AbbVie Reports Full-Year and Fourth-Quarter 2022 Financial Results

  • Reports Full-Year Diluted EPS of $6.63 on a GAAP Basis, an Increase of 2.8 Percent; Adjusted Diluted EPS of $13.77 , an Increase of 16.4 Percent; These Results Include an Unfavorable Impact of $0.39 Per Share related to 2022 Acquired IPR&D and Milestones Expense 1
  • Delivers Full-Year Net Revenues of $58.054 Billion , an Increase of 3.3 Percent on a Reported Basis and 5.1 Percent on an Operational Basis
  • Full-Year Global Net Revenues from the Immunology Portfolio Were $28.924 Billion , an Increase of 14.4 Percent on a Reported Basis, or 16.0 Percent on an Operational Basis; Global Humira Net Revenues Were $21.237 billion ; Global Skyrizi Net Revenues Were $5.165 Billion ; Global Rinvoq Net Revenues Were $2.522 Billion
  • Full-Year Global Net Revenues from the Hematologic Oncology Portfolio Were $6.577 Billion , a Decrease of 9.0 Percent on a Reported Basis, or 7.6 Percent on an Operational Basis; Global Imbruvica Net Revenues Were $4.568 Billion ; Global Venclexta Net Revenues Were $2.009 Billion
  • Full-Year Global Net Revenues from the Neuroscience Portfolio Were $6.528 Billion , an Increase of 10.1 Percent on a Reported Basis, or 11.6 Percent on an Operational Basis; Global Botox Therapeutic Net Revenues Were $2.719 Billion ; Global Vraylar Net Revenues Were   $2.038 Billion
  • Full-Year Global Net Revenues from the Aesthetics Portfolio Were $5.333 Billion , an Increase of 1.9 Percent on a Reported Basis, or 5.1 Percent on an Operational Basis; Global Botox Cosmetic Net Revenues Were $2.615 Billion ; Global Juvederm Net Revenues Were $1.428 Billion
  • Reports Fourth-Quarter Diluted EPS of $1.38 on a GAAP Basis, a decrease of 38.9 Percent; Adjusted Diluted EPS of $3.60 , an increase of 16.9 Percent; These Results Include an Unfavorable Impact of $0.13 Per Share Related to Fourth-Quarter 2022 Acquired IPR&D and Milestones Expense
  • Delivers Fourth-Quarter Net Revenues of $15.121 Billion , an Increase of 1.6 Percent on a Reported Basis and 3.8 Percent on an Operational Basis
  • Provides 2023 Adjusted Diluted EPS Guidance Range of $10.70 to $11.10 , which Excludes Any Unfavorable Impact Related to Acquired IPR&D and Milestones Expense

ABBVie (NYSE:ABBV) announced financial results for the fourth quarter and full year ended December 31, 2022 .

"2022 was another highly productive year capping a decade of outstanding performance. Since our inception, we have built a diverse portfolio of growth products with significant leadership positions, developed a robust pipeline of innovative assets and created a culture of strong execution," said Richard A. Gonzalez , chairman and chief executive officer, AbbVie. "Looking forward, we have a solid foundation which will allow us to absorb the U.S. Humira loss of exclusivity, return to strong top-line growth in 2025 and drive top-tier financial performance over the long term."

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.

Fourth   -Quarter Results

  • Worldwide net revenues were $15.121 billion , an increase of 1.6 percent on a reported basis, or 3.8 percent on an operational basis.
  • Global net revenues from the immunology portfolio were $7.925 billion , an increase of 17.5 percent on a reported basis, or 19.5 percent on an operational basis.
    • Global Humira net revenues of $5.579 billion increased 4.6 percent on a reported, or 6.0 percent on an operational basis. U.S. Humira net revenues were $5.006 billion , an increase of 9.9 percent. Internationally, Humira net revenues were $573 million , a decrease of 26.5 percent on a reported basis, or 16.9 percent on an operational basis.
    • Global Skyrizi net revenues were $1.576 billion , an increase of 76.1 percent on a reported basis, or 78.9 percent on an operational basis.
    • Global Rinvoq net revenues were $770 million , an increase of 49.0 percent on a reported basis, or 55.4 percent on an operational basis.
  • Global net revenues from the hematologic oncology portfolio were $1.631 billion , a decrease of 12.9 percent on a reported basis, or 11.2 percent on an operational basis.
    • Global Imbruvica net revenues were $1.115 billion , a decrease of 19.5 percent, with U.S. net revenues of $841 million and international profit sharing of $274 million .
    • Global Venclexta net revenues were $516 million , an increase of 5.7 percent on a reported basis, or 12.2 percent on an operational basis.
  • Global net revenues from the neuroscience portfolio were $1.710 billion , an increase of 3.4 percent on a reported basis, or 5.1 percent on an operational basis.
    • Global Botox Therapeutic net revenues were $728 million , an increase of 8.5 percent on a reported basis, or 10.7 percent on an operational basis.
    • Global Vraylar net revenues were $565 million , an increase of 15.5 percent.
    • Global Ubrelvy net revenues were $197 million , an increase of 7.7 percent.
  • Global net revenues from the aesthetics portfolio were $1.287 billion , a decrease of 8.5 percent on a reported basis, or 4.2 percent on an operational basis.
    • Global Botox Cosmetic net revenues were $642 million , an increase of 2.6 percent on a reported basis, or 7.1 percent on an operational basis.
    • Global Juvederm net revenues were $322 million , a decrease of 25.4 percent on a reported basis, or 19.0 percent on an operational basis.
  • On a GAAP basis, the gross margin ratio in the fourth quarter was 72.4 percent. The adjusted gross margin ratio was 86.0 percent.
  • On a GAAP basis, selling, general and administrative (SG&A) expense was 22.6 percent of net revenues. The adjusted SG&A expense was 20.8 percent of net revenues.
  • On a GAAP basis, research and development (R&D) expense was 11.8 percent of net revenues. The adjusted R&D expense was 11.5 percent of net revenues, reflecting funding actions supporting all stages of our pipeline.
  • Acquired IPR&D and milestones expense was 1.6 percent of net revenues.
  • On a GAAP basis, the operating margin in the fourth quarter was 36.4 percent. The adjusted operating margin was 52.1 percent.
  • Net interest expense was $476 million .
  • On a GAAP basis, the tax rate in the quarter was 16.6 percent. The adjusted tax rate was 13.4 percent.
  • Diluted EPS in the fourth quarter was $1.38 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $3.60 . These results include an unfavorable impact of $0.13 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 European Commission (EC) approved Skyrizi (risankizumab, 600 mg intravenous induction and 360 mg subcutaneous maintenance therapy) as the first specific interleukin-23 (IL-23) inhibitor 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 approval is supported by results from three Phase 3 studies in which Skyrizi demonstrated significant improvement in clinical remission and endoscopic response, compared to placebo, as both induction and maintenance therapy. This approval marks the third indication for Skyrizi in the European Union (EU). Skyrizi is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.
  • At the American College of Rheumatology's (ACR) annual meeting, AbbVie shared 36 abstracts that underscore AbbVie's commitment to advancing research to help more people living with rheumatic diseases. Analyses presented showcased data from the clinical trial programs evaluating Rinvoq (upadacitinib) for the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (AS) as well as data evaluating Skyrizi for the treatment of psoriasis (PsO) and PsA.
  • AbbVie announced that the U.S. Food and Drug Administration (FDA) accepted, for priority review, the Biologics License Application (BLA) for epcoritamab, an investigational subcutaneous bispecific antibody for the treatment of adult patients with relapsed/refractory (r/r) large B-cell lymphoma (LBCL). Additionally, AbbVie announced the European Medicines Agency (EMA) validated AbbVie's Marketing Authorization Application (MAA) for epcoritamab for the treatment of adult patients with r/r diffuse LBCL. Both applications are supported by data from the EPCORE NHL-1 Phase 2 trial evaluating the safety and preliminary efficacy of subcutaneous epcoritamab in adult patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin's lymphoma (NHL). Epcoritamab is being co-developed by Genmab and AbbVie.
  • At the American Society of Hematology (ASH) Annual Meeting, AbbVie presented results from nearly 65 abstracts, including 15 oral presentations, across eight types of cancer. Highlights included four oral presentations evaluating investigational epcoritamab for the treatment of r/r follicular lymphoma (FL), previously untreated FL, r/r diffuse LBCL as well as Richter's syndrome; data from cohort three of the Phase 2 REFINE study evaluating navitoclax in combination with ruxolitinib in JAK inhibitor-naïve patients with myelofibrosis (MF); data from the Phase 2 CAPTIVATE and Phase 3 GLOW studies evaluating fixed-duration treatment in patients with chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL) who received the Imbruvica (ibrutinib) + Venclexta (venetoclax) combination regimen. AbbVie also presented multiple abstracts evaluating Venclexta in approved CLL and acute myeloid leukemia (AML) indications and the investigational multiple myeloma (MM) indication. Imbruvica is jointly developed and commercialized with Janssen Biotech, Inc. Venetoclax is being developed by AbbVie and Roche and is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.
  • AbbVie announced that the FDA approved Vraylar (cariprazine) as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults. The approval marks the fourth indication for Vraylar, which is now the first and only dopamine and serotonin partial agonist FDA-approved for the most common forms of depression – as an adjunctive treatment for MDD and the treatment of depressive episodes associated with bipolar I disorder. The approval is supported by clinical data demonstrating the efficacy and well-established tolerability of Vraylar as an adjunctive treatment for MDD with an antidepressant therapy. Vraylar is being co-developed by AbbVie and Gedeon Richter Plc.
  • At the European Headache Federation Congress (EHC) 2022, AbbVie shared 15 abstracts which underscore its commitment to people living with migraine. Presentations highlighted late-breaking data from the Chronic Migraine Epidemiology and Outcomes - International (CaMEO-I) study, evaluating the frequency and burden of neck pain with headache among people with and without migraine, as well as results from the Phase 3 PROGRESS trial evaluating Qulipta (atogepant) for the preventive treatment of chronic migraine (CM) in patients living in Europe .
  • AbbVie announced new results from its exploratory NOVA phase 2 dose-ranging study evaluating the efficacy and safety of AGN-151607, a novel investigational neurotoxin for the prevention of postoperative atrial fibrillation (POAF) in cardiac surgery patients, at the American Heart Association Scientific Sessions meeting. The study's primary endpoint was not met for the modified intent-to-treat (mITT) population; however, the data showed relative risk reduction in specific study populations such as coronary artery bypass graft (CABG) patients and patients aged 65 years and older, as well as overall lower rates of rehospitalization within 30 days compared to placebo. Adverse Events (AEs) were numerically similar across all treatment groups.
  • AbbVie and HotSpot Therapeutics, Inc., a biotechnology company pioneering the discovery and development of small molecule allosteric therapies for the treatment of cancer and autoimmune diseases, announced an exclusive worldwide collaboration and option to license agreement for HotSpot's discovery-stage interferon regulatory factor 5 (IRF5) inhibitor program for the potential treatment of autoimmune diseases.
  • AbbVie and Immunome, a clinical-stage biopharmaceutical company that utilizes its human memory B cell platform to discover and develop first-in-class antibody therapeutics, announced a worldwide collaboration and option agreement directed to the discovery of up to 10 novel antibody-target pairs arising from three specified tumor types using Immunome's Discovery Engine.
  • AbbVie and Anima Biotech, announced a collaboration to discover and develop mRNA biology modulators for three targets across Immunology and Oncology. Anima will use its mRNA Lightning platform to discover novel mRNA biology modulators against the collaboration targets providing AbbVie exclusive rights to license and further develop and commercialize the programs.

Full-Year 2023 Outlook

AbbVie is issuing its adjusted diluted EPS guidance for the full-year 2023 of $10.70 to $11.10 . The company's 2023 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred during 2023, as both cannot be reliably forecasted.

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 fourth-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 and uses of future or conditional verbs, 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 expressed or implied 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," 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, and specifically declines, 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 December 31, 2022

(Unaudited)









% Change vs. 4Q21


Net Revenues (in millions)


Reported


Operational a


U.S.


Int'l.


Total


U.S.


Int'l.


Total


Int'l.


Total

NET REVENUES

$  12,192


$  2,929


$  15,121


4.4 %


(8.7) %


1.6 %


1.8 %


3.8 %

















Immunology

6,975


950


7,925


22.5


(9.5)


17.5


3.2


19.5

Humira

5,006


573


5,579


9.9


(26.5)


4.6


(16.9)


6.0

Skyrizi

1,403


173


1,576


84.3


29.1


76.1


47.9


78.9

Rinvoq

566


204


770


48.6


50.1


49.0


74.5


55.4

















Hematologic Oncology

1,110


521


1,631


(18.7)


2.6


(12.9)


8.8


(11.2)

Imbruvica b

841


274


1,115


(24.6)


1.6


(19.5)


1.6


(19.5)

Venclexta

269


247


516


7.7


3.7


5.7


17.0


12.2

















Aesthetics

835


452


1,287


(4.7)


(14.8)


(8.5)


(3.4)


(4.2)

Botox Cosmetic

422


220


642


6.4


(4.0)


2.6


8.3


7.1

Juvederm Collection

128


194


322


(28.3)


(23.3)


(25.4)


(12.4)


(19.0)

Other Aesthetics

285


38


323


(5.3)


(21.4)


(7.6)


(11.7)


(6.2)

















Neuroscience

1,506


204


1,710


4.7


(5.7)


3.4


7.2


5.1

Botox Therapeutic

614


114


728


9.6


2.8


8.5


16.2


10.7

Vraylar

564


1


565


15.4


n/m


15.5


n/m


15.5

Duodopa

23


84


107


(18.3)


(15.8)


(16.3)


(3.2)


(6.5)

Ubrelvy

197



197


7.5


n/m


7.7


n/m


7.7

Qulipta

52



52


>100.0


n/m


>100.0


n/m


>100.0

Other Neuroscience

56


5


61


(66.2)


(8.8)


(64.5)


(1.1)


(64.3)

















Eye Care

338


252


590


(49.7)


(12.4)


(38.5)


(1.3)


(35.2)

Lumigan/Ganfort

56


67


123


(22.1)


(13.0)


(17.4)


(3.3)


(12.4)

Alphagan/Combigan

41


33


74


(59.4)


(16.2)


(47.4)


(4.5)


(44.1)

Restasis

103


7


110


(70.5)


(49.0)


(69.6)


(45.0)


(69.4)

Other Eye Care

138


145


283


(7.7)


(7.8)


(7.7)


4.5


(1.4)

















Other Key Products

791


195


986


(1.5)


(18.4)


(5.4)


(6.2)


(2.6)

Mavyret

193


187


380


(1.8)


(18.8)


(11.0)


(6.5)


(4.4)

Creon

337



337


3.0


n/m


3.0


n/m


3.0

Linzess/Constella

261


8


269


(6.5)


(7.5)


(6.6)


2.2


(6.3)



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/m = not meaningful

AbbVie Inc.

Key Product Revenues

Twelve Months Ended December 31, 2022

(Unaudited)









% Change vs. 12M21


Net Revenues (in millions)


Reported

Operational a


U.S.


Int'l.


Total


U.S.


Int'l.


Total


Int'l.


Total

NET REVENUES

$  45,713


$  12,341


$  58,054


5.1 %


(2.7) %


3.3 %


5.5 %


5.1 %

















Immunology

24,897


4,027


28,924


18.1


(4.0)


14.4


5.7


16.0

Humira

18,619


2,618


21,237


7.4


(22.2)


2.6


(14.9)


3.8

Skyrizi

4,484


681


5,165


80.4


50.4


75.7


67.1


78.3

Rinvoq

1,794


728


2,522


41.2


91.4


52.8


>100.0


58.1

















Hematologic Oncology

4,435


2,142


6,577


(15.6)


8.6


(9.0)


13.9


(7.6)

Imbruvica b

3,426


1,142


4,568


(20.7)


5.1


(15.5)


5.1


(15.5)

Venclexta

1,009


1,000


2,009


8.0


12.9


10.4


24.6


16.1

















Aesthetics

3,324


2,009


5,333


(0.8)


6.7


1.9


15.6


5.1

Botox Cosmetic

1,654


961


2,615


16.2


18.9


17.2


28.8


20.8

Juvederm Collection

548


880


1,428


(16.7)


0.3


(7.0)


8.9


(2.1)

Other Aesthetics

1,122


168


1,290


(11.5)


(14.9)


(12.0)


(8.3)


(11.1)

















Neuroscience

5,681


847


6,528


12.3


(2.3)


10.1


7.7


11.6

Botox Therapeutic

2,255


464


2,719


12.1


5.6


10.9


15.3


12.6

Vraylar

2,037


1


2,038


17.9


n/m


17.9


n/m


17.9

Duodopa

95


363


458


(6.7)


(11.3)


(10.4)


(0.8)


(2.0)

Ubrelvy

680



680


23.2


n/m


23.3


n/m


23.3

Qulipta

158



158


>100.0


n/m


>100.0


n/m


>100.0

Other Neuroscience

456


19


475


(30.5)


4.8


(29.6)


9.0


(29.5)

















Eye Care

1,603


1,098


2,701


(33.3)


(5.7)


(24.3)


3.7


(21.2)

Lumigan/Ganfort

242


272


514


(11.0)


(11.3)


(11.2)


(3.0)


(6.8)

Alphagan/Combigan

202


144


346


(45.8)


(7.9)


(34.6)


2.5


(31.5)

Restasis

621


45


666


(49.6)


(20.2)


(48.3)


(13.8)


(48.0)

Other Eye Care

538


637


1,175


2.3


(1.2)


0.4


8.7


5.9

















Other Key Products

3,036


818


3,854


2.9


(17.2)


(2.2)


(7.9)


0.1

Mavyret

755


786


1,541


0.2


(17.8)


(9.9)


(8.5)


(4.7)

Creon

1,278



1,278


7.3


n/m


7.3


n/m


7.3

Linzess/Constella

1,003


32


1,035


(0.4)


0.3


(0.3)


7.6


(0.1)



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/m = not meaningful

AbbVie Inc.

Consolidated Statements of Earnings

(Unaudited)


(in millions, except per share data)

Fourth Quarter

Ended December 31


Twelve Months

Ended December 31


2022


2021


2022


2021

Net revenues

$       15,121


$       14,886


$       58,054


$       56,197

Cost of products sold

4,170


4,320


17,414


17,446

Selling, general and administrative

3,417


3,260


15,260


12,349

Research and development a

1,790


1,827


6,510


6,922

Acquired IPR&D and milestones a

243


405


697


1,124

Other operating (income) expense, net

(1)



56


432

Total operating costs and expenses

9,619


9,812


39,937


38,273









Operating earnings

5,502


5,074


18,117


17,924









Interest expense, net

476


571


2,044


2,384

Net foreign exchange loss

40


16


148


51

Other expense, net

2,021


216


2,448


2,500

Earnings before income tax expense

2,965


4,271


13,477


12,989

Income tax expense

493


226


1,632


1,440

Net earnings

2,472


4,045


11,845


11,549

Net earnings (loss) attributable to noncontrolling interest

(1)


1


9


7

Net earnings attributable to AbbVie Inc.

$          2,473


$          4,044


$        11,836


$        11,542









Diluted earnings per share attributable to AbbVie Inc.

$            1.38


$            2.26


$            6.63


$            6.45









Adjusted diluted earnings per share b

$            3.60


$            3.08


$          13.77


$          11.83









Weighted-average diluted shares outstanding

1,778


1,778


1,778


1,777



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 $162 million for the twelve months ended
December 31, 2021 and had no impact on the three months ended December 31, 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. Weighted-average
diluted shares outstanding includes the effect of dilutive securities.

AbbVie Inc.

Reconciliation of GAAP Reported to Non-GAAP Adjusted Information

(Unaudited)


1.     Specified items impacted results as follows:








Quarter Ended December 31, 2022

(in millions, except per share data)






Earnings


Diluted







Pre-tax


After-tax a


EPS

As reported (GAAP)






$              2,965


$              2,473


$                1.38

Adjusted for specified items:











Intangible asset amortization






1,961


1,636


0.92

Acquisition and integration costs






215


199


0.11

Change in fair value of contingent consideration






2,114


2,113


1.19

Income tax items







(143)


(0.08)

Other






157


144


0.08

As adjusted (non-GAAP)






$              7,412


$              6,422


$                3.60


a Represents net earnings attributable to AbbVie Inc.


Acquisition and integration costs primarily include costs related to the Allergan acquisition. Income tax items include a benefit of $323 million related to
tax law changes partially offset by certain other tax related items. 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 December 31, 2022 included acquired IPR&D and milestones
expense of $243 million on a pre-tax and after-tax basis, representing an unfavorable impact of $0.13 to both diluted EPS and adjusted diluted EPS.


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




Quarter Ended December 31, 2022

(in millions)


Cost of
products
sold


SG&A


R&D


Other
operating
income,
net


Other
expense,
net

As reported (GAAP)


$      4,170


$      3,417


$            1,790


$                   (1)


$           2,021

Adjusted for specified items:











Intangible asset amortization


(1,961)





Acquisition and integration costs


1


(205)


(11)



Change in fair value of contingent consideration






(2,114)

Other


(99)


(62)


(38)


1


41

As adjusted (non-GAAP)


$      2,111


$      3,150


$             1,741


$                  —


$              (52)



3.     The adjusted tax rate for the fourth quarter of 2022 was 13.4 percent, as detailed below:








Quarter Ended December 31, 2022

(dollars in millions)






Pre-tax
earnings


Income taxes


Tax rate

As reported (GAAP)






$             2,965


$                493


16.6 %

Specified items






4,447


498


11.2 %

As adjusted (non-GAAP)






$             7,412


$                991


13.4 %

AbbVie Inc.

Reconciliation of GAAP Reported to Non-GAAP Adjusted Information

(Unaudited)


1.     Specified items impacted results as follows:








Quarter Ended December 31, 2021

(in millions, except per share data)






Earnings


Diluted







Pre-tax


After-tax a


EPS

As reported (GAAP)






$              4,271


$              4,044


$                2.26

Adjusted for specified items:











Intangible asset amortization






1,806


1,490


0.84

Acquisition and integration costs






(191)


(212)


(0.12)

Change in fair value of contingent consideration






232


232


0.13

Litigation matters






200


167


0.09

Impacts related to tax law changes







(265)


(0.15)

Other






41


58


0.03

As adjusted (non-GAAP)






$              6,359


$              5,514


$                3.08


a Represents net earnings attributable to AbbVie Inc.


Acquisition and integration costs reflect a recovery of certain Allergan acquisition-related regulatory fees partially offset by Allergan-related integration
costs and Soliton acquisition costs. Other primarily includes COVID-19 related expenses and certain tax related items.


Beginning in the first quarter of 2022, the company includes acquired IPR&D and milestones expense in its reportednon-GAAP financial measures.
Reported GAAP earnings and adjusted non-GAAP earnings for the three months ended December 31, 2021 included acquired IPR&D and milestones
expense of $405 million on a pre-tax and after-tax basis, representing an unfavorable impact of $0.23 to both diluted EPS and adjusted diluted EPS.


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






Quarter Ended December 31, 2021

(in millions)




Cost of
products
sold


SG&A


R&D


Other
expense,
net

As reported (GAAP)




$    4,320


$             3,260


$             1,827


$              216

Adjusted for specified items:











Intangible asset amortization




(1,806)




Acquisition and integration costs




(43)


250


(16)


Change in fair value of contingent consideration







(232)

Litigation matters





(200)



Other




(23)


(3)


(13)


(2)

As adjusted   (non-GAAP)




$    2,448


$             3,307


$             1,798


$               (18)



3.     The adjusted tax rate for the fourth quarter of 2021 was 13.3 percent, as detailed below:








Quarter Ended December 31, 2021

(dollars in millions)






Pre-tax
earnings


Income taxes


Tax rate

As reported (GAAP)






$             4,271


$                226


5.3 %

Specified items






2,088


618


29.6 %

As adjusted   (non-GAAP)






$             6,359


$                844


13.3 %

AbbVie Inc.

Reconciliation of GAAP Reported to Non-GAAP Adjusted Information

(Unaudited)


1.     Specified items impacted results as follows:







Twelve Months Ended December 31, 2022

(in millions, except per share data)





Earnings


Diluted






Pre-tax


After-tax a


EPS

As reported (GAAP)





$           13,477


$          11,836


$                6.63

Adjusted for specified items:










Intangible asset amortization





7,689


6,430


3.61

Intangible asset impairment





770


604


0.34

Acquisition and integration costs





810


766


0.43

Change in fair value of contingent consideration





2,761


2,770


1.55

Pylera divestiture





(172)


(126)


(0.07)

Litigation matters





2,506


2,028


1.13

Income tax items






(26)


(0.02)

Other





429


315


0.17

As adjusted (non-GAAP)





$           28,270


$          24,597


$              13.77


a Represents net earnings attributable to AbbVie Inc.


Acquisition and integration costs primarily 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. Income tax items include a benefit of $323 million related to
tax law changes partially offset by certain other tax related items. 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 twelve months ended December 31, 2022 included acquired IPR&D and
milestones expense of $697 million on a pre-tax and $682 million on an after-tax basis, representing an unfavorable impact of $0.39 to both
diluted EPS and adjusted diluted EPS.


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



Twelve Months Ended December 31, 2022

(in millions)

Cost of
products
sold


SG&A


R&D


Other
operating
expense,
net


Other
expense,
net

As reported (GAAP)

$      17,414


$    15,260


$             6,510


$                  56


$           2,448

Adjusted for specified items:










Intangible asset amortization

(7,689)





Intangible asset impairment

(770)





Acquisition and integration costs

(83)


(468)


(30)


(229)


Change in fair value of contingent consideration





(2,761)

Pylera divestiture




172


Litigation matters


(2,506)




Other

(259)


(160)


(45)


1


34

As adjusted (non-GAAP)

$        8,613


$    12,126


$             6,435


$                  —


$             (279)



3.     The adjusted tax rate for the full-year 2022 was 13.0 percent, as detailed below:







Twelve Months Ended December 31, 2022

(dollars in millions)





Pre-tax
earnings


Income taxes


Tax rate

As reported (GAAP)





$           13,477


$             1,632


12.1 %

Specified items





14,793


2,032


13.7 %

As adjusted (non-GAAP)





$           28,270


$             3,664


13.0 %

AbbVie Inc.

Reconciliation of GAAP Reported to Non-GAAP Adjusted Information

(Unaudited)


1.     Specified items impacted results as follows:







Twelve Months Ended December 31, 2021

(in millions, except per share data)





Earnings


Diluted






Pre-tax


After-tax a


EPS

As reported (GAAP)





$           12,989


$           11,542


$                6.45

Adjusted for specified items:










Intangible asset amortization





7,718


6,419


3.60

Acquisition and integration costs





344


215


0.12

Change in fair value of contingent consideration





2,679


2,677


1.50

Litigation matters





307


253


0.14

Impacts related to tax law changes






(265)


(0.15)

Other





360


313


0.17

As adjusted (non-GAAP)





$           24,397


$           21,154


$              11.83


a Represents net earnings attributable to AbbVie Inc.


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


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 twelve months ended December 31, 2021 included acquired IPR&D and
milestones expense of $1.1 billion on a pre-tax and 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 $0.90 to both diluted EPS and adjusted diluted EPS.


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



Twelve Months Ended December 31, 2021

(in millions)

Cost of
products
sold


SG&A


R&D


Other
operating
expense,
net


Other
expense,
net

As reported (GAAP)

$    17,446


$    12,349


$             6,922


$               432


$            2,500

Adjusted for specified items:










Intangible asset amortization

(7,718)





Acquisition and integration costs

(215)


(25)


(104)



Change in fair value of contingent consideration





(2,679)

Litigation matters


(307)




Other

(88)


(53)


(300)


68


13

As adjusted (non-GAAP)

$      9,425


$    11,964


$             6,518


$               500


$              (166)



3.     The adjusted tax rate for the full-year 2021 was 13.3 percent, as detailed below:











Twelve Months Ended December 31, 2021

(dollars in millions)





Pre-tax
earnings


Income taxes


Tax rate

As reported (GAAP)





$           12,989


$            1,440


11.1 %

Specified items





11,408


1,796


15.8 %

As adjusted (non-GAAP)





$           24,397


$            3,236


13.3 %

Cision View original content: https://www.prnewswire.com/news-releases/abbvie-reports-full-year-and-fourth-quarter-2022-financial-results-301742639.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

Download the PDF here.

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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