On January 10, 2020, AbbVie and Allergan Copyright 2023 AbbVie Inc. North Chicago, Illinois, U.S.A. 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.

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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. YOU ARE ABOUT TO LEAVE FOR A 3RD PARTY WEBSITE.

Lemzoparlimab is being developed through a collaboration with AbbVie and I-Mab. The adjusted R&D expense was 11.3 percent of net revenues, reflecting funding actions supporting all stages of our pipeline. 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. 1.

Web2021 Annual Report on Form 10-K and 2022 Proxy Statement. An archived edition of the call will be available after 11:00 a.m. Central time. << 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. 2 Administrative Costs take into account: 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). "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year's foreign exchange rates. 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 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. The adjusted operating margin was 49.3 percent. AbbVie expects to deliver adjusted diluted EPS for the full-year 2022 of $14.00 to $14.20. AbbVie is issuing its GAAP diluted EPS guidance for the full-year 2022 of $9.26 to $9.46. 2021 Annual Report 6 MB. Allergan Aesthetics announced the successful completion of its acquisition of Soliton, Inc.

Reconciliation of GAAP Reported to Non-GAAP Adjusted Information. 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. AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. This milestone marked the second FDA-approved indication for Skyrizi. AbbVie announced the FDA approved Skyrizi for the treatment of adults with active PsA. On a GAAP basis, selling, general and administrative expense was 21.9 percent of net revenues. >> The "Yes" link below will take you out of the AbbVie family of websites. 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. 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. 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 call will be webcast through AbbVie's Investor Relations website at investors.abbvie.com. On a GAAP basis, selling, general and administrative expense was 21.9 percent of net revenues. AbbVie announced that it has extended its preclinical oncology research collaboration agreement with the. Note: "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year's foreign exchange rates. 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. 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. 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. AbbVie confirmed prior revenue guidance of greater than.

Acquired IPR&D primarily reflects upfront payments related to R&D collaborations and licensing arrangements with third parties. This area is reserved for members of the news media. 8 0 obj Readers should not rely upon the information in these pages as current or accurate after their publication dates.

Other primarily includes COVID-19 related expenses and tax related items. 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. 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. 3 0 obj On a GAAP basis, the operating margin in the fourth quarter was 34.1 percent. 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. 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.

Refer to the Key Product Revenues schedules for further details. This milestone marked the third FDA-approved indication for Rinvoq. 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. | The adjusted tax rate for the fourth quarter of 2021 was 12.5 percent, as detailed below: 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. At the American Academy of Ophthalmology Annual Meeting (AAO), AbbVie presented new data from its leading eye care portfolio. Acquired IPR&D primarily reflects upfront payments related to R&D collaborations and licensing arrangements with third parties. Quick Links. Web0.500% Senior Notes due 2021 ABBV21C New York Stock Exchange 1.500% Senior Notes due 2023 ABBV23B New York Stock Exchange 1.375% Senior Notes due 2024 ABBV24 Percentage change is calculated using adjusted net revenues. Diluted earnings per share attributable to AbbVie Inc. Weighted-average diluted shares outstanding. 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. 2019 Annual Report (1.2 MB) April 29, 2019. from 8 AM - 9 PM ET. AbbVie Inc. Reconciliation of GAAP Reported to Non-GAAP Adjusted Information. Site map 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. To ensure we're delivering on our commitments, we track and report our progress and continually evaluate our efforts relative to external frameworks such as the Universidad de Panam. 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). /BitsPerComponent 8 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. The adjusted operating margin was 49.7 percent. 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. /Title ( a b b v - 2 0 2 0 1 2 3 1) This is the second collaboration extension and builds on the partnership established in 2014 and extended in 2018. %PDF-1.4 NORTH CHICAGO,Ill., July 30, 2021 /PRNewswire/ --AbbVie (NYSE:ABBV) announced financial results for the second quarter ended June 30, 2021.

AbbVie has no 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. Reconciliation of GAAP Reported to Non-GAAP Adjusted Information. AbbVie Reports Full-Year and Fourth-Quarter 2022 Financial Results Reports Full-Year Diluted EPS of $6.63 on a GAAP Basis, an Increase of 2.8 Percent; Adjusted 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. The adjusted gross margin ratio was 83.6 percent. "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. - Reports Second-Quarter Diluted EPS of $0.42 on a GAAP Basis; Adjusted Diluted EPS of $3.11. 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. U.S. Humira net revenues were $4.257 billion, an increase of 7.1%. /Type /XObject 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. At the American Society of Hematology Annual Meeting (ASH), AbbVie presented results from nearly 30 abstracts across 8 types of cancer. Skyrizi is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.

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