Glecaprevir/Pibrentasvir

Conducting Phase 3 Enabling Activities, Including Discussions with U.S. Food & Drug Administration (FDA), for Zelicapavir, an N-Protein Inhibitor in Development to Treat Respiratory Syncytial Virus (RSV) Introduced New Immunology Program Focused on MRGPRX2 Inhibition; On Track to Select a Development Candidate in 2H 2026 On Track to File an Investigational New Drug Application (IND) in 1Q 2026 and Report Phase 1 Data in 4Q 2026 for EDP-978, an Oral, Once-Daily KIT Inhibitor Clinical Candidate On Track to File an IND in 2H 2026 for EPS-3903, an Oral, Once-Daily STAT6 Inhibitor Development Candidate Strong Financial Position of $241.9 Million Supported by Continuing Retained Royalties, with Cash Runway Expected to Fund Operations into Fiscal 2029 WATERTOWN, Mass. --(BUSINESS WIRE)--Feb. 9, 2026-- Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and immunological diseases, today reported financial results for its fiscal first quarter ended December 31, 2025 . “Enanta entered the year with significant momentum, advancing our leading RSV treatment portfolio with preparation for a Phase 3 study and expanding our immunology pipeline with the introduction of our third program focused on developing oral MRGPRX2 inhibitors for type 2 immune driven diseases,” said Jay R. Luly , Ph.D., President and Chief Executive Officer at Enanta Pharmaceuticals . “With zelicapavir demonstrating clinically meaningful benefits in pediatric and high‑risk adult RSV studies and EDP‑323 showing promise not only in treatment, but also in post‑exposure prophylaxis, we are driving forward first-in-disease programs that have the potential to fundamentally change RSV patient care. In tandem, we are further building out our immunology portfolio, which now includes highly selective inhibitors of KIT, STAT6 and MRGPRX2.” Fiscal First Quarter Ended December 31, 2025 Financial Results Total revenue for the three months ended December 31, 2025 was $18.6 million and consisted of royalty revenue from worldwide net sales of MAVYRET®/MAVIRET® (glecaprevir/pibrentasvir), AbbVie’s eight-week treatment for chronic hepatitis C virus, compared to $17.0 million for the three months ended December 31, 2024 . The increase in revenue is due to an increase in AbbVie’s product sales. A portion (54.5%) of Enanta’s ongoing royalty revenue from AbbVie’s net sales of MAVYRET®/MAVIRET® is paid to OMERS, one of Canada’s largest defined benefit pension plans, pursuant to a royalty sale transaction affecting royalties earned after June 2023 . For financial reporting purposes, the transaction was treated as debt, with the upfront purchase payment of $200.0 million recorded as a liability. Each quarter, Enanta records 100% of the royalty earned as revenue and then amortizes the debt liability proportionally as 54.5% of the cash royalty payments are paid to OMERS through June 30, 2032 . This is subject to a cap of 1.42 times the purchase payment, after which point 100% of the cash royalty payments will be retained by Enanta. Interest expense was $3.1 million for the three months ended December 31, 2025 , as compared to interest expense of $2.0 million for the three months ended December 31, 2024 . Research and development expenses totaled $20.9 million for the three months ended December 31, 2025 , compared to $27.7 million for the three months ended December 31, 2024 . The decrease was due to a decrease in clinical trial expenses for Enanta’s RSV programs, partially offset by increased costs associated with the Company’s immunology programs. General and administrative expenses totaled $9.0 million for the three months ended December 31, 2025 , compared to $12.8 million for the three months ended December 31, 2024 . The decrease was due to a decrease in stock-based compensation expenses and a decrease in legal expenses related to the Company’s patent infringement lawsuits against Pfizer. Interest and investment income, net, totaled $2.4 million for the three months ended December 31, 2025 , compared to $2.8 million for the three months ended December 31, 2024 . The decrease in interest and investment income was due to lower interest rates year over year. Enanta recorded an income tax expense of less than $0.1 million for the three months ended December 31, 2025 , compared to an income tax benefit of $0.4 million for the three months ended December 31, 2024 . Enanta recorded interest earned on its federal income tax refund during the three months ended December 31, 2024 , until the $33.8 million refund was received in April 2025 . Net loss for the three months ended December 31, 2025 was $11.9 million , or a loss of $0.42 per diluted common share, compared to a net loss of $22.3 million , or a loss of $1.05 per diluted common share, for the corresponding period in 2024. Enanta’s cash, cash equivalents and short-term and long-term marketable securities totaled $241.9 million at December 31, 2025 . Enanta expects that its current cash, cash equivalents and marketable securities, as well as its retained portion of future royalty revenue, will be sufficient to meet the anticipated cash requirements of its existing business and development programs into fiscal 2029. Virology Enanta’s virology pipeline includes the leading portfolio in development for oral RSV treatment, consisting of zelicapavir, Enanta’s lead, once-daily N-protein inhibitor, and EDP-323, its once-daily L-protein inhibitor, both of which received Fast Track designation from the U.S. Food and Drug Administration . In September 2025 , Enanta announced positive data from RSVHR, a Phase 2b study evaluating zelicapavir in a high-risk adult outpatient population, including the elderly and those with asthma, chronic obstructive pulmonary disease, or congestive heart failure. A clinically meaningful improvement in time to complete resolution of all 13 RSV symptoms was observed for zelicapavir compared to placebo, with an improvement of 6.7 days for patients with congestive heart failure, chronic obstructive pulmonary disease or age 75 or older, termed the HR3 population. Zelicapavir also showed an improvement in time to complete resolution on the 29-parameter total RiiQ™ symptom scale of 7.2 days for the HR3 population compared to placebo. The study met key secondary endpoints, including a reduction in hospitalization and antiviral effects. Zelicapavir has been dosed in more than 700 people to date and continues to be well-tolerated with a favorable safety profile. Enanta continues to conduct Phase 3 enabling activities, with the goal of aligning with the FDA in the second quarter of 2026 on an adult Phase 3 trial design and overall registration path. In parallel, Enanta is exploring potential business development opportunities related to its RSV program. Enanta’s second RSV candidate, EDP-323, can be used alone or in combination with other agents, such as zelicapavir, to potentially broaden the treatment window or addressable patient populations. In October 2025 , the Company presented data on a post-exposure prophylaxis analysis performed in subjects who were not infected by Day 5 after RSV exposure in the previously disclosed EDP-323 Phase 2a human challenge study. The data showed the potential for EDP-323 to be effective in preventing RSV infection when initiated up to five days after RSV exposure, building on the previously reported EDP-323 challenge study treatment data. Enanta continues to conduct Phase 3 enabling activities, with the goal of aligning with the FDA in the second quarter of 2026 on an adult Phase 3 trial design and overall registration path. In parallel, Enanta is exploring potential business development opportunities related to its RSV program. In October 2025 , the Company presented data on a post-exposure prophylaxis analysis performed in subjects who were not infected by Day 5 after RSV exposure in the previously disclosed EDP-323 Phase 2a human challenge study. The data showed the potential for EDP-323 to be effective in preventing RSV infection when initiated up to five days after RSV exposure, building on the previously reported EDP-323 challenge study treatment data. Immunology Enanta’s immunology pipeline is focused on designing and developing highly potent and selective oral inhibitors for the treatment of inflammatory diseases, by targeting key drivers of the type 2 immune response. In January 2026 , Enanta announced its third immunology program targeting MRGPRX2, a non-canonical G-Protein-Coupled-Receptor (GPCR) expressed predominantly on mast cells. Inhibiting MRGPRX2 may have potential to address multiple chronic inflammatory diseases including urticaria, asthma, prurigo nodularis and others. Currently, Enanta is advancing novel, potent and selective oral inhibitors of MRGPRX2. The Company’s prototype MRGPRX2 inhibitors exhibit potent inhibition in vitro and in vivo. Specifically, they demonstrate MRGPRX2 inhibition with nanomolar potency (EC50 of 1-2nM) in cellular assays and prevent skin mast cell activation in humanized MRGPRX2 mouse models. Further, the Company’s MRGPRX2 prototype inhibitors show potent activity across multiple MRGPRX2 agonists. These prototypes are highly selective for MRGPRX2 versus other GPCRs, and show favorable in vitro and in vivo ADME properties supporting once daily dosing. Enanta continues to evaluate multiple compounds in preclinical studies and expects to select a development candidate in the second half of 2026. Enanta recently selected EDP-978, a novel, potent and selective oral KIT inhibitor, as its clinical candidate for the treatment of chronic spontaneous urticaria and potentially other mast cell driven diseases. EDP-978 demonstrates nanomolar potency in both binding and cellular assays, sub-nanomolar activity in vivo, and high selectivity for KIT versus other kinases. EDP-978 also exhibits favorable in vitro and in vivo ADME properties preclinically. The Company is on track to submit an IND in the first quarter, with topline Phase 1 data expected in the fourth quarter of 2026. Enanta plans to have two presentations of pre-clinical data related to its KIT program at the 2026 American Academy of Allergy , Asthma & Immunology (AAAAI) Annual Meeting taking place February 27 to March 2, 2026 . In November 2025 , Enanta nominated EPS-3903, a novel, potent and selective oral STAT6 inhibitor, as its lead development candidate for the treatment of atopic dermatitis and other diseases currently treated by dupilumab. Preclinical data show EPS-3903 exhibits nanomolar activity in binding and cellular assays and high selectivity for STAT6. Importantly, EPS-3903 shows rapid, continuous and complete (>90%) inhibition of phosphorylated STAT6 (pSTAT6) after oral dosing in mice. Further, EPS-3903 demonstrates efficacy comparable to dupilumab in multiple disease models. Specifically, in a house dust mite asthma model, treatment with EPS-3903 results in complete (>90%) inhibition of lung pSTAT6 and decreased inflammation comparable to dupilumab, including clinically relevant biomarkers of eosinophils and TARC in the lung and serum IgE. Additionally, in an MC903 atopic dermatitis mouse model, EPS-3903 demonstrates efficacy comparable to dupilumab, with complete (>90%) inhibition of pSTAT6 in the skin and spleen, as well as a robust decrease in serum IgE. EPS-3903 has favorable in vitro and in vivo ADME properties with once-daily dosing potential. The Company is currently performing scale-up and IND enabling activities and targeting an IND filing in the second half of 2026. Enanta plans to have four presentations of pre-clinical data related to its STAT6 program at Immunology2026TM, held by the American Association of Immunologists (AAI), taking place April 15-19, 2026 . Enanta plans to have two presentations of pre-clinical data related to its KIT program at the 2026 American Academy of Allergy , Asthma & Immunology (AAAAI) Annual Meeting taking place February 27 to March 2, 2026 . Enanta plans to have four presentations of pre-clinical data related to its STAT6 program at Immunology2026TM, held by the American Association of Immunologists (AAI), taking place April 15-19, 2026 . Corporate Enanta plans to issue its fiscal second quarter financial results press release on May 11, 2026 . About Enanta Pharmaceuticals, Inc. Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for viral infections and immunological diseases. Enanta’s clinical programs are currently focused on respiratory syncytial virus (RSV) and its earlier-stage immunology pipeline aims to develop treatments for inflammatory diseases by targeting key drivers of the type 2 immune response, with KIT, STAT6 and MRGPRX2 inhibition. Glecaprevir, a protease inhibitor discovered by Enanta, is part of one of the leading treatment regimens for curing hepatitis C virus (HCV) infection and is sold by AbbVie in numerous countries under the tradenames MAVYRET® ( U.S. ) and MAVIRET® (ex- U.S. ) (glecaprevir/pibrentasvir). A portion of Enanta’s royalties from HCV products developed under its collaboration with AbbVie contribute ongoing funding to Enanta’s operations. Please visit www.enanta.com for more information. Forward Looking Statements This press release contains forward-looking statements, including statements with respect to the timeline and prospects for advancement of Enanta’s clinical programs in RSV and its preclinical immunology programs, including its programs targeting KIT, STAT6 and MRGPRX2 inhibition. Statements that are not historical facts are based on management’s current expectations, estimates, forecasts and projections about Enanta’s business and the industry in which it operates and management’s beliefs and assumptions. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors and risks that may affect actual results include: the impact of development, regulatory and marketing efforts of others with respect to vaccines and competitive treatments for RSV; the discovery and development risks of Enanta’s programs in virology and immunology; Enanta’s limited clinical development experience; Enanta’s ability to partner its RSV or other programs; Enanta’s need to attract and retain senior management and key research and development personnel; Enanta’s need to obtain and maintain patent protection for its product candidates and avoid potential infringement of the intellectual property rights of others; and other risk factors described or referred to in “Risk Factors” in Enanta’s Form 10-K for the fiscal year-ended September 30, 2025 , and any other periodic reports filed more recently with the Securities and Exchange Commission. Enanta cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Enanta undertakes no obligation to update or revise these statements, except as may be required by law. Tables to Follow 2025 2024 $ 18,615 $ 16,959 20,859 27,656 9,009 12,846 29,868 40,502 (11,253 ) (23,543 ) (3,083 ) (1,962 ) 2,422 2,799 (11,914 ) (22,706 ) (24 ) 416 $ (11,938 ) $ (22,290 ) $ (0.42 ) $ (1.05 ) $ (0.42 ) $ (1.05 ) 28,748 21,238 28,748 21,238 2025 2025 $ 37,437 $ 32,298 148,412 156,566 8,493 6,882 4,342 8,590 198,684 204,336 56,055 — 34,308 35,395 37,003 37,549 3,360 3,360 93 92 $ 329,503 $ 280,732 $ 1,885 $ 1,948 7,575 12,751 31,981 30,710 3,287 3,146 44,728 48,555 102,822 111,132 53,782 54,757 1,311 1,311 269 260 202,912 216,015 126,591 64,717 $ 329,503 $ 280,732 View source version on businesswire.com: https://www.businesswire.com/news/home/20260209293558/en/ Media and Investors Contact: Jennifer Viera 617-744-3848 jviera@enanta.com Source: Enanta Pharmaceuticals, Inc.

Corporate News Reports Full-Year Diluted EPS of $2.36 on a GAAP Basis, a Decrease of 1.3 Percent; Adjusted Diluted EPS of $10.00, a Decrease of 1.2 Percent; These Results Include an Unfavorable Impact of $2.76 Per Share Related to 2025 Acquired IPR&D and Milestones Expense Delivers Full-Year Net Revenues of $61.160 Billion, an Increase of 8.6 Percent on a Reported Basis and 8.5 Percent on an Operational Basis Full-Year Global Net Revenues from the Immunology Portfolio Were $30.406 Billion, an Increase of 14.0 Percent on a Reported Basis, or 13.9 Percent on an Operational Basis; Global Skyrizi Net Revenues Were $17.562 Billion; Global Rinvoq Net Revenues Were $8.304 Billion; Global Humira Net Revenues Were $4.540 Billion Full-Year Global Net Revenues from the Neuroscience Portfolio Were $10.767 Billion, an Increase of 19.6 Percent on a Reported Basis, or 19.4 Percent on an Operational Basis; Global Vraylar Net Revenues Were $3.621 Billion; Global Botox Therapeutic Net Revenues Were $3.769 Billion; Combined Global Ubrelvy and Qulipta Net Revenues were $2.307 Billion Full-Year Global Net Revenues from the Oncology Portfolio Were $6.655 Billion, an Increase of 1.5 Percent on a Reported Basis, or 1.4 Percent on an Operational Basis; Global Imbruvica Net Revenues Were $2.869 Billion; Global Venclexta Net Revenues Were $2.792 Billion; Global Elahere Net Revenues Were $690 Million Full-Year Global Net Revenues from the Aesthetics Portfolio Were $4.860 Billion, a Decrease of 6.1 Percent on a Reported Basis, or 5.9 Percent on an Operational Basis; Global Botox Cosmetic Net Revenues Were $2.602 Billion; Global Juvederm Net Revenues Were $993 Million Reports Fourth-Quarter Diluted EPS of $1.02 on a GAAP Basis; Adjusted Diluted EPS of $2.71; These Results Include an Unfavorable Impact of $0.71 Per Share Related to Fourth-Quarter 2025 Acquired IPR&D and Milestones Expense Delivers Fourth-Quarter Net Revenues of $16.618 Billion, an Increase of 10.0 Percent on a Reported Basis and 9.5 Percent on an Operational Basis Provides 2026 Adjusted Diluted EPS Guidance Range of $14.37 to $14.57; Excludes Any Unfavorable Impact Related to Acquired IPR&D and Milestones Expense NORTH CHICAGO, Ill., Feb. 4, 2026 /PRNewswire/ -- AbbVie (NYSE:ABBV) announced financial results for the fourth quarter and full year ended December 31, 2025. "2025 was another outstanding year for AbbVie. We delivered record net sales in just the second full year following the U.S. Humira loss of exclusivity, underscoring the strength of our diversified growth platform. We also advanced promising new treatments for patients while enhancing the breadth and depth of our pipeline with strategic investments," said Robert A. Michael, chairman and chief executive officer, AbbVie. "Based on our strong fundamentals, we expect another year of robust growth in 2026. This momentum combined with our investments in innovation position AbbVie for long-term success." Fourth-Quarter Results Worldwide net revenues were $16.618 billion, an increase of 10.0 percent on a reported basis, or 9.5 percent on an operational basis. Global net revenues from the immunology portfolio were $8.626 billion, an increase of 18.3 percent on a reported basis, or 17.7 percent on an operational basis. Global Skyrizi net revenues were $5.006 billion, an increase of 32.5 percent on a reported basis, or 31.9 percent on an operational basis. Global Rinvoq net revenues were $2.374 billion, an increase of 29.5 percent on a reported basis, or 28.6 percent on an operational basis. Global Humira net revenues were $1.246 billion, a decrease 25.9 percent on a reported basis, or 26.1 percent on an operational basis. Global net revenues from the neuroscience portfolio were $2.961 billion, an increase of 17.9 percent on a reported basis, or 17.3 percent on an operational basis. Global Vraylar net revenues were $1.022 billion, an increase of 10.5 percent. Global Botox Therapeutic net revenues were $990 million, an increase of 13.4 percent on a reported basis, or 13.0 percent on an operational basis. Global Ubrelvy net revenues were $339 million, an increase of 12.0 percent. Global Qulipta net revenues were $288 million, an increase of 42.6 percent on a reported basis, or 41.8 percent on an operational basis. Global net revenues from the oncology portfolio were $1.664 billion, a decrease of 1.5 percent on a reported basis, or 2.5 percent on an operational basis. Global Imbruvica net revenues were $671 million, a decrease of 20.8 percent. Global Venclexta net revenues were $710 million, an increase of 8.6 percent on a reported basis, or 6.4 percent on an operational basis. Global Elahere net revenues were $182 million, an increase of 22.6 percent on a reported basis, or 21.3 percent on an operational basis. Global net revenues from the aesthetics portfolio were $1.286 billion, a decrease of 0.9 percent on a reported basis, or 1.2 percent on an operational basis. Global Botox Cosmetic net revenues were $717 million, an increase of 4.2 percent on a reported basis, or 3.8 percent on an operational basis. Global Juvederm net revenues were $249 million, a decrease of 10.7 percent on a reported basis, or 10.8 percent on an operational basis. On a GAAP basis, the gross margin ratio in the fourth quarter was 72.6 percent. The adjusted gross margin ratio was 83.6 percent. On a GAAP basis, selling, general and administrative (SG&A) expense was 23.4 percent of net revenues. The adjusted SG&A expense was 22.3 percent of net revenues. On a GAAP basis, research and development (R&D) expense was 15.5 percent of net revenues. The adjusted R&D expense was 15.4 percent of net revenues. Acquired IPR&D and milestones expense was 7.6 percent of net revenues. On a GAAP basis, the operating margin ratio in the fourth quarter was 27.3 percent. The adjusted operating margin ratio was 38.3 percent. Net interest expense was $655 million. On a GAAP basis, the tax rate in the quarter was 32.0 percent. The adjusted tax rate was 18.3 percent. Diluted EPS in the fourth quarter was $1.02 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $2.71. These results include an unfavorable impact of $0.71 per share related to acquired IPR&D and milestones expense. Global Skyrizi net revenues were $5.006 billion, an increase of 32.5 percent on a reported basis, or 31.9 percent on an operational basis. Global Rinvoq net revenues were $2.374 billion, an increase of 29.5 percent on a reported basis, or 28.6 percent on an operational basis. Global Humira net revenues were $1.246 billion, a decrease 25.9 percent on a reported basis, or 26.1 percent on an operational basis. Global Vraylar net revenues were $1.022 billion, an increase of 10.5 percent. Global Botox Therapeutic net revenues were $990 million, an increase of 13.4 percent on a reported basis, or 13.0 percent on an operational basis. Global Ubrelvy net revenues were $339 million, an increase of 12.0 percent. Global Qulipta net revenues were $288 million, an increase of 42.6 percent on a reported basis, or 41.8 percent on an operational basis. Global Imbruvica net revenues were $671 million, a decrease of 20.8 percent. Global Venclexta net revenues were $710 million, an increase of 8.6 percent on a reported basis, or 6.4 percent on an operational basis. Global Elahere net revenues were $182 million, an increase of 22.6 percent on a reported basis, or 21.3 percent on an operational basis. Global Botox Cosmetic net revenues were $717 million, an increase of 4.2 percent on a reported basis, or 3.8 percent on an operational basis. Global Juvederm net revenues were $249 million, a decrease of 10.7 percent on a reported basis, or 10.8 percent on an operational basis. 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 a voluntary agreement with the Trump administration to further advance access and affordability for Americans while protecting and investing in U.S. pharmaceutical innovation. Under the agreement, AbbVie will provide low prices in Medicaid, and expand affordable, direct-to-patient offerings for treatments used by millions of Americans. The company will also commit $100 billion in U.S. R&D and capital investments, including manufacturing, over the next decade. This three-year agreement provides AbbVie with exemption from tariffs and future pricing mandates. AbbVie announced it submitted applications for a new indication to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for Rinvoq (upadacitinib) in the treatment of adult and adolescent patients living with non-segmental vitiligo. The submissions are supported by data from the Phase 3 Viti-Up clinical trials, in which Rinvoq achieved the co-primary endpoints of 50 percent improvement in total body re-pigmentation (T-VASI 50) and 75 percent improvement in facial re-pigmentation (F-VASI 75) from baseline at week 48. If approved, Rinvoq will be the first systemic treatment for patients with vitiligo, addressing important treatment needs for those living with the chronic, unpredictable autoimmune disease. AbbVie announced it submitted an application to the EMA for expanded use of Aquipta (atogepant) for the acute treatment of adults with migraine. The submission was supported by data from the pivotal Phase 3 ECLIPSE study, evaluating the safety, efficacy and tolerability of Aquipta versus placebo for the acute treatment of migraine in adults. The study met its primary and key secondary endpoints, with Aquipta demonstrating superiority in pain freedom and freedom from the most bothersome migraine symptom two hours after treatment of the first migraine attack. Study results were shared as a late-breaking presentation at the European Headache Congress. AbbVie announced the FDA approval of Epkinly (epcoritamab) in combination with rituximab and lenalidomide (R2) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL). The approval is based on results from the Phase 3 EPCORE FL-1 study in which Epkinly with R2 demonstrated significantly superior progression-free survival (PFS) and overall response (OR) rates compared to standard of care R2, with approximately three out of four patients achieving a complete response (CR). This approval marks the third indication for Epkinly and first FDA approval for a bispecific combination therapy in lymphoma. Epkinly is being co-developed by AbbVie and Genmab. AbbVie announced topline results from the Phase 3 EPCORE DLBCL-1 trial evaluating Epkinly compared to investigator's choice of chemoimmunotherapy in adult patients with R/R diffuse large B-cell lymphoma (DLBCL). The study demonstrated an improvement in PFS and improvements were observed in CR rates, duration of response and time to next treatment among patients treated with Epkinly. The study did not demonstrate a statistically significant improvement in overall survival (OS). Based on the topline results from the trial, AbbVie along with partner Genmab will engage global regulatory authorities to discuss next steps. AbbVie and RemeGen announced an exclusive licensing agreement for the development, manufacturing and commercialization of RC148, a novel investigational Programmed Cell Death-1 (PD-1)/Vascular Endothelial Growth Factor (VEGF)-targeted bispecific antibody. RC148 is currently being developed by RemeGen as a monotherapy and in combination regimens across multiple advanced solid tumors including certain lung cancers. This transaction further strengthens AbbVie's diverse oncology portfolio and may offer new opportunities to explore combination regimens with AbbVie's antibody-drug conjugates (ADCs) such as investigational Temab-A (telisotuzumab adizutecan), across multiple solid tumors with high unmet need. AbbVie and West Pharmaceutical Services announced a definitive agreement for AbbVie to acquire a device manufacturing facility in Tempe, Arizona and associated intellectual property from West. The acquisition will support production of AbbVie's current and next-generation immunology and neuroscience medicines. Full-Year 2026 Outlook AbbVie is issuing its adjusted diluted EPS guidance for the full-year 2026 of $14.37 to $14.57. The company's 2026 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred during 2026, as both cannot be reliably forecasted. 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 www.abbvie.com. 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 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 2025 and 2024 are presented on both a reported and a non-GAAP basis. Reported results were prepared in accordance with generally accepted accounting principles in the United States (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" 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, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. 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 2024 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. Media: Investors: Gabby Tarbert Liz Shea (224) 244-0111 (847) 935-2211 Todd Bosse (847) 936-1182 Jeffrey Byrne (847) 938-2923 AbbVie Inc. Key Product Revenues Quarter Ended December 31, 2025 (Unaudited) % Change vs. 4Q24 Net Revenues (in millions) Reported Operationala U.S. Int'l. Total U.S. Int'l. Total Int'l. Total NET REVENUES $ 12,794 $ 3,824 $ 16,618 9.0 % 13.5 % 10.0 % 11.0 % 9.5 % Immunology 6,961 1,665 8,626 17.9 19.7 18.3 16.8 17.7 Skyrizi 4,355 651 5,006 31.5 39.8 32.5 35.1 31.9 Rinvoq 1,709 665 2,374 26.9 36.4 29.5 33.2 28.6 Humira 897 349 1,246 (27.9) (20.3) (25.9) (21.0) (26.1) Neuroscience 2,572 389 2,961 16.3 30.3 17.9 25.6 17.3 Vraylar 1,020 2 1,022 10.5 21.7 10.5 24.5 10.5 Botox Therapeutic 828 162 990 13.5 13.1 13.4 10.7 13.0 Ubrelvy 332 7 339 12.3 (3.7) 12.0 (3.0) 12.0 Qulipta 245 43 288 30.9 >100.0 42.6 >100.0 41.8 Vyalev 86 97 183 >100.0 >100.0 >100.0 >100.0 >100.0 Duodopa 17 75 92 (31.6) (10.4) (15.1) (14.9) (18.6) Other Neuroscience 44 3 47 (13.9) (20.1) (14.4) (19.0) (14.3) Oncology 997 667 1,664 (9.6) 13.6 (1.5) 10.8 (2.5) Imbruvicab 469 202 671 (25.0) (9.0) (20.8) (9.0) (20.8) Venclexta 332 378 710 6.2 10.8 8.6 6.6 6.4 Elahere 154 28 182 5.0 >100.0 22.6 >100.0 21.3 Epkinlyc 22 59 81 23.8 >100.0 >100.0 >100.0 >100.0 Other Oncology 20 — 20 n/m n/m n/m n/m n/m Aesthetics 811 475 1,286 (3.3) 3.3 (0.9) 2.5 (1.2) Botox Cosmetic 420 297 717 (2.1) 14.7 4.2 13.5 3.8 Juvederm Collection 107 142 249 (11.0) (10.5) (10.7) (10.7) (10.8) Other Aesthetics 284 36 320 (1.8) (14.5) (3.4) (15.0) (3.5) Eye Care 286 294 580 (19.7) 1.6 (10.1) (0.4) (11.0) Ozurdex 32 96 128 (10.4) 14.1 6.9 10.4 4.3 Lumigan/Ganfort 47 57 104 (19.0) (6.6) (12.6) (9.1) (13.9) Alphagan/Combigan 18 36 54 (54.8) (4.5) (30.5) (5.4) (30.9) Other Eye Care 189 105 294 (14.9) (1.5) (10.5) (2.3) (10.8) Other Key Products 711 173 884 (5.1) 5.3 (3.2) 1.3 (3.9) Mavyret 163 161 324 17.9 4.9 11.0 0.8 8.9 Creon 385 — 385 (0.8) n/m (0.8) n/m (0.8) Linzess/Constella 163 12 175 (26.8) 12.1 (25.1) 9.0 (25.2) 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 Twelve Months Ended December 31, 2025 (Unaudited) % Change vs. 12M24 Net Revenues (in millions) Reported Operationala U.S. Int'l. Total U.S. Int'l. Total Int'l. Total NET REVENUES $ 46,603 $ 14,557 $ 61,160 8.3 % 9.4 % 8.6 % 9.2 % 8.5 % Immunology 24,204 6,202 30,406 12.7 19.4 14.0 18.8 13.9 Skyrizi 15,202 2,360 17,562 50.7 44.6 49.9 43.0 49.7 Rinvoq 5,940 2,364 8,304 39.5 38.0 39.1 37.1 38.8 Humira 3,062 1,478 4,540 (57.1) (20.2) (49.5) (19.5) (49.4) Neuroscience 9,340 1,427 10,767 18.1 30.7 19.6 29.3 19.4 Vraylar 3,612 9 3,621 10.8 33.3 10.8 36.8 10.8 Botox Therapeutic 3,151 618 3,769 16.0 9.3 14.8 9.9 14.9 Ubrelvy 1,239 32 1,271 26.3 28.6 26.4 30.7 26.5 Qulipta 906 130 1,036 44.1 >100.0 57.3 >100.0 56.8 Vyalev 167 315 482 >100.0 >100.0 >100.0 >100.0 >100.0 Duodopa 73 308 381 (23.7) (12.3) (14.8) (14.1) (16.2) Other Neuroscience 192 15 207 (13.9) (0.4) (13.0) 2.8 (12.8) Oncology 4,080 2,575 6,655 (3.3) 10.3 1.5 9.9 1.4 Imbruvicab 2,048 821 2,869 (16.4) (8.6) (14.3) (8.6) (14.3) Venclexta 1,306 1,486 2,792 5.9 10.2 8.1 9.8 7.9 Elahere 607 83 690 27.2 >100.0 44.0 >100.0 43.4 Epkinlyc 86 185 271 42.3 >100.0 85.5 >100.0 85.0 Other Oncology 33 — 33 n/m n/m n/m n/m n/m Aesthetics 2,990 1,870 4,860 (8.5) (2.0) (6.1) (1.5) (5.9) Botox Cosmetic 1,504 1,098 2,602 (10.5) 5.7 (4.3) 6.2 (4.1) Juvederm Collection 385 608 993 (18.0) (14.1) (15.6) (13.6) (15.3) Other Aesthetics 1,101 164 1,265 (1.5) 1.8 (1.1) 2.7 (1.0) Eye Care 954 1,155 2,109 (10.2) (2.0) (5.9) (1.2) (5.5) Ozurdex 124 369 493 (10.1) 3.7 (0.2) 3.0 (0.7) Lumigan/Ganfort 189 221 410 1.2 (8.7) (4.4) (8.3) (4.2) Alphagan/Combigan 53 144 197 (43.3) (6.3) (20.4) (4.6) (19.4) Other Eye Care 588 421 1,009 (8.7) (1.4) (5.8) 0.5 (5.0) Other Key Products 3,011 725 3,736 4.0 (3.8) 2.4 (4.8) 2.2 Mavyret 635 682 1,317 6.7 (4.7) 0.4 (5.7) (0.2) Creon 1,512 — 1,512 9.3 n/m 9.3 n/m 9.3 Linzess/Constella 864 43 907 (5.7) 13.6 (4.9) 13.3 (4.9) 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) Fourth Quarter Ended December 31 Twelve Months Ended December 31 2025 2024 2025 2024 Net revenues $ 16,618 $ 15,102 $ 61,160 $ 56,334 Cost of products sold 4,552 4,396 18,204 16,904 Selling, general and administrative 3,895 3,855 14,010 14,752 Research and development 2,579 6,774 9,096 12,791 Acquired IPR&D and milestones 1,265 1,574 5,016 2,757 Other operating income (217) (7) (241) (7) Total operating costs and expenses 12,074 16,592 46,085 47,197 Operating earnings (loss) 4,544 (1,490) 15,075 9,137 Interest expense, net 655 610 2,627 2,160 Net foreign exchange loss 11 19 58 21 Other expense, net 1,210 150 5,793 3,240 Earnings (loss) before income tax expense 2,668 (2,269) 6,597 3,716 Income tax expense (benefit) 853 (2,246) 2,364 (570) Net earnings (loss) 1,815 (23) 4,233 4,286 Net earnings (loss) attributable to noncontrolling interest (1) (1) 7 8 Net earnings (loss) attributable to AbbVie Inc. $ 1,816 $ (22) $ 4,226 $ 4,278 Diluted earnings (loss) per share attributable to AbbVie Inc. $ 1.02 $ (0.02) $ 2.36 $ 2.39 Adjusted diluted earnings per sharea $ 2.71 $ 2.16 $ 10.00 $ 10.12 Weighted-average diluted shares outstanding 1,774 1,769 1,773 1,773 Adjusted weighted-average diluted shares outstandinga 1,774 1,773 1,773 1,773 a 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. Due to the GAAP net loss in the fourth quarter ended December 31, 2024, certain shares issuable under stock-based compensation plans that were dilutive on a non-GAAP basis were excluded from the computation of GAAP diluted EPS because the effects would have been antidilutive. AbbVie Inc. Reconciliation of GAAP Reported to Non-GAAP Adjusted Information (Unaudited) 1. Specified items impacted results as follows: Quarter Ended December 31, 2025 (in millions, except per share data) Earnings Diluted Pre-tax After-taxa EPS As reported (GAAP) $ 2,668 $ 1,816 $ 1.02 Adjusted for specified items: Intangible asset amortization 1,784 1,500 0.85 Change in fair value of contingent consideration 1,406 1,368 0.77 Other 51 146 0.07 As adjusted (non-GAAP) $ 5,909 $ 4,830 $ 2.71 a Represents net earnings attributable to AbbVie Inc. Specified items reflect the impact of applicable statutory tax rates. Reported GAAP earnings and adjusted non-GAAP earnings for the three months ended December 31, 2025 included acquired IPR&D and milestones expense of $1.3 billion on a pre-tax and after-tax basis, representing an unfavorable impact of $0.71 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, 2025 (in millions) Cost of productssold SG&A R&D Otheroperatingincome Otherexpense, net As reported (GAAP) $ 4,552 $ 3,895 $ 2,579 $ (217) $ 1,210 Adjusted for specified items: Intangible asset amortization (1,784) — — — — Change in fair value of contingent consideration — — — — (1,406) Other (42) (190) (16) 217 (20) As adjusted (non-GAAP) $ 2,726 $ 3,705 $ 2,563 $ — $ (216) 3. The adjusted tax rate for the fourth quarter of 2025 was 18.3 percent, as detailed below: Quarter Ended December 31, 2025 (dollars in millions) Pre-tax earnings Income taxes Tax rate As reported (GAAP) $ 2,668 $ 853 32.0 % Specified items 3,241 227 7.0 % As adjusted (non-GAAP) $ 5,909 $ 1,080 18.3 % AbbVie Inc. Reconciliation of GAAP Reported to Non-GAAP Adjusted Information (Unaudited) 1. Specified items impacted results as follows: Quarter Ended December 31, 2024 (in millions, except per share data) Earnings (Loss) Diluted Pre-tax After-taxa EPS As reported (GAAP) $ (2,269) $ (22) $ (0.02) Adjusted for specified items: Intangible asset amortization 1,896 1,607 0.90 Intangible asset impairment 4,476 3,512 1.98 Change in fair value of contingent consideration 279 271 0.15 Litigation matters 173 136 0.08 Income tax items — (1,869) (1.05) Other 258 209 0.12 As adjusted (non-GAAP) $ 4,813 $ 3,844 $ 2.16 a Represents net earnings (loss) attributable to AbbVie Inc. Specified items reflect the impact of applicable statutory tax rates. Intangible asset impairment reflects a partial after-tax impairment charge of $3.5 billion related to the emraclidine intangible asset acquired as part of the Cerevel Therapeutics acquisition. Income tax items primarily reflect an income tax benefit related to thesettlement of income tax examinations, partially offset by changes in income tax reserves. Reported GAAP earnings and adjusted non-GAAP earnings for the three months ended December 31, 2024 included acquired IPR&D and milestones expense of $1.6 billion on a pre-tax and after-tax basis, representing an unfavorable impact of $0.88 to both dilutedEPS and adjusted diluted EPS. 2. The impact of the specified items by line item was as follows: Quarter Ended December 31, 2024 (in millions) Cost of productssold SG&A R&D Other operatingincome Other expense, net As reported (GAAP) $ 4,396 $ 3,855 $ 6,774 $ (7) $ 150 Adjusted for specified items: Intangible asset amortization (1,896) — — — — Intangible asset impairment — — (4,476) — — Change in fair value of contingent consideration — — — — (279) Litigation matters — (173) — — — Other (47) (121) (25) 7 (72) As adjusted (non-GAAP) $ 2,453 $ 3,561 $ 2,273 $ — $ (201) 3. The adjusted tax rate for the fourth quarter of 2024 was 20.2 percent, as detailed below: Quarter Ended December 31, 2024 (dollars in millions) Pre-taxearnings (loss) Income taxes Tax rate As reported (GAAP) $ (2,269) $ (2,246) 99.0 % Specified items 7,082 3,216 45.4 % As adjusted (non-GAAP) $ 4,813 $ 970 20.2 % AbbVie Inc. Reconciliation of GAAP Reported to Non-GAAP Adjusted Information (Unaudited) 1. Specified items impacted results as follows: Twelve Months Ended December 31, 2025 (in millions, except per share data) Earnings Diluted Pre-tax After-taxa EPS As reported (GAAP) $ 6,597 $ 4,226 $ 2.36 Adjusted for specified items: Intangible asset amortization 7,377 6,221 3.50 Intangible asset impairment 847 701 0.39 Acquisition and integration costs 276 262 0.15 Change in fair value of contingent consideration 6,495 6,309 3.56 Other 100 65 0.04 As adjusted (non-GAAP) $ 21,692 $ 17,784 $ 10.00 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 Therapeutics acquisition. Reported GAAP earnings and adjusted non-GAAP earnings for the twelve months ended December 31, 2025 included acquiredIPR&D and milestones expense of $5.0 billion on a pre-tax and $4.9 billion on an after-tax basis, representing an unfavorableimpact of $2.76 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, 2025 (in millions) Cost of productssold SG&A R&D Other operating income Other expense, net As reported (GAAP) $ 18,204 $ 14,010 $ 9,096 $ (241) $ 5,793 Adjusted for specified items: Intangible asset amortization (7,377) — — — — Intangible asset impairment (847) — — — — Acquisition and integration costs (15) (172) (89) — — Change in fair value of contingent consideration — — — — (6,495) Other (163) (202) (22) 241 46 As adjusted (non-GAAP) $ 9,802 $ 13,636 $ 8,985 $ — $ (656) 3. The adjusted tax rate for the full-year 2025 was 18.0 percent, as detailed below: Twelve Months Ended December 31, 2025 (dollars in millions) Pre-taxearnings Income taxes Tax rate As reported (GAAP) $ 6,597 $ 2,364 35.8 % Specified items 15,095 1,537 10.2 % As adjusted (non-GAAP) $ 21,692 $ 3,901 18.0 % AbbVie Inc. Reconciliation of GAAP Reported to Non-GAAP Adjusted Information (Unaudited) 1. Specified items impacted results as follows: Twelve Months Ended December 31, 2024 (in millions, except per share data) Earnings Diluted Pre-tax After-taxa EPS As reported (GAAP) $ 3,716 $ 4,278 $ 2.39 Adjusted for specified items: Intangible asset amortization 7,622 6,461 3.63 Intangible asset impairment 4,476 3,512 1.98 Acquisition and integration costs 1,061 978 0.55 Change in fair value of contingent consideration 3,771 3,673 2.07 Litigation matters 910 721 0.41 Income tax items — (1,819) (1.02) Other 256 197 0.11 As adjusted (non-GAAP) $ 21,812 $ 18,001 $ 10.12 a Represents net earnings attributable to AbbVie Inc. Specified items reflect the impact of applicable statutory tax rates. Intangible asset impairment reflects a partial after-tax impairment charge of $3.5 billion related to the emraclidine intangible asset acquired as part of the Cerevel Therapeutics acquisition. Acquisition and integration costs primarily reflect costs related to theImmunoGen and Cerevel Therapeutics acquisitions. Income tax items primarily reflect an income tax benefit related to the settlement of income tax examinations, partially offset by changes in income tax reserves. Litigation matters primarily include charges related to actual and potential settlements of litigation. Reported GAAP earnings and adjusted non-GAAP earnings for the twelve months ended December 31, 2024 included acquiredIPR&D and milestones expense of $2.8 billion on a pre-tax and $2.7 billion on an after-tax basis, representing an unfavorableimpact of $1.52 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, 2024 (in millions) Cost ofproductssold SG&A R&D Other operating income Interestexpense, net Otherexpense, net As reported (GAAP) $ 16,904 $ 14,752 $ 12,791 $ (7) $ 2,160 $ 3,240 Adjusted for specified items: Intangible asset amortization (7,622) — — — — — Intangible asset impairment — — (4,476) — — — Acquisition and integration costs (225) (554) (258) — (24) — Change in fair value of contingent consideration — — — — — (3,771) Litigation matters — (910) — — — — Other (110) (54) (1) 7 — (98) As adjusted (non-GAAP) $ 8,947 $ 13,234 $ 8,056 $ — $ 2,136 $ (629) 3. The adjusted tax rate for the full-year 2024 was 17.4 percent, as detailed below: Twelve Months Ended December 31, 2024 (dollars in millions) Pre-tax earnings Income taxes Tax rate As reported (GAAP) $ 3,716 $ (570) (15.3) % Specified items 18,096 4,373 24.2 % As adjusted (non-GAAP) $ 21,812 $ 3,803 17.4 % SOURCE AbbVie For more information Contact us » Subscribe for email alerts Sign up Subscription management We also welcome the opportunity to hear from you in these social channels, but remember we work in a highly-regulated industry with unique legal considerations. Before engaging, please read and adhere to our established community guidelines for each channel. View our social media channel guidelines » AbbVie.com | Site Map | Terms of Use | Privacy Notice | Consumer Health Data Privacy Notice | Cookie Settings | Your Privacy Choices Copyright © 2026 AbbVie Inc. North Chicago, Illinois, U.S.A. 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