Venetoclax

编者按：今日（2月4日）是世界癌症日。在新药研发领域，针对各类癌症的新药研发始终是科学界、产业界关注的焦点。例如，在刚刚过去的2026年1月，多款癌症新药管线就迎来新的研发进展，比如双抗疗法、小分子等向美国FDA申报上市，拟治疗非小细胞肺癌、乳腺癌、胆管癌；还有多款新药获FDA突破性疗法认定，或公布积极的临床结果，等等。作为全球医药创新的赋能者，药明康德依托其一体化、端到端的CRDMO平台，持续助力全球合作伙伴加速创新疗法的研发进程，致力于将合作伙伴的更多突破性治疗方案带给癌症患者。 今日（2月4日）是世界癌症日。该疾病日由国际抗癌联盟（UICC）发起，旨在汇聚全球力量，提高公众对癌症的认知，并采取切实行动为患者提供支持。 在新药研发领域，针对各类癌症的新药研发始终是科学界、产业界关注的焦点。除了已经获批上市的新药，全球范围内还有上千条研发管线处于积极的临床研究阶段，涵盖各类新药类型。仅在刚刚过去的2026年1月，就有多款癌症新药管线迎来监管新进展，或披露新的临床研究数据。这些新药涉及小分子、抗体、抗体偶联药物（ADC）、siRNA疗法、多肽、癌症疫苗等，适应症包括非小细胞肺癌、乳腺癌、胆管癌、胃肠道间质瘤、卵巢癌、白血病、皮肤癌、胰腺癌等。 图片来源：123RF 多款癌症新药在美国申报上市或获FDA突破性疗法认定 2026年1月，多家公司宣布其在研管线向FDA申报上市，适应症涉及非小细胞肺癌、乳腺癌、胆管癌。 比如：Summit Therapeutics宣布，FDA已受理其为ivonescimab（依沃西）递交的生物制品许可申请，用于与化疗联合治疗EGFR突变的局部晚期或转移性非鳞状非小细胞肺癌（NSCLC）患者。该申请的PDUFA日期为2026年11月14日。Ivonescimab是一款在研PD-1/VEGF双抗双特异性抗体，最初由康方生物研发，Summit公司已获得其在北美、南美、欧洲、中东、非洲和日本等国家和地区的开发和商业化权益。 再如，Elevar Therapeutics宣布已向FDA递交在研、高选择性的口服FGFR2小分子抑制剂lirafugratinib的新药申请，拟作为二线治疗方案用于携带FGFR2融合或重排的胆管癌患者。RLY-4008是通过Relay Therapeutics公司专有技术平台对蛋白构象的动态平衡进行详细分析，从而开发出对FGFR2具特异性的抑制剂。其在癌细胞系中表现出FGFR2依赖性的抗癌活性，在缩小肿瘤同时，对其他靶标（包括FGFR家族的其他蛋白）影响极小，具有良好的抗脱靶特性。 Celcuity则宣布FDA已接受其在研广谱PI3K/AKT/mTOR（PAM）抑制剂gedatolisib的新药申请，用于治疗HR+、HER2-的PIK3CA野生型晚期乳腺癌患者。FDA授予该申请优先审评资格，并预计于2026年7月17日前完成审评。Gedatolisib是一款多靶点抑制剂，可强效靶向全部四种I类PI3K蛋白同工酶以及mTORC1和mTORC2，从而实现对PAM通路的全面阻断。 除了上述进展，还有多款癌症新药获FDA授予突破性疗法认定： Revolution Medicines公司宣布FDA已授予其靶向处于激活状态的RAS G12D（ON）突变体的选择性抑制剂zoldonrasib突破性疗法认定，用于治疗既往接受过抗PD-1/PD-L1治疗及含铂化疗，携带KRAS G12D突变的局部晚期或转移性非小细胞肺癌成人患者。Zoldonrasib是一种创新的三元复合物抑制剂，它可与环孢素A结合并形成一个复合物，从而选择性识别并抑制处于激活状态、具有致癌性的RAS G12D（ON）突变体； Cogent Biosciences宣布FDA授予其在研小分子bezuclastinib联合sunitinib突破性疗法认定，用于治疗既往接受过imatinib治疗的胃肠道间质瘤（GIST）患者。该公司计划于2026年4月完成该产品向FDA的NDA相关递交工作。Bezuclastinib是一种选择性酪氨酸激酶抑制剂，旨在强效抑制KIT基因中关键驱动突变产生的突变蛋白活性； 礼来（Eli Lilly and Company）宣布FDA已授予其在研ADC疗法sofetabart mipitecan（LY4170156）突破性疗法认定，用于治疗特定的铂耐药性上皮性卵巢癌、输卵管癌或原发性腹膜癌成年患者。Sofetabart mipitecan是一款新型叶酸受体α（FRα）靶向的ADC，采用专有连接子技术，并以exatecan作为有效载荷； 益普生（Ipsen）宣布FDA已授予在研单抗疗法IPN60340突破性疗法认定，与venetoclax和azacitidine（Ven-Aza）联用，用于治疗一线不适合强化治疗的急性髓系白血病（AML）。IPN60340靶向BTN3A，这是一种在多种癌症中广泛表达的关键免疫调节分子，可促进γ9δ2 T细胞对肿瘤细胞的识别和清除。 多款新药公布新临床数据，针对皮肤癌、卵巢癌等 除了上述监管进展，还有多款癌症在研管线公布新的临床数据，显示其临床应用潜力。 比如，Phio Pharmaceuticals公司公布了其siRNA疗法PH-762治疗皮肤癌的1b期临床试验积极结果。PH-762是利用该公司专有的INTASYL基因沉默技术开发的化合物，旨在沉默与各种类型皮肤癌有关编码PD-1的基因。在该研究中，22名皮肤癌患者完成了治疗，并接受了病灶部位的切除手术。20例皮肤鳞状细胞癌患者中，10例达到完全缓解（CR，病灶清除率达100%），2例达到接近CR（病灶清除率超过90%），以及2例部分缓解（PR，病灶清除率超过50%）。 BioVaxys Technology公司宣布其1b/2期临床试验PESCO研究取得积极初步结果，该研究旨在评估其开发的多肽疫苗maveropepimut-S（MVP-S）联合PD-1抑制剂及环磷酰胺在复发性上皮性卵巢癌患者中的安全性和疗效。MVP-S递送来自survivin家族的抗原肽、一种先天免疫激活剂和一种通用的CD4阳性T细胞辅助肽，旨在诱导特异性细胞毒性T细胞反应。该研究共纳入47例患者，所有患者接受至少两年随访。ORR为24%，DCR达82%，中位缓解持续时间为5.5个月。铂敏感患者的表现尤为突出，ORR达40%，DCR达90%。 Corcept Therapeutics宣布其关键性3期临床试验ROSELLA达到总生存期（OS）这一主要终点。该试验评估了其选择性皮质醇调节剂relacorilant联合白蛋白紫杉醇用于治疗铂耐药卵巢癌患者的效果。Relacorilant是一种口服选择性糖皮质激素受体（GR）拮抗剂，可通过与GR结合而不与机体其他激素受体结合，从而调节皮质醇活性。分析显示，与仅用白蛋白紫杉醇相比，接受relacorilant联合白蛋白紫杉醇患者的死亡风险降低了35%。接受relacorilant治疗患者的中位OS为16.0个月，而单用白蛋白紫杉醇患者的中位OS为11.9个月，两者相差4.1个月。此前，FDA已受理relacorilant用于治疗铂耐药卵巢癌的上市申请，并设定PDUFA日期为2026年7月11日。 Immuneering公司宣布，在一项正在进行的2a期临床试验中，在研MEK抑制剂atebimetinib（IMM-1-104）与改良吉西他滨/白蛋白紫杉醇（mGnP）联用，一线治疗晚期胰腺癌患者获得积极的OS和安全性结果。中位随访时间13.4个月时，atebimetinib组合疗法组的12个月总生存率达64%，标准治疗组在此前的临床试验中这一数值为35%。Atebimetinib是一款深度循环抑制剂（deep cyclic inhibitor，DCI），作用靶点为MEK。大多数疗法以持续抑制信号通路为设计目标，虽然可让肿瘤快速缩小，但迫使肿瘤产生适应性演变并产生耐药性，从而导致疗效不能持久。DCI的设计理念是以肿瘤尚未来得及适应的节奏进行脉冲式抑制，使肿瘤缓慢但持久地缩小。 除了上述新药研发进展，2026年1月，全球范围内癌症新药研发领域还迎来其他各类新进展，包括新锐融资、研发合作方面的进展等等。限于篇幅，此处不再一一列举。期待随着不同疗法模式的兴起，以及产业与学术界的通力合作，2026年会有更多好消息传出，推动癌症治疗的进步，造福更多癌症患者。 一体化平台赋能各类癌症新药开发 长期以来，药明康德都在支持全球合作伙伴从药物研究（R）、开发（D）到商业化生产（M）各个阶段的需求，通过一体化、端到端CRDMO模式，助力合作伙伴推进各类癌症突破性疗法加速研发进程、早日惠及患者。比如，药明康德旗下的生物学业务平台在肿瘤药物研发领域可以支持从靶点发现到体内外药理学、转化研究到临床生物标志物检测的研究需求，加速癌症项目的研究。 展望未来，药明康德将继续依托全球研发基地与生产网络，以一体化、端到端的CRDMO模式，提供高效、灵活的解决方案，持续赋能全球合作伙伴释放创新潜能，加速将科学突破转化成为新药、好药。 参考资料： [1]https://wuxibiology.com/biology-services/oncology-immunology/ 免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。 版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「医药观澜」微信公众号回复“转载”，获取转载须知。

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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