艾伯维(ABBV)
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U.S. FDA Approves SKYRIZI® (risankizumab-rzaa) for Ulcerative Colitis, Expanding AbbVie's Portfolio Across Inflammatory Bowel Disease
Prnewswire· 2024-06-19 06:18
文章核心观点 - 美国食品药品监督管理局(FDA)批准艾伯维(AbbVie)的SKYRIZI(risankizumab - rzaa)用于中度至重度活动性溃疡性结肠炎成人患者,使其成为首个获批用于中度至重度溃疡性结肠炎和中度至重度克罗恩病的IL - 23特异性抑制剂 [1] 药品获批依据 - SKYRIZI获批得到两项3期临床试验支持,分别是为期12周的诱导研究INSPIRE和为期52周的维持研究COMMAND [1] - 数据显示,诱导和维持研究的主要终点临床缓解以及关键次要终点内镜改善均已实现 [1] 溃疡性结肠炎情况 - 美国有超100万人患有溃疡性结肠炎,且患病人数持续上升 [2] - 溃疡性结肠炎是一种炎症性肠病,会导致消化道炎症和结肠内膜损伤,患者常出现腹痛、便血等症状,病程因人而异,严重时可导致手术、并发症甚至死亡 [2][6] 药品相关信息 - SKYRIZI是一种白细胞介素 - 23(IL - 23)抑制剂,通过与IL - 23的p19亚基结合选择性阻断IL - 23,已获批用于中度至重度活动性溃疡性结肠炎、斑块状银屑病、银屑病关节炎和克罗恩病 [10] - 该适应症的给药方案包括12周诱导期,每四周静脉注射三次1200mg剂量,随后是每八周皮下注射180mg或360mg的维持治疗,诱导期后可使用随身注射装置(OBI)在家中维持治疗 [2] 临床试验情况 INSPIRE诱导研究 - 这是一项多中心、随机、双盲、安慰剂对照的3期研究,评估每四周静脉注射1200mg risankizumab作为中度至重度活动性溃疡性结肠炎受试者诱导疗法的疗效和安全性 [7] - 主要终点是第12周的临床缓解,次要终点包括第12周的临床反应、内镜改善、组织学和内镜黏膜改善(HEMI) [7] COMMAND维持研究 - 这是一项3期、多中心、随机、双盲、对照的52周维持研究,评估180mg或360mg皮下注射risankizumab在中度至重度活动性溃疡性结肠炎成人患者中的疗效和安全性 [8] - 主要终点是第52周的临床缓解,次要终点包括第52周的内镜改善、组织学和内镜黏膜改善(HEMI)和无类固醇临床缓解 [9] 患者支持 - 艾伯维致力于帮助患者获取SKYRIZI等药物,为符合条件的商业保险患者提供患者支持计划和共付卡,可将自付费用降至每月低至0美元,还可能报销与静脉注射相关的自付费用 [4] - 对于医疗保险有限或无保险的患者,艾伯维提供myAbbVie Assist患者援助计划,为符合条件者免费提供SKYRIZI [5] 公司情况 - 艾伯维拥有强大的临床试验项目,致力于炎症性肠病(IBD)的前沿研究,希望消除IBD负担,对IBD患者生活产生积极长期影响 [19] - 艾伯维的使命是发现和提供创新药物,解决当前严重健康问题并应对未来医疗挑战,业务涉及免疫学、肿瘤学、神经科学、眼科护理等关键治疗领域 [20]
AbbVie: 5 Reasons That Make A Buy Case
Seeking Alpha· 2024-06-19 05:37
文章核心观点 - 尽管自3月以来艾伯维公司股价下跌3%,一季度财报公布后单日最大跌幅近5%,但公司业绩和前景在过去一个季度有所改善,有短期价格上涨可能,虽收购存在盈利风险,但仍维持买入评级 [3][16] 公司现状 - 自3月以来公司股价表现不佳,下跌3%,一季度财报公布后股价单日最大跌幅近5% [3] - 2023年公司营收不佳,下降6.4%,2024年第一季度营收同比增长0.7%,修美乐对营收的贡献从2023年的26.5%降至18.4% [4] 公司发展前景向好原因 业务好转 - 公司营收在连续四个季度收缩后出现转机,2024年第一季度营收同比增长0.7%,显示修美乐影响减弱 [4] - 剔除修美乐和收购因素后,公司营收增长强劲,达15.6%,高于2023年全年的8.4%,神经科学领域增长最大,达15.9% [5] - 免疫学领域除修美乐外增长51.6%,公司收购专注治疗溃疡性结肠炎和克罗恩病的Lands Biopharma,其溃疡性结肠炎治疗前景乐观;肿瘤学领域一季度增长9%,收购Immunogen后有望进一步提升,其卵巢癌治疗药物Elahere在一季度贡献了肿瘤学营收的4.2%,未来贡献可能超8% [6] 盈利改善 - 本季度每股收益(EPS)趋势较2023年有所改善,GAAP EPS大幅增长492.3%,调整后摊薄EPS降幅从2023年的19.3%收窄至6.1%,但本季度EPS受非运营活动影响,应关注运营收入,其增长1.1%,运营利润率为22.7%,略低于2023年全年的23.5% [8][9] 市场估值优势 - 基于运营收入的市场倍数表现良好,在市值前五的制药股中,其过去十二个月(TTM)的价格与运营收入(P/OI)比率为20.4倍,低于礼来公司的69.4倍和诺和诺德的39.3倍,略高于默克公司的20.1倍,该组平均P/OI为32.9倍,显示艾伯维有40%的上涨空间 [11] - 更传统的远期非GAAP P/E为15.3倍,低于上次的16倍,与医疗保健行业中位数19.3倍相比表现良好,但仍高于自身五年平均的10.7倍,三种市场倍数类型均显示艾伯维有上涨空间 [11][12] 股息收益可观 - 公司的远期股息收益率为3.65%,显著高于医疗保健行业1.44%的平均水平,且公司在过去10年持续支付和增加股息,预计2024年调整后EPS至少略高于去年,股息较为安全 [13] 公司面临的风险 - 公司积极进行收购,盈利已受到非运营因素的正负影响,进一步收购可能使盈利更难解读,并因成本因素产生负面影响,如百时美施贵宝公司因收购大幅降低盈利指引,股价前景受挫,艾伯维也可能出现类似情况 [14][15]
2 Dividend Stocks That Could Pay You for Life
The Motley Fool· 2024-06-16 20:30
There are other reasons to love these businesses, too.People invest in dividend stocks for various reasons. Some want the passive income; others reinvest the cash to boost long-term returns; still others find that corporations that can dish out regular (and growing) payouts are worth investing in. But few such investors would include dividend cuts on their wish list -- most want the payouts to go for as long as possible.Though many income stocks will eventually have to suspend or decrease their dividends, s ...
AbbVie Recommends Shareholders Reject Tutanota's "Mini-Tender" Offer
Prnewswire· 2024-06-15 04:08
NORTH CHICAGO, Ill., June 14, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) has been notified that Tutanota LLC (Tutanota) has commenced an unsolicited "mini-tender" offer, dated May 28, 2024, to purchase up to 250,000 shares of AbbVie common stock at $165.00 per share in cash (Offer Price).This offer is conditioned on, among other things, the closing price per share of AbbVie's common stock exceeding the Offer Price on the last full trading day prior to the expiration date of the offer. Tutanota also states in ...
AbbVie (ABBV) Buys Global Rights to Novel IBD Candidate
ZACKS· 2024-06-14 21:51
AbbVie (ABBV) announced that it is in-licensing exclusive global rights to develop and commercialize FG-M701, a next-generation TL1A antibody for the treatment of inflammatory bowel disease (IBD), from the Chinese biotech FutureGen Biopharmaceutical.IBD includes two conditions, Crohn's disease (CD) and ulcerative colitis (UC), both characterized by chronic inflammation in the gastrointestinal tract. FG-M701, a novel TL1A inhibitor, is in pre-clinical development. It has been developed by FutureGen leveragin ...
The Dividend Defenders: 3 Stocks That Will Protect and Grow Your Wealth Dividend Stocks
Investor Place· 2024-06-14 18:15
With the markets trading at all-time highs, it’s natural to want to protect your gains by turning to a more defensive strategy. As we’ve seen throughout history, when the markets go up, they tend to pull back to retest key averages and demand levels. Are we ready for a correction? Nobody knows for sure, but it doesn’t hurt to start defending your portfolio after a strong bull run.One way to do this is to buy defensive dividend stocks. These can add stability, reduce volatility and provide cash flow for futu ...
AbbVie and FutureGen Announce License Agreement to Develop Next-Generation Therapy for Inflammatory Bowel Disease
Prnewswire· 2024-06-13 19:59
- Global license agreement to focus on the development of FG-M701, a TL1A antibody, for the treatment of inflammatory bowel disease (IBD)NORTH CHICAGO, Ill. and BEIJING, June 13, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) and FutureGen Biopharmaceutical (Beijing) Co., Ltd. today announced a license agreement to develop FG-M701, a next generation TL1A antibody for the treatment of IBD currently in preclinical development.FG-M701 is a fully human monoclonal antibody targeting TL1A, a clinically validated targ ...
AbbVie, Inc. (ABBV) Goldman Sachs 45th Annual Global Healthcare Conference (Transcript)
Seeking Alpha· 2024-06-13 07:12
AbbVie, Inc. (NYSE:ABBV) Goldman Sachs 45th Annual Global Healthcare Conference June 12, 2024 10:00 AM ET Company Participants Robert Michael - President & COO Jeffrey Stewart - EVP & Chief Commercial Officer Roopal Thakkar - SVP & Chief Medical Officer, Global Therapeutics Scott Reents - EVP & CFO Conference Call Participants Chris Shibutani - Goldman Sachs Chris Shibutani Welcome everybody. Glad that you can join us. My name is Chris Shibutani, member at the Goldman Sachs Healthcare Research team. We are ...
AbbVie, Inc. (ABBV) Goldman Sachs 45th Annual Global Healthcare Conference (Transcript)
2024-06-13 07:12
会议主要讨论的核心内容 - 公司在2023年度实现了强劲的业绩表现,其中Humira收入下降幅度低于预期,Skyrizi和Rinvoq等新产品增长强劲,占公司收入比重超过80% [7][8][18] - 公司预计2025年及以后将实现高单位数的复合年收入增长,高于行业平均水平 [7][8] - 公司正在积极拓展免疫学领域的新适应症和新机制,包括与Landos NX-13等新机制的联合用药 [54][55][56][57][58] - 公司正在推进神经科学领域的新产品管线,如Cerevel公司的Emraclidine和Tavapadon,预计2026年上市 [61][62][63][64][65][66][67] - 公司在美容领域推出新一代神经毒素BoNT/E,预计2026年上市,有望进一步提升Botox的市场地位 [74][75] - 公司在肿瘤领域持续推进ADC和多特异性抗体等新机制,如Elahere和383等产品 [78][79] 问答环节重要的提问和回答 问题1 **Chris Shibutani 提问** 对于Humira收入下滑的情况,公司是如何进行预测和应对的? [15][16][17][19] **Robert Michael 回答** 公司对Humira收入下滑有较为精准的预测,主要基于对美国市场销量下降和国际市场时间性因素的判断 [16][17][19] 问题2 **Chris Shibutani 提问** 公司如何看待Skyrizi和Rinvoq等新产品在定价和市场准入方面的挑战? [23][24][25][26] **Jeffrey Stewart 回答** 公司采取了一系列策略来应对定价和市场准入的挑战,如进行大量头对头临床试验来证明产品优势,并与支付方进行积极沟通,保持了较为稳定的定价水平 [23][24][25][26] 问题3 **Chris Shibutani 提问** 公司在神经科学领域的新产品管线,如Cerevel公司的资产,有何发展计划和预期? [60][61][62][63][64][65][66][67] **Robert Michael 和 Scott Reents 回答** 公司对Cerevel公司的资产如Emraclidine和Tavapadon充满信心,预计2026年上市,有望重塑精神分裂症治疗市场 [61][62][63][64][65][66][67]
Blue-Chip Bonanzas: 3 Industry Leaders Trading at Unbelievable Discounts
Investor Place· 2024-06-13 03:39
When it comes to targeting discounted ideas in the equities sector, undervalued blue-chip stocks offer some of the most compelling prospects. First and foremost, blue chips earn the status through decades of business and earnings expansion. In other words, they’re predictable stalwarts that can be depended on in good times and bad.As an investor, understanding this point gives you a clear advantage. Usually, when you hear about a “cheap” security in the financial information sector, it’s tied to an exciting ...