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点击箭头处“蓝色字”，关注我们哦！！ 《Science》心脏研究特刊深度精读｜科技重构心血管病防治体系，从认知到诊疗全维度突破 2025年6月，西奈山伊坎医学院联合《Science》（AAAS）发布《心脏医学研究前沿》专属增刊，集结全球顶尖心血管领域专家的最新研究成果，聚焦动脉粥样硬化、房颤、二尖瓣脱垂、主动脉瘤、肺动脉高压等核心疾病，从病因认知颠覆、AI赋能全流程诊疗、新型药物与临床研究突破、全生命周期预防体系、难治性疾病前沿探索五大维度，系统阐述了心血管疾病防治的革命性进展。这份研究不仅改写了传统心血管病的认知逻辑，更以AI、基因技术、微创疗法为核心，构建了“精准化、整合化、全周期化”的全新诊疗体系，为全球超12亿心血管疾病高危人群带来全新防治思路。以下为原文核心内容的逐点精读，兼顾专业性与通俗性，还原研究全貌。 一、病因认知核心颠覆：心血管病并非“单器官病变”，而是代谢免疫神经跨系统全身性疾病 长期以来，临床将心血管病归为心脏和血管的局部问题（如“血脂高堵血管”“心脏瓣膜老化”），而西奈山团队通过大量基础与临床证据证实：心血管疾病的发生、发展是代谢、免疫、神经系统相互作用的结果，且与基因、环境、生活方式深度耦合。这一认知彻底打破了“头痛医头、脚痛医脚”的治疗局限，为靶向治疗提供了全新理论基础，也是本次研究的核心突破之一。 1. 动脉粥样硬化：从“脂质沉积病”升级为“脂质驱动的神经炎症疾病” 动脉粥样硬化是心梗、中风的首要诱因，传统“脂质假说”认为其核心是低密度脂蛋白（LDL）沉积形成血管斑块，但本次研究通过多中心临床数据和基础实验，完善了其发病机制： 脂质代谢失衡是基础：血液中过量的LDL会沉积在血管内膜下，这是斑块形成的前提，也是他汀类、PCSK9抑制剂等降脂药的作用基础； 免疫系统异常是核心推手：沉积的脂质会激活血管内皮细胞，吸引单核细胞从骨髓和脾脏迁移至血管壁并转化为巨噬细胞，巨噬细胞吞噬脂质形成“泡沫细胞”，同时释放炎症因子引发血管慢性炎症，加速斑块生长；更关键的是，克隆性造血（血液干细胞基因突变）会让免疫细胞更具“促炎性”，大幅提升斑块破裂风险； 神经系统紊乱是重要调控者：大脑与心脏的神经连接直接影响血管健康——长期情绪压力、睡眠不足、衰老会通过交感神经通路，促进骨髓生成更多免疫细胞，同时损伤血管内皮的保护功能；研究还发现，动脉粥样硬化血管的外膜神经密度会显著增加，神经纤维与免疫细胞相互作用，进一步放大炎症反应；此外，糖尿病、肥胖等代谢问题，会破坏下丘脑骨髓的神经回路，加剧血管病变，形成“代谢异常神经紊乱免疫激活”的恶性循环。 简言之，动脉粥样硬化并非单纯的“血管堵了”，而是脂质、免疫、神经三大系统共同作用的结果，这也解释了为何部分患者血脂控制良好，仍会突发心梗、中风。 2. 二尖瓣脱垂（MVP）：亚临床心肌炎症先于纤维化，是突发心脏骤停的“隐形元凶” 二尖瓣脱垂是最常见的心脏瓣膜病，影响全球2%3%的人群，美国约800万人患病，其最致命的并发症是突发心脏骤停（SCD）。此前临床认为心肌纤维化（疤痕组织）是心律失常和猝死的核心诱因，而西奈山团队的研究彻底推翻了这一结论： 炎症是疾病始动因素：通过PET/MRI融合影像检测发现，85%的MVP患者存在心肌炎症（18FFDG摄取阳性），且炎症早于纤维化出现；即使患者无明显的二尖瓣反流，炎症也会直接改变心肌细胞的电生理特性，诱发室性心律失常（如室早、室速），这也是约20%的MVP猝死患者无明显纤维化却发生意外的核心原因； 机械牵拉加剧炎症纤维化循环：脱垂的二尖瓣叶会对乳头肌、左心室下侧壁产生持续机械牵拉，导致局部心肌微小损伤，进而激活身体的“无菌性炎症反应”；炎症会进一步刺激成纤维细胞增殖，形成心肌纤维化，最终形成“机械牵拉炎症纤维化心律失常”的恶性循环，大幅提升猝死风险； 关键高危指标：研究明确了MVP的猝死高危因素——女性、双叶瓣脱垂、二尖瓣环分离、组织多普勒高流速信号，而心肌炎症+复杂室性心律失常是最核心的预警信号。 3. 遗传性胸主动脉瘤（TAA）：30余种基因突变主导，血管壁整体功能异常是核心 胸主动脉瘤素有“体内定时炸弹”之称，早期无症状，破裂后死亡率超80%，美国约50万人患病。传统观点认为其是“血管壁退行性变”，本次研究明确了遗传因素的核心作用和疾病的病理本质： 25%的TAA为单基因遗传病：已发现30余种孟德尔基因与TAA相关，这些基因主要调控血管壁的三大核心结构——①血管平滑肌细胞（ACTA2、MYH11基因）：突变会导致平滑肌细胞凋亡、收缩功能丧失；②细胞外基质（FBN1、COL3A1基因）：与马凡综合征、血管型埃勒斯当洛斯综合征相关，突变会导致血管壁弹性纤维、胶原纤维降解，失去结构稳定性；③TGFβ信号通路（TGFBR1/2、SMAD3基因）：与洛伊斯迪茨综合征相关，突变会导致血管壁炎症激活、修复功能异常； 非综合征型遗传占比高：部分患者无明显的全身结缔组织病表现（如马凡综合征的肢体细长、晶状体脱位），仅表现为主动脉瘤，即“非综合征型遗传性TAA”，这类患者的家族成员患病风险极高，需强制筛查； 瘤体大小并非唯一危险指标：普通患者主动脉瘤直径≥5.0cm时破裂风险显著升高，但遗传性患者（如洛伊斯迪茨综合征）直径≥4.5cm即有极高破裂风险，证实基因背景决定了瘤体的危险阈值，基因检测因此成为高危人群的必备筛查手段。 4. 房颤：节律异常不仅致中风，更直接引发大脑认知衰退 房颤是最常见的持续性心律失常，约1/3的人一生中会患病，此前临床诊疗仅关注“预防血栓性中风”，而本次研究发现，房颤与大脑认知衰退、老年痴呆密切相关，且这种关联独立于中风风险： 大脑灌注不足是核心机制：房颤时心脏节律紊乱，心房收缩功能丧失，导致心脏向大脑的供血量显著减少，尤其是海马体、颞叶等负责记忆和思维的脑区；即使患者规范服用抗凝药预防血栓，长期的脑灌注不足仍会导致神经元损伤、脑萎缩； 炎症与微栓塞的叠加作用：房颤患者常存在全身低度炎症，炎症会损伤脑血管内皮的保护功能；同时，心房内形成的微小血栓（未引发明显中风）会堵塞脑血管微动脉，进一步加剧脑损伤； 关键临床证据：研究证实，通过消融或药物恢复窦性心律后，患者的脑灌注水平可显著改善，早期认知衰退（如记忆力下降、反应变慢）也可部分逆转，这也让房颤的“节律控制”取代传统的“率控制”，成为临床治疗的核心目标。 二、AI赋能全流程诊疗：从早筛到预后，实现精准化、微创化、安全化 人工智能（AI）是本次研究的核心技术抓手，结合CT、MRI、PET等先进影像技术和微创介入技术，彻底改变了传统心血管病诊疗的“经验化、有创化、粗放化”模式，实现了“早筛诊断手术预后”全流程的精准化；同时，一系列新型消融、介入器械的研发，让心血管手术的风险大幅降低、效率显著提升，成为诊疗革新的核心方向。 1. 早期筛查：AI+无创技术，揪出“隐匿的心血管风险” 心血管疾病的致命性核心在于“早期无症状、筛查不及时”，而AI+无创检测技术的结合，让“早发现、早干预”成为可能，且筛查手段更便捷、更精准，适合大规模人群推广。 （1）AI影像分析：给血管斑块“精准分期”，避免过度检查与漏诊 冠脉CT angiography（CCTA）+AI：AI能对冠脉CT影像进行自动分割、量化分析，不仅能识别早期动脉斑块，还能精准判断斑块的成分（钙化、非钙化、低衰减脂质核心）、纤维帽厚度、斑块负荷，甚至像给癌症分期一样给斑块“分级”，评估其破裂风险；同时，AI能结合血流储备分数（FFRCT），通过计算流体动力学判断血管狭窄是否具有临床意义，避免不必要的有创冠脉造影，减少患者痛苦和医疗成本； 3D血管超声+AI：针对外周动脉（颈动脉、股动脉、腹主动脉），AI赋能的3D血管超声能精准检测出无症状的亚临床斑块，且操作便捷、无辐射，适合中青年高危人群的大规模筛查； PET/MRI融合影像+AI：能同时检测血管斑块的炎症活性（18FFDG PET）和纤维化程度（MRILGE），精准识别“高风险易损斑块”，为早期干预提供明确依据，大幅降低心梗、中风的发生概率。 （2）无创居家监测：从“医院筛查”到“居家预警”，提前捕捉病情恶化信号 本次研究重点验证了多款无创居家监测设备的有效性，已进入临床后期或正式应用，核心包括： 语音分析+AI（HearO应用）：患者通过智能手机录制日常语音，AI分析语音的频率、振幅等特征，就能检测出肺淤血（心衰急性发作的核心前兆），原理是肺淤血会导致气道水肿，改变语音发声的共振；该技术已完成国际多中心临床试验（DETECTHF），结果预计2026年发布，其优势是无侵入性、操作便捷，适合心衰患者居家监测； 穿戴式多模态传感器（Sentinel CPM）：贴于胸部的轻便设备，能实时监测心率、呼吸模式、心脏声学、组织阻抗等指标，通过AI算法预警心衰、心律失常的发作；临床试验（CONGESTHF）证实，其能精准检测出心衰患者的淤血状态，指导居家调药； 远程介电阻抗传感器（ReDS）：利用迷你雷达技术，无创评估肺部液体积聚量，无需抽血或做影像检查；研究证实，其能帮助医生判断心衰患者的出院时机，指导居家康复，大幅降低30天急诊住院率。 2. 介入手术：AI导航+新型消融技术，让复杂手术更安全、更高效 心脏导管室是心血管介入治疗的核心阵地，西奈山团队在该领域的技术创新，让复杂病变（如血管分叉病变、房颤）的治疗不再依赖医生的“个人经验”，手术成功率大幅提升，并发症显著降低，微创化成为主流。 （1）AI驱动的病变评估与手术指导：为导管室装上“智能大脑” AIQCA系统（AngioQuant.AI）：能对血管造影视频进行实时自动量化分析，精准识别病变位置、狭窄程度、血管直径，为支架植入提供精准的尺寸、长度和位置建议，避免“经验性选择”导致的支架贴壁不良、边支闭塞等并发症； BifurcAID 3D系统：针对难度极高的冠状动脉分叉病变（支架植入后易出现边支闭塞、再狭窄，是临床治疗的难点），该系统结合AI病变评估，为手术提供分步指导（如主支支架植入时机、边支扩张方式），大幅降低边支闭塞的风险，提升手术成功率，目前已成为全球分叉病变手术的重要指导工具。 （2）脉冲场消融（PFA）：房颤治疗的“革命性技术”，取代传统热消融 房颤的传统消融技术为射频消融（热）和冷冻消融（冷），均为“热损伤”原理，易损伤食管、膈神经、肺静脉等周围正常组织，且手术时间长达26小时，患者恢复慢；而本次研究重点验证的脉冲场消融（PFA），彻底改变了房颤消融的临床格局： 核心原理：利用高能量、短时长（微秒/纳秒级）的电脉冲，使异常心肌细胞的细胞膜发生电穿孔，导致细胞凋亡，实现精准消融；而食管、神经、肺静脉等正常组织的细胞膜结构与心肌细胞不同，不会被电穿孔损伤，具有天然的组织特异性； 临床核心优势：① 安全性极高：17642例多中心临床数据证实，无一人发生食管损伤、肺静脉狭窄、膈神经麻痹等严重并发症，解决了传统消融的最大痛点；② 手术效率高：手术时间从26小时缩短至1小时内，医生学习曲线短，易推广；③ 消融效果持久：可对肺静脉进行多次“冗余消融”，提升肺静脉隔离的持久性，降低房颤复发率； 临床地位：目前已成为房颤消融的首选技术，尤其适用于阵发性房颤、持续性房颤，甚至合并心衰、瓣膜病的房颤患者，是本次研究中最具临床转化价值的技术突破之一。 3. 预后评估：AI+基因/转录组检测，实现“用药精准化”，避免无效用药 临床中常出现患者对降脂、抗心衰、抗血小板药物反应不一的情况（即“千人一方”的弊端），而本次研究证实，AI结合基因、外周血单核细胞转录组数据，能精准预测患者对药物的反应，实现“个性化用药”，让治疗“对症下药”，提升疗效并降低副作用。 降脂药疗效预测：西奈山团队的YELLOW II/III试验证实，通过分析患者外周血单核细胞的转录组数据，构建的18基因kTSP模型，能以高灵敏度和特异性，预测患者是否能通过他汀类/PCSK9抑制剂（evolocumab）增厚血管斑块的纤维帽（纤维帽是斑块的“保护壳”，增厚能显著降低破裂风险）；对于无应答者，可及时调整治疗方案（如加用抗炎药），避免无效用药； 抗血小板药物个体化：结合CYP2C19基因检测（该基因决定氯吡格雷的代谢效率，突变会导致药物失效）和AI风险评分，能精准评估患者的血栓/出血风险，为其制定个性化的抗血小板方案（如氯吡格雷、替格瑞洛的选择，以及“强化治疗+减量维持”的时长），避免“过度治疗导致出血”（如牙龈出血、胃出血）或“治疗不足导致血栓”； 心衰患者预后预测：AI结合患者的临床数据（年龄、心衰分级、左心室射血分数）、影像数据（心脏MRI的纤维化程度）、生物标志物（BNP、肌钙蛋白），能精准预测心衰患者的再住院率和死亡率，指导个体化的随访频率和治疗方案调整（如是否加用器械治疗）。 三、新型药物与临床研究突破：靶向“残留风险”，攻克传统治疗痛点 即使患者规范服用他汀类降脂药、降压药、抗凝药，仍有部分存在心血管事件的“残留风险”（如炎症、高甘油三酯、血栓形成、代谢异常），这是传统心血管病治疗的核心痛点。本次研究聚焦这些痛点，研发了多款新型药物和治疗策略，同时推动了临床试验的革新，让研究结果更具临床实用性和普适性。 1. 靶向“残留风险”的新型药物研发：从“控制指标”到“直击病根” （1）降脂领域：长效制剂解决“依从性难题”，实现长期精准降脂 PCSK9抑制剂（inclisiran）：采用小干扰RNA（siRNA）技术，通过皮下注射抑制肝脏PCSK9蛋白的生成，从而降低低密度脂蛋白（LDLC）；其核心优势是长效——每半年注射一次，就能持续将LDLC降至<55mg/dL，彻底解决了传统他汀类药物需每日服用、患者依从性差的问题；西奈山团队主导的VICTORION1/2 PREVENT试验证实，该药物能显著降低心梗、中风风险，尤其适用于他汀类药物不耐受、效果不佳或无法坚持服药的患者； 靶向脂蛋白(a) [Lp(a)]：Lp(a)是独立的心血管危险因素，与心梗、中风密切相关，且目前尚无有效降脂药物；本次研究提到，针对Lp(a)的siRNA药物已进入临床后期，能显著降低Lp(a)水平，为高Lp(a)人群提供全新治疗选择，填补了临床空白。 （2）抗炎领域：靶向炎症因子，降低“血脂正常后的心血管风险” 针对血脂控制良好但血管炎症仍存在的患者，炎症是导致斑块破裂、心血管事件的核心原因，本次研究重点验证了两款抗炎药的临床价值： 白细胞介素6（IL6）抑制剂（ziltivekimab）：IL6是血管炎症的核心因子，能激活巨噬细胞、促进斑块炎症；西奈山团队主导的ARTEMIS试验证实，该药物能显著降低心梗患者的血管炎症水平，进一步降低心血管事件发生率，尤其适用于血脂控制良好但炎症指标（如hsCRP）升高的患者； 低剂量秋水仙碱：秋水仙碱能抑制巨噬细胞的激活和炎症因子的释放，研究证实，其能降低稳定性冠心病、心梗患者的心血管事件风险，且价格低廉、易获取，适合基层医疗机构推广。 （3）高甘油三酯领域：兼顾降脂与代谢改善，实现“多靶点获益” 高甘油三酯是心血管疾病的重要危险因素，且常与非酒精性脂肪肝（NAFLD）、胰岛素抵抗并存，传统降脂药（如贝特类）仅能降低甘油三酯，无法改善代谢异常；本次研究研发的成纤维细胞生长因子21（FGF21）类似物（pegozafermin），实现了“一箭双雕”： 核心疗效：不仅能显著降低甘油三酯水平（降幅达50%以上），还能改善肝脏脂肪变性、降低糖化血红蛋白（HbA1c），为合并脂肪肝、糖尿病的心血管患者提供了全新治疗选择； 临床进展：目前已进入3期临床试验，有望在短期内获批上市，填补了“降脂+代谢改善”的临床空白。 （4）抗血栓领域：平衡“血栓预防”与“出血风险”，开发“自救式”药物 “先强化后减量”的抗血小板策略：西奈山团队参与的TWILIGHT试验证实，对于支架植入患者，先采用“替格瑞洛+阿司匹林”强化抗血小板治疗3个月，再减量为“替格瑞洛单药”治疗，能在有效预防血栓的同时，将出血风险降低40%，成为目前支架术后抗血小板治疗的标准方案； 自救式快速抗血栓药物（selatogrel）：一种速效ADP受体拮抗剂，皮下注射后能快速抑制血小板聚集，阻止血栓形成；其核心优势是患者可自行使用——疑似心梗时，无需等待救护车，自行皮下注射即可提前干预，阻止病情恶化；目前正在开展SOSAMI临床试验，有望成为心梗患者的“院前自救神器”。 2. 临床试验的革新：从“小众化”到“全民化”，从“硬指标”到“患者导向” 过去的心血管临床试验多以白人男性为主，导致女性、少数族裔、老年患者、农村和低收入人群的诊疗数据缺失，研究结果难以适用于这些群体；同时，临床试验仅关注“死亡率、心梗率”等硬指标，忽视了患者的生活质量。本次研究推动了临床试验的全方位革新，让研究结果更具临床实用性和普适性。 （1）包容性入组：填补弱势群体的诊疗数据空白 RECHARGE试验：专门纳入女性、黑人和西班牙裔患者，研究冠状动脉旁路移植术（CABG）与经皮冠状动脉介入治疗（PCI）对其预后和生活质量的影响，填补了弱势群体血运重建方式选择的诊疗数据空白； 纳入老年和合并症患者：不再将80岁以上老年患者、合并糖尿病/肾病/心衰的患者排除在外，让研究结果更适用于临床真实人群，避免“临床试验有效，临床应用无效”的问题。 （2）试验设计创新：缩短研发周期，让新药/新疗法更快落地 平台试验：能同时评估多种疗法对同一疾病的效果，共享对照组，大幅缩短试验周期，降低研发成本；例如，针对心衰的平台试验，可同时评估多种新型抗心衰药物的有效性，比传统单药试验效率提升35倍； 适应性试验设计：能根据试验中期结果，实时调整样本量、治疗方案，避免无效治疗的继续，提升试验效率；例如，若中期结果显示某药物疗效显著，可提前终止试验并推进上市；若某药物无效，可及时剔除，减少患者暴露于无效治疗的风险； 真实世界证据（RWE）研究：将临床试验嵌入大型心血管登记数据库，利用真实世界的患者数据开展研究，结果更贴近临床实际，无需严格的试验入组/排除标准，且能快速验证新药/新疗法的长期疗效。 （3）评估指标革新：关注“患者生活质量”，实现“疗效与生活质量双提升” 现代心血管临床试验不再仅关注“死亡率、心梗率”等硬指标，还将患者生活质量、功能状态、认知水平、心理健康纳入评估，更符合临床实际需求： 房颤治疗：评估患者的心悸症状、运动耐量、睡眠质量； 心衰治疗：评估患者的NYHA分级、6分钟步行距离、日常生活能力； 血运重建治疗：评估患者的胸痛缓解情况、生活自理能力、心理健康评分。 四、全生命周期预防体系：从小孩到老人，心脑同护，防患于未然 心血管疾病的防治早已不再局限于“患病后治疗”，而是前移至全生命周期，本次研究构建了从儿童健康习惯培养（原始预防），到中青年亚临床病变筛查（一级预防），再到老年心脏大脑联合保护（二级预防）的完整预防体系，真正实现“防患于未然”；同时，强调“家族高危人群精准筛查”，让预防更具针对性。 1. 儿童期：原始预防，小学是培养心脏健康习惯的关键窗口期 原始预防是指“在危险因素出现前进行预防”，心血管疾病的危险因素（肥胖、高血压、高血脂、缺乏运动）多始于儿童期，因此儿童期的预防是终身心脏健康的基础。 核心项目：SHE基金会项目：西奈山联合哥伦比亚、西班牙、美国的学校开展的SHE（科学、健康与教育）项目，将心脏健康教育融入小学教育，通过“学校+家庭”联动，培养儿童的情绪管理能力、合理饮食和规律运动习惯；研究证实，该项目能显著降低儿童的肥胖率、血压水平和血脂水平，让孩子从小建立健康的生活方式，为终身心脏健康打基础； 关键窗口期：研究明确，小学阶段是儿童形成生活习惯的关键时期，此时的健康教育能产生长期效果；而学前儿童缺乏自主能力，中学儿童已形成不良习惯，难以纠正，因此小学是心脏健康教育的最佳窗口期。 2. 中青年期：一级预防，早筛亚临床动脉粥样硬化，提前干预阻止病变进展 中青年是心血管疾病“亚临床病变”的高发期（斑块形成但无症状），此时的早筛和干预，能有效阻止斑块进展，降低未来心梗、中风的风险，是心血管疾病预防的核心阶段。 核心筛查手段：无创3D血管超声（颈动脉、股动脉）、冠脉CT（CCTA），能精准检测出亚临床动脉粥样硬化斑块，且操作便捷、无辐射，适合3050岁高危人群（如高血压、糖尿病、肥胖、家族史、吸烟）定期筛查； 核心临床试验：PRECAD试验：西奈山团队主导的PRECAD试验证实，将3050岁心血管低风险人群的LDLC控制在<55mg/dL以下，结合严格的血压（<130/80mmHg）、血糖控制，能显著预防斑块形成或阻止其进展，大幅降低未来心血管事件的风险； 核心生活方式干预：西奈山团队的PESA研究（对4184名4055岁无症状人群进行20年随访）证实，吸烟、饮酒、缺乏运动、高盐高脂饮食是斑块进展的核心诱因，而戒烟、限酒、每周≥150分钟中等强度运动、低盐低脂饮食，能显著延缓斑块进展，甚至实现斑块逆转。 3. 老年期：二级预防，心脏健康与大脑健康联动，防治认知衰退 老年患者是心血管疾病的高发人群，且常合并认知衰退、老年痴呆，本次研究证实，心血管疾病与认知衰退密切相关，因此老年期的预防需实现“心脑同护”，这是本次预防体系的重要创新点。 心脑联动的核心机制：颈动脉斑块、高血压、房颤、心衰等心血管问题，会导致大脑供血不足、脑血管微栓塞、脑微血管病变，进而加速神经元损伤、脑萎缩，引发认知衰退和老年痴呆；研究发现，颈动脉斑块厚度每增加0.1mm，老年痴呆的风险就提升15%； 核心预防策略：① 严格控制心血管危险因素（血压、血脂、血糖、房颤），优先选择能保护脑血管的药物（如沙坦类降压药、他汀类降脂药）；② 定期进行认知功能评估（如MMSE、MoCA量表），早期发现认知衰退；③ 利用PET/MRI影像检测大脑代谢和结构变化，提前干预；④ 鼓励老年患者进行适度的认知训练（如读书、下棋）和身体运动（如散步、太极拳），延缓认知衰退。 4. 家族性高危人群：精准筛查，基于基因检测制定个性化预防方案 对于有心血管疾病家族史的人群（如遗传性主动脉瘤、心肌病、房颤），基因检测是精准预防的核心手段，本次研究明确了各类家族性疾病的筛查策略： 遗传性主动脉瘤：家族中有主动脉瘤/夹层患者的，建议进行基因检测，明确突变类型；对于突变携带者，从青少年期开始定期进行主动脉CT/MRI筛查，且根据基因类型制定个性化的筛查频率（如每6个月/1年）和手术阈值（如洛伊斯迪茨综合征4.5cm、马凡综合征5.0cm）； 遗传性心肌病：如肥厚型心肌病（HCM）、致心律失常性右室心肌病（ARVC），家族成员建议进行基因检测和心脏超声/心电图筛查，早期发现无症状患者，及时干预（如避免剧烈运动、植入ICD预防猝死）； 家族性房颤：有房颤家族史的人群，建议从40岁开始定期进行心电图/动态心电图筛查，同时控制血压、血脂，避免饮酒、熬夜，降低房颤发病风险。 五、难治性疾病前沿探索：基因技术+新型器械，为“无药可治”患者带来新希望 针对肺动脉高压、晚期心衰、遗传性心血管疾病等难治性心血管疾病（传统治疗效果差、死亡率高），本次研究利用基因编辑、人类诱导多能干细胞（hiPSC）、3D类器官、新型介入器械等前沿技术，开展了颠覆性研究，为这些“无药可治”的患者找到新的治疗方向，是本次研究的前沿亮点。 1. 肺动脉高压（PAH）：hiPSC+3D血管类器官，还原疾病真相，助力靶向药研发 肺动脉高压是一种进展迅速、死亡率极高的难治性疾病，传统的二维细胞模型难以还原其复杂的病变过程，而人类诱导多能干细胞（hiPSC）+3D血管类器官技术，为研发靶向药物提供了全新的模型，解决了“临床研究无合适模型”的核心痛点。 核心技术流程：利用CRISPR基因编辑技术，将肺动脉高压患者的体细胞（如皮肤细胞）转化为hiPSC，再将hiPSC分化为血管平滑肌细胞、内皮细胞，进而培育成3D血管类器官；该类器官能精准还原肺动脉高压患者的血管壁病变（如血管平滑肌细胞异常增殖、内皮细胞功能障碍、血管壁纤维化），以及细胞间的相互作用，比传统二维模型更贴近人体实际； 研究成果：利用该模型，西奈山团队已发现多个潜在的治疗靶点（如ALK1信号通路、PDGF信号通路），并正在研发针对性的靶向药物；同时，该模型可用于高通量药物筛选，大幅缩短新药研发周期，让靶向药更快落地临床。 2. 遗传性心血管疾病：基因编辑带来“治愈性治疗”希望 对于单基因遗传性心血管疾病（如遗传性主动脉瘤、肥厚型心肌病、长QT综合征），基因编辑技术（CRISPRCas9）为“治愈性治疗”提供了可能，本次研究在动物模型中取得了突破性进展： 动物模型验证成果：① 在遗传性主动脉瘤的小鼠模型中，利用CRISPRCas9修复TGFBR2基因突变，能显著改善血管壁结构，阻止主动脉瘤的形成和进展；② 在长QT综合征的小鼠模型中，修复KCNQ1基因突变，能恢复心肌细胞的钾离子通道功能，纠正心律失常，预防猝死； 临床转化方向：目前基因编辑技术仍处于动物模型阶段，未来的临床转化将聚焦于体内局部基因编辑（如通过导管将基因编辑工具递送至主动脉壁、心肌），避免全身基因编辑的副作用，提高治疗的安全性和精准性。 3. 晚期心衰：新型微创器械，逆转心脏重构，替代部分心脏移植 晚期心衰患者的心脏会发生不可逆的重构（左心室扩大、心肌收缩功能下降），传统药物治疗仅能缓解症状，严重的患者只能依靠心脏移植，但心脏供体严重短缺；本次研究研发的新型微创器械，为晚期心衰患者提供了全新的治疗选择，能逆转部分心脏重构，替代部分心脏移植。 AccuCinch装置：通过微创手术，将一个环状装置植入左心室，缩小左心室的直径，降低心脏壁的张力，逆转心脏重构；西奈山团队主导的CORCINCHHF试验证实，该装置结合指南指导的药物治疗，能显著改善心衰患者的左心室射血分数、运动耐量和生活质量，降低再住院率，尤其适用于无法进行心脏移植的患者； Aortix微轴流泵：一种导管式的主动脉内引流泵，通过血管插入主动脉，能降低心脏的前负荷和后负荷，改善心脏功能，同时增加肾脏灌注，改善肾功能；西奈山团队的DRAINHF试验证实，其能显著增加急性心衰合并肾损伤患者的液体清除，降低心衰恶化风险，是急性晚期心衰的重要急救器械。 4. 肺动脉去神经术（PADN）：为合并肺动脉高压的心衰患者带来新希望 肺动脉高压是心衰患者的常见并发症，会显著增加死亡率，传统药物治疗效果差，而肺动脉去神经术（PADN）是一种微创的介入治疗手段，为这类患者提供了全新选择： 核心原理：通过导管消融肺动脉的交感神经，抑制交感神经的过度激活，降低肺血管阻力，改善右心室功能（心衰合并肺动脉高压的核心问题是右心室衰竭）； 临床证据：西奈山团队参与的多中心临床试验证实，接受PADN治疗的心衰合并肺动脉高压患者，运动能力（6分钟步行距离）显著提升，肺血管阻力显著降低，临床恶化风险降低50%，且手术安全性高，无严重并发症，目前已成为临床二线治疗方案。 六、研究总结与未来展望：精准化、整合化、全周期化，心血管病将成可防、可治、可逆转的疾病 西奈山伊坎医学院的《心脏医学研究前沿》特刊，不仅系统展示了当下心血管领域的最新研究成果，更勾勒出未来心血管疾病防治的核心方向——精准化、整合化、全周期化，这三大方向将成为未来数十年心血管病研究和临床实践的核心指导原则。 1. 精准化：从“人群治疗”到“个体治疗” 以基因检测、AI、影像组学为核心，实现从“千人一方”到“一人一方”的转变，让筛查、诊断、治疗、预后的每一个环节都精准适配患者的基因背景、疾病特征和身体状况：例如，根据基因类型制定主动脉瘤的手术阈值，根据转录组数据选择降脂药，根据AI风险评分制定抗血小板方案。 2. 整合化：从“单器官诊疗”到“跨系统整合诊疗” 打破心脏、代谢、免疫、神经、大脑的诊疗边界，实现跨系统整合诊疗；同时，推动心脏病学家、免疫学家、神经科学家、数据科学家、工程师的跨学科合作，催生新的技术、药物和治疗策略：例如，针对动脉粥样硬化，联合降脂、抗炎、调节神经的药物进行综合治疗；针对房颤，结合节律控制和大脑保护进行干预。 3. 全周期化：从“患病后治疗”到“全生命周期预防” 构建从儿童期原始预防，到中青年期一级预防，再到老年期二级预防的完整预防体系，将心血管疾病的防治前移至“危险因素出现前”，真正实现“防患于未然”；同时，强调“心脑同护”“家族精准筛查”，让预防更具针对性和有效性。 4. 普通人的核心启示 对于普通人群而言，本次研究的核心启示在于：心血管疾病的防治，科技是支撑，生活方式是基础。无论技术多先进，从小养成健康的生活习惯（合理饮食、规律运动、戒烟限酒、规律作息），中青年定期进行心血管筛查，老年期兼顾心脏和大脑健康，有家族病史的早做基因检测，才是守护心脏健康的核心秘诀。 随着AI、基因编辑、类器官、新型器械等技术的进一步发展和临床转化，心血管疾病将从“全球头号死因”逐步成为可防、可治、可逆转的疾病；而这场由科学和技术驱动的革命，将为数亿心血管疾病患者带来更长久、更健康的生命。 链接：https://www.science.org/cms/asset/3146ebfc-b92e-44d3-8a56-403d9246f4be/icahn_booklet_2025_06_19.pdf 扫码关注公众号 · 获取更多学习笔记 Scan the code to follow the official account · Get more study notes 本公众号推送文章仅用于学术交流，【原创】代表原创编译，水平有限，不代表本平台对文本主张版权，如有侵权，请联系后台修改或删除。文献解读如有疏漏之处，我们深表歉意，请及时联系我们, 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Full Year 2025 Total Revenue Increased 38% YOY to Record $1.397 billion Full Year 2025 Royalty Revenue Increased 52% YOY to Record $868 million Completed Acquisitions of Elektrofi's Hypercon™ Technology and Surf Bio's Hyperconcentration Technology Reiterating 2026 Financial Guidance Ranges: Total Revenue of $1.710 - $1.810 billion, YOY Growth of 22% - 30% Adjusted EBITDA of $1.125 - $1.205 billion, YOY Growth of 71% - 83%1 Non-GAAP Diluted EPS of $7.75 - $8.25, YOY Growth of 87% - 99%1 SAN DIEGO, Feb. 17, 2026 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme" or the "Company") today reported its financial and operating results for the full year and fourth quarter ended December 31, 2025, and provided an update on its recent corporate activities. "2025 was a pivotal year for Halozyme as we delivered record total revenue of $1.4 billion, which was the result of continued growth in our ENHANZE business. In addition, we expanded our drug delivery technology portfolio with two acquisitions. Three ENHANZE‑enabled blockbusters, DARZALEX SC, Phesgo and VYVGART Hytrulo, drove royalty revenue growth of 52%, reaching a record $868 million in 2025. In the year, we also expanded our ENHANZE opportunities, adding three new collaboration and licensing agreements with Takeda, Merus and Skye Bioscience and gained one new target nomination from Roche. Furthermore, Janssen expanded the global reach of ENHANZE with approvals in the U.S., China and Japan for Rybrevant SC and new indication approvals in front line settings for DARZALEX Faspro. In parallel, we broadened our drug delivery portfolio with the acquisitions of the Hypercon technology and Surf Bio's hyperconcentration technology, which meaningfully expand, diversify and extend our long‑term royalty opportunity into the mid-2040s," said Dr. Helen Torley, President and Chief Executive Officer. Dr. Torley continued, "As we look ahead, our long-term outlook reflects the strong momentum and opportunity we have built through a broader drug delivery portfolio and offering to the biopharma industry. With royalty revenue projected to exceed $1 billion in 2026 and a clear line of sight to more than $2 billion in total revenue by 2028, Halozyme is entering its next phase of growth with strong conviction. Our projected 22% to 30% total revenue growth in 2026, combined with an expanding development pipeline with six projected new ENHANZE and two Hypercon development program starts, plus plans to sign three or more ENHANZE and Hypercon partnerships in 2026, all reinforce the durability of our revenue. With our strong cash generation and a diversified set of high‑value royalty drivers, we remain focused on delivering sustained long‑term value for shareholders." Fourth Quarter and Recent Corporate Highlights: In December 2025, Halozyme completed the acquisition of Surf Bio, Inc. ("Surf Bio"), subsequently renamed Halozyme Surf Bio, Inc., resulting in an expansion of Halozyme's drug delivery technology portfolio and the potential for future growth through new collaboration agreements. In December 2025, Halozyme announced that a German court had granted Halozyme's request for a preliminary injunction ordering Merck Sharp & Dohme Corp. ("Merck") to refrain from distributing and offering Keytruda® SC in Germany. In November 2025, Halozyme completed the acquisition of Elektrofi Inc. ("Elektrofi"), subsequently renamed Halozyme Hypercon, Inc., resulting in an expansion of Halozyme's drug delivery technology portfolio and the potential for future growth through new collaboration agreements. In November 2025, Halozyme completed the sale of $750.0 million aggregate principal amount of the 2031 Convertible Notes and $750.0 million aggregate principal amount of the 2032 Convertible Notes. The Company used a portion of the net proceeds to fund the cost of entering into the 2031 Capped Call Transactions and the 2032 Capped Call Transactions. The Company also used a portion of the net proceeds to enter into privately negotiated agreements with certain holders of its outstanding 2027 Convertible Notes and 2028 Convertible Notes to repurchase their 2027 Convertible Notes and 2028 Convertible Notes for cash through privately negotiated transactions entered into concurrently with or shortly after the offering. In November 2025, Halozyme entered into an amendment to the Company's credit agreement that, among other things extended the maturity date and increased the borrowing capacity of the Company's existing revolving credit facility from $575.0 million to $750.0 million. Fourth Quarter and Recent Partner Highlights: In January 2026, Janssen announced the U.S. Food and Drug Administration ("FDA") approved DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone ("D-VRd") for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. In December 2025, Halozyme and Skye Bioscience entered into a non-exclusive global collaboration and license agreement that provides Skye Bioscience access to ENHANZE® for the development and potential commercialization of an SC formulation of nimacimab for the treatment of obesity. In December 2025, Halozyme and Takeda entered into a new global collaboration and exclusive license agreement which provides Takeda with access to ENHANZE® for use with vedolizumab, marketed globally as ENTYVIO®, for the treatment of adults with moderately to severely active Crohns' disease or ulcerative colitis, which are the two main forms of inflammatory bowel disease. In December 2025, Roche nominated a new undisclosed non-exclusive target to be studied using ENHANZE®. In the fourth quarter of 2025, the ongoing argenx ARGX-121 Phase 1 program was expanded to include an SC-arm evaluating ARGX-121 with ENHANZE® in healthy adults. In December 2025, Janssen announced the FDA approved RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) for the treatment of patients with epidermal growth factor receptor ("EGFR")-mutated locally advanced or metastatic non-small cell lung cancer ("NSCLC"). In December 2025, Janssen received approval from the National Medical Products Administration in China for RYBREVANT™ FASPRO for the first-line treatment of adult patients with advanced NSCLC. In December 2025, Janssen received approval from the Ministry of Health, Labour and Welfare in Japan for RYBROFAZ® (amivantamab) with ENHANZE® for the first-line treatment of adult patients with advanced NSCLC. In December 2025, Halozyme entered into a commercial license and supply agreement with Viatris under which Halozyme licenses and supplies an auto-injector product for self-administered SC selatogrel for the treatment of acute myocardial infarction in adult patients. In November 2025, Janssen announced the FDA approved DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) co-formulated with ENHANZE®, as single treatment of adult patients with high-risk smoldering multiple myeloma. In November 2025, Halozyme and Merus entered into a non-exclusive global collaboration and license agreement that provides Merus access to ENHANZE® technology for a single target. Merus intends to explore development and potential commercialization of SC administration of petosemtamab, an EGFR and leucine-rich repeat-containing G-protein coupled receptor 5 bispecific antibody, for the treatment of head and neck cancer. Full Year and Fourth Quarter 2025 Financial Highlights: Total revenue for the full year was $1,396.6 million, compared to $1,015.3 million in 2024. The 38% year-over-year increase was primarily driven by royalty revenue growth and an increase in product sales. Revenue included $867.8 million in royalties, an increase of 52% compared to $571.0 million in 2024, primarily driven by continued sales uptake of ENHANZE® partner products that have launched since 2020, predominantly by VYVGART® Hytrulo by argenx, DARZALEX® SC by Janssen and Phesgo® by Roche in all geographies. Cost of sales for the full year was $228.8 million, compared to $159.4 million in 2024. The increase in cost of sales was primarily due to an increase in product sales and labor allocation initiatives. Amortization of intangibles expense for the full year was $76.7 million, compared to $71.0 million in 2024. The increase in amortization of intangibles expense was due to the acquisition of Elektrofi in November 2025. Research and development expense for the full year was $81.5 million, compared to $79.0 million in 2024. The increase was primarily due to the acquisition of Elektrofi and Surf Bio, partially offset by lower compensation expense driven by resource optimization, labor allocation initiatives, and timing of planned investments in ENHANZE® related to the development of our new high-yield rHuPH20 manufacturing process. Selling, general and administrative expense for the full year was $207.1 million, compared to $154.3 million in 2024. The increase was primarily due to an increase in consulting and professional service fees, including litigation costs incurred in connection with a patent infringement litigation case, diligence and transaction-related costs incurred in support of the acquisition of Elektrofi and Surf Bio, and an increase in compensation expense. Net income for the full year was $316.9 million, compared to $444.1 million in 2024. Net Income included acquired in-process research and development ("IPR&D") expense of $284.9 million related to the Surf Bio acquisition in the fourth quarter of 2025. Adjusted EBITDA for the full year was $657.6 million, compared to $632.2 million in 2024.1,2 Adjusted EBITDA included acquired IPR&D expense of $284.9 million related to the Surf Bio acquisition in the fourth quarter of 2025. GAAP diluted earnings per share for the full year was $2.56, compared to $3.43 in 2024. Non-GAAP diluted earnings per share was $4.15, compared to $4.23 in 2024.1,2 GAAP and non-GAAP diluted earnings per share included an unfavorable impact of approximately $2.30 per share related to acquired IPR&D expense for the Surf Bio acquisition in the fourth quarter of 2025. Total revenue in the fourth quarter was $451.8 million, compared to $298.0 million in the fourth quarter of 2024. The 52% year-over-year increase was primarily driven by royalty revenue growth and an increase in product sales. Revenue included $258.0 million in royalties, an increase of 51% compared to $170.4 million in the fourth quarter of 2024, primarily driven by continued sales uptake of ENHANZE® partner products that have launched since 2020, predominantly by VYVGART® Hytrulo by argenx, DARZALEX® SC by Janssen and Phesgo® by Roche in all geographies. Net loss in the fourth quarter was $141.6 million, compared to net income of $137.0 million in the fourth quarter of 2024. Net loss included acquired IPR&D expense of $284.9 million related to the Surf Bio acquisition in the fourth quarter of 2025. Adjusted EBITDA in the fourth quarter was $21.9 million, compared to $195.8 million in the fourth quarter of 2024.1,2 Adjusted EBITDA included acquired IPR&D expense of $284.9 million related to the Surf Bio acquisition in the fourth quarter of 2025. GAAP diluted loss per share in the fourth quarter was $1.20, compared to GAAP diluted earnings per share $1.06 in the fourth quarter of 2024. Non-GAAP diluted loss per share was $0.24 compared to Non-GAAP diluted earnings per share of $1.26 in the fourth quarter of 2024.1,2 GAAP and non-GAAP diluted loss per share in the fourth quarter of 2025 included an unfavorable impact of $2.42 per share related to acquired IPR&D expense for the Surf Bio acquisition in the fourth quarter of 2025. Cash, cash equivalents, restricted cash and marketable securities were $145.4 million on December 31, 2025, compared to $596.1 million on December 31, 2024. The decrease was primarily driven by cash used for the Elektrofi and Surf Bio acquisitions and share repurchases, partially offset by the net proceeds from issuance of convertible notes and cash generated from operations. Financial Outlook for 2026 The Company is reiterating its 2026 financial guidance ranges, which were last updated on January 28, 2026. For the full year 2026, the Company expects: Total revenue of $1.710 billion to $1.810 billion, representing growth of 22% to 30% over 2025 total revenue, primarily driven by increases in royalty revenue and product sales from API. Revenue from royalties of $1.130 billion to $1.170 billion, representing growth of 30% to 35% over 2025. Adjusted EBITDA of $1.125 billion to $1.205 billion, representing growth of 71% to 83% over 2025, including new Hypercon™ and Surf Bio investment of approximately $60 million. Non-GAAP diluted earnings per share of $7.75 to $8.25, representing growth of 87% to 99% over 2025. The Company's earnings per share guidance includes new Hypercon™ and Surf Bio investment of approximately $60 million and does not consider the impact of potential future share repurchases. Table 1. 2026 Financial Guidance Webcast and Conference Call Halozyme will host its Quarterly Update Conference Call for the fourth quarter and full year ended December 31, 2025 today, Tuesday, February 17, 2026, at 1:30 p.m. PT/4:30 p.m. ET. The conference call may be accessed live with pre-registration via link: . The call will also be webcast live through the "Investors" section of Halozyme's corporate website and a recording will be made available following the close of the call. To access the webcast and additional documents related to the call, please visit Halozyme.com. About Halozyme Halozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. As the innovators of ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution facilitates the subcutaneous delivery of injected drugs and fluids, reducing treatment burden and improving convenience. ENHANZE® has touched more than one million patient lives through ten commercialized products across over 100 global markets and is licensed to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical, Acumen Pharmaceuticals, Merus N.V. and Skye Bioscience. Halozyme expanded its drug delivery technology portfolio to develop partner products using Hypercon™ and the Surf Bio hyperconcentration technology. Hypercon™ is an innovative microparticle technology expected to set a new standard in hyperconcentration of drugs and biologics by reducing injection volume for the same dosage and enabling administration in at‑home and healthcare‑provider settings. The development of the Surf Bio polymer‑based hyperconcentration technology further broadens the range of biologics that can be delivered subcutaneously, meaningfully expanding the scope of opportunities across therapeutic modalities. The Hypercon™ technology has been licensed to leading biopharmaceutical partners, including Janssen, Eli Lilly and argenx. Halozyme also develops, manufactures and commercializes drug-device combination products using advanced auto-injector technologies designed to improve convenience, reliability and tolerability, enhancing patient comfort and adherence. The Company has two proprietary commercial products, Hylenex® and XYOSTED®, partnered commercial products and ongoing development programs with Teva Pharmaceuticals and McDermott Laboratories Limited, an affiliate of Viatris Inc. Halozyme is headquartered in San Diego, CA, with offices in Ewing, NJ; Minnetonka, MN; and Boston, MA. Minnetonka is also the site of its operations facility. For more information, visit and connect with us on LinkedIn. Note Regarding Use of Non-GAAP Financial Measures In addition to disclosing financial measures prepared in accordance with U.S. generally accepted accounting principles ("GAAP"), this press release and the accompanying tables contain certain Non-GAAP financial measures. The Company reports earnings before interest, taxes, depreciation, and amortization ("EBITDA"), adjusted EBITDA, Non-GAAP diluted earnings per share, Non-GAAP diluted shares, and guidance with respect to those measures, in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The Company calculates Non-GAAP diluted earnings per share excluding share-based compensation expense, amortization of debt discounts, intangible asset amortization, one-time items, if any, such as changes in contingent liabilities, inventory adjustments, impairment charges, transaction costs for business combinations, severance and share-based compensation acceleration expenses, intellectual property litigation costs, inducement expenses related to convertible notes, and certain adjustments to income tax expense. The Company calculates Non-GAAP diluted shares excluding the dilutive impact of convertible notes which is used in calculating Non-GAAP diluted earnings. The Company calculates EBITDA excluding interest, taxes, depreciation and amortization. The Company calculates adjusted EBITDA excluding one-time items, if any, such as changes in contingent liabilities, inventory adjustments, impairment charges, transaction costs for business combinations, severance and share-based compensation acceleration expenses and intellectual property litigation costs. Reconciliations between GAAP and Non-GAAP financial measures are included at the end of this press release. The Company does not provide reconciliations of forward-looking adjusted measures to GAAP due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation, including adjustments that could be made for changes in share-based compensation expense and the effects of any discrete income tax items. For the same reasons, the Company is unable to address the probable significance of the unavailable information. The Company provides Non-GAAP financial measures that it believes will be achieved; however, it cannot accurately predict all of the components of the adjusted calculations and the GAAP measures may be materially different than the Non-GAAP measures. The Company evaluates other items of income and expense on an individual basis for potential inclusion in the calculation of Non-GAAP financial measures and considers both the quantitative and qualitative aspects of the item, including (i) its size and nature, (ii) whether or not it relates to the Company's ongoing business operations and (iii) whether or not the Company expects it to occur as part of the Company's normal business on a regular basis. Non-GAAP financial measures do not have any standardized meaning and are therefore unlikely to be comparable to similarly titled measures presented by other companies. These Non-GAAP financial measures are not meant to be considered in isolation and should be read in conjunction with the Company's consolidated financial statements prepared in accordance with GAAP, and are not prepared under any comprehensive set of accounting rules or principles. In addition, from time to time in the future there may be other items that the Company may exclude for purposes of its Non-GAAP financial measures, and the Company may in the future cease to exclude items that it has historically excluded for purposes of its Non-GAAP financial measures. The Company considers these Non-GAAP financial measures to be important because they provide useful measures of the operating performance of the Company, exclusive of factors that do not directly affect what the Company considers to be its core operating performance, as well as unusual events. The Non-GAAP measures also allow investors and analysts to make additional comparisons of the operating activities of the Company's core business over time and with respect to other companies, as well as assessing trends and future expectations. The Company uses Non-GAAP financial information in assessing what it believes is a meaningful and comparable set of financial performance measures to evaluate operating trends, as well as in establishing portions of our performance-based incentive compensation programs. Safe Harbor Statement In addition to historical information, the statements set forth in this press release include forward-looking statements including, without limitation, statements concerning the Company's financial performance (including the Company's expected financial outlook for 2026) and expectations for future growth, profitability, revenue durability, total revenue, royalty revenue, royalty revenue duration, EBITDA, Adjusted EBITDA, and non-GAAP diluted earnings-per-share, and shareholder value. Forward-looking statements also include future plans, objectives, expectations and intentions related to the acquisitions of Elektrofi and Surf Bio, such acquisitions' expected impact and contributions to the Company's and combined group's operations and financial results (including potential development and commercialization of partnered products and timing related to these events), as well as the expected benefits of the acquisitions. Forward-looking statements related to Elektrofi's and Surf Bio's intellectual property include expectations for length of patent terms and patent expirations and the expected impact such patents may have on the duration, durability and amounts of future royalty payments the Company may receive from licensing such intellectual property. Forward-looking statements regarding the Company's ENHANZE® drug delivery technology may include the possible benefits and attributes of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs and facilitating more rapid delivery and administration of higher volumes of injectable medications through subcutaneous delivery. Forward-looking statements regarding the Company's business may include potential growth and receipt of royalty and milestone payments driven by our partners' development and commercialization efforts, potential new clinical trial study starts and advancement of partnered development programs, regulatory submissions and product launches, the size and growth prospects of our partners' drug franchises, potential new or expanded collaborations and collaborative targets, and potential approvals of new partnered or proprietary products, and the potential timing of these events. These forward-looking statements are typically, but not always, identified through use of the words "expect," "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "preliminary," "possible," "should," "continue," and other words of similar meaning and involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Actual results could differ materially from the expectations contained in these forward-looking statements as a result of several factors, including uncertainties concerning future matters such as market conditions, changes in domestic and foreign business, changes in the competitive environment in which the Company operates, the expected benefits of its acquisitions of Elektrofi and Surf Bio, unexpected early expiration or termination of the patent terms for the Company's drug delivery technologies, unexpected levels of revenues, expenditures and costs, unexpected results or delays in the growth of the Company's business, or in the development, regulatory review or commercialization of the Company's partnered or proprietary products, regulatory approval requirements, unexpected adverse events or patient outcomes and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company's most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, including under the headings "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations". Except as required by law, the Company undertakes no duty to update forward-looking statements to reflect events after the date of this release. Contacts: Tram Bui VP, Investor Relations and Corporate Communications 609-333-7668 [email protected] Sydney Charlton Teneo 917-972-8407 [email protected] SOURCE Halozyme Therapeutics, Inc. 21% more press release views with Request a Demo