Richter's syndrome

Four lead programs on track to deliver clinical data and to inform future development plans Recent equity financing extends cash runway into 2026, enabling advancement of Prelude’s pipeline through critical milestones WILMINGTON, Del., Aug. 03, 2023 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated (Nasdaq: PRLD), a clinical-stage precision oncology company, today reported financial results for the second quarter ended June 30, 2023, and provided a corporate update. Kris Vaddi, Ph.D., Chief Executive Officer of Prelude stated, “With the recent financing that extended our cash runway into 2026, we are in a strong position to advance our diverse pipeline of potentially best and/or first-in-class compounds to address the needs of patients with certain underserved cancers. Our focus remains on generating critical data for each of our molecules to make key strategic decisions. As disclosed recently, and based on additional data generated in this quarter, PRT2527 (CDK9 inhibitor) and PRT1419 (MCL1 inhibitor) demonstrated differentiated clinical safety profiles and strong target inhibition and are continuing to enroll patients with hematological malignancies, which is where we see the best opportunities for these molecules.” “Our first-in-class selective SMARCA2 degrader, PRT3789, and next generation CDK4/6 inhibitor, PRT3645, are progressing well in Phase 1 and are on track to reach confirmation doses in the first half of 2024 and by year end 2023, respectively,” added Dr. Vaddi. “Based on meaningful progress made in the first half of the year, we look forward to sharing updates and clarity around strategic prioritization of our pipeline in the coming months.” Pipeline Updates PRT2527- CDK9 Inhibitor Program The Company believes its highly selective CDK9 inhibitor, PRT2527, has the potential to avoid off-target toxicities, achieve substantial clinical activity and become the best-in-class CDK9 inhibitor, making it amenable for combination with other therapies. PRT2527 has completed a Phase 1 multi-dose escalation study (NCT05159518) in patients with solid tumors. In this trial, PRT2527 was shown to achieve high levels of target inhibition and the potential to be better tolerated than existing CDK9 inhibitors, specifically, manageable neutropenia and an absence of meaningful gastrointestinal events or hepatotoxicity. * *AACR2023 Poster Presentation A Phase 1 multi-dose escalation study (NCT05665530) is currently ongoing in hematologic malignancies. Patient recruitment for hematological clinical trials in the US is highly competitive and this trial has recently been expanded to include global sites to support patient recruitment. The Company’s objective is to establish a biologically active confirmation dose by Q1 2024. As part of this Phase 1 multi-dose escalation trial, the Company intends to expand the Phase 1 clinical trial and evaluate PRT2527 in combination with zanubrutinib. Potential indications for PRT2527 include aggressive B-cell lymphoma subtypes, mantle cell lymphoma (MCL), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) including Richter syndrome, and T-cell lymphoma subtypes. The Company intends to provide a program update by year end on the CDK9 inhibitor program and present initial results at a future scientific meeting. PRT1419- MCL1 Inhibitor ProgramPRT1419 is a potent and selective MCL1 inhibitor. With its optimized PK/PD profile, the Company believes PRT1419 has the potential to achieve greater target engagement and provide patients with better clinical outcomes as well as improved safety and tolerability, as compared to other MCL1 inhibitors in development. PRT1419 has completed a Phase 1 multi-dose escalation study (NCT04837677) in patients with solid tumors. In this study, PRT1419 demonstrated an acceptable safety and tolerability profile in patients with advanced and metastatic solid tumors. No cardiac toxicity was observed. Pharmacokinetics/pharmacodynamics and safety data in the 80 mg/m2 QW dose cohort support further evaluation of this dose in future studies. A Phase 1 multi-dose escalation clinical trial of PRT1419 in patients with hematologic malignancies is ongoing (NCT05107856). In this trial, PRT1419 is being evaluated as monotherapy for myeloid malignancies and in combination with azacitidine or venetoclax for patients with relapsed/refractory myeloid or B-cell malignancies. The Company will provide a clinical update on PRT1419 by year end. PRT3645- Next Generation CDK4/6 Inhibitor ProgramPRT3645 is a highly potent and selective next generation CDK4/6 inhibitor with the potential to provide improved safety and tolerability outcomes and higher, more effective brain and tissue penetration than current CDK4/6 inhibitors. In preclinical models in vivo, PRT3645 has been shown to be efficacious in multiple cancers as monotherapy as well as when combined with KRAS inhibitors, MEK inhibitors and with a brain penetrant HER2 receptor kinase inhibitor. Additionally, oral administration of PRT3645 has been shown to induce tumor regressions in preclinical models that are resistant to currently approved CDK4/6 inhibitors. Together, these data suggest that PRT3645 may extend the benefit of CDK4/6 inhibition beyond HR+ breast cancer. A Phase 1 multi-dose escalation clinical trial of PRT3645 (NCT05538572) is underway and the Company expects to reach a biologically active dose confirmation in Q4 2023. Potential indications for PRT3645 in combination with other therapies, in addition to breast cancer with or without brain metastases, include endometrial, sarcomas, glioblastomas, non-small cell lung cancer, head and neck cancers. The Company intends to provide a program update by year end and present initial results at a future scientific meeting. PRT3789- SMARCA2 Targeted Protein Degrader ProgramPRT3789 is a first-in-class highly selective degrader of SMARCA2 protein, which along with SMARCA4 controls gene regulation through chromatin remodeling. Cancer cells with SMARCA4 mutations are dependent on SMARCA2 for their growth and survival and selectively degrading SMARCA2 induces cell death in cancer cells while sparing normal cells. PRT3789 is efficacious and well tolerated in preclinical models of SMARCA4 deleted/mutated cancers as monotherapy and in combination with standards of care. The Company believes a selective SMARCA2 degrader has the potential to be of benefit in up to 70,000 US/EU cancer patients with the SMARCA4 mutation. Patients with SMARCA4 mutations or deletions may have poor clinical outcomes and limited treatment options. Therefore, mutated, or deleted SMARCA4 cancers provides a potential biomarker to select those patients most likely to respond to treatment with a highly selective SMARCA2 degrader. A Phase 1 multi-dose escalation clinical trial of PRT3789 is ongoing (NCT05639751) in biomarker selected SMARCA4 mutated cancers. The Company intends to evaluate PRT3789 as monotherapy as well as in combination. The Company intends to provide a program update by year end and expects to reach confirmation dose in the first half of 2024. SMARCA2- Oral ProgramThe Company has also recently nominated a new chemical entity as a potent, orally bioavailable and highly selective SMARCA2 degrader candidate (>1000x over SMARCA4) and intends to file an IND early in 2024. Second Quarter 2023 Financial Results Cash, Cash Equivalents and Marketable Securities: In May 2023, the Company completed a public offering of common stock, raising gross proceeds of $113.0 million before deducting underwriting discounts, commissions and offering expenses. Net proceeds received, $110.4 million, will be focused on the continued development and expansion of the Company’s product pipeline. Cash, cash equivalents, and marketable securities as of June 30, 2023, were $255.0 million. Prelude anticipates that its existing cash, cash equivalents and marketable securities will fund the Company’s operations into 2026. Research and Development (R&D) Expenses: For the second quarter of 2023, R&D expense increased to $25.0 million from $21.3 million for the prior year period. Research and development expenses increased primarily due to the timing of our clinical research programs. We expect our R&D expenses to vary from quarter to quarter, primarily due to the timing of our clinical development activities. General and Administrative (G&A) Expenses: For the second quarter of 2023, G&A expenses decreased to $7.4 million from $8.2 million for the prior year period. General and administrative expenses decreased reflecting the Company’s careful management of its G&A expenses. Net Loss: For the three months ended June 30, 2023, net loss was $30.4 million, or $0.54 per share compared to $27.4 million, or $0.58 per share, for the prior year period. Included in the net loss for the quarter ended June 30, 2023, was $6.7 million of non-cash expense related to the impact of expensing share-based payments, including employee stock options, as compared to $6.0 million for the same period in 2022. About Prelude Therapeutics Prelude Therapeutics is a clinical-stage precision oncology company developing innovative drug candidates targeting critical cancer cell pathways. The Company’s diverse pipeline is comprised of highly differentiated, potentially best-in-class proprietary small molecule compounds aimed at addressing clinically validated pathways for cancers with selectable underserved patients. Prelude’s pipeline includes four candidates currently in clinical development: PRT1419, a potent, selective inhibitor of MCL1, PRT2527, a potent and highly selective CDK9 inhibitor, PRT3645 a next generation CDK4/6 inhibitor, PRT3789 an IV administered, potent and highly selective SMARCA2 degrader, and a preclinical oral candidate targeting SMARCA2. For more information, visit our website and follow us on LinkedIn and Twitter. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, anticipated discovery, preclinical and clinical development activities, the timing and/or announcements relating to the reporting of expected findings for PRT1419, PRT2527, PRT3645, PRT3789, and its preclinical oral SMARCA2 degrader, the potential benefits of Prelude’s product candidates and platform, and the sufficiency of cash and cash equivalents to fund operating expenses and capital expenditures into 2026. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Although Prelude believes that the expectations reflected in such forward-looking statements are reasonable, Prelude cannot guarantee future events, results, actions, levels of activity, performance or achievements, and the timing and results of biotechnology development and potential regulatory approval is inherently uncertain. Forward-looking statements are subject to risks and uncertainties that may cause Prelude's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to Prelude's ability to advance its product candidates, the receipt and timing of potential regulatory designations, approvals and commercialization of product candidates, clinical trial sites and our ability to enroll eligible patients, supply chain and manufacturing facilities, Prelude’s ability to maintain and recognize the benefits of certain designations received by product candidates, the timing and results of preclinical and clinical trials, Prelude's ability to fund development activities and achieve development goals, Prelude's ability to protect intellectual property, and other risks and uncertainties described under the heading "Risk Factors" in documents Prelude files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and Prelude undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof. PRELUDE THERAPEUTICS INCORPORATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(UNAUDITED) Three Months Ended June 30, (in thousands, except share and per share data) 2023 2022 Operating expenses: Research and development $24,966 $21,310 General and administrative 7,432 8,151 Total operating expenses 32,398 29,461 Loss from operations (32,398) (29,461)Other income, net 1,967 2,087 Net loss $(30,431) $(27,374)Per share information: Net loss per share of common stock, basic and diluted $(0.54) $(0.58)Weighted average common shares outstanding, basic and diluted 56,240,491 47,276,684 Comprehensive loss Net loss $(30,431) $(27,374)Unrealized (loss) gain on marketable securities, net of tax (313) 19 Comprehensive loss $(30,744) $(27,355) PRELUDE THERAPEUTICS INCORPORATED BALANCE SHEETS(UNAUDITED) (in thousands, except share data) June 30,2023 December 31,2022 Assets Current assets: Cash and cash equivalents $26,446 $30,605 Marketable securities 228,543 171,123 Prepaid expenses and other current assets 5,221 2,652 Total current assets 260,210 204,380 Restricted cash 4,044 4,044 Property and equipment, net 6,082 4,908 Right-of-use asset 918 1,792 Prepaid expenses and other non-current assets 9,357 5,376 Total assets $280,611 $220,500 Liabilities and stockholders’ equity Current liabilities: Accounts payable $5,585 $6,777 Accrued expenses and other current liabilities 8,667 13,093 Operating lease liability 938 1,832 Total current liabilities 15,190 21,702 Other liabilities 3,361 3,361 Total liabilities 18,551 25,063 Commitments (Note 8) Stockholders’ equity: Voting common stock, $0.0001 par value: 487,149,741 shares authorized; 41,958,456 and 36,496,994 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively 4 4 Non-voting common stock, $0.0001 par value: 12,850,259 shares authorized; 12,850,259 and 11,402,037 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively 1 1 Additional paid-in capital 655,473 531,682 Accumulated other comprehensive loss (711) (1,692)Accumulated deficit (392,707) (334,558)Total stockholders’ equity 262,060 195,437 Total liabilities and stockholders’ equity $280,611 $220,500 Investor Contact:Lindsey TrickettVice President, Investor Relations240.543.7970ltrickett@preludetx.com Media Contact:Helen ShikShik Communications 617.510.4373Helen@ShikCommuncations.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