數讀財報

連續第四年實現雙位數增長,業務多頭并進且勢頭強勁

艾伯維進入一個重要的新階段。

艾伯維2018全年及第四季度財報

年度關鍵數據
調整后的全球凈收入327.33億美元,營運層面增長15.2%
調整后的每股收益為 7.91美元,增幅為41.3%
修美樂(HUMIRA)全年全球銷售額為199.36億美元,營運層面增幅 7.4%
血液腫瘤產品組合全球凈收入 39.34億美元,報告層面增長45.9%
丙肝產品全球凈收入36.16億美元

第四季度關鍵數據
全球凈收入83.05億美元,營運層面增長8.3%
修美樂(HUMIRA)全球銷售額營運層面增長1.4%
血液腫瘤產品組合全球凈收入11.3億美元,報告層面增長50.2%
丙肝產品全球凈收入8.62億美元
調整后的研發費用占凈收入的16.5%

第四季度重要事件

*本部分所列信息涉及尚未在中國獲批的產品。此信息僅作信息分享用途,不應被理解為這些產品將在中國注冊或獲批。

  • 美國FDA通過加速審批途徑批準了艾伯維的VENCLEXTA (venetoclax)與阿扎胞苷(azacitidine)、地西他濱(decitabine)或低劑量阿糖胞苷(LDAC)聯用以治療75歲及以上新確診為急性髓系白血病(AML)的患者,或因合并癥不適合使用強誘導化療的患者。[i]
  • 歐盟委員會(European Commission)已批準VENCLYXTO(venetoclax)聯合rituximab方案用于治療既往至少接受過一種療法的復發性/難治性(R/R)慢性淋巴細胞白血病(CLL)患者的一項II類變更申請。此次批準是基于3期臨床研究MURANO的數據。[ii]
  • 在美國血液學會(ASH)年會暨展覽會上,艾伯維公布了VENCLEXTA和IMBRUVICA(ibrutinib)的最新數據,包括評估venetoclax聯合rituximab方案用于治療R/R CLL患者的3期臨床研究MURANO的最新數據。[iii]
  • 艾伯維已向美國FDA提交了一份新藥申請(NDA),并向歐洲藥品管理局(EMA)提交了一份上市許可申請 (MAA),申請批準在研的口服選擇性JAK1抑制劑upadacitinib用于治療中重度類風濕關節炎成人患者。[iv]
  • 在美國風濕病學會(ACR)/美國風濕病衛生專家協會(ARHP)年會上,艾伯維公布了upadacitinib和修美樂的最新數據,涵蓋包括類風濕關節炎、銀屑病關節炎、幼年特發性關節炎和葡萄膜炎在內的多種風濕疾病。[v]
  • 在歐洲消化疾病周(UEGW)會議上,艾伯維展示了旗下消化領域產品組合(包括修美樂和在研產品)的相關數據,其中包括首次公布的評估upadacitinib治療中至重度活動性潰瘍性結腸炎的2b期臨床研究(U-ACHIEVE)的數據。[vi]
  • 在美國婦科腔鏡學會(AAGL) 婦科微創全球大會上,艾伯維與Neurocrine Biosciences共同公布了評估elagolix治療子宮肌瘤患者的有效性和安全性的兩項關鍵3期臨床研究ELARIS UF-1和ELARIS UF-2的更多結果。這項3期臨床研究項目的數據將用于支持預計在2019年中提交的elagolix用于治療子宮肌瘤的注冊申請。[vii]
  • 在美國肝病研究學會(AASLD)年會上,艾伯維公布了旗下泛基因型慢性丙型肝炎(HCV)治療方案MAVIRET(glecaprevir/pibrentasvir)在伴代償期肝硬化的初治患者中獲得的新數據。3b期研究EXPEDITION-8研究顯示,基因1、2、4、5和6型患者經過8周MAVIRET治療后,持續病毒學應答(SVR12)達到100%。MAVIRET目前已獲批作為8周治療無肝硬化的丙肝初治患者的泛基因型療法。[viii]

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2019年全年預期

艾伯維預計2019年調整后的全年每股收益指導范圍為8.65至8.75美元,中間價增長10.0%。[ix]

董事長兼首席執行官 Richard A.Gonzalez

“2018年,我們的業績表現卓越:營運層面的收入增長超過15%,每股收益增長超過40%。艾伯維正步入一個重要的新階段。我們的業務增長勢頭不減,加上幾款新產品的上市,都將驅動我們在2019年再次實現強勁的盈利增長,并使我們在更長時間內保持增長。”

[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-na?ve 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."