copies of the similar Humira from AbbVie ($ABBV) and Remicade from Johnson & Johnson ($JNJ). The companies are also developing biosimilars of Sanofi’s ($SNY) blockbuster insulin Lantus and Roche’s ($RHHBY) cancer treatment Herceptin.

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AMGEN ANNOUNCES 2025 FIRST QUARTER DIVIDEND

Amgen (NASDAQ:AMGN) today announced that its Board of Directors declared a $2.38 per share dividend for the first quarter of 2025. The dividend will be paid on March 7, 2025 to all stockholders of record as of the close of business on February 14, 2025 .

About Amgen
Amgen discovers, develops, manufactures and delivers innovative medicines to help millions of patients in their fight against some of the world's toughest diseases. More than 40 years ago, Amgen helped to establish the biotechnology industry and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today. Amgen is advancing a broad and deep pipeline that builds on its existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases.

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CLEO Further Expands Ovarian Cancer Trial with Siles Health

CLEO Further Expands Ovarian Cancer Trial with Siles Health

Cleo Diagnostics (COV:AU) has announced CLEO Further Expands Ovarian Cancer Trial with Siles Health

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BLINCYTO® ADDED TO CHEMOTHERAPY SIGNIFICANTLY IMPROVES SURVIVAL IN NEWLY DIAGNOSED PEDIATRIC PATIENTS WITH B-CELL PRECURSOR ACUTE LYMPHOBLASTIC LEUKEMIA

Phase 3 Study Results Demonstrated Three Year, Disease-Free Survival of 96%

Amgen (NASDAQ:AMGN) today announced new data demonstrating that adding BLINCYTO ® (blinatumomab) to chemotherapy significantly improves disease-free survival (DFS) in newly diagnosed pediatric patients with National Cancer Institute (NCI) standard risk (SR) B-cell acute lymphoblastic leukemia (B-ALL) of average or higher risk of relapse. The data are from a Phase 3 study (AALL1731) conducted by the Children's Oncology Group. The results were simultaneously published in the New England Journal of Medicine and will be presented during the plenary session on Sunday, Dec. 8 at 2 p.m. PT at the 66 th American Society of Hematology (ASH) Annual Meeting & Exposition in San Diego .

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AMGEN ANNOUNCES $1 BILLION MANUFACTURING EXPANSION IN NORTH CAROLINA

Investment Establishes Second Facility in Holly Springs ; Builds on Previous $550M Commitment

Amgen (NASDAQ: AMGN) today announced a $1 billion expansion to establish a second drug substance manufacturing facility in North Carolina . This brings the company's total planned investment in Holly Springs to more than $1.5 billion building on its previously announced $550 million commitment.

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