伴抑制物血友病全球市场约277 亿元，国内用药结构落后亟需新疗法： 血友病是一种遗传性出血性罕见病，全国存量血友病患者人群大约为14 万人，抑制物发生比例约 18%。目前伴抑制物血友病患者国际主流用药为重组VIIa、PCC（凝血酶原复合物）和艾美赛珠单抗， 2024 年全球销售额分别为82.7 亿元（仅为Novoseven 的数据，Sevenfact 数据未知）、128.1 亿元（2023 年数据）和366.8 亿元（其中伴抑制物适应症预计约66.0 亿元），合计市场约277 亿元。 投资建议：预计公司2025-2027 年营业收入分别为2.94/4.48/10.96 亿元，归母净利润-0.76/-0.56/2.89 亿 元，2025/2026/2027 年PS 分别为43.06/28.24/11.55 倍，首次覆盖，给予"增持"评级。 受到药物供应和主流药物可及性影响，国内伴抑制物市场仍以PCC 为主。 风险提示：波米泰酶α审评速度不及预期风险；临床数据不及预期风险；存量业务不及预期风险；股权 质押风险；医保谈判降价的不确定性风险。 FXa 波米泰酶α为FIC，我们预计仅国内市场销售峰值20 亿元以上：波米 ...

Core Viewpoint - Amgen (AMGN) reported strong first-quarter earnings and sales for 2025, with total revenues increasing by 9% year over year and product revenues rising by 11% to $7.87 billion, driven by volume growth despite price declines [1][2][3] Revenue Performance - Total revenues rose 9% year over year, with product revenues increasing 11% to $7.87 billion, reflecting strong volume growth across all areas [1][2] - Sales of key products such as Prolia, Xgeva, Repatha, Blincyto, and Evenity exceeded estimates, with 14 products achieving double-digit volume growth [3][4] Key Drug Performance - Repatha generated $656 million in sales, up 27% year over year, with volume growth of 41% offset by a 9% price decline [4] - Evenity recorded sales of $442 million, a 29% increase year over year, driven by strong demand [5] - Prolia revenues reached $1.1 billion, up 10% from the previous year, as higher volumes mitigated lower pricing impacts [5] Rare Disease Drug Sales - Sales of rare disease drugs rose 3% year over year to $1 billion, with Tepezza and Krystexxa impacted by U.S. wholesaler inventory changes [8][9] - Tepezza sales declined 10% to $381 million, while Krystexxa remained flat at $236 million; Uplizna grew 14% to $91 million, and Tavneos saw a 76% increase to $90 million [9] Oncology Portfolio - Amgen's oncology portfolio grew 10% year over year, generating over $2 billion in sales, with Blincyto as a key driver at $370 million, up 52% [10][11] - Xgeva delivered revenues of $566 million, while Kyprolis saw a 14% decline to $324 million due to competitive pressures [11] Biosimilars Contribution - Biosimilar portfolio sales increased by 35% year over year to $735 million, with new products like Wezlana contributing significantly [12][13] - Wezlana generated $150 million in sales, while Pavblu brought in $99 million [13] Inflammation Drugs - Otezla sales were $437 million, up 11%, while Enbrel revenues declined 10% to $510 million, with both products beating estimates [15] Overall Conclusion - Amgen's key medicines, including Evenity, Repatha, and Blincyto, drove sales growth, offsetting declines from oncology biosimilars and established products like Enbrel [16] - Increased pricing pressures and competition are expected to impact sales of several products, with potential revenue headwinds from brands like Otezla and Lumakras [17]

Q1 '25 Earnings Call May 1, 2025 Safe Harbor Statement This presentation contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd. or Kyowa Kirin Co., Ltd.), the performance of Otezla® (a ...

Core Viewpoint - Amgen is set to report its first-quarter 2025 results on May 1, with expectations of strong sales driven by volume growth in key products, although pricing pressures may impact overall revenue [1][4]. Sales Estimates - The Zacks Consensus Estimate for first-quarter sales is $7.96 billion, with earnings expected at $4.16 per share [1]. - Specific sales estimates for key products include Evenity at $406 million, Repatha at $616 million, Kyprolis at $381 million, and Blincyto at $333 million [2]. Patent Expiration Impact - Patents for Prolia and Xgeva expired in February 2025 in the U.S., leading to anticipated significant sales erosion due to biosimilar competition, with estimates of $990 million for Prolia and $542 million for Xgeva [3]. New Product Contributions - Newer drugs like Tezspire and Tavneos are expected to contribute positively to top-line growth, alongside the successful launch of Imdelltra for advanced small cell lung cancer [4]. Declining Sales of Established Products - Sales of Enbrel and Otezla are projected to decline due to price reductions and historical trends related to benefit plan changes and increased co-pay expenses [5][6]. Biosimilars Performance - Increased competition is expected to negatively impact revenues from oncology biosimilars, while sales of Amjevita/Amgevita are likely to have increased [7]. - Amgen launched biosimilars Wezlana and Pavblu, with investors keenly observing their sales performance [8]. Operating Margin Expectations - Amgen anticipates the lowest operating margin of the year at around 42% for the first quarter, with R&D costs expected to rise while SG&A costs as a percentage of sales are projected to decline [9]. Earnings Surprise History - Amgen has a strong earnings surprise history, beating estimates in the last four quarters with an average surprise of 5.23% [10]. Earnings Prediction Model - The current model does not predict a definitive earnings beat for Amgen, with an Earnings ESP of -0.05% and a Zacks Rank of 3 [12].