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. 1. Safety results were also consistent with the previous Phase 3 induction study and the known profile of Rinvoq, with no new safety risks observed. This milestone marked the third FDA-approved indication for Rinvoq. 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. On a GAAP basis, the tax rate in the quarter was 8.1 percent. AbbVie is a member of the S&P Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years. AbbVie announced the FDA approved Skyrizi for the treatment of adults with active PsA. 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. 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. Subscription management. AbbVie announced the European Commission (EC) approved Rinvoq (upadacitinib) for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents 12 years and older who are candidates for systemic therapy. It is clinically proven to firm and tighten the look of crepey skin, prevent and reduce the look of sagging, smooth deep lines and wrinkles and enhance skin tone evenness. A total of 33 abstracts, including 4 oral … Other primarily includes tax settlements and COVID-19 related expenses. Under the terms of the agreement, AbbVie will pay REGENXBIO a. | The application is primarily based on data from two pivotal Phase 3 studies involving 750 patients. 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. Specified items impacted results as follows: Change in fair value of contingent consideration. Other primarily includes tax related items and COVID-19 related charitable contributions and expenses. 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 Inc has reached its limit for free report views. On a GAAP basis, research and development expense was 13.7 percent of net revenues. On a GAAP basis, the operating margin in the first quarter was 31.5 percent. If approved by the European Commission (EC), Venclyxto in combination with hypomethylating agents would be a new regimen for patients with AML. 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. 3. AbbVie announced that Skyrizi is now available in the U.S. as a single-dose 150 mg injection for the treatment of adults with moderate to severe plaque psoriasis (PsO). 10-K. Filing Date. 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. AbbVie announced that it submitted applications to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking approval for Skyrizi (risankizumab, 150 mg) for the treatment of adults with active psoriatic arthritis (PsA). | Under the multi-year agreement, AbbVie will utilize Caribou's next-generation Cas12a CRISPR hybrid RNA-DNA genome editing and cell therapy technologies to research and develop two new CAR-T cell therapies directed to targets specified by AbbVie. 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 Internet site that you have requested may not be optimized to your screen size. At the 2021 American Academy of Neurology (AAN) Annual Meeting, AbbVie presented data across its neuroscience portfolio. Patients who received the continuous 24 hours/day subcutaneous infusion of ABBV-951 showed statistically significant increases in "On" time without troublesome dyskinesia, compared to oral levodopa/carbidopa, after 12 weeks. Refer to the Reconciliation of GAAP Reported to Non-GAAP Adjusted Information for further details. The call will be webcast through AbbVie's Investor Relations website at investors.abbvie.com. Before engaging, please read and adhere to our established community guidelines for each channel. The company's 2022 financial guidance is also being provided on both a reported and a non-GAAP basis. (Unaudited) (In millions, except per share data), Acquired in-process research and development, Net earnings attributable to noncontrolling interest. 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. In AbbVie's second-quarter 2021 financial reports announced on July 30, the company noted that global Humira net revenues for the quarter increased 4.8% to $5.068 billion, or 3.6% on an operational basis. The adjusted SG&A expense was 22.2 percent of net revenues. We track and report our progress to ensure we are delivering on our commitments and supporting our people, communities and stakeholders. On a GAAP basis, research and development expense was 12.3 percent of net revenues. Oceaneering. 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. 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. 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. Site map The adjusted operating margin was 51.1 percent. 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. Refer to the Reconciliation of GAAP Reported to Non-GAAP Adjusted Information for further details. Refer to the Reconciliation of GAAP Reported to Non-GAAP Adjusted Information for further details. AbbVie will host an investor conference call today at 8:00 a.m. Central time to discuss our first-quarter performance. 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. The adjusted R&D expense was 12.1 percent of net revenues, reflecting funding actions supporting all stages of our pipeline. Data from this head-to-head superiority study will be a key component of global regulatory submissions and full results will be presented at a future medical meeting or submitted for publication in a peer-reviewed journal. If approved, atogepant will be the first and only oral CGRP receptor antagonist specifically developed for the preventive treatment of migraine. In these studies, significantly more patients treated with Rinvoq achieved the primary and all secondary endpoints compared to placebo. All ranked secondary endpoints were also met. 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. Upgrade Your Profile and unlock all your annual reports. 3. At the American College of Rheumatology's (ACR) annual meeting, AbbVie shared 38 abstracts from across its rheumatology portfolio that underscored AbbVie's … At the United European Gastroenterology (UEG) Week, AbbVie shared 13 abstracts including 7 live presentations that reinforced AbbVie's commitment to advancing research in inflammatory bowel disease (IBD). AbbVie confirmed prior revenue guidance of greater than. Note: "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year's foreign exchange rates. Milestones and other R&D expenses include milestone payments for previously announced collaborations and the purchase of FDA priority review vouchers from third parties. A total of 33 abstracts, including 4 oral … The adjusted tax rate for the first nine months of 2020 was 11.0 percent, as detailed below: Subscribe for email alerts 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. | Full results from the SELECT-AXIS 2 trial will be presented at a future medical meeting and submitted for publication in a peer-reviewed journal. 3. Adjusted net revenues exclude specified items. The overall safety findings in these pivotal studies were generally consistent with the known safety profile of Skyrizi. This milestone marks the fourth EC-approved indication for Rinvoq. The adjusted SG&A expense was 21.2 percent of net revenues. Highlights included two Botox Cosmetic (OnabotulinumtoxinA) abstracts that were recognized as "Best of Cosmetic Oral Abstracts". Cork Metropolitan Area. NORTH CHICAGO, Ill., Feb. 2, 2022 /PRNewswire/ -- AbbVie (NYSE:ABBV) announced financial results for the fourth quarter and full year ended December 31, 2021. 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. * Represents product(s) acquired as part of the Allergan acquisition. 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. 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. According to this report the psoriasis therapeutics market size was valued at $22.9 billion in 2021, and is estimated to reach $55.8 billion by 2031, growing at a CAGR of 9.3% from 2022 to 2031. Financial results for 2021 and 2020 are presented on both a reported and a non-GAAP basis. 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. If approved, CD will mark the third indication for Skyrizi in the EU. In both studies AGN-190584 met the primary endpoint reaching statistical significance in improvement in near vision without a loss of distance vision. 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. "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.". The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. 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. On a GAAP basis, the tax rate in the quarter was 13.8 percent. 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 … SkinMedica Neck Correct Cream was designed to prevent the early signs as well as treat the visible appearance of moderate to severe neck aging. Other primarily includes COVID-19 related expenses and tax related items. 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. 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. "Operational" comparisons are presented at constant currency rates and reflect comparative local currency net revenues at the prior year's foreign exchange rates. and neuroscience. Allergan Aesthetics announced the launch of SkinMedica Neck Correct Cream, the first product from the professional-grade skincare line formulated to address the specific biology of the skin on the neck and décolleté area. AbbVie announced that it submitted a NDA to the FDA for investigational AGN-190584 (pilocarpine 1.25%) ophthalmic solution for the treatment of presbyopia. 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. Allergan Aesthetics announced the successful completion of its acquisition of Soliton, Inc. 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. 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 recommended dose of Rinvoq for AD in adults is 15 mg or 30 mg once daily based on individual patient presentation, and 15 mg once daily for adolescents and adults 65 years and older. No new safety risks were observed compared to the known safety profile of Rinvoq. Highlights included final results from PROviDE, a long-term, real-world study, evaluating the effectiveness of Duodopa (levodopa-carbidopa intestinal gel) in patients with advanced PD as well as additional data on the long-term, real-world use of Botox in patients with spasticity and cervical dystonia. The company's 2021 financial guidance is also being provided on both a reported and a non-GAAP basis. 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. a     Represents net earnings attributable to AbbVie Inc. 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. 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. AbbVie Reports Second-Quarter 2021 Financial Results. The call will be webcast through AbbVie's Investor Relations website at investors.abbvie.com. Additionally, all ranked secondary endpoints, including clinical, endoscopic and histologic outcomes, were met. Oct 10, 2022 Today, U.S.-based AbbVie is among the top three pharmaceutical companies worldwide based on sales of drugs and treatments. 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. The adjusted SG&A expense was 22.2 percent of net revenues. AbbVie announced that it submitted an application to the FDA 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). - Reports Second-Quarter Diluted EPS of $0.42 on a GAAP Basis; Adjusted Diluted EPS of $3.11. 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. 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. Reconciliation of GAAP Reported to Non-GAAP Adjusted Information. Annual Quarterly 2021 2020 2019 Revenue 56,197.00 Gross Profit 38,883.00 Net Income 11,542.00 2021 (millions USD) Income Statement table Balance Sheet Annual … Unless otherwise specified, all product names appearing in this Internet site are trademarks owned by or licensed to AbbVie Inc., its subsidiaries or affiliates. Percentage change is calculated using adjusted net revenues. In Study 2, Rinvoq (15 mg, once daily) met the primary endpoint of ASAS40 at week 14 versus placebo (45 percent compared to 23 percent) and met the first 12 of 14 ranked secondary endpoints in patients with nr-axSpA. AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. 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. Report Locked. 2. d   Reflects profit sharing for Imbruvica international revenues. Milestones and other R&D expenses include milestone payments for previously announced collaborations. AbbVie announced the launch of Refresh Digital lubricant eye drops, a new lubricant eye drop formulated to specifically relieve dryness and irritation that may occur from prolonged screen time. "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.". 1. "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year's foreign exchange rates. AbbVie Financial Statements 2009-2021 | ABBV | MacroTrends Commodities Exchange Rates Interest Rates Economy AbbVie Financial Statements 2009-2021 | ABBV Prices Financials Revenue & Profit Assets & Liabilities Margins Price Ratios Other Ratios Other Metrics Income Statement Balance Sheet Cash Flow Statement Key Financial Ratios View Annual Reports An archived edition of the call will be available after 11:00 a.m. Central time. 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.

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