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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