数读财报

连续第四年实现双位数增长,业务多头并进且势头强劲

艾伯维进入一个重要的新阶段。

艾伯维2018全年及第四季度财报

年度关键数据
调整后的全球净收入327.33亿美元,营运层面增长15.2%
调整后的每股收益为 7.91美元,增幅为41.3%
修美乐(HUMIRA)全年全球销售额为199.36亿美元,营运层面增幅 7.4%
血液肿瘤产品组合全球净收入 39.34亿美元,报告层面增长45.9%
丙肝产品全球净收入36.16亿美元

第四季度关键数据
全球净收入83.05亿美元,营运层面增长8.3%
修美乐(HUMIRA)全球销售额营运层面增长1.4%
血液肿瘤产品组合全球净收入11.3亿美元,报告层面增长50.2%
丙肝产品全球净收入8.62亿美元
调整后的研发费用占净收入的16.5%

第四季度重要事件

*本部分所列信息涉及尚未在中国获批的产品。此信息仅作信息分享用途,不应被理解为这些产品将在中国注册或获批。

  • 美国FDA通过加速审批途径批准了艾伯维的VENCLEXTA (venetoclax)与阿扎胞苷(azacitidine)、地西他滨(decitabine)或低剂量阿糖胞苷(LDAC)联用以治疗75岁及以上新确诊为急性髓系白血病(AML)的患者,或因合并症不适合使用强诱导化疗的患者。[i]
  • 欧盟委员会(European Commission)已批准VENCLYXTO(venetoclax)联合rituximab方案用于治疗既往至少接受过一种疗法的复发性/难治性(R/R)慢性淋巴细胞白血病(CLL)患者的一项II类变更申请。此次批准是基于3期临床研究MURANO的数据。[ii]
  • 在美国血液学会(ASH)年会暨展览会上,艾伯维公布了VENCLEXTA和IMBRUVICA(ibrutinib)的最新数据,包括评估venetoclax联合rituximab方案用于治疗R/R CLL患者的3期临床研究MURANO的最新数据。[iii]
  • 艾伯维已向美国FDA提交了一份新药申请(NDA),并向欧洲药品管理局(EMA)提交了一份上市许可申请 (MAA),申请批准在研的口服选择性JAK1抑制剂upadacitinib用于治疗中重度类风湿关节炎成人患者。[iv]
  • 在美国风湿病学会(ACR)/美国风湿病卫生专家协会(ARHP)年会上,艾伯维公布了upadacitinib和修美乐的最新数据,涵盖包括类风湿关节炎、银屑病关节炎、幼年特发性关节炎和葡萄膜炎在内的多种风湿疾病。[v]
  • 在欧洲消化疾病周(UEGW)会议上,艾伯维展示了旗下消化领域产品组合(包括修美乐和在研产品)的相关数据,其中包括首次公布的评估upadacitinib治疗中至重度活动性溃疡性结肠炎的2b期临床研究(U-ACHIEVE)的数据。[vi]
  • 在美国妇科腔镜学会(AAGL) 妇科微创全球大会上,艾伯维与Neurocrine Biosciences共同公布了评估elagolix治疗子宫肌瘤患者的有效性和安全性的两项关键3期临床研究ELARIS UF-1和ELARIS UF-2的更多结果。这项3期临床研究项目的数据将用于支持预计在2019年中提交的elagolix用于治疗子宫肌瘤的注册申请。[vii]
  • 在美国肝病研究学会(AASLD)年会上,艾伯维公布了旗下泛基因型慢性丙型肝炎(HCV)治疗方案MAVIRET(glecaprevir/pibrentasvir)在伴代偿期肝硬化的初治患者中获得的新数据。3b期研究EXPEDITION-8研究显示,基因1、2、4、5和6型患者经过8周MAVIRET治疗后,持续病毒学应答(SVR12)达到100%。MAVIRET目前已获批作为8周治疗无肝硬化的丙肝初治患者的泛基因型疗法。[viii]

 

2019年全年预期

艾伯维预计2019年调整后的全年每股收益指导范围为8.65至8.75美元,中间价增长10.0%。[ix]

董事长兼首席执行官 Richard A.Gonzalez

“2018年,我们的业绩表现卓越:营运层面的收入增长超过15%,每股收益增长超过40%。艾伯维正步入一个重要的新阶段。我们的业务增长势头不减,加上几款新产品的上市,都将驱动我们在2019年再次实现强劲的盈利增长,并使我们在更长时间内保持增长。”

[i] AbbVie announced the U.S. Food and Drug Administration (FDA) granted accelerated approval to VENCLEXTA (venetoclax) in combination with azacitidine, or decitabine, or low-dose cytrabine (LDAC) for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials, which are expected to be completed in 2019. The approval in AML is the third provided under priority review by the FDA for VENCLEXTA, which has been granted four Breakthrough Therapy Designations (BTDs) by the FDA. Venetoclax is being developed by AbbVie and Roche and is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S

[ii] AbbVie announced the European Commission (EC) has approved the type-II variation application for VENCLYXTO (venetoclax) in combination with rituximab for the treatment of patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) who have received at least one prior therapy. This approval allows more patients to receive VENCLYXTO in combination with rituximab in the second-line setting. It also gives healthcare providers the ability to prescribe this medicine to a broader population of patients with R/R CLL than the previously approved indication for VENCLYXTO as monotherapy in the European Union. The approval is based on results from the Phase 3 MURANO trial, which demonstrated a statistically significant improvement in investigator-assessed progression-free survival (PFS) for patients who received VENCLYXTO plus rituximab compared with bendamustine plus rituximab.

[iii] At the American Society of Hematology Annual Meeting & Exposition (ASH), AbbVie presented data from nearly 40 abstracts, including 13 oral presentations and more than 20 poster presentations. Multiple studies investigating VENCLEXTA and IMBRUVICA (ibrutinib) across a number of hematologic malignancies were presented, including updated results from the Phase 3 MURANO trial of venetoclax in combination with rituximab in patients with R/R CLL, which showed that treatment with VENCLEXTA and rituximab provided sustained benefits in PFS and minimal residual following an additional year of follow-up data.

[iv] AbbVie announced that it submitted a New Drug Application (NDA) to the FDA and a marketing authorization application (MAA) to the European Medicines Agency for upadacitinib, an oral investigational JAK1-selective inhibitor, for the treatment of adult patients with moderate to severe rheumatoid arthritis. The NDA and MAA are supported by data from the global upadacitinib SELECT Phase 3 rheumatoid arthritis program evaluating more than 4,900 patients with moderate to severe rheumatoid arthritis across five Phase 3 studies. In the SELECT program, results showed that upadacitinib improved signs and symptoms of rheumatoid arthritis, inhibited radiographic progression and improved physical function, both as a monotherapy and in combination with conventional synthetic DMARDs.

[v] At the American College of Rheumatology (ACR)/Association for Rheumatology Health Professionals (ARHP) Annual Meeting, AbbVie presented new data for upadacitinib and HUMIRA, with 35 abstracts presented across multiple rheumatic conditions, including rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis and uveitis. Included in the presentations were data from three of the five pivotal studies from the SELECT Phase 3 program.

[vi] At the United European Gastroenterology Week (UEGW) conference, AbbVie showcased its gastroenterology portfolio with 11 presentations of HUMIRA and pipeline data, including the first presentation of data from a Phase 2b study (U-ACHIEVE) evaluating upadacitinib in adult patients with moderately to severely active ulcerative colitis. Results from the U-ACHIEVE study demonstrated that after 8 weeks, upadacitinib (15/30/45 mg, once daily) met the primary endpoint of clinical remission (per adapted Mayo Score) and ranked secondary endpoints, including endoscopic improvement, clinical remission (per Full Mayo Score) and clinical response.

[vii] At the American Association of Gynecologic Laparoscopists (AAGL) Global Congress on Minimally Invasive Gynecology, AbbVie, in cooperation with Neurocrine Biosciences, presented additional results from two replicate pivotal Phase 3 clinical trials ELARIS UF-1 and ELARIS UF-2 evaluating the efficacy and safety of elagolix in women with uterine fibroids. Results demonstrated that at the final month of the six-month treatment period, elagolix, in combination with low-dose hormone (add-back) therapy, reduced heavy menstrual bleeding associated with uterine fibroids compared to placebo. Data from the Phase 3 clinical trial program will support regulatory submission for elagolix in uterine fibroids, anticipated in mid-2019.

[viii] At the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), AbbVie presented new data for its pan-genotypic chronic hepatitis C virus (HCV) treatment, MAVYRET (glecaprevir/pibrentasvir), in treatment-naïve patients with compensated cirrhosis.

[ix] Provides 2019 GAAP Diluted EPS Guidance Range of $7.39 to $7.49; Provides 2019 Adjusted Diluted EPS Guidance Range of $8.65 to $8.75, Representing Growth of 10.0 Percent at the Midpoint.

Full-Year 2019 Outlook

AbbVie is issuing GAAP diluted EPS guidance for the full-year 2019 of $7.39 to $7.49.  The company's 2019 GAAP guidance does not reflect non-cash charges for contingent consideration adjustments related to the expected approval of risankizumab in the first half of the year.  AbbVie expects to deliver adjusted diluted EPS for the full-year 2019 of $8.65 to $8.75, representing growth of 10.0 percent at the mid-point. The company's 2019 adjusted diluted EPS guidance excludes $1.26 per share of intangible asset amortization expense, non-cash charges for contingent consideration adjustments, and other specified items.

[x] "We delivered exceptional performance in 2018, including operational revenue growth of more than 15 percent and EPS growth above 40 percent," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "We're entering an important new phase for AbbVie. The continued momentum of our business, combined with the launch and ramp of several new products, will allow us to drive strong earnings growth once again in 2019 and position us for growth over the longer term."