Leishmaniasis, Diffuse Cutaneous

– Series A financing co-led by Third Rock Ventures, RTW and Perceptive Xontogeny Venture Fund, and includes new investors Nextech, Janus Henderson Investors, Ally Bridge Group, Wellington Management, T. Rowe Price, Cormorant Asset Management and Piper Heartland with participation from existing seed investors – – Initial Phase 1 results with CARGO’s CD22 CAR T-cell therapy demonstrated durable complete responses in greater than 50% of patients with large B-cell lymphoma (LBCL) that is relapsed/refractory (R/R) to CD19 CAR T-cell therapy. CARGO plans to commence Phase 2 pivotal trial of CRG-022 (CD22 CAR) in mid-2023 in patients with LBCL that is R/R to CD19 CAR T-cell therapy – – CD22 CAR has been granted Breakthrough Therapy Designation by the FDA, which is intended to expedite the development and review of drugs for patients with significant unmet need – – CARGO Therapeutics was launched in 2021 by Samsara BioCapital in collaboration with CAR T pioneers, Crystal Mackall, MD, and Robbie Majzner, MD, and accomplished cancer advocate, Nancy Goodman, JD – SAN MATEO, Calif., March 01, 2023 (GLOBE NEWSWIRE) -- CARGO Therapeutics, Inc. (CARGO), a biotechnology company advancing a next generation of CAR T-cell therapies for cancer, today announced the close of a $200 million oversubscribed and upsized Series A financing. The financing was co-led by Third Rock Ventures, RTW Investments, LP and Perceptive Xontogeny Venture Fund, and includes additional new investors Nextech, Janus Henderson Investors, Ally Bridge Group, Wellington Management, funds and accounts advised by T. Rowe Price Associates, Inc., Cormorant Asset Management and Piper Heartland. Founding investor Samsara BioCapital and existing seed investors Red Tree Venture Capital and Emerson Collective also participated in the financing. CARGO is advancing what will potentially be a first and best-in-class autologous CD22 chimeric antigen receptor T-cell (CAR T) therapy as well as a pipeline of next generation CAR T-cell therapies for cancer using its proprietary cell engineering platform technologies. The proceeds from the financing will be used to advance CARGO’s autologous CD22 CAR T-cell therapy candidate, CRG-022, through a pivotal multicenter Phase 2 trial in patients with LBCL whose disease has relapsed or is refractory to CD19 CAR T-cell therapy. CARGO also intends to advance its proprietary platform technologies and discovery-stage programs to deliver better outcomes for patients with cancer who have high unmet need. “Approximately sixty percent of patients with LBCL who are treated with CD19 CARs do not experience durable responses due to disease resistance. Additionally, many patients lack access to these potentially curative therapies due to challenges related to manufacturing and reimbursement. CARGO Therapeutics is building upon deep expertise in understanding resistance to CAR T-cell therapies to deliver next generation cell products for patients,” said Gina Chapman, CEO of CARGO Therapeutics. "Our recent accomplishments and this new funding enable us to build a truly differentiated platform that is poised to meaningfully advance the cell therapy field. We are extremely pleased to have the support of seasoned new and current investors who share our vision of developing the next generation of best-in-class CARs that have the potential to extend life for many more patients.” The ongoing Phase 1 clinical trial (NCT04088890) is evaluating CD22 CAR T-cell therapy in patients with LBCL that is R/R to CD19 CAR cell therapy. Initial results from this trial were reported in Blood in April 2021. Updated results were presented at the Transplantation & Cellular Therapies meetings of ASTCT and CIBMTR on February 17, 2023 at the “Best Abstracts” session. Forty-one patients were enrolled, 40 underwent leukapheresis and 38 had successful manufacturing (95%). Thirty-eight participants were dosed at two different levels and had a median follow-up of 18.4 months. Infused patients were a median age of 65 years old, received a median of 4 prior lines of therapy (range 3-8), and 37 (97%) progressed after prior CAR19 therapy. The majority of patients had diffuse LBCL. The overall response (ORR) and complete response (CR) rates are 68% and 53% in the 38 patients. Only 1 of the 20 patients who achieved a CR has relapsed to date. At this interim analysis, the median overall survival was 22.5 months. Overall the CD22 CAR T toxicity pro manageable. On the basis of the Phase 1 data, CD22 CAR has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA), which is intended to expedite the development and review of drugs for patients with significant unmet need. In 2023, CARGO plans to commence a pivotal multicenter Phase 2 clinical trial to study the safety and efficacy of CRG-022 in patients with LBCL that is R/R to CD19 CAR cell therapy. CARGO also plans to study CRG-022 in pediatric B-cell Acute Lymphoblastic Leukemia (B-ALL). “CARGO’s unique approach to engineering CAR T-cell therapy has the potential to deliver best-in-class treatments for LBCL, for which there is no approved CD22-directed therapy,” said Reid Huber, PhD, partner at Third Rock Ventures. "Given CARGO’s progress to date and its experienced leadership team, CARGO is well-positioned to be first-to-market with an autologous CD22 CAR T-cell therapy that may extend life and give hope for a cure for patients with CD19 relapsed/refractory B-cell malignancies." In 2021, internationally recognized experts focused on immuno-oncology and CAR T-cell engineering, collaborated with Samsara BioCapital to operationalize CARGO Therapeutics (formerly Syncopation Life Sciences). Crystal Mackall, MD, and Robbie Majzner, MD, founded the Company with Nancy Goodman, JD. The founders' overarching mission was to overcome CAR resistance to extend the clinical benefit of CARs for patients in need. Co-founder Crystal Mackall added, “CARGO was founded to make a meaningful difference to patients’ lives. The differentiated CD22 clinical pro in more than 100 patients has shown impressive activity with a very favorable safety profile, and in combination with CARGO’s proprietary platforms, positions us to build and deliver the next generation of CAR T therapies.” About CRG-022 CRG-022 is CARGO's investigational cell therapy that is composed of autologous T-cells transduced with a lentiviral vector (m971-BBZ) expressing a CD22-targeting CAR. CD22 is a transmembrane protein expressed on normal B-cells and B-cell malignancies. CRG-022 is currently being evaluated in a Phase 1/1b clinical trial of autologous CD22 CAR T-cells in children and young adults with recurrent or refractory (R/R) B-cell malignancies. Initial results in adults demonstrate the safety and antitumor activity of CAR T-cell therapy targeting CD22 in patients with LBCL that is R/R to CD19 CAR cell therapy. CARGO’s CD22 CAR has a unique design which is associated with efficacy in the clinic that has not been seen with other CD22 CARs. CARGO believes that CRG-022 has the potential to treat LBCL in patients for whom prior CD19 CAR T-cell therapies have failed. About Large B-Cell Lymphoma (LBCL) Lymphoma that affects B lymphocytes are called B-cell lymphomas. B-cells make antibodies to fight infections and are an important part of the human immune system. B-cell lymphomas account for approximately 85% of non-Hodgkin lymphomas (NHL) in the United States. LBCL is an aggressive (fast-growing) lymphoma that occurs most commonly in people over the age of 60, though it can occur in childhood. About CARGO Therapeutics (formerly Syncopation Life Sciences) Our mission is to outsmart cancer and develop the next generation of best-in-class chimeric antigen receptor T-cell (CAR T) therapies. Our proprietary platform technologies enable us to engineer and develop next-generation best-in-class CARs that incorporate complex therapeutic cargo with the potential to achieve durable responses that are curative for more cancer patients. Our founders are pioneers and world experts in CAR T-cell therapy, and our team has experience and success developing, manufacturing, launching and commercializing oncology and cell therapy products. For more information, please visit the CARGO Therapeutics website at About Third Rock Ventures Third Rock Ventures is a leading healthcare venture firm focused on advancing disruptive areas of science and medicine to deliver breakthroughs to patients. By starting with big ideas and fostering collaboration among people with expertise in science, medicine, business and strategy, we aim to discover, launch and build innovative companies that can transform the lives of patients. Our mission is to be the preferred partner for entrepreneurs, investors, employees and industry to build great companies that discover and develop products that make a difference for the patients we serve. For more information, please visit . About RTW Investments, LP RTW Investments, LP is a New York-based, global, full life-cycle investment firm that focuses on identifying transformational and disruptive innovations across the biopharmaceutical and medical technologies sectors. As a leading partner of industry and academia, RTW combines deep scientific expertise with a solution-oriented investment approach to advance emerging medical therapies by building and supporting the companies and/or academics developing them. For further information about RTW, please visit . About Perceptive Xontogeny Venture Funds The Perceptive Xontogeny Venture Funds (“PXV Funds”) are Perceptive Advisors investment vehicles focused purely on early-stage, private venture investments in life sciences companies. Primary investments for the Funds include companies that are seeking a lead investor for Series A and B financings, which include both companies that are seeded and incubated at Xontogeny and companies that are seeded and incubated by other organizations, accelerators and seed investors. The PXV Funds are also open to participating in syndicated Series A and B financings as a co-lead or passive investor with other venture capital firms. For more information, visit . About Samsara BioCapital Samsara BioCapital is a new breed of biotech investment fund focused on translating cutting-edge biology into new therapies to treat patients with unmet medical needs. Founded in 2016 by Srinivas Akkaraju, M.D., Ph.D., our team of scientists, investors and entrepreneurs takes a long-term view on value creation across all stages of public and private life science companies. We believe in a collaborative, hands-on approach, working closely with entrepreneurs to harness exciting scientific advances and build leading companies. Samsara actively manages assets on behalf of endowments, foundations and family offices. For more information, please visit . About Crystal Mackall, MD Dr. Mackall is the Ernest and Amelia Gallo Family Professor of Pediatrics and Internal Medicine at Stanford University. She serves as Founding Director of the Stanford Center for Cancer Cell Therapy, Associate Director of Stanford Cancer Institute, Leader of the Cancer Immunology and Immunotherapy Program, and Director of the Parker Institute for Cancer Immunotherapy at Stanford. During a 27-year tenure at NCI, culminating as Chief of the Pediatric Oncology Branch, and now at Stanford, she has led an internationally recognized translational research program focused on immuno-oncology. Dr. Mackall’s lab invented the CD22 CAR that is the focus of this license application (Haso, Blood 2014), and she played a leading role in the NCI CD22 CAR clinical trial (Fry, Nat Med 2018; Shah, JCO, 2020). About Robbie Majzner, MD Dr. Majzner is the Taube Distinguished Scholar for Pediatric Immunotherapy and an Assistant Professor of Pediatrics at Stanford University School of Medicine. His work has identified target antigen density as a major contributor to CAR T-cell efficacy, and he has generated novel CAR architectures capable of overcoming low target antigen density (Majzner et al., Cancer Discovery, 2020). He has also generated and optimized novel receptors to recognize antigens over-expressed on pediatric solid tumors such as GD2 (Mount/Majzner et al., Nature Medicine, 2018) B7-H3 (Majzner et al., Clinical Cancer Research, 2019), and ALK (Walker/Majzner et al., Molecular Therapy, 2017), several of which are now in first-in-child clinical trials. About Nancy Goodman, JD Ms. Goodman is the CEO of Kids v Cancer, author and lead advocate of the RACE for Children Act and the Creating Hope Act Rare Pediatric Priority Review Voucher Program. Among the honors she has received are: American Association of Cancer Research Distinguished Advocacy Award, Fast Company Magazine as top ten most innovative nonprofits (award to Kids v Cancer), US Food and Drug Administration Group Recognition Award, Member of U.S. Vice President Biden’s Blue Ribbon Pediatric Oncology Panel for the Cancer Moonshot, Member of National Cancer Institute Board of Scientific Counselors. CARGO is outsmarting cancer to deliver more cures. Source: CARGO Therapeutics, Inc. Find more information at cargo-tx.com Follow us on LinkedIn: CARGO Therapeutics Follow us on Twitter: @CARGOTx Media Contact: Maura Gavaghan maura@redhousecomms.com

Reports Full-Year Diluted EPS of $6.63 on a GAAP Basis, an Increase of 2.8 Percent; Adjusted Diluted EPS of $13.77, an Increase of 16.4 Percent; These Results Include an Unfavorable Impact of $0.39 Per Share related to 2022 Acquired IPR&D and Milestones Expense1 Delivers Full-Year Net Revenues of $58.054 Billion, an Increase of 3.3 Percent on a Reported Basis and 5.1 Percent on an Operational Basis Full-Year Global Net Revenues from the Immunology Portfolio Were $28.924 Billion, an Increase of 14.4 Percent on a Reported Basis, or 16.0 Percent on an Operational Basis; Global Humira Net Revenues Were $21.237 billion; Global Skyrizi Net Revenues Were $5.165 Billion; Global Rinvoq Net Revenues Were $2.522 Billion Full-Year Global Net Revenues from the Hematologic Oncology Portfolio Were $6.577 Billion, a Decrease of 9.0 Percent on a Reported Basis, or 7.6 Percent on an Operational Basis; Global Imbruvica Net Revenues Were $4.568 Billion; Global Venclexta Net Revenues Were $2.009 Billion Full-Year Global Net Revenues from the Neuroscience Portfolio Were $6.528 Billion, an Increase of 10.1 Percent on a Reported Basis, or 11.6 Percent on an Operational Basis; Global Botox Therapeutic Net Revenues Were $2.719 Billion; Global Vraylar Net Revenues Were $2.038 Billion Full-Year Global Net Revenues from the Aesthetics Portfolio Were $5.333 Billion, an Increase of 1.9 Percent on a Reported Basis, or 5.1 Percent on an Operational Basis; Global Botox Cosmetic Net Revenues Were $2.615 Billion; Global Juvederm Net Revenues Were $1.428 Billion Reports Fourth-Quarter Diluted EPS of $1.38 on a GAAP Basis, a decrease of 38.9 Percent; Adjusted Diluted EPS of $3.60, an increase of 16.9 Percent; These Results Include an Unfavorable Impact of $0.13 Per Share Related to Fourth-Quarter 2022 Acquired IPR&D and Milestones Expense Delivers Fourth-Quarter Net Revenues of $15.121 Billion, an Increase of 1.6 Percent on a Reported Basis and 3.8 Percent on an Operational Basis Provides 2023 Adjusted Diluted EPS Guidance Range of $10.70 to $11.10, which Excludes Any Unfavorable Impact Related to Acquired IPR&D and Milestones Expense NORTH CHICAGO, Ill., Feb. 9, 2023 /PRNewswire/ -- AbbVie (NYSE:ABBV) announced financial results for the fourth quarter and full year ended December 31, 2022. "2022 was another highly productive year capping a decade of outstanding performance. Since our inception, we have built a diverse portfolio of growth products with significant leadership positions, developed a robust pipeline of innovative assets and created a culture of strong execution," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "Looking forward, we have a solid foundation which will allow us to absorb the U.S. Humira loss of exclusivity, return to strong top-line growth in 2025 and drive top-tier financial performance over the long term." Fourth-Quarter Results Worldwide net revenues were $15.121 billion, an increase of 1.6 percent on a reported basis, or 3.8 percent on an operational basis. Global net revenues from the immunology portfolio were $7.925 billion, an increase of 17.5 percent on a reported basis, or 19.5 percent on an operational basis. Global Humira net revenues of $5.579 billion increased 4.6 percent on a reported, or 6.0 percent on an operational basis. U.S. Humira net revenues were $5.006 billion, an increase of 9.9 percent. Internationally, Humira net revenues were $573 million, a decrease of 26.5 percent on a reported basis, or 16.9 percent on an operational basis. Global Skyrizi net revenues were $1.576 billion, an increase of 76.1 percent on a reported basis, or 78.9 percent on an operational basis. Global Rinvoq net revenues were $770 million, an increase of 49.0 percent on a reported basis, or 55.4 percent on an operational basis. Global net revenues from the hematologic oncology portfolio were $1.631 billion, a decrease of 12.9 percent on a reported basis, or 11.2 percent on an operational basis. Global Imbruvica net revenues were $1.115 billion, a decrease of 19.5 percent, with U.S. net revenues of $841 million and international profit sharing of $274 million. Global Venclexta net revenues were $516 million, an increase of 5.7 percent on a reported basis, or 12.2 percent on an operational basis. Global net revenues from the neuroscience portfolio were $1.710 billion, an increase of 3.4 percent on a reported basis, or 5.1 percent on an operational basis. Global Botox Therapeutic net revenues were $728 million, an increase of 8.5 percent on a reported basis, or 10.7 percent on an operational basis. Global Vraylar net revenues were $565 million, an increase of 15.5 percent. Global Ubrelvy net revenues were $197 million, an increase of 7.7 percent. Global net revenues from the aesthetics portfolio were $1.287 billion, a decrease of 8.5 percent on a reported basis, or 4.2 percent on an operational basis. Global Botox Cosmetic net revenues were $642 million, an increase of 2.6 percent on a reported basis, or 7.1 percent on an operational basis. Global Juvederm net revenues were $322 million, a decrease of 25.4 percent on a reported basis, or 19.0 percent on an operational basis. On a GAAP basis, the gross margin ratio in the fourth quarter was 72.4 percent. The adjusted gross margin ratio was 86.0 percent. On a GAAP basis, selling, general and administrative (SG&A) expense was 22.6 percent of net revenues. The adjusted SG&A expense was 20.8 percent of net revenues. On a GAAP basis, research and development (R&D) expense was 11.8 percent of net revenues. The adjusted R&D expense was 11.5 percent of net revenues, reflecting funding actions supporting all stages of our pipeline. Acquired IPR&D and milestones expense was 1.6 percent of net revenues. On a GAAP basis, the operating margin in the fourth quarter was 36.4 percent. The adjusted operating margin was 52.1 percent. Net interest expense was $476 million. On a GAAP basis, the tax rate in the quarter was 16.6 percent. The adjusted tax rate was 13.4 percent. Diluted EPS in the fourth quarter was $1.38 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $3.60. These results include an unfavorable impact of $0.13 per share related to acquired IPR&D and milestones expense. Recent Events AbbVie announced the European Commission (EC) approved Skyrizi (risankizumab, 600 mg intravenous induction and 360 mg subcutaneous maintenance therapy) as the first specific interleukin-23 (IL-23) inhibitor for the treatment of adults with moderately to severely active Crohn's disease (CD) who have had inadequate response, lost response or were intolerant to conventional or biologic therapy. The approval is supported by results from three Phase 3 studies in which Skyrizi demonstrated significant improvement in clinical remission and endoscopic response, compared to placebo, as both induction and maintenance therapy. This approval marks the third indication for Skyrizi in the European Union (EU). Skyrizi is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally. At the American College of Rheumatology's (ACR) annual meeting, AbbVie shared 36 abstracts that underscore AbbVie's commitment to advancing research to help more people living with rheumatic diseases. Analyses presented showcased data from the clinical trial programs evaluating Rinvoq (upadacitinib) for the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (AS) as well as data evaluating Skyrizi for the treatment of psoriasis (PsO) and PsA. AbbVie announced that the U.S. Food and Drug Administration (FDA) accepted, for priority review, the Biologics License Application (BLA) for epcoritamab, an investigational subcutaneous bispecific antibody for the treatment of adult patients with relapsed/refractory (r/r) large B-cell lymphoma (LBCL). Additionally, AbbVie announced the European Medicines Agency (EMA) validated AbbVie's Marketing Authorization Application (MAA) for epcoritamab for the treatment of adult patients with r/r diffuse LBCL. Both applications are supported by data from the EPCORE NHL-1 Phase 2 trial evaluating the safety and preliminary efficacy of subcutaneous epcoritamab in adult patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin's lymphoma (NHL). Epcoritamab is being co-developed by Genmab and AbbVie. At the American Society of Hematology (ASH) Annual Meeting, AbbVie presented results from nearly 65 abstracts, including 15 oral presentations, across eight types of cancer. Highlights included four oral presentations evaluating investigational epcoritamab for the treatment of r/r follicular lymphoma (FL), previously untreated FL, r/r diffuse LBCL as well as Richter's syndrome; data from cohort three of the Phase 2 REFINE study evaluating navitoclax in combination with ruxolitinib in JAK inhibitor-naïve patients with myelofibrosis (MF); data from the Phase 2 CAPTIVATE and Phase 3 GLOW studies evaluating fixed-duration treatment in patients with chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL) who received the Imbruvica (ibrutinib) + Venclexta (venetoclax) combination regimen. AbbVie also presented multiple abstracts evaluating Venclexta in approved CLL and acute myeloid leukemia (AML) indications and the investigational multiple myeloma (MM) indication. Imbruvica is jointly developed and commercialized with Janssen Biotech, Inc. 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. AbbVie announced that the FDA approved Vraylar (cariprazine) as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults. The approval marks the fourth indication for Vraylar, which is now the first and only dopamine and serotonin partial agonist FDA-approved for the most common forms of depression – as an adjunctive treatment for MDD and the treatment of depressive episodes associated with bipolar I disorder. The approval is supported by clinical data demonstrating the efficacy and well-established tolerability of Vraylar as an adjunctive treatment for MDD with an antidepressant therapy. Vraylar is being co-developed by AbbVie and Gedeon Richter Plc. At the European Headache Federation Congress (EHC) 2022, AbbVie shared 15 abstracts which underscore its commitment to people living with migraine. Presentations highlighted late-breaking data from the Chronic Migraine Epidemiology and Outcomes - International (CaMEO-I) study, evaluating the frequency and burden of neck pain with headache among people with and without migraine, as well as results from the Phase 3 PROGRESS trial evaluating Qulipta (atogepant) for the preventive treatment of chronic migraine (CM) in patients living in Europe. AbbVie announced new results from its exploratory NOVA phase 2 dose-ranging study evaluating the efficacy and safety of AGN-151607, a novel investigational neurotoxin for the prevention of postoperative atrial fibrillation (POAF) in cardiac surgery patients, at the American Heart Association Scientific Sessions meeting. The study's primary endpoint was not met for the modified intent-to-treat (mITT) population; however, the data showed relative risk reduction in specific study populations such as coronary artery bypass graft (CABG) patients and patients aged 65 years and older, as well as overall lower rates of rehospitalization within 30 days compared to placebo. Adverse Events (AEs) were numerically similar across all treatment groups. AbbVie and HotSpot Therapeutics, Inc., a biotechnology company pioneering the discovery and development of small molecule allosteric therapies for the treatment of cancer and autoimmune diseases, announced an exclusive worldwide collaboration and option to license agreement for HotSpot's discovery-stage interferon regulatory factor 5 (IRF5) inhibitor program for the potential treatment of autoimmune diseases. AbbVie and Immunome, a clinical-stage biopharmaceutical company that utilizes its human memory B cell platform to discover and develop first-in-class antibody therapeutics, announced a worldwide collaboration and option agreement directed to the discovery of up to 10 novel antibody-target pairs arising from three specified tumor types using Immunome's Discovery Engine. AbbVie and Anima Biotech, announced a collaboration to discover and develop mRNA biology modulators for three targets across Immunology and Oncology. Anima will use its mRNA Lightning platform to discover novel mRNA biology modulators against the collaboration targets providing AbbVie exclusive rights to license and further develop and commercialize the programs. Full-Year 2023 Outlook AbbVie is issuing its adjusted diluted EPS guidance for the full-year 2023 of $10.70 to $11.10. The company's 2023 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred during 2023, as both cannot be reliably forecasted. About AbbVie 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 . Follow @abbvie on Twitter, Facebook or LinkedIn. Conference Call AbbVie will host an investor conference call today at 8:00 a.m. Central time to discuss our fourth-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 and uses of future or conditional verbs, 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 expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, 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, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. Company Codes: NYSE:ABBV

Reports Full-Year Diluted EPS of $6.63 on a GAAP Basis, an Increase of 2.8 Percent; Adjusted Diluted EPS of $13.77 , an Increase of 16.4 Percent; These Results Include an Unfavorable Impact of $0.39 Per Share related to 2022 Acquired IPR&D and Milestones Expense 1 Delivers Full-Year Net Revenues of $58.054 Billion , an Increase of 3.3 Percent on a Reported Basis and 5.1 Percent on an Operational Basis Full-Year Global Net Revenues from the Immunology Portfolio Were $28.924 Billion , an Increase of 14.4 Percent on a Reported Basis, or 16.0 Percent on an Operational Basis; Global Humira Net Revenues Were $21.237 billion ; Global Skyrizi Net Revenues Were $5.165 Billion ; Global Rinvoq Net Revenues Were $2.522 Billion Full-Year Global Net Revenues from the Hematologic Oncology Portfolio Were $6.577 Billion , a Decrease of 9.0 Percent on a Reported Basis, or 7.6 Percent on an Operational Basis; Global Imbruvica Net Revenues Were $4.568 Billion ; Global Venclexta Net Revenues Were $2.009 Billion Full-Year Global Net Revenues from the Neuroscience Portfolio Were $6.528 Billion , an Increase of 10.1 Percent on a Reported Basis, or 11.6 Percent on an Operational Basis; Global Botox Therapeutic Net Revenues Were $2.719 Billion ; Global Vraylar Net Revenues Were $2.038 Billion Full-Year Global Net Revenues from the Aesthetics Portfolio Were $5.333 Billion , an Increase of 1.9 Percent on a Reported Basis, or 5.1 Percent on an Operational Basis; Global Botox Cosmetic Net Revenues Were $2.615 Billion ; Global Juvederm Net Revenues Were $1.428 Billion Reports Fourth-Quarter Diluted EPS of $1.38 on a GAAP Basis, a decrease of 38.9 Percent; Adjusted Diluted EPS of $3.60 , an increase of 16.9 Percent; These Results Include an Unfavorable Impact of $0.13 Per Share Related to Fourth-Quarter 2022 Acquired IPR&D and Milestones Expense Delivers Fourth-Quarter Net Revenues of $15.121 Billion , an Increase of 1.6 Percent on a Reported Basis and 3.8 Percent on an Operational Basis Provides 2023 Adjusted Diluted EPS Guidance Range of $10.70 to $11.10 , which Excludes Any Unfavorable Impact Related to Acquired IPR&D and Milestones Expense NORTH CHICAGO, Ill. , Feb. 9, 2023 /PRNewswire/ -- AbbVie (NYSE:ABBV) announced financial results for the fourth quarter and full year ended December 31, 2022 . "2022 was another highly productive year capping a decade of outstanding performance. Since our inception, we have built a diverse portfolio of growth products with significant leadership positions, developed a robust pipeline of innovative assets and created a culture of strong execution," said Richard A. Gonzalez , chairman and chief executive officer, AbbVie. "Looking forward, we have a solid foundation which will allow us to absorb the U.S. Humira loss of exclusivity, return to strong top-line growth in 2025 and drive top-tier financial performance over the long term." Note: "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year's foreign exchange rates. 1 Beginning in the first quarter 2022, AbbVie includes the impact of upfront and milestone payments related to collaborations, licensing agreements and other asset acquisitions in its reported non-GAAP financial measures. Fourth -Quarter Results Worldwide net revenues were $15.121 billion , an increase of 1.6 percent on a reported basis, or 3.8 percent on an operational basis. Global net revenues from the immunology portfolio were $7.925 billion , an increase of 17.5 percent on a reported basis, or 19.5 percent on an operational basis. Global Humira net revenues of $5.579 billion increased 4.6 percent on a reported, or 6.0 percent on an operational basis. U.S. Humira net revenues were $5.006 billion , an increase of 9.9 percent. Internationally, Humira net revenues were $573 million , a decrease of 26.5 percent on a reported basis, or 16.9 percent on an operational basis. Global Skyrizi net revenues were $1.576 billion , an increase of 76.1 percent on a reported basis, or 78.9 percent on an operational basis. Global Rinvoq net revenues were $770 million , an increase of 49.0 percent on a reported basis, or 55.4 percent on an operational basis. Global net revenues from the hematologic oncology portfolio were $1.631 billion , a decrease of 12.9 percent on a reported basis, or 11.2 percent on an operational basis. Global Imbruvica net revenues were $1.115 billion , a decrease of 19.5 percent, with U.S. net revenues of $841 million and international profit sharing of $274 million . Global Venclexta net revenues were $516 million , an increase of 5.7 percent on a reported basis, or 12.2 percent on an operational basis. Global net revenues from the neuroscience portfolio were $1.710 billion , an increase of 3.4 percent on a reported basis, or 5.1 percent on an operational basis. Global Botox Therapeutic net revenues were $728 million , an increase of 8.5 percent on a reported basis, or 10.7 percent on an operational basis. Global Vraylar net revenues were $565 million , an increase of 15.5 percent. Global Ubrelvy net revenues were $197 million , an increase of 7.7 percent. Global net revenues from the aesthetics portfolio were $1.287 billion , a decrease of 8.5 percent on a reported basis, or 4.2 percent on an operational basis. Global Botox Cosmetic net revenues were $642 million , an increase of 2.6 percent on a reported basis, or 7.1 percent on an operational basis. Global Juvederm net revenues were $322 million , a decrease of 25.4 percent on a reported basis, or 19.0 percent on an operational basis. On a GAAP basis, the gross margin ratio in the fourth quarter was 72.4 percent. The adjusted gross margin ratio was 86.0 percent. On a GAAP basis, selling, general and administrative (SG&A) expense was 22.6 percent of net revenues. The adjusted SG&A expense was 20.8 percent of net revenues. On a GAAP basis, research and development (R&D) expense was 11.8 percent of net revenues. The adjusted R&D expense was 11.5 percent of net revenues, reflecting funding actions supporting all stages of our pipeline. Acquired IPR&D and milestones expense was 1.6 percent of net revenues. On a GAAP basis, the operating margin in the fourth quarter was 36.4 percent. The adjusted operating margin was 52.1 percent. Net interest expense was $476 million . On a GAAP basis, the tax rate in the quarter was 16.6 percent. The adjusted tax rate was 13.4 percent. Diluted EPS in the fourth quarter was $1.38 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $3.60 . These results include an unfavorable impact of $0.13 per share related to acquired IPR&D and milestones expense. Note: "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year's foreign exchange rates. Recent Events AbbVie announced the European Commission (EC) approved Skyrizi (risankizumab, 600 mg intravenous induction and 360 mg subcutaneous maintenance therapy) as the first specific interleukin-23 (IL-23) inhibitor for the treatment of adults with moderately to severely active Crohn's disease (CD) who have had inadequate response, lost response or were intolerant to conventional or biologic therapy. The approval is supported by results from three Phase 3 studies in which Skyrizi demonstrated significant improvement in clinical remission and endoscopic response, compared to placebo, as both induction and maintenance therapy. This approval marks the third indication for Skyrizi in the European Union (EU). Skyrizi is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally. At the American College of Rheumatology's (ACR) annual meeting, AbbVie shared 36 abstracts that underscore AbbVie's commitment to advancing research to help more people living with rheumatic diseases. Analyses presented showcased data from the clinical trial programs evaluating Rinvoq (upadacitinib) for the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (AS) as well as data evaluating Skyrizi for the treatment of psoriasis (PsO) and PsA. AbbVie announced that the U.S. Food and Drug Administration (FDA) accepted, for priority review, the Biologics License Application (BLA) for epcoritamab, an investigational subcutaneous bispecific antibody for the treatment of adult patients with relapsed/refractory (r/r) large B-cell lymphoma (LBCL). Additionally, AbbVie announced the European Medicines Agency (EMA) validated AbbVie's Marketing Authorization Application (MAA) for epcoritamab for the treatment of adult patients with r/r diffuse LBCL. Both applications are supported by data from the EPCORE NHL-1 Phase 2 trial evaluating the safety and preliminary efficacy of subcutaneous epcoritamab in adult patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin's lymphoma (NHL). Epcoritamab is being co-developed by Genmab and AbbVie. At the American Society of Hematology (ASH) Annual Meeting, AbbVie presented results from nearly 65 abstracts, including 15 oral presentations, across eight types of cancer. Highlights included four oral presentations evaluating investigational epcoritamab for the treatment of r/r follicular lymphoma (FL), previously untreated FL, r/r diffuse LBCL as well as Richter's syndrome; data from cohort three of the Phase 2 REFINE study evaluating navitoclax in combination with ruxolitinib in JAK inhibitor-naïve patients with myelofibrosis (MF); data from the Phase 2 CAPTIVATE and Phase 3 GLOW studies evaluating fixed-duration treatment in patients with chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL) who received the Imbruvica (ibrutinib) + Venclexta (venetoclax) combination regimen. AbbVie also presented multiple abstracts evaluating Venclexta in approved CLL and acute myeloid leukemia (AML) indications and the investigational multiple myeloma (MM) indication. Imbruvica is jointly developed and commercialized with Janssen Biotech, Inc. 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. AbbVie announced that the FDA approved Vraylar (cariprazine) as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults. The approval marks the fourth indication for Vraylar, which is now the first and only dopamine and serotonin partial agonist FDA-approved for the most common forms of depression – as an adjunctive treatment for MDD and the treatment of depressive episodes associated with bipolar I disorder. The approval is supported by clinical data demonstrating the efficacy and well-established tolerability of Vraylar as an adjunctive treatment for MDD with an antidepressant therapy. Vraylar is being co-developed by AbbVie and Gedeon Richter Plc. At the European Headache Federation Congress (EHC) 2022, AbbVie shared 15 abstracts which underscore its commitment to people living with migraine. Presentations highlighted late-breaking data from the Chronic Migraine Epidemiology and Outcomes - International (CaMEO-I) study, evaluating the frequency and burden of neck pain with headache among people with and without migraine, as well as results from the Phase 3 PROGRESS trial evaluating Qulipta (atogepant) for the preventive treatment of chronic migraine (CM) in patients living in Europe . AbbVie announced new results from its exploratory NOVA phase 2 dose-ranging study evaluating the efficacy and safety of AGN-151607, a novel investigational neurotoxin for the prevention of postoperative atrial fibrillation (POAF) in cardiac surgery patients, at the American Heart Association Scientific Sessions meeting. The study's primary endpoint was not met for the modified intent-to-treat (mITT) population; however, the data showed relative risk reduction in specific study populations such as coronary artery bypass graft (CABG) patients and patients aged 65 years and older, as well as overall lower rates of rehospitalization within 30 days compared to placebo. Adverse Events (AEs) were numerically similar across all treatment groups. AbbVie and HotSpot Therapeutics, Inc., a biotechnology company pioneering the discovery and development of small molecule allosteric therapies for the treatment of cancer and autoimmune diseases, announced an exclusive worldwide collaboration and option to license agreement for HotSpot's discovery-stage interferon regulatory factor 5 (IRF5) inhibitor program for the potential treatment of autoimmune diseases. AbbVie and Immunome, a clinical-stage biopharmaceutical company that utilizes its human memory B cell platform to discover and develop first-in-class antibody therapeutics, announced a worldwide collaboration and option agreement directed to the discovery of up to 10 novel antibody-target pairs arising from three specified tumor types using Immunome's Discovery Engine. AbbVie and Anima Biotech, announced a collaboration to discover and develop mRNA biology modulators for three targets across Immunology and Oncology. Anima will use its mRNA Lightning platform to discover novel mRNA biology modulators against the collaboration targets providing AbbVie exclusive rights to license and further develop and commercialize the programs. Full-Year 2023 Outlook AbbVie is issuing its adjusted diluted EPS guidance for the full-year 2023 of $10.70 to $11.10 . The company's 2023 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred during 2023, as both cannot be reliably forecasted. About AbbVie 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 . Conference Call AbbVie will host an investor conference call today at 8:00 a.m. Central time to discuss our fourth-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 and uses of future or conditional verbs, 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 expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, 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, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. AbbVie Inc. Key Product Revenues Quarter Ended December 31, 2022 (Unaudited) % Change vs. 4Q21 Net Revenues (in millions) Reported Operational a U.S. Int'l. Total U.S. Int'l. Total Int'l. Total NET REVENUES $  12,192 $  2,929 $  15,121 4.4 % (8.7) % 1.6 % 1.8 % 3.8 % Immunology 6,975 950 7,925 22.5 (9.5) 17.5 3.2 19.5 Humira 5,006 573 5,579 9.9 (26.5) 4.6 (16.9) 6.0 Skyrizi 1,403 173 1,576 84.3 29.1 76.1 47.9 78.9 Rinvoq 566 204 770 48.6 50.1 49.0 74.5 55.4 Hematologic Oncology 1,110 521 1,631 (18.7) 2.6 (12.9) 8.8 (11.2) Imbruvica b 841 274 1,115 (24.6) 1.6 (19.5) 1.6 (19.5) Venclexta 269 247 516 7.7 3.7 5.7 17.0 12.2 Aesthetics 835 452 1,287 (4.7) (14.8) (8.5) (3.4) (4.2) Botox Cosmetic 422 220 642 6.4 (4.0) 2.6 8.3 7.1 Juvederm Collection 128 194 322 (28.3) (23.3) (25.4) (12.4) (19.0) Other Aesthetics 285 38 323 (5.3) (21.4) (7.6) (11.7) (6.2) Neuroscience 1,506 204 1,710 4.7 (5.7) 3.4 7.2 5.1 Botox Therapeutic 614 114 728 9.6 2.8 8.5 16.2 10.7 Vraylar 564 1 565 15.4 n/m 15.5 n/m 15.5 Duodopa 23 84 107 (18.3) (15.8) (16.3) (3.2) (6.5) Ubrelvy 197 — 197 7.5 n/m 7.7 n/m 7.7 Qulipta 52 — 52 >100.0 n/m >100.0 n/m >100.0 Other Neuroscience 56 5 61 (66.2) (8.8) (64.5) (1.1) (64.3) Eye Care 338 252 590 (49.7) (12.4) (38.5) (1.3) (35.2) Lumigan/Ganfort 56 67 123 (22.1) (13.0) (17.4) (3.3) (12.4) Alphagan/Combigan 41 33 74 (59.4) (16.2) (47.4) (4.5) (44.1) Restasis 103 7 110 (70.5) (49.0) (69.6) (45.0) (69.4) Other Eye Care 138 145 283 (7.7) (7.8) (7.7) 4.5 (1.4) Other Key Products 791 195 986 (1.5) (18.4) (5.4) (6.2) (2.6) Mavyret 193 187 380 (1.8) (18.8) (11.0) (6.5) (4.4) Creon 337 — 337 3.0 n/m 3.0 n/m 3.0 Linzess/Constella 261 8 269 (6.5) (7.5) (6.6) 2.2 (6.3) 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. n/m = not meaningful AbbVie Inc. Key Product Revenues Twelve Months Ended December 31, 2022 (Unaudited) % Change vs. 12M21 Net Revenues (in millions) Reported Operational a U.S. Int'l. Total U.S. Int'l. Total Int'l. Total NET REVENUES $  45,713 $  12,341 $  58,054 5.1 % (2.7) % 3.3 % 5.5 % 5.1 % Immunology 24,897 4,027 28,924 18.1 (4.0) 14.4 5.7 16.0 Humira 18,619 2,618 21,237 7.4 (22.2) 2.6 (14.9) 3.8 Skyrizi 4,484 681 5,165 80.4 50.4 75.7 67.1 78.3 Rinvoq 1,794 728 2,522 41.2 91.4 52.8 >100.0 58.1 Hematologic Oncology 4,435 2,142 6,577 (15.6) 8.6 (9.0) 13.9 (7.6) Imbruvica b 3,426 1,142 4,568 (20.7) 5.1 (15.5) 5.1 (15.5) Venclexta 1,009 1,000 2,009 8.0 12.9 10.4 24.6 16.1 Aesthetics 3,324 2,009 5,333 (0.8) 6.7 1.9 15.6 5.1 Botox Cosmetic 1,654 961 2,615 16.2 18.9 17.2 28.8 20.8 Juvederm Collection 548 880 1,428 (16.7) 0.3 (7.0) 8.9 (2.1) Other Aesthetics 1,122 168 1,290 (11.5) (14.9) (12.0) (8.3) (11.1) Neuroscience 5,681 847 6,528 12.3 (2.3) 10.1 7.7 11.6 Botox Therapeutic 2,255 464 2,719 12.1 5.6 10.9 15.3 12.6 Vraylar 2,037 1 2,038 17.9 n/m 17.9 n/m 17.9 Duodopa 95 363 458 (6.7) (11.3) (10.4) (0.8) (2.0) Ubrelvy 680 — 680 23.2 n/m 23.3 n/m 23.3 Qulipta 158 — 158 >100.0 n/m >100.0 n/m >100.0 Other Neuroscience 456 19 475 (30.5) 4.8 (29.6) 9.0 (29.5) Eye Care 1,603 1,098 2,701 (33.3) (5.7) (24.3) 3.7 (21.2) Lumigan/Ganfort 242 272 514 (11.0) (11.3) (11.2) (3.0) (6.8) Alphagan/Combigan 202 144 346 (45.8) (7.9) (34.6) 2.5 (31.5) Restasis 621 45 666 (49.6) (20.2) (48.3) (13.8) (48.0) Other Eye Care 538 637 1,175 2.3 (1.2) 0.4 8.7 5.9 Other Key Products 3,036 818 3,854 2.9 (17.2) (2.2) (7.9) 0.1 Mavyret 755 786 1,541 0.2 (17.8) (9.9) (8.5) (4.7) Creon 1,278 — 1,278 7.3 n/m 7.3 n/m 7.3 Linzess/Constella 1,003 32 1,035 (0.4) 0.3 (0.3) 7.6 (0.1) 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. n/m = not meaningful AbbVie Inc. Consolidated Statements of Earnings (Unaudited) (in millions, except per share data) Fourth Quarter Ended December 31 Twelve Months Ended December 31 2022 2021 2022 2021 Net revenues $       15,121 $       14,886 $       58,054 $       56,197 Cost of products sold 4,170 4,320 17,414 17,446 Selling, general and administrative 3,417 3,260 15,260 12,349 Research and development a 1,790 1,827 6,510 6,922 Acquired IPR&D and milestones a 243 405 697 1,124 Other operating (income) expense, net (1) — 56 432 Total operating costs and expenses 9,619 9,812 39,937 38,273 Operating earnings 5,502 5,074 18,117 17,924 Interest expense, net 476 571 2,044 2,384 Net foreign exchange loss 40 16 148 51 Other expense, net 2,021 216 2,448 2,500 Earnings before income tax expense 2,965 4,271 13,477 12,989 Income tax expense 493 226 1,632 1,440 Net earnings 2,472 4,045 11,845 11,549 Net earnings (loss) attributable to noncontrolling interest (1) 1 9 7 Net earnings attributable to AbbVie Inc. $          2,473 $          4,044 $        11,836 $        11,542 Diluted earnings per share attributable to AbbVie Inc. $            1.38 $            2.26 $            6.63 $            6.45 Adjusted diluted earnings per share b $            3.60 $            3.08 $          13.77 $          11.83 Weighted-average diluted shares outstanding 1,778 1,778 1,778 1,777 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 $162 million for the twelve months ended December 31, 2021 and had no impact on the three months ended December 31, 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. Weighted-average diluted shares outstanding includes the effect of dilutive securities. AbbVie Inc. Reconciliation of GAAP Reported to Non-GAAP Adjusted Information (Unaudited) 1.     Specified items impacted results as follows: Quarter Ended December 31, 2022 (in millions, except per share data) Earnings Diluted Pre-tax After-tax a EPS As reported (GAAP) $              2,965 $              2,473 $                1.38 Adjusted for specified items: Intangible asset amortization 1,961 1,636 0.92 Acquisition and integration costs 215 199 0.11 Change in fair value of contingent consideration 2,114 2,113 1.19 Income tax items — (143) (0.08) Other 157 144 0.08 As adjusted (non-GAAP) $              7,412 $              6,422 $                3.60 a Represents net earnings attributable to AbbVie Inc. Acquisition and integration costs primarily include costs related to the Allergan acquisition. Income tax items include a benefit of $323 million related to tax law changes partially offset by certain other tax related items. Other primarily includes restructuring charges associated with streamlining global operations. 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 December 31, 2022 included acquired IPR&D and milestones expense of $243 million on a pre-tax and after-tax basis, representing an unfavorable impact of $0.13 to both diluted EPS and adjusted diluted EPS. 2.     The impact of the specified items by line item was as follows: Quarter Ended December 31, 2022 (in millions) Cost of products sold SG&A R&D Other operating income, net Other expense, net As reported (GAAP) $      4,170 $      3,417 $            1,790 $                   (1) $           2,021 Adjusted for specified items: Intangible asset amortization (1,961) — — — — Acquisition and integration costs 1 (205) (11) — — Change in fair value of contingent consideration — — — — (2,114) Other (99) (62) (38) 1 41 As adjusted (non-GAAP) $      2,111 $      3,150 $             1,741 $                  — $              (52) 3.     The adjusted tax rate for the fourth quarter of 2022 was 13.4 percent, as detailed below: Quarter Ended December 31, 2022 (dollars in millions) Pre-tax earnings Income taxes Tax rate As reported (GAAP) $             2,965 $                493 16.6 % Specified items 4,447 498 11.2 % As adjusted (non-GAAP) $             7,412 $                991 13.4 % AbbVie Inc. Reconciliation of GAAP Reported to Non-GAAP Adjusted Information (Unaudited) 1.     Specified items impacted results as follows: Quarter Ended December 31, 2021 (in millions, except per share data) Earnings Diluted Pre-tax After-tax a EPS As reported (GAAP) $              4,271 $              4,044 $                2.26 Adjusted for specified items: Intangible asset amortization 1,806 1,490 0.84 Acquisition and integration costs (191) (212) (0.12) Change in fair value of contingent consideration 232 232 0.13 Litigation matters 200 167 0.09 Impacts related to tax law changes — (265) (0.15) Other 41 58 0.03 As adjusted (non-GAAP) $              6,359 $              5,514 $                3.08 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. Other primarily includes COVID-19 related expenses and certain tax related items. Beginning in the first quarter of 2022, the company includes acquired IPR&D and milestones expense in its reportednon-GAAP financial measures. Reported GAAP earnings and adjusted non-GAAP earnings for the three months ended December 31, 2021 included acquired IPR&D and milestones expense of $405 million on a pre-tax and after-tax basis, representing an unfavorable impact of $0.23 to both diluted EPS and adjusted diluted EPS. 2.     The impact of the specified items by line item was as follows: Quarter Ended December 31, 2021 (in millions) Cost of products sold SG&A R&D Other expense, net As reported (GAAP) $    4,320 $             3,260 $             1,827 $              216 Adjusted for specified items: Intangible asset amortization (1,806) — — — Acquisition and integration costs (43) 250 (16) — Change in fair value of contingent consideration — — — (232) Litigation matters — (200) — — Other (23) (3) (13) (2) As adjusted (non-GAAP) $    2,448 $             3,307 $             1,798 $               (18) 3.     The adjusted tax rate for the fourth quarter of 2021 was 13.3 percent, as detailed below: Quarter Ended December 31, 2021 (dollars in millions) Pre-tax earnings Income taxes Tax rate As reported (GAAP) $             4,271 $                226 5.3 % Specified items 2,088 618 29.6 % As adjusted (non-GAAP) $             6,359 $                844 13.3 % AbbVie Inc. Reconciliation of GAAP Reported to Non-GAAP Adjusted Information (Unaudited) 1.     Specified items impacted results as follows: Twelve Months Ended December 31, 2022 (in millions, except per share data) Earnings Diluted Pre-tax After-tax a EPS As reported (GAAP) $           13,477 $          11,836 $                6.63 Adjusted for specified items: Intangible asset amortization 7,689 6,430 3.61 Intangible asset impairment 770 604 0.34 Acquisition and integration costs 810 766 0.43 Change in fair value of contingent consideration 2,761 2,770 1.55 Pylera divestiture (172) (126) (0.07) Litigation matters 2,506 2,028 1.13 Income tax items — (26) (0.02) Other 429 315 0.17 As adjusted (non-GAAP) $           28,270 $          24,597 $              13.77 a Represents net earnings attributable to AbbVie Inc. Acquisition and integration costs primarily include costs related to the Allergan acquisition. Litigation matters primarily include a charge related to a potential settlement of litigation involving Allergan's past sales of opioid products. Income tax items include a benefit of $323 million related to tax law changes partially offset by certain other tax related items. Other primarily includes restructuring charges associated with streamlining global operations. 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 twelve months ended December 31, 2022 included acquired IPR&D and milestones expense of $697 million on a pre-tax and $682 million on an after-tax basis, representing an unfavorable impact of $0.39 to both diluted EPS and adjusted diluted EPS. 2.     The impact of the specified items by line item was as follows: Twelve Months Ended December 31, 2022 (in millions) Cost of products sold SG&A R&D Other operating expense, net Other expense, net As reported (GAAP) $      17,414 $    15,260 $             6,510 $                  56 $           2,448 Adjusted for specified items: Intangible asset amortization (7,689) — — — — Intangible asset impairment (770) — — — — Acquisition and integration costs (83) (468) (30) (229) — Change in fair value of contingent consideration — — — — (2,761) Pylera divestiture — — — 172 — Litigation matters — (2,506) — — — Other (259) (160) (45) 1 34 As adjusted (non-GAAP) $        8,613 $    12,126 $             6,435 $                  — $             (279) 3.     The adjusted tax rate for the full-year 2022 was 13.0 percent, as detailed below: Twelve Months Ended December 31, 2022 (dollars in millions) Pre-tax earnings Income taxes Tax rate As reported (GAAP) $           13,477 $             1,632 12.1 % Specified items 14,793 2,032 13.7 % As adjusted (non-GAAP) $           28,270 $             3,664 13.0 % AbbVie Inc. Reconciliation of GAAP Reported to Non-GAAP Adjusted Information (Unaudited) 1.     Specified items impacted results as follows: Twelve Months Ended December 31, 2021 (in millions, except per share data) Earnings Diluted Pre-tax After-tax a EPS As reported (GAAP) $           12,989 $           11,542 $                6.45 Adjusted for specified items: Intangible asset amortization 7,718 6,419 3.60 Acquisition and integration costs 344 215 0.12 Change in fair value of contingent consideration 2,679 2,677 1.50 Litigation matters 307 253 0.14 Impacts related to tax law changes — (265) (0.15) Other 360 313 0.17 As adjusted (non-GAAP) $           24,397 $           21,154 $              11.83 a Represents net earnings attributable to AbbVie Inc. 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. Other primarily includes the purchase of FDA priority review vouchers from third parties, COVID-19 related expenses, restructuring charges associated with streamlining global operations and certain tax related items. 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 twelve months ended December 31, 2021 included acquired IPR&D and milestones expense of $1.1 billion on a pre-tax and after-tax basis, as well as other operating expense related to the Calico collaboration of $500 million on a pre-tax and after-tax basis, representing an unfavorable impact of $0.90 to both diluted EPS and adjusted diluted EPS. 2.     The impact of the specified items by line item was as follows: Twelve Months Ended December 31, 2021 (in millions) Cost of products sold SG&A R&D Other operating expense, net Other expense, net As reported (GAAP) $    17,446 $    12,349 $             6,922 $               432 $            2,500 Adjusted for specified items: Intangible asset amortization (7,718) — — — — Acquisition and integration costs (215) (25) (104) — — Change in fair value of contingent consideration — — — — (2,679) Litigation matters — (307) — — — Other (88) (53) (300) 68 13 As adjusted (non-GAAP) $      9,425 $    11,964 $             6,518 $               500 $              (166) 3.     The adjusted tax rate for the full-year 2021 was 13.3 percent, as detailed below: Twelve Months Ended December 31, 2021 (dollars in millions) Pre-tax earnings Income taxes Tax rate As reported (GAAP) $           12,989 $            1,440 11.1 % Specified items 11,408 1,796 15.8 % As adjusted (non-GAAP) $           24,397 $            3,236 13.3 % SOURCE AbbVie