Allergan Aesthetics announced the successful completion of its acquisition of Soliton, Inc. At the American Academy of Ophthalmology Annual Meeting (AAO), AbbVie presented new data from its leading eye care portfolio. GEMINI 1 data, in combination with data from the GEMINI 2 study, formed the basis of the AGN-190584 New Drug Application (NDA) currently under review with the FDA, which the agency is expected to act on by the end of 2021. At the EULAR 2021 Virtual Congress of Rheumatology, AbbVie presented new data in 41 abstracts covering its portfolio of immunology assets including Rinvoq, Skyrizi, Humira (adalimumab) and its pipeline across multiple rheumatic diseases. At the American Society of Hematology Annual Meeting (ASH), AbbVie presented results from nearly 30 abstracts across 8 types of cancer. | On a GAAP basis, research and development expense was 12.3 percent of net revenues. 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. Reflects profit sharing for Imbruvica international revenues. Acquired IPR&D primarily reflects upfront payments related to R&D collaborations and licensing arrangements with third parties. The overall safety findings in these pivotal studies were generally consistent with the known safety profile of Skyrizi. The FDA cited its ongoing review of Pfizer's post-marketing study, ORAL Surveillance, evaluating tofacitinib in patients with rheumatoid arthritis (RA). NORTH CHICAGO, Ill., March 13, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced it will present more than 20 abstracts, including one late WebCash Flow AbbVie Inc. Quarterly Annual Net Operating Cash Flow 0 2B 4B 6B 8B Dec 2021 Mar 2022 Jun 2022 Sep 2022 Dec 2022 Advertisement Overview Financials Stocks: SEC filings Access all of AbbVie's SEC filings. 3. 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. Readers should not rely upon the information in these pages as current or accurate after their publication dates. 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. 3. The change column indicates the company's relative position in this list compared to its relative position in the preceding year; i.e., an increase would be moving closer to rank 1 and vice versa. 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. 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 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 call will be webcast through AbbVie's Investor Relations website at investors.abbvie.com.

Milestones and other R&D expenses include milestone payments for previously announced collaborations and the purchase of FDA priority review vouchers from third parties. 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 extension is for an additional three years, beginning in 2022, and AbbVie and Calico will each commit to contribute an additional. The new muscles for treatment include additional muscles of the elbow and forearm, intrinsic hand muscles and thumb muscles. 2020 10-K/A. An archived edition of the call will be available after 11:00 a.m. Central time.

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. 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. /Title ( a b b v - 2 0 2 0 1 2 3 1) 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. The adjusted tax rate for the full-year 2020 was 11.2 percent, as detailed below: Subscribe for email alerts On a GAAP basis, research and development expense was 12.3 percent of net revenues. "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.". 3. Safety results were consistent with the previous Phase 3 induction studies and the known safety profile of Rinvoq, with no new safety risks observed. The company's 2022 financial guidance is also being provided on both a reported and a non-GAAP basis. The overall safety findings in these pivotal studies were generally consistent with the known safety profile of Skyrizi. "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. /Type /ExtGState 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. WebAnnual Reports Year in Review 2021 Annual Reports View the Report Download Report (Desktop) Download Report (Mobile) Previous Year in Review PDFs Year in Review 2020 Year in Review 2019 Year in Review 2018 Year in Review 2017 Year in Review 2016 Year in Review 2015 Year in Review 2014 Year in Review 2013 Year in Review 2012 Year in stream Copyright 2023 AbbVie Inc. North Chicago, Illinois, U.S.A. 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. View our social media channel guidelines , AbbVie.com April 04, 2023. 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 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 assumes no duty to update the information to reflect subsequent developments. No formal regulatory action has been taken on the sNDAs for Rinvoq in PsA, AS or AD. Diluted earnings per share attributable to AbbVie Inc. Weighted-average diluted shares outstanding. Specified items impacted results as follows: Change in fair value of contingent consideration. The safety results in this study were consistent with the known profile of Rinvoq, with no new safety risks observed. << AbbVie is updating its GAAP diluted EPS guidance for the full-year 2021 from $7.27 to $7.47 to $6.04 to $6.14. Home. Readers should not rely upon the information in these pages as current or accurate after their publication dates. The adjusted operating margin was 49.3 percent. The company presented PROs for AGN-190584, new analyses from the Phase 3 ARTEMIS studies examining the duration of intraocular pressure (IOP) lowering and biodegradation kinetics of Durysta as well as real world data from the multicenter EXPAND study evaluating twelve-month outcomes of an investigation into a novel placement of the Xen Gel Stent. Quarter and Six Months Ended June 30, 2021 and 2020, (Unaudited) (In millions, except per share data), Acquired in-process research and development, Earnings (loss) before income tax expense, Net earnings (loss) attributable to noncontrolling interest. WebAnnual Reports. 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. 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. Adjusted net revenues exclude specified items. REQUEST PRINTED MATERIALS To request information via email, please follow this link; INVESTOR CONTACTS Learn how to contact our transfer agent and investor relations The applications are supported by two Phase 3 studies in which Skyrizi demonstrated improved skin and joint symptoms and physical function, with a greater proportion of patients achieving minimal disease activity versus placebo. The adjusted tax rate for the first six months of 2021 was 12.4 percent, as detailed below: a Represents net earnings attributable to AbbVie Inc. Acquisition and integration costs reflect transaction, financing and integration costs related to the Allergan acquisition as well as the amortization of the acquisition date fair value step-up for inventory. Specified items impacted results as follows: Change in fair value of contingent consideration. On a GAAP basis, the operating margin in the second quarter was 31.8 percent. AbbVie announced that the EC approved Venclyxto (venetoclax) in combination with a hypomethylating agent, azacitidine or decitabine, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. 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. The adjusted SG&A expense was 22.2 percent of net revenues. On a GAAP basis, net interest expense was. 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. AbbVie confirmed prior revenue guidance of greater than. Title. AbbVie has no 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. 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. 3. 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. 3. Annual No new safety risks were observed compared to the known safety profile of Rinvoq. Reconciliation of GAAP Reported to Non-GAAP Adjusted Information. The impact of the specified items by line item was as follows: 3. - Reports Second-Quarter Diluted EPS of $0.42 on a GAAP Basis; Adjusted Diluted EPS of $3.11. 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. ABBV ie (NYSE: ABBV) will announce its first-quarter 2023 financial results on Thursday, April 27, 2023 before the market opens. 2020 Annual General Meeting. 2021 Proxy Statement 4 MB. 3 0 obj 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. WebThe following table lists the largest biotechnology and pharmaceutical companies ranked by revenue in billion USD. AbbVie has reported net revenues of nearly $56.2bn for the full year 2021 on a GAAP Basis, representing a rise of 22.7% compared to $45.8bn for the full year 2020. 4 0 obj 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. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. 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. Diluted earnings (loss) per share attributable to AbbVie Inc. Weighted-average diluted shares outstanding, Adjusted weighted-average diluted shares outstandinga. Refer to the Reconciliation of GAAP Reported to Non-GAAP Adjusted Information for further details. 1. /CreationDate (D:20211231161244Z) 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. This milestone marked the second 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. 2014 Annual Report 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). On a GAAP basis, the operating margin in the fourth quarter was 34.1 percent. 2021 10-K. 2021 Proxy Statement. NORTH CHICAGO,Ill., Feb.2, 2022 /PRNewswire/ -- AbbVie (NYSE:ABBV) announced financial results for the fourth quarter and full year ended December 31, 2021. 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. 3. 2020 Annual Report. 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. "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 Allergan integration also continues to track exceptionally well, with both the neuroscience and aesthetics portfolios delivering double-digit sequential growth. /Subtype /Image AbbVie. 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. Other primarily includes restructuring charges associated with streamlining global operations and COVID-19 related expenses. Diluted earnings per share attributable to AbbVie Inc. Weighted-average diluted shares outstanding. At the Association for Research in Vision and Ophthalmology (ARVO) 2021 Annual Virtual Meeting, AbbVie presented new data, including real-world evidence and patient-reported outcomes (PROs), for products across its eye care portfolio and pipeline. Results from the GLOW study demonstrated how the fixed-duration, all-oral combination showed superior progression-free survival (PFS) compared to chlorambucil plus obinutuzumab in first-line CLL as well as deeper and longer intervals of remission. Milestones and other R&D expenses include milestone payments for previously announced collaborations. 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. AbbVie is raising its adjusted diluted EPS for the full-year 2021 from $12.37 to $12.57 to $12.52 to $12.62. Web2021 Annual Report . 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. This area is reserved for members of the news media. - 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. Highlights included two Botox Cosmetic (OnabotulinumtoxinA) abstracts that were recognized as "Best of Cosmetic Oral Abstracts". /ColorSpace /DeviceGray 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 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. endobj Other primarily includes tax related items and COVID-19 related charitable contributions and expenses. Reports Third-Quarter Diluted EPS of $2.21 on a GAAP Basis, an Increase of 24.2 Percent; Adjusted

Twelve Months Ended December 31, 2021 (Unaudited) (In millions, except The adjusted tax rate for the first six months of 2020 was 10.6 percent, as detailed below: Subscribe for email alerts In the study, significantly more Rinvoq-treated patients achieved the primary endpoint of clinical remission (per Adapted Mayo Score) compared to patients on placebo (15 mg: 42 percent, 30 mg: 52 percent, placebo: 12 percent) at one year. 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. Financial results for 2021 and 2020 are presented on both a reported and a non-GAAP basis. Terms of use Other primarily includes tax related items and COVID-19 related expenses. 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 adjusted operating margin was 49.7 percent. /Creator ( w k h t m l t o p d f 0 .

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 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 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). On a GAAP basis, the tax rate in the quarter was 33.8 percent. View our social media channel guidelines , AbbVie.com The safety results in this study were consistent with the known profile of Rinvoq, with no new safety risks observed. Universidad de Panam. "Operational" comparisons are presented at constant currency rates and reflect comparative local currency net revenues at the prior year's foreign exchange rates. Reported results were prepared in accordance with GAAP and include all revenue and expenses recognized during the period. Reflects profit sharing for Imbruvica international revenues. 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. Web2021 Annual Report. YOU ARE ABOUT TO LEAVE FOR A 3RD PARTY WEBSITE. W k h t m l t o p D f 0 both a reported and a Non-GAAP.... 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Include all revenue and expenses recognized during the period observed compared to the known safety profile of Rinvoq raising! 12.52 to $ 9.46 ranked by revenue in billion USD call will be webcast through 's! Health issues today and address the medical challenges of tomorrow full-year 2021 from $ 12.37 to $ to... Attributable to AbbVie Inc. Weighted-average diluted shares outstanding to track exceptionally well, no! Annual no new safety risks were observed compared to the Reconciliation of GAAP to! Reconciliation of GAAP reported to Non-GAAP adjusted information for further details 2022 of $ on. Media channel guidelines, AbbVie.com April 04, 2023 read and adhere to our established guidelines! 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. In addition, 39 percent of patients receiving Skyrizi 360 mg achieved endoscopic remission compared to 13 percent of patients in the induction-only control group and 29 percent of Skyrizi 360 mg-treated patients achieved deep remission compared to 10 percent in the induction-only control group. 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. | 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. Based upon the momentum of our business, we are raising our full year 2021 EPS guidance and believe AbbVie is very well positioned for the long term.". 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. Milestones and other R&D expenses include milestone payments for previously announced collaborations. /ca 1.0 Milestones and other R&D expenses include milestone payments for previously announced collaborations. Before engaging, please read and adhere to our established community guidelines for each channel. a Representsnet 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. 2019 Annual Report on Form 10-K and 2020 Proxy Net earnings (loss) attributable to AbbVie Inc. This marks the sixth BTD granted to Venclexta and a submission of a sNDA for Venclexta in higher-risk MDS is planned for later this year. Quick Links. /CA 1.0

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