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Biogen(BIIB) - 2024 Q1 - Quarterly Results
2024-04-24 19:02
Press Release Cambridge, Mass. – Apr. 24, 2024 Biogen reports first quarter 2024 GAAP EPS growth of 1% and Non-GAAP EPS growth of 8% First quarter revenue $2.3 billion; GAAP diluted EPS $2.70; Non-GAAP diluted EPS $3.67 First quarter product revenue decreased 3% and total revenue decreased 7%, while GAAP operating income grew 10% and Non-GAAP operating income grew 24%; meaningful improvement in both gross and operating margins due to Fit for Growth program and R&D prioritization LEQEMBI launch uptake accele ...
Biogen tops quarterly profit estimates as cost cuts take hold, Leqembi launch picks up
CNBC· 2024-04-24 18:47
A test tube is seen in front of displayed Biogen logo in this illustration taken on, December 1, 2021. Biogen on Wednesday reported first-quarter profit that topped estimates as the company's cost-cutting efforts took hold and sales of its closely watched Alzheimer's drug, Leqembi, came in higher than expected. Biogen and Eisai's Leqembi became the first drug found to slow the progression of Alzheimer's disease to win approval in the U.S. in July. The treatment's launch has been sluggish, but uptake appeare ...
Biogen Inc. (BIIB) Falls More Steeply Than Broader Market: What Investors Need to Know
Zacks Investment Research· 2024-04-02 06:56
In the latest market close, Biogen Inc. (BIIB) reached $214.83, with a -0.37% movement compared to the previous day. This change lagged the S&P 500's 0.2% loss on the day. On the other hand, the Dow registered a loss of 0.6%, and the technology-centric Nasdaq increased by 0.11%. Heading into today, shares of the company had lost 2.41% over the past month, lagging the Medical sector's gain of 2.21% and the S&P 500's gain of 3.32% in that time. The investment community will be closely monitoring the performan ...
Eisai Completes Submission of LEQEMBI® (lecanemab-irmb) Supplemental Biologics License Application for IV Maintenance Dosing for the Treatment of Early Alzheimer's Disease to the U.S. FDA
Prnewswire· 2024-04-01 07:30
LEQEMBI治疗 - LEQEMBI用于治疗早期阿尔茨海默病(AD)患者,包括轻度认知障碍或轻度痴呆阶段的患者[1] - 早期AD的治疗具有紧迫性,因为早期和持续治疗可以减缓AD的进展,持续治疗可能在清除大脑中的斑块后延长益处[4] - LEQEMBI治疗患者中,ARIA的发生率较高,包括症状性ARIA和无症状但放射学上严重的ARIA[16] LEQEMBI不良反应 - LEQEMBI在研究2中最常见的导致停药的不良反应是ARIA-H微出血,导致LEQEMBI治疗患者中有2%(15/898)停药,而安慰剂组中有<1%(1/897)的患者停药[1] - 在研究2中,LEQEMBI治疗患者(N=898)中报告的最常见不良反应是输注相关反应(LEQEMBI:26%;安慰剂:7%),ARIA-H(LEQEMBI:14%;安慰剂:8%),ARIA-E(LEQEMBI:13%;安慰剂:2%),头痛(LEQEMBI:11%;安慰剂:8%),中枢神经系统表面铁沉着症(LEQEMBI:6%;安慰剂:3%),皮疹(LEQEMBI:6%;安慰剂:4%),以及恶心/呕吐(LEQEMBI:6%;安慰剂:4%)[2] LEQEMBI批准 - LEQEMBI是Eisai和BioArctic战略研究联盟的成果,是一种针对聚集的可溶(原纤维)和不溶性淀粉样蛋白β(Aβ)的人源化免疫球蛋白G1(IgG1)单克隆抗体。LEQEMBI已在美国、日本和中国获得批准,用于治疗阿尔茨海默病(AD)。LEQEMBI的FDA批准是基于Eisai的全球Clarity AD临床试验的3期数据,该试验达到了主要终点和所有关键次要终点,结果具有统计学意义[3]
Biogen Inc. (BIIB) Stifel 2024 Virtual CNS Days (Transcript)
Seeking Alpha· 2024-03-20 02:16
Biogen公司发展 - 公司在2024年3月19日举行了Stifel 2024虚拟CNS Days会议,主要涉及公司发展和医疗主管的讨论[1] - 过去一年取得了重大进展,重点投资于能够带来最大回报和增值的项目[3] - 完成了Reata收购,并重新调整了公司结构和成本基础以支持未来增长[4] 新产品上市 - 公司着眼于新产品上市,如阿尔茨海默病、弗里德雷希共济失调症和产后抑郁症[5] - 在阿尔茨海默病领域继续扩大领先地位,推进针对Tau的资产,认为Tau可能代表阿尔茨海默病未来的另一个方面[6] 研发管道和扩展计划 - 公司致力于增加研发管道的生产力,确保定期推出药物,并在评估外部机会方面保持警惕[7] - 计划扩展到免疫学和罕见疾病领域,同时继续关注小分子、生物制剂和ASO等技术[10] Angelman综合症研究 - 公司在Angelman综合症研究中取得了一些初步结果,包括对患者的临床评估和EEG数据的分析[28] - 采用了多种临床评估指标,包括Bayley量表和临床整体印象评估,以评估治疗潜力[25] - 计划进行Angelman综合症的关键试验,并将根据临床评估和EEG结果来确定合适的终点[33] BIIB121和Lecanemab项目 - BIIB121 ASO具有2-甲氧基乙基结构骨架,与SPINRAZA相似,认为这是更好的骨架[35] - BIIB121的给药方案基于PK/PD数据,每三个月一次给药可见临床益处,与Roche的rugonersen每六个月一次给药不同[37] - Lecanemab的皮下注射数据显示与静脉注射相当,支持皮下注射的可行性[40]
Biogen Inc. (BIIB) Stifel 2024 Virtual CNS Days (Transcript)
2024-03-20 02:16
业绩总结 - Biogen公司在过去一年取得了重大进展,重点投资于能够带来最大回报和增值的领域[4] - Biogen公司完成了Reata收购,并重新调整了公司结构和成本基础以支持未来增长[4] - Biogen公司在商业方面看到了新产品上市的执行年,包括阿尔茨海默病、弗里德雷希共济失调症和产后抑郁症[5] - Biogen公司继续在阿尔茨海默病领域扩大领先地位,推进针对Tau蛋白的资产,认为Tau蛋白可能代表阿尔茨海默病未来的另一个方面[6] - Biogen公司计划继续增加管线的生产力,确保定期推出药物[7] 新产品和新技术研发 - Biogen公司在罕见疾病领域的目标是通过创新和驱动结果来取得突破性进展[16] - Biogen公司在Angelman综合征的研究中看到了一些早期结果,正在综合分析数据以做出决策[27] - BIIB121的剂量方案基于PK/PD数据,Q3给药对Angelman症状有益[38] - Litifilimab在SLE和CLE的Phase II研究中达到主要终点[63] - Dapi在SLE患者中表现出良好的耐受性,并在多个临床和免疫参数上与安慰剂有显著差异[68] 市场扩张和并购 - Biogen公司与研究主管和企业战略主管密切合作,认为在神经学和罕见疾病领域有更多扩展的潜力[8] - Eisai计划分两个阶段提交Lecanemab的皮下给药监管文件[44] - 公司计划在Lupus领域进行两项Phase III研究,其中一项涉及Litifilimab,另一项涉及Dapi[66] 其他新策略和有价值的信息 - 公司对Litifilimab的Phase III计划持乐观态度,认为该药物有望取得重要数据[66] - 公司对Dapi的Phase III研究结果持谨慎态度,但仍对该药物的途径和潜力表示乐观[70] - CD40L的BI失败是在狼疮性肾炎领域,需要寻找主要终点和关键次要终点的显著变化[72]
Here's Why Biogen Inc. (BIIB) Gained But Lagged the Market Today
Zacks Investment Research· 2024-03-19 06:56
股价表现 - Biogen Inc. (BIIB) 最新收盘价为$219.40,较前一天上涨了+0.04%[1] - Biogen Inc. 股价表现落后于标普500指数的日涨幅0.63%[1] - Biogen Inc. 过去一个月股价上涨了0.1%,不及医疗行业0.91%和标普500指数1.76%的涨幅[2] 财务预测 - 投资者将密切关注Biogen Inc. 即将公布的财报,预计每股收益为$3.48,同比增长2.35%[3] - Biogen Inc. 预计年度每股收益为$15.48,营收为$94.7亿,分别较去年增长了+5.16%和-3.75%[4] 分析师预测 - 分析师对Biogen Inc. 的最新预测修订可能反映了最新的短期业务趋势,这些修订通常表达了分析师对公司业务运营和盈利能力的积极态度[5] - 研究表明,这些预测修订与即将到来的股价表现有直接关联,Zacks Rank 模型整合了这些预测变化并提供了一个功能评级系统[6] 公司估值 - Biogen Inc. 目前的前瞻市盈率为14.17,相比行业的24.2,显示出一定的折价[8] - BIIB 目前的PEG比率为1.83,与行业平均PEG比率1.58相比,也考虑了公司的预期盈利增长[9] 行业评级 - 医疗-生物医学和遗传学行业属于医疗行业,目前的 Zacks Industry Rank 为71,在所有行业中排名前29%[10] - Zacks Industry Rank 通过测量各行业内个股的平均 Zacks Rank 来评估各行业群体的实力,研究显示,排名前50%的行业胜过后50%的行业[11] 股票指标 - Biogen Inc. 目前的 Zacks Rank 为3 (Hold),过去30天内,共识每股收益预测上调了0.06%[7] - 在即将到来的交易日中,应用 Zacks.com 关注这些股票相关指标[12]
Why Is Biogen Inc. (BIIB) Up 2.6% Since Last Earnings Report?
Zacks Investment Research· 2024-03-15 00:36
It has been about a month since the last earnings report for Biogen Inc. (BIIB) . Shares have added about 2.6% in that time frame, underperforming the S&P 500. Will the recent positive trend continue leading up to its next earnings release, or is Biogen Inc. due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at its most recent earnings report in order to get a better handle on the important drivers. Q4 Earnings & Sales Miss Estimates Biogen’s ...
Biogen Inc. (BIIB) Stock Falls Amid Market Uptick: What Investors Need to Know
Zacks Investment Research· 2024-03-13 06:56
In the latest market close, Biogen Inc. (BIIB) reached $227.36, with a -1.18% movement compared to the previous day. This move lagged the S&P 500's daily gain of 1.12%. Meanwhile, the Dow experienced a rise of 0.61%, and the technology-dominated Nasdaq saw an increase of 1.54%. The company's stock has dropped by 5.99% in the past month, falling short of the Medical sector's gain of 2.49% and the S&P 500's gain of 2.06%. Investors will be eagerly watching for the performance of Biogen Inc. in its upcoming ea ...
New Biomarker Data Add Further Evidence Supporting the Potential Benefit of SPINRAZA® (nusinersen) in Infants and Toddlers with Unmet Clinical Needs after Gene Therapy
Newsfilter· 2024-03-06 20:30
New data from the RESPOND study show that neurofilament levels, an indicator of neurodegeneration, were reduced in nearly all study participants treated with SPINRAZA Reductions in biomarker complement previously reported RESPOND efficacy results showing improved motor function in most participants treated with SPINRAZA after gene therapy CAMBRIDGE, Mass., March 06, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (NASDAQ:BIIB) announced interim 6-month biomarker data from the initial 29 participants in the open-label ...