AbbVie Reports Full-Year and Fourth-Quarter 2021 Financial Results

ABBVie (NYSE:ABBV) announced financial results for the fourth quarter and full year ended December 31, 2021 .

"We delivered another year of outstanding performance in 2021 with double-digit revenue and EPS growth that were well above our initial expectations," said Richard A. Gonzalez , chairman and chief executive officer, AbbVie. "We are entering 2022 with significant momentum and expect our diverse set of growth assets, robust pipeline and excellent execution to deliver continued strong performance this year and over the long term."

Fourth-Quarter Results

  • Worldwide net revenues were $14.886 billion , an increase of 7.4 percent on a reported basis, or 7.5 percent on an operational basis.
  • Global net revenues from the immunology portfolio were $6.746 billion , an increase of 13.2 percent on a reported basis, or 13.3 percent on an operational basis.
    • Global Humira net revenues of $5.334 billion increased 3.5 percent on a reported and operational basis. U.S. Humira net revenues were $4.553 billion , an increase of 6.0 percent. Internationally, Humira net revenues were $781 million , a decrease of 9.1 percent on a reported basis, or 8.8 percent on an operational basis, due to biosimilar competition.
    • Global Skyrizi net revenues were $895 million .
    • Global Rinvoq net revenues were $517 million .
  • Global net revenues from the hematologic oncology portfolio were $1.873 billion , an increase of 4.6 percent on a reported basis, or 4.7 percent on an operational basis.
    • Global Imbruvica net revenues were $1.385 billion , a decrease of 2.7 percent, with U.S. net revenues of $1.114 billion and international profit sharing of $271 million .
    • Global Venclexta net revenues were $488 million , an increase of 33.3 percent on a reported basis, or 34.0 percent on an operational basis.
  • Global net revenues from the neuroscience portfolio were $1.654 billion , an increase of 19.0 percent on a reported and operational basis.
    • Global Botox Therapeutic net revenues were $671 million , an increase of 18.3 percent on a reported basis, or 18.1 percent on an operational basis.
    • Vraylar net revenues were $489 million , an increase of 21.8 percent.
    • Global Ubrelvy net revenues were $183 million .
  • Global net revenues from the aesthetics portfolio were $1.407 billion , an increase of 23.3 percent on a reported basis, or 22.8 percent on an operational basis.
    • Global Botox Cosmetic net revenues were $626 million , an increase of 27.0 percent on a reported basis, or 26.6 percent on an operational basis.
    • Global Juvederm net revenues were $432 million , an increase of 30.6 percent on a reported basis, or 29.8 percent on an operational basis.
  • On a GAAP basis, the gross margin ratio in the fourth quarter was 71.0 percent. The adjusted gross margin ratio was 83.6 percent.
  • On a GAAP basis, selling, general and administrative expense was 21.9 percent of net revenues. The adjusted SG&A expense was 22.2 percent of net revenues.
  • On a GAAP basis, research and development expense was 12.3 percent of net revenues. The adjusted R&D expense was 12.1 percent of net revenues, reflecting funding actions supporting all stages of our pipeline.
  • On a GAAP basis, the operating margin in the fourth quarter was 34.1 percent. The adjusted operating margin was 49.3 percent.
  • On a GAAP basis, net interest expense was $571 million .
  • On a GAAP basis, the tax rate in the quarter was 5.3 percent. The adjusted tax rate was 12.5 percent.
  • Diluted EPS in the fourth quarter was $2.26 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $3.31 .

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 confirmed prior revenue guidance of greater than $15 billion in combined Skyrizi (risankizumab) and Rinvoq (upadacitinib) risk-adjusted sales in 2025. AbbVie expects each asset to deliver risk-adjusted sales of greater than $7.5 billion in 2025. Skyrizi is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.
  • AbbVie announced that the U.S. Food and Drug Administration (FDA) approved Rinvoq for the treatment of moderate to severe atopic dermatitis (AD) in adults and children 12 years of age and older whose disease did not respond to previous treatment and is not well controlled with other pills or injections, including biologic medicines, or when use of other pills or injections is not recommended. The approval includes two dose strengths (15 mg and 30 mg, once daily) and is supported by efficacy and safety data from one of the largest registrational Phase 3 programs for AD with more than 2,500 patients evaluated across three studies. This milestone marked the third FDA-approved indication for Rinvoq.
  • AbbVie announced the FDA approved Rinvoq (15 mg, once daily) for the treatment of adults with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. The approval is supported by two Phase 3 clinical studies where Rinvoq showed efficacy across multiple measures of disease activity in active PsA with a safety profile consistent with that seen in rheumatoid arthritis (RA). This milestone marked the second FDA-approved indication for Rinvoq.
  • AbbVie announced the FDA approved Skyrizi for the treatment of adults with active PsA. The approval is supported by two Phase 3 clinical studies where Skyrizi demonstrated significant improvement in joint symptoms, including swollen, tender and painful joints, compared to placebo. This milestone marked the second FDA-approved indication for Skyrizi.
  • AbbVie announced the European Commission (EC) approved Skyrizi alone or in combination with methotrexate (MTX), for the treatment of active PsA in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). The positive opinion is based on data from two pivotal Phase 3 studies which evaluated the efficacy and safety of Skyrizi in adults with active PsA and marks Skyrizi's second indication in the European Union (EU).
  • AbbVie announced that it submitted applications to the FDA and European Medicines Agency (EMA) seeking approval for Rinvoq (15 mg, once daily) for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA). The submissions are supported by the Phase 3 SELECT-AXIS 2 (study 2) clinical trial in which Rinvoq demonstrated significant improvements in signs and symptoms as well as physical function and disease activity versus placebo. No new safety risks were observed compared to the known safety profile of Rinvoq. In addition, AbbVie requested label enhancements for Rinvoq in the EU to include adult patients with active AS who had an inadequate response to biologic DMARDs, based on newly generated clinical data. These data were also provided to the FDA in support of the agency's ongoing review of the supplemental New Drug Application (sNDA) for Rinvoq in AS.
  • AbbVie announced that it submitted an application to the EMA seeking approval for Skyrizi (600 mg intravenous induction and 360 mg subcutaneous maintenance therapy) for the treatment of patients 16 years and older with moderate to severe Crohn's disease (CD). The submission is supported by three pivotal Phase 3 studies in which Skyrizi demonstrated significant improvements in clinical remission and endoscopic response as both induction and maintenance therapy. The overall safety findings in these pivotal studies were generally consistent with the known safety profile of Skyrizi. If approved, CD will mark the third indication for Skyrizi in the EU.
  • AbbVie announced positive top-line results from the Phase 3 induction study, U-EXCEED, which showed Rinvoq (45 mg, once daily) achieved both primary endpoints of clinical remission and endoscopic response at week 12 as well as key secondary endpoints in patients with moderate to severe CD. The safety results in this study were consistent with the known profile of Rinvoq, with no new safety risks observed. U-EXCEED is the first of two Phase 3 induction studies to evaluate the safety and efficacy of Rinvoq in adults with moderate to severe CD and full results from the study will be presented at a future medical meeting and submitted for publication in a peer-reviewed journal.
  • At the American College of Rheumatology's (ACR) annual meeting, AbbVie shared 38 abstracts from across its rheumatology portfolio that underscored AbbVie's commitment to advancing its portfolio of medicines to help more people living with rheumatic diseases. Highlights included new efficacy data on Rinvoq in people with active PsA and axial involvement, new long-term analysis evaluating the sustainability of response to Rinvoq among patients with RA as well as efficacy and safety data from the KEEPsAKE 1 and KEEPsAKE 2 trials evaluating Skyrizi in adults with PsA treated through 24 weeks.
  • AbbVie announced that the FDA granted Breakthrough Therapy Designation (BTD) to investigational telisotuzumab vedotin (Teliso-V) for the treatment of patients with advanced/metastatic epidermal growth factor receptor (EGFR) wild type, nonsquamous non-small cell lung cancer (NSCLC) with high levels of c-Met overexpression whose disease has progressed on or after platinum-based therapy. The BTD is supported by interim data from the ongoing Phase 2 LUMINOSITY study and a Phase 3 study is planned to begin in the first half of 2022.
  • At the American Society of Hematology Annual Meeting (ASH), ABBVie presented results from nearly 30 abstracts across 8 types of cancer. Highlights included data from the Phase 2 CAPTIVATE and Phase 3 GLOW studies evaluating minimal residual disease (MRD) and disease-free survival outcomes with fixed duration treatment in patients with chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL) who received the Imbruvica (ibrutinib) + Venclexta (venetoclax) combination regimen; results from several studies evaluating Venclexta in approved and investigational indications; as well as data evaluating ABBV-383, epcoritamab and lemzoparlimab. 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. Imbruvica is jointly developed and commercialized with Janssen Biotech, Inc. Epcoritamab is being co-developed by Genmab and ABBVie. Lemzoparlimab is being developed through a collaboration with ABBVie and I-Mab.
  • Allergan Aesthetics announced the successful completion of its acquisition of Soliton, Inc. The addition of Soliton and its technology complements Allergan Aesthetics' portfolio of non-invasive body contouring treatments to now include a proven treatment for the appearance of cellulite.
  • At the American Society for Dermatologic Surgery meeting, Allergan Aesthetics presented 6 abstracts from its leading portfolio of aesthetic treatments and products, which highlighted its approach to innovative science and commitment to bring new and impactful treatments to customers and patients globally. Highlights included two Botox Cosmetic (OnabotulinumtoxinA) abstracts that were recognized as "Best of Cosmetic Oral Abstracts".
  • AbbVie announced the FDA approved Vuity (pilocarpine HCl ophthalmic solution) 1.25% for the treatment of presbyopia, commonly known as age-related blurry near vision, in adults. Vuity is the first and only FDA-approved eye drop to treat this common and progressive eye condition that affects nearly half of the U.S. adult population. The approval is supported by two pivotal Phase 3 studies that demonstrated Vuity works in as early as 15 minutes and lasts for up to 6 hours, as measured on day 30, to improve near and intermediate vision without impacting distance vision.
  • At the American Academy of Ophthalmology Annual Meeting (AAO), AbbVie presented new data from its leading eye care portfolio. Highlights included new pooled post-hoc analyses and patient-reported outcomes of Vuity 1.25%, analyses on Durysta (bimatoprost intracameral implant) and 3 real-world data studies on the glaucoma patient journey.
  • AbbVie announced that it has extended its preclinical oncology research collaboration agreement with the University of Chicago through 2025. Under the agreement, the organizations will continue working together to advance research in several areas, focusing on oncology, and AbbVie gains an option for an exclusive license to certain University of Chicago discoveries made as part of the collaboration.

Full-Year 2022 Outlook

AbbVie is issuing its GAAP diluted EPS guidance for the full-year 2022 of $9.26 to $9.46 . AbbVie expects to deliver adjusted diluted EPS for the full-year 2022 of $14.00 to $14.20 . The company's 2022 adjusted diluted EPS guidance excludes $4.74 per share of intangible asset amortization expense, non-cash charges for contingent consideration adjustments and other specified items.

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, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , LinkedIn or Instagram .

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 2021 and 2020 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. 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. The company's 2022 financial guidance is also being provided on both a reported and a non-GAAP basis.

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 2020 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 December 31, 2021

(Unaudited)









% Change vs. 4Q20


Net Revenues (in millions)


Reported


Operational a


U.S.


Int'l.


Total


U.S.


Int'l.


Total


Int'l.


Total

NET REVENUES

$11,677


$3,209


$14,886


9.5%


0.5%


7.4%


0.9%


7.5%

Immunology

5,696


1,050


6,746


14.2


8.3


13.2


9.0


13.3

Humira

4,553


781


5,334


6.0


(9.1)


3.5


(8.8)


3.5

Skyrizi

761


134


895


68.6


82.1


70.5


84.8


70.9

Rinvoq

382


135


517


57.1


>100.0


84.4


>100.0


85.2

















Hematologic Oncology

1,363


510


1,873


(0.7)


22.5


4.6


23.1


4.7

Imbruvica b

1,114


271


1,385


(4.3)


4.6


(2.7)


4.6


(2.7)

Venclexta

249


239


488


19.4


51.8


33.3


53.5


34.0

















Aesthetics

877


530


1,407


21.1


27.1


23.3


25.8


22.8

Botox Cosmetic

397


229


626


31.3


20.3


27.0


19.3


26.6

Juvederm Collection

180


252


432


22.8


36.8


30.6


35.3


29.8

Other Aesthetics

300


49


349


9.1


15.3


9.9


13.9


9.7

















Neuroscience

1,440


214


1,654


21.1


7.1


19.0


7.0


19.0

Botox Therapeutic

561


110


671


18.9


15.4


18.3


14.1


18.1

Vraylar

489



489


21.8


n/a


21.8


n/a


21.8

Duodopa

29


99


128


0.1


(2.0)


(1.5)


(0.7)


(0.5)

Ubrelvy

183



183


>100.0


n/a


>100.0


n/a


>100.0

Other Neuroscience

178


5


183


(19.9)


42.0


(18.9)


34.3


(19.0)

















Eye Care

672


288


960


7.6


(4.7)


3.6


(3.8)


3.9

Lumigan/Ganfort

72


77


149


6.2


(9.2)


(2.4)


(9.0)


(2.3)

Alphagan/Combigan

102


39


141


9.0


(4.3)


4.9


(3.6)


5.1

Restasis

350


14


364


4.9


28.1


5.7


32.8


5.9

Other Eye Care

148


158


306


14.2


(4.8)


3.6


(3.7)


4.2

















Women's Health

216


7


223


(12.5)


(18.4)


(12.7)


(22.1)


(12.8)

Lo Loestrin

123


5


128


(10.6)


16.1


(10.0)


9.9


(10.1)

Orilissa/Oriahnn

37


2


39


3.6


44.1


4.8


37.2


4.6

Other Women's Health

56



56


(24.2)


(75.9)


(26.2)


(75.8)


(26.2)

















Other Key Products

1,146


283


1,429


0.9


(8.6)


(1.1)


(6.8)


(0.7)

Mavyret

197


230


427


(10.9)


(11.6)


(11.3)


(9.4)


(10.1)

Creon

327



327


7.8


n/a


7.8


n/a


7.8

Lupron

148


44


192


6.1


5.4


6.0


5.5


6.0

Linzess/Constella

278


9


287


0.1


20.4


0.6


17.4


0.5

Synthroid

196



196


0.9


n/a


0.9


n/a


0.9



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

AbbVie Inc.

Key Product Revenues

Twelve Months Ended December 31, 2021

(Unaudited)









% Change vs. 12M20


Net Revenues (in millions)


Reported

Comparable Operational a, b


U.S.


Int'l.


Total


U.S.


Int'l.


Total


U.S.


Int'l.


Total

ADJUSTED NET REVENUES c

$43,435


$12,687


$56,122


24.6%


16.1%


22.6%


12.3%


4.7%


10.5%

Immunology

21,087


4,197


25,284


16.2


4.8


14.1


16.2


1.2


13.5

Humira

17,330


3,364


20,694


7.6


(9.6)


4.3


7.6


(12.8)


3.7

Skyrizi

2,486


453


2,939


79.6


>100.0


84.9


79.6


>100.0


84.0

Rinvoq

1,271


380


1,651


94.8


>100.0


>100.0


94.8


>100.0


>100.0



















Hematologic Oncology

5,255


1,973


7,228


2.8


28.0


8.7


2.8


26.2


8.3

Imbruvica d

4,321


1,087


5,408


0.4


7.7


1.8


0.4


7.7


1.8

Venclexta

934


886


1,820


16.1


66.2


36.1


16.1


60.9


34.0



















Aesthetics

3,350


1,883


5,233


>100.0


>100.0


>100.0


44.7


52.2


47.3

Botox Cosmetic*

1,424


808


2,232


>100.0


90.0


>100.0


57.4


42.6


51.8

Juvederm Collection*

658


877


1,535


>100.0


>100.0


>100.0


53.6


61.3


57.9

Other Aesthetics*

1,268


198


1,466


90.2


>100.0


93.0


29.2


56.9


32.1



















Neuroscience

5,061


866


5,927


76.8


36.7


69.5


23.0


10.6


21.1

Botox Therapeutic*

2,012


439


2,451


74.3


89.0


76.7


20.5


22.8


20.9

Vraylar*

1,728



1,728


81.7


n/a


81.7


24.5


n/a


24.5

Duodopa

102


409


511


(1.0)


4.6


3.4


(1.0)


(0.1)


(0.3)

Ubrelvy*

552



552


>100.0


n/a


>100.0


>100.0


n/a


>100.0

Other Neuroscience*

667


18


685


26.3


77.4


27.2


(17.7)


14.2


(17.2)



















Eye Care

2,403


1,164


3,567


65.9


58.2


63.3


5.6


2.2


4.5

Lumigan/Ganfort*

273


306


579


64.7


44.1


53.1


(0.1)


(10.2)


(5.6)

Alphagan/Combigan*

373


156


529


66.5


52.5


62.1


5.7


1.7


4.5

Restasis*

1,234


56


1,290


63.3


75.3


63.8


4.1


24.9


4.9

Other Eye Care*

523


646


1,169


72.7


66.1


69.0


12.9


7.6


10.0



















Women's Health

771


25


796


19.1


(1.6)


18.3


(16.0)


(33.7)


(16.6)

Lo Loestrin*

423


14


437


21.9


43.3


22.5


(18.5)


(4.9)


(18.2)

Orilissa/Oriahnn

139


6


145


15.4


57.7


16.7


15.4


47.6


16.4

Other Women's Health*

209


5


214


16.2


(57.5)


11.7


(24.8)


(73.9)


(27.7)



















Other Key Products

4,322


1,167


5,489


10.3


(3.9)


6.9


2.8


(7.1)


0.6

Mavyret

754


956


1,710


(4.0)


(8.5)


(6.5)


(4.0)


(10.8)


(7.8)

Creon

1,191



1,191


6.9


n/a


6.9


6.9


n/a


6.9

Lupron

604


179


783


0.5


18.0


4.0


0.5


15.0


3.4

Linzess/Constella*

1,006


32


1,038


55.1


77.3


55.7


8.0


9.9


8.1

Synthroid

767



767


(0.6)


n/a


(0.6)


(0.6)


n/a


(0.6)



a

"Comparable Operational" comparisons include full-period current year and prior year results for Allergan products, as if the acquisition closed on January 1, 2019, and are presented at constant currency rates that reflect comparative local currency net revenues at the prior year's foreign exchange rates.

b

All historically reported Allergan revenues have been recast to conform to AbbVie's revenue recognition accounting policies and reporting conventions for certain rebates and discounts. Historically reported Allergan revenues also exclude Zenpep and Viokace product revenues, which were both divested as part of the acquisition, as well as specified items.

c

Adjusted net revenues exclude specified items. Refer to the Reconciliation of GAAP Reported to Non-GAAP Adjusted Information for further details. Percentage change is calculated using adjusted net revenues.

d

Reflects profit sharing for Imbruvica international revenues.

* Represents product(s) acquired as part of the Allergan acquisition.

n/a = not applicable

AbbVie Inc.

Consolidated Statements of Earnings

Quarter and Twelve Months Ended December 31, 2021 and 2020

(Unaudited) (In millions, except per share data)



Fourth Quarter

Ended December 31


Twelve Months

Ended December 31


2021


2020


2021


2020

Net revenues

$       14,886


$       13,858


$       56,197


$       45,804

Cost of products sold

4,320


4,684


17,446


15,387

Selling, general and administrative

3,260


3,231


12,349


11,299

Research and development

1,827


1,890


7,084


6,557

Acquired in-process research and development

405


300


962


1,198

Other operating expense, net



432


Total operating costs and expenses

9,812


10,105


38,273


34,441









Operating earnings

5,074


3,753


17,924


11,363









Interest expense, net

571


618


2,384


2,280

Net foreign exchange loss

16


17


51


71

Other expense, net

216


4,625


2,500


5,614

Earnings (loss) before income tax expense

4,271


(1,507)


12,989


3,398

Income tax expense (benefit)

226


(1,545)


1,440


(1,224)

Net earnings

4,045


38


11,549


4,622

Net earnings attributable to noncontrolling interest

1


2


7


6

Net earnings attributable to AbbVie Inc.

$          4,044


$               36


$       11,542


$          4,616









Diluted earnings per share attributable to AbbVie Inc.

$            2.26


$            0.01


$            6.45


$            2.72









Adjusted diluted earnings per share a

$            3.31


$            2.92


$          12.70


$          10.56









Weighted-average diluted shares outstanding

1,778


1,776


1,777


1,673



a

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

Quarter Ended December 31, 2021

(Unaudited) (In millions, except per share data)


1.     Specified items impacted results as follows:


4Q21


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)

Acquired IPR&D

405


405


0.23

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)

$               6,764


$               5,919


$                 3.31


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. Acquired IPR&D represents initial costs to acquire rights to in-process R&D projects through R&D collaborations, licensing arrangements or other asset acquisitions. Other primarily includes COVID-19 related expenses and tax related items.


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


4Q21


Cost of products sold


SG&A


R&D


Acquired IPR&D


Other expense, net

As reported (GAAP)

$       4,320


$       3,260


$       1,827


$          405


$          216

Adjusted for specified items:










Intangible asset amortization

(1,806)





Acquisition and integration costs

(43)


250


(16)



Acquired IPR&D




(405)


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 12.5 percent, as detailed below:



4Q21


Pre-tax earnings


Income taxes


Tax rate

As reported (GAAP)

$              4,271


$                  226


5.3 %

Specified items

2,493


618


24.8 %

As adjusted (non-GAAP)

$              6,764


$                  844


12.5 %

AbbVie Inc.

Reconciliation of GAAP Reported to Non-GAAP Adjusted Information

Quarter Ended December 31, 2020

(Unaudited) (In millions, except per share data)


1.     Specified items impacted results as follows:



4Q20


Earnings (Loss)


Diluted


Pre-tax


After-tax a


EPS

As reported (GAAP)

$              (1,507)


$                    36


$                 0.01

Adjusted for specified items:






Intangible asset amortization

1,838


1,444


0.81

Acquisition and integration costs

467


399


0.22

Milestones and other R&D expenses

48


39


0.02

Acquired IPR&D

300


296


0.16

Change in fair value of contingent consideration

4,675


4,671


2.63

Tax audit settlements


(140)


(0.08)

Impacts related to tax law changes


(1,492)


(0.84)

Other

92


(28)


(0.01)

As adjusted (non-GAAP)

$               5,913


$               5,225


$                 2.92


a Represents net earnings attributable to AbbVie Inc.


Acquisition and integration costs reflect integration costs and amortization of the acquisition date fair value step-up for inventory related to the Allergan acquisition. Milestones and other R&D expenses include milestone payments for previously announced collaborations. Acquired IPR&D represents initial costs to acquire rights to in-process R&D projects through R&D collaborations, licensing arrangements or other asset acquisitions. Other primarily includes tax related items and COVID-19 related expenses.


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


4Q20


Cost of products sold


SG&A


R&D


Acquired  IPR&D


Other expense, net

As reported (GAAP)

$     4,684


$     3,231


$     1,890


$        300


$     4,625

Adjusted for specified items:










Intangible asset amortization

(1,838)





Acquisition and integration costs

(272)


(126)


(69)



Milestones and other R&D expenses



(48)



Acquired IPR&D




(300)


Change in fair value of contingent consideration





(4,675)

Other

(51)


(16)


(22)



(3)

As adjusted (non-GAAP)

$     2,523


$     3,089


$     1,751


$           —


$         (53)


3.     The adjusted tax rate for the fourth quarter of 2020 was 11.6 percent, as detailed below:



4Q20


Pre-tax earnings (loss)


Income taxes


Tax rate

As reported (GAAP)

$             (1,507)


$             (1,545)


102.5 %

Specified items

7,420


2,231


30.1 %

As adjusted (non-GAAP)

$              5,913


$                  686


11.6 %

AbbVie Inc.

Reconciliation of GAAP Reported to Non-GAAP Adjusted Information

Twelve Months Ended December 31, 2021

(Unaudited) (In millions, except per share data)


1.     Specified items impacted results as follows:


12M21


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

Milestones and other R&D expenses

359


307


0.17

Acquired IPR&D

962


948


0.53

Calico collaboration

500


500


0.28

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

88


100


0.06

As adjusted (non-GAAP)

$             25,946


$             22,696


$               12.70


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. Milestones and other R&D expenses include milestone payments for previously announced collaborations and the purchase of FDA priority review vouchers from third parties. Acquired IPR&D represents initial costs to acquire rights to in-process R&D projects through R&D collaborations, licensing arrangements or other asset acquisitions. Other primarily includes COVID-19 related expenses, restructuring charges associated with streamlining global operations and tax related items, offset by milestone revenue under an existing collaboration agreement.


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


12M21


Net revenues


Cost of products sold


SG&A


R&D


Acquired  IPR&D


Other operating expense, net


Other expense, net

As reported (GAAP)

$   56,197


$   17,446


$   12,349


$     7,084


$        962


$        432


$     2,500

Adjusted for specified items:














Intangible asset amortization


(7,718)






Acquisition and integration costs


(215)


(25)


(104)




Milestones and other R&D expenses




(359)




Acquired IPR&D





(962)



Calico collaboration






(500)


Change in fair value of contingent consideration







(2,679)

Litigation matters



(307)





Other

(75)


(88)


(53)


(103)



68


13

As adjusted (non-GAAP)

$   56,122


$     9,425


$   11,964


$     6,518


$          —


$           —


$       (166)


3.     The adjusted tax rate for the full-year 2021 was 12.5 percent, as detailed below:



12M21


Pre-tax earnings


Income taxes


Tax rate

As reported (GAAP)

$            12,989


$              1,440


11.1 %

Specified items

12,957


1,803


13.9 %

As adjusted (non-GAAP)

$            25,946


$              3,243


12.5 %

AbbVie Inc.

Reconciliation of GAAP Reported to Non-GAAP Adjusted Information

Twelve Months Ended December 31, 2020

(Unaudited) (In millions, except per share data)


1.     Specified items impacted results as follows:


12M20


Earnings


Diluted


Pre-tax


After-tax a


EPS

As reported (GAAP)

$               3,398


$               4,616


$                 2.72

Adjusted for specified items:






Intangible asset amortization

5,805


4,805


2.87

Acquisition and integration costs

3,366


3,023


1.81

Milestones and other R&D expenses

273


241


0.14

Acquired IPR&D

1,198


1,194


0.71

Change in fair value of contingent consideration

5,753


5,749


3.43

Tax audit settlements


(200)


(0.12)

Impacts related to tax law changes


(1,689)


(1.02)

Other

239


42


0.02

As adjusted (non-GAAP)

$             20,032


$             17,781


$               10.56


a Represents net earnings attributable to AbbVie Inc.


Acquisition and integration costs reflect transaction and financing costs, compensation expense and other integration costs as well as amortization of the acquisition date fair value step-up for inventory related to the Allergan acquisition. Milestones and other R&D expenses include milestone payments for previously announced collaborations and the purchase of an FDA priority review voucher from a third party. Acquired IPR&D represents initial costs to acquire rights to in-process R&D projects through R&D collaborations, licensing arrangements or other asset acquisitions. Other primarily includes tax related items and COVID-19 related charitable contributions and expenses.


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


12M20


Net revenues


Cost of products sold


SG&A


R&D


Acquired  IPR&D


Interest expense, net


Net foreign exchange loss


Other expense, net

As reported (GAAP)

$   45,804


$   15,387


$   11,299


$     6,557


$     1,198


$     2,280


$            71


$     5,614

Adjusted for specified items:
















Intangible asset amortization


(5,805)







Acquisition and integration costs


(1,292)


(1,416)


(384)



(274)



Milestones and other R&D expenses




(273)





Acquired IPR&D





(1,198)




Change in fair value of contingent consideration








(5,753)

Other

(20)


(115)


(80)


(70)




9


(3)

As adjusted (non-GAAP)

$   45,784


$     8,175


$     9,803


$     5,830


$          —


$     2,006


$            80


$       (142)


3.     The adjusted tax rate for the full-year 2020 was 11.2 percent, as detailed below:


12M20


Pre-tax earnings


Income taxes


Tax rate

As reported (GAAP)

$              3,398


$             (1,224)


(36.0) %

Specified items

16,634


3,469


20.9 %

As adjusted (non-GAAP)

$            20,032


$              2,245


11.2 %

Cision View original content: https://www.prnewswire.com/news-releases/abbvie-reports-full-year-and-fourth-quarter-2021-financial-results-301473737.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.

News Provided by Canada Newswire via QuoteMedia

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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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  BPH Global Ltd

Notice of Extraordinary General Meeting/Proxy Form

Notice is hereby given that an Extraordinary General Meeting of Shareholders of BPH Global Limited ACN 009 104 330 will be held at 3:00pm AEST on 24 May 2024 at Suite 5, Level 12, 530 Collins Street, Melbourne VIC 3000 (Meeting).

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Biotech Market Update: Q1 2024 in Review

The first quarter of 2024 witnessed a surge in initial public offerings (IPOs) and mergers and acquisitions (M&A) within the biotech industry, signaling continued interest from investors.

AstraZeneca’s acquisition of start-up Amolyt on March 14, and its longtime biotech partner Fusion Pharmaceuticals for US$2.4 billion on March 19 marked the third acquisition of a radiopharmaceutical developer in recent months. As of writing, there have been 14 M&A deals struck in 2024, according to data from Biopharma Dive.

Investment bank Jefferies released data in early March revealing that the sector was on track to earn its highest quarterly total in three years, reflecting the cautiously optimistic outlook at this year's JPM24 conference.

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AMGEN TO PRESENT TEZSPIRE® PHASE 2A COPD DATA AT ATS 2024

Planning Underway for Phase 3 Development of Tezepelumab in COPD

Amgen (NASDAQ:AMGN) today provided an update regarding the results of the Phase 2a COURSE trial for TEZSPIRE ® (tezepelumab-ekko) in chronic obstructive pulmonary disease (COPD), which were accepted for presentation in the Clinical Trials Symposium at The American Thoracic Society (ATS) 2024 International Conference on Monday, May 20 from 9:15-11:15 a.m. PDT .

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Biotech Stocks: 5 Biggest Companies in 2024

What are the top biotech companies? The following five stocks have market capitalizations worth billions of dollars and operate in countries all around the globe.

Plus, these big-name biotech players have pipelines stuffed with potentially disruptive products — and enough revenue to recover should some of those products fail.

This means that investors can experience the excitement of biotech investing while minimizing risk. Although returns are never guaranteed, company size can insulate investors from volatility.

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SIRONA BIOCHEM Corporate Update April 2024

SIRONA BIOCHEM Corporate Update April 2024

Sirona Biochem Corp . (TSX-V: SBM) (FSE: ZSB) (OTC: SRBCF) (" Sirona " or the " Company ") provides the following update:

Dear shareholders,

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Sirona Biochem Announces Close of Private Placement

Sirona Biochem Announces Close of Private Placement

Vancouver, British Columbia – April 4, 2024 Sirona Biochem Corp . (TSX-V: SBM) (Frankfurt: ZSB) (" Sirona ") has closed its private placement (Private Placement") for gross proceeds of $132,500 CAD. The Private Placement consists of 1,325,000 units, (the "Units") at a price of $0.10 per Unit. Each Unit consists of one common share and one transferable share purchase warrant, each whole warrant exercisable into one additional common share of the Company for a period of 2 years from the date of issue at a price of $0.15 per Share in year one and $0.25 per Share in year two. All securities issued under the Private Placement are subject to statutory hold periods expiring on August 4, 2024.

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