ADMA Biologics(ADMA)
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ADMA Biologics(ADMA) - 2023 Q4 - Annual Report
2024-02-28 00:00
公司业务展望 - 公司预计2024年的年收入约为3.3亿美元,2025年可能达到3.8亿美元[10] - 预计2024年和2025年的净利润分别为6500万美元及1.15亿美元以上[10] - 2023年公司实现了运营历史上首次的正现金流[10] 产品治疗效果 - ASCENIV是一种含有多种抗体的血浆衍生IVIG产品,用于治疗PIDD或PI[12] - BIVIGAM是一种含有广泛抗体的血浆衍生IVIG产品,用于治疗PI[13] - ASCENIV在PIDD患者中表现良好,未报告严重细菌感染,商业销售于2019年10月开始[17] - RI-002在PIDD患者中展示了积极的结果,未报告严重不良事件,符合FDA指导要求[19] - RI-002的安全性与其他免疫球蛋白相当[19] - ASCENIV成功治疗两名患有RSV的免疫受损儿童[20] - RI-001在免疫受损、RSV感染患者中显示出显著改善[20] - ASCENIV可能用于治疗RSV或其他呼吸道病毒感染[21] 公司发展战略 - 公司目标是成为生产、营销和开发特殊生物制剂的领导者[23] - 加大Nabi-HB的市场营销力度[24] - 扩大ASCENIV的FDA批准用途[25] - 提高Boca设施和ADMA BioCenters的运营效率和毛利率[26] - 广泛实施创新的AI项目ADMAlytics以提高供应链和生产运营效率[27] 血浆产品市场 - 美国的免疫和高免疫球蛋白产品销售额预计在2022年约为105亿美元,到2030年预计将超过200亿美元[17] - 美国2021年收集了约3900万升的血浆[38] - 2022年美国免疫球蛋白产品销售额约为105亿美元,预计到2030年将超过200亿美元[40] - 血浆来源于超过1000家FDA许可的捐赠中心,经过自动化血浆分离过程[41] - 血浆制品的生产周期大约为7至12个月[42] 法规合规 - FDA要求公司在临床试验过程中进行广泛的监测和审计[58] - FDA要求公司提交年度进展报告,包括临床试验结果[58] - FDA要求公司在15天内提交IND安全报告,包括严重和意外的不良事件[58] - FDA要求公司在7天内通知FDA任何意外致命或危及生命的疑似不良反应[58] - FDA要求公司提交临床试验结果以在ClinicalTrials.gov网站上列出[58] - FDA允许在特定情况下向患者提供调查中的生物制品[58] - FDA要求公司提交生物制品许可申请(BLA),包括产品候选开发结果和临床试验结果[60] - FDA审查BLA以确定产品是否安全、纯净、有效,并符合cGMP[61] - FDA在批准营销申请之前通常会对生产设施进行检查[61] - FDA可能会要求进行后续监测计划以监测已上市产品的效果[62] 支付和定价 - BIVIGAM、ASCENIV和Nabi-HB的销售在一定程度上依赖于第三方支付者的报销[75] - 第三方支付者对医疗产品和服务的价格和医疗必要性进行越来越严格的审查[76] - 制造商必须参与并履行医疗保险药品折扣计划、州医疗补充折扣计划和其他政府定价计划的价格报告义务[78] - 制造商必须向CMS报告平均销售价格,否则可能面临民事罚款[79] - 制造商必须参与VA联邦供应计划定价计划,VA、DoD、Coast Guard和PHS购买的创新药品价格受到限制[80] - 制造商必须参与Tricare零售药房计划,向DoD支付创新药品处方的季度回扣[80] - 制造商必须向CMS提供Medicare Part D受益人使用的品牌处方药的70%折扣[80] 法律合规 - ACA对我们的业务产生了重大影响,包括改变了医疗保健的融资方式,影响了药品行业[82] - ACA增加了制造商必须支付的最低医疗补贴,扩大了制造商的医疗补贴责任范围[82] - ACA要求制造商向CMS报告与美国执照医生等相关的信息,未按时、准确或完整报告可能导致民事罚款[82] - ACA可能导致Medicare和其他医疗保健资金的额外减少,对我们的行业和产品销售产生负面影响[83] - 美国已经通过了与报销相关的立法变化,可能会影响我们未来商业化的产品的支付[83] - 美国对药品定价实践越来越感兴趣,可能会对我们的产品定价产生负面影响[83] 数据隐私和环保 - 公司员工应努力节约资源,减少水消耗和排放,通过回收和其他节能措施[91] - 公司致力于零事故、零伤害和零泄漏或环境危害的废物管理政策[93] - 公司积极赞助和参与行业相关的慈善活动,鼓励员工积极参与和志愿服务[94]
Adma Biologics (ADMA) Surpasses Market Returns: Some Facts Worth Knowing
Zacks Investment Research· 2024-02-22 07:56
股价表现 - Adma Biologics (ADMA) 最新收盘价为 $5.18,较前一天上涨了 +0.58% [1] - Adma Biologics 过去一个月股价下跌了 2.28%,落后于医疗行业的 3.87% 增长和标普500指数的 2.99% 增长 [2] 财务预测 - 分析师预计 Adma Biologics 将发布每股收益为 $0.02,同比增长 133.33%,预计营收为 $73.5 百万美元,同比增长 47.06% [3] 估值变化 - 近期分析师对 Adma Biologics 的估值发生了变化,这些变化反映了短期业务趋势的演变,正面的估值修订传达了分析师对公司业绩和利润潜力的信心 [4] 股票评级 - Zacks Rank 模型显示 Adma Biologics 目前的评级为 2 (买入),该模型自 1988 年以来表现出色,1 股票的平均年回报率为 +25% [6] 市盈率比较 - Adma Biologics 目前的前瞻市盈率为 23.06,高于行业平均值 21.39,意味着公司的股价溢价 [7] 行业排名 - 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 87,在所有 250+ 个行业中处于前 35% [8] 行业实力 - Zacks Industry Rank 通过计算组内个别股票的平均 Zacks Rank 来评估各行业群体的实力,研究显示,排名前 50% 的行业的表现是排名后 50% 的两倍 [9] 监控建议 - 使用 Zacks.com 监控所有这些影响股价的指标,并在未来的交易日内持续关注 [10]
Adma Biologics (ADMA) Exceeds Market Returns: Some Facts to Consider
Zacks Investment Research· 2024-02-16 07:46
Adma Biologics (ADMA) closed the latest trading day at $5.40, indicating a +1.31% change from the previous session's end. The stock outperformed the S&P 500, which registered a daily gain of 0.58%. At the same time, the Dow added 0.91%, and the tech-heavy Nasdaq gained 0.3%.The infectious disease drug developer's shares have seen an increase of 8.11% over the last month, surpassing the Medical sector's gain of 2.39% and the S&P 500's gain of 4.61%.Market participants will be closely following the financial ...
Here's Why Momentum in Adma Biologics (ADMA) Should Keep going
Zacks Investment Research· 2024-02-15 22:51
While "the trend is your friend" when it comes to short-term investing or trading, timing entries into the trend is a key determinant of success. And increasing the odds of success by making sure the sustainability of a trend isn't easy.Often, the direction of a stock's price movement reverses quickly after taking a position in it, making investors incur a short-term capital loss. So, it's important to ensure that there are enough factors -- such as sound fundamentals, positive earnings estimate revisions, ...
New Strong Buy Stocks for February 13th
Zacks Investment Research· 2024-02-13 20:51
Here are five stocks added to the Zacks Rank #1 (Strong Buy) List today:Inhibikase Therapeutics, Inc. (IKT) : This pharmaceutical company has seen the Zacks Consensus Estimate for its current year earnings increasing 16% over the last 60 days.Equitrans Midstream Corporation (ETRN) : This midstream energy company has seen the Zacks Consensus Estimate for its current year earnings increasing 11.7% over the last 60 days.ADMA Biologics, Inc. (ADMA) : This biopharmaceutical company has seen the Zacks Consensus E ...
3 Medical Stocks to Buy as the Sector Continues to Grow
Zacks Investment Research· 2024-02-09 22:16
Since late last year, the healthcare sector has seen a steady rise. As of January, an otherwise indifferent month for the broad sectors other than tech and financials, health care advanced 3%, and is up 7.1% over the past 12 months.The sector is riding on investors' current bet on healthcare to emerge as one of the winners for 2024. As is, the regular demand for medical services is not dependent on the peaks and troughs of a market, especially one that has remained volatile with an eye on the Fed’s tight mo ...
Adma Biologics (ADMA) Stock Declines While Market Improves: Some Information for Investors
Zacks Investment Research· 2024-02-08 07:50
Adma Biologics (ADMA) ended the recent trading session at $5.18, demonstrating a -1.71% swing from the preceding day's closing price. This move lagged the S&P 500's daily gain of 0.82%. Meanwhile, the Dow experienced a rise of 0.41%, and the technology-dominated Nasdaq saw an increase of 0.95%.The infectious disease drug developer's shares have seen an increase of 3.94% over the last month, surpassing the Medical sector's gain of 3.2% and falling behind the S&P 500's gain of 5.59%.Market participants will b ...
Is Adma Biologics (ADMA) a Buy as Wall Street Analysts Look Optimistic?
Zacks Investment Research· 2024-02-06 23:31
经纪推荐 - 投资者在做出股票买入、卖出或持有决策之前通常会参考华尔街分析师的推荐[1] - Adma Biologics目前的平均经纪推荐(ABR)为1.00,表示强烈买入[2] - 经纪推荐趋势显示,虽然ABR建议购买Adma Biologics,但仅凭此信息做出投资决策可能不明智[4] - 经纪公司对所覆盖股票存在强烈的正面偏见,通常会给出更多“强烈买入”推荐[5] Zacks Rank - 经纪推荐与Zacks Rank不同,Zacks Rank是基于盈利预期修订的量化模型[9] - 经验研究表明,盈利预期修订与近期股价走势之间存在强烈相关性[11] - Zacks Rank对所有经纪分析师提供的当年盈利预期进行比例分配,保持五个等级之间的平衡[12] - Zacks Rank与ABR的另一个关键区别是及时性,Zacks Rank能够及时反映公司业务趋势变化的盈利预期修订[13] 公司盈利预期 - Adma Biologics当前年度盈利预期的Zacks Consensus Estimate在过去一个月内增长了26.4%至-0.02美元[14] - 分析师对公司盈利前景的乐观态度,以及他们在修订盈利预期方面的强烈一致性,可能是股票在短期内飙升的合理原因[15] - 最近一次共识预期变化的规模,以及与盈利预期相关的其他三个因素,导致Adma Biologics的Zacks Rank为2(买入)[16]
Does Adma Biologics (ADMA) Have the Potential to Rally 31.55% as Wall Street Analysts Expect?
Zacks Investment Research· 2024-02-05 23:56
Shares of Adma Biologics (ADMA) have gained 18.9% over the past four weeks to close the last trading session at $5.23, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $6.88 indicates a potential upside of 31.6%.The average comprises four short-term price targets ranging from a low of $6 to a high of $9, with a standard deviation of $1.44. While the lowest estimate indicates an i ...
New Strong Buy Stocks for January 31st
Zacks Investment Research· 2024-01-31 20:05
Here are five stocks added to the Zacks Rank #1 (Strong Buy) List today:ADMA Biologics, Inc. (ADMA) : This biopharmaceutical company has seen the Zacks Consensus Estimate for its current year earnings increasing 33.3% over the last 60 days.Inhibikase Therapeutics, Inc. (IKT) : This clinical-stage pharmaceutical company has seen the Zacks Consensus Estimate for its current year earnings increasing nearly 16% over the last 60 days.YPF Sociedad Anónima (YPF) : This international energy company engaging in the ...