Nintedanib esylate

引言：从 “烟雾病” 到 “烟雾病理”     在呼吸科门诊工作了三十多年，我常常会问患者一个问题：“您知道烟草病学是什么吗？” 大部分人的回应都是摇头。他们熟悉慢阻肺、肺癌、间质性肺病这些疾病，却很难把它们和小小的香烟联系起来。这其实值得我们医生反思 —— 当疾病的治疗被划分成各个专科领域，那些疾病共同的根源往往就被我们忽视了。     烟草病学，简单来说，就是专门研究烟草使用对人体健康造成的危害，以及探讨相关防治策略的交叉学科。在 2025 年，中国和国际呼吸领域发布了许多重要的指南与共识，从肺癌筛查到慢阻肺管理，从戒烟干预到免疫治疗等各个方面，都体现出一个清晰的学术方向：回归疾病的根源，进行整体防控。     接下来，我将从临床一线的角度出发，对 2025 年度烟草病学的相关进展进行系统梳理和深度解读。希望能给同行们提供一些参考，也为患者朋友们点亮一盏认知的明灯，让大家更清楚地了解这一领域的知识。 一、流行病学新图景：烟草烟雾下的 “三驾马车” 1.1 肺癌：中国女性的沉默危机     肺癌一直是全球和中国死亡率最高的恶性肿瘤。《中华医学会肺癌临床诊疗指南（2025 版）》的最新数据表明，中国肺癌的发病在性别和地域上有明显差异。特别值得注意的是，中国女性肺癌患者中，不吸烟的比例比西方国家高很多。这说明除了烟草本身，像二手烟、室内空气污染、基因易感性等因素，在中国人群患肺癌的过程中也起着重要作用。     但这绝不意味着我们可以小看烟草的危害。研究已经明确显示，吸烟的人患肺癌的风险是不吸烟的人的 10 - 25 倍，而且吸烟的量越大、时间越长，患肺癌的风险就越高。在我的临床工作中，就见过很多 50 - 60 岁的男性患者，他们吸烟史大多超过 30 包年，等确诊肺癌的时候，往往已经到了局部晚期或者发生了远处转移。 1.2 慢阻肺：被低估的 “隐形杀手”     《国家基层慢性阻塞性肺疾病防治及管理实施指南（2025）》指出，中国 40 岁及以上人群中，慢阻肺的患病率高达 13.7%，患者总数差不多有 1 亿人。这个数字真的很惊人，相当于每 10 个中老年人里，就有 1 - 2 个人患有慢阻肺，然而，知道自己患病并且接受规范治疗的人还不到 10%。     烟草暴露是导致慢阻肺的首要危险因素。大约 80 - 90% 的慢阻肺死亡都和吸烟有关。2025 年 GOLD 报告特别强调了 “早发现、早干预” 的重要性，建议对于有吸烟史、职业暴露史或者家族史的高危人群，要定期进行肺功能筛查。 1.3 间质性肺疾病：烟草相关纤维化的新认知     间质性肺疾病（ILD）是一类比较复杂的疾病，其中特发性肺纤维化（IPF）和吸烟的关系最为紧密。《间质性肺疾病年度进展 2025》提到，吸烟是 IPF 的独立危险因素，吸烟的人患 IPF 的风险是不吸烟的人的 1.6 - 2.3 倍。另外，吸烟还和脱屑性间质性肺炎（DIP）、呼吸性细支气管炎伴间质性肺疾病（RB - ILD）等疾病密切相关。 二、肺癌筛查新纪元：LDCT 与戒烟的 “双轮驱动” 2.1 《中国肺癌低剂量 CT 筛查指南（2025 年版）》核心更新     2025 年，中国肺癌筛查指南有了重大更新，核心理念可以总结为 “精准定位、风险分层、综合干预”： 高危人群定义更新： 年龄要≥50 岁； 吸烟史≥20 包年（包括已经戒烟，但戒烟时间不到 15 年的人）； 或者有职业暴露史（比如接触石棉、氡、铍、铬、镉、镍、硅、煤烟等）； 或者一级亲属中有患肺癌的。 筛查策略优化： 推荐每年进行 LDCT 筛查； 强调利用解剖变异和 AI 辅助诊断； 引入风险预测模型，实现个性化的筛查间隔。     这次更新和 NCCN 2025、USPSTF 的建议一致，都强调 LDCT 是目前唯一被证实能够降低肺癌死亡率的筛查方法。 2.2 “筛查 + 戒烟”：黄金组合的临床价值     《肺癌筛查及肺结节健康管理专家共识（2025 版）》最有前瞻性的一点就是：把戒烟咨询和宣传融入到肺癌筛查的整个过程中。这个理念的改变意义深远。     研究发现，参加 LDCT 筛查的吸烟者，他们的戒烟意愿比普通人群要高很多。利用筛查这个机会进行简短的戒烟干预，能让戒烟成功率提高 2 - 3 倍。这很好理解，当患者看到自己肺部有结节或者磨玻璃影的时候，“吸烟有害健康” 就不再是抽象的概念，而是实实在在的恐惧，改变行为的动力自然就大大增加了。     在临床实践中，我通常用 “三步法” 来把筛查和戒烟干预结合起来： 告知：清楚地向患者解释 CT 检查发现的异常和吸烟之间的关系； 建议：强烈建议患者戒烟，告诉他们戒烟是降低肺癌风险最根本、最有效的办法； 支持：给患者提供戒烟药物处方，并且做好随访支持。 三、慢阻肺管理新策略：从 “治疗” 到 “管理” 的范式转变 3.1 GOLD 2025 核心更新要点     GOLD 2025 报告在之前 ABCD 分组的基础上，又进一步强调了以下内容： 心血管风险评估：慢阻肺患者发生心血管事件的风险明显增加，GOLD 2025 首次建议对所有慢阻肺患者进行心血管风险评估，包括做心电图、超声心动图以及检测生物标志物。 急性加重管理：急性加重是慢阻肺病程的关键转折点。指南推荐： 首选短效支气管扩张剂（SABA/SAMA）； 全身使用糖皮质激素（泼尼松 40mg/d，连用 5 天）可以缩短恢复时间； 当出现痰量增加、脓痰等典型细菌感染症状时，使用抗生素。 稳定期治疗优化： 双支气管扩张剂（LABA/LAMA）是症状管理的基础； 对于急性加重高风险的患者，推荐添加 ICS（吸入糖皮质激素）； 血嗜酸粒细胞计数≥300/μL 是对 ICS 反应良好的预测指标。 3.2 中西医结合的新视角     《慢性阻塞性肺疾病中西医结合诊疗指南（2025 版）》为慢阻肺管理提供了具有中国特色的方案： 稳定期：通过益肺健脾、补肾固本，配合西医规范治疗； 急性加重期：采用清热化痰、宣肺平喘的方法，还能缩短抗生素使用时间； 康复期：打太极拳、练八段锦等传统功法，可以改善运动耐量。     在临床工作中，我发现中西医结合治疗对于改善患者生活质量、减少急性加重次数，确实有独特的优势，尤其适合老年患者以及有多种合并症的患者群体。 3.3 运动处方：被忽视的 “药物”     《慢性阻塞性肺疾病人群运动处方临床路径》的发布，标志着运动干预从简单的 “建议” 变成了正式的 “处方”。指南推荐： 有氧训练：像步行、踏车，每周进行 3 - 5 次，每次 20 - 30 分钟； 抗阻训练：进行上下肢肌力训练，每周 2 - 3 次； 呼吸肌训练：比如缩唇呼吸、腹式呼吸，每天 2 次。     我经常跟住院患者说：“肺康复就像是给肺做‘理疗’，效果不比任何药物差。” 大量的科学证据都证明，肺康复可以改善患者呼吸困难的症状，提高运动耐量，减少再次住院的几率，从成本效益比来看，比任何单一药物治疗都要好。 四、间质性肺疾病诊疗进展：精准医学的曙光 4.1 抗纤维化药物：从 “延缓” 到 “希望”     特发性肺纤维化（IPF）曾经被叫做 “不是癌症的癌症”，预后非常差。不过近年来，抗纤维化药物的出现改变了这种情况。 尼达尼布与吡非尼酮：两项重要的临床试验（INPULSIS 和 ASCEND）证明，尼达尼布和吡非尼酮可以显著延缓 IPF 患者 FVC（用力肺活量）下降的速度，大概能延缓 50%。2025 年的最新研究还发现，早期开始使用抗纤维化治疗的患者，他们的无进展生存期（PFS）明显延长了。 新药研发动态：BI 1015550 是一种新型磷酸二酯酶 4B 抑制剂，II 期临床试验显示它可以改善 IPF 患者的肺功能，III 期临床试验正在进行中。另外，PD - 1/PD - L1 轴也正在成为纤维化肺疾病治疗的潜在新靶点。 4.2 诊断技术的进步     《间质性肺疾病年度进展 2025》强调了多学科讨论（MDD）在 ILD 诊断中的核心地位。高分辨率 CT（HRCT）依然是诊断的关键依据，AI 辅助诊断系统的应用也在不断提高诊断的一致性和准确性。     对于病因不明确的 ILD，经支气管冷冻肺活检（TBLC）和外科肺活检（SLB）可以提供组织病理学方面的依据。不过，选择活检的时机和方式，需要综合考虑风险和获益，特别是对于年纪大、心肺功能差的患者。 五、免疫治疗与靶向治疗：肺癌治疗的革命性突破 5.1 PD - 1/PD - L1 抑制剂：从 “晚期” 到 “早期”     免疫检查点抑制剂彻底改变了晚期非小细胞肺癌（NSCLC）的治疗局面。2025 年多项临床试验有了新的数据更新： 晚期 NSCLC 一线治疗：KEYNOTE - 024 的长期随访数据表明，PD - L1 高表达（≥50%）的患者，接受帕博利珠单抗单药治疗，中位总生存期（OS）超过 30 个月，比化疗组要好很多。IMPOWER - 110 研究显示，阿替利珠单抗单药治疗 PD - L1 高表达患者，中位 OS 达到 20.2 个月。 围手术期治疗：CheckMate - 816 研究证实，纳武利尤单抗联合化疗用于可切除 NSCLC 的新辅助治疗，病理完全缓解率（pCR）达到 24%，比单纯化疗组显著提高。这一结果开创了免疫治疗应用于早期肺癌的先河。 5.2 安全性管理：不可忽视的另一面     免疫相关不良事件是 PD - 1/PD - L1 抑制剂特有的毒性表现。2025 年中国《免疫检查点抑制剂临床应用指南》特别强调： 肺炎：发生率大概在 3 - 5%，严重的肺炎可能会危及生命； 内分泌毒性：像甲状腺功能异常、垂体炎等； 皮肤毒性：皮疹、瘙痒、白癜风样改变等。     临床医生必须时刻保持警惕，建立起早识别、早干预的全程管理体系。 六、戒烟干预：临床医生最被低估的 “处方” 6.1 戒烟的医学证据 戒烟的好处超乎很多人的想象： 戒烟 1 年后，冠心病风险降低 50%； 戒烟 5 年后，口腔癌、喉癌、食管癌风险降低 50%； 戒烟 10 年后，肺癌风险降低约 50%； 戒烟 15 年后，心血管疾病风险就和不吸烟的人差不多了。 GOLD 2025 明确指出：“戒烟是唯一被证实可以延缓肺功能下降速度、改善慢阻肺预后的干预措施。” 6.2 临床戒烟干预策略     世界卫生组织推荐的 “5A” 法是标准的戒烟流程： Ask（询问）：每次患者就诊都要询问吸烟情况； Advise（建议）：强烈建议患者戒烟； Assess（评估）：评估患者的戒烟意愿； Assist（帮助）：为患者提供戒烟支持和药物； Arrange（安排）：安排随访。 药物治疗： 尼古丁替代疗法（NRT），比如口香糖、贴片、吸入剂； 伐尼克兰，这是一线首选药物，戒烟成功率大概在 30 - 40%； 安非他酮，适合伴有抑郁症状的患者。     在临床实践中，我常常告诉患者：“戒烟不是靠意志力就能做到的，吸烟成瘾是一种疾病，需要医学帮助。” 把戒烟这件事从单纯的道德层面剥离，让患者明白这是一种需要治疗的疾病，而不是个人品质问题，这是和患者建立治疗联盟的第一步。 七、未来展望：从 “疾病治疗” 到 “健康促进”     站在 2025 年这个时间点，回顾烟草病学领域的发展历程，我们可以看到，从 “治疗已经发生的疾病” 到 “预防疾病发生” 的宏大画卷正在徐徐展开。 7.1 精准医学与个体化治疗     基因检测、液体活检、人工智能辅助诊断等新技术的应用，正让呼吸系统疾病的诊断和治疗变得更加精准。对于肺癌患者，基于 ctDNA - MRD（循环肿瘤 DNA 微小残留病灶）的适应性治疗策略正在改变传统治疗模式。对于慢阻肺患者，血嗜酸粒细胞计数、炎症因子谱等生物标志物正在为治疗决策提供指导。 7.2 多学科协作（MDT）模式的深化     肺癌、慢阻肺、间质性肺疾病都不是单一科室能够独立处理的。呼吸科、胸外科、肿瘤科、影像科、康复科、营养科等多学科协作，已经成为规范化诊疗的标准配置。 7.3 从 “以疾病为中心” 到 “以患者为中心”     无论是《肺癌筛查及肺结节健康管理专家共识（2025 版）》对患者知情同意的重视，还是慢阻肺管理中对患者报告结局（PROs）的关注，都体现了医学人文关怀的回归。治疗的目标不再仅仅是延长患者的生命，还包括提高患者的生活质量，维护患者的尊严。 结语：一根香烟的重量     在三十多年的临床生涯中，我见过太多因为吸烟而走向生命尽头的患者。他们中有权势显赫的企业家，有教书育人的教师，还有享受天伦之乐的慈祥祖父…… 躺在病床上，他们最常说的一句话就是：“早知道，当初就不该吸烟。”     作为医生，我们面对的不仅仅是疾病本身，更是背后一个个鲜活的生命和完整的家庭。每一次劝导患者戒烟，每一次建议患者进行早期筛查，每一次提供规范化治疗，都是在和死神的博弈中，为患者争取更多生存的机会。     烟草病学的研究进展，让我们从科学的角度更深入地了解了烟草烟雾的危害机制，也为我们提供了更多的干预方法。然而，医学的最终价值，不在于发表了多少论文，而在于能够改变多少患者的命运。     希望每一位读到这篇文章的读者，无论是医生还是患者，都能成为控烟行动的践行者和传播者。因为，每一根香烟的背后，都承载着生与死的重量。 互动话题：各位读者，对于吸烟与这些疾病的关联，您有什么看法或者身边有相关的故事吗？医生朋友们，在临床工作中，您在劝导患者戒烟、进行疾病筛查和治疗方面，有没有什么特别的经验或者遇到过什么困难呢？欢迎在评论区分享交流。 新 春 快 乐 2026 New Year 马 年 吉 祥 2026 New Year 免责声明 本文为基于当前医学研究与临床指 南的科普性文章，旨在提供信息参 考，不构成任何具体的医疗建议。 所有诊断和治疗决策，请务必咨询 并遵从您的主治医生。 2026 转发给需要的家人朋友，一起科学控病！ @关注我， 带你用医生的视角看懂呼吸世界！

Conference call today at 9:00 am ET Q4 2025 revenues of $112M, +46% vs. Q4 2024 Furoscix ® Q4 2025 net sales of $23M, +91% vs. Q4 2024 Afrezza ® Q4 2025 net sales of $23M, +25% vs. Q4 2024 2025 full year revenues of $349M, +22% vs. 2024 Successfully completed the acquisition of scPharmaceuticals Inc. (scPharma) Program updates: Afrezza pediatric indication PDUFA date May 29, 2026 Furoscix ReadyFlow ™  Autoinjector PDUFA date July 26, 2026 DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Feb. 26, 2026 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions for cardiometabolic and orphan lung diseases, today reported financial results for the fourth quarter and year ended December 31, 2025, and provided a business update. “MannKind closed 2025 with strong momentum across our commercial portfolio and meaningful progress in our pipeline. The addition of Furoscix strengthens our cardiometabolic franchise, while Afrezza and UT-related revenues continue to deliver sustained growth,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “As we enter a catalyst‑rich 2026, with two upcoming FDA decisions, and Nintedanib DPI INFLO-1 Phase 1b topline data, we believe we are well‑positioned to drive long‑term value for patients, providers and shareholders. Our team’s hard work over the last several years is culminating in significant milestones with the potential to drive near-term growth.” Business Update and Upcoming Milestones Commercial Products Furoscix Furoscix (furosemide injection) generated $23 million in net sales following the October 7, 2025, acquisition, compared to $12 million in Q4 2024 as reported by scPharma, a 91% increase FDA accepted for review a supplemental New Drug Application (sNDA) for Furoscix ReadyFlow Autoinjector; with a PDUFA target action date of July 26, 2026; if approved, it would deliver an IV-equivalent diuretic dose (subcutaneous furosemide injection 80 mg/ml) in under 10 seconds Afrezza Afrezza (insulin human) Inhalation Powder Q4 2025 net sales were $23 million, compared to $18 million in Q4 2024, a 25% increase FDA accepted for review the supplemental Biologics License Application (sBLA) for Afrezza in pediatrics, with a PDUFA target action date of May 29, 2026; if approved, it would be the first needle-free insulin option for pediatric patients In Q1 2026, the FDA approved updated Afrezza label providing starting dose guidance when switching from multiple daily injections (MDI) or insulin pump mealtime therapy ADA Standards of Care in Diabetes – 2026 now recommends clinicians evaluate inhaled insulin as a prandial option at every patient visit, moving it into routine care conversations and creating a catalyst for broader adoption Afrezza launched in India by Cipla Development Nintedanib DPI (MNKD-201) Enrollment underway in Phase 1b (INFLO-1) study, top line data expected in 2H 2026 Initiated Phase 2 clinical trial (INFLO-2) in idiopathic pulmonary fibrosis (IPF) and plan to enroll first patient in Q2 2026 Other Programs Formulating investigational molecule (MNKD-1501) under the expanded collaboration with United Therapeutics (UT) using MannKind’s proprietary Technosphere® platform Initiated pre-clinical development of Bumetanide DPI (MNKD-701) Corporate Update Completed acquisition of scPharma on October 7, 2025 Cash, cash equivalents and investments as of December 31, 2025, totaled $176 million Fourth Quarter and Full Year 2025 Financial Results Revenues Three Months Ended December 31, 2025 2024 $ Change % Change Revenues (Dollars in thousands) Royalties $ 33,564 $ 27,009 $ 6,555 24 % Collaborations and services 27,986 26,710 1,276 5 % Afrezza 22,878 18,279 4,599 25 % Furoscix (1) 23,178 — 23,178 N/A V-Go 4,349 4,778 (429 ) (9 %) Total revenues $ 111,955 $ 76,776 $ 35,179 46 % (1) Amount represents revenue earned beginning on the scPharma acquisition date of October 7, 2025. Year Ended December 31, 2025 2024 $ Change % Change Revenues (Dollars in thousands) Royalties $ 128,116 $ 102,335 $ 25,781 25 % Collaborations and services 106,713 100,840 5,873 6 % Afrezza 74,587 64,041 10,546 16 % Furoscix (1) 23,178 — 23,178 N/A V-Go 16,372 18,288 (1,916 ) (10 %) Total revenues $ 348,966 $ 285,504 $ 63,462 22 % (1) Amount represents revenue earned beginning on the scPharma acquisition date of October 7, 2025. Total revenues for the fourth quarter and full year 2025 rose due to increases in revenue from royalties, collaborations and services, and commercial product sales. The increase in royalties was due to UT’s increase in net revenue from sales of Tyvaso DPI ® . Collaborations and services revenue grew due to increased units sold to UT. Revenue from commercial sales increased primarily due to net sales from Furoscix beginning on the scPharma acquisition date of October 7, 2025 as well as an increase in net sales of Afrezza over the prior periods. Operating Expenses and Other Financial Highlights Cost of goods sold – commercial, excluding amortization of acquired intangible assets, was $13.9 million for the fourth quarter of 2025, compared to $4.8 million for the same period in 2024, an increase of 190%. For the full year 2025, Cost of goods sold – commercial, excluding amortization of acquired intangible assets, was $26.8 million, compared to $17.4 million for the same period in 2024, an increase of 54%. These increases are primarily attributable to the inclusion of Furoscix following the acquisition on October 7, 2025, as well as increased sales of Afrezza. Cost of revenue – collaborations and services was $15.7 million for the fourth quarter of 2025, compared to $14.8 million for the same period in 2024, an increase of 6%. For the full year 2025, cost of revenue – collaborations and services was $61.2 million, compared to $59.2 million for the same period in 2024, an increase of 3%. These increases are primarily the result of a higher number of units of Tyvaso DPI sold through to UT compared to the prior periods. Research and development ("R&D") expenses were $27.6 million for the fourth quarter of 2025 compared to $11.1 million for the same period in 2024, an increase of 148%. For the full year 2025, R&D expenses were $66.3 million compared to $45.9 million in the same period in 2024, an increase of 45%. These increases were primarily attributable to the ICoN-1 clinical study for MNKD-101, which was discontinued in the fourth quarter of 2025, clinical production scale-up for MNKD-201, personnel costs primarily due to a full-year of costs associated with the third quarter of 2024 Pulmatrix transaction, which bolstered our research capabilities and capacity, and ReadyFlow Autoinjector-related expenses. These increases were partially offset by the completion of INHALE-3, the Phase 1 clinical study for MNKD-201, and toxicology studies in 2024, as well as lower costs for INHALE-1 as the study was closed out in the second quarter of 2025. Selling, general and administrative ("SG&A") expenses were $58.4 million for the fourth quarter of 2025 compared to $24.0 million for the same period in 2024, an increase of 144%. For the full year 2025, SG&A expenses were $144.1 million compared to $94.3 million in the same period in 2024, an increase of 53%. These increases primarily reflect the inclusion of SG&A costs associated with the promotion and support of Furoscix as well as transaction-related costs incurred as part of the acquisition of scPharma. The remainder of the increase was largely attributable to higher headcount and personnel-related expenses in our commercial group as well as increased promotional costs in preparation to support the potential pediatric launch of Afrezza in 2026. Conference Call MannKind will host a conference call and presentation webcast to discuss these results today at 9:00 a.m. Eastern Time. The webcast will be accessible via a link on MannKind’s website. A replay will also be available in the same location within 24 hours after the call and accessible for approximately 90 days. About MannKind MannKind Corporation (Nasdaq: MNKD) is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions. Focused on cardiometabolic and orphan lung diseases, we develop and commercialize treatments that address serious unmet medical needs, including diabetes, pulmonary hypertension, and fluid overload in heart failure and chronic kidney disease. With deep expertise in drug-device combinations, MannKind aims to deliver therapies designed to fit seamlessly into daily life. Learn more at mannkindcorp.com. Forward-Looking Statements Statements in this press release that are not statements of historical fact are forward-looking statements that involve risks and uncertainties. These statements include, without limitation, statements regarding MannKind's expectations about 2026 being a catalyst-rich year; the FDA’s potential approval of the sBLA for Afrezza for the pediatric population and of the sNDA for Furoscix ReadyFlow Autoinjector, and the expected timing thereof; expectations regarding MannKind’s ongoing and planned clinical trials and nonclinical studies, including the timing for enrollment for the Phase 2 clinical trial of MNKD-201 in IPF and the expected timing for data readouts from the Phase 1b clinical trial of MNKD-201, and preclinical development of MNKD-701; the potential benefits of Furoscix ReadyFlow Autoinjector and Afrezza Inhalation Powder in pediatrics, if approved; the ADA’s Standards of Care in Diabetes 2026 recommendations for inhaled insulin creating a catalyst for broader adoption; and MannKind being positioned to drive long-term value. Words such as “believes,” “anticipates,” “plans,” “expects,” “intend,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind’s current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with developing product candidates; risks and uncertainties related to unforeseen delays that may impact the timing of clinical trials and reporting data; risks associated with safety and other complications of our products and product candidates; risks associated with the regulatory review process; risks associated with competition; manufacturing risks; market adoption risks; and other risks detailed in MannKind’s filings with the Securities and Exchange Commission (“SEC”), including under the “Risk Factors” heading of its Annual Report on Form 10-K for the year ended December 31, 2025, being filed with the SEC later today. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release. Tyvaso DPI is a trademark of United Therapeutics Corporation. Furoscix is a registered trademark and Furoscix ReadyFlow is a trademark of scPharmaceuticals Inc., a subsidiary of MannKind Corporation. AFREZZA, MANNKIND, TECHNOSPHERE and V-GO are registered trademarks of MannKind Corporation. MannKind Contacts: Investor Relations Kate Miranda (617) 921-5461 Email: ir@mnkd.com Media Relations Christie Iacangelo (818) 292-3500 Email: media@mnkd.com MANNKIND CORPORATION AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS Three Months Ended December 31, Year Ended December 31, 2025 2024 2025 2024 (In thousands except per share data) Revenues: Commercial product sales $ 50,405 $ 23,057 $ 114,137 $ 82,329 Collaborations and services 27,986 26,710 106,713 100,840 Royalties 33,564 27,009 128,116 102,335 Total revenues 111,955 76,776 348,966 285,504 Expenses: Cost of goods sold – commercial, excluding amortization of acquired intangible assets 13,927 4,808 26,800 17,429 Cost of revenue – collaborations and services 15,746 14,796 61,160 59,173 Research and development 27,588 11,138 66,348 45,893 Selling, general and administrative 58,411 23,972 144,135 94,329 Amortization of acquired intangible assets 3,973 — 3,973 — (Gain) loss on foreign currency transaction (3 ) (4,433 ) 7,749 (3,907 ) Total expenses 119,642 50,281 310,165 212,917 (Loss) income from operations (7,687 ) 26,495 38,801 72,587 Other income (expense): Interest income, net 1,637 2,825 8,053 12,615 Interest expense on liability for sale of future royalties (3,885 ) (3,452 ) (14,449 ) (16,172 ) Interest expense on financing liability (2,451 ) (2,467 ) (9,750 ) (9,828 ) Impairment of available-for-sale investment — — (6,409 ) (1,550 ) Interest expense (7,536 ) (1,562 ) (13,830 ) (11,981 ) Other (expense) income (1,009 ) — (1,009 ) 32 Gain on bargain purchase — — — 5,259 Loss on settlement of debt — (13,394 ) — (20,444 ) Total other expense (13,244 ) (18,050 ) (37,394 ) (42,069 ) Income before income tax (benefit) expense (20,931 ) 8,445 1,407 30,518 Income tax (benefit) expense (4,983 ) 1,023 (4,456 ) 2,930 Net (loss) income $ (15,948 ) $ 7,422 $ 5,863 $ 27,588 Net (loss) income per share – basic $ (0.05 ) $ 0.03 $ 0.02 $ 0.10 Weighted average shares used to compute net (loss) income per share – basic 307,260 279,191 305,639 274,415 Net (loss) income per share – diluted $ (0.05 ) $ 0.03 $ 0.02 $ 0.10 Weighted average shares used to compute net (loss) income per share – diluted (1) 307,260 290,631 314,112 283,844 (1) Diluted weighted average shares ("DWAS") differs from basic weighted average shares due to the weighted average number of shares that would be outstanding upon exercise or vesting of outstanding share-based payments to employees and conversion of convertible notes. For the year ended December 31, 2025, DWAS included 8.5 million shares issuable upon exercise or vesting of outstanding share-based payments. MANNKIND CORPORATION AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS December 31, 2025 December 31, 2024 (In thousands except share and per share data) ASSETS Current assets: Cash and cash equivalents $ 74,882 $ 46,339 Short-term investments 96,464 150,917 Accounts receivable, net 38,367 11,804 Inventory 35,313 27,886 Prepaid expenses and other current assets 46,553 31,360 Total current assets 291,579 268,306 Restricted cash 745 737 Long-term investments 5,012 5,482 Property and equipment, net 82,423 85,365 Goodwill 67,595 1,931 Developed technology - on-body infusor 190,027 — IPR&D - ReadyFlow Formulation 129,600 — Other intangible assets 5,072 5,265 Other assets 20,129 26,757 Total assets $ 792,182 $ 393,843 LIABILITIES AND STOCKHOLDERS' DEFICIT Current liabilities: Accounts payable $ 9,034 $ 6,792 Accrued expenses and other current liabilities 64,628 40,293 Senior convertible notes – current 36,280 — Liability for sale of future royalties – current 14,298 12,283 Contingent consideration - current 21,132 — Financing liability – current 10,328 10,062 Deferred revenue – current 15,331 12,407 Total current liabilities 171,031 81,837 Liability for sale of future royalties – long term 136,985 137,362 Financing liability – long term 93,092 93,877 Deferred revenue – long term 39,977 51,160 Recognized loss on purchase commitments – long term 65,952 58,204 Operating lease liability 10,689 11,645 Contingent consideration -long term 5,114 — Milestone liabilities 2,003 2,523 Term loan 318,361 — Senior convertible notes — 36,051 Total liabilities 843,204 472,659 Commitments and contingencies Stockholders' deficit: Undesignated preferred stock, $0.01 par value – 10,000,000 shares authorized; — — no shares issued or outstanding as of December 31, 2025 or December 31, 2024 Common stock, $0.01 par value – 800,000,000 shares authorized; 3,078 3,029 307,832,587 and 302,959,782 shares issued and outstanding as of December 31, 2025 and December 31, 2024, respectively Additional paid-in capital 3,141,741 3,118,865 Accumulated other comprehensive income 115 1,109 Accumulated deficit (3,195,956 ) (3,201,819 ) Total stockholders' deficit (51,022 ) (78,816 ) Total liabilities and stockholders' deficit $ 792,182 $ 393,843 Non-GAAP Measures To supplement our consolidated financial statements presented under GAAP, we are presenting non-GAAP net income (loss) and non- GAAP net income (loss) per share - basic, which are non-GAAP financial measures. We are providing these non-GAAP financial measures to disclose additional information to facilitate the comparison of past and present operations, and they are among the indicators management uses as a basis for evaluating our financial performance. We believe that these non-GAAP financial measures, when considered together with our GAAP financial results, provide management and investors with an additional understanding of our business operating results, including underlying trends. These non-GAAP financial measures are not meant to be considered in isolation or as a substitute for comparable GAAP measures; should be read in conjunction with our consolidated financial statements prepared in accordance with GAAP; have no standardized meaning prescribed by 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 we may exclude for purposes of our non-GAAP financial measures; and we may in the future cease to exclude items that we have historically excluded for purposes of our non-GAAP financial measures. Likewise, we may determine to modify the nature of its adjustments to arrive at our non-GAAP financial measures. Because of the non-standardized definitions of non- GAAP financial measures, the non-GAAP financial measures as used by us in this report have limits in their usefulness to investors and may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies. The following table reconciles our financial measures for net income (loss) and net income (loss) per share ("EPS") for basic weighted average shares as reported in our consolidated statement of operations to a non-GAAP presentation: Three Months Ended December 31, Year Ended December 31, 2025 2024 2025 2024 Net Income Basic EPS Net Income Basic EPS Net Income Basic EPS Net Income (Loss) Basic EPS (In thousands except per share data) GAAP reported net (loss) income $ (15,948 ) $ (0.05 ) $ 7,422 $ 0.03 $ 5,863 $ 0.02 $ 27,588 $ 0.10 Non-GAAP adjustments: Stock compensation 6,972 0.02 5,818 0.02 24,195 0.08 21,358 0.08 Interest expense on liability for sale of future royalties 3,885 0.01 3,452 0.01 14,449 0.05 16,172 0.06 Sold portion of royalty revenue (1) (3,357 ) (0.01 ) (2,701 ) (0.01 ) (12,812 ) (0.04 ) (10,234 ) (0.04 ) Acquisition-related expenses (2) 6,017 0.03 — — 9,690 0.03 — — Amortization of intangible assets acquired 3,973 0.01 — — 3,973 0.01 — — (Gain) loss on foreign currency transaction (3 ) — (4,433 ) (0.02 ) 7,749 0.03 (3,907 ) (0.01 ) Impairment loss on available-for-sale investment — — — — 6,409 0.01 1,550 0.01 Gain on bargain purchase — — — — — — (5,259 ) (0.02 ) Loss on settlement of debt — — 13,394 0.05 — — 20,444 0.07 Non-GAAP adjusted net income (loss) $ 1,539 $ 0.01 $ 22,952 $ 0.08 $ 59,516 $ 0.19 $ 67,712 $ 0.25 Weighted average shares used to compute net income (loss) per share – basic 307,260 279,191 305,639 274,415 (1) Represents the non-cash portion of the 1% royalty on net sales of Tyvaso DPI earned during the years ended December 31, 2025 and 2024 which is remitted to the royalty purchaser and recognized as royalties from collaborations in our consolidated statements of operations. Our revenues from royalties from collaborations during the year ended December 31, 2025 and 2024 totaled $128.1 million and $102.3 million, respectively, of which $12.8 million and $10.2 million, respectively, is remitted to the royalty purchaser. (2) Represents transaction fees incurred during the year ended December 31, 2025 associated with the acquisition of scPharma.