Darvadstrocel ( TiGenix)

Pictured: Takeda's office in Cambridge, Massachusetts/iStock, hapabapa Takeda on Thursday released the business report for its 2023 fiscal year, touting a modest increase in annual revenue while forecasting a profit hit for the coming year tied to the continued sales erosion of its ADHD therapy Vyvanse (lisdexamfetamine dimesylate). For the fiscal year that ended March 31, 2024, Takeda booked more than $27 billion in revenue. This figure represents a 1.5% increase at constant exchange rates from its fiscal year 2023 revenue of $25.8 billion. Despite the revenue bump, Takeda’s net profit for the year dropped 57% to $925 million, from approximately $2 billion during the previous fiscal year. Takeda’s reported operating profit likewise took a 50.3% hit, dropping from $3.15 billion to $1.37 billion in the fiscal year 2023. According to the pharma’s investor presentation, the drop in reported operating profit could be attributed to higher operating expenditure as well as “impairments” with its Crohn’s disease stem cell therapy Alofisel (darvadstrocel) and lung cancer tyrosine kinase inhibitor Exkivity (mobocertinib). In October 2023, Alofisel failed its Phase III ADMIRE-CD II study, unable to significantly improve 24-week combined remission in patients with complex Crohn’s perianal fistulas. The company subsequently decided not to regulatory approval in the U.S., according to its presentation on Thursday. The same month, Takeda withdrew Exkivitiy globally after it failed the confirmatory Phase III EXCLAIM-2 study. Looking ahead to the rest of the current fiscal year, Takeda tempered investor expectations and lowered its core operating profit guidance by approximately 10%. The Japanese multinational now anticipates booking around $6.4 million (or ¥1 billion) in the coming year. Takeda’s forecast also includes a “flat to slightly declining” annual revenue. This annual guidance reflects the continued sales erosion that Takeda is expecting to weather as generic versions of its ADHD medicine Vyvanse hit the market. First approved in 2003, Vyvanse lost several crucial patent protections in 2023, including those that covered adult indications in February, and those for pediatric use in August. There are at least 12 impending generic version of Vyvanse from companies such as Sandoz, Teva and Mylan. Takeda has lined up several upcoming pipeline milestones to make up for Vyvanse’s loss of exclusivity. In the coming fiscal year, for instance, it is planning to launch a Phase III study of its tyrosine kinase 2 inhibitor zasocitinib in psoriatic arthritis, as well as a head-to-head study versus BMS’s Sotyktu (deucravacitinib) in psoriasis. The pharma is also awaiting a Phase III readout for its cholesterol 24-hydroxylase inhibitor soticlestat in the first half of the fiscal year. The drug candidate is being studied for Dravet syndrome or Lennox-Gastaut syndrome, two rare epileptic conditions. Aside from its promising pipeline, Takeda will also implement an “enterprise-wide efficiency program,” which will start in fiscal year 2024, according to its business report. The pharma expects this strategic initiative to cost nearly $900 million. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

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。武士刀起，管线落！在研发的道路上，杀伐决断，勇于放弃也是一种积极的策略。继去年半年报武田宣布砍掉4条管线后，近日又披露停止了6个管线项目。近期，多家全球知名药企纷纷揭晓了最新财报，除了各项财务数据备受瞩目外，其研发管线的战略调整同样引起了业界的广泛关注。尤其被终止的研发项目，它们背后的故事与经验教训对于整个行业而言都极具借鉴意义，有助于其他企业在研发道路上规避风险，少走弯路，减少不必要的探索。例如罗氏将从其研发管线中剔除5款神经学领域资产和3款肿瘤资产（包括2款死磕十多年的AD药物），旨在平衡整体投资组合价值并加速开发更有价值资产。辉瑞也砍掉3条管线，涉及到广谱抗真菌类，抗肿瘤药和1款B7H4/CD3双抗。除了罗氏、辉瑞等药企，武田制药在最新披露信息中显示，净利下降和管理层变动，也终止了6个研发项目。2023财年前三季度，武田全球总收入为3.21万亿日元（约合220亿美元），同比增长4.6%。净利润为1471亿日元，同比下降49%。该公司预计其2023财年营收将达到3.9万亿日元（合266亿美元）。武田公司表示，其利润的变化反映了仿制药的竞争、新冠肺炎疫苗收入的减少以及研发、数据和技术方面投资的增加。近期，武田在人事变动和对外合作方面也动作频频。CFO辞职，肿瘤学部门换帅首席财务官Costa Saroukos将于4月1日辞职，以便更接近他在澳大利亚的家人。他在这份工作上工作了六年，并帮助完成了制药史上最大的交易之一——2019 年以 620 亿美元收购夏尔。Takeda CEO Christophe Weber评价称其在此交易中发挥了重要作用。此外，武田还宣布前CRISPR Therapeutics公司首席医学官PK Morrow于1月29日接替ChrisArendt担任肿瘤学部门负责人。Christophe Weber, Takeda CEO在对外合作方面，今年2月初武田花费3亿美元购买Protagonist的PhIII罕见病药物。去年12月JCR Pharmaceuticals宣布武田决定停止与JCR合作，开发使用腺相关病毒（AAV）结合JCR J-Brain Cargo技术的基因疗法。近日有媒体报道，武田制药终止了六条研发管线。这些项目包括治疗伴有复杂肛瘘的克罗恩病的Cx601、针对帕金森病的TAK-071、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以及预防寨卡病毒感染的TAK-426。这些决策主要基于临床试验结果未达到预期、战略调整以及对市场需求和流行病学的评估。武田制药表示，这些举措是为了最大化公司价值和资源利用效率。具体项目和原因如下：研发总裁Andy Plump在更新研发管线时提到，武田在细胞治疗方面将聚焦通用型细胞治疗的研发，削减了其他处于I期临床试验阶段的3项CAR-T细胞治疗项目，分别为TAK-102、TAK-103和TAK-940。TAK-102和TAK-103针对实体肿瘤开发，而TAK-940则是为CD19针对多发性骨髓瘤。此外武田在本周四宣布，将于2024财年上半年在全球范围内启动其正在研究中的口服ORX2激动剂TAK-861在1型嗜睡症的全球三期临床试验，并放弃在2型嗜睡症中开发该候选药物的计划。在对112名NT1患者进行的具有主要和关键次要终点的P2b研究中取得积极结果后，武田开发了几种食欲素受体激动剂，并有望扩大特许经营权的规模。参考资料：https://assets-dam.takeda.com/image/upload/v1706756054/Global/Investor/Financial-Results/FY2023/Q3/q3_fy2023_press_release.pdf