Venetoclax

Milestone underscores execution of pivotal Phase 2/3 trial evaluating Annamycin in combination with cytarabine for relapsed or refractory acute myeloid leukemia (AML) Fully treated, randomized, double-blind n=90 Part A population sets up Annamycin dose selection for Part B, with balanced representation of AML patients who failed 7+3 chemotherapy and venetoclax-based regimens HOUSTON, Oct. 30, 2026 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc. (Nasdaq: MBRX) (“Moleculin” or the “Company”) today announced that dosing has been completed in Part A of its pivotal Phase 2/3 MIRACLE trial evaluating Annamycin in combination with cytarabine (AnnAraC) for the treatment of adults with relapsed or refractory acute myeloid leukemia (R/R AML). The Company remains on track to report comprehensive Part A data in the first quarter of 2027. Reaching this treatment milestone represents continued execution in the MIRACLE trial as the Company advances toward a comprehensive analysis of the full 90-patient Part A population. The planned Q1 2027 data readout is expected to provide important insights into the potential of AnnAraC across clinically distinct R/R AML patient populations and support selection of the optimal Annamycin dose for advancement into Part B of the trial. The expanded Part A dataset is expected to provide further insight into AnnAraC in patients who have relapsed from or are refractory to different first-line AML treatment approaches, including intensive 7+3 chemotherapy and venetoclax-based regimens. The Company expects the final Part A population to reflect an approximately 50/50 split between these treatment groups, compared with an approximately 70/30 split, respectively, among the first 45 subjects. This broader representation is expected to help characterize AnnAraC’s potential across patient populations with differing treatment histories and clinical challenges. “Reaching the completion of dosing in Part A represents another important step toward our planned Q1 2027 comprehensive n=90 data readout,” said Walter Klemp, Chairman and Chief Executive Officer of Moleculin. “Combined with the continued absence of cardiotoxicity in blinded interim data, we believe our Q1 2027 readout positions us to select our Part B dose and to define Annamycin's potential role across today's R/R AML landscape.” About the MIRACLE Trial MIRACLE is a pivotal Phase 2/3 study of Annamycin in combination with cytarabine for the treatment of adult subjects with AML who are refractory to, or have relapsed (R/R) after, induction therapy. Part A of the trial is a randomized, double-blind portion of the study that compares two different doses of Annamycin plus cytarabine to a control arm of cytarabine plus placebo, all with just one cycle of therapy. Importantly, as specified by the MIRACLE protocol, remission rates for all three arms, including the control arm, reflect outcomes measured after only a single cycle of therapy. The most commonly cited historical benchmarks in this setting, including the MIRROS and CLASSIC I studies, as well as Moleculin’s own MB-106 study, permitted multiple cycles of treatment. The Company therefore expects absolute remission rates for both the control and Annamycin arms to be lower than those reported in such multi-cycle datasets and believes the most meaningful comparison is the performance of the Annamycin arms relative to the concurrent, randomized control arm evaluated on the same single-cycle basis. The comprehensive Part A analysis is expected to evaluate efficacy and safety across the complete randomized population and support selection of the optimal Annamycin dose for advancement into Part B of MIRACLE. For additional information on the MIRACLE trial, please visit ClinicalTrials.gov and reference Identifier NCT06788756. About Moleculin Biotech, Inc. Moleculin Biotech, Inc. is a Phase 3 clinical stage pharmaceutical company advancing a pipeline of therapeutic candidates addressing hard-to-treat tumors and viruses. The Company’s lead program, Annamycin (also known as naxtarubicin), has shown to be an efficacious and well tolerated anthracycline designed to avoid multidrug resistance mechanisms and to lack the cardiotoxicity common with currently prescribed anthracyclines. Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases. The Company is conducting the MIRACLE (Moleculin R/R AML AnnAraC Clinical Evaluation) Trial (MB-108), a pivotal, adaptive design, multi-center, randomized, double-blind, placebo-controlled Phase 2/3 trial evaluating Annamycin in combination with cytarabine (also referred to as “Ara-C”), together referred to as AnnAraC, for the treatment of relapsed or refractory acute myeloid leukemia. Following a successful Phase 1B/2 study (MB-106), with input from the FDA, the Company believes it has substantially de-risked the development pathway toward a potential approval for Annamycin for the treatment of AML. This study remains subject to appropriate future filings with potential additional feedback from the FDA and their foreign equivalents. Additionally, the Company is developing WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic and other cancers. Moleculin also has in its pipeline a portfolio of antimetabolites, including WP1122 for the potential treatment of pathogenic viruses, as well as certain cancer indications. For more information about the Company, please visit www.moleculin.com and connect on X, LinkedIn and Facebook. Forward-Looking Statements Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the potential efficacy and safety of Annamycin and AnnAraC in R/R AML, the continued absence of cardiotoxicity based on blinded interim data, expected timing of the comprehensive Part A data readout in Q1 2027, the anticipated composition of the Part A population including the expected approximate 50/50 split between patients who failed intensive 7+3 chemotherapy and those who failed venetoclax-based regimens, the potential for Part A data to support dose selection for Part B, and the potential for Part A data to support dose selection for Part B. Moleculin will require significant additional financing, for which the Company has no commitments, in order to conduct its clinical trials as described in this press release, and the milestones described in this press release assume the Company’s ability to secure such financing on a timely basis. Although Moleculin believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. The Company relies on the reports of its expert with regard to the absence of cardiotoxicity. The dataset referenced in this press release is subject to the review of the data from future subjects in its current and future clinical trials and long-term follow-up with subjects in its current trials. Moleculin has attempted to identify forward-looking statements by terminology including ‘believes,’ ‘estimates,’ ‘anticipates,’ ‘expects,’ ‘plans,’ ‘projects,’ ‘intends,’ ‘potential,’ ‘may,’ ‘could,’ ‘might,’ ‘will,’ ‘should,’ ‘approximately’ or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (SEC) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events. Investor Contact:JTC Team, LLCJenene Thomas(908) 824-0775MBRX@jtcir.com

Reports Third-Quarter Diluted EPS of $2.37 on a GAAP Basis, an Increase of Over 100.0 Percent; Adjusted Diluted EPS of $3.82, an Increase of Over 100.0 Percent; These Results Include an Unfavorable Impact of $0.11 Per Share Related to Acquired IPR&D and Milestones Expense Delivers Third-Quarter Net Revenues of $17.404 Billion, an Increase of 10.3 Percent on a Reported Basis or 10.5 Percent on an Operational Basis Third-Quarter Global Net Revenues from the Immunology Portfolio Were $9.165 Billion, an Increase of 16.3 Percent on a Reported Basis, or 16.6 Percent on an Operational Basis; Global Skyrizi Net Revenues Were $5.776 Billion; Global Rinvoq Net Revenues Were $2.706 Billion; Global Humira Net Revenues Were $683 Million Third-Quarter Global Net Revenues from the Neuroscience Portfolio Were $3.389 Billion, an Increase of 19.4 Percent on a Reported Basis, or 19.5 Percent on an Operational Basis; Global Vraylar Net Revenues Were $1.068 Billion; Global Botox Therapeutic Net Revenues Were $1.080 Billion; Combined Global Ubrelvy and Qulipta Net Revenues Were $847 Million; Global Vyalev Net Revenues Were $286 Million Third-Quarter Global Net Revenues from the Oncology Portfolio Were $1.696 Billion, an Increase of 0.8 Percent on a Reported Basis, or 0.9 Percent on an Operational Basis; Global Venclexta Net Revenues Were $803 Million; Global Imbruvica Net Revenues Were $522 Million; Global Elahere Net Revenues Were $224 Million Third-Quarter Global Net Revenues from the Aesthetics Portfolio Were $1.176 Billion, a Decrease of 1.4 Percent on a Reported Basis, or 1.8 Percent on an Operational Basis; Global Botox Cosmetic Net Revenues Were $669 Million; Global Juvederm Net Revenues Were $222 Million Successfully Completed Acquisition of Apogee Therapeutics, Deepening AbbVie's Robust Immunology Pipeline Raises 2026 Adjusted Diluted EPS Guidance Range from $13.76 - $13.96 to $13.95 - $13.99, which Includes an Unfavorable Impact of $0.69 Per Share Related to Acquired IPR&D and Milestones Expense Incurred Year-To-Date Through the Third Quarter 2026 Announces 2027 Dividend Increase of 5.2 Percent, Beginning with Dividend Payable in February 2027 NORTH CHICAGO, Ill. , Oct. 30, 2026 /PRNewswire/ -- AbbVie (NYSE:ABBV) announced financial results for the third quarter ended September 30, 2026. "AbbVie continues to deliver outstanding results, reflecting solid execution across our diverse portfolio," said Robert A. Michael, chairman and chief executive officer, AbbVie. "We also enhanced our long-term growth potential by securing key regulatory approvals, generating differentiated clinical data and completing the acquisition of Apogee Therapeutics. Given our strong outlook and significant momentum, we are once again increasing AbbVie's full-year guidance and raising our quarterly dividend." Third-Quarter Results Worldwide net revenues were $17.404 billion, an increase of 10.3 percent on a reported basis, or 10.5 percent on an operational basis. Global net revenues from the immunology portfolio were $9.165 billion, an increase of 16.3 percent on a reported basis, or 16.6 percent on an operational basis. Global Skyrizi net revenues were $5.776 billion, an increase of 22.7 percent on a reported basis, or 22.9 percent on an operational basis. Global Rinvoq net revenues were $2.706 billion, an increase of 23.9 percent on a reported basis, or 24.3 percent on an operational basis. Global Humira net revenues were $683 million, a decrease of 31.2 percent on a reported basis, or 30.6 percent on an operational basis. Global net revenues from the neuroscience portfolio were $3.389 billion, an increase of 19.4 percent on a reported basis, or 19.5 percent on an operational basis. Global Vraylar net revenues were $1.068 billion, an increase of 14.3 percent. Global Botox Therapeutic net revenues were $1.080 billion, an increase of 9.8 percent. Global Ubrelvy net revenues were $449 million, an increase of 26.9 percent. Global Qulipta net revenues were $398 million, an increase of 38.2 percent on a reported basis, or 38.5 percent on an operational basis. Global Vyalev net revenues were $286 million. Global net revenues from the oncology portfolio were $1.696 billion, an increase of 0.8 percent on a reported basis, or 0.9 percent on an operational basis. Global Venclexta net revenues were $803 million, an increase of 10.7 percent. Global Imbruvica net revenues were $522 million, a decrease of 26.1 percent. Global Elahere net revenues were $224 million, an increase of 31.0 percent on a reported basis, or 31.2 percent on an operational basis. Global net revenues from the aesthetics portfolio were $1.176 billion, a decrease of 1.4 percent on a reported basis, or 1.8 percent on an operational basis. Global Botox Cosmetic net revenues were $669 million, an increase of 4.9 percent on a reported basis, or 4.1 percent on an operational basis. Global Juvederm net revenues were $222 million, a decrease of 11.9 percent on a reported basis, or 11.8 percent on an operational basis. On a GAAP basis, the gross margin ratio in the third quarter was 75.4 percent. The adjusted gross margin ratio was 85.1 percent. On a GAAP basis, selling, general and administrative (SG&A) expense was 23.5 percent of net revenues. The adjusted SG&A expense was 21.2 percent of net revenues. On a GAAP basis, research and development (R&D) expense was 14.7 percent of net revenues. The adjusted R&D expense was 13.9 percent of net revenues. Acquired IPR&D and milestones expense was 1.2 percent of net revenues. On a GAAP basis, the operating margin ratio in the third quarter was 36.0 percent. The adjusted operating margin ratio was 48.7 percent. On a GAAP basis, net interest expense was $700 million. The adjusted net interest expense was $688 million. On a GAAP basis, the tax rate in the quarter was 12.6 percent. The adjusted tax rate was 13.6 percent. Diluted earnings per share (EPS) in the third quarter was $2.37 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $3.82. These results include an unfavorable impact of $0.11 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 it completed its acquisition of Apogee Therapeutics, deepening AbbVie's robust immunology pipeline with diverse assets targeting dermatologic, respiratory and other inflammatory and immunological diseases. The acquisition includes zumilokibart, a late-stage, half-life extended monoclonal antibody targeting IL-13 for atopic dermatitis (AD), as well as APG273, a potential best-in-category long-acting combination targeting IL-13 and thymic stromal lymphopoietin (TSLP) in asthma. AbbVie announced the U.S. Food and Drug Administration (FDA) approved Skyrizi (risankizumab) for subcutaneous (SC) induction in the treatment of moderately to severely active Crohn's disease (CD). The approval offers adult CD patients an additional option for induction of Skyrizi and is supported by positive data from the Phase 3 AFFIRM study. The FDA also approved an update to the U.S. prescribing information's warning and precautions for Skyrizi, across all indications, to allow healthcare providers to use clinical judgment when determining whether tuberculosis testing is needed. Additionally, AbbVie announced it submitted an application to the European Medicines Agency (EMA) seeking approval for Skyrizi for SC induction in the treatment of adult patients with moderately to severely active CD. AbbVie announced positive topline results from the Phase 3 INTREPID study evaluating the safety and efficacy of lutikizumab, an investigational dual-variable-domain IL-1α/1β antagonist, in adults and adolescents with moderate to severe hidradenitis suppurativa (HS). In the study, lutikizumab met the primary endpoint, achieving a significantly higher response rate of Hidradenitis Suppurativa Clinical Response 75 (HiSCR 75) at Week 16 compared with placebo and also met the majority of ranked secondary endpoints, including significant improvements in HS-related skin pain at Week 8 and significant reductions in the occurrence of HS flares over the first 16 weeks. Lutikizumab was generally well tolerated, with no new safety concerns identified. These data will be presented at a future medical congress. Additional data from this study, including results from a 36-week blinded extension period, are expected next year and will be used to support regulatory submissions for lutikizumab in HS in the second half of 2027. At the American College of Gastroenterology (ACG) 2026 Annual Scientific Meeting, AbbVie shared new Skyrizi and Rinvoq (upadacitinib) data which demonstrated disease control for patients living with inflammatory bowel disease (IBD). Highlights included new Phase 3 AFFIRM data which showed higher rates of clinical and endoscopic response in CD patients treated with SC Skyrizi versus placebo across all efficacy endpoints and observed subgroups; open-label extension analyses that demonstrated sustained endoscopic outcomes over time with Skyrizi, even in patients with complex disease characteristics and prior treatment exposure; and real-world studies that showed patients with advanced CD achieved disease control with Rinvoq, highlighting its potential benefit for difficult-to-treat patients. At the 2026 United European Gastroenterology (UEG) Week, AbbVie showcased 20 presentations that underscored the breadth of its IBD research programs. Key disclosures included late-breaking results from the Phase 2a TARGET-CD trial for combination therapy ABBV-466 (Skyrizi + ABBV-382) which demonstrated higher endoscopic remission rates than either Skyrizi or ABBV-382 monotherapy at Week 12, the primary endpoint, with remission rates continuing to increase through Week 24 in patients with moderate to severe CD. AbbVie also presented long-term and real-world data for Skyrizi and Rinvoq that provided additional insight into clinical and endoscopic outcomes in moderately to severely active CD and ulcerative colitis (UC). At the 2026 European Academy of Dermatology and Venereology (EADV) Congress, AbbVie presented data from 60 abstracts reflecting AbbVie's expanding portfolio across a wide spectrum of immune-mediated skin diseases. Highlights included late-breaking presentations from the Phase 3 Viti-Up-1 and Viti-Up-2 studies of Rinvoq in non-segmental vitiligo (NSV), which showed continued facial and total body repigmentation through week 76; primary results from the Phase 2 APEX Part B study evaluating zumilokibart in adult patients with moderate to severe AD, which showed all three dose regimens met the primary endpoint with significantly greater improvements in Eczema Area and Severity Index-75 (EASI-75) response rates versus placebo at week 16; and data showing how lutikizumab targets neutrophilic inflammation and fibroblast activation in HS. AbbVie announced the FDA approved Juvmo (tavapadon) tablets as the only selective D1/D5 receptor agonist for the treatment of adults with Parkinson's disease (PD). Taken once daily with or without levodopa therapy, Juvmo offers patients a differentiated approach to motor symptom control across the PD continuum. This approval is supported by the Phase 3 TEMPO program, which demonstrated significant improvements in daily functioning, increased "on" time without troublesome dyskinesia and a favorable safety profile. AbbVie announced positive topline results from the Phase 3 LUNA study, which evaluated Qulipta (atogepant), a calcitonin gene-related peptide (CGRP) receptor antagonist, for the preventive treatment of menstrual migraine in adults. In the study, Qulipta demonstrated statistically significant reductions in migraine days associated with the menstrual period, meeting the primary and all eight ranked secondary endpoints versus placebo. Menstrual migraine is a recurrent, debilitating migraine pattern, with attacks occurring around or during the menstrual period. No treatment options are currently approved for menstrual migraine, underscoring the urgent need for care approaches specifically designed for this patient population. At Psych Congress 2026, AbbVie presented new real-world data supporting the effectiveness of Vraylar (cariprazine), which showed meaningful improvements in depressive symptoms, functioning and quality of life among adults living with major depressive disorder and bipolar I depression. These findings provide additional evidence that the benefits observed with Vraylar in clinical trials can also be achieved in routine practice, where patients often have more complex treatment needs. Vraylar is being co-developed by AbbVie and Gedeon Richter. AbbVie announced submission of a Biologics License Application (BLA) to the FDA for etentamig, a next-generation BCMA x CD3 bispecific T-cell engager, for the treatment of patients living with relapsed/refractory multiple myeloma (RRMM). The submission is supported by positive results from the Phase 3 CERVINO study which demonstrated that etentamig achieved significant improvements in overall response rate (ORR, 74%) and progression-free survival (PFS, 60%) versus investigator's choice of standard available therapies in triple-class exposed adults with RRMM who had received at least two prior lines of therapy. Etentamig demonstrated low rates of cytokine release syndrome and fatal infections with monthly dosing from initiation following a single step-up dose. These results support the potential for etentamig treatment across a range of settings, including community-based care, offering a potentially differentiated treatment option for patients and providers. AbbVie and Genmab announced positive topline results from the Phase 3 EPCORE DLBCL-2 trial evaluating fixed treatment duration Epkinly (epcoritamab), a T-cell engaging bispecific antibody with SC administration, in combination with standard of care rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP), compared to R-CHOP alone, in newly diagnosed patients with diffuse large B-cell lymphoma (DLBCL). The trial demonstrated a statistically significant and clinically meaningful improvement in PFS in DLBCL patients, as the risk of disease progression or death was reduced by 51%. The safety pro Epkinly when administered in combination with standard of care R-CHOP was generally well tolerated and consistent with the previously reported safety profiles of the individual agents. Based on the topline results, Genmab and AbbVie will engage global regulatory authorities. Epkinly is being co-developed by AbbVie and Genmab. AbbVie announced the FDA granted two Breakthrough Therapy Designations (BTDs) for telisotuzumab adizutecan (Temab-A), a next-generation, c-Met-directed antibody-drug conjugate (ADC) with a novel topoisomerase 1 inhibitor, in colorectal cancer (CRC) and non-small cell lung cancer (NSCLC). These designations represent the first BTDs for Temab-A. At the 23 rd International Myeloma Society (IMS) Annual Meeting, AbbVie presented research demonstrating the breadth of its myeloma pipeline. Highlights included a plenary presentation featuring full results from the Phase 3 CERVINO study evaluating etentamig; as well as data from ABBV-2001, a trispecific T-cell engager; surzetoclax, a BCL-2 inhibitor; and combination approaches. At the 2026 World Conference on Lung Cancer (WCLC), AbbVie shared new data showcasing its strategy aimed at building a lung cancer pipeline spanning next-generation immunotherapies, targeted ADCs and the potential for novel combination approaches. Presentations included clinical data from ABBV-1480, Temab-A and ABBV-706 programs across NSCLC and small cell lung cancer (SCLC). ABBV-1480 is developed in partnership with RemeGen. At the 2026 European Society for Medical Oncology (ESMO), AbbVie presented new data across its solid tumor pipeline that underscored the potential of AbbVie's oncology portfolio to address diverse patient needs through next-generation ADCs, combination approaches and precision medicine. Data across multiple assets in various stages of development highlighted longer-term survival, combination and biomarker findings. Allergan Aesthetics announced the FDA accepted for review its supplemental BLA for Botox Cosmetic (onabotulinumtoxinA) for the temporary improvement in the appearance of marked to very marked masseter muscle prominence (MMP) associated with masseter muscle activity in adults. The submission is supported by two Phase 3 studies, demonstrating statistically significant improvements in MMP and patient satisfaction with treatment. If approved, Botox Cosmetic would become the first neurotoxin indicated for this condition in the U.S. and expand its portfolio to a fifth aesthetic indication. At the European Association for the Study of Diabetes (EASD) 2026 Annual Meeting, AbbVie announced detailed Phase 1 data for ABBV-295, a long-acting amylin analog being developed for the treatment of obesity. Data presented demonstrated an approximately 11- to 12-day half-life and dose-proportional increases in plasma exposure, supporting evaluation of ABBV-295 at dosing intervals beyond weekly administration, including every-other-week and monthly regimens. ABBV-295 also showed meaningful body weight reduction and a favorable tolerability pro all evaluated dose levels, with topline results announced earlier this year. Findings support advancement of ABBV-295 into Phase 2 development for chronic weight management. AbbVie announced an agreement with Valkai to apply advanced artificial intelligence (AI) across targeted areas of clinical development. The agreement is designed to strengthen integrated AI capabilities across clinical development to help accelerate the pace at which scientific innovation reaches patients. AbbVie and Iambic, a clinical-stage life sciences and technology company developing novel medicines through its AI-driven discovery and development platform, announced a multi-year strategic relationship to accelerate the discovery and development of small molecule therapies in immunology, neuroscience and oncology. The strategic relationship will pursue programs with first-in-class and best-in-class potential, combining Iambic's molecular superintelligence platform with AbbVie's therapeutic area expertise. Full-Year 2026 Outlook AbbVie is raising its adjusted diluted EPS guidance for the full year 2026 from $13.76 - $13.96 to $13.95 - $13.99, which includes an unfavorable impact of $0.69 per share related to acquired IPR&D and milestones expense incurred year-to-date through the third quarter 2026. The company's 2026 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred beyond the third quarter of 2026, as both cannot be reliably forecasted. AbbVie does not provide a reconciliation of forward-looking non-GAAP financial measures, including adjusted diluted earnings per share to the most directly comparable generally accepted accounting principles in the United States (GAAP) financial measures because AbbVie is unable to predict with reasonable certainty, without unreasonable effort, the amount and timing of changes in fair value of contingent consideration, intangible asset impairments, acquisition and integration costs, litigation matters, income tax items and other adjustments. These items are uncertain, depend on various factors and could have a material impact on AbbVie's GAAP results for the guidance period. Company Declares Dividend Increase of 5.2 Percent AbbVie is announcing today that its board of directors declared an increase in the company's quarterly cash dividend from $1.73 per share to $1.82 per share beginning with the dividend payable on February 16, 2027 to shareholders of record as of January 15, 2027. This reflects an increase of approximately 5.2 percent, continuing AbbVie's strong commitment to returning cash to shareholders through a growing dividend. Since the company's inception in 2013, AbbVie has increased its quarterly dividend by 355 percent. AbbVie is a member of the S&P Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years. About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions 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 including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn , Facebook , Instagram , X and YouTube . Conference Call AbbVie will host an investor conference call today at 8:00 a.m. Central Time to discuss our third-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 2026 and 2025 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. 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," "estimate," "intend," "plan," "target," "may," "could" and "will," 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, changes to laws and regulations applicable to our industry, drug pricing reform and government pricing programs, risks related to the use of artificial intelligence or other emerging technologies, and the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes, tariffs and changes in U.S. and international trade policies, and other uncertainties and risks associated with global business operations. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date made. 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 most recently filed Annual Report on Form 10-K, as updated by its Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and in other documents 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. Media: Investors: Cat Langel Liz Shea (708) 508-3524 (847) 935-2211 Todd Bosse (847) 936-1182 Jeffrey Byrne (847) 938-2923 AbbVie Inc. Key Product Revenues Quarter Ended September 30, 2026 (Unaudited) % Change vs. 3Q25 Net Revenues (in millions) Reported Operational a U.S. Int'l. Total U.S. Int'l. Total Int'l. Total NET REVENUES $13,333 $4,071 $17,404 10.5 % 9.8 % 10.3 % 10.6 % 10.5 % Immunology 7,315 1,850 9,165 16.8 14.1 16.3 15.6 16.6 Skyrizi 5,019 757 5,776 22.9 21.6 22.7 23.2 22.9 Rinvoq 1,924 782 2,706 23.4 25.1 23.9 26.4 24.3 Humira 372 311 683 (39.9) (16.8) (31.2) (15.2) (30.6) Neuroscience 2,939 450 3,389 19.3 20.0 19.4 20.7 19.5 Vraylar 1,064 4 1,068 14.3 43.5 14.3 46.0 14.3 Botox Therapeutic 912 168 1,080 10.5 5.8 9.8 5.6 9.8 Ubrelvy 438 11 449 27.3 13.9 26.9 15.0 26.9 Qulipta 333 65 398 32.1 80.2 38.2 82.3 38.5 Vyalev 154 132 286 >100.0 55.6 >100.0 57.2 >100.0 Other Neuroscience 38 70 108 (36.0) (15.3) (23.9) (14.6) (23.5) Oncology 973 723 1,696 (5.7) 11.1 0.8 11.4 0.9 Venclexta 385 418 803 13.0 8.7 10.7 8.6 10.7 Imbruvica b 340 182 522 (33.0) (8.3) (26.1) (8.3) (26.1) Elahere 166 58 224 9.6 >100.0 31.0 >100.0 31.2 Epkinly c 43 65 108 >100.0 35.1 57.7 39.5 60.8 Other Oncology 39 — 39 >100.0 62.6 >100.0 62.6 >100.0 Aesthetics 723 453 1,176 (2.3) 0.1 (1.4) (1.0) (1.8) Botox Cosmetic 388 281 669 2.4 8.6 4.9 6.5 4.1 Juvederm Collection 90 132 222 (6.3) (15.4) (11.9) (15.3) (11.8) Other Aesthetics 245 40 285 (7.6) 5.5 (6.0) 6.5 (5.9) Other Key Products 800 165 965 (3.5) (7.1) (4.1) (4.9) (3.7) Mavyret 115 150 265 (21.2) (9.7) (15.1) (7.4) (13.9) Creon 361 — 361 (2.2) n/m (2.2) n/m (2.2) Linzess 324 15 339 3.2 31.1 4.2 31.8 4.2 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. c Epkinly U.S. revenues reflect profit sharing. International revenues reflect product revenues as well as profit sharing from certain international territories. n/m = not meaningful AbbVie Inc. Key Product Revenues Nine Months Ended September 30, 2026 (Unaudited) % Change vs. 9M25 Net Revenues (in millions) Reported Operational a U.S. Int'l. Total U.S. Int'l. Total Int'l. Total NET REVENUES $37,163 $12,233 $49,396 9.9 % 14.0 % 10.9 % 10.7 % 10.1 % Immunology 19,809 5,432 25,241 14.9 19.7 15.9 16.5 15.2 Skyrizi 13,561 2,203 15,764 25.0 28.9 25.6 24.9 25.1 Rinvoq 5,094 2,256 7,350 20.4 32.8 23.9 29.2 22.9 Humira 1,154 973 2,127 (46.7) (13.8) (35.4) (15.2) (35.9) Neuroscience 8,169 1,323 9,492 20.7 27.6 21.6 22.7 20.9 Vraylar 3,034 10 3,044 17.0 44.9 17.1 42.8 17.1 Botox Therapeutic 2,618 513 3,131 12.7 12.6 12.7 8.3 12.0 Ubrelvy 1,147 33 1,180 26.5 31.7 26.7 29.6 26.6 Qulipta 872 172 1,044 32.0 97.2 39.6 91.2 38.9 Vyalev 371 372 743 >100.0 70.9 >100.0 64.0 >100.0 Other Neuroscience 127 223 350 (38.0) (8.7) (22.0) (12.9) (24.3) Oncology 2,791 2,186 4,977 (9.5) 14.6 (0.3) 11.5 (1.5) Venclexta 1,095 1,249 2,344 12.4 12.8 12.6 7.9 10.0 Imbruvica b 1,009 601 1,610 (36.1) (2.9) (26.8) (2.9) (26.8) Elahere 487 146 633 7.4 >100.0 24.5 >100.0 23.3 Epkinly c 104 190 294 64.7 49.9 54.9 50.5 55.3 Other Oncology 96 — 96 >100.0 >100.0 >100.0 >100.0 >100.0 Aesthetics 2,188 1,456 3,644 0.5 4.3 2.0 0.9 0.7 Botox Cosmetic 1,159 906 2,065 6.9 13.1 9.5 8.7 7.6 Juvederm Collection 278 421 699 0.3 (9.8) (6.0) (11.8) (7.2) Other Aesthetics 751 129 880 (8.1) 1.0 (6.9) (1.2) (7.2) Other Key Products 2,377 518 2,895 3.3 (6.2) 1.5 (9.7) 0.8 Mavyret 431 480 911 (8.8) (7.8) (8.3) (11.2) (10.1) Creon 1,067 — 1,067 (5.4) n/m (5.4) n/m (5.4) Linzess 879 38 917 25.5 19.9 25.2 16.0 25.0 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. c Epkinly U.S. revenues reflect profit sharing. International revenues reflect product revenues as well as profit sharing from certain international territories. n/m = not meaningful AbbVie Inc. Consolidated Statements of Earnings (Unaudited) (in millions, except per share data) Third Quarter Ended September 30 Nine Months Ended September 30 2026 2025 2026 2025 Net revenues $ 17,404 $ 15,776 $ 49,396 $ 44,542 Cost of products sold 4,285 5,304 12,794 13,652 Selling, general and administrative 4,087 3,569 11,297 10,115 Research and development 2,567 2,319 7,383 6,517 Acquired IPR&D and milestones 216 2,680 1,251 3,751 Other operating income (18) — (18) (24) Total operating costs and expenses 11,137 13,872 32,707 34,011 Operating earnings 6,267 1,904 16,689 10,531 Interest expense, net 700 667 2,024 1,972 Other expense, net 738 523 4,519 4,630 Earnings before income tax expense 4,829 714 10,146 3,929 Income tax expense 609 526 1,613 1,511 Net earnings 4,220 188 8,533 2,418 Net earnings attributable to noncontrolling interest 2 2 7 8 Net earnings attributable to AbbVie Inc. $ 4,218 $ 186 $ 8,526 $ 2,410 Diluted earnings per share attributable to AbbVie Inc. $ 2.37 $ 0.10 $ 4.79 $ 1.34 Adjusted diluted earnings per share a $ 3.82 $ 1.86 $ 10.12 $ 7.29 Weighted-average diluted shares outstanding 1,772 1,772 1,772 1,772 a Refer to the Reconciliation of GAAP Reported to Non-GAAP Adjusted Information for further details. AbbVie Inc. Reconciliation of GAAP Reported to Non-GAAP Adjusted Information (Unaudited) 1. Specified items impacted results as follows: Quarter Ended September 30, 2026 (in millions, except per share data) Earnings Diluted Pre-tax After-tax a EPS As reported (GAAP) $ 4,829 $ 4,218 $ 2.37 Adjusted for specified items: Intangible asset amortization 1,669 1,419 0.79 Acquisition and integration costs 408 391 0.22 Change in fair value of contingent consideration 829 809 0.46 Other 131 (42) (0.02) As adjusted (non-GAAP) $ 7,866 $ 6,795 $ 3.82 a Represents net earnings attributable to AbbVie Inc. Specified items reflect the impact of applicable statutory tax rates. Acquisition and integration costs primarily reflect costs related to the Apogee Therapeutics, Inc. acquisition. Reported GAAP earnings and adjusted non-GAAP earnings for the three months ended September 30, 2026 included acquired IPR&D and milestone expense of $216 million on a pre-tax and $205 million on an after-tax basis, representing an unfavorable impact of $0.11 to both diluted EPS and adjusted diluted EPS. 2. The impact of the specified items by line item was as follows: Quarter Ended September 30, 2026 (in millions) Cost of products sold SG&A R&D Other operating income Interest expense, net Other expense, net As reported (GAAP) $ 4,285 $ 4,087 $ 2,567 $ (18) $ 700 $ 738 Adjusted for specified items: Intangible asset amortization (1,669) — — — — — Acquisition and integration costs (4) (250) (142) — (12) — Change in fair value of contingent consideration — — — — — (829) Other (11) (149) — 18 — 11 As adjusted (non-GAAP) $ 2,601 $ 3,688 $ 2,425 $ — $ 688 $ (80) 3. The adjusted tax rate for the third quarter of 2026 was 13.6 percent, as detailed below: Quarter Ended September 30, 2026 (dollars in millions) Pre-tax earnings Income taxes Tax rate As reported (GAAP) $ 4,829 $ 609 12.6 % Specified items 3,037 460 15.1 % As adjusted (non-GAAP) $ 7,866 $ 1,069 13.6 % AbbVie Inc. Reconciliation of GAAP Reported to Non-GAAP Adjusted Information (Unaudited) 1. Specified items impacted results as follows: Quarter Ended September 30, 2025 (in millions, except per share data) Earnings Diluted Pre-tax After-tax a EPS As reported (GAAP) $ 714 $ 186 $ 0.10 Adjusted for specified items: Intangible asset amortization 1,871 1,576 0.89 Intangible asset impairment 847 701 0.39 Acquisition and integration costs 212 207 0.12 Change in fair value of contingent consideration 776 755 0.43 Other (40) (119) (0.07) As adjusted (non-GAAP) $ 4,380 $ 3,306 $ 1.86 a Represents net earnings attributable to AbbVie Inc. Specified items reflect the impact of applicable statutory tax rates. Intangible asset impairment reflects impairment charges of $847 million related to the Resonic and Durysta intangible assets. Acquisition and integration costs primarily reflect costs related to the Capstan acquisition. Reported GAAP earnings and adjusted non-GAAP earnings for the three months ended September 30, 2025 included acquired IPR&D and milestone expense of $2.7 billion on a pre-tax and after-tax basis, representing an unfavorable impact of $1.50 to both diluted EPS and adjusted diluted EPS. 2. The impact of the specified items by line item was as follows: Quarter Ended September 30, 2025 (in millions) Cost of products sold SG&A R&D Other expense, net As reported (GAAP) $ 5,304 $ 3,569 $ 2,319 $ 523 Adjusted for specified items: Intangible asset amortization (1,871) — — — Intangible asset impairment (847) — — — Acquisition and integration costs (5) (144) (63) — Change in fair value of contingent consideration — — — (776) Other (34) (13) — 87 As adjusted (non-GAAP) $ 2,547 $ 3,412 $ 2,256 $ (166) 3. The adjusted tax rate for the third quarter of 2025 was 24.5 percent, as detailed below: Quarter Ended September 30, 2025 (dollars in millions) Pre-tax earnings Income taxes Tax rate As reported (GAAP) $ 714 $ 526 73.7 % Specified items 3,666 546 14.9 % As adjusted (non-GAAP) $ 4,380 $ 1,072 24.5 % AbbVie Inc. Reconciliation of GAAP Reported to Non-GAAP Adjusted Information (Unaudited) 1. Specified items impacted results as follows: Nine Months Ended September 30, 2026 (in millions, except per share data) Earnings Diluted Pre-tax After-tax a EPS As reported (GAAP) $ 10,146 $ 8,526 $ 4.79 Adjusted for specified items: Intangible asset amortization 5,106 4,353 2.45 Acquisition and integration costs 431 410 0.23 Change in fair value of contingent consideration 4,734 4,613 2.60 Other 631 95 0.05 As adjusted (non-GAAP) $ 21,048 $ 17,997 $ 10.12 a Represents net earnings attributable to AbbVie Inc. Specified items reflect the impact of applicable statutory tax rates. Acquisition and integration costs primarily reflect costs related to the Apogee Therapeutics, Inc. acquisition. Reported GAAP earnings and adjusted non-GAAP earnings for the nine months ended September 30, 2026 included acquired IPR&D and milestones expense of $1.3 billion on a pre-tax and $1.2 billion on an after-tax basis, representing an unfavorable impact of $0.69 to both diluted EPS and adjusted diluted EPS. 2. The impact of the specified items by line item was as follows: Nine Months Ended September 30, 2026 (in millions) Cost of products sold SG&A R&D Other operating income Interest expense, net Other expense, net As reported (GAAP) $ 12,794 $ 11,297 $ 7,383 $ (18) $ 2,024 $ 4,519 Adjusted for specified items: Intangible asset amortization (5,106) — — — — — Acquisition and integration costs (7) (257) (155) — (12) — Change in fair value of contingent consideration — — — — — (4,734) Other (20) (377) (221) 18 — (31) As adjusted (non-GAAP) $ 7,661 $ 10,663 $ 7,007 $ — $ 2,012 $ (246) 3. The adjusted tax rate for the first nine months of 2026 was 14.5 percent, as detailed below: Nine Months Ended September 30, 2026 (dollars in millions) Pre-tax earnings Income taxes Tax rate As reported (GAAP) $ 10,146 $ 1,613 15.9 % Specified items 10,902 1,431 13.1 % As adjusted (non-GAAP) $ 21,048 $ 3,044 14.5 % AbbVie Inc. Reconciliation of GAAP Reported to Non-GAAP Adjusted Information (Unaudited) 1. Specified items impacted results as follows: Nine Months Ended September 30, 2025 (in millions, except per share data) Earnings Diluted Pre-tax After-tax a EPS As reported (GAAP) $ 3,929 $ 2,410 $ 1.34 Adjusted for specified items: Intangible asset amortization 5,593 4,721 2.67 Intangible asset impairment 847 701 0.39 Acquisition and integration costs 273 256 0.14 Change in fair value of contingent consideration 5,089 4,941 2.79 Other 52 (75) (0.04) As adjusted (non-GAAP) $ 15,783 $ 12,954 $ 7.29 a Represents net earnings attributable to AbbVie Inc. Specified items reflect the impact of applicable statutory tax rates. Intangible asset impairment reflects impairment charges of $847 million related to the Resonic and Durysta intangible assets. Acquisition and integration costs primarily reflect costs related to the Capstan acquisition. Reported GAAP earnings and adjusted non-GAAP earnings for the nine months ended September 30, 2025 included acquired IPR&D and milestones expense of $3.8 billion on a pre-tax and $3.6 billion on an after-tax basis, representing an unfavorable impact of $2.05 to both diluted EPS and adjusted diluted EPS. 2. The impact of the specified items by line item was as follows: Nine Months Ended September 30, 2025 (in millions) Cost of products sold SG&A R&D Other operating income Other expense, net As reported (GAAP) $ 13,652 $ 10,115 $ 6,517 $ (24) $ 4,630 Adjusted for specified items: Intangible asset amortization (5,593) — — — — Intangible asset impairment (847) — — — — Acquisition and integration costs (10) (171) (92) — — Change in fair value of contingent consideration — — — — (5,089) Other (126) (13) (3) 24 66 As adjusted (non-GAAP) $ 7,076 $ 9,931 $ 6,422 $ — $ (393) 3. The adjusted tax rate for the first nine months of 2025 was 17.9 percent, as detailed below: Nine Months Ended September 30, 2025 (dollars in millions) Pre-tax earnings Income taxes Tax rate As reported (GAAP) $ 3,929 $ 1,511 38.5 % Specified items 11,854 1,310 11.1 % As adjusted (non-GAAP) $ 15,783 $ 2,821 17.9 % View original content: SOURCE AbbVie