Subasumstat

According to Takeda's 2023 fiscal year business report, the company's annual total revenue reached 4,263.8 billion yen, an increase of 5.9% year-over-year. However, net profit declined by 54.6% to 144.1 billion yen. This decline was primarily attributed to the loss of exclusivity for Azilva (a hypertension drug) and Vyvanse (used to treat ADHD and binge eating disorder), as well as the failed development of Alofisel (a stem cell therapy for Crohn's disease) and Exkivity (a lung cancer tyrosine kinase inhibitor). Faced with these challenges, Takeda has announced a corporate restructuring to improve profitability in the coming years. The company expects to incur a one-time restructuring cost of 140 billion yen (around $9 billion) in 2024. Takeda stated that the restructuring measures will involve employee optimization, cost-cutting, and pipeline adjustments, with the goal of increasing the core profit margin by 1% to 2.5% annually, ultimately reaching a level of 30%. As part of the pipeline adjustments, Takeda has discontinued a total of 18 products, including several cancer treatment products such as Exkivity (lung cancer), TAK-981 (cancer therapy), TAK-007 (cell therapy), TAK-573 (multiple myeloma and solid tumors), TAK-102/TAK-103 (solid tumors), and TAK-940 (multiple myeloma). Following the restructuring, Takeda plans to fill the gaps by introducing high-quality products. Orserdulatinib, a third-generation oral BCR-ABL tyrosine kinase inhibitor already approved in China, has been selected as an acquisition target. The drug is used to treat chronic myeloid leukemia with the T315I mutation and patients who are resistant and/or intolerant to first- and second-generation TKIs. According to a report by Asieris Pharmaceuticals, the cumulative sales of orserdulatinib have already exceeded 300 million RMB, and its sales growth has been significant after being covered by medical insurance, indicating its vast market potential. On the other hand, AbbVie's acquisition strategy has been focused on its strengths in the immunology field. Humira, once the world's best-selling drug, has ceded its "drug king" status to Merck's Keytruda (pembrolizumab) due to patent expiration and biosimilar competition. Analysts note that pharmaceutical companies need to adjust their strategies in a timely manner to address the rise of new "drug kings" and the challenges posed by upcoming patent expirations. Currently, the acquisition of biotech companies to supplement product pipelines has become a common strategy among multinational pharmaceutical companies. While ensuring alignment with their own strategic goals, these companies conduct in-depth assessments of biotech companies' pipeline assets and innovation value to optimize their industrial layouts. Analysts emphasize that for large multinational pharmaceutical companies, acquiring "external innovation" through mergers and licensing is just as critical as "internal R&D." Approximately one-third of global innovative drug revenue comes from internal R&D, while two-thirds comes from mergers and collaborations. However, some companies' reliance on external innovation is significantly higher than the average, reaching 60% to 70%. Analysts further note that since 2023, innovative products from China have frequently appeared in transactions involving multinational pharmaceutical companies, indicating that domestic Chinese pharmaceutical companies and their products are gradually gaining international recognition, a positive sign.

声明：因水平有限，错误不可避免，或有些信息非最及时，欢迎留言指出。本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及）;本文不构成任何投资建议 6月21日，亚盛医药（6855.HK）宣布，针对武田股权投资公司事宜，该交易已于2024年6月20日交割，交易款项已到账。根据相关协议条款，亚盛医药已以每股认购股份 24.09850 港元（约相当于 3.08549 美元）的股份购买价向武田成功配发总共24,307,322股认购股份，总金额约为7500万美元，自此武田成为亚盛医药第二大股东。 这项协议最早于6月14日披露，亚盛医药与武田就公司的具有best-in-class潜力的第三代BCR-ABL酪氨酸激酶抑制剂（TKI）耐立克®（奥雷巴替尼）达成独家许可协议。一旦选择权被行使，武田将获得开发及商业化奥雷巴替尼的全球权利许可，惟中国大陆、中国香港特别行政区、中国澳门特别行政区、中国台湾等地区除外。 根据该选择权协议的条款，亚盛医药将于协议签署后收到1亿美元的选择权付款，并有资格获得最高约12亿美元的选择权行使费以及额外的潜在里程碑付款。 武田以7500万美元获得亚盛医药7.7%的股份，成为亚盛医药第二大股东，入股价格较交易宣布前20日收盘均价溢价25%； 整体来看，本次海外BD协议暂时缓解了亚盛医药资金短缺的燃眉之急，对公司经营起到一定正向作用。但就长远而言，本次协议对于公司未来发展的影响仍有待观察。 亚盛医药在收到武田制药支付的1亿美元选择权付款后，需全权负责耐立克®（奥雷巴替尼）的所有临床开发。而在新药研发全流程中，临床试验阶段是研发费用支出的大头，且随着临床进度的推进研发费用逐步增多。同时，海外临床试验成本远高于国内，通常为国内的3倍以上。 在此背景下，武田制药仅支付了1亿美元选择权付款就锁定了奥雷巴替尼未来的海外权益，无需承担海外临床研发费用，即便算上选择权行使费及额外的潜在里程碑付款总额也仅13亿美元。对于亚盛医药而言，权益出让的价格或许并不算高。 从既往国内外创新药企BD案例来看，如研发费用等由卖方承担或是双方共同承担，则通常买方需支付给卖方更高额的首付款。例如，百利天恒与百时美施贵宝就BL-B01D1达成独家许可合作协议的首付款达8亿美元；阿斯利康与第一三共就DS-8201达成合作协议的首付款达13.5亿美元。 亚盛医药之所以选择以并不高的价格出让唯一商业化产品的海外权益或许也是无奈之举。2023年，公司实现归母净利润为-9.26亿元，亏损额已连续三年扩大。同期经营活动产生的现金流量净额为-7.26亿元，其关键产品还在开展临床试验，每年还有数亿元的研发投入。 此次，亚盛医药再度增发2430.73万股股份，占已发行股本比例约8.38%，入股价格约为24.1港币/股，股份配售价格再创新低。此外，亚盛医药目前还向美国证券交易委员会递交了建议首次公开发售的F-1表格登记声明草案，拟于美股市场寻求上市。 首次公开发售预计在证交会完成审查程序后进行，这意味着公司融资渠道将进一步拓宽。2019年，亚盛医药IPO首发募资3.7亿港元，随后亚盛医药进行了4次配售，募资金额分别为7.02亿港元、11.71亿港元、3.88亿港元和5.5亿港元。截至2023年12月31日，亚盛医药的现金及银行结余为10.93亿元。 在唯一商业化产品国内市场销售情况不佳，海外市场权益已低价转让的情况之下，自身造血能力不足依赖外部融资输血的亚盛医药何时能走出困境，实现扭亏为盈仍有待进一步观察。 此外，根据武田财报，2023年武田共有18款药物从管线中剔除，其中就包括多款肿瘤产品管线。例如，肺癌产品Exkivity、癌症疗法TAK-981、细胞疗法 TAK-007、多发性骨髓瘤和实体瘤的TAK-573、实体瘤的TAK-102/TAK-103、多发性骨髓瘤的TAK-940等。 在剥离重组后，武田也需要优质产品补位。而根据武田此次发布的新闻稿件，选择收购的奥雷巴替尼是一款第三代口服BCR-ABL酪氨酸激酶抑制剂（TKI）。目前，奥雷巴替尼已在中国获批上市，用于治疗任何TKI耐药，并伴有T315I突变的慢性髓细胞白血病慢性期（CP-CML）或加速期（AP-CML）成年患者以及对一代和二代TKI耐药和/或不耐受的CP-CML成年患者。 根据亚盛医药财报，奥雷巴替尼已累计销售超3亿元。2023年3月，全国医保覆盖生效后，该产品的临床用药可及性进一步提升，第二季度销售盒数同比增长560%，销售收入增长153%，这也意味着该药物具有较强的市场潜力。 总结 当下，跨国药企收购Biotech已然是一套成熟运行的商业模式，资本寒潮中，资金链充裕的跨国药企更是屡屡出手。从公司来看，MNC是国内药企首选的合作对象，其中与阿斯利康、GSK等大公司合作尤为频繁。恒瑞医药、翰森制药等传统药企也纷纷在License out方面发力，产品接连授权出海。“出海”不仅给企业提供了更丰富的资金支持，同时提高了中国药企在临床试验设计、患者群体选择等方面的经验，增强了其研发能力，驱动行业高速发展。 参考资料： [1]公司公告 [2]新浪财经