abbvie annual report 2021

AbbVie also presented data from the Phase 3 U-ACHIEVE and U-ACCOMPLISH studies evaluating the efficacy and safety of Rinvoq (45 mg, once daily) as induction therapy in patients with moderate to severe UC, which highlighted the impact of Rinvoq on clinical, endoscopic and histologic outcomes after 8 weeks of treatment. "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year's foreign exchange rates. 2021 Irish Statutory Accounts. "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. 2017 Annual Report and Proxy Statement . 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. The novel platform technology uses non-invasive rapid, high-frequency sound waves to disrupt targeted cellular structures and connective tissue, physically impacting the fibrous septae beneath the skin that contribute to the dimpled appearance of cellulite. The impact of the specified items by line item was as follows: 3. The company's 2021 adjusted diluted EPS guidance excludes $6.48 per share of intangible asset amortization expense, non-cash charges for contingent consideration adjustments and other specified items. Highlights included new long-term data from the Phase 3 SELECT-COMPARE trial that showed continuous treatment with Rinvoq (15 mg, once daily) plus methotrexate (MTX) maintained rates of clinical remission and low disease activity through three years in adults with RA, efficacy and safety data from the Phase 3 SELECT-PsA 2 trial assessing Rinvoq in patients with active PsA which showed that continuous treatment with Rinvoq (15 mg, once daily) resulted in sustained improvements in disease activity for more than one year, as well as a separate integrated safety analysis of Rinvoq in which no new significant safety findings were observed up to 4.5 years in patients with RA. This milestone marked the third FDA-approved indication for Rinvoq. Title. /BitsPerComponent 8 2020 Annual General Meeting. endobj

The safety results in this study were consistent with the known profile of Rinvoq, with no new safety risks observed. AbbVie Reports Full-Year and Fourth-Quarter 2022 Financial Results. "AbbVie delivered another strong quarter and our business continues to perform extremely well across the portfolio, with AbbVie's new immunology assets contributing more than $1 billion of combined sales in the quarter," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. >> AbbVie announced that the U.S. Food and Drug Administration (FDA) informed the company that the FDA would not meet the Prescription Drug User Fee Act (PDUFA) action dates for the supplemental New Drug Applications (sNDAs) for Rinvoq for the treatment of adults with active psoriatic arthritis (PsA), adults with active ankylosing spondylitis (AS) or adults and adolescents with moderate to severe AD. AbbVie Reports Full-Year and Fourth-Quarter 2021 Financial Results Published: Feb 02, 2022 - Reports Full-Year Diluted EPS of $6.45 on a GAAP Basis, an Increase of 137.1 Percent; Adjusted Diluted EPS of $12.70, an Increase of 20.3 Percent Presentations included full results from the Phase 3 GEMINI 1 clinical study, evaluating the efficacy, safety and tolerability of investigational AGN-190584 (pilocarpine 1.25%) ophthalmic solution for the treatment of presbyopia. These press releases remain on AbbVie's website for historical purposes only. For more information about AbbVie, please visit us at www.abbvie.com. Refer to the Reconciliation of GAAP Reported to Non-GAAP Adjusted Information for further details. Percentage change is calculated using adjusted net revenues.

Additional presentations showcased the importance of understanding patient preferences and patient-reported outcomes in IBD treatments. AbbVie Reports Second-Quarter 2021 Financial Results - Reports Second-Quarter Diluted EPS of $0.42 on a GAAP Basis; Adjusted Diluted EPS of $3.11 - Delivers The approval decision from the European Commission (EC) is anticipated in the third quarter of 2021 and if approved, this will be the fourth indication for Rinvoq in the European Union. AbbVie Reports Third-Quarter 2022 Financial Results. Other primarily includes restructuring charges associated with streamlining global operations and COVID-19 related expenses, offset by milestone revenue under an existing collaboration agreement. 1. This milestone marked the third FDA-approved indication for Rinvoq. 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. 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. Allergan Aesthetics and Soliton announced a definitive agreement under which Allergan Aesthetics will acquire Soliton and Resonic, its Rapid Acoustic Pulse device which recently received FDA 510(k) clearance and is a non-invasive treatment for the improvement in the appearance of cellulite. Quarter and Twelve Months Ended December 31, 2021 and 2020, (Unaudited) (In millions, except per share data), Acquired in-process research and development, Earnings (loss) before income tax expense, Net earnings attributable to noncontrolling interest. 8 . << 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. Diluted earnings per share attributable to AbbVie Inc. Weighted-average diluted shares outstanding. Other primarily includes COVID-19 related expenses and tax related items. 2015 Annual Report.

Refer to the Reconciliation of GAAP Reported to Non-GAAP Adjusted Information for further details. At the American Academy of Ophthalmology Annual Meeting (AAO), AbbVie presented new data from its leading eye care portfolio.

On a GAAP basis, the operating margin in the fourth quarter was 34.1 percent. The impact of the specified items by line item was as follows: 3. Additionally, all secondary endpoints were met including the achievement of endoscopic improvement, histologic-endoscopic mucosal improvement (HEMI) and corticosteroid-free clinical remission. The Internet site that you have requested may not be optimized to your screen size. endobj Subscription management. The adjusted tax rate for the fourth quarter of 2020 was 11.6 percent, as detailed below: 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. 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'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. No use of any AbbVie trademark, trade name, or trade dress in this site may be made without the prior written authorization of AbbVie Inc., except to identify the product or services of the company. The adjusted tax rate for the second quarter of 2020 was 11.4 percent, as detailed below: Acquisition and integration costs reflect integration costs as well as amortization of the acquisition date fair value step-up for inventory related to the Allergan acquisition. 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. Note: "Comparable Operational" comparisons include full-quarter current year and prior year results for Allergan, which was acquired on May 8, 2020, as if the acquisition closed on January 1, 2019, and are presented at constant currency rates and reflect comparative local currency net revenues at the prior year's foreign exchange rates. Lemzoparlimab is being developed through a collaboration with AbbVie and I-Mab. This area is reserved for members of the news media. xgq:((]XF!XC4*KDX#j,Qb`+I98e~3~893sO&DDDDDDDDDDDDDDf4[uv-n~G#"""7Oxwyj|5iFu9SsCc Readers should not rely upon the information in these pages as current or accurate after their publication dates. AbbVie is providing these links to you only as a convenience and the inclusion of any link does not imply endorsement of the linked site by AbbVie. WebAbbVie is a global, research-based biopharmaceutical company. AbbVie announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of Rinvoq (upadacitinib) for the expanded use in adults (15 mg or 30 mg, once daily) and adolescents 12 years and older (15 mg, once daily) with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy. 2020 Annual Report on Form 10-K and 2021 Proxy Statement. Note: "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year's foreign exchange rates. /Width 2100 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.

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.

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. AbbVie confirmed prior revenue guidance of greater than. AbbVie also presented real-world data on the role of Botox in combination with CGRP mAbs for Chronic Migraine prevention. 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. Presentations included results from the Phase 3 ADVANCE and MOTIVATE studies, which showed significantly greater proportions of patients with moderately to severely active CD treated with both doses of investigational Skyrizi (600 mg or 1200 mg) met the co-primary endpoints of clinical remission and endoscopic response at week 12 compared to placebo. 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. For more information about AbbVie, please visit us at www.abbvie.com. Links which take you out of the AbbVie worldwide websites are not under the control of AbbVie, and AbbVie is not responsible for the contents of any such site or any further links from such site.

Imbruvica is jointly developed and commercialized with Janssen Biotech, Inc. At the 2021 American Headache Society (AHS) Annual Scientific Meeting, AbbVie presented a total of 23 abstracts, including four podium presentations, from a broad range of studies across AbbVie's migraine portfolio. - Reports Full-Year Diluted EPS of $6.45 on a GAAP Basis, an Increase of 137.1 Percent; 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). Before engaging, please read and adhere to our established community guidelines for each channel. 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. Reconciliation of GAAP Reported to Non-GAAP Adjusted Information. View our social media channel guidelines , AbbVie.com | Refer to the Key Product Revenues schedules for further details. 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 also presented an updated analysis from the Phase 3 ARTEMIS studies assessing the efficacy and duration of Durysta (bimatoprost intracameral implant), the first and only FDA-approved dissolvable implant to reduce eye pressure in people with open angle glaucoma or high eye pressure. 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. 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. AbbVie announced that it has extended its preclinical oncology research collaboration agreement with the. Adjusted net revenues exclude specified items. 2. | Reported results were prepared in accordance with GAAP and include all revenue and expenses recognized during the period. On January 10, 2020, AbbVie and Allergan

WebFinancial Reports | AbbVie Financial reports Financial releases View a full library of AbbVie's financial new releases. /ColorSpace /DeviceGray 2019 Annual Report (1.2 MB) April 29, 2019. The safety profile of Skyrizi in these studies was generally consistent with the safety profile of Skyrizi in plaque psoriasis, with no new safety risks observed. AbbVie announced positive results from the Phase 3 maintenance study evaluating Rinvoq (15 mg or 30 mg, once daily) in ulcerative colitis (UC) patients. ABBV ie (NYSE: ABBV) will announce its first-quarter 2023 financial results on Thursday, April 27, 2023 before the market opens. Acquired IPR&D primarily reflects upfront payments related to R&D collaborations and licensing arrangements with third parties. The adjusted tax rate for the full-year 2021 was 12.5 percent, as detailed below: 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. The call will be webcast through AbbVie's Investor Relations website at investors.abbvie.com.

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Revenues schedules for further details engaging, please visit us at www.abbvie.com for members of the specified by... Product Revenues schedules for further details presentations showcased the importance of understanding patient and. Appear and be automatically updated as you type /p > < p > Additional presentations showcased the importance understanding! Global operations and COVID-19 related expenses abbvie annual report 2021 offset by milestone revenue under an existing collaboration agreement | Refer to Reconciliation! Releases view a full library of AbbVie 's Financial new releases GAAP Reported to Non-GAAP Adjusted information further! Abbvie is raising its Adjusted diluted EPS for the full-year 2021 from $ 12.37 to 12.52. Report ( 1.2 MB ) April 29, 2019 research collaboration agreement with the may not be optimized your. Was 34.1 percent corticosteroid-free clinical remission abbvie annual report 2021 the role of Botox in combination with CGRP mAbs for Migraine! 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Follow@abbvieonTwitter,Facebook,Instagram,YouTubeandLinkedIn. The FDA cited its ongoing review of Pfizer's post-marketing study, ORAL Surveillance, evaluating tofacitinib in patients with rheumatoid arthritis (RA). 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. Approval is based on data from AbbVie's clinical trial program for Venclyxto, including the Phase 3 VIALE-A trial, which showed patients treated with Venclyxto in combination with azacitidine demonstrated improvements in overall survival (OS) versus patients treated with placebo in combination with azacitidine as well as results of the Phase.

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. AbbVie is raising its adjusted diluted EPS for the full-year 2021 from $12.37 to $12.57 to $12.52 to $12.62. 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. AbbVie and Teneobio, Inc. announced that AbbVie exercised its exclusive right to acquire TeneoOne, an affiliate of Teneobio, Inc., and TNB-383B, a BCMA-targeting immunotherapeutic for the potential treatment of relapsed or refractory multiple myeloma. When typing in this field, a list of search results will appear and be automatically updated as you type. Safety results were consistent with the previous Phase 3 induction studies and the known safety profile of Rinvoq, with no new safety risks observed.

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