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Document PRESS RELEASE AbbVie Reports Second-Quarter 2022 Financial Results Reports Second-Quarter Diluted EPS of $0.51 on a GAAP Basis, an Increase of 21.4 Percent Adjusted Diluted EPS of $3.37, an Increase of 11.2 Perc

Key Takeaway: AbbVie Reports Second-Quarter 2022 Financial Results Reports Second-Quarter Diluted EPS of $0.51 on a GAAP Basis, an Increase of 21.4 Percent Adjusted Diluted EPS of $3.37, an Increase of 11.2 Percent These Results Include an Unfavorable Impact of $0.14 Per Share related to Acqu

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AbbVie Reports Second-Quarter 2022 Financial Results
Reports Second-Quarter Diluted EPS of $0.51 on a GAAP Basis, an Increase of 21.4 Percent Adjusted Diluted EPS of $3.37, an Increase of 11.2 Percent These Results Include an Unfavorable Impact of $0.14 Per Share related to Acquired IPR D and Milestones Expense 1
Delivers Second-Quarter Net Revenues of $14.583 Billion, an Increase of 4.5 Percent on a Reported Basis and 6.1 Percent Operationally
Second-Quarter Global Net Revenues from the Immunology Portfolio Were $7.207 Billion, an Increase of 17.8 Percent on a Reported Basis, or 19.2 Percent on an Operational Basis U.S. Humira Net Revenues Were $4.664 Billion, an Increase of 9.6 Percent Internationally, Humira Net Revenues Were $699 Million, a Decrease of 13.8 Percent on a Reported Basis, or 7.3 Percent on an Operational Basis, Due to Biosimilar Competition Global Skyrizi Net Revenues Were $1.252 Billion Global Rinvoq Net Revenues Were $592 Million Combined Global Skyrizi and Rinvoq Net Revenues Were $1.844 Billion
Second-Quarter Global Net Revenues from the Hematologic Oncology Portfolio Were $1.650 Billion, a Decrease of 9.1 Percent on a Reported Basis, or 7.9 Percent on an Operational Basis Global Imbruvica Net Revenues Were $1.145 Billion, a Decrease of 17.1 Percent, with U.S. Net Revenues of $862 Million and International Profit Sharing of $283 Million Global Venclexta Net Revenues Were $505 Million
Second-Quarter Global Net Revenues from the Neuroscience Portfolio Were $1.658 Billion, an Increase of 13.7 Percent on a Reported Basis, or 15.2 Percent on an Operational Basis Global Botox Therapeutic Net Revenues Were $678 Million Vraylar Net Revenues Were $492 Million
Second-Quarter Global Net Revenues from the Aesthetics Portfolio Were $1.371 Billion, a Decrease of 4.4 Percent on a Reported Basis, or 2.1 Percent on an Operational Basis Global Botox Cosmetic Net Revenues Were $695 Million Global Juvederm Net Revenues Were $344 Million, Unfavorably Impacted by COVID-19 Restrictions in China and Suspension of Aesthetics Operations in Russia
Confirms 2022 Adjusted Diluted EPS Guidance Range of $13.78 - $13.98, which Includes an Unfavorable Impact of $0.23 Per Share Related to Acquired IPR D and Milestones Expense Incurred Year-To-Date Through the Second Quarter 2022
NORTH CHICAGO, Ill., July 29, 2022 - AbbVie (NYSE ABBV) announced financial results for the second quarter ended June 30, 2022.
We delivered another strong quarter with substantial progress for our new products and indications. Importantly, Skyrizi and Rinvoq continued their impressive ramps and are on pace to deliver approximately $7.5 billion in combined annual sales, underscoring their significant potential," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. The momentum of our business, combined with advances across our pipeline continue to support AbbVie's promising long-term outlook.
Second-Quarter Results
Worldwide net revenues were $14.583 billion, an increase of 4.5 percent on a GAAP basis, or 6.1 percent on an operational basis.
Global net revenues from the immunology portfolio were $7.207 billion, an increase of 17.8 percent on a reported basis, or 19.2 percent on an operational basis.
Global Humira net revenues of $5.363 billion increased 5.8 percent on a reported basis, or 6.8 percent on an operational basis. U.S. Humira net revenues were $4.664 billion, an increase of 9.6 percent. Internationally, Humira net revenues were $699 million, a decrease of 13.8 percent on a reported basis, or 7.3 percent on an operational basis, due to biosimilar competition.
Global Skyrizi net revenues were $1.252 billion, an increase of 85.9 percent on a reported basis, or 88.3 percent on an operational basis.
Global Rinvoq net revenues were $592 million, an increase of 56.3 percent on a reported basis, or 60.7 percent on an operational basis.
Combined global Skyrizi and Rinvoq net revenues were $1.844 billion.
Global net revenues from the hematologic oncology portfolio were $1.650 billion, a decrease of 9.1 percent on a reported basis, or 7.9 percent on an operational basis.
Global Imbruvica net revenues were $1.145 billion, a decrease of 17.1 percent, with U.S. net revenues of $862 million and international profit sharing of $283 million.
Global Venclexta net revenues were $505 million, an increase of 16.2 percent on a reported basis, or 21.2 percent on an operational basis.
Global net revenues from the neuroscience portfolio were $1.658 billion, an increase of 13.7 percent on a reported basis, or 15.2 percent on an operational basis.
Global Botox Therapeutic net revenues were $678 million, an increase of 12.6 percent on a reported basis, or 14.5 percent on an operational basis.
Vraylar net revenues were $492 million, an increase of 13.9 percent.
Global Ubrelvy net revenues were $185 million.
Global net revenues from the aesthetics portfolio were $1.371 billion, a decrease of 4.4 percent on a reported basis, or 2.1 percent on an operational basis.
Global Botox Cosmetic net revenues were $695 million, an increase of 18.9 percent on a reported basis, or 21.2 percent on an operational basis.
Global Juvederm net revenues were $344 million, a decrease of 19.5 percent on a reported basis, or 15.7 percent on an operational basis, unfavorably impacted by COVID-19 restrictions in China and suspension of aesthetics operations in Russia.
On a GAAP basis, the gross margin ratio in the second quarter was 71.4 percent. The adjusted gross margin ratio was 84.7 percent.
On a GAAP basis, selling, general and administrative expense was 37.1 percent of net revenues. The adjusted SG A expense was 20.8 percent of net revenues.
Research and development expense was 11.0 percent of net revenues on both a GAAP and Non-GAAP adjusted basis.
Acquired IPR D and milestones expense was 1.8 percent of net revenues.
On a GAAP basis, the operating margin in the second quarter was 22.6 percent. The adjusted operating margin was 51.0 percent, which includes an unfavorable 180 basis point impact from acquired IPR D and milestones expense.
Net interest expense was $532 million.
On a GAAP basis, the tax rate in the quarter was 21.6 percent. The adjusted tax rate was 13.4 percent.
Diluted EPS in the second quarter was $0.51 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $3.37. These results include an unfavorable impact of $0.14 per share related to acquired IPR D and milestones expense.
AbbVie announced that the U.S. Food and Drug Administration (FDA) approved Skyrizi (risankizumab) as the first and only specific interleukin-23 inhibitor for the treatment of adults with moderately to severely active Crohn's disease (CD). The approval is supported by three pivotal Phase 3 studies in which Skyrizi demonstrated significant improvements in clinical remission and endoscopic response, compared to placebo, as both induction and maintenance therapy. This marks Skyrizi's third FDA approved indication. Skyrizi is a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.
AbbVie announced that the FDA approved Rinvoq (upadacitinib, 15 mg, once daily) for the treatment of adults with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. The approval is supported by data from two pivotal clinical trials in which Rinvoq delivered rapid and meaningful disease control. This approval marks the fifth FDA approved indication for Rinvoq in chronic immune-mediated diseases.
AbbVie announced the European Commission (EC) approved Rinvoq (45 mg (induction dose) and 15 mg and 30 mg (maintenance doses)) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC). The approval is based on results from two Phase 3 induction studies and one maintenance study in which significantly more patients treated with Rinvoq achieved the primary and all secondary endpoints compared to placebo.
AbbVie announced the EC approved Rinvoq (15 mg, once daily) for the treatment of adult patients with active non-radiographic axial spondyloarthritis (nr-Axial SpA). The approval is based on results from the Phase 3 SELECT-AXIS 2 study in which Rinvoq met the primary endpoint and 12 of 14 ranked secondary endpoints.
AbbVie announced that it submitted applications for a new indication to the FDA and European Medicines Agency (EMA) for Rinvoq (45 mg (induction dose) and 15 mg and 30 mg (maintenance doses)) for the treatment of adult patients with moderately to severely active CD. The submissions are supported by three Phase 3 clinical trials demonstrating Rinvoq achieved the co-primary endpoints of clinical remission and endoscopic response as induction and maintenance treatment.
AbbVie announced positive top-line results from the Phase 3 maintenance study, U-ENDURE, evaluating Rinvoq in adult patients with moderate to severe CD. The results showed Rinvoq (15 mg or 30 mg, once daily) achieved the co-primary endpoints of endoscopic response and clinical remission, as well as the secondary endpoint of endoscopic remission, at one year (week 52) compared to placebo. The safety results in this study were generally consistent with the known profile of Rinvoq, with no new safety risks observed. Full results from the study will be presented at upcoming medical conferences and published in a peer-reviewed journal.
At the Digestive Disease Week (DDW) Annual Meeting, AbbVie presented 27 abstracts that reinforced its leadership in advancing research and the standards of care across multiple gastroenterological conditions. Presentations included further analyses of Phase 3 clinical study programs for Rinvoq in moderately to severely active UC and investigational use of Skyrizi in moderately to severely active CD.
At the European Alliance of Associations for Rheumatology (EULAR) 2022 Congress, AbbVie showcased its leadership in rheumatology research with new data across multiple inflammatory joint diseases. Key data presented included SELECT-AXIS 2 trial results evaluating the efficacy and safety of Rinvoq in patients with nr-Axial SpA, and in patients with AS two-year data from the SELECT-PsA 1 and SELECT-PsA 2 studies of Rinvoq in patients with psoriatic arthritis (PsA) and results of the one-year data evaluating the efficacy and safety of Skyrizi in patients with active PsA in the KEEPsAKE 1 and KEEPsAKE 2 clinical trials.
Recent Events (Continued)
At the American Society of Clinical Oncology (ASCO) Annual Meeting and European Hematology Association (EHA) Congress, AbbVie presented 46 abstracts for six investigational and approved medicines across eight cancer types. Highlights included new data that showed Venclexta (venetoclax) plus obinutuzumab demonstrated sustained progression-free survival (PFS) in chronic lymphocytic leukemia (CLL) patients after four years off treatment results from a Phase 2 trial of epcoritamab which showed clinically meaningful efficacy in challenging-to-treat, highly refractory, large B-cell lymphoma (LBCL) patients and new data from the Phase 2 REFINE study of investigational navitoclax in combination with ruxolitinib that is supportive of early intervention in myelofibrosis (MF) to achieve improved clinical outcomes in spleen volume reduction (SVR), symptom score and bone marrow fibrosis (BMF). 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. Epcoritamab is being co-developed by AbbVie and Genmab.
AbbVie announced that it submitted a New Drug Application (NDA) to the FDA for ABBV-951 (foscarbidopa foslevodopa) for the treatment of motor fluctuations in patients with advanced Parkinson's disease (PD). The submission is based on results from a Phase 3, head-to-head, randomized and controlled clinical trial demonstrating statistically significant improvement in On time without troublesome dyskinesia compared to oral immediate-release carbidopa levodopa (CD LD). If approved, ABBV-951 will offer patients the first continuous subcutaneous delivery of CD LD prodrugs.
AbbVie announced that it submitted a supplemental NDA to the FDA for Qulipta (atogepant) to support label expansion for the preventive treatment of migraine in adult patients with chronic migraine. AbbVie also submitted a marketing authorization application for Qulipta with the EMA for the preventive treatment of migraine in adult patients who have at least four migraine days per month.
At the American Headache Society (AHS) Annual Scientific Meeting, AbbVie presented 29 abstracts that covered a wide range of studies across AbbVie's migraine portfolio. Presentations highlighted positive results from the Phase 3 PROGRESS trial investigating Qulipta for the preventive treatment of migraine in patients with chronic migraine, clinical trial results evaluating Ubrelvy (ubrogepant) for acute treatment of migraine and data evaluating Botox (onabotulinumtoxinA) for the preventive treatment of migraine in patient with chronic migraine.
At the American Psychiatric Association (APA) Annual Meeting, AbbVie presented positive data from a Phase 3 trial of Vraylar (cariprazine, 1.5 mg day) for the adjunctive treatment of major depressive disorder (MDD) in patients with an inadequate response to ongoing antidepressant therapy. The study met its primary endpoint of statistically significant improvement using the Montgomery- sberg Depression Rating Scale (MADRS) total score in patients compared with placebo. Vraylar's safety profile was consistent with that of previous studies across indications in the treatment of adults with depressive episodes associated with bipolar I disorder, the acute treatment of manic or mixed episodes associated with bipolar I disorder and schizophrenia. Vraylar is being co-developed by AbbVie and Gedeon Richter Plc.
At the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, AbbVie presented new data from its leading portfolio of eye care treatments. Highlights included new data on Vuity (pilocarpine HCl ophthalmic solution) 1.25%, the first and only FDA-approved eye drop for the treatment of presbyopia (age-related blurry near vision) in adults, and Durysta (bimatoprost intracameral implant), a first-of-its-kind biodegradable implant to lower eye pressure for glaucoma patients.
AbbVie and Cugene Inc., a clinical-stage biotechnology company focused on developing next-generation precision immunology and oncology medicines to treat autoimmune disease and cancer, announced an exclusive worldwide license option agreement for CUG252, a potential best-in-class Treg-selective IL-2 mutein, as well as other novel IL-2 muteins, for the potential treatment of autoimmune and inflammatory diseases.
Recent Events (Continued)
AbbVie and iSTAR Medical announced a strategic transaction to further develop and commercialize iSTAR Medical's MINIject device, a next-generation minimally invasive glaucoma surgical (MIGS) device for patients with glaucoma. This alliance accelerates iSTAR Medical's goal to bring MINIject to more patients globally and provides an opportunity for AbbVie to further expand its diverse eye care portfolio.
Full-Year 2022 Outlook
AbbVie is confirming its adjusted diluted EPS guidance range for the full-year 2022 of $13.78 - $13.98 which includes an unfavorable impact of $0.23 per share related to acquired IPR D and milestones expense incurred year-to-date through the second quarter 2022. The company's 2022 adjusted diluted EPS guidance excludes any impact from acquired IPR D and milestones that may be incurred beyond the second quarter of 2022, as both cannot be reliably forecasted.
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, eye care, virology and gastroenterology, in addition to products and services across our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow abbvie on Twitter, Facebook or LinkedIn.
AbbVie will host an investor conference call today at 8 00 a.m. Central time to discuss our second-quarter performance. The call will be webcast through AbbVie's Investor Relations website at investors.abbvie.com. An archived edition of the call will be available after 11 00 a.m. Central time.
Non-GAAP Financial Results
Financial results for 2022 and 2021 are presented on both a reported and a non-GAAP basis. Reported results were prepared in accordance with GAAP and include all revenue and expenses recognized during the period. Non-GAAP results adjust for certain non-cash items and for factors that are unusual or unpredictable, and exclude those costs, expenses, and other specified items presented in the reconciliation tables later in this release. Beginning in the first quarter of 2022, the company includes the impact of upfront and milestone payments related to collaborations, licensing agreements, and other asset acquisitions in its reported non-GAAP financial measures. Prior periods have been revised to conform to the current period presentation. AbbVie's management believes non-GAAP financial measures provide useful information to investors regarding AbbVie's results of operations and assist management, analysts, and investors in evaluating the performance of the business. Non-GAAP financial measures should be considered in addition to, and not as a substitute for, measures of financial performance prepared in accordance with GAAP.
Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words believe, expect, anticipate, project and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, the failure to realize the expected benefits of AbbVie's acquisition of Allergan or to promptly and effectively integrate Allergan's business, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, Risk Factors, of AbbVie's 2021 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
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Key Product Revenues
Quarter Ended June 30, 2022
% Change vs. 2Q21
Net Revenues (in millions) Reported Operational a
U.S. Int'l. Total U.S. Int'l. Total Int'l. Total
NET REVENUES $11,410 $3,173 $14,583 5.6% 0.6% 4.5% 7.6% 6.1%
Immunology 6,155 1,052 7,207 20.3 4.9 17.8 13.4 19.2
Humira 4,664 699 5,363 9.6 (13.8) 5.8 (7.3) 6.8
Skyrizi 1,079 173 1,252 91.1 59.1 85.9 73.9 88.3
Rinvoq 412 180 592 39.4 100.0 56.3 100.0 60.7
Hematologic Oncology 1,115 535 1,650 (15.7) 8.5 (9.1) 12.9 (7.9)
Imbruvica b 862 283 1,145 (21.6) 0.5 (17.1) 0.5 (17.1)
Venclexta 253 252 505 13.4 19.1 16.2 29.3 21.2
Aesthetics 883 488 1,371 (4.5) (4.2) (4.4) 2.1 (2.1)
Botox Cosmetic 449 246 695 22.4 12.9 18.9 19.2 21.2
Juvederm Collection 147 197 344 (24.9) (15.0) (19.5) (8.1) (15.7)
Other Aesthetics 287 45 332 (20.9) (24.4) (21.4) (20.2) (20.8)
Neuroscience 1,438 220 1,658 16.2 (0.3) 13.7 9.4 15.2
Botox Therapeutic 557 121 678 14.2 5.6 12.6 15.6 14.5
Vraylar 492 - 492 13.9 n a 13.9 n a 13.9
Duodopa 26 94 120 3.2 (7.4) (5.4) 2.2 2.3
Ubrelvy 185 - 185 47.6 n a 47.6 n a 47.6
Qulipta 33 - 33 n m n a n m n a n m
Other Neuroscience 145 5 150 (13.6) 9.6 (12.9) 12.9 (12.8)
Eye Care 407 310 717 (34.1) 2.5 (22.0) 10.8 (19.3)
Lumigan Ganfort 60 70 130 (17.4) (8.1) (12.5) (0.9) (8.7)
Alphagan Combigan 54 38 92 (48.5) (2.3) (35.6) 6.6 (33.1)
Restasis 151 17 168 (51.5) 14.9 (48.4) 24.2 (48.0)
Other Eye Care 142 185 327 9.7 7.4 8.4 16.0 13.2
Other Key Products 768 203 971 3.7 (17.8) (1.6) (9.7) 0.4
Mavyret 203 195 398 0.2 (18.0) (9.7) (9.8) (5.3)
Creon 318 - 318 13.6 n a 13.6 n a 13.6
Linzess Constella 247 8 255 (4.2) (12.5) (4.5) (7.8) (4.4)
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.
Key Product Revenues
Six Months Ended June 30, 2022
% Change vs. 6M21
Net Revenues (in millions) Reported Operational a
U.S. Int'l. Total U.S. Int'l. Total Int'l. Total
NET REVENUES $21,758 $6,363 $28,121 5.9% (0.8)% 4.3% 5.3% 5.7%
Immunology 11,240 2,108 13,348 15.3 (0.2) 12.5 7.0 13.8
Humira 8,657 1,442 10,099 6.0 (18.6) 1.7 (13.1) 2.7
Skyrizi 1,860 332 2,192 77.8 64.7 75.7 78.1 77.9
Rinvoq 723 334 1,057 33.7 100.0 55.1 100.0 59.2
Hematologic Oncology 2,217 1,079 3,296 (12.9) 14.4 (5.5) 18.5 (4.4)
Imbruvica b 1,736 582 2,318 (17.2) 5.6 (12.5) 5.6 (12.5)
Venclexta 481 497 978 7.5 26.8 16.5 36.7 21.1
Aesthetics 1,729 1,016 2,745 4.6 10.2 6.6 16.2 8.7
Botox Cosmetic 862 474 1,336 28.3 21.5 25.8 27.7 28.1
Juvederm Collection 295 459 754 (7.5) 6.7 0.7 13.0 4.3
Other Aesthetics 572 83 655 (13.6) (18.3) (14.2) (14.3) (13.7)
Neuroscience 2,711 435 3,146 19.2 0.8 16.2 9.1 17.5
Botox Therapeutic 1,057 235 1,292 15.3 8.0 13.9 16.3 15.5
Vraylar 919 - 919 18.1 n a 18.1 n a 18.1
Duodopa 50 191 241 (1.2) (7.2) (6.0) 1.3 0.8
Ubrelvy 323 - 323 56.4 n a 56.4 n a 56.4
Qulipta 44 - 44 n m n a n m n a n m
Other Neuroscience 318 9 327 (1.7) 10.4 (1.4) 12.6 (1.3)
Eye Care 903 585 1,488 (21.2) (0.7) (14.3) 7.4 (11.6)
Lumigan Ganfort 127 143 270 (8.3) (6.9) (7.5) (0.1) (3.9)
Alphagan Combigan 124 75 199 (32.3) (3.1) (23.6) 6.0 (20.9)
Restasis 386 28 414 (33.2) (0.2) (31.7) 14.0 (31.0)
Other Eye Care 266 339 605 7.7 2.6 4.8 10.5 9.3
Other Key Products 1,457 421 1,878 4.0 (15.6) (1.1) (8.2) 0.8
Mavyret 372 406 778 (0.4) (15.9) (9.1) (8.4) (4.9)
Creon 605 - 605 9.2 n a 9.2 n a 9.2
Linzess Constella 480 15 495 1.3 (3.8) 1.1 0.7 1.2
a Operational comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year's foreign exchange rates.
b Reflects profit sharing for Imbruvica international revenues.
Consolidated Statements of Earnings
Quarter and Six Months Ended June 30, 2022 and 2021
(Unaudited) (In millions, except per share data)
Second Quarter Ended June 30 Six Months Ended June 30
2022 2021 2022 2021
Net revenues $ 14,583 $ 13,959 $ 28,121 $ 26,969
Cost of products sold 4,170 4,523 8,222 8,736
Selling, general and administrative 5,412 3,164 8,539 6,006
Research and development a 1,609 1,767 3,106 3,434
Acquired IPR D and milestones a 269 132 414 317
Other operating income (172) (68) (172) (68)
Total operating costs and expenses 11,288 9,518 20,109 18,425
Operating earnings 3,295 4,441 8,012 8,544
Interest expense, net 532 606 1,071 1,228
Net foreign exchange loss 47 14 72 23
Other expense, net 1,533 2,658 757 2,263
Earnings before income tax expense 1,183 1,163 6,112 5,030
Income tax expense 255 394 691 706
Net earnings 928 769 5,421 4,324
Net earnings attributable to noncontrolling interest 4 3 7 5
Net earnings attributable to AbbVie Inc. $ 924 $ 766 $ 5,414 $ 4,319
Diluted earnings per share attributable to AbbVie Inc. $ 0.51 $ 0.42 $ 3.03 $ 2.41
Adjusted diluted earnings per share b $ 3.37 $ 3.03 $ 6.52 $ 5.92
Weighted-average diluted shares outstanding 1,776 1,776 1,777 1,776
a During the three months ended March 31, 2022, AbbVie changed its classification of development milestone expense associated with licensing and collaboration arrangements in the consolidated statement of earnings. Milestone payments incurred prior to regulatory approval, which were previously included in research and development expense, are now presented as acquired IPR D and milestones expense. The reclassification decreased research and development expense and increased acquired IPR D and milestones expense by $35 million for the three months and $150 million for the six months ended June 30, 2021. The company believes this presentation assists users of the financial statements to better understand the total upfront and subsequent development milestone payments incurred to acquire in-process research and development projects. Prior periods have been revised to conform to the current period presentation. The reclassification had no impact on total operating costs and expenses, operating earnings, net earnings, net earnings attributable to AbbVie, Inc., earnings per share, or total equity.
b Refer to the Reconciliation of GAAP Reported to Non-GAAP Adjusted Information for further details.
Reconciliation of GAAP Reported to Non-GAAP Adjusted Information
Quarter Ended June 30, 2022
(Unaudited) (In millions, except per share data)
1. Specified items impacted results as follows
2Q22
Earnings Diluted
Pre-tax After-tax a EPS
As reported (GAAP) $ 1,183 $ 924 $ 0.51
Adjusted for specified items
Intangible asset amortization 1,849 1,556 0.88
Acquisition and integration costs 109 98 0.05
Change in fair value of contingent consideration 1,609 1,621 0.91
Pylera divestiture (172) (126) (0.07)
Litigation matters 2,203 1,779 1.00
Other 159 154 0.09
As adjusted (non-GAAP) $ 6,940 $ 6,006 $ 3.37
a Represents net earnings attributable to AbbVie Inc.
Acquisition and integration costs reflect integration costs related to the Allergan acquisition. Litigation matters primarily includes a charge related to a potential settlement of litigation involving Allergan's past sales of opioid products. Other primarily includes restructuring charges associated with streamlining global operations and COVID-19 related expenses.
Beginning in the first quarter of 2022, the company includes acquired IPR D and milestones expense in its reported non-GAAP financial measures. Reported GAAP earnings and adjusted non-GAAP earnings for the three months ended June 30, 2022 included acquired IPR D and milestones expense of $269 million on a pre-tax and $254 million on an after-tax basis, representing an unfavorable impact of $0.14 to both diluted EPS and adjusted diluted EPS.
2. The impact of the specified items by line item was as follows
2Q22
Cost of products sold SG A R D Other operating income Other expense, net
As reported (GAAP) $ 4,170 $ 5,412 $ 1,609 $ (172) $ 1,533
Adjusted for specified items
Intangible asset amortization (1,849) - - - -
Acquisition and integration costs (28) (79) (2) - -
Change in fair value of contingent consideration - - - - (1,609)
Pylera divestiture - - - 172 -
Litigation matters - (2,203) - - -
Other (61) (95) - - (3)
As adjusted (non-GAAP) $ 2,232 $ 3,035 $ 1,607 $ - $ (79)
3. The adjusted tax rate for the second quarter of 2022 was 13.4 percent, as detailed below
2Q22
Pre-tax earnings Income taxes Tax rate
As reported (GAAP) $ 1,183 $ 255 21.6 %
Specified items 5,757 675 11.7 %
As adjusted (non-GAAP) $ 6,940 $ 930 13.4 %
Reconciliation of GAAP Reported to Non-GAAP Adjusted Information
Quarter Ended June 30, 2021
(Unaudited) (In millions, except per share data)
1. Specified items impacted results as follows
2Q21
Earnings Diluted
Pre-tax After-tax a EPS
As reported (GAAP) $ 1,163 $ 766 $ 0.42
Adjusted for specified items
Intangible asset amortization 1,999 1,662 0.95
Acquisition and integration costs 135 106 0.05
Change in fair value of contingent consideration 2,692 2,690 1.51
Litigation matters 107 93 0.05
Other 130 107 0.05
As adjusted (non-GAAP) $ 6,226 $ 5,424 $ 3.03
a Represents net earnings attributable to AbbVie Inc.
Acquisition and integration costs reflect integration costs related to the Allergan acquisition. Other primarily includes the purchase of an FDA priority review voucher from a third party, restructuring charges associated with streamlining global operations and COVID-19 related expenses.
Beginning in the first quarter of 2022, the company includes acquired IPR D and milestones expense in its reported non-GAAP financial measures. Reported GAAP earnings and adjusted non-GAAP earnings for the three months ended June 30, 2021 included acquired IPR D and milestones expense of $132 million on a pre-tax and after-tax basis, representing an unfavorable impact of $0.08 to both diluted EPS and adjusted diluted EPS.
2. The impact of the specified items by line item was as follows
2Q21
Cost of products sold SG A R D Other operating income Other expense, net
As reported (GAAP) $ 4,523 $ 3,164 $ 1,767 $ (68) $ 2,658
Adjusted for specified items
Intangible asset amortization (1,999) - - - -
Acquisition and integration costs (24) (94) (17) - -
Change in fair value of contingent consideration - - - - (2,692)
Litigation matters - (107) - - -
Other (21) (10) (167) 68 -
As adjusted (non-GAAP) $ 2,479 $ 2,953 $ 1,583 $ - $ (34)
Last updated: Jul 29, 2022